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Reinventing
existing medications
2024
Annual report
Hyloris
: Annual report 2024
p1
Ce rapport annuel 2023 comprend le rapport de gestion conformément à l’article 12 de l’arrêté royal du
14 novembre 2007 relatif aux obligations des émetteurs d’instruments financiers admis sur un marché
réglementé. Toutes les informations qui doivent être incluses dans ce rapport de gestion en vertu des
articles 3:6 et 3:32 du Code belge des sociétés et des associations sont rapportées dans toutes les sections
différentes de ce rapport annuel.
Contents
Profile
p.2
Key Figures
p.4
Message to the Shareholders
p.6
Business Overview
p.8
Environmental, Social, and Governance
p.32
The Hyloris Share
p46
Corporate Governance
p48
Consolidated Financial Statements
p.98
Auditor’s Report
p.182
Glossary and Other Info
p.188
This Annual Report 2024 includes the management report in
accordance with article 12 of the Royal Decree of 14 November 2007
relating to the obligations of issuers of financial instruments admitted
on a regulated market. All information required to be included in such
management report pursuant to articles 3:6 and 3:32 of the Belgian
Code of Companies and Associations is reported throughout all
difference sections of this Annual Report.
Hyloris
: Annual report 2024
p2
Hyloris:
Unlocking
Potential for Underserved
Patients
Hyloris is a specialty biopharmaceutical company with a clear
mission: to improve the lives of patients with unmet medical needs
by developing innovative treatments that deliver real therapeutic
value.
We focus on unlocking the untapped potential of existing drugs by making
meaningful improvements through strategic reformulation and repurposing. This
approach allows us to address critical gaps in care and build a robust pipeline
of proprietary, complex products that offer clear advantages over current
therapies.
We currently have three commercialized products, developed in collaboration
with trusted partners:
Maxigesic
®
IV
– A novel, dual-mode, non-opioid analgesic for post-operative
pain management.
Podofilox Gel
– The first U.S. generic version of Condylox
®
gel, used topically
to treat external genital and perianal warts caused by specific strains of the
Human Papilloma Virus (HPV).
Sotalol IV
– An intravenous formulation for the treatment of atrial fibrillation.
Hyloris has a very extensive pipeline of over 20 new product candidates. To
streamline development and reduce risk, Hyloris employs a focused strategy and
primarily utilizes the U.S. FDA’s 505(b)(2) pathway—along with similar expedited
approval routes globally –designed for drugs with established safety profiles.
This strategy allows to accelerate clinical development, lower costs, and bring
therapies to market faster – delivering timely solutions to the patients who need
them most.
Profile
44.5
FTEs
19
women
30
men
Hyloris is proud to
be a diverse and
inclusive team of
49 professionals
(44.5 FTEs, 19
women and 30 men)
representing 13
nationalities.
Hyloris
: Annual report 2024
p3
Specialty biopharma
Adding value and innovation to existing drug assets for core unmet medical needs
Broad Pipeline
With 3 marketed products, a pipeline of 20 innovative product candidates and 2 high
barrier generics (as of March 30, 2025)
In Europe (Belgium) and US
Founded in 2012 in the heart of Europe
Strong Network and Knowhow
KOL & partners network, in-house research facility with a new and improved R&D lab
Listed
Listed on the Euronext Brussels Stock Exchange (HYL:BB)
Efficacy, safety, new use,
compliance, onset of action,
drug titration, convenience
Reinventing existing
medicines
Reformulations
Combinations
New
indications
Unique features
for the benefit of
Patients
Physicians
Payers
p4
Hyloris
: Annual report 2024
Cash position of
23.6
million
23
Portfolio
Products*
Key figures
2024
Strong Equity
at
32.1
million
Total revenue
8.5
million
(+ 305%)
* (as of March 30, 2025, does not include 2 high barrier generics in development)
p5
Hyloris
: Annual report 2024
3
Commercial
Products:
• Maxigesic
®
IV (U.S. & ROW)
for the treatment of post-
operative pain
• Podofilox Gel (U.S.) for
the treatment of genital &
perianal warts
• Sotalol IV (U.S.) for
the treatment of atrial
fibrillation
3
FDA Approved
Products
20
Products in
Development
1
FINANCIAL HIGHLIGHTS 2024
(Year ended 31 December)
(in € thousands)
2024
2023
Variance
Total revenue and other income
10,043
4,214
138%
Revenues
8,458
2,087
305%
Other operating income
1,584
2,127
(26%)
Cost of sales
(227)
(93)
144%
Operating expenses
(16,946)
(20,114)
(16%)
Research and development expenses
(10,265)
(14,421)
(29%)
General and administration expenses
(5,627)
(5,546)
1%
Share of result of equity-accounted investees
(81)
(147)
(45%)
Impairment on equity accounted investees
(972)
-
-
Operating result
(7,130)
(15,993)
(55%)
Net financial result
788
613
29%
Net result
(6,342)
(15,380)
(59%)
Net operating cashflow
(6,903)
(12,808)
(48%)
Cash and cash equivalents
23,594
30,406
(22%)
Hyloris
: Annual report 2024
p6
Message to the
Shareholders
Dear Shareholders,
First of all, thank you for
your continued trust in
Hyloris.
Hyloris is steadily evolving and
expanding, building on our
expertise in the repurposing
and reformulation of existing
molecules to bring innovative,
high-value treatments to the
market. Over the past year, we
have made significant progress
- advancing our pipeline
of promising new product
candidates, securing several key
licensing agreements, and rolling
out our commercial assets.
These achievements underscore
our long-term vision and
strengthen our commitment to
sustainable continued growth.
Our strategy remains focused
on rapid and cost-effective
drug development, primarily
utilizing the U.S. FDA’s 505(b)
(2) regulatory pathway and
similar frameworks worldwide.
This approach allows us to
leverage existing data, hence
reducing development timelines
and mitigating risks, ultimately
enabling us to deliver impactful
therapies that address critical
unmet medical needs.
Accelerating Commercial
Growth
2024 was a transformative year
for Hyloris. The U.S. launch
of Maxigesic IV (marketed as
Combogesic IV by our partner
Hikma Pharmaceuticals) marked
a major milestone, unlocking
significant market potential. With
reimbursement in place since
October 1, we anticipate growing
commercial traction in the
coming years. Meanwhile, the
approval and launch of Podofilox
Gel, the first generic
alternative to Condylox
Gel, demonstrates
our capability
in navigating
regulatory
pathways and
bringing cost-
effective
solutions to the
market.
Beyond
approvals, we are expanding our
future commercial footprint with
the addition of new high-value
product candidates. In 2024 we
expanded our portfolio with a
product candidate for Vulvar
Lichen Sclerosis, addressing
a significant unmet need in
women’s health care. We also
announced the development
of a long-acting formulation of
a well-known ulcer treatment
for horses, providing a more
convenient and effective solution
for managing equine gastric
ulcers.
In 2025 we continued to
grow our pipeline by adding
Intravenous Pantoprazole RTU
(Ready-to-Use), which offers
a crucial solution for medical
professionals by eliminating
the need for reconstitution,
enhancing both efficiency and
safety in hospital settings.
Following that we added
Ondansetron Extended-Release
Tablets, aimed at preventing
chemotherapy-induced nausea
and vomiting, which further
strengthens our commitment
to addressing essential
unmet medical needs. Most
recently, we announced a
new injectable iron therapy,
developed in collaboration with
AFT Pharmaceuticals, which is
expected to enter into Phase 3
shortly. This project follows our
disciplined approach in terms of
investment timeline and financial
commitment. In parallel, we
significantly broadened the
international reach of Valaciclovir
Oral Liquid, securing expanded
Hyloris
: Annual report 2024
p7
access across numerous countries
outside the U.S., driven by growing
global demand and strong
commercial interest beyond our
initial market.
Advancing Our Pipeline
Looking ahead, we are preparing
for a wave of new regulatory
filings and clinical advancements.
The U.S. FDA’s acceptance of our
Valacyclovir Oral Suspension
NDA sets the stage for a potential
approval that will offer a valued
alternative for patients with
difficulty swallowing tablets.
The positive clinical results for
Dofetilide IV strengthen our
cardiovascular portfolio, an area
where we see significant growth
opportunities. In addition, we
received positive feedback from
the Independent Data Monitoring
Committee (IDMC) on the ongoing
Phase 2 trial for Alenura.
With up to nine product
submissions planned before
the end of 2026 and a pipeline
targeting 30 products in
development or on the market by
the end of 2025, we are driving
one of the most ambitious growth
strategies in our sector. This
momentum, coupled with ongoing
evaluations of go-to-market
strategies and partnerships,
positions us for sustained success.
Strengthening Corporate
Governance
We recognize the importance
of strong corporate governance
in maintaining stakeholder
trust and ensuring long-term
sustainability. We are actively
implementing measures to
enhance transparency, reinforce
compliance, and uphold the
highest ethical standards across
all aspects of our business. Our
Board of Directors, recently
enhanced with the addition of
Mr. Vincent van Dessel, former
CEO of Euronext Brussels, and
Mrs. Revital Rattenbach, the
CEO of 4P Pharma, remains
committed to continuous
improvement, ensuring that our
governance framework supports
the company’s strategic growth
while safeguarding shareholder
interests.
Driving Sustainable Growth
Hyloris remains committed
to operational efficiency and
shareholder value. Our disciplined
approach ensures that new
products are developed at an
average cost of less than € 7
million (not adjusted inflation)
within seven years, highlighting
our reinforcing our financial
discipline. The substantial increase
in royalty and milestone payments
obtained in 2024 on the initial
first commercial products,
underscores the strength
of our business model,
and we continue to
explore new strategic
partnerships that
will fuel further
expansion.
As we look to
the future, we
see a company
poised for
significant
growth, empowered by a
world-class team, an expanding
commercial footprint, and a
pipeline rich with high-impact
therapies. With 2025 shaping
up to be our most dynamic year
yet, we remain confident in our
ability to create lasting value for
patients, physicians, partners, and
shareholders.
Thank you for your continued
trust and support.
Sincerely,
Stijn Van Rompay
Co-CEO
Thomas Jacobsen
Co-CEO
Hyloris
: Annual report 2024
p9
Business
overview
Geared for growth
Hyloris Pharmaceuticals experienced significant financial growth in
2024, with total revenue and other income surpassing €10 million,
marking a 138% increase year-over-year. This surge was primarily driven
by increased royalties and milestone payments (+305%). Notably, the
company reduced its net losses by 59%, achieving the lowest annual net
loss since its IPO, at €6.3 million.
Despite continued investments in research and development (R&D),
Hyloris successfully decreased its net operating cash outflows compared
to 2023 underscoring the company’s dedication to financial discipline
while prioritizing innovation.
Hyloris’ financial health remains robust, with a strong equity position of
€32.1 million and cash reserves totaling €23.6 million, and no financial
debt. This solid foundation positions the company to capitalize on future
growth opportunities.
Hyloris remains well-positioned for sustained expansion, driven by a
growing portfolio of innovative treatments and an expanding global
footprint. The launches of Maxigesic® IV and Podofilox gel mark just
the beginning, with additional product rollouts planned across key
international markets. Furthermore, strategic commercial partnerships
and a strong pipeline are set to accelerate revenue growth and reinforce
the company’s leadership in reformulated and repurposed medicines.
p.10
Hyloris:
Annual report 2024
Contents
Commercial Progress
..........................................................................................................................
11
Expanded Pipeline
...............................................................................................................................
12
Our Mission
............................................................................................................................................
13
Strategy & Strengths
...........................................................................................................................
14
Commercial Portfolio
..........................................................................................................................
18
Development Portfolio
.......................................................................................................................
21
Post-Closing Business Events
...........................................................................................................
30
p.11
Hyloris:
Annual report 2024
Commercial Progress
Hyloris made significant progress across its commercial
portfolio in 2024.
Maxigesic
®
IV
Growing
momentum
for
Maxigesic
®
IV
is
evidenced by the recent U.S. launch, a rise in
royalty contributions from existing commercial
partnerships, and new strategic out-licensing
agreements in key markets such as China and
Brazil
with
partners
Xizang
Weixinkang
Pharmaceutical Co., Ltd and Halex Istar.
Maxigesic
®
IV, co-developed with our partner AFT
Pharmaceuticals,
is
a
patented,
unique
combination of Paracetamol and Ibuprofen for
intravenous infusion for the treatment of mild to
moderate acute pain.
The non-opioid analgesic space and the market
for post-operative pain is growing rapidly and is
forecasted to reach $1.7 billion in 2028 in the
U.S., up from $745 million in 2019.
Maxigesic
®
IV is currently licensed to partners
covering over 100 countries across the globe. It
has received approval in over 50 countries and
has been launched in more than 30 of those
markets. In 2024:
Submissions
for
marketing
authorization
were made in several countries in Europe, the
Middle East, Africa, Latin America, and Asia.
Marketing authorizations were granted in 14
countries including Kenya, Thailand and
Pakistan.
Launches occurred in 11 countries, most
notably the U.S., the UK and South Africa.
Hikma Pharmaceuticals, a leading supplier of
complex, injectable hospital products in the
U.S. launched Maxigesic
®
IV in the U.S. under
the tradename Combogesic
®
IV in February
2024. Hikma announced in July 2024 that the
U.S. Centers for Medicare and Medicaid
Services (CMS) assigned a unique, permanent
Healthcare
Common
Procedure
Coding
System (HCPCS) J-code for Combogesic
®
IV
which became effective October 1, 2024.
Podofilox gel
In December 2023, our partner Padagis US LLC
(Padagis) received a marketing authorization for
Podofilox gel 0.5% (previously referenced as HY-
016)
from
the
U.S.
FDA.
Podofilox
is
an
antimycotic drug for the topical treatment of
external genital and perianal warts caused by the
Human
Papilloma
Virus
(HPV),
a
common
sexually transmitted disease. Podofilox was
launched shortly after its approval and is the first
generic approved for Condylox
®
Gel in the U.S.
Sotalol IV
Sotalol IV is a novel, patented, intravenous
formulation of Sotalol for the treatment of atrial
fibrillation,
and
life-threatening
ventricular
arrhythmias, developed for the U.S. Sotalol IV
reduces hospital stay length and potentially the
overall cost of care, while potentially improving
patient outcomes.
p.12
Hyloris:
Annual report 2024
Valacyclovir Oral Liquid
Hyloris continued to execute on its strategy of
partnering with strong commercial organizations
to maximize the reach and impact of its products.
During the year, the company signed a significant
out-licensing
agreement
with
Rosemont
Pharmaceuticals for Valacyclovir Oral Liquid.
These types of collaborations are a core part of
Hyloris’ business model, allowing the company to
focus on innovation and development while
leveraging
the
commercial
strength
of
its
partners to bring treatments to patients more
efficiently.
RTU Tranexamic Acid IV
An agreement was also signed with Avenacy for
the exclusive commercialization of Ready-to-Use
Tranexamic Acid Intravenous 10 mg/ml 100 ml in
the U.S. An ANDA has already been submitted to
the U.S. Food and Drug Administration (FDA) by
Hyloris with a decision anticipated in 2025.
Expanded Pipeline
2 new product candidates in 2024
In January 2024,
HY-091, a novel candidate for the management of Vulvar Lichen Sclerosus (VLS),
was
announced. Hyloris entered into a partnership with AFT Pharmaceuticals (AFT) to develop a novel topical
treatment for the treatment VLS - a chronic inflammatory condition affecting an estimated 3% of women,
causing severe pain, itching, and discomfort that significantly impacts their quality of life. HY-091 targets
to have an extended-duration release of a known molecular entity and to offer a convenient application
method, ensuring simplicity and improving compliance.
In August 2024, Hyloris announced the development of
HY-095, a long-acting injectable formulation of
a well-known Proton Pump Inhibitor (PPI) designed to treat Equine Gastric Ulcer Syndrome (EGUS
).
EGUS is a condition in horses characterized by the development of ulcers in the stomach lining caused by
stomach acid and digestive enzymes. EGUS is a widespread condition affecting millions of horses globally
and causes significant discomfort, weight loss, and reduced performance.
p.13
Hyloris:
Annual report 2024
Our Mission
Hyloris is a mission-driven company dedicated to
improving lives. We focus on underserved
medical needs and strive to deliver meaningful
innovation
to
the
healthcare
system
by
reformulating
and
repurposing
existing
pharmaceuticals. Our ultimate goal is to enhance
therapeutic
outcomes and
make
a
lasting
difference in the lives of patients around the
world.
We have built a strong and growing portfolio of
proprietary
reformulated
and
repurposed
product candidates. This reflects our deep
expertise
and
unwavering
commitment
to
advancement
and
innovation.
Since
our
inception, we’ve strategically shifted toward
more complex, repurposed patent-protected
products
moving
higher
up
the
pharmaceutical value chain.
Our
development
strategy
centers
on
a
streamlined and efficient approach. We primarily
leverage the 505(b)(2) regulatory pathway in the
U.S. and equivalent pathways globally. These
frameworks are designed for drugs with already-
established safety and, in sometimes efficacy,
allowing for reduced clinical requirements. This
helps us shorten development timelines, lower
costs, and minimize risk — bringing promising
therapies to patients faster.
To drive our innovation engine, we maintain
active
engagement
with
key
stakeholders,
including
healthcare
professionals,
patient
advocacy groups, payers, academic institutions,
and potential partners. We also capitalize our
extensive global sourcing network and robust in-
house R&D capabilities.
We focus on creating value-added medicines
through
reinventing
existing
medicines
pharma’s sweet spot.
p.14
Hyloris:
Annual report 2024
Strategy & Strengths
FOCUS ON VALUE CREATION THROUGH
EFFICIENT DEVELOPMENT
The Company’s mission is to generate value
through product development. We prioritize
products eligible for the
505(b)(2) pathway
due to its numerous advantages. Compared to
the traditional 505(b)(1) pathway, typically
used for new chemical entities, this approach
allows for faster development, reduced risks,
and lower costs.
BUILDING A PIPELINE OF INNOVATIVE
SOLUTIONS
Hyloris is dedicated to creating a robust
portfolio of patented, complex, and valuable
products that address unmet medical needs.
We achieve this by leveraging a time and
capital-efficient
approach
the
505(b)(2)
regulatory pathway in the U.S. and similar
pathways in other countries. This streamlined
process allows us to focus our resources on
developing products with significant market
potential.
Hyloris employs a rigorous selection process
for our 505(b)(2) product candidates. This
process involves:
Sourcing and Validation:
All candidates are
identified through multiple channels and
validated based on scientific and medical
insights
from
our
extensive
network
of
physicians and key opinion leaders (KOLs).
Strategic Selection Criteria
: All candidates
must meet predefined criteria, including:
Ability
to
address
significant
unmet
medical needs
Technical feasibility for development
Development cost €7 million or less
1
Development timeline under 7 years
Potential for patent and trade secret
protection
Strong expected return on investment
Hyloris’ goal is to establish a diversified and
growing product pipeline with 30 key assets
by 2025.
This will solidify our position as a
leader
in
the
development
of
505(b)(2)
products.
1
The Hyloris cost, not adjusted for inflation
p.15
Hyloris:
Annual report 2024
Advantages of the 505(b)2 pathway
Reduced Risks and Costs
: Development risks and costs associated with reformulating existing
drugs are substantially lower compared to developing entirely new chemical entities, as existing
safety and efficacy data can be leveraged.
Lower Formulation Risk
: Developing new formulations of well-documented drugs
reduces
potential formulation issues.
Reduced
Clinical and Regulatory Risk
: Reformulating approved drugs typically requires fewer
clinical
studies, leading to a higher probability of success and faster regulatory approval.
Shorter Timelines
: Development timelines are significantly shorter, averaging five years
compared to eight to fifteen years for new chemical entities (NCEs).
Lower Commercial Risk
: Since these products reference established drugs, there is greater user
awareness among physicians and payers. We will leverage this awareness by demonstrating the
added value our products bring to the market.
Patentability
: While the chemical entity of 505(b) (2) products typically cannot be patented,
patents can be filed on an innovative formulation, method of use, route of administration, dosing
regimen, pharmacokinetic profile, manufacturing process, drug delivery system, and novel forms
such as salts, polymorphs, or co-crystals.
PROTECTING
INNOVATION
AND
BUILDING
EXPERTISE
For all our 505(b)(2) candidates, we have a
comprehensive long-term strategy to file and
protect intellectual property (IP) and maximize
the commercial lifespan. Our diverse and robust
patent portfolio provides extensive protection,
covering
dosages,
formulations,
medical
indications, and production methods.
TAILORED GO-TO-MARKET STRATEGIES
Our go-to-market strategy is flexible and tailored
to meet the specific needs of each product. For
our cardiovascular portfolio in the U.S., we are
currently evaluating whether to go to market
independently or pursue a licensing partnership.
For other products, our approach is to license out
at a late stage of development, ensuring that we
can leverage strong local partners to maximize
sales and reach in key regions.
GENERATING
REVENUE
STREAMS
FOR
SUSTAINABLE GROWTH
We currently have three products on the market.
Additionally, we have filed Valacyclovir Oral
Liquid for approval in the U.S. As our R&D efforts
are progressing across a broad range of assets
we expect multiple product filings in 2025 and
2026, which will fuel growth. For future products,
we anticipate out-licensing the majority at a late
stage of development, while retaining flexibility
to
bring
select
products
to
market
independently. This strategy prioritizes ongoing
product sales over upfront milestone payments,
allowing us to retain a significant share of the net
product margin from our commercial partners.
p.16
Hyloris:
Annual report 2024
Looking ahead
We continue to build strong momentum in our
product development and commercialization
efforts. We have expanded our pipeline with five
new product candidates – two in 2024 and three
more in early 2025 – reinforcing our commitment
to addressing unmet medical needs. Notably, we
submitted
the
NDA
for
Valacyclovir
Oral
Suspension in the U.S., a significant milestone in
our portfolio’s progression.
In parallel, we executed multiple out-licensing
agreements, including a key deal with Rosemont
Pharmaceuticals
for
Valacyclovir
Oral
Suspension in the U.S. These partnerships
validate our strategy of developing differentiated
medicines and expanding patient access through
strategic collaborations.
Commercial
The Company is on a mission to turbocharge its
product pipeline in 2025, aiming to reach 30
products and product candidates by year-end.
The business development team will continue to
pursue new opportunities including early-stage
concepts, while securing commercial partners
for our late-stage portfolio.
Maxigesic
®
IV
– We expect to see adoption in the
U.S. market as Hikma begun promoting the
product and the U.S. Centers for Medicare and
Medicaid Services (CMS) assigned a unique,
permanent
Healthcare
Common
Procedure
Coding System (HCPCS) J-code. The J-code
became effective October 1, 2024.
Outside of the U.S. we anticipate additional
marketing authorizations in countries where
submissions were made, followed by commercial
launches.
R&D
The company is making steady progress on the
development of its various product candidates.
With 20 reformulated and repurposed product
candidates, and 2 high-barrier generics, several
clinical trials are expected to start and/or
conclude in 2025, including the following:
Alenura™
: A pivotal Phase 2 clinical trial
comparing the effectiveness of Alenura™
against
its
individual
components
and
placebo is expected to reach Last Patient
Last Visit (LPLV) by the end of 2025.
Dofetilide IV
: The pivotal clinical trial has
been successfully completed in early 2025
and
will
support
the
upcoming
U.S.
regulatory submission.
Atomoxetine
Oral
Liquid
:
The
manufacturing of the registration batches
was completed before the summer of 2024.
The data readout for the trial supporting the
U.S. submission is expected in Q2 2025.
Hyloris
is
also
targeting
additional
territories, which will require an additional
clinical trial (anticipated in H2-2025).
Phosphate
Oral
Liquid
:
The
contract
manufacturing organization (CMO) has been
selected, and registration batches are set to
be
manufactured
in
H1
2025,
with
regulatory filing anticipated in early 2026.
HY-095
:
Formulation
development
is
ongoing with an external partner. The
Company expects initial prototype testing in
horses to begin before or by the summer of
2025.
Metolazone
IV
:
Registration
batch
manufacturing
was
delayed
due
to
p.17
Hyloris:
Annual report 2024
unforeseen issues resulting in a delay of the
clinical trial. The company believes the
manufacturing issues have been resolved
and is preparing the pivotal clinical trial.
Aspirin IV
: Following successful registration
batches,
which
demonstrated
sufficient
product stability, an additional API source
will be incorporated to finalize the CMC
section. New registration batches have been
executed to qualify this new API source. A
pivotal study to support the U.S. filing is
expected to start in Q3 2025, with a data
readout expected in late Q4 2025.
HY-074:
A
PK bridging study is estimated to
start at the end of 2025.
XTRAZA
(Tranexamic
Acid
Oral
Mouth
Rinse): LPLV for the Phase 3 trial, which
started in November 2023, is expected by
year-end, with study results anticipated in
H1 2026.
The company anticipates several regulatory
achievements in the next 15 months including:
Valaciclovir Oral Suspension
(previously
HY-029): Positive pivotal clinical study results
demonstrated
comparable
relative
bioavailability to Valtrex
®
tablets, as sold in
the U.S, under fasted conditions. These
results further strengthened the clinical data
package and supported the NDA submission
to the U.S. FDA in December 2024. A PDUFA
date has been set for October 12, 2025.
p.18
Hyloris:
Annual report 2024
Commercial Portfolio
MAXIGESIC
®
IV: U.S. FDA
APPROVED FOR THE TREATMENT
OF POST-OPERATIVE PAIN
Highlight: Hikma Pharmaceuticals
launched in early 2024 under the
registered tradename Combogesic IV.
Post-operative pain and the opioid crisis
Pain, a distressing combination of sensory and
emotional feelings, is typically caused by tissue
damage or illness. As a widespread condition, it
significantly impacts patient health and quality of
life. The duration of pain can be short-lived
(acute pain) or long-lasting (chronic pain). In
hospitals, acute pain is often categorized as
either post-operative or non-operative. Post-
operative pain results from tissue damage
during surgery, which stimulates nerves and
triggers a sensory and emotional response in the
brain.
Despite its predictability after surgery, managing
post-operative
pain
remains
a
significant
challenge for anaesthesiologists. In the United
States alone, over 50 million surgeries were
performed in 2019. Pain is still the leading cause
of unexpected hospital readmissions following
surgery. More than 80% of patients experience
moderate pain, and a significant portion (31-
37%) suffers from severe or extreme pain
23
.
2
Coley K et al.
J
Clin Anesth. 2002
3
Wonuk Koh et al, Korean
J
Anesthesiol. 2015
MAXIGESIC
®
IV in 2024
Traditionally,
pain
management
is
achieved
through the use of specific medications. This
makes it one of the most frequently addressed
issues
by
physicians.
However,
significant
improvements in pain management strategies
have been limited in recent decades. Pain
medications can be classified into two main
groups:
Anesthetics
are drugs used to induce a
temporary loss of sensation or awareness of
feeling (ie pain). Anesthetics are categorized
as either general (loss of consciousness) or
local (small area such as a surgical site).
Analgesics
, in contrast, are medications
specifically used to relieve pain without
causing a loss of consciousness. These are
classified as either opioid or non-opioid.
Maxigesic
®
IV is a powerful analgesic that can
help manage post-operative pain in a way that
may decrease reliance on opioids.
11
Authorizations
14
p.19
Hyloris:
Annual report 2024
Our potential solution: Maxigesic
®
IV: an
innovative,
patented,
iv
formulation
of
paracetamol plus ibuprofen to combat the
opioid crisis
Injectable
formulations
of
analgesics
are
commonly chosen when oral medications cannot
be taken by patients. This can occur when a
faster onset of pain relief is needed, or when
injection
is
simply
the
more
convenient
administration method. In hospital settings, a
variety of reasons can prevent patients from
taking medications orally. These reasons include
post-
anesthesia
sedation,
other
forms
of
sedation, nausea, vomiting, limitations of the
gastrointestinal system, or other underlying
conditions.
Maxigesic
®
IV represents a novel and unique
combination. This injectable solution, designed
for post-operative use in hospitals, combines
1000mg
of
paracetamol
with
300mg
of
ibuprofen.
There exists a pressing need for safer and more
effective pain management options in hospitals
that do not rely on opioids. Due to its unique dual
mode of action, Maxigesic
®
IV has the potential
to become a valuable tool for treating pain. This
4
Daniels et al, 2019, Clinical Therapeutics
5
Maxigesic
®
IV Phase 3 exposure study. Study ID No
AFT-
MXIV-11.
NCT04005755.
Submitted
for
publication
potential comes without the side effects and
risks of addiction associated with opioids.
Findings
from
a
randomized,
double-blind,
placebo- controlled Phase 3 trial involving 276
patients who underwent bunion surgery were
positive. The trial demonstrated that Maxigesic
®
IV
was
well-tolerated
and
offered
several
advantages. Compared to ibuprofen IV or
paracetamol IV administered alone at the same
doses, Maxigesic
®
IV provided a faster onset of
action and superior pain relief. Additionally, a
range of secondary endpoints supported the
superior analgesic effect of Maxigesic
®
IV,
including a reduction in opioid consumption
compared to the paracetamol IV and ibuprofen
IV treatment groups (P<0.005)
4
. Furthermore, an
additional exposure study has confirmed the
efficacy and safety of Maxigesic
®
IV in a broader
patient population over a longer treatment
period
5
.
In the U.S., where chronic opioid usage in
patients following surgery averages around 9%,
ranging
from
4%
to
24%
among
various
specialties, drug overdoses involving opioids
resulted in over 80,000 deaths in the U.S. in 2021.
Patients who experienced an opioid overdose
account nearly USD 2 billion in annual hospital
costs
6
.
6
https://pubmed.ncbi.nlm.nih.gov/27163960
p.20
Hyloris:
Annual report 2024
PODOFILOX GEL
U.S. FDA approved for the treatment of
genital & perianal warts caused by certain
types of the human papilloma virus (HPV)
Podofilox Gel is an antimycotic drug for the
topical treatment of external genital and perianal
warts caused by certain types of the Human
Papilloma Virus (HPV). Around 1% of the sexually
active population in the U.S. presents with genital
or perianal warts. To date there is a vaccine for
HPV but no cure.
In December 2023, our partner Padagis US LLC
(Padagis) received marketing authorization for
Podofilox Gel 0.5% from the FDA. Padagis
launched the product in December 2023. It is the
first generic for Condylox
®
Gel in the U.S.
For the 12 months period ending December
2022,
Condylox
®
Gel
had
U.S.
sales
of
approximately $9 million according to IQVIA
Health.
SOTALOL IV
U.S. FDA approved for the treatment of atrial
fibrillation and life-threatening ventricular
tachycardia
Atrial fibrillation (AF) is an irregular heartbeat
that starts in the upper chambers of the heart
(atria). Normally, these chambers beat regularly
and in a coordinated way with the lower
chambers (ventricles). With AF, the atria quiver
instead of beating effectively, which disrupts the
normal flow of blood through the heart. AF can
cause symptoms like heart palpitations, fatigue,
shortness of breath, and dizziness. It can also
increase risk of stroke and heart failure. There
are different types of AF, and treatment options
depend on the severity and frequency of the
condition.
Antiarrhythmic drugs are frequently given in
hospitals to control the heart’s rhythm. Oral
potassium channel blockers are the leading type,
with amiodarone, dronedarone, and sotalol
being prominent examples. While commonly
used, sotalol carries a strong warning due to the
increased risk of irregular heartbeats they can
cause. Because of this risk, patients starting
treatment with sotalol require close monitoring
in a hospital setting for several days until safe
drug levels are established in their bloodstream.
Traditionally, patients starting sotalol require a 3-
day hospital stay for monitoring. Sotalol IV is
infused for over one-hour. It acts quickly,
allowing for a smooth transition from initial IV
administration to long-term oral treatment. This
approach, beginning with Sotalol IV followed by
oral
sotalol,
could
potentially
significantly
shorten hospital stays.
In March 2020, the FDA approved the expanded
label of Sotalol IV to using Sotalol IV in adult AF
patients until near steady- state exposure to
Sotalol is achieved prior to initiating or increasing
oral Sotalol dosing.
p.21
Hyloris:
Annual report 2024
Development Portfolio
Cardiovascular
Our cardiovascular development portfolio currently contains 6 product candidates at varying stages of
development. The Company is currently evaluating the most effective path to commercialize the cardio
products, which may involve self-commercialization or partnering through licensing agreements
7
.
ASPIRIN IV
Indication
Decrease the risk of morbidity and mortality
associated with an emergency cardiac event
(such as myocardial infarction (AMI) or stroke).
Unmet Need
When AMI or ischemic stroke is suspected,
patients are instructed to chew or swallow an
aspirin tablet as soon as possible. However,
clinical research has shown that oral aspirin
takes between 20 and 40 minutes to take full
effect and the amount of aspirin absorbed is
highly variable.
7
The presented chart’s timelines are indicative only.
Even if a product candidate is already in (advanced) clinical stage of development, costs for the manufacturing-related
activities can still be incurred.
8
www.strokei
nfo.org
Potential Solution
An intravenous formulation of aspirin for a faster
onset of action and to decrease inter/intra-
patient variability of aspirin absorption.
Intellectual Property
’38, granted and pending applications.
Target Population
Every year about 850,000 people in the U.S.
experience a heart attack and about 800,000
experience a stroke, of which 87% are ischemic
(blocking the blood flow to the brain)
8
.
p.22
Hyloris:
Annual report 2024
MILRINONE ER
Indication
The treatment of right heart failure due to Left
Ventricular Device (LVAD).
Unmet Need
Currently, milrinone is only available as an
intravenous medication, which limits its use to
hospital settings or specialized outpatient care
and requires continuous infusion due to its short
half-life. Although also used off-label for longer-
term, IV milrinone is currently approved for
short-term use (up to 48-hours).
Potential Solution
An approved oral extended-release version
could significantly improve patient convenience
and adherence by enabling home use, reducing
hospital
dependence,
and
avoiding
the
complications and costs associated with IV
therapy and could allow for long term use.
Special Regulatory Designation
Orphan Drug Designation
Target Population
In 2020, there were about 14,000 patients with an
LVAD implant in the U.S. and 30% of these
patients developed right heart failure. Over the
next coming years, the LVAD patient population
is expected to grow at an average annual growth
rate of 6% in the U.S.
Intellectual Property
Confidential
DOFETILIDE IV
Indication
Conversion and maintenance of normal sinus
rhythm in patients with atrial fibrillation or atrial
flutter.
Unmet Need
Patients who are unable to take oral medication
or
that
require
faster
onset.
Initiation
of
dofetilide currently requires a minimum of 3
days of in-hospital monitoring.
Potential Solution
Dofetilide IV is an innovative intravenous (IV)
formulation designed to provide controlled
administration for patients and more rapid drug
loading. Following IV initiation, patients can
transition
to
oral
dofetilide
for
long-term
maintenance therapy or continue the use of the
IV formulation.
Intellectual Property
‘39 & ‘43, granted and pending applications.
HY-074 IV
Indication
Reduce the risk of morbidity and mortality
associated with an emergency cardiac event
(such as myocardial infarction (AMI) or stroke).
Unmet Need
Despite the need for fast onset of action drugs in
an acute cardiac event, the majority of current
standard of care treatments only available in oral
form.
Potential Solution
Intravenous formulation of a current standard of
care treatment to offer faster onset of action,
more convenient administration, and dosage
control.
p.23
Hyloris:
Annual report 2024
Intellectual Property
Applications filed (expiry ‘43 & ‘44 upon grant)
Target Population
Every year about 1.6 million people in the U.S.
experience a heart attack or stroke
9
.
METOLAZONE IV
Indication
The treatment of salt and water retention
including:
edema
accompanying
congestive
heart
failure;
edema
accompanying
renal
diseases,
including the nephrotic syndrome and
states of diminished renal function.
Unmet Need
Congestive Heart Failure (CHF) is progressive and
there is currently no cure available.
Patients can be administered a combination of a
loop diuretic with a thiazine-like diuretic such as
metolazone
tablets.
However,
tablet
formulations have highly variable bioavailability
and erratic absorption, particularly in patients
with severe gastrointestinal oedema.
Potential Solution
Intravenous formulation of metolazone for faster
onset of action (essential in critical care);
improved drug absorption and concomitant
treatment possible.
Intellectual Property
’38 & ‘44; granted & pending applications.
Target Population
1 in 4 individuals are projected to develop heart
failure in their lifetime.
Approximately 6.7 million Americans over the
age of 20 currently live with heart failure, a figure
projected to rise to 8.7 million by 2030, 10.3
million by 2040
9
.
HY-075
Indication
Prevention
and
treatment
of
specific
cardiovascular diseases.
Unmet Need
The currently approved oral solid requires
frequent dosing changes and adjustments.
Potential Solution
An oral liquid solution designed to significantly
improve drug administration, ease of use, and
dosage control, potentially resulting in potential
better compliance and patient outcomes.
Intellectual Property
Confidential.
Target Population
Cardiovascular disease is the leading cause of
death in the U.S. with more than 370,000 deaths
every year.
9
Heart Failure Society of America
(HFSA)
p.24
Hyloris:
Annual report 2024
Development Portfolio
Other Value-Added
Our portfolio
10
of other value-added products currently contains 14 product candidates at varying
stages of development. All products in the value-added portfolio are intended to be commercialized
through region-specific partners who have intimate knowledge of their target markets.
TRANEXAMIC ACID ORAL RINSE
(PREVIOUSLY HY-004)
Indication
To prevent and treat excessive bleeding in
patients on blood thinners undergoing dental
procedures.
10
The presented chart’s timelines are indicative only.
Even if a product candidate is already in (advanced) clinical stage of development, costs for the manufacturing-related
activities can still be incurred.
Unmet
Need
Patients on blood thinners can experience
significant bleeding during dental procedures.
Currently, tranexamic acid is only approved in
the
U.S.
as
an
injectable
product
for
hemophiliacs undergoing a tooth extraction,
or as a tablet.
Our high barrier generic products, TXA RTU and Fusidic Acid Cream have not been included in the above overview.
ADHD: attention deficit hyperactivity disorder; Miconazole-DB: miconazole-domiphen bromide; rVVC: recurring vulvovaginal
candidiasis; AML: Acute Myeloid Leukemia; SCLC: Small cell Lung Cancer
p.25
Hyloris:
Annual report 2024
Potential Solution
A reformulated oral rinse developed for use in
minor
surgical
procedures
with
complications/bleedings intended for use by
dental
care
professionals
in
patients
on
anticoagulant therapy.
Intellectual
Property
’39; granted and pending.
ALENURA™
Indication
Treatment of pain associated with interstitial
cystitis/ bladder pain syndrome (IC/BPS).
Unmet
Need
There is currently no standardized treatment
protocol or cure available. Available treatments
have significant limitations such as high cost,
delayed onset of effect, and serious side effects.
IC/BPS is more prevalent in women, although
men can experience symptoms as well. It is
estimated at least 6 million people in the U.S.
suffer from the condition.
Potential Solution
A ready-to-use solution with an innovative dual
mode of action that may provide immediate
symptom relief and potentially aid in the
regeneration of the bladder lining. Alenura
combines
lidocaine,
a
well-established
anesthetic, in a new alkalinized form, with
heparin,
a
glycosaminoglycan
(GAG)
component of bladder mucous membranes.
The product is being co-developed with U.S.
based Vaneltix.
Intellectual
Property
’38; granted and pending.
PTX-252 (PREVIOUSLY PLECOID
AGENT)
Indication
Treatment of Acute Myeloid Leukemia (AML).
Unmet Need
AML is an aggressive hematological malignancy
that originates from immature white blood cells
in the bone marrow. AML generally spreads
quickly to the bloodstream where it can then
spread to other parts of the body including
lymph nodes, spleen, and the central nervous
system. The 1-year and 5-year survival rates are
approximately 50% and below 30%, respectively.
Research has shown that treatment resistant
AML has significantly elevated levels of toxic
metals in their bone marrow and blood. This
contributes to the poor overall survival rate.
Potential Solution
An intravenous solution containing a chelating
agent as an adjunctive therapy to chemotherapy,
aimed at decreasing elevated blood levels of
toxic metals. We are co-developing this product
with Pleco Therapeutics.
Intellectual Property
Pending applications. Orphan drug
designation
has been granted in the U.S.
p.26
Hyloris:
Annual report 2024
MICONAZOLE/DOMIPHEN
BROMIDE CREAM
Indication
Treatment
of
difficult
to
eradicate
vaginal
infection(s) caused by Candida yeast and/or
bacteria, especially those involving a biofilm.
Unmet Need
Current
treatments
for
these
chronic
and
debilitating vaginal infection(s) include topical
and systemic antifungal agents. These products
are not always effective and may cause severe
side effectswith prolonged use.
Potential Solution
A topical formulation for the treatment of
infections.
This
formulation
allows
direct
delivery to the vaginal mucosa, helping to
address infections that may persist despite
systemic antifungal therapy.
Intellectual Property
‘38 & ‘44 Granted & pending applications
11
2022 IMS Sales Data
ATOMOXETINE ORAL LIQUID
Indication
Treatment of Attention Deficit Hyperactivity
Disorder (ADHD).
Unmet
Need
ADHD
is
among
the
most
common
neurobehavioral problems affecting children
between the age of 6 and 17. It is a chronic
disorder characterized by developmentally
inappropriate and impaired attention, motor
hyperactivity,
and
impulsivity.
These
symptoms often continue into adulthood. The
prevalence of ADHD in the U.S. ranges from 2%
to 18% in this age group.
Treatment options for ADHD are categorized
as either
a
stimulant
or
a
nonstimulant.
Atomoxetine
is
the
leading
nonstimulant
medication for ADHD
11
.
However, dosing for children and adolescents
weighing less than 70 kg is weight-based and
can be difficult to titrate. If the dose is too
small, the desired effect may not occur. If the
dose is too large patients can experience side
effects ranging from dry mouth to blurred
vision. Atomoxetine is also notoriously bitter
tasting.
p.27
Hyloris:
Annual report 2024
Potential Solution
A taste-masked oral solution of atomoxetine
for precise dosing and titration as well as
palatability.
Intellectual
Property
‘36-’44; granted & pending applications.
HY-083
Indication
Treatment of Idiopathic rhinitis.
Unmet
Need
Idiopathic
rhinitis
is
a
medical
disorder
characterised
by
a
collection
of
nasal
symptoms that resemble nasal allergies and
hay fever (allergic rhinitis) but are not caused
by a known cause like allergens or infectious
triggers.
Idiopathic
rhinitis
features
an
overexpression of TRPV1 in the nasal mucosa
giving rise to nasal obstruction, rhinorrhoea
(colloquially: a runny nose), and/or sneezing.
Approximately 19 million people in the US and
25.8
million
in
Europe
are
affected
by
idiopathic rhinitis and seek treatment.
Current
treatment
options
for
idiopathic
rhinitis are not consistently successful. This
leads to unnecessary and often ineffective
surgery for severe cases, such as nasal semtum
corrections
and/or
inferior
turbinate
reductions.
Potential Solution
A
proprietary
product
to
activate
and
depolarise
TRPV1
receptors
leading
to
restoration of a normal function of the nasal
mucosa.
Intellectual
Property
Confidential.
HY-088
Indication
Treatment of hypophosphatemia.
Unmet
Need
Hypophosphatemia is a deficiency of the vital
mineral phosphate in the blood. While mild
hypophosphatemia
is common and many
patients
are
asymptomatic,
severe
hypophosphatemia can be life-threatening
and requires medical treatment. The condition
can result in different health challenges,
including
muscle
and
bone
weakness,
respiratory or heart failure, seizures or coma.
Deficiency of this vital mineral is always linked
to an underlying condition, such as diabetes,
anorexia, use of diuretics or alcohol abuse.
Currently,
physicians
mostly
rely
on
compounded drugs which have, by definition,
not been submitted for regulatory scrutiny
regarding safety, efficacy, and quality.
Potential Solution
An oral solution submitted for regulatory
approval to replace compounded drugs.
Intellectual
Property
Confidential.
HY-090
Indication
Treatment of Burning Mouth Syndrome (BMS).
Unmet
Need
Burning
mouth
syndrome
(BMS)
is
characterized by burning pain in an otherwise
normal oral mucosa lasting at least four to six
months. The condition is idiopathic, and the
underlying
pathophysiology
is
not
well
understood.
Patients
with
burning
mouth
syndrome
commonly experience changes in
gustatory function.
The reported prevalence ranges from 0.7% to
5% of individuals in the U.S. and occurs more
frequently in women than men, with a female-
p.28
Hyloris:
Annual report 2024
to-male ratio of 7:1. Prevalence increases with
age in both men and women, with the highest
prevalence
reported
in
postmenopausal
women aged 60–69 years.
Potential Solution
A novel oral solution that works locally to treat
symptoms of BMS.
Intellectual
Property
Confidential.
HY-091
Indication
Treatment of Vulvar Lichen Sclerosis.
Unmet
Need
Vulvar Lichen Sclerosus (VLS) is a chronic,
distressing, inflammatory disease with an
enormous impact on quality of life. Women
with VLS can experience severe pain, intense
persistent itching, and skin discoloration.
There is no curative treatment for VLS, which
usually occurs in postmenopausal women,
although children and premenopausal women
may also be affected. In advanced stages, the
condition severely affects the quality of life and
is associated with increased risk of vulvar
squamous cell carcinoma. It is a highly
underdiagnosed condition,
which affects 0.1%
to 3% of the general population.
Potential Solution
A user-friendly mucoadhesive product with a
convenient application method that ensures
simplicity and compliance, offering targeted
relief for patients experiencing discomfort,
itching, and pain associated with VLS by
reducing inflammation and scarring in the
affected area of skin and helping in restoring
the skin structure.
Intellectual
Property
Confidential.
HY-095
Indication
EGUS, or Equine Gastric Ulcer Syndrome, is a
condition in horses characterized by the
development of ulcers in the lining of the
stomach.
Unmet Need
Current treatment for EGUS typically involves
daily oral administration of a proton pump
inhibitor for a 28-day course with the possibility
of a 14-day extension. The oral formulation can
present
several
limitations
including
the
necessity for daily dosing, resistance from the
horse, inconsistent dosing and adherence, low
bioavailability, and variability in absorption,
resulting in suboptimal ulcer management.
Potential Solution
HY-095 is a long-acting injectable product
candidate, targeting reliable, sustained drug
delivery.
Intellectual Property
Confidential
p.29
Hyloris:
Annual report 2024
READY-TO-USE
PANTOPRAZOLE IV
Indication
Conditions caused by gastric acidity
Unmet Need
The existing lyophilized (freeze-dried) version
requires reconstitution prior to administration.
Reconstitution is a more complex and resource-
intensive
process
that
adds
unnecessary
preparation
time,
effort,
and
cost
for
administration.
Potential Solution
A ready-to use formulation eliminates the need
for reconstitution, offering an immediate and
efficient solution for healthcare professionals.
Intellectual Property
Confidential
ONDANSETRON EXTENDED
RELEASE (ER)
Indication
Relief from nausea and vomiting associated
with chemotherapy, radiotherapy, and post-
operative recovery (CINV/RINV).
Unmet Need
Patients, especially those undergoing cancer
treatments or post-operative recovery, often
experience nausea and vomiting over long
periods, hence requiring consistent, sustained
symptom relief.
Potential Solution
Ondansetron ER is a once-daily, patented,
bimodal
extended-release
formulation
of
ondansetron, designed to provide sustained
relief.
Hyloris is preparing to transfer commercial
manufacturing to a CMO.
Intellectual Property
‘34; granted patents.
HY-094
Indication
Iron Deficiency
Unmet Need
Iron deficiency, the most common nutritional
disorder globally, occurs when the body lacks
adequate iron to produce hemoglobin, the
protein in red blood cells that carries oxygen.
While oral and intravenous iron therapies are
available, many patients struggle with side
effects,
adherence
issues,
or
accessibility
challenges,
underscoring
the
need
for
improved treatment options.
Potential Solution
The new innovative product candidate, which
has completed Phase 2b trials, aims to address
limitations of current options by offering a
more patient–friendly treatment.
Intellectual Property
Confidential.
p.30
Hyloris:
Annual report 2024
Outside our core strategic focus, we have 2 high barrier generic
products in development:
FUSIDIC ACID CREAM
, a generic for the Canadian market. of an off-patent reference product.
TRANEXAMIC ACID RTU
, a ready to use tranexamic acid solution for infusion. The product has
been filed as a generic in the U.S. and as a value-added product outside the U.S., where it has
already been partnered in Canada, Australia, New Zealand, South-Korea and Switzerland.
p.31
Hyloris:
Annual report 2024
Post-Closing Business Events
(See additional information in Notes 30)
XTRAZA™
(Tranexamic Acid Oral Rinse) was licensed to
Colonis Pharma for the UK.
Pantoprazole
Ready-To-Use
was
added
to
the
development portfolio in February 2025.
Ondansetron
Extended-Release
Oral
,
a
product
candidate for the management of nausea and vomiting,
was licensed from Redhill Biopharma and announced in
February 2025.
The U.S. FDA acceptance of a New Drug Application (NDA)
for
Valacyclovir Oral Liquid
was announced in February.
Positive Study Results for
Dofetilide IV
were announced
in March.
A Positive IDMC recommendation to continue the
Alenura
®
Phase 2 study following interim assessment was
announced in March.
HY-094
, a new injectable iron product candidate, was
added to the portfolio in March 2025. HY-094 is the fourth
co-development with AFT Pharmaceuticals.
Hyloris
: Annual report 2024
p32
Hyloris
: Annual report 2024
p33
Environmental,
Social, and
Governance
Introduction
As the pharmaceuticals sector continues to evolve, the importance
of Environmental, Social, and Governance considerations can not go
unnoticed. While recent developments in Europe have seen a slowdown
in regulatory sustainability reporting requirements, the momentum for
transparency and accountability remains a critical focus for our industry.
At Hyloris, we recognize the pressing need to address environmental
challenges, promote social responsibility, and uphold governance
standards that reflect our company values. We believe that sustainability
is not merely a compliance obligation but a way to create value.
Therefore, it remains our ambition to transparently share our
sustainability journey based on best practices. In this way, we hope to
build trust with our investors, partners, end-users, and the public, while
we continue our push to improve the lives of patients facing unmet
medical needs.
Hyloris
: Annual report 2024
p34
General
Information
Our Approach to
Sustainability
Since 2022, Hyloris concentrated
its efforts on selected Sustainable
Development Goals (SDGs). These SDGs
guided us in identifying three strategic
imperatives that align with our mission
and values:
01
Commitment to the Good
Health and Well-Being of
Society
02
Commitment to
Environmental
Sustainability
03
Commitment to
Responsible Leadership
As Hyloris continues to grow, we remain
committed to these goals as we recognize
their importance in fostering a sustainable
future. However, To strengthen our
sustainability efforts and reporting, we
have opted to streamline our strategy in
alignment with the Corporate Sustainability
Reporting Directive (CSRD) guidelines
wherever feasible. As a result, this report
will address, on a voluntary basis, most
topics outlined by the CSRD’s European
Sustainability Reporting Standards (ESRS),
allowing us to communicate our progress
and impact in a more meaningful and
transparent manner.
Hyloris has also carried out a Gap analysis
with an external partner to identify areas for
improvement and the data to be collected
for the future sustainability report in
accordance with the CSRD.
Hyloris
: Annual report 2024
p35
Enhancing our Initiatives through the
integration of SDGs and ESRS
ESRS S1:
Own
Workforce
ESRS S4:
Consumers &
End-Users
ESRS E4:
Biodiversity and
Ecosystems
ESRS E1:
Climate
Change
ESRS E2:
Pollution
E
S
R
S
G
1
:
B
u
s
i
n
e
s
s
C
o
n
d
u
c
t
E
S
R
S
G
1
:
B
u
s
i
n
e
s
s
C
o
n
d
u
c
t
Hyloris
: Annual report 2024
p36
Environmental
The importance
of Environmental
considerations in
Pharmaceuticals
The positive impact and beneficial effects
of medicinal products on society are well
known and acknowledged. However, as
environmental issues are becoming more and
more urgent, there is a need for additional
focus of the sector in addressing the biggest
risks for our climate and planet.
Some of the key challenges
in our sector:
Pollution of Air, Water, and Soil
The contamination of water bodies and soils
with pharmaceutical residues has emerged
as a significant environmental concern.
Pharmaceutical compounds, along with their
metabolites and conjugates, primarily enter
the environment through human excretion.
These substances make their way into
sewage treatment systems, where they may
undergo degradation, become adsorbed to
sewage sludge, or ultimately be released into
surface water.
Hyloris
: Annual report 2024
p37
Increasingly, traces of various medicinal
products, including antibiotics, are detected
in surface water, groundwater, and soil,
posing risks to human health, wildlife, and
overall biodiversity.
Climate Change and Greenhouse Gas
Emissions
Climate change has become one of the
most urgent challenges of our time,
impacting the environment, economies,
and societies around the globe. The Earth’s
average temperature is steadily rising due
to the accumulation of greenhouse gases,
particularly carbon dioxide (CO2), in the
atmosphere. This increase in temperature
is not merely a statistic; it manifests in more
frequent and severe weather events, rising
sea levels, and disruptions to ecosystems. In
this context, it is essential for governments,
organizations, and individuals to make more
conscious decisions to minimize their carbon
footprints and contribute to a sustainable
future.
How Hyloris is
addressing these
Environmental
challenges
Environmental Risk Assessments
At Hyloris, we understand the potential
negative impacts pharmaceuticals can have
on the environment. Therefore, we diligently
perform environmental risk assessments
(ERAs) for all new medicinal products in
accordance with regulatory requirements to
estimate the exposure of the environment
to the new drug substance and assess the
potential effects. In this way, we make sure
to protect our planet and ecosystems from
potential harm.
Reducing our CO2 Footprint
The Hyloris headquarters is located in
LégiaPark, Liège, in a BREEAM-certified
building that has achieved an “Excellent”
performance rating. BREEAM, which stands
for the Building Research Establishment
Environmental Assessment Method, is a
widely recognized standard for measuring
the sustainability and environmental
performance of buildings. Receiving
an “Excellent” rating reflects a strong
commitment to sustainability, including
efficient use of utilities such as water and
energy, as well as the use of sustainable
materials. Additionally, this rating highlights
the focus on providing a comfortable and
healthy indoor environment, featuring
good air quality and plenty of natural light,
which contributes to the well-being of our
employees and visitors.
In further efforts to reduce our carbon
footprint, we have made significant progress
in our transition to a sustainable vehicle
fleet. As part of our ongoing efforts to
completely move away from combustion
engines, we have switched to using only
hybrid and fully electrical vehicles. By
investing in cleaner transportation options,
we are taking yet another important step to
address our direct emissions and promote
a greener future for our employees and the
communities we serve.
Hyloris
: Annual report 2024
p38
Self-Employed
35
Employees
14
Social
Our People
At Hyloris, we recognize that our people
are our greatest asset. Our workforce is
the driving force behind our innovation,
creativity, and commitment to improving
healthcare outcomes for our patients.
As we continue to grow and evolve, we
remain committed to attracting and
retaining top talent around the world by
fostering a supportive, transparent, and
inclusive work environment based on our
core values.
Workforce in statistics:
Hyloris utilizes a flexible structure to
leverage expertise around the world. Under
this structure, a significant majority of our
workforce is operating as self-employed
professionals. This model allows us to bring in
specialists with unique skills and experiences
that can enhance project outcomes and drive
innovation. Regardless of employment status,
we remain committed to equal treatment and
inclusivity of our team members. Since we are
one team, the next social topics in this section
will dive a bit deeper into our team dynamics,
exploring how our diverse backgrounds and
experiences contribute to a collaborative
environment.
Hyloris
: Annual report 2024
p39
A diverse pool of talent:
Irrespective of gender, ethnicity, or
nationality, Hyloris wants to attract the best
people where possible. Our dedication to
global expertise focuses on bringing together
individuals with different viewpoints and
experiences, ultimately aimed at creating
a dynamic team that is better equipped
to tackle the complex challenges in the
biopharmaceutical industry.
We are proud of our nearly perfectly
balanced gender ratio across the
organization. This balance is a testament
to our dedication to creating an inclusive
workplace, regardless of gender.
However, we do recognize that our female
representation at the top level does not yet
align with our overall diversity.
Currently, only 1 out of our 7 Directors on
the Board is a woman, highlighting an area
where we are seeking improvement. We
are committed to enhancing diversity at all
levels of our organization and are focused on
attracting women with valuable experience
to contribute to our highest decision-making
body.
Fair Pay for All
We are committed to ensuring that our
employees receive adequate wages that
reflect their contributions and comply
with local legislation. We understand
the importance of fair compensation
in promoting employee satisfaction
and retention, and we strive to create a
transparent and equitable pay structure.
In addition to adhering to legal requirements,
we conduct an annual review process that
evaluates employee performance against
pre-defined targets and goals. This process
is designed to recognize and reward the
hard work of all employees, entitling them to
bonuses and salary increases based on their
achievements. By linking compensation to
performance, we hope to foster a culture of
accountability and motivation, encouraging
our team members to strive for excellence in
their roles.
Male
Representation
Female
Representation
Different
Nationalities
61
%
39
%
13
Austrian
Belgian
Danish
Dutch
French
Greek
Indian
Moroccan
Portuguese
Slovenia
Spanish
Swiss
USA
Hyloris
: Annual report 2024
p40
Transparency in
Remuneration
Transparency is key at Hyloris, and we
believe that open communication about
our remuneration practices is essential
to building trust with our employees and
stakeholders. To this end, we share an
extensive Remuneration Report as part of
the Corporate governance chapter, providing
detailed insights into our compensation
structure and practices. We have also
established a comprehensive remuneration
policy designed to attract, motivate, and
retain expert individuals who are critical
to our success. A core principle of our
remuneration policy is to ensure consistency
between the remuneration of executives and
that of all staff members. We recognize that
every role within Hyloris contributes to our
mission, and we strive to create a balanced
approach to compensation that reflects this
value.
Hyloris
: Annual report 2024
p41
Social Protection
We prioritize the well-being of our
employees by ensuring comprehensive
social protection coverage in alignment with
local legislation across the various countries
where we operate. Our commitment to
social protection encompasses safeguarding
our employees against loss of income due
to significant life events, including sickness,
unemployment, employment injury and
acquired disability, parental leave, and
retirement.
Work-Life Balance
In our efforts to promote a sustainable work-
life balance, we offer a flexible workspace
that accommodates the diverse needs of
our employees. Our hybrid working model
allows team members to blend remote
and in-person work, promoting flexibility
and enhancing productivity. Additionally,
we provide hotel accommodations for
employees who need to bridge in-person
workdays, ensuring that they can maintain a
healthy balance between their professional
and personal lives.
Training and Development
Talent and expertise are essential drivers of
success in our sector. To foster professional
growth, we provide our employees with
access to a range of training programs.
By allocating resources for training and
development, we motivate our team
members to pursue initiatives that align
with their individual needs and career
aspirations. In the coming years, we will
continue to enhance our training program
by establishing a consistent framework
and ensuring regular follow-up on our
employees’ training hours. This commitment
not only supports their professional
development but also strengthens our
organization.
Healthy and Safe? - Check!
At Hyloris, maintaining a safe and healthy
work environment is one of our top
priorities, as we believe that the well-being
of our employees is just as crucial as the
health and safety outcomes of our products
for patients. Our commitment to workplace
safety is embodied in our dedicated 5-year
workplace safety plan, which includes
well-defined processes, mandatory safety
training, and regular medical checkups for
our lab personnel.
There have been
0 work-related accidents
at Hyloris, a testament to our proactive
approach and the collective responsibility of
our employees to uphold safety standards.
Hyloris
: Annual report 2024
p42
Our Patients
It is our mission to improve patients’
lives. By focusing on unmet medical
needs, we aim to bring added value to the
healthcare system through innovative
reformulations and repurposing of existing
pharmaceuticals.
In that aspect, Hyloris aims to bring positive
impacts to patients and healthcare professionals
by aligning with the highest standards and
regulatory requirements in terms of quality, safety,
and data collection. More specifically, we focus
on the 505(b)(2) regulatory pathway in the U.S.
and similar pathways in other countries, which is
designed for existing pharmaceuticals where safety
is already established. In this way, we can speed
up the development process, leading to faster
product launches and quicker access to innovative
treatments for those patients who need them most.
Unmet
medical needs
Quicker
Access
Innovative
Treatments
Quality
Pharmaceuticals
Established
Safety
Affordable
Medicines
Hyloris
: Annual report 2024
p43
Spotlight Impacts
Providing a solution for the
Opioid Crisis
The global fight against drug abuse is
increasingly adopting a health-centered
approach, as highlighted by the United
Nations’ Sustainable Development Agenda.
This is crucial given the alarming impact of
drugs, which the World Health Organization
(WHO) reports claim over half a million lives
annually, with opioids responsible for 70%
of these deaths. The rise in opioid overdoses
is linked to their use for post-operative pain
relief and the emergence of potent illicit
opioids.
In response to this public health crisis,
Hyloris proudly introduces Maxigesic
®
IV, a novel non-opioid analgesic for post-
operative pain management. Approved
in the U.S. in 2023, Maxigesic
®
IV provides
a vital alternative to traditional opioids,
which have significantly contributed to the
opioid epidemic. The U.S. has experienced
more than double the opioid-related deaths
compared to other countries, underscoring
the urgent need for effective non-opioid
solutions.
Maxigesic® IV is now approved in over
50 countries, with plans for further
marketing authorization submissions in
more than 30 countries, including low-
and middle-income countries (LMICs).
This expansion reflects our commitment
to addressing the global opioid crisis and
aligns with our Environmental, Social,
and Governance (ESG) goals. By offering
healthcare professionals a safe and effective
alternative for pain management, we aim
to reduce reliance on opioids and enhance
patient outcomes.
The leading cause of death:
Cardiovascular Diseases
Cardiovascular diseases (CVDs) represent
a pressing global health crisis, claiming
millions of lives annually. In 2019 alone, the
World Health Organization (WHO) reported
that CVDs were responsible for a staggering
17.9 million deaths, accounting for over a
third of all global fatalities. Heart attacks
and strokes are particularly devastating,
comprising 85 % of these tragic outcomes.
In response to this critical public health
challenge, Hyloris is committed to making
a significant impact by dedicating one-third
of our product development pipeline to
addressing cardiovascular diseases. Our
pioneering product, Sotalol IV, specifically
targets atrial fibrillation, emphasizing both
patient safety and cost-effectiveness.
Sotalol IV is designed to significantly reduce
hospital stays—from an average of three
days to just one—especially in the U.S.
market, where overnight hospital costs can
be prohibitively high. This reduction not
only enhances patient outcomes but also
alleviates the financial burden on healthcare
systems. By prioritizing innovative solutions
like Sotalol IV, Hyloris is actively contributing
to the fight against cardiovascular diseases,
improving lives while promoting sustainable
healthcare practices.
Hyloris
: Annual report 2024
p44
Governance
Business Conduct
At Hyloris, we adhere to the
highest possible ethical standards
in our operations. This includes
integrity, fairness, and respect
for human rights. As part of this
commitment, all employees are
required to follow comprehensive
ethical guidelines
addressing
core principles such as personal
conduct, conflict of interest,
confidentiality, influence, and
competition.
As a Belgian listed company,
Hyloris is also subject to the
2020 Belgian Code on Corporate
Governance, more information
on our
Corporate Governance
Charter
can be found in the
dedicated chapter.
In addition to this, we have a
dedicated
Dealing Code
to
ensure compliance with market
regulations and to promote
transparency and integrity
in trading. These policies are
designed specifically to prevent
insider trading and ensure all
investors have access to the
same information and can make
informed decisions based on
publicly available data.
Hyloris
: Annual report 2024
p45
Quality and Ethics in Clinical
Trials
While clinical trials involving human subjects
are a limited aspect of the development
and registration process for our new drugs,
Hyloris is fully committed to upholding
internationally recognized standards of
quality and patient safety whenever such
trials are conducted. We prioritize the
well-being of participants and ensure
that all clinical research adheres to the
highest ethical and scientific principles. By
following these rigorous standards, we aim
to generate reliable data that supports the
safety and efficacy of our products.
Limited Animal Testing
The protection and welfare of animals is
very important for Hyloris. By leveraging
the 505(b)(2) development pathway in the
US and similar pathways in other countries,
Hyloris reduces the need for extensive
early-stage research compared to traditional
505(b)(1) approaches for new drugs. This
streamlined process allows us to focus our
efforts on developing valuable medicines
while minimizing the use of animal testing.
We remain committed to implementing
alternatives to animal testing, such as
in-vitro techniques, wherever possible,
ensuring that our research and development
practices align with our ethical standards
and sustainability goals. Whenever there is
no alternative solution, and studies need
to be carried out on animals, we ensure
compliance with specific animal welfare
regulations along with the oversight of an
ethics committee.
Hyloris is
committed
to upholding
the highest
standards
of corporate
governance, and
will continue
to do so in the
future
p.46
Hyloris:
Annual report 2024
The Hyloris Share
Hyloris Pharmaceuticals SA (ticker: HYL:BB) has been listed on Euronext Brussels since 29 June
2020
Data and graph can be found at
https://live.euronext.com/en/product/equities/BE0974363955-XBRU
PERFORMANCE TO DATE OF HYLORIS VERSUS BEL20 AND
NEXT BIOTECH SINCE IPO
-80%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
06-2020
12-2020
06-2021
12-2021
06-2022
12-2022
06-2023
12-2023
06-2024
12-2024
HYLORIS
BEL20
NEXT BIOTECH
p.47
Hyloris:
Annual report 2024
HYLORIS PERFORMANCE TO DATE
ANALYST COVERAGE AND RATING
Degroof Petercam, David Seynnaeve:
Buy
Kepler Chevreux, Christophe Dombu:
Buy
KBC Securities, Jacob Mekhael:
Hold
Van Lanschot Kempen, Suzanne van Voorthuizen:
Under review
BREAKDOWN OF SHARE CAPITAL
Based on transparency notifications and latest denominator
Based on online notification (FSMA website) of managers’ transactions
Total number of outstanding voting rights (denominator)
28,000,374
Total number of securities carrying voting rights not yet issued
309,313
Share capital (
excluding share premium
)
€140,001
0
2
4
6
8
10
12
14
16
18
20
06-2020
12-2020
06-2021
12-2021
06-2022
12-2022
06-2023
12-2023
06-2024
12-2024
HYLORIS
27.65%
13.78%
6.21%
5.38%
3.72%
43.26%
Stijn Van Rompay (Founder &co-CEO)
Thomas Jacobsen (Founder & co-CEO)
Nick Reunbrouck
Scorpiaux BV
Pieter Van Rompay
Free float
Hyloris is followed by the analysts
listed. Please note that any
opinions, estimates or forecasts
regarding Hyloris’ performance
made by these analysts are theirs
alone and do not represent
opinions, forecasts or predictions
of Hyloris or its management
Hyloris
: Annual report 2024
p49
Corporate
governance
Introduction
Hyloris’ Corporate Governance Charter is in line with the 2020 Belgian
Code on Corporate Governance (the Corporate Governance Code 2020),
which the Company needs to apply, in accordance with a ‘comply or
explain’ approach, pursuant to Article 3:6, §2, 1° CCA and the Royal
Decree of May 12, 2019 specifying the corporate governance code to be
complied with by listed companies.
The Corporate Governance Charter describes the main aspects of
the corporate governance of the Company, including its governance
structure, the terms of reference of the Board of Directors and its
committees and other important topics. The Corporate Governance
Charter must be read together with the Company’s Articles of Association,
which have been amended by the Extraordinary General Shareholders’
Meeting of June 11, 2024.
The Corporate Governance Charter and Articles of Association can
be consulted on the website of Hyloris at: https://hyloris.com/our-
governance.
p.50
Hyloris :
Annual report 2024
Contents
Introduction
...........................................................................................................................................
49
1.
Compliance with the Corporate Governance Code
.................................................
51
2.
Board of Directors
..............................................................................................................
53
3.
Remuneration Report
.......................................................................................................
65
4.
Internal control and
Risk Management Systems
...................................................
79
5.
Market abuse regulations
...............................................................................................
87
6.
Conflicts of interest and related parties
....................................................................
88
7.
Share capital, shares and shareholders
......................................................................
90
p.51
Hyloris :
Annual report 2024
1.
Compliance with the
Corporate Governance Code
As a Belgian listed company, Hyloris is subject to
the 2020 Belgian Code on Corporate Governance
(the Corporate Governance Code 2020). A copy
of the Corporate Governance Code 2020 is
available
on
the
Corporate
Governance
Committee’s website.
Companies are required to disclose the extent to
which they comply with the principles and best
practice provisions of the Corporate Governance
Code 2020 in their annual report. If a company
deviates from these principles, it must explain
why and to what extent.
Hyloris is committed to applying the corporate
governance principles outlined in the Corporate
Governance Code 2020, which are reflected in its
Corporate Governance Charter. This charter
aligns with the best practice provisions of the
Corporate Governance Code 2020 and outlines
key aspects of Hyloris’ corporate governance,
including its governance structure, the terms of
reference of the Board of Directors and its
committees, and other important governance
topics.
Both the Corporate Governance Charter and
Articles of Association are available on our
website.
This section of the annual report provides factual
insights into the corporate governance policy
pursued in the financial year 2024. Hyloris strives
to
apply
the
principles
of
the
Corporate
Governance Charter as fully as possible, while
ensuring they align with the unique character of
the Company.
Hyloris recognizes the importance of strong
corporate governance and fully endorses the
principles of the Corporate Governance Code
2020, following a ‘comply or explain’ approach in
accordance with Article 3:6, §2, 1° CCA and the
Royal Decree of May 12, 2019, which specifies the
corporate governance code applicable to listed
companies.
Hyloris deviates from certain best practice
provisions outlined in the Corporate Governance
Code 2020 for the reasons detailed in this
section. These deviations pertain exclusively to
our remuneration practices, which align with the
Remuneration Policy approved at our 2024
Annual General Meeting of Shareholders.
The Board of Directors believes that these
deviations are justified given Hyloris’ activities,
size, and the specific circumstances in which the
company operates.
Provision 2.19
: the powers of the members of
the Executive Management other than the Co-
CEO’s are determined by the Co-CEO’s rather
than by the Board of Directors as the members
of the Executive Management perform their
functions under the leadership of the Co-CEO’s,
to whom the day-to-day management and
additional well-defined powers were delegated
by the Board of Directors.
Provision 4.14
: no independent internal audit
function has been established yet. This deviation
is explained by the size of the Company. The
Audit Committee will regularly assess the need
for the creation of an independent internal audit
function.
Provision 7.6
: except for the Chairman, who
holds 2025 ESOP warrants, the Non-Executive
members of the Board of Directors do not
receive part of their remuneration in the form of
shares. This deviation is explained by the fact
p.52
Hyloris :
Annual report 2024
that the interests of the non-executive members
of
the
Board
of
Directors
are
currently
considered to be sufficiently oriented to the
creation of long-term value for the Company.
Since its listing in 2020, Hyloris has always
focused on a long-term perspective as reflected
in its strategic decision to grow the portfolio of
product candidates over the next few years. The
Board of Directors has indeed decided not to
provide remuneration in the form of shares in
the company for non-executive directors and is
of the opinion that, considering the limited size
of the total remuneration package awarded to
non-executive directors, the total or partial
remuneration in the form of shares of the
company would not have a meaningful impact on
the behavior or decisions of the company’s non-
executive directors. The Board of Directors will
continue to safeguard that the contributions of
the non-executive directors are made with the
long term company’s interest in mind.
Provision
7.9
:
for
the
same
reasons
as
mentioned with respect to provision 7.6; no
minimum threshold of shares to be held by the
members of the Executive Committee has yet
been set. The Board has determined that there
are sufficient safeguards in place to ensure that
the members of the executive management take
decisions and perform their tasks in accordance
with the interest of the Company in the long
term. The members of the Executive Committee
also hold shares and/or ESOP Warrants which
requires them to always take into consideration
a
long-term
perspective
of
the
Company,
especially as the ESOP Warrants are only vested
after a period of 4 years after granting and
cannot
be
exercised
before
the
4th
year
following the year of the offer (see 7.2).
Provision 7.10
: the Board believes that there is
no need to formally define a maximum for the
variable short-term remuneration for executive
Directors as this remuneration (package) is
completely
in
line
with
the
remuneration
(package) of the other members of the Executive
committee and also considers the low amounts
of
this
short-term
variable
remuneration
compared to other listed companies. For 2024,
the total maximum variable remuneration for
those members of the Executive Committee still
in service on December 31, 2024 is on average
13%
of
the
total
amount
of
the
fixed
remuneration.
Provision 7.12
: the Board believes it is not
opportune to have specific provisions to claim
back or withhold payment of the variable part of
the remuneration of the members of the
Executive
Management
mainly
because
it
believes that there are sufficient contractual
rights and rights under common law available
that allow it to claim back such amounts.
Good corporate governance is dynamic and
evolves in response to the company’s changing
circumstances and global governance standards.
It
must
be
tailored
to
adapt
to
these
developments.
The
Board
of
Directors
is
committed to regularly reviewing and updating
the Corporate Governance Charter as needed to
ensure it remains aligned with the company’s
structure, operations, and best practices.
p.53
Hyloris :
Annual report 2024
2.
Board of Directors
2.1.
Composition of the Board of Directors
Since
the
appointment
by
the
General
Shareholders’ Meeting on September 30, 2024,
the
Board
of
Directors
consists
of
seven
members, including two Executive Directors
(who are part of the Executive Committee) and
five Non-Executive Directors, of whom three are
Independent Directors.
Currently,
the
Board
includes
one
female
Director. To meet gender diversity requirements,
Hyloris is actively seeking new Non-Executive
Directors, with a specific focus on attracting
female Board Members, in accordance with
Article 3:6 § 2, 6° of the Belgian Companies Code
and the Law of July 28, 2011. The company is
committed to ensuring the appropriate quorum
and gender diversity is achieved by 2026 (the
sixth year after the Initial Public Offering).
Hyloris intends to appoint at least one additional
female Non-Executive Director before 2026 and
is confident this requirement will be met. Moving
forward, the company will continue to prioritize
gender diversity when renewing Board members
and filling new positions.
Despite operating with a relatively small team
and a flat structure, Hyloris considers diversity
across the entire organization, which already
reflects a broad range of gender, nationality, age,
seniority, and educational backgrounds.
The table below provides an overview of the
members of the Board of Directors since
September 30, 2024, along with their respective
terms as of the date of this annual report:
Name
Age
Position
Start
of term
End
of term*
Mr. Stefan Yee
63
Non-Executive Director
Chairman of the Board of Directors
2024
2028
Mr. Stijn Van Rompay
1
49
Executive Director
2024
2028
Mr. Thomas Jacobsen
2
50
Executive Director
2024
2028
Mr. Leon Van Rompay
3
75
Non-Executive Director
2024
2028
Mr. Marc Foidart
49
Independent Director
2024
2028
Ms. Revital Rattenbach
48
Independent Director
2024
2028
Mr. Vincent Van Dessel
66
Independent Director
2024
2028
1
Acting through SVR Management BV
2
Acting through Jacobsen Management BV
3
Acting through Van Rompay Management BV
p.54
Hyloris :
Annual report 2024
*In subsequent sections, it will be assumed that when a director is mentioned by name that they are acting through
the management company identified in this table.
Stefan Yee
Stefan Yee has more than 30 years of experience in audit, corporate law, mergers and
acquisitions, corporate finance, investment banking and private equity with companies
as KPMG, Linklaters, the Flemish investment bank Lessius, the Belgian Corporation for
International Investment (SBI/BMI), Beluga (Euronext Brussels) and as the founder and
CEO of the PE Group, a Belgian privately held private equity firm. Stefan is, and has
been an investor and/or board member of several listed and private companies such
as, amongst others, Beluga, Encare group (Mensura), AXI, The Reference, Alro Holdings,
Loomans Group, United Brands, Capco, Faseas International (Spacewell), HD Partners (Dekabo group),
AED Rent, UnifiedPost Group, NRG New Generation, Axiles Bionics, including several healthcare
companies Docpharma (listed on Euronext Brussels until its acquisition in 2005 by Matrix Laboratories for
€218M), Uteron Pharma and Imcyse). Stefan holds a Master’s Degree in Law and Business Management
from the Universities of Brussels (VUB and ULB Solvay Business School) and the University of Chicago (as
a BAEF Fellow).
Stijn Van Rompay
Stijn Van Rompay has over 20 years of experience in leadership positions in the
pharmaceutical industry and is the co-founder and CEO of the Company. Stijn also
co-founded, and was CEO of, Alter Pharma, a pharmaceutical company focused on
the development of complex generics and pharmacy-related products. He was also
co-CEO of Uteron Pharma, a company focused on innovative female healthcare
products, which was sold to Watson for up to $305M in 2013. Prior to these positions,
Stijn was CFO and afterwards CEO of Docpharma (listed on Euronext Brussels until its
acquisition in 2005 by Matrix Laboratories for €218M) a generics and medical device
company. He also holds several Non-Executive Director positions in the biotech sector and acts as an
advisor to venture capital investors. Stijn holds a Master in Applied Economics from the University of
Antwerp and an honorary doctorate from Long Island University.
Thomas Jacobsen
Thomas Jacobsen has over 20 years of experience in the pharmaceutical industry,
with expertise in operational management, business development, licensing, and
research and development. He co-founded Alter Pharma and prior to this, he worked
with Docpharma, where he focused on out-licensing of Docpharma’s products.
Thomas started his career in the Scandinavian-based generics company Alternova,
where he was responsible for licensing, product registration and launches. Thomas
holds a Master’s Degree in Pharmacy from the University of Copenhagen and a
Business Degree from Copenhagen Business School.
p.55
Hyloris :
Annual report 2024
Leon Van Rompay
Leon Van Rompay has more than 40 years of experience in the pharmaceutical
industry. During his professional career he held several positions including country &
area manager (covering major territories) and Board member of the Zambon Group.
He was founder and CEO of Docpharma and served on different Boards including
Ecodis and Uteron Pharmaceuticals. He was a founding member of BIGE/IBES (Belgian
Institute for Health and Economics), the B.G.A. (Belgian Generic Association), BAPIE
(Belgian Association of Parallel Import and Export) and was an executive committee
member and Board member of the Belgian Pharmaceutical Industry Association. He also was a member
of the pharmaceutical deontological commission and responsible for this commission in the industry
association executive committee. He was interim-CEO of the Belgian women’s health company, Mithra, a
Euronext listed company.
Marc Foidart
Marc Foidart is co- founder and Executive Chairman of Eyed Pharma SA, a start-up
company developing innovative controlled release micro-implants in ophthalmology
and is also co-founder of EKLO ASBL. Marc is also investment manager of Epimede
SA, a €50 million Belgian private high-tech growth fund. He has more than 15 years
of experience in strategic consulting and investment at all stages of development of
small and medium high tech-high growth life sciences enterprises. He played a key
role in several financing rounds at critical development stages of various Belgian
biotech companies including, Mithra Pharmaceuticals SA, Imcyse SA, Uteron Pharma SA, PDC Line Pharma
SA, Diagenode SA. As an entrepreneur, Marc is co-founder and past CEO of Arlenda SA, a spin-off company
of the University of Liège providing expert statistical solutions to the pharmaceutical, chemical and
environmental industries. Marc is associate professor at the University of Liege since 2011 and obtained
a Master in Business Engineering from the University of Liège (1998).
Revital Rattenbach
Revital Rattenbach is an accomplished entrepreneur and leader with a proven track
record of bringing groundbreaking biotech innovations from conception to clinical
stages. Holding an MBA from IAE Paris and a PhD in Biology of Ageing from the
Université René Descartes, Paris, she combines deep scientific expertise with robust
business acumen. As the Founder and CEO of 4P-Pharma, Revital has successfully
transitioned multiple assets into clinical phases, leveraging partnerships with
regulatory bodies like the EMA and FDA.
In her role as Co-Founder and President of both 4Living and 4Moving Biotech, she has pioneered
treatments for osteoarthritis and complications from viral infections, securing multiple patents and
leading international clinical trials. Her strategic vision is evident in her leadership, having spearheaded
p.56
Hyloris :
Annual report 2024
significant collaborations with industry giants such as Sanofi, and navigating complex regulatory
landscapes to drive product development and market entry.
Revital has received multiple awards including the US Gallien nomination and the European Commission’s
Seal of Excellence.
Vincent Van Dessel
Vincent Van Dessel started his career as a stockbroker in 1984 at Cohen, De Greef,
Van Dessel & C° in Brussels and later (1989) Van Dessel & C° in Antwerp. He joined the
Brussels Stock Exchange in 1992 as Director Markets and Listing and later became
member of the management board of the Brussels Exchanges. At the merger of the
Amsterdam, Paris and Brussels exchanges into Euronext in September 2000, he
became member of the executive committee. From January 2000 to June 2003,
Vincent Van Dessel was Chairman of the Market Authority of the Brussels Exchanges,
responsible for members admission, listing, company information and the
supervision of the markets. From 2003 to 2009, he was General Manager of Euronext Brussels. Vincent
has been member of the Managing Board of NYSE Euronext Group and Chairman and CEO of NYSE
Euronext Brussels from 2009 till the takeover by InterContinental Exchange at the end of 2013.
After the spin-off of Euronext from NYSE Euronext in 2014 and until June 2023 (as CEO) and November
2023 (as Chairman of Euronext Brussels), he was member of the Management Board of Euronext and
Chairman and CEO of Euronext Brussels. He has been appointed member of the Board of VFB on 7 May
2024 and became Chairman as from 1 January 2025.
Vincent Van Dessel also acted as:
Chairman of the Belgian Working Group Financial Markets which successfully organized the transition
to the euro of the Belgian financial markets and products
Member of the Steering Committee of the European Money Markets Institute (managing the Euribor
index)
Member of the Corporate Governance Commission of Belgium
Guest lecturer in different universities of which KU Leuven, UCL, Solvay Business School, HEC Liège,
Antwerp University and Paris Sorbonne.
Vincent Van Dessel is PhD in Applied Economics from the KU Leuven University, Belgium
p.57
Hyloris :
Annual report 2024
2.2.
Activity Report
In 2024, alongside discussions on financial
reporting and the operational development of
the Company, the Board of Directors dedicated
significant attention to the forensic investigation
on
the
Transactions
with
Qliniq,
product
development, and business development, with a
strong focus on expanding the Company’s
growth and strategy.
Additionally, the Board closely monitored the
Company’s
cash
requirements,
regularly
evaluating potential measures to address these
financial needs.
The Board of Directors convened seventeen
times in 2024, being:
Sixteen
meetings
with
the
previous
Board members, and
One meeting in December 2024 with the
newly appointed Board members.
The following chart provides a comprehensive
overview of the attendance of Board members
throughout 2024*:
Mr. Stefan Yee
17/17
Mr. Stijn Van Rompay
17/17
Mr. Thomas Jacobsen
15/17
Mr. Leon Van Rompay
17/17
Mr. Marc Foidart
16/17
Mrs. Carolyn Myers
12/16
Mr. James Gale
14/16
Mr. Chris Buyse
13/16
Ms. Revital Rattenbach
1/1
Mr. Vincent Van Dessel
1/1
Including those Board members whose mandate
has ended in September 2024.
In 2024, the Board of Directors did not convene
for specific decision-making as prescribed by
article 7:97 of the Belgian Company Code with
respect to a decision relating to a related party as
defined by EC Directive 1606/2002, nor with
respect to any decisions on conflicts of interest.
p.58
Hyloris :
Annual report 2024
2.3.
Committees of the Board of Directors
The Board had already established two Board
Committees: the Audit Committee and the
Remuneration & Nomination Committee.
At its meeting of February 28, 2024, the Board of
Directors decided to install a new “Product
Selection Committee”. While the committee has
not yet been activated and no members have
been
appointed,
the
Company
intends
to
evaluate its setup and initiate its activities during
the course of 2025.
Currently, no Scientific Committee has been
formally established within the Company.
Audit Committee
Composition
The Audit Committee, a subcommittee of the
Board of Directors, consists of board members
and operates under the authority defined by law
and the Corporate Governance Code. The Board
of
Directors
may
also
assign
additional
responsibilities as needed. The committee plays
a crucial role in supporting the Board by ensuring
effective oversight across all areas, including risk
management.
The Audit Committee is comprised of the
following members:
Mr. Vincent Van Dessel
,
Independent Director, Chairperson of the Audit
committee
Mr. Stefan Yee
,
Non-Executive Director
Mr. Marc Foidart
,
Independent Director
The Audit Committee consists of at least three (3)
non-executive directors, with at least one third
being
independent
directors.
Its
members
collectively possess expertise in the company's
field of activities, and at least one member has
specialized
competence
in
accounting
and
auditing. The Chairman of the Board of Directors
nominates candidates for Audit Committee
membership, subject to approval by the Board.
The Board also selects the Chairman of the Audit
Committee from among its members; however,
the Chairman of the Board of Directors is not
eligible to chair the committee.
Members of the Audit Committee have full
access to the Executive Committee and any other
employees
necessary
to
fulfil
their
responsibilities.
Additionally,
the
company's
statutory auditor has direct and unrestricted
access
to
the
Chairperson
of
the
Audit
Committee.
Mission
In accordance with Article 7:99 of the Companies
and Associations Code, the Audit Committee
fulfills the following missions:
a)
communication to the Board of Directors of
the legal control of the statutory and
consolidated accounts and explanations on
how the legal control on the statutory and
consolidated accounts has contributed to the
integrity of the financial information and on
the role played by the Audit Committee in
this process;
b)
monitoring the process of preparing financial
information and making recommendations
or proposals to ensure its integrity;
c)
monitoring
the
effectiveness
of
the
company's internal control systems and risk
management;
d)
evaluation of the need to establish an
internal auditor and its effectiveness;
e)
monitoring the statutory audit of the annual
and
consolidated
accounts,
including
monitoring the issues and recommendations
made by the auditor and, if applicable, by the
auditor responsible for the audit of the
consolidated accounts;
f)
review and monitoring of the independence
of the auditor and, if applicable, of the
auditor responsible for the audit of the
p.59
Hyloris :
Annual report 2024
consolidated accounts, particularly regarding
the
justification
for
the
provision
of
additional services to the company. In
particular, it analyzes with the auditor the
risks to the independence thereof and the
safeguard measures applied to mitigate
these risks, when the total fees relating to an
entity referred to in Article 1:12 of the
Companies and Associations Code exceed
the criteria set by Article 4, § 3, of Regulation
(EU) No. 537/201;
g)
recommendation to the Board of Directors of
the company for the appointment of the
auditor and, if applicable, of the auditor
responsible for the audit of the consolidated
accounts, in accordance with Article 16, § 2,
of Regulation (EU) No. 537/2014. The Audit
Committee has the power to investigate any
matters falling within its remit, subject to
compliance with legal restrictions on access
to commercial and other confidential data.
For this purpose, it has the necessary
resources and access to all information and
may request opinions from internal and
external experts. The responsibility of the
members of the Audit Committee towards
the Board of Directors is to assume the
mission stipulated in this regulation with the
diligence of a good family father and in
complete autonomy.
The Audit Committee carries out its mission in
the following three areas:
a) Financial information for shareholders and third
parties.
The Audit Committee, with the support of the
CFO as needed, reviews the annual and semi-
annual
social
and
consolidated
financial
statements, prospectuses, and other financial
reports before they are submitted to the Board
of Directors. Interim financial data, prepared
under the CFO’s responsibility, is presented to
the Audit Committee for review, ensuring the
Board can effectively oversee the financial
reporting process.
In
its
review
of
the
financial
information
preparation
process,
the
Audit
Committee
assesses the relevance and consistency of the
Hyloris Group’s accounting standards, including
criteria for consolidating accounts within the
group. This review focuses on ensuring the
completeness
and
coherence
of
financial
information.
The Audit Committee also evaluates any changes
to accounting principles and valuation rules,
providing an informed opinion to the Board of
Directors, particularly regarding their impact on
financial statements.
Additionally,
the
CFO
updates
the
Audit
Committee on the accounting methods used for
significant
or
unusual
transactions
where
multiple treatment approaches exist, as well as
the
rationale
behind
activities
conducted
through specific structures.
b) Internal control and risk management
At least once a year, the Audit Committee reviews
the internal control and risk management
systems established by the Executive Committee
to ensure that key risks – including those related
to compliance with laws and regulations – are
effectively
identified,
managed,
and
communicated in alignment with the framework
approved by the Board of Directors. Additionally,
the Audit Committee examines the internal
control
and
risk
management
disclosures
included in the Corporate Governance Statement
of the annual report.
c) External audit
The Audit Committee reviews reports prepared
by the auditor(s), including disclosures on all
relationships between the auditor(s) and the
company or its group. It evaluates the nature,
quality, and scope of the auditor(s)' work, the
coordination of audit activities within the Hyloris
Group, and the conclusions drawn from their
work,
including
management
letters.
Additionally, the committee assesses the extent
to which the Co-CEO’s consider and implement
the
recommendations
provided
by
the
auditor(s).
p.60
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Annual report 2024
The Audit Committee recommends to the Board
of Directors the appointment, potential renewal,
and remuneration of the auditor(s) for certifying
both
the
statutory
accounts
of
Hyloris
Pharmaceuticals and the group’s consolidated
accounts.
It
also
ensures
the
auditors’
independence
in
accordance
with
the
Companies
and
Associations
Code.
Any
additional engagements falling under Article 3:62
of
the
Companies
and
Associations
Code,
whether performed by the auditor(s) or affiliated
entities, require prior authorization from the
Audit Committee.
Evaluation
The Audit Committee evaluates its internal rules
and their effectiveness at least every three years,
and, if necessary, recommends adjustments to
the Board of Directors.
Meetings
The Audit Committee, convened by its Chairman,
meets at least four times a year or as needed to
effectively fulfill its responsibilities. Meetings are
considered valid when a majority of members
are present or represented. The committee may
hold meetings via telephone, video conference,
or online platforms. Unless explicitly stated
otherwise in the regulations, decisions may also
be made by written consent of the directors.
Depending on the agenda items, the Chairman of
the Audit Committee may invite the CFO, the Co-
CEO’s, or any member of the management
and/or any senior executive of the company.
The auditor(s), who are key interlocutors of the
Audit Committee, may request to meet with the
committee at any time without prior justification.
If necessary, they may be accompanied by an
operational manager.
Topics related to the audit plan and any issues
arising from the audit process are regularly
included on the Audit Committee’s agenda. Two
meetings each year are primarily dedicated to
reviewing the annual and semi-annual financial
statements, during which the auditor(s) present
their findings. These meetings also provide an
opportunity for open discussions with the
auditor(s) on any matters within the Audit
Committee’s
scope,
including
key
audit
observations and significant weaknesses in
internal control.
The Chairman of the Audit Committee or any two
of
its
members
may
convene
a
meeting
whenever necessary.
Additionally, the Audit Committee may assign
specific tasks to the auditor(s) or other experts
and request reports on their findings. The
auditor(s) may also communicate directly with
the Board of Directors through its Chairman
while keeping the Audit Committee informed.
In their decision-making process, members of
the Audit Committee will seek consensus.
The minutes of the Audit Committee meetings
are
kept
at
the
Secretariat
of
Hyloris
Pharmaceuticals. The minutes are signed by the
Chairman of the Audit Committee and by the
members who wish to do so. The Chairman of
the Audit Committee presents activity reports to
the Board of Directors. All members of the Board
of Directors, as well as the auditor(s), have access
to
said
minutes.
Members
of
the
Audit
Committee
are
bound
to
confidentiality
regarding
the
information
received
during
meetings.
The Audit Committee convened 5 times in 2024*.
Mr. Marc Foidart
5/5
Mr. Stefan Yee
5/5
Mr. James Gale
4/5
Mr. Chris Buyse
4/5
Mr. Vincent Van Dessel
1/1
Mr. Gale and Mr. Buyse were replaced as Directors
of the company at the general shareholders
meeting of September 30, 2024. Mr. Van Dessel
was appointed by same shareholders meeting.
p.61
Hyloris :
Annual report 2024
Remuneration and Nomination Committee
Since September 30, 2024, the Remuneration
and Nomination committee consists of the
following members:
Mr. Stefan Yee
,
Chairperson of the Renumeration and
Nomination Committee
Ms. Revital Rattenbach
,
Independent Director
Mr. Marc Foidart
,
Independent Director
The Remuneration and Nomination Committee
is
composed
exclusively
of
Non-Executive
Directors, including at least one independent
director as defined by Article 7:87 of the Belgian
Code of Companies and Associations. This
composition ensures independence and helps
prevent conflicts of interest in the design,
adjustment,
and
implementation
of
the
Remuneration Policy for Executive Committee
members.
The
Co-CEO’s
and
Executive
Committee members do not participate in the
committee’s deliberations regarding their own
compensation. The committee is chaired by
either the Chairperson of the Board of Directors
or another Non-Executive Director.
Members of the Remuneration Committee must
possess the necessary expertise in remuneration
policy, as demonstrated by their experience and
previous roles (see 2.2 Composition of the Board
of Directors for more details on their curriculum
vitae). The Co-CEO’s may attend committee
meetings in an advisory capacity whenever the
remuneration of another Executive Committee
member is under discussion.
The primary role of the Remuneration and
Nomination
Committee
is
to
make
recommendations to the Board of Directors
regarding the appointment and compensation of
Directors and Executive Committee members. Its
key responsibilities include:
As part of its remuneration function:
o
Recommending the remuneration policy
and other compensation proposals that
the Board of Directors must submit to the
General Shareholders’ Meeting.
o
Proposing
individual
remuneration
packages for Directors and Executive
Committee members, in line with the
approved
remuneration
policy.
This
includes variable remuneration, long-
term performance bonuses (whether
linked to shares or not), stock options
(warrants) or other financial instruments,
and
severance
packages.
Where
applicable,
the
committee
also
formulates proposals that the Board of
Directors must present to the General
Shareholders’ Meeting.
o
Preparing
the
remuneration
report,
ensuring it aligns with the approved
remuneration policy, for inclusion in the
corporate governance statement, which
forms part of the Company’s annual
report.
o
Presenting
and
explaining
the
remuneration
report
at
the
Annual
General Shareholders’ Meeting.
As part of its nomination function:
o
Recommending
candidates
for
appointment as Board members and
Executive Committee members.
o
Developing succession plans to ensure an
orderly transition for Board members.
o
Leading the re-appointment process for
Board members.
o
Overseeing the succession planning of
Executive Committee members, ensuring
regular and strategic attention is given to
leadership continuity.
o
Promoting
leadership
development
initiatives and diversity programs to foster
a strong and inclusive talent pipeline.
The Remuneration and Nomination Committee
meets as often as necessary to
fulfil its
responsibilities effectively and at least twice a
p.62
Hyloris :
Annual report 2024
year. It regularly reports to the Board of Directors
on its activities and findings.
At the end of each Board member’s term, the
committee conducts an evaluation of their
performance,
assessing
factors
such
as
attendance at Board and committee meetings,
level of commitment, constructive participation
in discussions, and contribution to decision-
making. Additionally, it considers whether each
Board member’s skills and expertise remain
aligned with the company's evolving needs.
Based on the results of this evaluation, the Board
of Directors takes appropriate action, which may
include proposing new Board members, deciding
not
to
reappoint
existing
members,
or
implementing other measures to ensure the
Board’s continued effectiveness.
The Remuneration and Nomination Committee
convened 2 times in 2024.
Mr. Stefan Yee
2/2
Mrs. Carolyn Myers
2/2
Mr. Marc Foidart
2/2
Ms. Revital Rattenbach
0/0*
Ms. Myers was replaced as Directors of the
company at the general shareholders meeting of
September
30,
2024.
Ms.
Rattenbach
was
appointed by same shareholders meeting and
therefor was not a member of the Remuneration
and
Nomination
Committee
yet
when
the
meetings were held.
Product Selection Committee
At its meeting on February 28, 2024, the Board of
Directors established a new Product Selection
Committee. The committee is composed of at
least two non-executive Board members, along
with the Co-CEO’s and the COO. The committee
has not yet been activated and no members have
been appointed yet but the Company intends to
evaluate its setup and initiate its activities during
the course of 2025.
The Product Selection Committee is responsible
for preparing proposals for the Board of
Directors regarding the approval of new product
candidates. It evaluates potential products,
considering key aspects such as:
Development stage and regulatory pathway
Costs associated with further development,
registration, and commercialization
Market
potential
and
competitive
positioning
Pricing strategy and expected financial
return
The committee meets as needed to effectively
fulfill its responsibilities and reports regularly to
the
Board
of
Directors,
particularly
when
presenting
a
new
product
candidate
for
approval.
Members of the Product Selection Committee
have
unrestricted
access
to
the
Executive
Committee and any other employees necessary
to carry out their duties.
Scientific Committee
The Company has not yet formally established a
Scientific Committee.
p.63
Hyloris :
Annual report 2024
2.5.
Executive Committee
The Board of Directors has established an
Executive
Committee
and
appointed
its
members in consultation with the Co-CEO’s,
based
on
recommendations
from
the
Remuneration and Nomination Committee. The
Executive Committee serves as an advisory body
to the Board of Directors and does not constitute
a “conseil de direction” / “directieraad” as defined
in Article 7:104 of the CCA. The Board prioritizes
maintaining
a
balanced
and
well-rounded
Executive team.
When proposing candidates for the Executive
Committee,
the
selection
process
carefully
considers
educational
and
professional
backgrounds, complementary skills, knowledge,
and experience, as well as diversity in age,
gender, and nationality. While all diversity
requirements are met, the gender requirement
remains an area for further progress. Members
of the Executive Committee come from diverse
educational and multidisciplinary professional
backgrounds. The 5 members of the committee
represent three different nationalities.
As
of
December
31,
2024,
the
Executive
Committee consisted of the following members:
Mr. Stijn Van Rompay
4
,
Co-Chief Executive Officer
Mr. Thomas Jacobsen
5
,
Co- Chief Executive Officer & Chief
Business Development Officer
Mr. Dietmar Aichhorn
,
Chief Operating Officer
M
r. Christophe Maréchal
6
,
Chief Financial Officer
The Executive Committee generally meets every
week. The members of the Executive Committee
also
meet
on
an
informal
basis
through
conference and video calls every time it is
required for its proper functioning.
4
Acting through SVR Management BV.
Stijn Van Rompay
Stijn Van Rompay has over
20 years of experience in
leadership positions in the
pharmaceutical
industry,
and is the co-founder and
Co-CEO of the Company.
Stijn co-founded, and was
CEO of, Alter Pharma, a
pharmaceutical
company
focused
on
the
development
of
complex
generics
and
pharmacy-related products. He was also co-CEO
of Uteron Pharma, a company focused on
innovative female healthcare products, which
was sold to Watson for $305M in 2013. Prior to
these positions, Stijn was CFO and afterwards
CEO of Docpharma (listed on Euronext Brussels
until
its
acquisition
in
2005
by
Matrix
Laboratories for €218M) a generics and medical
device company. He also holds several Non-
Executive Director positions in the biotech sector
and acts as an advisor to venture capital
investors.
Stijn holds a Master in Applied Economics from
the University of Antwerp.
Thomas Jacobsen
Thomas Jacobsen has over
20 years of experience in the
pharmaceutical
industry,
with
expertise
in
operational
management,
business
development,
licensing, and research and
development. He co-founded Alter Pharma and
prior to this, he worked with Docpharma, where
he focused on out-licensing of Docpharma’s
products. Thomas started his career in the
Scandinavian-based
generics
company
5
Acting through Jacobsen Management BV.
6
Acting through CMM&C BV.
p.64
Hyloris :
Annual report 2024
Alternova,
where
he
was
responsible
for
licensing, product registration and launches.
Thomas holds a master’s degree in pharmacy
from the University of Copenhagen and a
Business Degree from Copenhagen Business
School.
Dietmar Aichhorn
Dietmar Aichhorn has more
than 20 years of experience
in
the
pharmaceutical
industry leading teams in a
broad range of functions,
including,
development,
regulatory,
clinical
development, product launch and logistics of
small
molecules,
biologics
and
Advanced
Therapy Medicinal Products. Before joining
Hyloris in October 2020, Dietmar worked in
clinical development at Polpharma Biologics and
Vira Therapeutics, Innovacell Biotechnology as
Head of Development. Dietmar’s experience also
includes Strategic Planning, M&A and post-
merger integration at Mylan and Novartis.
Dietmar holds a degree in chemistry and a
degree in economy from Vienna University of
Economy and is a lecturer at the Medical
University of Innsbruck and the Austrian Medical
Association.
Christophe Maréchal
Christophe Maréchal is an
experienced executive with
a
strong
background
in
financial
and
strategic
leadership. With over 30
years
of
professional
experience,
he
has
held
senior financial roles across various industries,
including
pharmaceuticals,
EPC,
telecommunications, glass manufacturing, and
banking. His career includes key positions with
major
international
organizations
such
as
Orange and AGC, and Mithra Pharmaceuticals,
providing him with valuable global exposure.
Christophe has expertise in corporate finance,
equity fundraising, investor relations, mergers
and acquisitions, tax planning, treasury, supply
chain
optimization,
and
financial
risk
management.
He
has
developed
and
implemented
strategies
to
drive
long-term
business growth and improve operational and
financial performance.
He holds a Master of Business Administration in
Commercial Engineering from the University of
Liège, Belgium, and has studied econometrics at
the Katholieke Universiteit Brabant in Tilburg,
Netherlands.
p.65
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3.
Remuneration Report
3.1.
Remuneration Policy - General
3.1.1.
Introduction
The
Remuneration
Policy
of
Hyloris
Pharmaceuticals SA has been established in
accordance with the Belgian Code of Companies
and
Associations
(BCCA)
and
the
recommendations of the Belgian Corporate
Governance Code (Code 2020). This policy has
been in effect since January 1, 2021.
The Remuneration Policy applies to all Non-
Executive Directors, Executive Directors, and
other members of the Executive Committee.
Executive Directors are also members of the
Executive Committee.
At the time of Board approval, Hyloris did not
have any other individuals holding management
positions as defined under Article 7:121 of the
BCCA.
Our remuneration policy is available on our
website here.
3.1.2.
Objective of the Hyloris’
Remuneration Policy
Our Remuneration Policy is designed to reward
contributions that drive the achievement of
company objectives and create long-term value
for stakeholders. Hyloris aims to remain a
competitive market player by benchmarking
against
appropriate
peer
groups
and
incentivizing high-level performance.
The
primary
objective
of
the
Hyloris
Remuneration Policy is to attract, motivate, and
retain diverse, highly qualified, and experienced
individuals who are essential to achieving our
corporate, strategic, and operational goals. We
strive
to
offer
competitive
remuneration
packages that align with market practices in key
regions where we compete for top talent.
Additionally, the policy ensures fairness and
consistency between executive and employee
remuneration while effectively managing risks
and controlling wage-related costs.
The
Board
of
Directors
mandates
the
Remuneration Committee to assess and evaluate
the
remuneration
packages
of
Executive
Directors,
Non-Executive
Directors,
and
employees. The committee consults with the
Board and considers comprehensive workforce
remuneration
data,
market
research,
and
industry benchmarks to ensure all employees
receive
competitive
and
motivating
compensation.
As Hyloris continues to evolve in a dynamic and
competitive environment, the Remuneration
Policy will be regularly reviewed and updated to
maintain alignment with market standards. Any
proposed
amendments
will
be
subject
to
approval by the General Shareholders’ Meeting.
Reflecting our Mission and Values
Our Remuneration Policy is designed to reinforce
our mission, identity, and core values. We
recognize the intrinsic motivation of our team to
contribute to our mission and believe that
aligning the interests of our senior leadership
team with those of our stakeholders is essential
for long-term success.
p.66
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Our Mission
We are committed to transforming patients’
lives by providing medicines that address
unmet
medical
needs.
Achieving
this
mission requires success across a range of
complex
and
competitive
activities,
including:
Discovering, researching, and developing
highly innovative pharmaceutical product
candidates.
Establishing
and
maintaining
strategic
collaborations with key industry experts
worldwide.
Managing
resources
efficiently
and
responsibly
to
advance
our
products
through regulatory approval.
Commercializing our products effectively,
ensuring that our innovative therapies reach
the patients who need them most.
Our Commitment to Talent
We strongly believe that our long-term success
depends on our ability to attract and retain top-
tier
talent—individuals
who
are
deeply
committed to executing our business objectives
while upholding and promoting our identity and
core values.
Our
Core
Values
and
Leadership
Competencies
Core Values:
Taking initiative - Problem Solving - Courage
- Entrepreneurship - Initiative
Functional
Knowledge
and
Skills
-
Communication - Decisiveness - Planning &
Organisation
Teamwork & Orientation - Collaboration -
Ambition – Energy
Service to others - Building trust – Integrity
Leadership Competences:
Coach/Develop others
Empower/Delegate others
Lead change
Strategically focused
Remuneration Policy Objectives
Our Remuneration Policy is designed to foster
long-term success by attracting and retaining top
talent while aligning compensation with our
strategic goals. This policy enables us to:
Attract, retain, and motivate top talent by
offering
market-competitive
remuneration packages tailored to the
regions in which we operate.
Drive long-term value creation over
short-term gains through a balanced
equity-based compensation approach,
including ESOP Warrants, as well as
short-term
and
long-term
variable
remuneration schemes.
Align
variable
remuneration
for
Executive
Committee
members
with
challenging short-term goals that directly
support
our
long-term
business
objectives and core values.
Commitment
to
Fair
&
Transparent
Compensation
We
are
committed
to
ensuring
that
our
remuneration packages are competitive, aligned
with market practices, and transparent. We
actively
engage
in
open
dialogue
with
stakeholders
to
continuously
enhance
the
quality and clarity of our disclosures.
Role of the Remuneration & Nomination
Committee
Any decision regarding the remuneration of
Executive Committee members will be based on
a recommendation from the Remuneration and
Nomination Committee. The committee will
justify its recommendations by assessing the
competitiveness, reasonableness, and fairness
of proposed compensation, considering:
The unique talents and expertise of the
individual.
The value they bring to the company.
p.67
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Industry
benchmarks
and
market
standards.
This approach ensures that our remuneration
framework remains equitable, performance-
driven, and aligned with our long-term strategic
vision.
3.1.3.
Deviation from the Remuneration Policy
In exceptional circumstances, the Board of
Directors may choose to deviate from specific
provisions of this Remuneration Policy if such a
deviation is deemed necessary to:
Protect the company’s long-term interests
and sustainability.
Safeguard the company’s viability.
Procedural Safeguards for Deviation
If the Board decides to grant remuneration
outside the scope of this policy, the following
procedural requirements will apply:
Value-Based & Competitive Compensation
Any
remuneration
granted
must
be
commensurate with the value the individual
brings to the company.
It must be competitive within the relevant
market(s) where we compete for talent.
For executives, a significant portion of the
compensation must be performance-based,
linked to specific strategic targets.
Remuneration and Nomination Committee
Consultation
The
Remuneration
and
Nomination
Committee will be consulted on any proposed
deviation before it is approved.
Transparency & Shareholder Oversight
Any deviations from the policy will be
disclosed in the annual remuneration report.
The report will outline:
o
The rationale for the deviation.
o
The expected duration of the deviation.
Shareholders will have the opportunity to
provide an advisory vote on remuneration
practices for the respective year.
By
implementing
these
strict
governance
measures, we ensure that any deviation from the
policy
remains
exceptional,
justified,
and
transparent, maintaining alignment with our
corporate strategy and stakeholder interests.
3.1.4.
Changes to the Remuneration Policy
This 2025 remuneration policy is based on the
principles of the current (2024) policy and no
changes were made.
Hyloris does not anticipate any material changes
to this policy in the next two years but will review
the Remuneration Policy regularly in order to
reflect market conditions and optimize and - as
the case may be - improve the objective of the
Remuneration Policy to attract, motivate and
retain diverse, qualified and expert individuals.
p.68
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Annual report 2024
3.2.
Remuneration Policy for Non-Executive Directors
The remuneration of Non-Executive Directors
will be reviewed and adjusted as necessary
through regular benchmarking exercises to
ensure
that
compensation
remains
fair,
competitive, and aligned with market standards.
This approach helps to attract, retain, and
motivate qualified Non-Executive Directors.
Committee Compensation
Non-Executive Directors who serve on special
committees of the Board receive additional fees
as compensation for the extra commitment and
responsibilities associated with these roles.
Those serving on multiple committees—such as
the Remuneration Committee and the Audit
Committee—will receive appropriate additional
compensation for each position.
Approval Process
The Board of Directors submits proposed
adjustments to the remuneration of Non-
Executive
Directors
for
approval
by
the
shareholders
at
the
Annual
Shareholders’
Meeting.
Equal Compensation Policy
The Remuneration and Nomination Committee
and the Board agree that all Non-Executive
Directors—including
independent
directors
under Article 7:87 of the BCCA—should receive
equal compensation as outlined below.
Remuneration Structure
Non-Executive Directors receive:
A fixed annual remuneration for their role
on the Board.
An additional fixed annual remuneration for
serving
on
a
Board
committee
(e.g.,
Remuneration
Committee
or
Audit
Committee).
As of December 31, 2024, the remuneration for Non-Executive Directors is as follows:
Board of
Directors
Chairperson
Board of
Directors
Member
Audit
Committee
Member
Remuneration &
Nomination Committee
Member
Product Selection
Committee
Member
€17.5k
€17.5k
€5k
€5k
€7.5k
The Remuneration & Nomination Committee
may also propose granting a certain number of
shares to align with Principle 7.6 of the Belgian
Corporate Governance Code. If such shares are
granted, they must be held for at least three
years after being awarded and for at least one
year after the Board member has left the Board
of Directors.
Additional Compensation Guidelines
Non-Executive Directors do not receive any
fringe benefits or variable remuneration
p.69
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Annual report 2024
(e.g., performance-related pay such as
bonuses).
Reasonable out-of-pocket expenses (e.g.,
travel costs) incurred in the course of their
duties will be reimbursed.
The mandate of a Non-Executive Director can be
revoked at any time (‘ad nutum’) without
entitlement to any indemnity payment. There are
no employment or service agreements between
the Company and Non-Executive Directors—who
are not part of the Executive Management
Team—that
provide
for
notice
periods
or
severance compensation.
3.3.
Remuneration Policy for Executive Committee
members
3.3.1.
Introduction
Hyloris aims to provide market-competitive
compensation to attract, retain, and motivate
highly qualified professionals, while ensuring
alignment with the scope of their responsibilities.
The remuneration scheme for the Co-Chief
Executive Officer (Co-CEO’s) and other Executive
Committee members is structured to balance
short-term operational performance with the
long-term goal of creating sustainable value,
while also considering the interests of all
stakeholders.
This scheme consists of:
A fixed component: an annual base salary
paid in cash.
A variable component:
o
Short-term variable remuneration: a cash
bonus tied to performance.
o
Long-term variable remuneration: as
from January 1, 2025, a retention bonus
based on the achievement of specific
EBITDA targets.
Equity-based
incentives:
Executive
Committee members may receive ESOP
Warrants
as
part
of
their
long-term
compensation.
Article 7:91 of the BCCA reads: “Unless otherwise
provided for in the articles of association or
expressly
approved
by
the
shareholders’
meeting, at least one-quarter of the variable
remuneration of an executive director in a
public-listed
company
must
be
based
on
predetermined
and
objectively
measurable
performance criteria over a period of at least two
years, and another quarter must be based on
predetermined
and
objectively
measurable
criteria over a period of at least three years.”
Hyloris has exercised its right to deviate from
Article 7:91 of the BCCA through its Articles of
Association. Additionally, Article 7:91 states that
its principles do not apply when the variable
portion of remuneration does not exceed 25% of
the total annual remuneration. As a result, the
specific rules on variable remuneration outlined
in Article 7:91 do not apply to Hyloris.
Furthermore, the Board of Directors retains the
discretion
to
adjust
the
total
variable
remuneration—either upward or downward—to
ensure that the compensation remains fair and
reasonable. This includes the flexibility to grant
variable remuneration even if performance
targets were not fully met, particularly in cases
where
unforeseen
external
circumstances
hindered target achievement.
p.70
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Annual report 2024
Conversely,
in
cases
of
significant
overachievement, the Board of Directors may
decide to increase variable remuneration to
accurately reflect the individual's exceptional
contribution to the Company.
3.3.2.
Fixed Remuneration
The fixed annual remuneration consists of a cash
fee, the amount of which is determined by the
Board of Directors, based on recommendations
from the Remuneration Committee. This fee is
paid in monthly installments.
Certain Executive Committee members may
receive reimbursements for expenses incurred
in the performance of their duties. To ensure that
the remuneration remains competitive, fair, and
aligned
with
market
practices,
Hyloris
will
regularly conduct external salary benchmarking
exercises. This approach helps to attract, retain,
and motivate highly qualified professionals with
the most suitable expertise and experience.
3.3.3.
Short-Term Variable
Remuneration
Short-term variable cash incentives are awarded
based on the achievement of predetermined
performance targets. At the beginning of each
financial year, the Board of Directors defines the
company's key priorities (Corporate Targets: see
note 3.3.5) and establishes specific, challenging
performance
objectives
aligned
with
these
priorities. The Board also determines the relative
weight of each target and the metrics used to
assess achievement.
Principles for Granting Short-Term Variable
Remuneration:
Performance-Based
Compensation
A
portion of remuneration is linked to individual
performance
and
Hyloris’
overall
performance over the past calendar year. This
ensures
optimal
alignment
of
individual
interests
with
those
of
Hyloris,
its
shareholders, and other stakeholders.
Merit-Driven
Approach
Variable
remuneration is granted based on individual
contributions,
assessed
through
Hyloris’
performance-rating system, which evaluates
both individual targets (Personal Targets) and
company-wide objectives (Corporate Targets).
Corporate
Targets
These
include
key
performance indicators (KPIs) related to
Hyloris’ research activities (OPS), business
development
(BD),
and
financial
performance. These targets are designed to
drive company growth and long-term value
creation for all shareholders (see the Business
overview chapter).
Short-Term Variable Remuneration Structure
1. Executive Committee Members (excluding the
Co-CEO’s)
The short-term variable remuneration is divided
into two components:
60% is based on Personal Targets achieved,
reflecting individual contributions.
40% is based on the Corporate Targets
achieved by Hyloris, ensuring alignment
with company-wide performance.
2. Co-Chief Executive Officers (Co-CEO’s)
The CEO's short-term variable remuneration also
consists of two components:
25%
is
determined
by
the
average
achievement of Personal Targets by other
Executive Committee members, reinforcing
a leadership-driven approach.
75% is based on the Corporate Targets
achieved by Hyloris, ensuring the Co-CEO's
compensation
is
strongly
tied
to
the
company’s overall success.
Annual Target Setting and Evaluation Process
Corporate and Personal Targets
p.71
Hyloris :
Annual report 2024
Both Corporate and Personal Targets are
established annually.
The Board of Directors sets the Corporate
Targets
for
all
Executive
Committee
members, considering recommendations
from the Remuneration Committee.
The
Co-CEO’s
Personal
Targets
are
determined
by
the
Board
upon
the
Remuneration
Committee’s
recommendation, which is based on a
proposal from the Chairman.
The Co-CEO sets the Personal Targets for
other Executive Committee members.
Short-Term Variable Remuneration Cap
The total short-term variable remuneration
may exceed 25% of an Executive Committee
member’s total fixed annual remuneration.
However,
the
Remuneration
and
Nomination Committee has currently set
this amount at on average at 13% of the total
fixed annual remuneration for 2024.
Performance Evaluation and Payout
Short-term variable remuneration is only
paid when targets are met, either wholly or
partially.
Co-CEO’s Personal Targets: Evaluated by the
Remuneration Committee after the Audit
Committee validates the annual financial
results. The Board makes the final decision.
Other
Executive
Committee
Members'
Personal Targets: Evaluated by the Co-CEO’s,
deliberated
by
the
Remuneration
Committee, and ultimately decided by the
Board.
Performance
is
assessed
based
on
a
weighted average of the achievement rate of
Personal Targets.
Approval and Payment Timeline
The Board of Directors approves any short-
term
variable
remuneration
before
payment.
Typically,
during
Q1
of
the
following
calendar year, the Board evaluates target
achievements and approves payouts.
Payouts are usually processed within the same
quarter.
3.3.4.
Long-Term Variable
Remuneration
A long-term variable remuneration will be rolled
out starting January 1, 2025. This long-term
variable remuneration scheme will be based on
the achievement by the Company of certain pre-
set
cash-based
financial
results.
For
each
Member of the Executive Committee, a fixed
amount will be paid the first time a tranche of
EUR 20 Mio EBITDA (calculated on a recurring
basis) will be achieved by the Company and this
up to EUR 80 Mio or 4 tranches of EUR 20 Mio.
The total amount, if this long-term remuneration
would be paid out to all Members of the
Executive Committee and the entire senior
management team, would be approximately
between 1.7 % and 2.7 % of the realized EBITDA,
depending on the realized EBITDA-level.
The
total
target
short-term
variable
remuneration
amount
for
an
Executive
Committee member (i.e., the sum of the first and
second components described above) together
with the long-term variable remuneration may
exceed
25%
of
the
total
fixed
annual
remuneration
of
an
Executive
Committee
member.
3.3.5.
2025 Corporate Targets
The 2025 Corporate Targets for Hyloris are
defined by the Board of Directors and used as a
strong guidance for defining the Personal
Targets of the entire Hyloris team
Operations/R&D: 35%
Business Development: 30%
Finance: 20%
p.72
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Annual report 2024
Corporate (including Corporate
Governance): 15%
3.3.6.
Fringe Benefits
Executive Committee members do not receive
any fringe benefits.
3.3.7.
Contract
Term
and
Severance Payment
All Executive Committee members provide their
services
under
a
Belgian-law-governed
management agreement with Hyloris. The terms,
notice periods, and severance arrangements are
outlined below.
Severance & Dismissal Policy
Hyloris is committed to preventing "pay for
failure" by ensuring that severance payments are
not granted in cases of serious misconduct or
negligence. Specifically:
No severance payment will be made if an
Executive
Committee
member
is
dismissed due to seriously culpable or
negligent behavior.
No severance payment will be made if an
Executive Committee member resigns
voluntarily, except in cases where the
resignation is due to serious misconduct
or
negligence
on
the
part
of
the
Company.
This policy ensures fairness and accountability
while aligning with corporate governance best
practices.
Mr. Stijn Van Rompay (Co-CEO)
The current services agreement with Mr. Stijn
Van Rompay has been entered into between Mr.
Van
Rompay’s
Belgian
incorporated
management company SVR Management BV and
the Company effective as from 1 September
2019, for an indefinite period. It can be
terminated by both the Company upon six
months’ notice or payment of compensation
equivalent to the fixed remuneration of a three-
month period. It can be terminated by SVR
Management BV upon three months’ notice or
payment of compensation equivalent to the fixed
remuneration of such three-month period. The
agreement
also
provides
for
reasons
for
immediate termination because of a breach by
either party (e.g., serious contractual breach,
bankruptcy, in- solvency, non-performance of
the consultancy services for 25 consecutive days,
etc.).
In the event of termination of the services
agreement, the agreement provides for a non-
compete period (subject to certain exceptions) of
18 months after termination, against a payment
of 100% of the fixed fee over such 18 months’
period. However, SVR Management BV will not be
entitled to this payment if it terminates the
services agreement at its own initiative or if the
Company terminates the services agreement for
breach
of
contract
imputable
to
SVR
Management BV.
Mr. Thomas Jacobsen (Co- CEO & CBDO)
The current services agreement with Mr. Thomas
Jacobsen has been entered into between Mr.
Thomas
Jacobsen’s
Belgian
incorporated
management company Jacobsen Management
BV and the Company effective as from 1
November 2019, for an indefinite period. It can
be terminated by the Company upon six months’
notice or payment of compensation equivalent
to the fixed remuneration of a three-month
period. It can be terminated by Jacobsen
Management BV upon three months’ notice or
payment of compensation equivalent to the fixed
remuneration of such a three-month period. The
agreement
also
provides
for
reasons
for
immediate termination because of breach of
either party (e.g., serious contractual breach,
bankruptcy, in- solvency, non-performance of
the consultancy services for 25 consecutive days,
etc.).
p.73
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Annual report 2024
In the event of termination of the services
agreement, the agreement provides for a non-
compete period of 18 months after termination,
against a payment of 100% of the fixed fee over
that
18-month
period.
However,
Jacobsen
Management BV will not be entitled to this
payment if it terminates the services agreement
at its own initiative or if the Company terminates
the services agreement for breach of contract
imputable to Jacobsen Management BV.
Mr. Dietmar Aichhorn (COO)
The current services agreement with Mr. Dietmar
Aichhorn has been entered into as from 1
October 2020, for an indefinite period. As from
December 2023, the services agreement was
transferred to Mr. Aichhorn’s management
company DDA Management GmbH. During the
first 3 years, this services agreement can be
terminated
by
the
Company
and
DDA
Management GmbH upon three months’ notice
or payment of compensation equivalent to the
fixed remuneration of a three-month period.
After 3 years, it can be terminated by the
Company and DDA Management GmbH six
months’
notice
period
or
payment
of
compensation
equivalent
to
the
fixed
remuneration of such a six-month period. The
agreement
also
provides
for
reasons
for
immediate termination because of a breach by
either party (e.g. serious contractual breach,
bankruptcy, insolvency, non-performance of the
consultancy services for 25 consecutive days,
etc.).
In the event of termination of the services
agreement, the agreement provides for a non-
compete period of 12 months after termination
against a payment of 50% of the fixed fee over
such 12 months’ period. However, the Company
is entitled to waive this non-compete payment if
the services agreement is terminated at the
initiative of DDA Management GmbH. The non-
compete payment will not be due if the Company
terminates the services agreement for breach of
contract imputable to DDA Management GmbH.
Mr. Christophe Maréchal
The
current
services
agreement
with
Mr.
Christophe Maréchal has been entered into
between Mr. Maréchal’s Belgian incorporated
management company CMM&C BV and the
Company effective as from 9 December 2024, for
an indefinite period. It can be terminated by the
Company upon three months’ notice or payment
of
compensation
equivalent
to
the
fixed
remuneration of a three-month period. It can be
terminated by CMM&C BV upon three months’
notice period or payment of compensation
equivalent to the fixed remuneration of such a
three-month
period.
The
agreement
also
provides for reasons for immediate termination
because of a breach by either party (e.g. serious
contractual breach, bankruptcy, insolvency, non-
performance of the consultancy services for 25
consecutive days, etc.).
In the event of termination of the services
agreement, the agreement provides for a non-
compete period of 12 months after termination
against a payment of 50% of the fixed fee over
such 12 months’ period. However, CMM&C BV
will not be entitled to this payment if it
terminates the services agreement at its own
initiative or if the Company terminates the
services agreement for breach of contract
imputable to CMM&C BV.
p.74
Hyloris :
Annual report 2024
3.3.8.
Evolution of the Evaluation & Performance of Hyloris
2021
2022
2023
2024
Remuneration of Excom Members
(1)
€903K
€1.091K
€1,123K
€1,092K
(2)
Remuneration of (Co-)CEO’s
(3)
€210K
€208K
€213K
€327K
Net profit
€(11,6)M
€(11,9)M
€(15,4)M
€(6,3)M
Average remuneration of employees
(4)
€108K
€127K
€108K
€102K
(1): Includes the remuneration of the former CFO & CLO until their respective dates of resignation from the Excom
(2): Excludes any potential variable or exit payment to the former CFO & CLO
(3): As from the end of July 2024, the company appointed 2 Co-CEO’s.
(4) Including consultants with a service agreement
3.3.9.
Warrants and Other
Share-Convertible
Securities
Upon
recruiting
new
Executive
Committee
members, the board of directors may decide to
make an additional one-time sign-on grant of
equity incentives if the board of directors deems
this necessary to attract a specific highly qualified
individual.
The Board of Directors may decide to grant the
members of the Executive Committee new
(annual) grants of equity incentives, consisting of
Warrants. Equity incentives will always be subject
to a multi-year vesting scheme. As a result, the
overall value for the members of the Executive
Committee will be directly related to the value
created for the Company's shareholders over the
course of the vesting period. Vesting is subject to
the Executive Committee members’ continued
involvement with the Company.
The members of the Executive Committee (as
well as other colleagues of Hyloris) can be
granted Warrants or other instruments that
allow the holder to acquire shares through
schemes that need to be pre-approved by the
annual Shareholder’s Meeting.
Article 7:91, first paragraph of the BCCA states
that a director—within three years from the date
of the grant—may not definitively acquire shares
by way of remuneration or exercise share
options or any other right to acquire shares. The
company’s articles of association may deviate
from this rule. Article 3 of the Articles of
Association of Hyloris explicitly allows the Board
to deviate from this rule when proposing the
variable remuneration scheme. In any event, the
ESOP warrants can only be exercised as from the
4
th
year following the year of the offer. No lock-
up period applies to any shares acquired after
the exercise of such ESOP warrants.
On the date of this Annual Report, a total of
195.000 ESOP (2025) warrants was granted to
and accepted by the members of the Executive
Committee. (see: 7.2.2. Summary
of
the
Outstanding Warrant Plans).
p.75
Hyloris :
Annual report 2024
3.4.
Minimum Shareholding
No minimum threshold has been set for shares
to be held by the Members of the Executive
Committee, as the remuneration package for the
Executive
Committee
is
already
sufficiently
geared towards sustainable long-term value
creation and, moreover, because two of the 4
Members of the Executive Committee already
hold a significant block of shares in the Company
as co-founder of the Company.
3.5.
Clawback
No specific claw-back rights have been provided
to the benefit of the Company in respect of
variable remuneration granted to the members
of the Executive Management allowing the
Company to partially or fully claim back any
variable
cash
compensation
paid
to
the
members of the Executive Management, based
on incorrect information about meeting the
performance targets on which the variable
remuneration
is
based,
or
about
the
circumstances
on
which
the
variable
remuneration was made dependent, or if such
incorrect information was also due to fraud on
the part of the beneficiary.
The Company believes that there are sufficient
contractual rights and rights under common law
available that allow it to claim back such
amounts. In any event, over the past 4 years,
since its initial listing on Euronext Brussels, there
have been no circumstances that would have
given rise to a full or partial claw-back of the
variable remuneration of any of the members of
the Executive Committee, if such claw back
provisions would have been provided.
3.6.
Pension Scheme
Hyloris does not have a complementary pension
scheme for any Non-Executive Director or any
Executive Committee member.
p.76
Hyloris :
Annual report 2024
3.7.
Remuneration
3.7.1.
Remuneration of Non-
Executive Directors
The
remuneration
package
for
the
Non-
Executive Directors was revised and approved by
the Shareholders’ Meeting of the Company held
on June 11, 2024 and consists of a fixed annual
fee of €17,500 for the Non-Executive Directors
and €5,000 for the members of the various
Committees.
Any changes to these fees will be submitted to
the Shareholders’ Meeting for approval. The
Executive Directors will not receive any specific
remuneration
in
consideration
for
their
membership of the Board of Directors.
For the remuneration of the Independent
Directors
in
2024,
the
total
remuneration
amounted to €112 thousand. The table below
provides an overview of the remuneration of the
Non- Executive Directors*.
Name
Remuneration
Mr. Stefan Yee
€23,750
Mr. Leon Van Rompay
7
€13,750
Mr. Marc Foidart
8
€23,750
Mrs. Carolyn Myers
€13,125
Mr. James Gale
€13,125
Mr. Chris Buyse
€13,125
Ms. Revital Rattenbach
€5,625
Mr. Vincent Van Dessel
€5,625
7
Acting through Van Rompay Management BV
8
Acting through Noshaq Partners SCRL
9
Calculated as % of all outstanding warrants (309,313
warrants outstanding as at December 31, 2024, not taking
Ms. Myers, Mr. Gale and Mr. Buyse were replaced as
Directors of the company at the general shareholders
meeting of September 30, 2024. Mr. Van Dessel and Ms.
Rattenbach were appointed by same shareholders
meeting.
The table below provides an overview of
significant positions of warrants held directly or
indirectly by the Non-Executive Members of the
Board of Directors on December 31, 2024.
Warrants
9
Name
Number
%
Mr. Stefan Yee
0
*
0%
Mr. Leon Van Rompay
0
0%
Mr. Marc Foidart
0
0%
Mrs. Carolyn Myers
0
0%
Mr. James Gale
0
0%
Mr. Chris Buyse
0
0%
Ms. Revital Rattenbach
0
0%
Mr. Vincent Van Dessel
0
0%
Mr. Yee held 100,000 ESOP 2019 warrants that have
expired on December 31, 2024, without being exercised
The Non-Executive Members of the Board of
Directors do not hold any shares in the Company.
into account the warrants of the 2019 ESOP Warrant plan
that expired on December 31, 2024)
p.77
Hyloris :
Annual report 2024
3.7.2.
Remuneration of
Executive Directors and
Members of the
Executive Committee
The remuneration package for the members of
the Executive Management consists of a fixed
cash compensation and a variable cash incentive.
A one-time equity incentive was granted to some
of the members of the Executive Management at
the time of their hiring and may be granted in the
future upon proposal of the remuneration
committee and approval of the Board of
Directors.
In
2024,
the
following
remuneration
and
compensation was paid or accrued to the Co-
CEO’s (i.e., Mr. Stijn Van Rompay and Mr. Thomas
Jacobsen) and the other members (including the
former CFO &CLO until their respective dates of
resignation from the Excom) of the Executive
Management of Hyloris:
Co-CEO’s (2)
Other members of the Executive
management
Annual base salary
€282,099
€738,302
Annual variable salary (1)
€45,199
€26,407
Supplementary pension plan
(defined contribution)
n.a.
n.a.
Car lease / transport
allowance
n.a.
n.a.
Medical plan
n.a.
n.a.
(1): Excludes any potential variable or exit payment to the former CFO & CLO
(2): As from the end of July, 2024, the company appointed 2 Co-CEO’s.
The
2024
ratio
between
the
highest
remuneration of the members of the Executive
Committee and the lowest remuneration (in full-
time equivalent) of Hyloris’ employees amounted
to 7-to-1.
The ratio is calculated based on the lowest FTE
pay per 31 December 2024, excluding trainees
and internships. The remuneration which has
been taken into account in this exercise includes
the annual base salary, annual cash bonus and (if
any) exceptional bonus; annual cash bonus is
included in the year upon which performance is
based and not in the year in which it is paid.
Share options (warrants) are excluded from the
calculations.
For an overview of significant positions of
warrants held directly or indirectly by the
Executive Committee Members on December 31,
2024: see 2.2.
p.78
Hyloris :
Annual report 2024
3.8.
Appraisals
3.8.1.
Board of Directors and
Committees of the Board of
Directors
The
Board
is
responsible
for
a
periodic
assessment of its own effectiveness to ensure
continuous improvement in the governance of
the Company. The contribution of each director
is evaluated periodically. The Chairman of the
Board and the performance of his role within the
Board are also carefully evaluated. Furthermore,
the Board will assess the operation of the
Committees at least every two to three years. For
this assessment, the results of the individual
evaluation of the Directors are taken into
consideration.
The Non-Executive Directors continuously (and
formally once a year) assess their interaction
with the Executive Directors and the Executive
Committee and reflect on how to streamline the
interactions between both the Non-Executive
Directors and Executive.
The Board may request the Remuneration
Committee, where appropriate and if necessary,
in consultation with external experts, to submit a
report
commenting
on
the
strengths
and
weaknesses to the Board and make proposals to
appoint
new
Directors
or
to
not
re-elect
Directors. A Director who did not attend 50% of
the Board meetings will not be considered for re-
election on the occasion of the renewal of the
mandate.
The evaluation of the operation of the Board of
Directors in terms of its scope, composition,
operation, and that of its Committees, as well as
of its interaction with the Executive Committee,
took place on April 23, 2025 under the leadership
of the Chairman of the Board of Directors. This
evaluation resulted in a positive assessment and
also
indicated
a
few
recommendations
to
improve the performance of the Board of
Directors, of the Executive Committee and of its
interaction between the Board of Directors and
the Executive Committee.
3.8.2.
Executive Committee
The Co- CEO’s and the Remuneration Committee
formally assess the operation as well as the
performance
of
the
Executive
Committee
annually.
The
evaluation
of
the
Executive
Committee occurs in the context of determining
the variable remuneration of the Executive
Committee members.
The performance-rating system of Hyloris for the
achievement of the Personal Targets of each
Member of the Executive Committee is based on
a formal HR evaluation process with a scoring
(from 1 to 6, whereby a rating of 6 reflects a 100
% achievement of the target) given by the Co-
CEO’s. For the Co-CEO’s, the performance rating
for the achievement of his Personal Targets is
based on the average of the Personal Targets
achieved by the other members of the Executive
Committee. The achievement of the Corporate
Targets is assessed by the Chairman of the
Board. In accordance with the relevant Corporate
Governance
principles,
the
Remuneration
Committee assesses the performance ratings
and contributions of the Co-CEO’s and the other
members of the Executive Management for both
the Personal and Corporate Targets. Finally, and
after
validation
by
the
Remuneration
and
Nomination Committee, the performance rating
is submitted for approval to the Board of
Directors. For the performance rating over
calendar year 2024, the Remuneration and
Nomination Committee made its assessment
and recommendation on April 23, 2025.
The Board of Directors has taken note of the
positive assessment by the Remuneration and
Nomination Committee and determined that the
corporate objectives for 2024, which were aimed
at
supporting
the
company’s
long-term
p.79
Hyloris :
Annual report 2024
performance, had been achieved at a rate of
60%. The variable remuneration for 2024 also
considered the contributions of the members of
the
Executive
Committee
toward
these
achievements and their individual targets that
were assessed at an average of 83.17%. The
Board
of
Directors
approved
the
recommendations of the Remuneration and
Nomination Committee on April 23, 2025.
4.
Internal control and
Risk Management Systems
4.1.
Internal Mechanism
The Board of Directors, the Audit Committee and
the Executive Committee are responsible for
measuring business risks and the effectiveness
of the internal control and risk management
systems.
The Executive Committee has set-up internal risk
management and control systems within the
Company to assure the realisation of the
company objectives, the reliability of financial
information and reporting, the adherence to
applicable
laws
and
regulations
and
the
monitoring and management of the internal and
external impact of the risks identified.
The Board of Directors has delegated an active
role to the Audit Committee to monitor the
design, implementation and execution of these
internal risk management and control systems.
The Audit Committee assists the Board of
Directors in respect of control issues in general
and acts as the interface between the Board of
Directors and the external auditors of the
Company.
No internal audit role has currently been
assigned due the size of the business. Internal
audit activities may be outsourced from time to
time
whereby
the
Audit
Committee
will
determine frequency of these audits and select
topics to be addressed.
4.2.
Risk Analysis
A potential investor should carefully consider the
following risk factors and all other information
contained in the annual report before making an
investment decision regarding the Company’s
shares. If any of these risks would occur, the
business,
financial
condition
or
results
of
operations of the Company would likely be
materially and/or adversely affected. In such
case, the price of the shares could decline, and
an investor could lose all or part of the
investment. These include but are not limited to:
4.2.1.
Risks
Related
to
Hyloris’
Business Activities
Hyloris has a limited operating history and has
not yet generated any substantial revenues.
p.80
Hyloris :
Annual report 2024
Hyloris has incurred operating losses, negative
operating cash flows and an accumulated loss
since inception and Hyloris may not be able to
achieve or subsequently maintain profitability.
Hyloris is executing its strategy in accordance
with its business model, the viability of which has
not been demonstrated.
Hyloris performance depends primarily on the
success of its product candidates, a majority of
which are in the early reformulation and clinical
development stage and have not yet received
regulatory approval.
Even if Hyloris, or its partners, receive regulatory
approval for any of its product candidates, it may
be unable to launch the product successfully and
the revenue that Hyloris generates from sales of
such product, if any, may be limited. Even if
Hyloris obtains approval for any of its product
candidates,
it
will
be
subject
to
ongoing
obligations and continued regulatory review,
which may result in significant unforeseen
additional expense.
Despite receiving regulatory approval for a
product candidate, competitors may receive
regulatory approval for a product that is identical
or substantially the same as one of Hyloris’
product candidates, which may prevent Hyloris
from commercializing its product candidates in
accordance with its business plan or result in
significant delays in doing so.
Hyloris is planning to organize its sales and
marketing functions to execute its commercial
strategy with respect to its IV Cardiovascular
Portfolio in the U. S. and to secure suitable sales
and marketing partners for its other products. If
Hyloris is unable to do so, it may not successfully
commercialize any of its product candidates.
Certain of Hyloris’ Directors and members of
Hyloris’ Executive Committee hold directorships
or
shareholdings
in
other
pharmaceutical
companies, which could create potential conflicts
of interest.
Hyloris may be unable to successfully manage its
growth.
4.2.2.
Risks
Related
to
the
Pharmaceutical Industry
Regulatory Risk
The pharmaceutical industry is highly regulated,
and our business is subject to a wide range of
complex and evolving laws and regulations.
These
include
regulations
related
to
drug
approval, manufacturing practices, marketing,
sales, and post-market surveillance. Changes in
regulatory
requirements
or
delays
in
the
approval of our products by regulatory agencies
such as the European Medicines Agency (EMA) or
other global authorities could negatively impact
our ability to market and sell our products.
Failure to comply with regulatory standards or
the imposition of new regulations could result in
fines,
sanctions,
or
restrictions
on
our
operations.
Clinical Trial and Development Risk
The
development
of
new
pharmaceutical
products is a long, costly, and uncertain process.
Clinical trials may fail to demonstrate the safety
or efficacy of a drug, and there is no guarantee
that
our
drug
candidates
will
successfully
complete clinical trials or receive regulatory
approval. Negative results from clinical trials or
delays
in
meeting
trial
milestones
could
adversely affect our financial performance and
market
prospects.
Any
termination
or
suspension of, or delays in the commencement
or completion of, any necessary clinical trials in
respect to any of Hyloris’ product candidates,
including because of Hyloris’ reliance on third
parties to conduct such clinical trials, could result
in increased costs to Hyloris, delay or limit its
ability to generate revenue and adversely affect
Hyloris’ commercial prospects.
p.81
Hyloris :
Annual report 2024
Market Risk and Competition
The pharmaceutical industry is highly competitive,
with
numerous
companies
and
organizations
pursuing similar therapeutic targets. Existing and
potential competitors may develop or market
products that are more effective, safer, or more
cost-efficient than our own, potentially limiting
our market share. Additionally, the entry of
generic versions of our patented products
following patent expiry or other factors could
lead to significant revenue loss.
Intellectual Property Risk
Our business is dependent on the protection of
intellectual
property,
including
patents,
trademarks, and trade secrets. There is a risk that
our intellectual property rights may not be
adequately protected or enforced, or that
competitors may challenge our patents or design
around
our
technology.
Additionally,
the
expiration of patents could result in increased
competition from generic manufacturers, which
may
negatively
impact
our
financial
performance, prospects and revenue.
Economic and Financial Risk
Our business is subject to macroeconomic
factors,
including
changes
in
healthcare
spending, currency fluctuations, inflation, and
interest rates. Adverse economic conditions
could result in reduced demand for our products,
delayed payments, or challenges in obtaining
financing. Additionally, our reliance on third-
party
suppliers,
contractors,
and
co-
development partners exposes us to financial
risks if any of these parties experience financial
difficulties or fail to meet their obligations.
Supply Chain Risk
We depend on third-party suppliers for the
production
of
raw
materials,
active
pharmaceutical ingredients (APIs), and finished
products. Disruptions in the supply chain,
whether due to natural disasters, geopolitical
events, labor strikes, or other factors, could lead
to delays in production, shortages of critical
materials, or increased costs, which could
adversely affect our ability to manufacture and
deliver products on time. Commercialization of
Hyloris’ product candidates could be delayed,
halted, or made less profitable if those third
parties fail to obtain and maintain the required
approvals from the FDA or comparable foreign
regulatory authorities, or otherwise fail to
provide Hyloris with sufficient quantities of its
products.
Pricing and Reimbursement Risk
Hyloris’ ability to successfully market its product
candidates will depend in part on the level of
reimbursement that healthcare organizations,
including
government
health
administration
authorities, private health coverage insurers and
other healthcare payors, provide for the cost of
Hyloris’ products and related treatments. Our
revenues may be affected by changes in
healthcare policies, reimbursement rates, and
pricing regulations. Governments and private
insurers may implement pricing controls or
reductions
in
reimbursement
rates
for
pharmaceutical products, which could adversely
impact
our
revenue
streams.
Additionally,
negative public perception of drug pricing or
pressure from governments and consumers
could result in reputational harm and decreased
sales.
Legal and Litigation Risk
The pharmaceutical industry is subject to a high
risk of litigation, including claims related to
product
liability,
intellectual
property,
and
antitrust matters. Any adverse outcomes in such
proceedings could result in significant legal costs,
damages, or reputational harm, which could
have a material negative impact on our financial
results and operations.
Environmental, Social, and Governance (ESG)
Risk
p.82
Hyloris :
Annual report 2024
Changes
in
environmental,
social,
and
governance
(ESG)
standards
or
societal
expectations could affect our operations. Failure
to comply with emerging ESG regulations or
adapt to shifting consumer preferences for more
sustainable, ethical, and socially responsible
practices could negatively impact our reputation,
operations, and financial performance.
Cybersecurity and Data Protection Risk
As a pharmaceutical company, we handle
sensitive data related to patient health, clinical
trials, and proprietary research. The risk of
cybersecurity breaches, data leaks, or other
technological disruptions could result in the loss
of confidential information, regulatory penalties,
and reputational damage. Additionally, failure to
comply with data protection regulations, such as
the General Data Protection Regulation (GDPR),
could expose us to fines and legal action.
4.2.3.
Macroeconomic Conditions
and Rising Interest Rates
As an international pharmaceutical company, we
are exposed to risks associated with currency
fluctuations,
foreign
exchange
rates,
and
geopolitical instability. These factors may affect
the profitability of our operations, particularly in
countries outside of the Eurozone, and could
impact our ability to conduct business smoothly
in certain regions.
The Company acknowledges that the global
macroeconomic environment has experienced
significant volatility in recent years, driven by
factors such as inflationary pressures, fluctuating
commodity prices, and shifts in consumer and
business confidence. Additionally, central banks
worldwide, including the European Central Bank
and the U.S. Federal Reserve, have raised interest
rates in response to inflation concerns. Rising
interest rates could made drug development
more expensive. For Hyloris, the impact of
increased costs in a rising rate environment
could partially be offset by a positive effect
resulting from the Company’s significant cash
position
which
should
generate
additional
deposit income. The company was free of
financial debt at the end of 2024 and has limited
exposure to exchange rates with non-European
countries.
While the Company continues to monitor these
developments closely, rising interest rates may
lead to increased borrowing costs, reduced
consumer spending, and changes in investment
patterns, which could affect the Company’s
financial
performance.
Additionally,
higher
interest rates may impact the valuation of assets,
exchange rates, and the overall cost structure of
the Company’s operations.
The Company is also aware of the potential long-
term implications of these macroeconomic
trends,
including
the
possibility
of
slower
economic growth, changes in demand for
healthcare products, and evolving regulatory
responses to address inflation and economic
instability. As the situation remains dynamic and
uncertain, it is difficult to fully assess the
potential impact of these macroeconomic factors
on the Company's future business performance.
4.2.4.
Dependency
on
Third-
Party
Co-Development
Partners
Hyloris’ business is dependent on the continuous
generation of new ideas and the development of
new product candidates to stay ahead of the
competition.
Hyloris
relies
and
expects
to
continue to rely in large part on the know-how of
its development partners with respect to the
current portfolio. Hyloris expects to be less
reliable from external partners in the future for
the development and expansion of its portfolio.
Our
company
frequently
enters
into
collaborations with third-party co-development
p.83
Hyloris :
Annual report 2024
partners to advance the research, development,
and
commercialization
of
pharmaceutical
products. These partnerships are essential to our
strategy,
enabling
us
to
leverage
external
expertise, resources, and technologies. However,
such collaborations expose us to a variety of
risks, including:
Operational Risk
: The success of our co-
development efforts is highly dependent on
the performance and capabilities of our
third-party partners. If any partner fails to
meet agreed-upon milestones, experience
delays,
or
encounters
technical
or
regulatory setbacks, it could result in a delay
or failure to bring products to market.
Intellectual
Property
Risk
:
Co-
development
agreements
may
involve
sharing proprietary intellectual property,
which could expose our company to the risk
of intellectual property disputes, misuse, or
challenges to the ownership and protection
of our innovations.
Financial Risk
: Payments to third-party
partners, as well as potential revenue-
sharing
agreements,
could
impact
our
financial
results.
Moreover,
if
a
co-
development partner experiences financial
difficulties or fails to fulfill its obligations, our
ability to recoup investments or generate
expected returns may be compromised.
Regulatory Risk
: Co-development partners
may not fully adhere to regulatory standards
or fail to navigate complex regulatory
environments effectively. This could result in
delays in clinical trials, product approvals, or
market access, which in turn could adversely
affect our business and reputation.
Strategic Risk
: If a partner decides to alter
its strategic focus, withdraw from the
partnership, or pursue alternative projects,
we may lose critical resources, expertise, or
momentum in our development programs.
To mitigate these risks, we carefully select our co-
development
partners,
negotiate
detailed
contracts
that
clearly
outline
each
party's
responsibilities, and monitor progress closely.
However, despite these precautions, the risks
associated with third-party partnerships remain
a significant consideration for our business.
In addition, Hyloris depends on the execution of
its partners AltaThera, AFT Pharmaceuticals, and
Padagis
for
successful
roll-out
and
commercialization
of
its
three
commercial
products,
Sotalol
IV,
Maxigesic®
IV,
and
Podofilox Gel respectively. Additionally, Hyloris’
product candidates could be subject to labelling
and
other
marketing
re-
strictions
and
withdrawal from the market and Hyloris may be
subject to penalties if it fails to comply with
regulatory requirements or if it experiences
unanticipated
problems
with
its
product
candidates.
4.2.5.
Political and Economic
Uncertainty in the United
States
The ongoing political and economic uncertainties
in the United States present significant risks that
may adversely affect our business operations,
financial performance, and growth prospects.
Political
volatility,
including
changes
in
government
policies,
regulations,
or
trade
relationships, as well as economic challenges
such as inflation, fluctuations in interest rates, or
shifts in consumer spending, could lead to
unpredictable market conditions.
In particular, healthcare and pharmaceutical
policy changes at the federal level, including
potential alterations to drug pricing regulations,
reimbursement models, and approval processes,
could have a direct impact on our ability to
operate effectively within the U.S. market.
Additionally, the U.S. economy’s cyclical nature,
combined with the possibility of an economic
p.84
Hyloris :
Annual report 2024
downturn, may result in reduced demand for
certain products, delays in capital investments,
or disruptions in supply chains, particularly in the
context of global trade tensions.
The increasing political polarization in the U.S.
and its potential to affect international relations
could
also
pose
risks
to
our
operations,
especially in the realm of regulatory compliance,
tariffs,
and
cross-border
trade.
While
we
continue to monitor developments closely, any
significant changes in U.S. policies, whether
through legislation, executive actions, or shifts in
political leadership, could have material adverse
effects on our ability to execute our strategic
initiatives and achieve our financial objectives.
Given our exposure to the U.S. market, we
caution that developments in this environment
may lead to increased operational complexity,
regulatory costs, and unpredictability, which
could negatively impact our business.
4.2.6.
Geopolitical Risks
Related to the Russia-
Ukraine Conflict
The
ongoing
conflict
between
Russia
and
Ukraine, which began in February 2022, has
created significant geopolitical and economic
uncertainty. The evolving nature of the conflict,
along with the potential for further escalation,
may impact global supply chains, regulatory
environments, and market conditions in ways
that cannot be fully predicted or controlled.
The Company recognizes that the conflict could
result in disruptions to operations, including
delays in the production and distribution of
pharmaceutical products, as well as potential
impacts
on
raw
material
availability,
transportation,
and
financial
markets.
Additionally, the Company is aware of the
broader
economic
consequences,
such
as
inflationary pressures and currency fluctuations,
which could affect business performance.
Although the Company continues to monitor the
situation
closely
and
adjust
its
strategies
accordingly, it is important to note that the full
scope and duration of the conflict remain
uncertain, and any further developments may
have material adverse effects on the Company’s
financial position, results of operations, and
future prospects.
4.2.7.
Health Crisis or
Geo-Political Instability
The occurrence of a pandemic, epidemic, other
health crisis or geo-political imbalance could
have a negative impact on Hyloris’ product
development activities, including its access to
APIs, the conduct of its clinical trials and its ability
to source required funding, which could delay or
prevent it from executing its strategy as planned.
4.2.8.
Risks Related to the
Shares
The market price of the shares might be affected
by a variety of factors outside management
control, such as the global economic situation,
the competition, sector M&A and it is difficult to
mitigate the risk.
If equity research analysts do not publish
research reports on Hyloris, or if they change
their recommendations regarding the shares in
an adverse way, the market price of the shares
may fall, and the trading volume may decline.
Future sell-off of substantial amounts of shares,
or the perception that such sell-off may occur,
could adversely affect the market value of the
shares.
p.85
Hyloris :
Annual report 2024
4.3.
Controls, Supervision and Corrective Actions
4.3.1.
External Control
At the Company’s Shareholders’ Meeting held on
June 14, 2022, KPMG Réviseurs d’Entreprises
BV/SRL has been appointed as statutory auditor
of the Company for a period of three years. The
mandate will expire at the end of the general
meeting called to approve the accounts for the
2024
financial
year.
KPMG
Réviseurs
d’Entreprises SRL has appointed Tanguy Legein,
réviseur
d’entreprises,
as
permanent
representative.
In 2024, a total amount of 104 K€ for audit fees
was paid to the statutory auditor and its network,
and 7k € for audit related engagements (legal
assignments). No tax services were performed by
KPMG during 2024.
It
will
be
proposed
to
the
Company’s
Shareholders’ Meeting held on June 10, 2025 to
appoint BDO Réviseurs d’Entreprises BV/SRL as
statutory auditor of the Company for a period of
three years. The mandate will expire at the end
of the general meeting called to approve the
accounts for the 2027 financial year. BDO
Réviseurs d’Entreprises SRL shall appoint Mr.
Christophe Pelzer, réviseur d’entreprises, as its
permanent representative.
4.3.2.
Internal Control
Supervision and monitoring of the operations of
the Company is done on a permanent basis at all
levels within the Company.
The Executive Committee develops a long-term
financial
plan
(5-year
business
plan)
incorporating the Company strategy. This plan is
monitored on a regular basis and updated twice
a year to keep it in line with the strategy plans.
The Executive Committee also develops an
annual budget which is approved by the Board
and which is closely monitored during the year.
Management reporting is prepared monthly,
which details the variances between the actuals
and the budget.
Internal control activities are performed by the
Finance Department related to accounting and
financial information and by all persons in charge
for all matters related to the operational
activities of the company. When deviations are
identified, there are reported to the head of
department. As of the date of this report there is
not yet a dedicated Internal Audit Function,
function
is
supported
by
the
Finance
Department.
In order to properly manage identified risks, the
Company has set up the following procedures
and reporting processes:
a budgeting process has been installed with
a strong involvement of all departments of
the
Company
which
provide
a
more
accurate forecast of the spending on a more
granular level;
the company has developed procedures
relating
to
various
business
processes
(procurement, payroll, IT, investments, cash
management);
the
company
has
developed
procedures in the following cycles:
expenditures,
payroll,
IT,
cash
management and books closing and
reporting;
the company has developed a monthly
reporting tool which allows a close
monitoring of the financial information.
The company has a monthly reporting
of the actual spending;
p.86
Hyloris :
Annual report 2024
information
systems
have
been
developed to assist the company and
are constantly being adjusted to meet
new needs as they arise;
external financial reports are produced
twice a year (half year reports ended 30
June and full year reports ended 31
December);
half-year and full-year reporting are
discussed by the audit committee and
all
critical
accounting
issues
and
financial uncertainties are reported and
discussed.
The
Executive
Committee
supervises
the
implementation of internal controls and risk
management, considering the recommendations
of the Audit Committee.
The Executive Committee is also in charge of
proposing
the
Audit
Committee
corrective
actions when identified.
In 2024, the Company made the following
improvements in its internal processes:
Enterprise resource ERP (Business Central)
was further developed to improve controls
and reporting;
the internal budgeting and forecasting
process was further improved;
improvements were made to the handling of
payroll and consultants transactions and
payments;
credit risk reporting and committee have
been developed and take place on a regular
basis;
The Board of Directors has formally engaged a
leading legal firm with recognized expertise in
corporate governance and regulatory
compliance to conduct a comprehensive review
of the Company’s existing governance and
compliance frameworks. The objective of this
engagement is to assess current practices and
policies, and to formulate recommendations
aimed at aligning them with prevailing best
practices for listed entities, the applicable
provisions of the Financial Services and Markets
Authority (FSMA), and the commitments
previously communicated to the market
following the conclusion of the 2024 forensic
investigation. The scope of this review will also
include recommendations regarding the role
and structure of the internal audit function
within the Company.
The Company has not received any updates
regarding the FSMA's review or any related
matters concerning the QliniQ transactions
since September 2024.
p.87
Hyloris :
Annual report 2024
5.
Market abuse regulations
To
prevent
insider
trading
and
market
manipulation, as required by the Market Abuse
Regulation, we have a Dealing Code available on
our website. This code outlines the rules for
directors and executives when buying or selling
our
company's
shares
and
other
financial
instruments. It restricts their trading activity to
specific periods and requires them to declare
their transactions.
Our Governance Charter also has safeguards to
prevent the misuse of confidential information
by anyone with access, including directors,
shareholders, managers, and employees. While
insiders may receive this information for their
work, they are strictly prohibited from trading
our company's related financial instruments.
We maintain a comprehensive insider list, which
includes all current and past employees or
associates
who
have
(or
had)
access
to
confidential information. This list is regularly
updated and provided to the Financial Services
and
Markets
Authority
(FSMA)
upon
their
request.
p.88
Hyloris :
Annual report 2024
6.
Conflicts of interest and
related parties
6.1.
Conflicts of Interest
In the interest of fair and impartial decision-
making,
Belgian
law
(Article
7:96
of
the
Companies and Associations Code) requires
directors to disclose any potential conflicts of
interest arising from their personal financial
holdings.
In such cases, directors must inform the board
chair immediately. Conflicts can involve personal
finances, family ties (up to second-degree
relatives), or other outside activities. When a
conflict arises, the director cannot participate in
discussions or votes on that specific issue.
Hyloris has additional internal rules to manage
potential
conflicts
beyond
the
legal
requirements. These include situations where a
close relative of a director or executive has a
financial stake that conflicts with the company's
decisions, or if the director/executive holds a
position in another company with conflicting
interests.
If a board member encounters such a conflict,
they must inform the board at the meeting's
start. The board then decides if the member can
participate in the discussion and vote on the
matter.
The
board
meeting
minutes
will
document how the situation was handled, but
these details won't be made public.
For executive management conflicts, the issue is
presented to the board for a decision.
Currently, no conflicts of interest exist among
directors
or
executives
that
haven't
been
disclosed to the board. In any past instances,
Hyloris
has
followed
the
legal
procedures
outlined in Article 7:96
6.2.
Related Party Transactions
Hyloris adheres to a comprehensive procedure
established
to
safeguard
the
integrity
of
decisions involving related parties, as defined by
International Accounting Standard 24 (IAS 24) as
adopted by the European Union. This procedure,
mandated
by
Article
7:97
of
the
Belgian
Companies and Associations Code (CCA), applies
to all material transactions where a potential
conflict of interest could arise between the
Company and a related party.
To ensure objectivity, an independent committee
comprised
of
three
directors
meticulously
reviews such transactions. This committee issues
a written and reasoned opinion to the Board of
Directors, addressing the elements outlined in
Article 7:97, Section 3.2 of the CCA. Notably, the
Board is precluded from approving a transaction
if a director with a conflict of interest is involved.
In such instances, or if all directors are conflicted,
the proposed transaction is submitted for
approval to the General Shareholders' Meeting.
Following shareholder approval, the Board may
then execute the transaction. The Board is
obligated to document its adherence to this
procedure within the meeting minutes, with
p.89
Hyloris :
Annual report 2024
justifications provided for any deviations from
the committee's opinion.
Furthermore, the statutory auditor verifies the
financial
and
accounting
information
documented within the Board minutes and the
committee's
opinion
for
material
inconsistencies,
based
on
the
information
available within the scope of their audit. This
auditor's opinion is then attached to the Board
minutes.
In accordance with Article 7:97, Section 4.1 of the
CCA, the Company publicly discloses all decisions
or transactions falling under this procedure.
It's important to note that this procedure is not
applicable to routine transactions conducted at
market rates, transactions with a value less than
1% of the Company's consolidated net assets,
decisions
regarding
director
or
executive
committee
remuneration,
acquisitions
or
disposals of own shares, interim dividend
payments, or capital increases authorized under
the existing share capital without limitations or
cancellation of existing shareholder preferential
subscription rights.
6.2.1.
Transactions with Related
Parties
The Board of Directors of Hyloris has not applied
the procedure set forth in Articles 7:96 and 7:97
CCA, in 2023.
6.2.2.
Transactions with
Affiliates
Article 7:97 of the Belgian Code on Companies
and
Associations
provides
for
a
special
procedure
which
must
be
followed
for
transactions
with
the
Company’s
affiliated
companies or subsidiaries. Such a procedure
does not apply to decisions or transactions that
are entered into the ordinary course of business
at usual market conditions or for decisions and
transactions whose value does not exceed one
percent of the Companies’ consolidated net
assets.
The Board of Directors of Hyloris has not applied
the special procedure set forth in Article 7:97 CCA
for transactions with the Company’s affiliated
companies or subsidiaries, in 2023.
p.90
Hyloris :
Annual report 2024
7.
Share capital, shares and
shareholders
7.1.
History of Capital – Capital Increase and Issuance of
Shares
7.1.1.
Securities Issued by the
Company
As of December 31, 2024, the Company’s capital
amounted
to
€140,001.87
(excluding
issue
premium) represented by 28,000,374 ordinary
shares without nominal value.
The Company created four stock option plans
under
which
warrants
were
granted
to
employees,
directors,
consultants
and
shareholders
of
the
Company
and
its
subsidiaries: the transaction warrants in May
2017
and
three
ESOP
Warrants
plans
in
December 2019, December 2020, and June 2022.
The 2019 ESOP Warrant plan expired on
December 31, 2024 without any warrants being
exercised.
See
Note
7.2
for
additional
information. A new 2025 ESOP Warrants plan has
been created by the Company in January 2025
(see
Note 29
– Subsequent Events).
7.1.2.
History of Capital since
IPO
Authorised Capital
In accordance with the Articles of Association, the
Extraordinary General Shareholders’ meeting of
the Company authorised the Board of Directors
to increase the share capital of the Company, in
one
or
several
times,
and
under
certain
conditions set forth in extenso in the articles of
association.
On June 11, 2024, the General Meeting of
Shareholders
decided,
in
accordance
with
articles 604 juncto 607, para. 2, 2° of the Belgian
Company Code to give, for a period of five years
starting on June 11, 2024, the authorisation to
the Board of Directors to increase the capital of
the Company with a maximum amount of
€140,001.87 (excluding issue premium). The
General Meeting of Shareholders also decided to
give this authorisation to the Board in case of
reception by the Company of a communication
by the Financial Services and Markets Authority
(FSMA) stating that the FSMA has been informed
of a public takeover bid regarding the Company,
for all public take-over bids notified to the
Company three years after June 11, 2024.
Consequently, the Board is therefore authorised
to increase the share capital of the Company
within the framework of the authorised capital
for a maximum amount of €140,001.87 (as of
December 31, 2024, excluding issue premium).
7.1.3.
Changes in Capital
At any given time, the Shareholders’ Meeting can
resolve to increase or decrease the share capital
of the Company. Such resolution must satisfy the
quorum and majority requirements that apply to
an amendment of the articles of association.
p.91
Hyloris :
Annual report 2024
7.2.
Warrants Plans
7.2.1.
Warrant Plans Issued
The Company created five warrant plans under
which warrants were granted to employees,
directors, consultants and shareholders of the
Company and its subsidiaries: the transaction
warrants in May 2017 (exercised in June 2022)
and the ESOP Warrants plans in December 2019
(expired on December 31, 2024), November 2020
and June 2022, as well as a new ESOP Warrant
plan issued in January 2025.
7.2.2.
Summary of the
Outstanding Warrant
Plans
ESOP Warrants
On December 31, 2019, the Company approved,
in principle, the issue of 90,825 warrants in the
context of an employee stock ownership plan,
subject to the ESOP Warrants being offered to,
and accepted by, the beneficiaries thereof, who
must be employees, directors or consultants of
the Company and/or its subsidiaries. As a result
of the Share Split, each ESOP Warrant was
automatically “divided” into four. All of these
warrants expired on December 31, 2024 without
being exercised.
On November 27, 2020, the Company approved,
in principle, the issue of 400,000 warrants in the
context of a second employee stock ownership
plan, subject to the ESOP Warrants being offered
to, and accepted by, the beneficiaries thereof,
who must be employees, directors or consultants
of the Company and/or its subsidiaries. Under
this plan, 185,500 ESOP Warrants are granted
and outstanding on 31 December, 2024 and
214,500 ESOP Warrants have lapsed or were
cancelled or forfeited.
On June 22, 2022, the Company approved, in
principle, the issue of 213,500 ESOP Warrants in
the context of a third employee stock ownership
plan. Under this plan, 123,813 ESOP Warrants are
granted and outstanding on 31 December, 2024
and 89,688 ESOP Warrants have lapsed, were
cancelled or forfeited.
On January 20, 2025, the Company approved, in
principle, the issue of 650,000 ESOP Warrants in
the
context
of
a
fourth
employee
stock
ownership plan. Under this 2025 plan, 611,500
ESOP
Warrants
are
currently
granted
and
accepted as of the date of this Annual Report.
All ESOP Warrants have been granted free of
charge.
Each ESOP Warrant entitles its holder to
subscribe for one new Share at an exercise price
determined by the Board of Directors in line with
a report on the real value of the underlying Share
at the date of the offering of the ESOP Warrants
in accordance with article 43, §4, 2° of the Belgian
Stock Option Act of March 26, 1999.
The exercise price for the ESOP Warrants is equal
(a) to the average closing price of the Company’s
shares during the thirty (30) days preceding the
offer or (b) to the last closing price preceding the
day of the offer. It is possible that, when the
evolution of the share price is such that such a
discount is justified to grant to the beneficiaries
of the warrant plan warrants with an exercise
price similar to the exercise price of the warrants
that others beneficiaries of the warrant plan
have acquired and in order to ensure equality
between the beneficiaries of the warrant plan as
much as possible, that the exercise price of the
Stock Option Warrants will be equal to eighty-five
percent (85 %) of the average closing price of the
Company’s shares during the thirty (30) days
preceding the offer or (b) at the last closing price
preceding the day of the offer (i.e. a maximum
discount of fifteen percent (15 %)).
The new Shares (if any) that will be issued
pursuant to the exercise of the ESOP Warrants,
p.92
Hyloris :
Annual report 2024
will be ordinary shares representing the capital,
of the same class as the then existing Shares,
fully paid, with voting rights and without nominal
value. They will have the same rights as the then
existing Shares and will be profit sharing as from
any distribution in respect of which the relevant
ex-dividend date falls after the date of their
issuance.
The ESOP Warrants shall only be acquired in a
final manner (“vested”) in cumulative tranches
over a period of four years as of the starting date
(determined for each beneficiary separately).
ESOP Warrants can only be exercised by the
relevant holder of such ESOP Warrants, provided
that they have effectively vested, as of the
beginning of the fourth calendar year following
the year in which the Company granted the ESOP
Warrants to the holders thereof. As of that time,
the ESOP Warrants can be exercised during the
first fifteen days of each quarter. However, the
terms and conditions of the ESOP Warrants
provide that the ESOP Warrants can or must also
be exercised, regardless of whether they have
vested or not, in several specified cases of
accelerated vesting set out in the issue and
exercise conditions.
The terms and conditions of the ESOP Warrants
contain customary good leaver and bad leaver
pro- visions in the event of termination of the
professional
relationship
between
the
beneficiary
and
Hyloris.
The
terms
and
conditions of the ESOP Warrants also provide
that all ESOP Warrants (whether or not vested)
will become exercisable during a special exercise
period to be organised by the Board in the event
of certain liquidity events. These liquidity events
include (i) a transfer of all or substantially all
Shares of the Company; (ii) a merger, demerger
10
Calculated as % of total number of voting rights at 31 December 2024
(28,000,374)
11
In the 2025 warrant plan (note 30), the Management team accepted the
following number of warrants : Mr. Van Rompay : 45,000 ; Mr. Jacobsen :
30,000 ; Mr. Maréchal : 60,000 ; Mr. Aichorn : 60,000
or other corporate restructuring resulting in the
share- holders holding the majority of the voting
rights in the Company prior to the transaction
not holding the majority of the voting rights in
the surviving entity after the transaction; (iii) the
launch of a public takeover bid on the Shares;
and
(iv)
any
action
or
transaction
with
substantially the same economic effect as
determined by the Board of Directors.
The table below provides an overview of the
shares and warrants held by the members of the
Executive Committee at the date of December
31, 2024.
Shares
Name
Number
%
10
Mr. Stijn Van Rompay
7,743,067
27.65%
Mr. Thomas Jacobsen
3,857,838
13.78%
Mr. Christophe Maréchal
0
0%
Mr. Dietmar Aichhorn
32,500
0.12%
ESOP warrants
Name
Number
11
%
12
Mr. Stijn Van
Rompay
0
0%
Mr. Thomas
Jacobsen
0
0%
Mr. Christophe
Maréchal
0
0%
Dr. Dietmar Aichhorn
40,000
6.38%
12
Calculated as % of total number of warrants accepted at the date at 31 December
2024 (627,271)
p.93
Hyloris :
Annual report 2024
HYLORIS ESOP SCHEMES
As of the date of this Annual Report, the following warrant schemes (which are called
inschrijvingsrechten/ droits de souscription under the BCCA) are still active, of which the details (i.e.,
conditions for the granting, term, vesting period, exercise) are set out in the following table. The
conditions for the granting of these warrants and the vesting period help to align the interests of the
Executive Committee members with the longterm interests of Hyloris, its shareholders and other
stakeholders.
ESOP Scheme 2020
ESOP Scheme 2022
ESOP Scheme 2025
Conditions for
Granting
Employees, directors
or consultants of
Hyloris
Pharmaceuticals
and/or its subsidiaries
Employees, directors
or consultants of
Hyloris
Pharmaceuticals
and/or its subsidiaries
Employees, directors
or consultants of
Hyloris
Pharmaceuticals
and/or its subsidiaries
Term
10 years
7 years
6 years
Vesting Period
The 2020 plan is subject
to services conditions so
that it will vest gradually
over the next four years
(25% after 1 year, and
1/48 for every additional
month).
The 2022 plan is subject
to services conditions so
that it will vest gradually
over the next four years
(25% after 1 year, and
1/48 for every additional
month).
The 2025 plan is subject
to services conditions so
that it will vest gradually
over the next four years
(10 after 1 year, 15%
after 2 years, 25% after
3 years, 50% after 4
years).
Exercise
Warrants which are
definitively acquired
(“vested”) may be
exercised from the first
(1) of January of the
fourth (4th) calendar
year following that of
the Date of the Offer
and this, only during
the first fortnight. (the
first fifteen (15) days) of
each quarter. The first
fortnight (the first
fifteen (15) days) of the
last quarter of the
validity period of the
Stock Option Warrants
constitutes the last
possible exercise
period. Each fiscal
period will end on the
last business day of the
relevant fiscal period.
Warrants which are
definitively acquired
(“vested”) may be
exercised from the
first (1) of January of
the fourth (4th)
calendar year following
that of the Date of the
Offer and this, only
during the first
fortnight. (the first
fifteen (15) days) of
each quarter. The first
fortnight (the first
fifteen (15) days) of the
last quarter of the
validity period of the
Stock Option Warrants
constitutes the last
possible exercise
period. Each fiscal
period will end on the
last business day of
the relevant fiscal
period.
Warrants which are
definitively acquired
(“vested”) may be
exercised from the
first (1) of January of
the fourth (4th)
calendar year following
that of the Date of the
Offer and this, only
during the first
fortnight. (the first
fifteen (15) days) of
each quarter. The first
fortnight (the first
fifteen (15) days) of the
last quarter of the
validity period of the
Stock Option Warrants
constitutes the last
possible exercise
period. Each fiscal
period will end on the
last business day of
the relevant fiscal
period.
p.94
Hyloris :
Annual report 2024
7.3.
Consequences in Case of a Public Take-Over Bid
The Extraordinary Meeting of Shareholders of
June 11, 2024 decided to give the authorisation
to the Board to increase the capital of the
Company in case of reception by the Company of
a communication by the Financial Services and
Markets Authority (FSMA) stating that the FSMA
has been informed of a public takeover bid
regarding the Company, for all public take-over
bids notified to the Company three years after
June 11, 2024. At the Extraordinary General
Meeting of 11 June 2024, the Board of Directors
approved the renewal of this authorisation for a
period of three years from the date of the
Extraordinary General Meeting.
Pursuant to the resolution of the Extraordinary
Shareholders’ Meeting of June 11, 2024, the
Board of Directors of the Company is authorised
to acquire and accept in pledge its own Shares
without the total number of own Shares, held or
accepted in pledge by the Company exceeds 20%
of the total number of Shares, for a consideration
of at least €1 and at most 30% above the
arithmetic average of the closing price of the
Company’s Share during the last thirty days of
stock exchange listing prior to the decision of the
Board of Directors to acquire or accept in pledge.
The
Board
of
Directors
is
furthermore
authorised, subject to and with effect as from the
completion of the Offering, to acquire or accept
in pledge its own Shares where such acquisition
or acceptance in pledge is necessary to prevent
imminent serious harm to the Company.
The Company may transfer its own Shares in
accordance with the Belgian Code of Companies
and Associations and article 11 of its Articles of
Association. And the Board of Directors of the
Company is also authorised to transfer its own
Shares to one or more specific persons other
than employees.
The authorisations referred to above also apply
to the Company, the direct subsidiaries of the
Company, insofar as necessary, the indirect
subsidiaries of the Company, and, insofar as
necessary, every third party acting in its own
name but on behalf of those companies.
There are no agreements between shareholders
which are known by the Company and may result
in restrictions on the transfer of securities and/or
the exercise of voting rights.
There are no holders of any shares with special
voting rights. Each shareholder is entitled to one
vote per share. Voting rights may be suspended
as provided in the Company’s Articles of
Association and the applicable laws and articles.
The Company is not a party to agreements which,
upon a change of control of the Company or
following a takeover bid can enter into force or,
subject to certain conditions can be amended, be
terminated by the other parties thereto or give
the other parties thereto (or beneficial holders
with respect to bonds) a right to an accelerated
repayment of outstanding debt obligations of the
Company under such agreements.
p.95
Hyloris :
Annual report 2024
7.4.
Shareholders
Belgian legislation (the Law of May 2, 2007 on the
disclosure of major shareholdings in Companies
whose shares are admitted to trading on a
regulated market, and the Royal Decree of
February 14, 2008 on the disclosure of major
shareholdings) imposes disclosure requirements
on each natural person or legal entity (including
registered business associations without legal
personality and trusts) that acquires or transfers,
directly or indirectly, (i) securities with voting
rights or (the right to exercise) voting rights,
(ii) securities granting the right to acquire existing
securities with voting rights, or (iii) securities that
are referenced to existing securities with voting
rights and with economic effect similar to that of
the securities referred to in (ii), whether or not
they confer a right to a physical settlement, if, as
a result of such acquisition or transfer, the total
number of voting rights (deemed to be) linked to
securities referred to in (i) through (iii)) directly or
indirectly held by such natural person or legal
entity, acting alone or in concert with others,
reaches, rises above or falls below a threshold of
5%, or a multiple of 5%, of the total number of
voting rights attached to the securities of the
Company.
A notification duty applies also if (a) the voting
rights (linked to securities) referred to in (i) or (b)
the voting rights deemed to be linked to
securities referred to in (ii) and (iii), taken
separately, reaches, rises above or falls below
the threshold.
The
Company
has
introduced
additional
disclosure thresholds of 3% and 7.5% in its
Articles of Association.
The graph hereafter provides an overview of the
shareholders of Hyloris Pharmaceuticals SA,
taking
into
account
the
transparency
notifications received pursuant to the Law of May
2, 2007 on the disclosure of large shareholders
(situation as per December 31, 2024).
Major shareholdings
Based on transparency notifications and latest denominator
Based on online notification (FSMA website) of managers’ transactions
Total number of outstanding voting rights (denominator)
28,000,374
Total number of securities carrying voting rights not yet issued
309,313
Share capital (
excluding share premium
)
€140,001
27.65%
13.78%
6.21%
5.38%
3.72%
43.26%
Stijn Van Rompay (Founder &co-CEO)
Thomas Jacobsen (Founder & co-CEO)
Nick Reunbrouck
Scorpiaux BV
Pieter Van Rompay
Free float
p.96
Hyloris :
Annual report 2024
At December 31, 2024, there are 28,000,374
ordinary shares representing a total share capital
of the Company of €140,001.87 (excluding issue
premium). There are only ordinary shares, and
there are no special rights attached to any of the
ordinary shares, nor special shareholder rights
for any of the shareholders of the Company. The
Company has issued a total of (i) 400,000 ESOP
warrants (November 2020) of which 213,500
warrants were forfeited, (iii) 213,500 ESOP
Warrants (June 2022) of which 89,688 ESOP
Warrants were forfeited. All the warrants give
right to subscribe to an equal number of shares.
As per 31 December 2024, a total of 309,313
ESOP warrants were outstanding.
7.5.
Dividends and Dividend Policy
7.5.1.
Entitlement to Dividends
In
accordance
with
the
Belgian
Code
of
Companies and Associations, the distribution of
profits to shareholders is determined through a
vote at the Annual General Meeting. This vote is
based on the most recently audited financial
statements prepared in accordance with Belgian
Generally
Accepted
Accounting
Principles
(Belgian GAAP).
A non-binding proposal for
dividend distribution is typically presented by the
Board of Directors.
The Board of Directors also possesses the
authority to declare interim dividends, subject to
adherence to relevant legal restrictions.
The Company's capacity to distribute dividends
hinges
on
the
presence
of
sufficient
"distributable profits" as defined by Belgian law.
This determination is based on the Company's
stand-alone statutory accounts prepared in
accordance with Belgian GAAP.
Specifically,
dividend
distribution
can
only
proceed
if,
following
the
declaration
and
issuance of said dividends, the Company's net
assets (as reflected in the non-consolidated
financial statements at the most recent fiscal
year-end) remain above a minimum threshold.
This threshold is calculated by subtracting
provisions, liabilities, and (in most cases) non-
amortized
incorporation
and
research
&
development costs from the total assets on the
balance sheet (all in accordance with Belgian
accounting rules). Additionally, the minimum
threshold may be further increased by non-
distributable reserves, such as any unamortized
revaluation surpluses.
It is important to note that Belgian law and the
Company's Articles of Association mandate the
allocation of 5% of the annual net profit
("bénéfices nets"/"nettowinst") to a legal reserve
within the stand-alone statutory accounts. This
allocation continues until the legal reserve
reaches 10% of the Company's share capital. As
the legal reserve currently falls below this
requirement, a portion of future annual net
profits
will
be
directed
to
this
reserve,
consequently limiting the available pool for
dividend distribution.
Belgian law dictates that the right to collect
declared dividends on ordinary shares expires
five years after the date of declaration by the
Board of Directors.
Thereafter, the Company is
no longer obligated to pay such dividends.
p.97
Hyloris
: Annual report 2024
7.5.2.
Dividend Policy
The Company has not previously distributed
dividends on its shares.
Any future declaration
of dividends will be contingent upon a thorough
examination
of
the
Company's
financial
performance, current financial health, capital
needs, and other factors deemed relevant by the
Board of Directors.
Neither Belgian law nor the Company's Articles of
Association
mandate
the
distribution
of
dividends.
At present the Board of Directors intends to
retain all generated earnings, if any, to fuel the
Company's development and growth initiatives.
Consequently,
dividend
payments
to
shareholders are not anticipated in the near
future.
The determination of the Company's dividend
policy remains within the purview of the Board of
Directors and is subject to potential future
adjustments.
Hyloris
: Annual report 2024
p99
Consolidated
Financial
Statements
Statement of the
board of directors
On 28 April, 2025, we hereby confirm that, to the best of our knowledge:
• the consolidated financial statements, established in accordance with
International Financial Reporting Standards (“IFRS”) as adopted by
the European Union, give a true and fair view of the equity, financial
position and financial performance of Hyloris Pharmaceuticals SA and of
the entities included in the consolidation as a whole;
• the annual report on the consolidated financial statements includes
a fair overview of the development and the performance of the
business and the position of Hyloris Pharmaceuticals SA and of the
entities included in the consolidation, together with a description of the
principal risks and uncertainties to which they are exposed.
• the ESEF version of the annual financial report (official version) takes
precedence over any other versions (PDF, etc.) in the event of a conflict
between these different versions.
Signed by Stijn Van Rompay (Co-CEO), Thomas Jacobsen (Co-CEO) and
Stefan Yee (Chairman) on behalf of the Board of Directors
p.100
Hyloris
: Annual report 2024
Contents
1.
CONSOLIDATED FINANCIAL STATEMENTS
..............................................................
101
2.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
...................................
105
3.
ABBREVIATED STATUTORY FINANCIAL STATEMENTS
.............................................
178
4.
STATUTORY NOTES
....................................................................................................
180
5.
AUDITORS’ REPORT
...................................................................................................
182
6.
GLOSSARY AND OTHER INFORMATION
...................................................................
190
 
p.101
Hyloris
: Annual report 2024
Consolidated Financial Statements
(as
at 31 December 2024)
Consolidated
Statement
of
Financial
Position
ASSETS
(in € thousands)
Note
31
December
2024
31
December
2023
Non-current
assets
11,628
12,373
Intangible assets
7
3,838
3,828
Property, plant and equipment
340
429
Right-of-use assets
8
1,652
1,724
Equity accounted investees
9
2,748
3,801
Other financial assets
10
1,000
1,000
Trade and other receivables
11
2,050
1,591
Current
assets
29,707
35,308
Trade and other receivables
11
4,858
3,565
Other financial assets
10
556
499
Current tax assets
24.3
508
244
Prepayments
12
191
594
Cash and cash equivalents
13
23,594
30,406
TOTAL
ASSETS
41,335
47,681
EQUITY
AND
LIABILITIES
(in € thousands)
Note
31
December
2024
31
December
2023
Equity
14
32,143
39,069
Share capital
140
140
Share premium
121,513
121,513
Retained earnings, excluding profit (loss) for the reporting period
(80,128)
(65,381)
Retained earnings, profit (loss) for the reporting period
(6,342)
(15,380)
Share based payment reserve
26
944
2,161
Cost of Capital
(4,460)
(4,460)
Other reserves
476
476
Liabilities
9,192
8,613
Non-current
liabilities
2,030
1,853
Borrowings
15
1,489
1,510
Other financial liabilities
15
368
344
Provisions
16
173
-
Current
liabilities
7,162
6,759
Borrowings
15
326
241
Other financial liabilities
15
3,000
3,200
Provisions
16
408
-
Trade and other liabilities
17
3,428
3,318
TOTAL
EQUITY
AND
LIABILITIES
41,335
47,681
The accompanying notes are an integral part of these consolidated financial statements.
 
 
p.102
Hyloris
: Annual report 2024
Consolidated
Statement
of
Profit
or
Loss
and
Other
Comprehensive
Income
(in € thousand)
Note
2024
2023
Revenues
19
8,458
2,087
Other operating income
22
1,584
2,127
Operating
income
10,043
4,214
Cost of sales
20
(227)
(93)
Research and development expenses
20
(10,265)
(14,421)
General and administrative expenses
20
(5,627)
(5,546)
Share of result of equity-accounted investees, net of tax
9
(81)
(147)
Impairment(s) on equity-accounted investees
9
(972)
-
Operating
expenses
(17,172)
(20,207)
Operating
profit/(loss)
(EBIT)
(7,130)
(15,993)
Financial income
23
1,165
898
Financial expenses
23
(378)
(285)
Profit/(loss)
before
taxes
(6,342)
(15,380)
Income taxes
24
-
-
PROFIT/(LOSS)
FOR
THE
PERIOD
(6,342)
(15,380)
Other comprehensive income
-
-
TOTAL
COMPREHENSIVE
INCOME
OF
THE
PERIOD
(6,342)
(15,380)
Profit/(loss) for the period attributable to the owners of the Company
(6,342)
(15,380)
Total comprehensive income for the period attributable to the owners of the
company
Basic and diluted earnings/(loss) per share (in €)
25
(0.23)
(0.55)
The accompanying notes are an integral part of these consolidated financial
statements
 
 
p.103
Hyloris
: Annual report 2024
Consolidated Statement of Changes in Equity
Attributable
to
equity
holders
of
the
company
Total
Equity
Share
capital
Share
Premium
Other
reserves
Retained
earnings
and result
of the
period
(in € thousand)
Share based
payment reserve
Cost of
Capital
Other
reserv
es
Balance at 31 December 2022
140
121,513
1,622
(4,460)
476
(65,381)
53,909
Share-based payments (note 26)
540
540
Total comprehensive income
(15,380)
(15,380)
Balance
at
31
December
2023
140
121,513
2,162
(4,460)
476
(80,761)
39,069
Share-based payments (note 26)
(584)
(584)
Transfer of SBP reserves to retained earnings
(note 26)
(633)
633
-
Total comprehensive income
(6,342)
(6,342)
Balance
at
31
December
2024
140
121,513
945
(4,460)
476
(86,471)
32,143
The accompanying notes are an integral part of these consolidated financial statements.
 
 
p.104
Hyloris
: Annual report 2024
Consolidated Statement of Cash Flows
(in € thousand)
Note
2024
2023
CASH
FLOW
FROM
OPERATING
ACTIVITIES
Profit/(loss) for the period
(6,342)
(15,380)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation, amortization and impairments
20
648
349
Impairment on equity-accounted investees
9
972
-
Provisions
16
581
-
Share-based payment expense
26
(584)
540
Net finance result
(788)
(613)
Share of profit of equity-accounted investees, net of tax
9
81
147
Other non-cash adjustments
-
15
Bank fees paid
(56)
(48)
Changes in working capital:
Trade and other receivables
11
(1,881)
29
Prepayments
12
403
1,155
Trade and other liabilities
17
140
1,050
Cash
generated
from
operations
(6,826)
(12,756)
Interest
paid
15/23
(77)
(52)
Net
cash
generated
from
operating
activities
(6,903)
(12,808)
CASH
FLOW
FROM
INVESTING
ACTIVITIES
Interest received
23
556
638
Purchases of property, plant and equipment
(29)
(298)
Purchases of Intangible assets
7
(268)
(452)
Proceeds of other financial assets
-
10,000
Net
cash
provided
by/(used
in)
investing
activities
259
9,889
CASH
FLOW
FROM
FINANCING
ACTIVITIES
Reimbursements of borrowings and other financial liabilities
15
(40)
-
Proceeds from borrowings and other financial liabilities
15
139
51
Reimbursements of lease liabilities
15
(267)
(170)
Interests paid
15
-
(12)
Net
cash
provided
by/(used
in)
financing
activities
(168)
(131)
NET
INCREASE
(DECREASE)
IN
CASH
AND
CASH
EQUIVALENTS
(6,812)
(3,051)
CASH
AND
CASH
EQUIVALENTS
at
beginning
of
the
period
30,406
33,457
CASH
AND
CASH
EQUIVALENTS
at
end
of
the
period,
calculated
23,594
30,406
The accompanying notes are an integral part of these consolidated financial statements.
 
p.105
Hyloris
: Annual report 2024
Notes to the Consolidated Financial Statements
1.
General information
Hyloris Pharmaceuticals SA (the “Company” or
“Hyloris”) is a limited liability company governed by
Belgian law. The address of its registered office is
Boulevard Patience et Beaujonc N°3/1, 4000 Liège,
Belgium.
Hyloris
is
a
specialty
biopharma
company
identifying and unlocking hidden potential in
existing medications for the benefit of patients and
the healthcare system. Hyloris applies its knowhow
and
technological
innovations
to
existing
pharmaceuticals and has built a broad proprietary
product pipeline that has the potential to offer
significant advantages over currently available
alternatives.
Hyloris currently has three partnered, commercial-
stage products: Maxigesic® IV, a non-opioid
analgesic for the treatment of pain and Podofilox
Gel, the first drug product generic to Condylox Gel
0.5%
®
in the U.S. and Sotalol IV for the treatment
of atrial fibrillation.
The Company’s development strategy primarily
focuses on the FDA’s 505(b)2 regulatory pathway,
which is specifically designed for pharmaceuticals
for which safety and efficacy of the molecule has
already been established. This pathway can
reduce the clinical burden required to bring a
product to market, and significantly shorten the
development timelines and reduce costs and risks.
As mentioned in the Half Year report of 2024, the
American
Arbitration
Association
denied
all
AltaThera
claims
and
confirmed
Hyloris’
ownership of its intellectual property. Hyloris is
pleased that the damages claims from AltaThera
have been rejected by the arbitration panel and
remains dedicated to safeguarding its intellectual
property rights while ensuring the continued
development and growth of its portfolio and
product candidates.
Please
refer
to
section
4.2.
of
Corporate
Governance for description of risks that may
impact the consolidated financial statements of
the Group.
The
consolidated
financial
statements
were
authorized for issue by the Board of Directors on
28 April 2025.
 
p.106
Hyloris
: Annual report 2024
2.
Summary of material
accounting policies
2.1
BASIS OF PREPARATION
The consolidated financial statements of the Group
for
the year ended December 31, 2024 have been
prepared
in accordance with IFRS (“International
Financial Reporting Standards”) as adopted by the
European
Union. These include all IFRS standards
and IFRIC
interpretations issued and effective as at
December
31,
2024.
No
new
standards,
amendments to standards or interpretations
were early adopted.
The
consolidated
financial
statements
are
presented in euro, which is the Company’s
functional currency. All amounts in this document
are
represented
in
thousands
of
euros
(€
thousands), unless noted otherwise. All references
in this Annual Report to “$”, “US dollars”, "U.S.
dollars" “dollar” and “USD” mean U.S. dollars and all
references to “€”, “EUR” and “euros” mean euros,
unless otherwise noted.
Due
to rounding, numbers presented throughout
these Consolidated Financial Statements may
not add up precisely to the totals provided and
percentages may
not precisely reflect the absolute
figures.
The financial statements are prepared on an
accrual basis and on the assumption that the
entity is in going concern and will continue in
operation in the foreseeable future (see also
Note
3.1
).
The
preparation
of
financial
statements
in
accordance
with
IFRS
Accounting
Standards
requires the use of certain critical accounting
estimates. It also requires management to exercise
judgment in the process of applying the Group
accounting policies. The areas involving a higher
degree of judgment or complexity, or areas where
assumptions and estimates are significant to the
consolidated financial statements are disclosed in
Note 3
.
Relevant
IFRS
accounting
pronouncements
adopted as from 2024 onwards
Several amendments and interpretations did
apply for the first time in 2024; but did not have
any
material
impact
on
the
consolidated
financial statements of the Group.
Amendments to IAS 1 Presentation of
Financial
Statements:
Classification
of
Liabilities as Current or Non-current and
Non-current
Liabilities
with
Covenants
(applicable for annual periods beginning on
or after January 1, 2024);
Lease Liability in a Sale and Leaseback –
Amendments to IFRS 16 Leases (issued on
22 September 2022);
Amendments to IAS 7 Statement of Cash
Flows and IFRS 7 Financial Instruments:
Disclosures–
Supplier
Finance
Arrangements (issued on 25 May 2023).
A number of new standards, amendments to
standards
and interpretations are not yet
effective for the year ended 31 December 2024,
and have not been applied in preparing these
consolidated financial statements:
Amendments to IAS 21 The Effects of Changes in
Foreign Exchange Rates: Lack of Exchangeability
,
issued on 15 august 2023, clarify when a currency
 
p.107
Hyloris
: Annual report 2024
is exchangeable into another currency (and when it
is not). When a currency is not exchangeable, a
company needs to estimate a spot rate. The
company’s objective when estimating a spot rate is
that it reflects the rate at which an orderly exchange
transaction would take place at the measurement
date
between
market
participants
under
prevailing
economic
conditions.
The
amendments
contain no specific requirements for
estimating a spot
rate. Under the amendments,
companies will need to provide new disclosures
to help users assess the impact
of using an
estimated
exchange
rate
on
the
financial
statements. The amendments are effective for
annual
reporting periods beginning on or after 1
January 2025 with early adoption permitted.
These amendments have been endorsed by the
EU.
IFRS 18 Presentation and Disclosure in Financial
Statements
, issued on 9 April 2024, will replace IAS
1 Presentation of Financial Statements. The new
standard will improve the quality of financial
reporting by:
requiring defined subtotals in the statement
of profit or loss;
requiring
disclosure
about
management-
defined performance measures; and adding
new
principles
for
aggregation
and
disaggregation of information.
The standard is effective for annual reporting
periods
beginning on or after 1 January 2027 with
early adoption permitted. The standard has not
yet been endorsed by the EU.
IFRS 19 Subsidiaries without Public Accountability:
Disclosures
, issued on 9 May 2024, will allow
eligible subsidiaries to apply IFRS Accounting
Standards with reduced disclosure requirements.
A subsidiary will be to apply the new standard in
its consolidated, separate
or individual financial
statements provided that, at the reporting date: it
does not have public accountability;
and its parent
produces consolidated financial statements under
IFRS Accounting Standards.
The standard is effective for annual reporting
periods
beginning on or after 1 January 2027 with
early adoption permitted. The standard has not
yet been endorsed by the EU.
Amendments to the Classification and Measurement
of Financial Instruments – Amendments to IFRS 9
and IFRS 7
, issued on 30 May 2024, will address
diversity in accounting practice by making the
requirements
more
understandable
and
consistent. The
amendments include: Clarifications
on
the
classification
of financial assets with
environmental, social and corporate governance
(ESG) and similar features—ESG- linked features in
loans could affect whether the loans
are measured
at amortized cost or fair value. To resolve any
potential diversity in practice, the amendments
clarify how the contractual cash flows on such loans
should be assessed.
Clarifications on the date on which a financial asset or
financial liability is derecognized. The IASB also
decided to develop an accounting policy option
to allow a
company to derecognize a financial
liability before it delivers cash on the settlement date
if specified criteria are met.
The
IASB
has
also
introduced
additional
disclosure
requirements
to
enhance
transparency
for
investors
regarding
investments in equity instruments designated at
fair value through other comprehensive income
and financial instruments with contingent features,
for example features tied to ESG-linked targets.
The amendments are effective for annual reporting
periods beginning on or after 1 January 2026 with
early adoption permitted. These amendments
have not yet been endorsed by the EU.
Annual Improvements Volume 11
, issued on 18
July 2024, include clarifications, simplifications,
corrections and changes aimed at improving the
p.108
Hyloris
: Annual report 2024
consistency of several IFRS Accounting Standards.
The amended accounting standards are:
FRS 1 First-time Adoption of International
Financial Reporting Standards;
IFRS 7 Financial Instruments: Disclosures and
its accompanying Guidance on implementing
IFRS 7;
IFRS 9 Financial Instruments;
IFRS 10 Consolidated Financial Statements;
and
IAS 7 Statement of Cash Flows.
The amendments are effective for annual reporting
periods beginning on or after 1 January 2026 with
early adoption permitted. These amendments have
not been endorsed by the EU.
Contracts
Referencing
Nature-dependent
Electricity
Amendments
to
IFRS
9
and
IFRS 7,
issued on 18 December 2024, will help
entities better report on the financial effects of
nature-dependent electricity contracts, which are
often structured as power purchase agreements
(PPAs). Nature-dependent electricity contracts help
companies to secure their electricity supply from
sources such as wind and solar power. The amount
of electricity generated under these contracts can
vary based on uncontrollable factors such as
weather
conditions.
Current
accounting
requirements may not adequately capture how
these contracts affect a company’s performance.
The amendments include:
clarifying the application of the ‘own use’
requirements;
permitting hedge accounting if these contracts
are used as hedging instruments; and
adding new disclosure requirements to enable
investors to understand the effect of these
contracts
on
a
company’s
financial
performance and cash flows.
The amendments are effective for annual reporting
periods beginning on or after 1 January 2026 with
early adoption permitted. These amendments have
not been endorsed by the EU.
Except for IFRS 18, for which the analysis is ongoing,
these amendments are not expected to have any
significant impact on the consolidated financial
statements of Hyloris.
2.2
CONSOLIDATION
Subsidiaries
Subsidiaries are all entities over which the Group
has control. Control is established when the Group is
exposed, or has the rights, to variable returns
from
its involvement with the subsidiary and has
the ability
to affect those returns through its power
over
the
subsidiary.
Subsidiaries
are
fully
consolidated from the
date on which control is
transferred to the Group. They
are de-consolidated
from the date that control ceases.
Intra-group balances and transactions and any
unrealized income and expenses (except for foreign
currency transactions gains or losses) arising from
intra-group transactions are eliminated. Unrealized
gains
arising
from
transactions
with
equity-
accounted investees are also eliminated against
the investment to the extent of the Groups interest
in the investee.
Unrealized losses are eliminated in the same
way as
unrealized gains, but only to the extent that
there is no
evidence of impairment.
Transactions under common control
For business combinations under common
control
(also “Transactions under common control”),
the Group
applies predecessor accounting.
The
consideration
for
each
acquisition
is
measured at the aggregate of the fair values (at the
date of acquisition) of assets transferred and
liabilities incurred
or
assumed,
and
equity
instruments issued by the Group in exchange for
control of the acquiree.
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Acquisition-related costs are recognized in profit or
loss as incurred.
Where applicable, the consideration for the
acquisition
includes
any
asset
or
liability
resulting
from
a
contingent
consideration
arrangement, measured at its acquisition- date
fair value.
The acquiree’s identifiable assets, liabilities, and
contingent liabilities that meet the recognition
criteria conditions for recognition under IFRS are
recognized
and
measured
at
the
carrying
amounts as recognized in the acquiree’s individual
financial statements, but adjusted for any deviations
with the accounting policies of the Group.
Any
difference
between
the
consideration
transferred
and the net assets at the acquisition
date is recognized in retained earnings.
The Group elected the accounting policy choice to
represent its comparatives and adjust its current
reporting
period
before
the
date
of
the
transaction as
if the transaction had occurred
before the start of the earliest period presented.
This restatement should not extend to periods
during which the entities were not under
common control.
2.3
JOINT ARRANGEMENTS
Joint control is the contractually agreed sharing
of control of an arrangement, which exists when
decisions about relevant activities require the
unanimous consent of the parties sharing
control.
Joint arrangements are classified as either a joint
venture or a joint operation.
A joint venture is a joint arrangement whereby the
parties that have joint control of the arrangement
have rights to the net assets of the arrangement.
The results, assets and liabilities of joint ventures are
incorporated
in
the
consolidated
financial
statements
using
the
equity
method
of
accounting,
except
when
the
investment is
classified as held for sale (in which case it is accounted
for in accordance with IFRS 5 Non-current Assets
Held for Sale).
Under the equity method, on initial recognition,
investments in joint ventures are recognised in the
consolidated statement of financial position at cost,
and the carrying amount is adjusted for post-
acquisition changes in the Group’s share of the net
assets of the joint venture, less any impairment of
the value of individual investments. Losses of a
joint venture in excess of the Group’s interest in
that joint venture (which includes any long-term
interests that, in substance
, form part of the
Group’s net investment in the associate or joint
venture) are recognised only to the extent that the
Group has incurred legal or constructive obligations
or made payments on behalf of the joint venture.
Any excess of the cost of acquisition over the Group’s
share of the net fair value of the identifiable assets and
(contingent)
liabilities
of
the
joint
venture
recognised at the date of acquisition is goodwill.
The goodwill is
included
within
the
carrying
amount of the investment and is assessed for
impairment as part of that investment.
Where a Group entity transacts with a joint venture
of the Group, profits and losses are eliminated to the
extent of the Group’s interest in the relevant joint
venture.
Unrealized
gains
arising
from
transactions
with equity-accounted investees are
eliminated against
the investment to the extent of
the Group’s interest in
the investee. Unrealised
losses are eliminated in the same way as
unrealised gains, but only to the extent that there
is no evidence of impairment.
A joint operation is a joint arrangement whereby the
parties that have joint control of the arrangement
have rights to the assets and obligations of the
liabilities relating to the arrangement.
A joint operator recognizes its assets, liabilities and
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transactions, including its share of those incurred
jointly. These assets, liabilities and transactions
are accounted for in accordance with the relevant
accounting standards.
2.4
FOREIGN CURRENCIES
Items included in the financial statements of each of
the Group’s entities are measured using the currency
of the primary economic environment in which
the entity operates (‘the functional currency’). The
consolidated financial statements are presented in
euro, which is the Group’s presentation currency.
Transactions in foreign currencies are translated
into the respective rates at the dates of the
transactions. Monetary assets and liabilities
denominated
in
foreign
currencies
are
translated into the functional currency at the
exchange rate at the reporting date. Non-
monetary
assets
and
liabilities
that
are
measured at
fair value in foreign currency are
translated into the functional currency at the
exchange
rate
when
the
fair
value
was
determined.
Non-monetary
items
that
are
measured based on historical cost in a foreign
currency are translated at the exchange rate at
the date of the
transaction. Foreign currency
differences are generally recognised in profit or loss
and presented within
financial result.
The principal exchange rate that has been used is
the US dollar. The following table presents the
exchange rates used for the USD/EUR.
1 EUR =
Closing Rate
Average Rate
Rate
December 31, 2024
1.0389
1.0824
December 31, 2023
1.1050
1.0813
2.5
INTANGIBLE ASSETS
Research
and
development
Internally-generated research and development
To assess whether an internally generated
intangible
asset
meets
the
criteria
for
recognition, the Company
classifies the internal
generation of assets into a
research phase and a
development phase.
No intangible asset arising from research is
recognized.
Expenditure
on
research
is
recognized as an expense when it is incurred.
An intangible asset arising from development is
recognized if, and only if, the Company can
demonstrate all of the following:
(i)
the technical feasibility of completing the
intangible asset so that it will be available for
use or sale;
(ii)
the intention to complete the intangible asset and
use or sell it;
(iii)
the ability to use or sell the intangible asset;
(iv)
how the intangible asset will generate probable
future economic benefits;
(v)
the availability of adequate technical, financial
and
other
resources
to
complete
the
development and to use or sell the intangible
asset; and
(vi)
the ability to measure reliably the expenditure
attributable to the intangible asset during its
development.
With
respect
to
the
technical
feasibility
condition, strong evidence is achieved only when
Phase III (i.e. final stage before filing for marketing
approval) of the related development project is
successfully
completed,
i.e.
when
filing
for
marketing approval from the
relevant regulatory
authorities. Consequently, internally generated
development expenses arising before this
p.111
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point, mainly the cost of clinical trials, are
expensed as incurred within Research and
development expenses.
In some cases (i.e. for high barrier generic products),
market approval was obtained previously, but
additional costs are incurred in order to improve
the process for an active ingredient. To the
extent that the above criteria are considered as
having been met, such expenses are recognized
as an asset in the balance sheet within intangible
assets as incurred. Similarly, some clinical trials,
for example those undertaken to obtain a
geographical extension for a molecule that
has
already obtained marketing approval in a major
market, may in certain circumstances meet the
above capitalization criteria, in which case the
related expenses are recognized as an asset in
the balance sheet within intangible assets.
The cost of an internally-generated intangible
asset is the sum of the expenditure incurred
from the date
when the intangible asset first meets
the recognition
criteria. The cost of an internally-
generated intangible asset comprises all directly
attributable costs necessary to create, produce
and prepare the asset to be capable of operating
in
the
manner
intended
by
management,
including any fees to register legal rights (patent costs)
and borrowing costs.
Separately acquired research and development
Payments for separately acquired research and
development are capitalized as intangible assets
provided that the following conditions are met:
(i)
the asset is identifiable, i.e. either separable (if it
can be sold, transferred, licensed) or it results from
contractual or legal rights;
(ii)
it is probable that the expected future economic
benefits that are attributable to the asset will flow
to the Group;
(iii)
the Group can control the resource; and
(iv)
the cost of the asset can be measured reliably.
The
second
condition
for
capitalization
(the
probability that the expected future economic
benefits from the asset will flow to the entity) is
considered to be satisfied for separately acquired
research and development. The management of
the company assesses whether and to
which
amount
milestone
payments
are
to
be
considered as related to the purchase of an asset
(capitalization) or related to outsourced research
and development. The
latter will be recognized as
research and development expenses when they
occur.
If
the
separately
acquired
research
and
development project meets the conditions for
capitalization as mentioned above, related upfront
and milestone payments to third parties are
recognized as intangible assets, and amortized on
a straight-line basis over their useful lives beginning
when marketing approval is obtained. However,
any subsequent expenditure on the relating
projects is added to the carrying amount of the
intangible asset only if it meets the recognition
criteria for capitalizing development costs (see
above section Internally-generated research and
development).
Payments
under
research
and
development
arrangements relating to access to technology or to
databases and payments made to purchase
generics dossiers are also capitalized as the
conditions
mentioned
above
are
met
upon
acquisition, and amortized on a straight-line basis
over the useful life of the intangible asset.
Subsequent
expenditure
incurred
are
only
capitalized if the expenditure meets the conditions
mentioned above for capitalizing development
costs.
Subcontracting arrangements, payments for
research
and
development
services,
and
continuous
payments
under
research
and
development collaborations which are unrelated
to the outcome of that collaboration, are
expensed over the service term except if as part
p.112
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of the development phase of the underlying
assets.
Non-refundable advance payments for goods
and services that will be used in future research
activities are expensed when the activity has
been performed or when the goods have been
received rather than when the payment is made.
Research
and
development
expenses
also
include upfront and milestone payments, to the
amount these payments are assessed to be
outsourced research and development and to
the
amount of the costs effectively occurred.
Intangible assets acquired through exchange of
assets
Intangible assets may be acquired in exchange
for a non-monetary asset or assets, or a
combination of monetary and non-monetary
assets.
In the event of such exchange of assets, the cost
of the
acquired asset is measured at fair value
unless (a) the exchange transaction lacks commercial
substance or (b)
the fair value of neither the asset
received, nor the asset given up is reliably
measurable.
If
the
acquired
asset
is
not
measured at fair value, its cost is measured at
the carrying amount of the asset given up.
Other intangible assets acquired separately
An intangible asset is recognized on the statement
of financial position when the following conditions are
met:
(i)
the asset is identifiable, i.e. either separable (if it
can be sold, transferred, licensed) or it results from
contractual or legal rights;
it is probable that the
expected future economic benefits that are
attributable to the asset will flow to the Group;
(ii)
the Group can control the resource; and
(iii)
the cost of the asset can be measured reliably.
The cost of a separately acquired intangible asset
comprises its purchase price, including import
duties and non-refundable purchase taxes, after
deducting trade discounts and rebates. Any
directly attributable cost of preparing the asset
for its intended use is also included in the cost of
the intangible asset.
Subsequent
measurement
Subsequent to initial recognition, intangible
assets are measured at cost less accumulated
amortization and any accumulated impairment
losses. Intangible assets are amortized on a
systematic basis over their useful life, using the
straight-line method. Amortization begins when
the asset is capable of operating in the manner
intended by management.
The estimated useful life and amortization
method are reviewed at the end of each
reporting period, with the
effect of any changes in
estimate being accounted for on
a prospective
basis.
The amortization expense is presented as part of
Cost of Sales in the Statement of Profit or Loss. The
applicable useful lives are determined based on the
period during
which the Company expects to receive
benefits from the underlying project. Key factors
considered to determine the useful life comprises
the duration of the patent protection and access
of competitors to the market.
Derecognition
An intangible asset is derecognized in case the
intangible asset is sold or out-licensed, or when
no future economic benefits are expected from use
or
disposal.
Gains
or
losses
arising
from
derecognition of an intangible asset, measured as the
difference between the net disposal proceeds and
the carrying amount of the asset, are recognized in
profit or loss when the asset is derecognized.
2.6
LEASES
Leases are recognized as a right-of-use asset and
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corresponding liability at the date of which the
leased
asset is available for use by the Group.
Lease liabilities include the net present value of the
following lease payments:
fixed payments (less any lease incentives
receivable),
variable lease payments that are based on an
index or rate,
the exercise price of a purchase option if the
group is reasonably certain to exercise that
option, and
payments of penalties for terminating the
lease, if the lease term reflects the group
exercising that option.
Lease payments to be made under reasonably
certain
extension options are also included in the
measurement of the liability.
The lease payments are discounted using the
interest rate implicit in the lease, if that rate can
be readily
determined, or the Group’s incremental
borrowing rate,
i.e. the rate of interest that a lessee
would have to pay to borrow over a similar term,
and with a similar security, the funds necessary
to obtain an asset of a similar value to the right-
of-use asset in a similar economic environment.
The group is exposed to potential future increases
in variable lease payments based on an index or
rate, which are not included in the lease liability
until they take effect. When adjustments to lease
payments based on an index or rate take effect, the
lease liability is reassessed and adjusted against the
right-of-use asset.
The lease liability is subsequently measured at
amortized cost under the effective interest method.
Finance expenses are recognized immediately in
profit or loss, unless they are directly attributable to
qualifying
assets,
in
which
case
they
are
capitalized.
Right-of-use assets are initially measured at cost
comprising the following:
the amount of the initial measurement of
lease liability, any lease payments made at or
before the commencement date less any lease
incentives received,
any initial direct costs, and
an estimate of the costs related to the
dismantling
and removal of the underlying
asset.
If it is reasonably certain that the Group will exercise
a
purchase option, the asset shall be depreciated
on a straight-line basis over its useful life. In all
other circumstances the asset is depreciated on
a straight-line basis over the shorter of the useful
life of the asset or the lease term.
The Group has
elected not to separate non-lease
components
and account for the lease and non-lease
components as a single lease component.
2.7
IMPAIRMENT OF NON-
FINANCIAL ASSETS
Intangible assets with indefinite useful lives and
intangible assets not yet available for use are not
subject to amortization, but are tested annually for
impairment, and whenever events or changes in
circumstances indicate that the carrying amount
may not be recoverable. Other assets which are
subject
to
amortization
are
reviewed
for
impairment whenever events or changes in
circumstances indicate that the carrying amount
may not be recoverable.
An impairment loss is recognized for the amount
by which the asset’s carrying amount exceeds its
recoverable amount. The recoverable amount is
the higher of an asset’s fair value less costs to sell
and value in use. To determine the value in use,
the forecasted future cash flows are discounted to
their present value using a pre-tax discount rate
that reflects current market assessments of the
time value of money and the risks specific to the
p.114
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asset.
When an impairment loss subsequently reverses,
the carrying amount of the asset is increased to
the revised estimate of its recoverable amount,
but so that the increased carrying amount does
not exceed the carrying amount that would have
been determined had no impairment loss been
recognized for the asset in prior years. A reversal
of an impairment loss is recognized immediately
in profit or loss.
2.8
REVENUE RECOGNITION
Revenue is measured based on the consideration
specified in a contract with a customer. The Group
recognizes revenue when it transfers control over
a good or service to a customer.
In applying IFRS 15 Revenue from contracts with
customers the Group determines the separate
performance obligations included within the
contract
with the customer. Currently the Group has
contracts
in which it grants a license. Some
contracts include additional services which are to
be provided such as
research and development
services and/or cost sharing
mechanisms. In general,
these are all considered separate performance
obligations.
The
transaction
price
is
allocated
to
each
performance obligation on a stand-alone selling
price basis.
The following paragraphs provide information
about the nature and timing of the satisfaction of
performance
obligations
in
contracts
with
customers, including
significant payment terms,
and the related revenue
recognition policies:
Royalties
Royalties received from commercialized products
are recorded in accordance with the royalty’s
exception as foreseen in IFRS 15 Revenue from
contracts with customers. Sales- or usage-based
royalties that are attributable to a license of
intellectual property of commercialized goods, are
recognized at the later of:
when the subsequent sale or usage occurs;
and
the satisfaction or partial satisfaction of the
performance obligation to which some or all
of the
sales- or usage-based royalty has been
allocated.
Currently, as well as at year-end 2023, the Group has 3
commercialized products for which royalties are
recorded, i.e., Sotalol IV, Maxigesic
®
IV and Podofilox.
For each commercialized product specific formulas are
stipulated in the contract to determine the royalties
attributable to the Group.
Payment terms in general are 30 days after the invoice
date.
Milestone payments
The royalty’s exception as applied for the revenue
recognition
of
royalties
does
not
apply
to
milestone payments which are determined with
reference to other events or indicators, i.e., not
sales or usage based. The current arrangements
which are held with
co-development partners can
include a license of intellectual property and an
obligation to finance research and development
costs for which the Group receives a consideration
of which a substantial portion of the total
consideration
is
contingent
on
achieving
milestones such as regulatory filling or FDA
approval
of
the
product
candidate.
These
milestone payments are generally considered
separate performance obligations within the co-
development agreement and are recognized in
accordance
with
the
variable
consideration
guidance included within IFRS 15 Revenue from
contracts with customers.
The Group only includes estimates of variable
consideration in the transaction price to the extent
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that it is ‘highly probable’ that a significant reversal
in the amount of cumulative revenue recognized
will not occur when the uncertainty associated
with the
variable consideration is resolved. In doing
so, the Group assesses the likelihood of a revenue
reversal arising from an uncertain future event and
the potential magnitude of the revenue reversal when
the uncertainty related to the variable consideration
has been resolved. Given the fact that receiving the
consideration is highly susceptible to factors outside
the entity’s influence and the fact that the uncertainty
about the consideration is not expected to be resolved
for a long period of time the Group only recognizes
the milestone payments when the milestone is
reached. As such this is not considered a significant
estimate with a high level of estimation uncertainty.
Payment terms are 30 days after the invoice date
except for AFT where the payment terms are agreed
between parties.
Out-license agreements
When the Group grants a license, that is distinct from
other promised goods or services in the contract, then
it evaluates the nature of the license to determine if it
is:
a right to access the entity’s intellectual property
as it exists throughout the license period. If this is
the case, then revenue from the license is
recognized over time; or
a right to use the entity’s intellectual property as
it exists at the point in time at which the license is
granted. If this is the case, then revenue from the
license is recognized at a point in time.
Up until December 31, 2024, the Group only granted
licenses with the right to use.
For licenses which are not distinct from other
performance obligations, the Group applies judgment
to assess the nature of the combined performance
obligations to determine whether the combined
performance obligations are satisfied over time or at
a point in time. If the performance obligation is
satisfied over time, revenue is recognized based on a
pattern that best reflects the transfer of control of the
service to the customer.
Payment terms are 30 days after the invoice date.
Other operating income - Services rendered to co-
development partners
Other operating income is measured based on the
consideration specified in a contract with a customer.
The Group recognizes income when it performs the
service to the customer and thus recognizes the
income over time.
These services are currently not presented as part of
Revenue, as these are not considered output of the
company’s ordinary activities but it could become core
business activities in the future.
2.9
COST OF SALES
Cost of sales are related to the sale of products and
are recognized when the associated revenue is
recognized. Cost of goods sold includes the
amortization of intangible assets for the product
candidates which are commercialized. Cost of sales
does not include any R&D costs due to the lack of
internal systems in place which would allow for
proper registration and follow-up of costs (incl.
personnel cost) and its allocation to cost of sales.
2.10
FINANCIAL ASSETS
The Group classifies its financial assets in the following
categories: financial assets at fair value through profit
and loss (FVTPL) or through other comprehensive
income (FVOCI) and financial assets at amortized cost.
The classification depends on the entity’s business
model for managing the financial assets and the
contractual terms of the cash flows. Management
determines the classification of its financial assets at
initial recognition.
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A financial asset is measured at amortized cost if it
meets both of the following conditions and is not
designated as at FVTPL (Fair Value Through Profit and
Loss Statement):
It is held within a business model whose objective
is to hold assets to collect contractual cash flow;
and
Its contractual terms give rise on specified dates
to cash flows that are solely payments of
principal and interest on the principal amount
outstanding.
On initial recognition of an equity investment that is
not held for trading, the Group may irrevocably elect
to
present
subsequent
changes
in
the
investment’s fair value in OCI. This election is made
on an investment-by- investment basis.
All financial assets not classified as measured at
amortized costs or FVOCI, as described above, are
measured at FVTPL. In assessing whether the
contractual cash flows are solely payments of
principal and interest, the Group considers the
contractual terms of the instrument. This
includes
assessing whether the financial asset contains a
contractual term that could change the timing or
amount of contractual cash flows such that is would
not meet this condition. In making this assessment,
the Group considers:
Contingent events that would change the
amount or timing of cash flows;
Terms that may adjust the contractile coupon
rate, including variable-rate features,
Prepayment and extension features; and
Terms that limit the Group’s claim to cash flows
from
specified
assets
(e.g.
non-recourse
features).
Trade receivables are initially recognized when
they are originated. All other financial assets are
initially recognized when the Group becomes a
party to the contractual provisions of the
instrument.
At initial recognition, the group measures a financial
asset at its fair value plus, in the case of a financial
asset not at fair value through profit or loss,
transaction costs that are directly attributable to
the acquisition of the financial asset. Transaction
costs of financial assets carried at fair value through
profit or loss are expensed in profit or loss. A trade
receivable
without
a
significant
financing
component is initially measured at the transaction
price.
Financial
assets
at
FVTPL
are
subsequently
measured at fair value. Net gains and losses,
including any interest or dividend income, are
recognized in the financial result in profit or loss.
Equity investments at FVOCI are subsequently
measured at fair value. Dividends are recognized
as income in profit or loss unless the dividend
clearly represents a recovery of part of the cost of
investments. Other net gains and losses are
recognized in OCI and are never reclassified to
profit or loss.
Financial
assets
at
amortized
cost
are
subsequently
measured at amortized cost using the
effective interest
method, less any impairment.
The Group assesses on a forward-looking basis the
expected credit losses associated with its financial
assets carried at amortized cost. For trade
receivables,
the group applies the simplified
approach
permitted
by
IFRS
9
Financial
Instruments, which requires expected lifetime
losses to be recognized from initial recognition
of the receivables.
The amount of the allowance is deducted from the
carrying amount of the asset and is recognized in
the income statement within ‘Cost of sales
’.
The Group derecognizes a financial asset only when
the contractual rights to the cash flows from the asset
expire, or when it transfers the financial asset and
substantially
all
the
risks
and
rewards
of
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ownership of the asset to another entity. If the
Group neither transfers nor retains substantially
all the risks and
rewards of ownership and
continues to control the
transferred asset, the
Group recognizes its retained
interest in the asset
and an associated liability for
amounts it may
have to pay. If the Group retains
substantially all
the risks and rewards of ownership
of a
transferred financial asset, the Group continues to
recognize the financial asset and also recognizes a
collateralized
borrowing
for
the
proceeds
received.
On de-recognition of a financial asset in its entirety,
the difference between the asset’s carrying amount
and the sum of the consideration received and
receivable is recognized in profit or loss.
Financial assets and financial liabilities are offset
and the net amount presented in the statement of
financial position when, and only when, the Group
currently has a legally enforceable right to set off the
amounts and it intends either to settle them on a
net basis or to realize the asset and settle the
liability simultaneously.
2.11
FAIR VALUE
MEASUREMENT
Fair value is the price that would be received to
sell an asset or paid to transfer a liability in an
orderly transaction between market participants
at the measurement date in the principal or, in
its absence,
the most advantageous market to
which the Group has access at that date. The fair
value of a liability reflects its non-performance risk.
A number of the Group’s accounting policies and
disclosure require the measurement of fair values,
for
both financial and non-financial assets and
liabilities.
When one is available, the Group measures the fair
value of an instrument using the quoted price in
an active market for that instrument. A market is
regarded as ‘active’ if transactions for the asset
or liability take
place with sufficient frequency and
volume to provide
pricing information on an
ongoing basis.
If there is no quoted price in an active market,
then the
Group uses valuation techniques that
maximise the use
of relevant observable inputs
and minimize the use of unobservable inputs.
The chosen valuation technique incorporates all
of the factors that market participants would
take into account in pricing a transaction.
If an asset or a liability measured at fair value has
a bid
price and an ask price, then the Group
measures assets
and long positions at a bid price
and liabilities and short positions at an ask price.
The best evidence of the fair value of a financial
instrument on initial recognition is normally the
transaction price – i.e. the fair value of the
consideration given or received. If the Group
determines that the fair value on initial recognition
differs from the transaction price and the fair value
is evidenced neither by a quoted price in an active
market for an identical asset or liability nor based
on
a
valuation
technique
for
which
any
unobservable inputs are judged to be insignificant
in relation to the measurement, then the financial
instrument is initially measured at fair value,
adjusted to defer the difference between the fair
value on initial recognition and the transaction
price. Subsequently, that difference is recognized
in profit or loss on an appropriate basis over the
life of the instrument but no later than when the
valuation
is
wholly
supported
by observable
market data or the transaction is closed out.
2.12
CASH AND CASH
EQUIVALENTS
Cash and cash equivalents include bank balances
and demand deposits meeting the criteria of cash
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and cash equivalents. Bank overdrafts are shown
within borrowings in current liabilities on the
statement of financial position.
Deposits with the same level of liquidity as cash,
i.e., can be withdrawn at any time without penalty
fee are cash. Deposits that don’t have the same
liquidity level as cash are only considered cash
equivalents if the following criteria are met:
Short term
investment, e.g. with a maturity
date of three months or less. Three months
is a presumption that may be rebutted when
the investment is held for the purpose of
meeting short-term commitments and when
the
instrument
otherwise
meets
the
definition of a cash equivalent;
Highly liquid and readily convertible into a
known amount of cash, i.e. the amount of
cash that would be received is known at the
time of the initial investment;
Subject to an insignificant risk of changes in
value;
Held for the purpose of meeting short-term
cash commitments.
Deposits which are excluded from cash and cash
equivalents are presented as other financial
assets
in the statement of financial
position.
2.13
SHARE CAPITAL
Ordinary
shares
are
classified
as
equity.
Incremental
costs directly attributable to the
issue of new shares are shown in equity as a
deduction, net of tax, from the proceeds.
2.14
GOVERNMENT GRANTS
The Company recognizes a government grant
only when there is reasonable assurance that the
Company will comply
with
the
conditions
attached to the grant and the grant will be
received.
Government grants are recognized in profit or loss
on a
systematic basis over the periods in which
the Company recognizes as expenses the related
costs
which
the
grants
are
intended
to
compensate. As a result, grants relating to costs
that are recognized as intangible assets
or
property, plant and equipment (grants related to
assets or investment grants) are deducted from the
carrying amount of the related assets and
recognized
in
the
profit
or
loss
statement
consistently with the amortization or depreciation
expense of the related
assets.
The portion of grants not yet released as income is
presented as deferred income in the statement of
financial position, within the Other current liabilities.
In the
statement
of
comprehensive
income,
government
grants are presented as other
operating income or
financial income depending
on the nature of the costs that are compensated.
Government grants that become receivable as
compensation for expenses or losses already
incurred are recognized in profit or loss of the
period in which they become receivable.
Recoverable cash advances
With respect to recoverable cash advances (RCA –
“avances récupérables”), the RCAs are initially
recognized, concomitantly with the occurrence of
subsidized expense, as a financial liability at fair
value (calculated based on present value of future
repayment of grants), determined as per IFRS 9.
To determine the fair value of the cash advances
received, the Company estimates future cash
outflows considering (i) assumptions regarding the
estimation of the timing and the probability of the
future sales or (ii) the probability that the Company
will notify the Walloon Region whether it will decide
or not to use the results of the research phase and
(iii) an appropriate discount rate.
If the amount of cash received would exceed the fair
p.119
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value of the liability, the difference would be
considered as a government grant, being recognized
in the income statement as operating income on a
systematic basis in order to match the expenses
incurred in accordance with IAS 20. The RCA grant
component is recognized in profit or loss under
"Other income" on a systematic basis over the
periods
in
which
the
entity
recognizes
the
underlying R&D expenses subsidized by the RCA.
The fair market value adjustments to the RCA
liability
are
recognized
in
the
consolidated
statement of comprehensive loss under “Other
income/expense” and as a non-cash adjustment in
“cash flows from operating activities” in the
consolidated statements of cash flows.
The RCAs liability component (RCA financial liability)
is subsequently measured at amortized cost using
the cumulative catch-up approach under which the
carrying amount of the liability is adjusted to the
present value of the future estimated revenue,
discounted at the liability’s original effective interest
rate. When modifying the estimated contractual
cash flows, the Company reviews if there are
indicators, either positive or negative, influencing
the estimation of the timing and level of the future
sales of the products benefiting from the support of
the Walloon Region. The difference between the
recalculated carrying amount and the initial carrying
amount is included in the caption “other operating
income/expenses” in the consolidated income
statement and in the financial expenses for the
impact of the discounting .
When repayment of recoverable cash advances may
be forgiven, the liability component of recoverable
cash advances is treated as a government grant and
taken to income only when there is reasonable
assurance that the entity will meet the terms for
forgiveness of the advance
R&D Tax Credit
In
Belgium,
companies
that
invest
in
environmentally
friendly
research
and
developments activities can benefit from increased
investment incentives or a tax credit.
Since 2020, the Group applies for the R&D tax credit
incentive set-up by the Federal government. When
capitalizing its R&D expenses under tax reporting
framework, the Group may either (i) get a reduction
of its taxable income (if any) corresponding to 13.5%
of the capitalized R&D expenses up to the year 2022,
20.5% for the year 2023 and 15.5% for the year 2024,
or (ii) if no sufficient taxable income is available,
apply for the refund of unutilized tax credits. The tax
credit should be claimed in the year in which the
investment takes place. Refund occurs five financial
years after the tax credit application filed by the
Group and for the part not yet recovered.
R&D tax credits are treated as a government grant
under IAS 20 and booked into other operating
income if the R&D activities are expensed, or as a
reduction to intangible assets if the development
activities
are
capitalized
and
subsequently
amortized together with the underlying
assets.
Exemption payroll taxes
The Group benefits from the Belgian tax incentive
regime for companies employing researchers, which
provides af partial exemption
from payment of
withholding tax.
Under this measure, eligible companies can
retain up to 80% of the withholding tax on the
salaries of employees involved in innovation and
R&D activities.
These payroll tax rebates are recognized in the line
Other
Operating
Income
in
the
financial
statements.
p.120
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2.15
EMPLOYEE BENEFITS
Short-term employee benefits
Short-term employee benefits are recorded as an
expense in the income statement in the period in
which the services have been rendered. Any
unpaid compensation is included in trade and
other liabilities
in the statement of financial
position. A liability is recognized to be paid if the
Group has a present legal
or constructive obligation
to pay this amount as a result of past service
provided by the employee and the obligation can
be estimated reliably.
2.16
SHARE-BASED
PAYMENTS
Equity-settled
share-based
payments
to
employees
and
others
providing
similar
services are measured at the fair value of the
equity instruments at the grant date. The fair
value determined at the grant date of
the
equity-settled share-based payments is expensed
on a straight-line basis over the vesting period, if
any,
based on the Company’s estimate of equity
instruments that will eventually vest, with a
corresponding increase in equity. At the end of
each reporting period, the Company revises its
estimate of the number of equity instruments
expected to vest and the vesting period. The
impact of the revision
of the original estimates, if
any, is recognized in profit or loss such that the
cumulative expense reflects the revised estimate,
with a corresponding adjustment to the
equity-
settled share-based payment reserve.
2.17
INCOME TAXES
Income tax expense represents the sum of the
current income tax and deferred tax.
Accounting for the current and deferred tax effects
of a transaction or other event is consistent with
the accounting for the transaction or event itself.
Therefore,
income taxes are recognized in profit or
loss except to the extent that it relates to items
recognized directly in
equity or in OCI.
Current tax comprises the expected tax payable
or receivable on the taxable income or loss for
the year
and any adjustment to the tax payable or
receivable in
respect of previous years.
The amount of current tax payable or receivable
is the best estimate of the tax
amount expected
to be paid or received that reflects
uncertainty
related to income taxes, if any.
The current income tax charge is calculated on
the basis of the tax laws enacted or substantively
enacted at the end of the reporting period in the
countries where
the Group’s subsidiaries operate
and generate taxable
income.
In
line
with
paragraph
46
of
IAS
12
Income
taxes,
management periodically evaluates positions
taken in tax returns with respect to situations in
which
applicable tax regulations are subject to
interpretation
and establishes uncertainty tax
provisions within tax
payable/receivable where
appropriate on the basis of
amounts expected to
be paid to the tax authorities. This evaluation is
made for tax periods open for audit by the
competent authorities.
Deferred tax is recognized on temporary differences
arising between the tax bases of assets and
liabilities
and
their
carrying
amounts
in
the
consolidated financial statements.
However, the deferred tax is not recognized for:
the initial recognition of goodwill (in case of
taxable temporary differences arising);
the initial recognition of an asset or liability in a
transaction other than a business combination
that at the time of the transaction affects neither
accounting nor taxable profit or loss and
deferred
tax
is
recognized
on
temporary
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differences
arising
on
investments
in
subsidiaries and associates, except for deferred
income tax liabilities where the timing of the
reversal
of
the
temporary
difference is
controlled by the Group and it is probable that
the temporary difference will not reverse in the
foreseeable future.
A deferred tax liability is recognized for all taxable
temporary differences, unless one of the above
exemptions would apply.
Deferred
tax
assets
are
recognized
for
deductible
temporary differences and unused tax
losses and tax
credits to the extent that it is
probable that taxable
profits will be available
against which they can be utilized. Future taxable
profits are determined based on the reversal of
relevant taxable temporary differences. If the
amount of taxable temporary differences is
insufficient to recognize a deferred tax asset in full,
then future taxable profits, adjusted for reversals of
existing temporary differences, are considered,
based on the
business plans for individual
subsidiaries in the Group.
Deferred tax assets and liabilities are measured
at the tax rates that are expected to apply to the
period when the asset is realized or the liability
is settled, based
on tax rates (and tax laws) that
have been enacted
or substantively enacted by
the end of the reporting period.
The carrying amount of deferred tax assets is
reviewed
at the end of each reporting period
and reduced to
the extent that it is no longer
probable that sufficient taxable profits will be
available to allow all or part of the asset to be
recovered. Unrecognized deferred tax assets are
reassessed
at
each
reporting
date
and
recognized to the extent that it has become
probable
that
future taxable profits will be
available against which they can be used.
Deferred taxes are calculated at the level of each fiscal
entity in the Group. Deferred tax assets and
liabilities are offset only if certain criteria are met.
2.18
FINANCIAL LIABILITIES
Financial liabilities (including borrowings and trade
and other payables) are classified as at amortized
cost.
All financial liabilities are initially recognized when
the Group becomes a party to the contractual
provisions of the instrument. Financial liabilities
are recognized initially at fair value, net of
transaction
costs
incurred.
Borrowings
are
subsequently
stated
at
amortized
cost;
any
difference
between
the
proceeds
(net
of
transaction costs) and the redemption value is
recognized in the income statement over the
period of the borrowings using the effective
interest method. A borrowing is classified as
current liability if it meets any of the following
conditions:
it is expected to be settled in the entity's normal
operating cycle;
it is held primarily for trading purposes;
it is due to be settled within 12 months after the
reporting date; or
it is not subject to the entity's right at the
reporting date to defer its settlement for at least
12 months after the reporting date.
Where the loan is from a shareholder acting in
the
capacity of a shareholder, the difference
between
cash received and fair value of the loan
at initial
recognition is reflected in equity because
the substance
of the favorable terms is typically a
contribution by a shareholder.
The Group derecognizes a financial liability when
its contractual obligations are discharged or
cancelled, or expire. The Group also derecognizes
a financial liability when its terms are modified and
the cash flows of the modified liability are
substantially different, in which case a new
financial liability based on the modified terms is
p.122
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recognized at fair value.
When a financial liability measured at amortized cost
is modified without this resulting in derecognition, a
gain or loss is recognized in profit or loss. The gain or
loss is calculated as the difference between the
original contractual cash flows and the modified
cash flows discounted at the original effective
interest rate.
2.19
DERIVATIVE FINANCIAL
INSTRUMENTS
The Group holds derivative financial instruments to
hedge
its
foreign
currency.
Derivatives
are
recognised initially at fair value at the date a
derivative contract
is entered into and are
subsequently remeasured to their fair value at
each reporting date and changes
therein are
generally recognized in the financial result in profit or
loss. A derivative with a positive fair value is recognised
as a financial asset whereas a derivative with a negative
fair value is recognised as a financial liability.
Derivatives are not offset in the financial statements
unless the Group has both legal right and intention
to offset. A derivative is presented as a non-current
asset (‘Other investments, including derivatives) or a
non-current liability (‘Other financial liabilities’) if the
remaining maturity of the instrument is more than
12 months and it is not expected to be realised or
settled within 12 months. Other derivatives are
presented as current assets or current liabilities.
2.20 PROVISIONS
In accordance with IAS 37 – Provisions, contingent
liabilities and contingent assets, a provision must
be recognized when:
A present obligation exists due to past events
It is probable that an outflow of economic
resources will be required to settle the
obligation
The amount of the obligation can be estimated
Provisions are determined by discounting the
expected future cash-flows at a pre-tax rate that
reflects current market assessments of the time of
money and the risks specific to the liability. The
unwinding of the discounting is recognized as
finance costs.
3. Critical accounting estimates
and judgments
In the application of the Group’s accounting policies,
which are described above, management is
required to make judgements, estimates and
assumptions
about the carrying amounts of
assets and liabilities that
are
not
readily
apparent from other sources. The estimates
and associated assumptions are based on
historical experience and other factors that are
considered to be relevant. Actual results may differ
from these estimates. The followings are areas
where key assumptions concerning the future,
and other key sources of estimation uncertainty
at the end of the
reporting period, have a
significant risk of causing a material adjustment to
p.123
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: Annual report 2024
the carrying amounts of assets and liabilities within
the next financial year.
3.1
GOING CONCERN
The Company has incurred net losses since its
inception, and for the 12 months ended December
31, 2024, its audited consolidated statement of
profit and loss and other comprehensive income
reflects both a net loss and accumulated losses
carried forward. The Board has reviewed and
approved the 10-year strategic business plan,
which was updated
with additional out-licensing
milestones revenues following new commercial
opportunities under negotiations. Taking into
account the cash and cash equivalents position of
€23.2 million as of December 31, 2024, the
anticipated cash flows generated by revenues
from its three commercialized products, the
expected proceeds from out-licensing agreements
in 2025, 2026 and beyond, the possibility of
accelerating
the
execution
of
out-licensing
agreements initially forecasted beyond 2026, the
expected
research
and
development
expenditures, the ability to delay or defer research
and development activities if necessary, and the
Company's ability to secure additional financing if
needed
through
ongoing
discussions
with
financial counterparties, the Board is of the
opinion that the audited consolidated financial
statements should be prepared under the going
concern assumption.
Whilst the current cash position is sufficient to
meet the Company’s immediate and mid-term
operational
needs
under
all
contemplated
scenarios, the Board acknowledges that, in one
scenario, where the cash runway extends at least
until July 2026, the Company may seek additional
funding to support the ongoing development of its
portfolio of new product candidates or to execute
other business opportunities. Discussions with
potential financial partners have already been
initiated to address such needs if they arise.
Accordingly, management has not identified any
material uncertainties that would cast significant
doubt on the Company’s ability to continue as a
going concern for a period of at least 12 months
following the approval date of the financial
statements at the General Meeting to be held on
June 10, 2025, in compliance with IAS 1 §25–26.
3.2
JOINT
COLLABORATIONS
The Company has entered into a number of
arrangements for the development, co-promotion
and/
or co-marketing of products. The Company
believes that a presentation of the main
arrangements is useful to an
understanding of
the financial statements.
Arrangement with FHP
In February 2021, Hyloris and FHP BV (FHP) entered
into a partnership to develop and commercialise
an
innovative
combination
therapy
for the
treatment of severe and recurrent vulvovaginal
candidiasis (rVVC). FHP is a special purpose vehicle
founded to exclusively develop a local topical
combination
formulation
of
the
well-known
antifungal Miconazole with Domiphen Bromide
(MCZ-DB).
Under the terms of the arrangement, Hyloris has
committed to milestone-related investments of
up
to EUR 4.3 million in FHP (of which EUR 1.3 million
is already paid). Hyloris holds 20% of the shares in
FHP (Class B) and is eligible to receive up to a
maximum of 45% and a minimum of 17.3% of the
net profits generated by FHP irrespective of the % of
shares held by Hyloris.
Hyloris is represented in the Board of Directors
by one member out of a total of four members.
Despite the fact Hyloris holds 20% of the shares in
FHP
and is represented in the Board of Directors
by one member out of a total of 4 members, the
Company
concluded that it has joint control based
on IFRS 11 - Joint Arrangements considering that
p.124
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: Annual report 2024
reserved matters significantly affecting the returns
of the joint arrangement require the unanimous
consent
of
all
shareholders.
The
joint
arrangement is classified as a joint venture as the
arrangement is structured through a separate
vehicle and the investors do not have rights to the
assets
and
obligations
for
the
liabilities.
Therefore, this arrangement is accounted for via
equity accounting, see
note 9.1
FHP is a related party, see
note 29.1
Arrangement with Pleco Therapeutics
In November 2021, Hyloris and Pleco Therapeutics
signed an agreement to co-develop and register
HY-086, a novel combination product of chelating
agents for
the treatment of Acute Myeloid
Leukaemia (AML) and Small Cell Lung Cancer
(SCLC).
Under the arrangement, Hyloris has provided €1
million that was converted into equity in June 2022
(7,944 shares at €126 per share)
Hyloris obtained global exclusive co-development
rights and future joint commercialization to the
Pleco technology in AML and SCLC. Hyloris
committed to fund (as R&D contribution) up to an
additional €7.7 million in pre-defined R&D activities.
Pleco funds all activities that are outside the
scope of the maximum €7.7 million funding
commitment from Hyloris. In exchange, Hyloris will
be eligible to receive up to 65% of the gross
product margin generated worldwide in AML and
SCLC. Hyloris became co-owner on all Pleco
patents (except for patents held by MD Anderson
Cancer
Center),
inventions,
co-development
information
and
market
information.
The
arrangement constitutes a joint operation.
Hyloris agreed in May 2022 to transfer its co-
ownership
rights
on the patent and patent
applications to Pleco in order for Pleco to be able
provide a pledge to RVO for an innovation credit
(“Innovatiekrediet”)
it
received.
Upon
full
reimbursement of
the innovation credit, the co-
ownership rights of the patent and patent
applications under the collaboration agreement
will revert back to Hyloris. The innovation credit
will be reimbursed to the authorities with the first
profits of PTX-252. Payment of profit share to the
shareholders
is
subordinated
until
full
reimbursement of the innovation credit.
At December 2024, The Group has invested €2.4
million within the co-development agreement
which
brings
the
outstanding
maximum
commitment to €5.3 million.
Furthermore,
Hyloris
entered
into
a
Management Consultancy Agreement in July
2022 for a total amount
of €2.5 million. Under this
agreement, Hyloris has and will support Pleco
Therapeutics with strategic advice until December
31
st
2024 with the possibility of an extension as
explained below. At reporting date, the Group
already invoiced €1,562 thousand of which €62
thousand recognized in 2024.
The nature of the
strategic advice is holistic, and forward-thinking,
with a focus on creating value. It covers a wide
range of areas including business development,
market
entry
strategies,
organisational
structure,
operational
efficiency,
investor
relations, and risk mitigation. After December 31st
2022, in case the total amount of the invoices
exceeds 50% of the amount of the innovation
credit (“Innovatiekrediet”) made available to Pleco,
further invoicing will be postponed until additional
amounts are made available of the innovation
credit and the agreement will be extended
accordingly with the same number of months so
that the total amount of invoices remains €2.5
million. The services rendered are booked as
Other Operating Income over time. In analogy
with IFRS15.B16, as a practical expedient, if the
entity has the right to invoice a customer in an
amount
that
corresponds
directly
with
its
performance to date, then it can recognize income
for that amount.
p.125
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: Annual report 2024
End
of
December
2024,
Hyloris
holds
an
ownership interest of 5.00% in Pleco Therapeutics
(corresponding to 5.35% of the voting rights) and is
entitled to one observer (‘waarnemer’) within the
Board of Directors of Pleco Therapeutics without
voting rights.
Based on the guidance of IAS 28 – Investments in
Associates and Joint Ventures, the Company
concluded that it does not have a significant
influence on Pleco Therapeutics considering the
following elements:
Holding of only 5.35% of the voting rights,
No voting representation in the Board of
Directors,
No
participation
in
policy-making
processes,
No interchange of key management
Pleco is developing other products with other
3
rd
parties which are currently in the
preclinical development stage, and
Pleco is not financially dependent of Hyloris.
The arrangement between Hyloris and Pleco
Therapeutics is a significant agreement for Pleco
Therapeutics,
but
does
not
preclude
Pleco
Therapeutics from making strategic decisions or
contracting other parties or other projects.
Based on these elements, Pleco is not in the
consolidation scope. The investment (€1.0 million)
is presented under “Other financial assets”.
Arrangement with Vaneltix
In December 2021, Hyloris entered into a strategic
collaboration with Vaneltix Pharma, Inc. (‘Vaneltix’)
for the development and commercialization of
Alenura
TM
as first-line drug treatment for acute pain
in
interstitial
cystitis/bladder
pain
syndrome
(IC/BPS).
Hyloris has committed to provide a maximum
of $6.7 million for supporting development-
related activities and granted a 6% interest
bearing loan of $0.5 million.
Under this strategic co-development agreement
Hyloris provided R&D services in the course of
2023 for a total amount of €145 thousand to
Vaneltix. These services were cross-charged by
Vaneltix since these are linked to the do-
development agreement and are in scope of the
Research and Development expenses to be
funded by Hyloris
Hyloris will be eligible to receive a tiered
percentage of the product margin generated by
Vaneltix. The
arrangement constitutes a joint
operation.
Hyloris will be listed as co-owner on all Vaneltix
patents,
inventions,
co-development
information
and
market
information.
In
addition, Hyloris hereby grants Vaneltix
a
license on Hyloris’ share of the Vaneltix patents
and inventions.
Hyloris also provided a loan of $0.5 million to
Vaneltix.
(
note 10)
In October 2023, Hyloris’ initial $6.7 million R&D
commitment
was
lowered
to
$4.8
million.
Separately, a $2.0 million Subscription Agreement
was executed to invest in Series D convertible
preferred stock.
Of the $2.0 million investment, $0.1 million was
used to fund a market study on product pricing
and positioning, the results of which were fully
shared with Hyloris.
As of December 2024, Hyloris had contributed $3.3
million
toward
development-related
activities.
Hyloris holds 4 shares of Vaneltix and is not
represented on the Board of Directors of
Vaneltix.
Vaneltix is a related party, see
note 29.1
.
Although Hyloris is holding less than 1% of the
p.126
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: Annual report 2024
voting rights, and has no voting representation
in the Board
of Directors, the Company
concluded, based on the guidance of IAS 28 -
Investments in Associates and
Joint Ventures,
that it does have significant influence
on Vaneltix
considering the following elements: Hyloris
is
currently one of the main financial contributors for
Vaneltix and Vaneltix is financially depending on
the
funding of Hyloris to be able to develop
Alenura
TM
.
The co-development agreement for Alenura
TM
is
a material transaction between Hyloris and
Vaneltix as
Vaneltix primarily focused of the
development of this
product only (other product
candidates
are
in
a
very
early
stage
of
development).
As a result, the Group is applying the equity method
of
accounting. As the percentage of ownership
interest is
very low (only 0.00053 %) the Group does
not take its %
share in the loss of Vaneltix in
deduction of the equity value.
See
note 9
on Equity Accounted Investees.
Arrangements with AFT
Maxigesic IV
Hyloris Pharmaceuticals SA and AFT have been
collaborating
in
the
development
of
the
Maxigesic IV product. AFT has now licensed the
product to a number of partners covering
multiple countries. Maxigesic IV is protected by
several
granted
and
pending
patent
applications.
Under
the
terms
of
the
development collaboration agreement between
Hyloris and AFT, Hyloris is eligible to receive a
share on any product related revenues, such as
license fees, royalties, milestone payments,
received by AFT. The arrangement
constitutes a
joint operation.
HY-089
On December 21
st
, 2023, Hyloris entered into a
partnership with AFT to co-develop HY-089, a
novel locally-acting product candidate for the
treatment of Burning Mouth Syndrome (BMS).
Under the terms of this equal partnership
agreement,
targeting
co-development
and
worldwide
commercialization,
Hyloris
is
responsible for ensuring the product formulation,
manufacturing activities and the coordination of
the
commercialization
in
Europe.
AFT
is
responsible for managing the clinical trials,
overseeing
all
aspects
to
ensure
effective
planning, execution and monitoring throughout
the
lifecycle,
and
the
coordination
of
the
commercialization outside of Europe. Parties are
jointly responsible for the commercialization in
the United States. The arrangement constitutes a
joint operation. Hyloris and AFT will share the net
profit and all external costs related to the
collaboration.
HY-091
Hyloris has entered into a partnership with AFT on
January
18
th
,
2024,
to
develop
a
novel
mucoadhesive film for the treatment of Vulvar
Lichen Sclerosus (VLS). HY-091 targets to have an
extended duration release of a known molecular
entity and to offer a convenient application
method,
ensuring
simplicity
and
improving
compliance.
Under the terms of the agreement, parties will co-
develop HY-091 for the purpose of registration
and
worldwide
commercialization.
Hyloris
is
responsible for ensuring the product formulation,
manufacturing activities and the coordination of
the
commercialization
in
Europe.
AFT
is
responsible for managing the clinical trials,
overseeing
all
aspects
to
ensure
effective
planning, execution and monitoring throughout
the trial life cycle, and the coordination of the
p.127
Hyloris
: Annual report 2024
commercialization outside of Europe. Parties are
jointly responsible for commercialization in the
United States. The arrangement constitutes a joint
operation. Hyloris and AFT will share the net profit
and all external costs related to the collaboration.
HY-095
On August 19
th
, 2024, Hyloris announced the
development of HY-095, a long-acting injectable
formulation
of
a
well-known
Proton
Pump
Inhibitor (PPI) designed to treat Equine Gastric
Ulcer Syndrome (EGUS). The Group has secured a
development partner that has product specific
proprietary technology and intellectual property
under development. Under the agreement the
partner
will
manage
the
drug
and
device
development within a predefined budget. Hyloris
will manage the clinical trials and fund the
development costs which are currently projected
to remain well below €7 million. After the
development costs are recovered, the profits will
be shared, with Hyloris entitled to retain up to 90%
of the net margin. Hyloris has also obtained an
option to extend the license for development for
human use under comparable terms. A global
commercialization
will
be
pursued
through
strategic
partnerships,
targeting
all
relevant
markets. The arrangement constitutes a joint
operation.
HY-094
Hyloris and AFT have entered into a late-stage
research and development program to introduce
an innovative injectable iron deficiency therapy to
the global market. As part of this program, Hyloris
and AFT have secured an exclusive global IP
license covering human use.
Under the terms of the agreement, Hyloris and
AFT will co-develop the candidate for registration
and global commercialization. Hyloris will oversee
product formulation, manufacturing and the
commercialization efforts in Europe. AFT will
manage the clinical trials, execution and the
commercialization outside Europe. Parties are
jointly responsible for commercialization in the
United States. Development costs, as well as all
net margin from sales and licensing, will be
distributed equally between AFT and Hyloris, after
a tiered profit participation for the licensor. The
agreement constitutes a joint operation.
3.3
LOAN TO ACADEMIC
PHARMACEUTICALS
Determining the fair value of the loan to API (see
note 4.1
) is assessed to a significant estimate as the
fair value is determined on the basis of significant
unobservable inputs.
3.4
RECOUP OF US
LITIGATION COSTS
Determining the fair value of the recoup of US
litigation costs against royalties payable to API (see
note 4.1) is assessed to a significant estimate as
the fair value is determined on the basis of
significant unobservable inputs.
3.5
SHARE-BASED
PAYMENTS
In accordance with IFRS 2 – Share-based Payment,
the
fair value of the warrants at grant date is
recognized
as an expense in the consolidated
statement of comprehensive income over the
vesting
period,
the
period
of
service.
Subsequently, the fair value is not re- measured.
The fair value of each warrant granted is
calculated
using
the
Black-Scholes
pricing
model.
This pricing model requires the input of subjective
p.128
Hyloris
: Annual report 2024
assumptions, which are detailed in
note 26
.
The ESOP schemes are structured with a vesting
period of 4 years (for each warrant scheme) with
the specificity that participants lose their vested
warrants in the event of termination at the
initiative of the participant, even during the
exercise period which varies between 1 and 6
years, depending on the warrant schemes. In
light to this specificity, the length of the vesting
period is variable depending on the estimated
actual exercise date of the warrants by the
participants.
3.6
IMPAIRMENT FHP
Please refer to the Equity Accounted Investees
section. (
note 9)
3.7
PROVISIONS –
DISCRETIONARY FEE
A provision related to the AltaThera arbitration for
discretionary fees to a law firm is recognized for
€581 thousand (of which €173 thousand is non-
current and €408 thousand is current).
Initial recognition (IAS 37)
The
obligation is initially recognized based on
expected cashflows discounted using a pre-
tax rate of 13.38%.
Measurement is based on a probability-
weighted cash flow approach (using 0.5% to
5% fee scenarios) which is detailed in
note 16
.
Sensitivity analysis
See
note 16
p.129
Hyloris
: Annual report 2024
4
. Financial instruments and
financial risk management
4.1
OVERVIEW OF FINANCIAL INSTRUMENTS
(in € thousand)
IFRS 9 Category
Input level
December
December
31, 2024
31, 2023
Investment in Pleco (note 10) (non-current)
FVOCI
3
1,000
1,000
Loan to Vaneltix (note10)
At amortized cost
556
499
Loan to API (note 11)
FVTPL
3
99
317
Recoup US litigation costs from API (note 11)
FVTPL
3
292
0
Trade receivables (note 11)
At amortised cost
3,810
2,970
Cash and cash equivalents (note 13)
At amortised cost
23,594
30,406
Total financial assets
29,351
35,192
Borrowings (note 15.1)
At amortised cost
1,816
1,750
Other financial liabilities (note 15.2)
At amortised cost
3,368
3,543
Trade and other liabilities (note 16)
(1)
At amortised cost
3,166
3,195
Total financial liabilities
8,350
8,488
1
Trade and Other receivables (VAT / R&D tax credit receivables and other receivables), prepayments and trade and other liabilities
(deferred income and employee benefit liabilities) that are not financial assets / liabilities are not included
p.130
Hyloris
: Annual report 2024
The
table
above
summarizes
all
financial
instruments by category in accordance with IFRS
9. The fair value of the financial instruments
measured at fair value are determined as follows:
Investment in Pleco: The investment is designated
at FVOCI because it’s not held for trading and it’s kept
for its expected future return on investment.
Considering
that Pleco is in the development
phase of its product candidates and does not
generate revenue yet, the cost of the investment
at transaction date has been
considered as an
appropriate estimate of the fair value as per
December 31, 2024 and 2023. In 2024 and 2023
there is no reason to adjust the fair value of this
investment as the current development program
is in line with the assumptions of the initial plan,
and discussions with regulatory authorities do not
indicate
any significant hurdles at this stage.
Loan to API: Discounted cash flows: the valuation
model
considers the present value of expected
payments, discounted using the market rate
and a company risk premium at the reporting
date. The assumption is that
the loan will be offset
by
royalties
payable
to
API
from
product
candidates
in 2042. The change compared to last
year is primarily due
to revised downward of future
cash-flows
related
to
products
which,
once
commercialized, would generate royalties payable to
API
and that the determination of
the fair value
was impacted by a change in the risk-
adjusted
rate (WACC) from 11.6% to 13.38%.
Recoup of US litigation costs: Discounted cash
flows similar to the Loan to API. The valuation
model
considers the present value of expected
payments, discounted using a WACC of 13.38%
at the reporting date. The assumption is that
the
recoup of US litigation costs will be offset by royalties
on product candidates
in 2044.
The Company considers that the carrying amounts
of financial assets and financial liabilities measured
at amortized cost in the consolidated financial
statements approximate their fair values.
4.2
FINANCIAL RISK
FACTORS
The Group’s activities expose it to a variety of
financial risks: market risk (including currency risk,
interest rate risk, and price risk), credit risk and
liquidity risk. There have been no changes in the
risk management since last year-end or in any risk
management policies.
4.3
FOREIGN EXCHANGE
RISK
The Company is currently exposed to foreign
currency risk, mainly relating to positions held in
USD.
The exposure to exchange differences of the
monetary assets and monetary liabilities of the
Group at the end of the reporting period are as
follows:
(in € thousand)
December
31,
December
31,
2024
2023
Assets
5,974
3,466
Liabilities
(2,411)
(817)
If the EUR had strengthened/weakened 1% against
the
USD with all other variables held constant,
the impact on the consolidated statement of
comprehensive income
would have been - €36
thousand
and
+€35
thousand
respectively.
Comparative information for 2023: if the
EUR
had strengthened/weakened 1% against the USD
with all other variables held constant, the impact
on
the
consolidated
statement
of
comprehensive income
would have been - €24
thousand and + €24 thousand
respectively.
By default, the company uses natural hedging
p.131
Hyloris
: Annual report 2024
by matching the foreign currency-denominated
revenues
with
the
foreign
currency-
denominated expenses. This approach relies on
the fact that when the company generates
revenues and incurs expenses in the same
currency, fluctuations in exchange rates have less
impact on the overall financial position.
The Group could as well use derivative financial
instruments to manage its exposure to the U.S.
Dollar arising from operational activities in the
form of cash
flow hedges. This exposure is hedged
with foreign
exchange forward contracts. At the
end of 2024 and 2023 there are no outstanding
foreign exchange forward contracts.
4.4
INTEREST RATE RISK
The Company is currently not exposed to significant
interest rate risk as the interest-bearing financial
liabilities and assets bear a fixed interest rate, which
are not subject to revision.
4.5
CREDIT RISK
Credit risk arises from cash and cash equivalents,
short-term bank deposits, as well as credit
exposure of
collaboration partners. Credit risk
refers to the risks that counterparty will default on
its contractual obligations resulting in financial loss
to the Company.
By the end of 2024, the Company has contracted
with many different customers spread over the
world (U.S., Europe and South-Asia). As a result,
there is credit risk that is characterized by
uncertainty in reimbursement value, delays in
payment, and ultimately non-payment. This could
potentially
impact
the
Company’s
revenue
recognition and cash collections.
For
each
customer,
annually,
the
financial
department reviews and sets a credit limit based
on key financial criteria, geographical area, nature
of the business and historical relationship
.
We sort our customers into groups which will help
to identify patterns and establish a risk profile.
Usually, the credit risk related to milestones,
royalties and profit share payment fall in one
specific group which may lead to offer extended
payments terms due to profile of the customers,
the nature of the business whereas the credit risk
related to other activities like services are classified
differently,
and
are
regularly
and
closely
monitored.
Trade accounts receivable amounted to €3,810
million as of December 31, 2024, and no allowance
for expected credit loss was recorded either in 2024
or during previous years. The increase compared to
prior year (€2,970 million as of December 31, 2023)
is mainly due to Valacyclovir milestones invoiced late
2024 and settled early 2025. During the first quarter
of 2025, about €2.5 million EUR of outstanding trade
receivables was collected.
Customer’s compliance with agreed credit terms is
regularly and closely monitored. The payment terms
to our partner AFT are extended and exceed 12
months
for the specific transactions (see
note 11
).
The average debtor’s payment period is 30 days after
invoice date. To measure the expected credit losses,
trade receivables have been grouped based on
credit risk characteristics and the days past due. In
assessing the
credit
risk
characteristics,
the
Company takes into account any indicators of
impairment up until the reporting date, and it
applies a pragmatic approach that is consistent
with the definition used for internal credit risk
management purposes. Given the high quality of
our customers the loss allowance provision at
year-end is zero. It is the management’s opinion
that at the above reporting date no further
provision for doubtful debts was required.
Cash and cash equivalents and current financial
assets are invested with several highly reputable
banks and financial institutions. The financial
p.132
Hyloris
: Annual report 2024
institutions have credit ratings varying from A to
AA- and are consequently considered as low credit
risk.
4.6
LIQUIDITY RISK
The Company’s main sources of cash inflows are
currently obtained through revenues. The liquidity
risk for the Group arises from the financial liabilities
but also from commitments and liquidities required
to be able to develop product candidates.
The
following
table
details
the
Company’s
remaining contractual maturity of its financial
liabilities with agreed repayment periods. The
tables have been drawn up based
on
the
undiscounted cash flows of financial liabilities
based on the earliest date on which the Company
can be required to pay. The tables include both
interest and principal cash flows. In Other financial
liabilities the liability to Purna Female Healthcare of
€3M (see
note 9
) is payable upon achievement of
development milestones, for which €1.5 million is
payable after the completion of the dose finding
study required for being able to start a phase 3
study and the remaining €1.5 million is payable
after the process validation report and completion
of enrollment of the phase 3 studies.
December 31, 2024
Within one year
>1 and <5 years
>5 and <10 years
Total
(In € thousand)
Borrowings
Lease liabilities
280
1,184
252
1,716
Borrowing of lab equipment
46
53
99
Other financial liabilities
Other loans
3,000
314
54
3,368
Provisions
408
173
581
Trade and other liabilities
3,428
3,428
Total
7,162
1,724
306
9,192
December 31, 2023
Within one year
>1 and <5 years
>5 and <10 years
Total
(In € thousand)
Borrowings
Lease liabilities
241
871
639
1,751
Other financial liabilities
Other loans
3,200
344
3,544
Trade and other liabilities
3,318
3,318
Total
6,759
1,215
639
8,613
p.133
Hyloris
: Annual report 2024
4.7
MARKET RISK
Market risk is the risk that changes in equity
prices
will affect the Group’s income or the value
of its holdings of financial instruments. The
objective of
market risk management is to
manage and control market risk exposures
within
acceptable
parameters,
while
optimizing the return. The primary goal of the
Group’s investment in equity securities is to hold
the
investments for the long term for strategic
purposes.
5
. Operating segments
The chief operating decision maker (CODM) of the
Company is the Board of Directors. The CODM
reviews the operating results and operating plans,
and makes resource allocation decisions on a
company-wide
basis;
therefore,
the
Group
operates as one segment.
According
to
IFRS
8,
reportable
operating
segments
are
identified
based
on
the
“management approach”. This approach stipulates
external segment reporting based on the Group’s
internal organizational and management structure
and on internal financial reporting to the chief
operating decision maker.
The
financial
information
is
organized
and
reported to CODM under one management
reporting covering all activities of the Company.
There is no specific component in the financial
information that would as such represent a specific
operating segment.
Information reported to the CODM is aggregated
and comprises all activities of the Company. The
Group’s activities are managed and operated in
one segment, pharmaceuticals. Strategic decision
and resources allocation are made at the Company
level by the CODM.
In 2024, total revenue surged to €8,458 thousand,
a fourfold increase compared to 2023 (€2,087
thousand). This impressive growth was primarily
driven by substantial royalties from Maxigesic
®
IV
and Podofilox, as well as a USD 2.1 million
milestone payment related to the commercial
launch of Maxigesic
®
IV in the U.S. Additionally,
upfront and regulatory milestones payments
related to the licensing and supply agreement on
Valacyclovir Oral Suspension, signed in December
2024, contributed to the
growth. In 2023, the
revenue related to royalties for €1,9 million for
Sotalol IV, Maxigesic IV and Padagis/Podofilox gel,
out-license agreements that provide a right to use
for €104 thousand and milestone billings for €54
thousand.
In € thousand
2024
2023
Royalties
4,901
1,929
Out-license agreements
247
104
Milestones
3,310
54
Total
revenues
8,458
2,087
In 2024, there are 4 customers (three in 2023)
individually exceeding 10% of total revenues, with
respective amounts of €3,191 thousand (€804
thousand
in
2023),
€2,785
thousand
(€244
thousand in 2023), €1,320 thousand and €914
thousand
(€881
thousand
in
2023).
Those
customers represent 97% of the total recognized
revenues (92% in 2023).
In the revenue recognition there are no material
contingencies nor amounts which are subject to
p.134
Hyloris
: Annual report 2024
significant estimation uncertainty. In some cases,
the payment terms extended to our partners such
as AFT, which have a low liquidity risk profile,
exceed
12
months.
See
note 11
for
trade
receivables.
5.1
GEOGRAPHICAL
INFORMATION
Revenues reported in the consolidated statement
of profit or loss and other comprehensive income
are mainly generated in the United States: € 5,588
thousand (€1,125 thousand in 2023); but also in
EMEA and Asia-Pacific regions. Non-current assets
recorded in the consolidated statement of financial
position are mainly located in Belgium, the country
of domicile of the Company.
6
. List of consolidated companies
(AS AT DECEMBER 31, 2024)
Company
name
Company
number
Location
% financial interest
Hyloris Pharmaceuticals SA
BE
0674.494.151
Blvd Patience et Beaujonc N°3/1, 4000 Liège
Parent
Hyloris Developments SA
BE
0542.737.368
Blvd Patience et Beaujonc N°3/1, 4000 Liège
99.99%
Hyloris SA
BE
0669.738.676
Blvd Patience et Beaujonc N°3/1, 4000 Liège
100.00%
Dermax SA
BE
0667.730.677
Blvd Patience et Beaujonc N°3/1, 4000 Liège
100.00%
The voting rights equal the percentage of financial interest held.
7
. Intangible assets
(in € thousand)
Development
costs
Assets
Purchase
License
fees
Prepayments
Total
Year
ended
December
31,
2024
Opening carrying amount
2,060
642
1,126
-
3,828
Additions
229
23
252
R&D Tax Credit
(15)
(1)
(16)
Amortization expense
(194)
(32)
(226)
Closing carrying amount
2,080
610
1,148
-
3,838
At
December
31,
2024
Cost
2,854
4,247
1,171
8,272
Accumulated amortization and
(774)
(3,637)
(23)
-
(4,434)
impairment
Carrying amount
2,080
610
1,148
-
3,838
p.135
Hyloris
: Annual report 2024
(in € thousand)
Development
Costs
Assets
Purchase
License
fees
Prepayments
Total
Year
ended
December
31,
2023
Opening carrying amount
1,678
685
1,125
119
3,607
Additions
325
325
R&D Tax Credit
(11)
(11)
Amortization expense
119
(119)
-
Impairment losses
(50)
(43)
(93)
Closing carrying amount
2,061
642
1,125
-
3,828
At
December
31,
2023
Cost
2,640
4,247
1,148
8,036
Accumulated amortization and
(580)
(3,605)
(23)
-
(4,208)
impairment
Carrying amount
2,060
642
1,126
-
3,828
In 2024, the Company acquired intangible assets
for a total of €252 thousand, of which (i) €125
thousand related to the development costs of
Maxigesic
®
IV, (ii) €56 thousand related to the
development costs of HY-039, €48 thousand
related to the development costs of HY-078 and
€23 thousand related in-licensing HY-087.
Grouping of intangible assets of a similar nature and
use:
Capitalized
development
costs:
external
incurred
development
costs:
Maxigesic
IV,
Podofilox gel, HY-039 and HY-078.
Assets purchase: acquisitions of intangibles
containing
pharmaceutical
development
data, development analysis for clinical study
and intellectual property rights. Used for
Maxigesic
®
IV,
Tranexamic Acid Mouth Rinse
and HY-075.
License
fees:
fees
used
in
in-licensing
agreements.
For
HY-029,
Atomoxetine,
Metolazone IV, Dofetilide IV, Aspirin IV U.S., HY-
074, HY-076, Milrinone, HY-087 and HY-088.
The 4 largest product or product (candidates) in
terms of
intangible assets are Maxigesic
®
IV
(carrying amount: €1,175 thousand), Aspirine IV U.S.
(carrying amount: €623 thousand) Podofilox gel
(carrying amount: €568 thousand) and Tranexamic
Acid
Mouth
Rinse
(carrying
amount:
€433
thousand). Only for Maxigesic
®
IV, the intangible
assets are amortized.
The intangible assets are not amortized until the
moment they are available for use as intended by
management, i.e. ready for commercialization.
The company has amortized since 2014 the
development costs of Sotalol IV, an asset for which
regulatory approval had been obtained. The useful
life of the development costs of Sotalol IV has
ended.
In 2022 the Company began amortising the
development costs of Maxigesic
®
IV for markets
outside the United States of America where market
approval had been obtained, currently totaling 64
countries. In 2024, as the product is available for use
in the United States of America, the amortization
has started for this market as well. Since the
commercial sales for Podofilox gel started late-
December 2023, the amortization started in 2024.
The amortization expenses are included in “Cost
of sales” in the consolidated statement of profit or
loss and other comprehensive income. The
applied amortization rate for all classes of assets
is 10%.
As long as the assets are not fully amortized, they
are tested for impairment if specific indicators are
p.136
Hyloris
: Annual report 2024
identified.
Intangible assets under construction are tested
for
impairment
on an
annual
basis.
The
impairment test conducted is performed by
product by estimating the recoverable amount.
The recoverable amount of the product is
estimated based on the forecasted future
cash
flows discounted to their present value using a pre-
tax discount rate that reflects current market
assessments of the time value of money and the
risks specific to the asset. The time horizon used for
the impairment testing is based on the period
during which the Company expects to generate
cash flows from the project, which period does not
exceed 10 years in the management estimates.
Based on the impairment tests conducted at
year-end, the recoverable amount of the different
products was estimated to be higher than their
carrying
amount
and no
impairment
was
required. The main assumptions used are the
discount
rate
and
the
success
of
market
penetration. As defined in
Note 2.8
, the discount
rate reflecting current market assessments of the
time value of money and the risks specific to the
asset, and which was used for the impairment test,
is estimated at 13.38% (was 11.85% in 2023).
The main input that lead to a discount rate of
13.38% are:
a risk free rate of 2.97% corresponding to the 10-
year OLO rate as of December 31, 2024 (2.58% last
year)
a beta factor of 0.99 (0.96 last year)
a market risk rate of 2.28% (2.77% last year);
a Company specific risk premium of 8.15% (6.6%
last year)
a cost of debt before tax of 6% (no change
compared to 2023)
We
tested
the
sensitivity
analysis
of
the
impairment tests by increasing the discount
rate by 4%, leading the discount rate to 17.38%.
We cumulatively decreased the success of
market penetration up to 40%, leading the
success to 60% and 20% respectively for the
commercial
products
and
product
in
developments. None of these changes to
assumptions resulted in an impairment loss.
No intangible assets have been pledged in the
context of financial liabilities.
p.137
Hyloris
: Annual report 2024
8
. Right-of-use assets
(in € thousand)
Land
and
buildings
Vehicles
and
equipment
Total
Year
ended
December
31,
2024
Opening carrying amount
1,486
238
1,724
Additions
89
141
230
Depreciation expense
(192)
(109)
(302)
Closing carrying amount
1,382
270
1,652
At
December
31,
2024
Cost
1,736
536
2,514
Accumulated depreciation and impairment
(353)
(266)
(862)
Carrying amount
1,382
270
1,652
Year
ended
December
31,
2023
Opening carrying amount
809
76
885
Additions
822
211
1,033
Depreciation expense
(145)
(49)
(194)
Closing carrying amount
1,486
238
1,724
At
December
31,
2023
Cost
1,647
395
2,284
Accumulated depreciation and impairment
(161)
(157)
(560)
Carrying amount
1,486
238
1,724
The depreciation expenses are all presented as
“General and administrative expenses”.
The Group rents its headquarter building and leases
all company cars. In 2023 the Group started with a
new lease contract for the labs. These contracts do
not include any purchase options. The lease term
considered for the building is 9 years, while for the
company cars the lease term ranges between 4 and
5 years.
The Group has lease contracts that include
termination options. These options are negotiated
by management to provide flexibility in managing
the leased assets and align with the Group’s
business needs. In the lease contracts there are
extension options. The lease contracts for the
building and the lab will be tacitly renewed, at its
end, for periods of one year unless notice given by
one of the parties by registered letter sent month 6
before
the
current
contractual
expiry
or
renunciation accepted, expressly and in writing, by
the other party.
The amounts recognized in profit or loss can be
summarized as follows:
(in € thousand)
2024
2023
Depreciation expense of right-of-use
(302)
(194)
assets
Interest expense on lease liabilities
(70)
(52)
Total amount recognized in profit or
loss
(372)
(246)
of which as:
General
and
administrative
expenses
(302)
(194)
(note 19)
Financial expenses (note 22)
(70)
(52)
p.138
Hyloris
: Annual report 2024
9
. Equity accounted investees
FHP
On 5 February 2021, the Group entered into a
partnership with FHP, located in Belgium, a spin-off
founded to develop and commercialise Miconazole-
Domiphen Bromide, and which is accounted under
the equity method of accounting. At the acquisition
date, the net assets of FHP were limited to the
available cash in the company hence no fair value
adjustment has been identified and as a result a
goodwill of 4,3 million was included in the carrying
amount, justified by the potential of the product
candidate. Hyloris committed to an investment of
€4,270 thousand, of which €1,270 thousand was
paid at acquisition date. The unpaid balance of
€3,000 thousand is recognized against a current
financial liability for €3,000 thousand (see
note
15.2
).
Hyloris owns 20% of FHP (later payments done
under the current contract) will not result in a higher
percentage of ownership) and is eligible, based on
contractual variables driven by the profitability of
the company, to receive up to a maximum of 45%
and a minimum of 17.3% of the net profits
generated by FHP. As long as there is no
commercialization of the product candidate, 20%
presents the Group’s economic interest in FHP’s net
assets. Hence the future economic interest of
Hyloris in FHP will be changed and will be driven by
the profitability of the company.
(in € thousand)
December
31,
December
31,
2024
2023
Opening carrying value
3,801
3948
Impairment on financial assets
(972)
-
Loss of the period
(81)
(147)
Carrying amount at
December 31
2,748
3,801
The following tables summarize the financial
information of FHP as included in its own financial
statements, adjusted for fair value and differences
in accounting policies, if needed.
(in € thousand)
December
December
31, 2024
31, 2024
Fixed Assets
-
-
Currents Assets
388
834
Amounts receivable within one
year
14
36
Cash at bank and in hand
374
798
TOTAL ASSETS
388
834
Capital and reserves
351
758
Capital
6,103
6,103
Uncalled capital contribution
-3,000
-3,000
Accumulated profits (losses)
-2,752
-2,345
Provisions and deferred taxes
-
-
Creditors
37
76
Amounts payable within one year
37
76
TOTAL LIABILITIES
388
834
p.139
Hyloris
: Annual report 2024
December
December
(in € thousand)
31, 2024
31, 2024
Operating income
Operating charges
-407
-737
Services and other goods
-407
-736
Other operating charges (-)
0
-1
Operating profit (loss)
-407
-737
Profit (Loss) for the period
before taxes (-)
-407
-737
Profit (loss) for the period
available for appropriation
-407
-737
Hyloris % of interest
20
20
Profit (loss) for the period
available for appropriation
-81
-147
(20%)
Reconciliation between (a) the 20% of rights to net
assets applied to FHP’s equity/net assets and (b) the
carrying amount of Hyloris’ interest in FHP:
(a)
20% of 4,200 shares: 840 shares
The capital of FHP amounts to €6,103 thousand
represented by 4,200 registered shares without
nominal value, of which 2,100 A1 shares, 1,260 A2
shares and 840 B shares (held by Hyloris).
Hyloris acquired 840 B shares. In exchange for the
840 B shares, Hyloris Pharmaceuticals (“Hyloris”)
made a contribution in cash of €4,270 thousand,
which was paid-up immediately for an amount of
€1,270 thousand. The remaining €3,000 thousand
will need to be paid when certain milestones are
reached. The first milestone of €1,500 thousand,
which
is
payable
“upon
completion
of
the
dosefinding study required to initiate a Phase 3
trial”. The second milestone, €1,500 thousand,
payable “upon the process validation report, six-
month stability data on registration batches and
completion of Phase 3 enrollment” remains not
due.(see
note 4.6
).
(b)
2,748 thousand
Committed investment of Hyloris: €4,270 thousand
- 20% of Retained earnings of FHP (loss): €550
thousand
- Impairment of financial asset : €972 thousand
= Hyloris’ carrying amount in FHP : €2,748 thousand
All shares are entitled to profit distribution.
However,
the
interest
in
the
profits
is
not
necessarily equal to the ownership interest and may
vary depending on the performance of FHP. Before
a
commercial
launch
no
dividends
will
be
distributed. As of the point in time of a commercial
launch
profits
will
be
distributed
to
the
shareholders
according
to
the
distribution
mechanism
set
forth
in
the
shareholders’
agreement. When FHP is exactly reaching its net
profit target established in the shareholder’s
agreement class B shares will be entitled to 20% and
class A (A1 + A2) shares will be entitled to 80% of the
net profits. If FHP does not reach its net profit target,
a higher interest in these net profits will be allocated
to the Class B shares (preferential class). As such,
the interest of the Class B shares in the net profits
may increase to 45%. On the other hand, if FHP
exceeds its net profit target, Class A shareholders
will be entitled to a higher interest in the net profits
(and Class B shareholders to a lower interest).
Impairment testing
Based on the revised business case (which does not
take
into
account
any
potential
revised
developments strategy) it is very likely that the net
profit
target
set
in
the
Subscription
and
Shareholders’ Agreement will not be achieved,
leading to the conclusion that Hyloris’ current 20%
stake in FHP could increase to 45% of the company’s
value upon sale or alternatively entitle Hyloris to
45% of the annual profits in accordance with the
agreement
mechanism
as
explained
above.
Multiple discussions took place with the FHP BV
shareholders until a clear development pathway
was identified and presented to the Board on March
13, 2025. As a result, the weighing of each NPV could
only be assessed at that time.
p.140
Hyloris
: Annual report 2024
The future cash flows of the Miconazole-Domiphen
Bromide asset were re-assessed and led to a result
of €2,748 thousand for the Value in Use of FHP,
reflecting a reduction of €1,053 thousand, taken
into account the result of €81 thousand share of
result of equity-accounted investees and thus
resulting in a €972 thousand impairment of the
equity-accounted investee. This re-assessment was
done using a discount rate of 13.38%, a forecasting
period of 15 years and risk-weighted cashflows
versus non-weighted cashflows.
The discount rate is based on a risk free rate of
2.97%, a risk premium of more than 10.00% and a
cost of debt after tax of 4.50%. Risk weighted
cashflows
were
used
to
reflect
the
actual
circumstances. The result of €2,748 thousand is a
weighted average of a risk adjusted valuation (2/3
rd
weight) and a non-adjusted valuation (1/3
rd
weight).
In accordance with IAS 36, the Group considered the
higher of VIU (Value in Use) and FVLCS (Fair Value
Less Cost to Sell).
A sensitivity analysis shows that when the timing of
the underlying expected annual profits differs one
year earlier or later than the calendar used, the
impairment would decrease by €368 thousand or
increase by €324 thousand. When the discount rate
increases or decreases by 1%, the impairment
would increase by €196 thousand or decrease by
€217 thousand. A change in weight to 50/50 for
calculating
the
average
would
decrease
the
impairment by €458 thousand. Using a stake of 35%
instead of 45% in the calculation would increase the
impairment by €610 thousand.
The investment balance of €3,000 thousand, to be
paid upon achievement of certain milestones was
accounted as a “Current Other Financial Liability” at
31
December,
2023.
The
Subscription
and
Shareholders’ Agreement clarifies that any unpaid
balance at the time of the first dividend distribution,
an Exit or Exit Liquidation, shall be paid-up in full
immediately prior to such dividend distribution, Exit
or Exit Liquidation. As such, the €3,000 thousand
liability stays under “Other Financial Liability at 31
December 2024 and is reported as “Current”.
Hyloris and FHP are currently considering a revised
development
plan
with
adjusted
milestone
payments.
Transactions with FHP
In 2024, there are no transactions with FHP. In 2023
Hyloris invoiced FHP for a total amount of €55
thousand related to PIND/IND services (€45k) and
CRO selection and qualification services (€9k).
Vaneltix
On 13 December 2021, the Group entered into a
Collaboration Agreement with Vaneltix Pharma Inc.
for the development and commercialization of
“Alenura”, a first line drug treatment for acute pain
in
interstitial
cystitis/bladder
pain
syndrome
(IC/BPS). Under the terms of the Agreement, the
Group provides staged investments of maximum
$6,700 thousand relating to R&D activities incurred
under the Agreement. An amount of $2,000
thousand was invested in an equity raise through a
Subscription Agreement signed on 17 October 2023
against 4 fully paid and non-assessable shares
(series D preferred stock) at $500 thousand per
share. This capital increase (part of the maximum
investment of $6,700 thousand) was provided to
cover R&D costs and has been recognized in 2023
as R&D expenses.
The Group applies the equity method in the
consolidated financial statements as the Group has
significant influence over Vaneltix (see note 3.2). As
the percentage of ownership is very low (only
0.00053%) the Group does not take its % share in
the loss of Vaneltix in deduction of the equity value.
In addition, the investor’s share of losses of an
equity-accounted investee is recognized only until
the carrying amount of the investor’s equity interest
in the investee is reduced to zero. After the
p.141
Hyloris
: Annual report 2024
investor’s interest is reduced to zero, a liability is
recognized only to the extent that the investor has
an obligation to fund the investee’s operations or
has made payments on behalf of the investee.
Given the losses of Vaneltix and the fact that Hyloris
does not have an obligation to fund the investee
(other than funding the product co-developed with
Vaneltix) under the terms of the Collaboration
Agreement), the carrying amount would be zero.
In an Addendum signed on 13 January 2025 parties
confirmed that the agreed investment amount of
$6,700 thousand, was allocated across distinct
activity “buckets”, each having a capped limit. Any
expenditures exceeding those individual caps are
not
covered
by
Hyloris.
Each
quarter,
all
expenditures incurred by Vaneltix, supported by an
invoice or similar proof and approved by Hyloris,
are allocated to the appropriate bucket. Hyloris is
only required to fund expenditures within buckets
that still have available financial reserves. The
Addendum also includes the agreement to offset
the
trade
receivables
outstanding
as
at
31
December 2024 (€137 thousand) with R&D funding.
Under the Agreement, The Group also granted a 6%
interest bearing loan of $500 thousand. In the
Amendment of 13 January 2025, the loan is
extended till 31 March 2025. If at that point,
principal amount and interest are not paid, Hyloris
may offset the amount against R&D fundings
amounts under the Agreement that become due.
Transactions with Vaneltix
In 2024 no services were provided to Vaneltix. In
2023 services for a total amount of €145 thousand
were provided under this co-development with
Vaneltix. These services were cross-charged by
Vaneltix
since
these
are
linked
to
the
co-
development agreement in scope of the Research
and Development Expenses to be funded by Hyloris
and therefore the income is netted with the cross-
charged Research and Development expenses by
Vaneltix.
10
. Other financial assets
The other financial assets can be detailed as
follows:
(in € thousand)
December
December
31,
2024
31,
2023
Shares Pleco
1,000
1,000
Therapeutics BV
Vaneltix loan
556
499
Other financial
1,556
1,499
assets
of which as:
Non-
current
1,000
1,000
Current
556
499
Shares: Pleco Therapeutics BV
In 2021, the Group entered into a partnership with
Pleco Therapeutics to develop PTX-252, a novel
chelating agent for the treatment of Acute Myeloid
Leukaemia (AML) and Small Cell Lung cancer (SCLC).
Hyloris provided a non-interest bearing convertible
loan of €1,000 thousand which has been converted
into 7,944 preferred shared (1 June 2022) at an
issuing price of €126 per share (which resulted in a
4.5%
ownership
of
the
company
Pleco
Therapeutics). See
note 4.1
for the valuation.
The Group is committed to fund up to an additional
€7,700 thousand; of which €2,4 million has been
already funded.
p.142
Hyloris
: Annual report 2024
Pleco will fund all activities that are outside the
scope of the maximum €7,700 thousand funding
commitment
from Hyloris. Hyloris will be eligible
to receive up to 65% of the net gross product
margin generated worldwide
in AML and SCLC.
Hyloris will be co-owner on all Pleco patents (except
for patents held by MD Anderson Cancer Center),
inventions,
co-development
information
and
market information. The arrangement constitutes a
joint operation.
In 2024 the Group had a few purchase transactions
with Pleco Therapeutics for product development
related services regarding pre-clinical, clinical and
CMC-related activities for a total amount of €297
thousand. In 2023, Hyloris had sales related to
strategic advice for an amount of €500 thousand and
purchases for product development regarding pre-
clinical, clinical and CMC-related activities for a total
amount of €2.2 million. As of 31 December 2024 the
outstanding commitment is €5.3 million (€7.7 million
- €2.4 million).
As of the reporting date, no impairment loss has
been recognized on the investment in Pleco
Therapeutics. A capital increase was completed by
Pleco in December 2024 as part of a Series B
funding round, based on an unchanged pre-
money valuation of EUR 25 million. This valuation
was confirmed by Pleco’s management and served
as the basis for recent capital contributions.
Pleco
achieved
significant
progress
in
its
preclinical, technical, and regulatory development.
The phase 1a clinical study program is scheduled
to commence in 2025, marking a key milestone in
the project’s advancement. Early results from the
Single Ascending Dose (SAD) portion of the study
are expected approximately three months after
initiation and will provide critical insights into the
therapy’s safety and tolerability.
In parallel, a portion of the targeted Series B
funding has already been secured, with additional
commitments
in
place.
Pleco’s
management
remains confident in its ability to attract a lead
investor as soon as the initial clinical results
become available.
These elements support and justify the conclusion
that no impairment of the investment is required
at this stage.
Vaneltix loan
On 13 December 2021, the Group entered into a
collaboration with Vaneltix Pharma, Inc. (a related
party
of
Hyloris)
for
the
development
and
commercialization of Alenura
TM
as first-line drug
treatment for acute pain in interstitial cystitis
/bladder pain syndrome (IC/BPS). Under the terms
of the agreement, the Group granted a 6% interest
bearing loan of $500 thousand.
The
initial
above
agreement
included
a
reimbursement at the earliest of i) 31 December
2023 or ii) sale of equity or other equity-linked
instruments by the Borrower to unaffiliated third
parties for financing purposes for an amount of at
least $5 million (the “Capital Increase”). A loan
amendment dated 17 October 2023 extended the
reimbursement date from 31 December 2023 to 31
August 2024. In a new Amendment dated 13
January 2025, the reimbursement date has been
extended till 31 March 2025. If at that point, the
loan has not repaid, Hyloris may offset the amount
against
R&D
fundings
amounts
under
the
Agreement that become due.
In case of a capital increase on or prior to the
reimbursement of the Loan in full, Hyloris shall
have the option to convert the entire principal
amount of the loan and all interest accrued into
shares.
Also under the terms of the agreement, the Group
will
provide
staged
investments
of
in
total
maximum
$
6,700
thousand
for
Phase
2,
manufacturing and regulatory related activities
(see
note
28.2
)
upon which $5,313 thousand has
p.143
Hyloris
: Annual report 2024
already been provided.
In 2024, Hyloris incurred 789 thousand of R&D
expenses compared to 2,744 thousand in 2023.
Management identified Vaneltix Pharma, Inc as a
related party of Hyloris (see
note 28.2
).
11
. Trade receivables and other
receivables
(in € thousand)
December
December
31,
2024
31,
2023
Trade receivables
3,710
2,970
Contract assets
100
-
API loan
99
317
Recoup US litigation costs from API
292
-
R&D Tax Credits
1,774
1,256
Tax Credit - Alenura
TM
581
368
VAT
329
218
Other amounts receivable
23
26
Total
trade
and
other
receivables
6,908
5,156
of which as:
Current
4,858
3,565
Non Current
2,050
1,591
At 53%, the greater part of the carrying amount of
the Group’s trade receivables (gross) is still
denominated in USD; the remaining portion of
outstanding trade receivable being denominated
in EUR. In 2023, it was mainly denominated in USD.
During the year, the payment terms for the
receivables have neither deteriorated nor been
renegotiated.
The maximum credit risk exposure at the end of
the reporting period is the carrying value of each
caption of receivables mentioned above. The
Group does not hold any collateral as security.
A contract assets of €100 thousand, relating to a
regulatory
milestone
for
Valacyclovir
Oral
Suspension, has been recognized as the underlying
performance obligation has largely been satisfied.
Other
amounts
receivable
mainly
includes
guarantees.
p.144
Hyloris
: Annual report 2024
API loan
A loan to API of $700 thousand is granted by
Hyloris to API, carrying a 0.1% interest per year.
This loan is presented as non-current. When the
royalties (or other payments) of 3 product
candidates, or any other product parties may
develop together in the future, exceed $200
thousand in a calendar year then the amount
exceeding $200 thousand will be used to repay the
loan. Hyloris can then withhold this amount from
royalty payments. The loan has been measured at
FVTPL using a discounting rate of 13.38% (11.6% in
2023) resulting in the recognition of a loss of €241
thousand, excluding FX effect, recognized as
financial expenses in 2024. For comparative
information, the financial expense in 2023 was
€173 thousand. The decrease of the fair value in
comparison to 2023 is mainly due to revision of
business cases used that now foresee a generation
of excess royalties (used to reimburse the loan) by
2042, instead of 2029, and the increase of the
discount rate.
The reimbursement of the loan is depending on
the success of the product candidates being
developed by the Group and not depending on any
action from the counterparty. (see note 4.1).
A sensitivity analysis shows that when the year of
reimbursement differs 1 year earlier or later than
the estimated calendar year of reimbursement,
the fair value increases by €13 thousand or
decreases by €12 thousand. When the discount
rate increases or decreases by 1%, the fair value of
the loan decreases by €12 thousand or increases
by €14 thousand.
Recoup US litigation costs from API.
In the context of its now concluded US arbitration
proceedings against Alta Thera Pharmaceuticals
LLC, Hyloris is contractually entitled to recover
from API 50% of all litigation costs incurred. As of
end 2024, total litigation costs incurred and
supported
by
Hyloris
amounted
to
$4,755
thousand; out of which $2,377 thousand can be
recovered from royalties payable to API.
Same mechanism of excess royalties as for the API
loan (see above) will be used to recover those
expenses and reimbursement will start once the
loan has been repaid. Business cases used foresee
a reimbursement by 2044.
The receivable has been measured at FVTPL using
a discounting rate of 13.38% resulting in the first
time recognition of a receivable of €292 thousand.
This amount is sensibly lower than the one
previously disclosed in the Subsequent Events
section of our 2024 Half-year Report (€0.9 million)
as a result of downward revision of underlying
future forecasts and increased discounting rate.
The
reimbursement
of
these
expenses
is
depending
on
the
success
of
the
product
candidates being developed by the Group and not
depending on any action from the counterparty.
(see
note 4.1
). A sensitivity analysis shows that
when the year of reimbursement differs 1 year
earlier or later than the estimated calendar year of
reimbursement, the fair value increases by €39
thousand or decreases by €34 thousand. When the
discount rate increases or decreases by 1%, the fair
value of the loan decreases by €38 thousand or
increases by €45 thousand.
R&D Tax Credits
The Group applies for R&D tax credit incentives
set-up by the Federal government and obtained
reasonable assurance in the current reporting
period that the Group will comply with the
conditions attached to the grant and that the grant
will be received. The Group recognized R&D tax
credits for a total of €499 thousand in Other
Operating Income (see
note 21
) and €15 thousand
in Intangible assets (see
note 7
). Also, in 2024, the
company corrected the Belgian R&D tax credit
calculation for 2023 by applying the correct
p.145
Hyloris
: Annual report 2024
deduction rate of 20.5% instead of the 13.5% rate
that had been incorrectly used, representing an
additional other income of €225 thousands. Based
on
applicable
tax
regulations,
a
first
cash
reimbursement of €130 thousand under the
Belgian tax credit regime is expected in 2025 .
Tax Credit - Alenura
TM
A Tax Credit of €576 thousand was granted from
an American state government for the clinical
development costs of the Alenura
TM
product
candidate which were incurred in 2023. The Tax
Credit is recognized when the approval of the grant
request has been confirmed by the authorities.
As of December 31, 2024, there are no outstanding
requests for Tax Credit related to development
costs of the Alenura
TM
being assessed by the
American state authorities. The amount of €368
thousand, recognized in 2023, has been paid in full
in November 2024.
12
. Prepayments
Pre-paid R&D expenses relate to payments made
by the Group for research and development
projects conducted by partners (co-development
projects) and will be recorded in profit and loss when
incurred.
At reporting date, the outstanding prepayments
(€191
thousand)
have
decreased
by
€403
thousand compared to December 31
st
2023 (594
thousand). The change in prepayments was mainly
determined by the collaboration with Vaneltix. Under
this collaboration, prepayments became payables,
presented as Trade Payable on the balance sheet, as
incurred R&D costs for this project exceeded the
project funding.
Prepayments
apply
to
both
research
and
development activities. Prepayments related to
research are expensed when they are incurred.
Development costs are also expensed in the Profit
or Loss when they are incurred up until the
moment that the recognition criteria under IAS 38
are met, i.e. upon filing for market authorization in
the context of 505b2 or when an asset is acquired as
an intangible asset, from when any further
development costs are capitalized as intangible
assets. Prepayments relating to development costs
are presented as intangible assets.
p.146
Hyloris
: Annual report 2024
13
. Cash and cash equivalent
The net cash position as presented in the consolidated statement of cash flows is as follows:
(in € thousand)
December
31,
December
31,
2024
2023
Cash at bank
23,594
20,196
Short-term deposit
-
10,210
Total
cash
23,594
30,406
and cash
equivalents
There are no outstanding short-term deposit as of year-end 2024 as the latest one(s) had maturity date(s) in
late December, 2024.
The term of the only deposit at year-end 2023 was from January 3, 2023 to January 3, 2024. It was classified
as cash equivalent as the nominal value of €10 million could be withdrawn considering a notice period of 32
days. A penalty was due if the amounts were withdrawn during the entire term. The penalty due depended
on when the deposit was withdrawn, during the initial 180 days the penalty would have amounted to 50% of
the already earned interest and after the initial 180 days the penalty would have amounted to 25% of the
already earned interest.
14
. Equity
14.1
OVERVIEW
(in € thousand)
December
31,
December
31,
2024
2023
Share capital
140
140
Share premium
121,513
121,513
Retained earnings
(86,470)
(80,761)
Other reserves
(3,070)
(1,823)
Total Equity attributable to
owners of the parent
32,143
39,069
14.2
CAPITAL MANAGEMENT
The Group manages its capital with the objective
of maintaining a solid equity position to support
the long-term development of the business and
reinforce the confidence of current and potential
investors and partners.
This approach aims to ensure that the Group can
continue as a going concern while preserving
strategic flexibility to finance its research and
development
pipeline
and
future
growth
opportunities. Also refer to
note 3.1
for further
details on going concern.
The Group is not subject to any externally imposed
capital requirements except those provided for by
law. The Group’s management reviews the capital
p.147
Hyloris
: Annual report 2024
structure of the Group on a regular basis. As part
of this review, management considers the cost of
capital and the risks associated with each financing
options. The Group’s objectives, policies and
processes for managing capital have remained
unchanged over the past few years.
The transaction costs of an equity transaction are
accounted for as a deduction from equity to the
extent
they
are
incremental
costs
directly
attributable
to
the
equity
transaction
that
otherwise would have been avoided.
14.3
SHARE CAPITAL AND
SHARE PREMIUM
Share Capital
As per December 31, 2023 and December 31,
2024, the share capital of the Group amounts to €
140,001.87 represented by 28,000,374 shares,
without
nominal
value,
each
representing
1/28,000,374th of the share capital of the Group.
The share capital of the Group is fully and
unconditionally subscribed for and is fully paid up.
All shares rank equally with regard to the Group’s
residual assets. Holders of these shares are
entitled to dividends as declared from time to time
and are entitled to one vote per share at general
meetings of the Group.
On June 8, 2020, the General Assembly issued an
authorized capital of €117,758.84. The Board is
allowed to use the authorized capital for a period
of 5 years.
On June 11, 2024, the General Assembly renewed
the authorized capital for a period of 5 years (as
from the date of the publication of the resolution)
amounting to €140,001.9 (excluding emission
premium).
As
per
December
31,
2024,
the
remaining
authorized
capital
amounted
to
€140,001.87
(compared to €110,920.13 as per December 31,
2023).
The following capital transactions have taken place since January 1, 2017:
Increase of share
Number
Issue price / share
Number
Date
Transaction
capital (incl. share
of
(rounded, incl.
of
shares after
premium) (€)
securitie
share
premium)
(€)
the
transaction
s
issues
7
June
2012
Incorporation
50,000
10,000 Shares
5.00
10,000
31 March 2017
Capital increase
11,500
2,300 Shares
5.00
12,300
12 May
2017
Share split
-
-
3,075,000
31 May 2018
Capital increase
2,750,000
248,711 Shares
11.06
3,323,711
31 May 2018
Capital increase
3,000,000
271,322 Shares
11.06
3,595,033
31
December
2019
Capital increase
18,259,783
2
855,409 Shares
21.35
4,450,442
8
June
2020
Share split
-
Share split (1
-
17,801,768
to 4)
30
June
2020
IPO on Euronext
61,821,500
5,750,000
10.75
23,551,768
shares
30
June
2020
Conversion
of
convertible
15,358,025
2,040,864
10.75
25,592,632
bonds
shares
31
July
31
2020
Over allotment option
2,580,000
240,000 shares
10.75
25,832,632
31 March 2022
Accelerated bookbuild
15,000,000
967,742 shares
15.50
26,800,374
22
June
2022
Transaction
warrants
2,832,000
1,200,000
2.36
28,000,374
exercised
shares
2
Accounting wise, the share issue of December 2019 was accounted for as from the date of establishment of common control in
Dermax.
p.148
Hyloris
: Annual report 2024
Share premium
As per December 31, 2023 and December 31, 2024, the share premium of the Group amounts to €121,513
thousand.
Other reserves
(in € thousand)
December
31,
December
31,
2024
2023
Share based payment
944
2,161
Cost of Capital
(4,460)
(4,460)
Other
476
476
Total Other reserves
(3,040)
(1,824)
The movement of the other reserves over the period can be explained by the decrease of €1,217 thousand
resulting from the share based payment expenses associated with the ESOP warrants (see
note 26
).
15
. BORROWINGS AND OTHER
FINANCIAL LIABILITIES
15.1
BORROWINGS
(in € thousand)
December
31,
December
31,
2024
2023
Lease liabilities
1,717
1,751
Borrowing lab equipment
99
-
Total
borrowings
1,816
1,751
of which as:
Non-current borrowings
1,489
1,510
Current
borrowings
326
241
For more details on the leases, we refer to
note 8
on “Right-of-use assets”.
The increase in lease liabilities, largely offset by
reimbursements, is due to
new cars for a value of
€141 thousand and the index effect of €89 thousand
on the leasing of the building and lab offices.
Borrowing of lab equipment represents the financing
arrangements (duration of 36 months starting in
February 2024 for an amount of €139 thousand with
an annual interest rate of 6.05%) contracted in 2024
with a financial partner for equipment acquired for
the lab.
The sale and lease back agreement, for an amount of
€139
thousand,
is
considered
a
financing
arrangement. To determine how to account for a
sale-and-lease back transaction, the Group first
considered whether the initial transfer of the
underlying asset from the Group to the buyer-lessor
was a sale. IFRS 15 was applied to determine whether
a sale had taken place. Based upon the facts and
circumstances, i.e. the lessor did not obtain control
over the asset, there was no sale in accordance with
IFRS 15. As a result, the Group continued to recognize
the underlying asset and recognized a financial
liability under IFRS 9 for the amount received from the
buyer-lessor. The financial liability is presented in the
line borrowings (
note 15.1
) and is measured at
amortized cost.
p.149
Hyloris
: Annual report 2024
The weighted average incremental borrowing
rate used for the measurement of the lease
liabilities is 3.95%. The incremental borrowing
costs for the cars is in a range
between 1.6% and
3.16%. The Group is not subject to financial
covenants. The underlying leased assets act as
pledge in the context of the lease liabilities.
15.2
OTHER FINANCIAL
LIABILITIES
The other financial liabilities can be detailed as follows:
(in € thousand)
December
31,
December
31,
2024
2023
Recoverable cash advance
68
44
Other financial liabilities
3,300
3,500
Other
financial
liabilities
3,368
3,544
of which as:
Non-current other financial
368
344
liabilities
Current other financial
3,000
3,200
liabilities
Recoverable cash advance
In June 2023 a recoverable cash advance related
to the
government grant for HY-083 was received
from the
Walloon region. A part of this cash
advance is a non-
refundable grant (€88 thousand)
and the other part is refundable to the Walloon
region (€169 thousand). In relation to the €169
thousand if the development of the product
candidate is successful and will be commercialized
the Group has to reimburse the advance. The
reimbursement includes a fixed amount and a
variable amount depending on the sales of the
product. If the product candidate is not successful
the
Group is not required to refund the advance
but only if the Group decides to transfer the IP
rights of the product candidate to the Walloon
region. In case the Group decides to keep the IP
rights, the fix part of the advance has to be
reimbursed and the financial liability
will be
derecognized.
Of the €169 thousand, 30% is fixed (€51 thousand)
and is, in accordance with the accounting
policies, considered a financial liability measured at
fair value (with changes in fair value recognised in
profit and loss) and 70% (€118 thousand) is
variable and accounted for as a government grant
and recognised in profit and loss on a systematic
basis over the period in which the related costs
which the grant is intended to compensate are
recognized as expenses. The variable part of the
refundable advance will be reimbursed via
royalties to be paid as of commercialization. In
2023 the variable part of the refundable advance
has been fully
recognized as Other income since
sufficient related costs
have
been
incurred
during the year. In 2024, Hyloris has incurred
sufficient costs to recognize additional grants but
decided not to proceed with any additional
recognition as the project has now a different
approach than the original development plan.
The indication of the product remains the same
and
this
new
approach
enhances
the
patentability which is an important factor for the
Walloon Region. A recall of the received cash
advance is unlikely. At a minimum, this evolution
might
necessitate
an
amendment
to
the
Convention with the Walloon Region.
Other financial Liabilities
The Group has license agreements with A.forall
Group (formerly Alter Pharma Group), including a
current financial liability of €200 thousand, which
became payable upon the first commercial launch
of Maxigesic IV in the US in early 2024 and a non-
current financial liability of €300 thousand, which will
become payable when worldwide annual sales for
Maxigesic IV reach €50 million. In a separate
agreement, A.forall Group had agreed to carry out
certain R&D activities (related to a specific product)
for Hyloris through a development partner. Hyloris
agreed to prepay and fund these R&D activities.
After reviewing the related costs incurred, Hyloris
sought reimbursement for the excess amount
funded. In August 2024, both parties reached a
final agreement on a repayment of €0.4 million.
p.150
Hyloris
: Annual report 2024
Hyloris and A.forall Group agreed to offset this
amount against the outstanding €0.2 million
financial liability for the commercial launch of
Maxigesic
IV
(presented
as
Other
non-cash
movements in table in
note 15.3
). A.forall Group
paid the remaining balance to Hyloris in August
2024.
Committed to milestone related investments
(contributions to the equity) in FHP (see
note 9
) the
Group has a current other financial liability of €3
million.
15.3
LIQUIDITY AND CASH
FLOW RECONCILIATION
The maturity table of the borrowings and the other
financial liabilities is presented in
note 4.6
on the
liquidity risk.
The following tables reconcile the movements of the financial liabilities to the cash flows arising from
financing activities:
Non-cash movements
31/12/2024
Accrued
(in € thousand)
interests
Opening
Change
and
Closing
carrying
Cash
Acqui-
Interest
Modifi-
Re-
in fair
exchange
carrying
amount
flows
sition
expenses
cation
Other
classes
value
differences
amount
Non-current financial liabilities
Lease liabilities
1,509
141
70
89
-374
1,435
Borrowing lab equipment
139
-85
54
Other financial liabilities
343
22
3
368
Current financial liabilities
Lease liabilities
241
-337
374
3
281
Borrowing lab equipment
-47
7
85
45
Other financial liabilities
3,200
-200
3,000
Total liabilities from
financing activities
5,294
-245
141
77
89
-200
0
22
6
5,184
Presented in the statement
of cash flows as follows:
Operating activities –
interests paid
-77
Financing activities -
reimbursement of borrowings
-40
Financing activities -
reimbursement of lease
-267
liabilities
Financing activities –
proceeds from borrowings
139
p.151
Hyloris
: Annual report 2024
Non-cash movements
31/12/2023
Accrued
(in € thousand)
interests
Opening
Interest
and
Closing
carrying
Cash
Acqui-
expenses
Modifi-
Re-
exchange
carrying
amount
flows
sition
leases
cation
Other
classes
differences
amount
Non-current financial liabilities
Lease liabilities
747
-
903
-1
-149
9
1,509
Other financial liabilities
300
51
-8
343
Current financial liabilities
Lease liabilities
134
-223
130
52
149
241
Other financial liabilities
3,212
-12
0
0
3,200
Total liabilities from
financing activities
4,394
-184
1,033
52
-1
0
0
1
5,295
Presented in the statement
of cash flows as follows:
Financing activities –
interests paid
-12
Financing activities -
reimbursement of lease
-170
liabilities
Financing activities –
proceeds from borrowings
51
Operating activities –
interest paid
-52
p.152
Hyloris
: Annual report 2024
16
. Provisions
On September 2022, an engagement letter was
signed with the law firm for the defense of Hyloris
joint clients against AltaThera Pharmaceuticals.
Discussions
are
ongoing
for
payment
of
discretionary fees to a law firm related to the
AltaThera arbitration. Final terms and conditions
are not yet agreed but a provision is recognized for
€581 thousand (of which €173 thousand is non-
current and €408 thousand is current) because of
existing present obligation at reporting date as a
result of past event based upon facts and
circumstances
available,
with
estimation
uncertainty on the amount and timing.
These
amounts represent a best estimation. These
discretionary fees consist of a fixed part and a
variable part which is partially current and partially
non current. The payment structure for the non
current portion is variable and based on a % share
of the future profits generated by a product
candidate. The % share is currently estimated
between 0.5% and 5%. The number of years that
the payments will occur is depending on the %
share
and
if
Hyloris
will
out-license
the
commercialization or does the commercialization
of the product candidate by itself. The payment
schedule is different between the 2 scenarios
because the estimated sales profits are different. In
the scenario of out-licensing the payments of the
non current part will occur between 2025 and 2035
when 0.5% share is applied. When 5% share is
applied the payment will occur in 2025 till 2027
since the amounts are much higher. In the scenario
of self-commercialization the payments will occur
between 2026 and 2033 if 0.5% share is applied and
between 2026 and 2028 if 5% is applied.
Although
uncertainties
remain
regarding
the
commercialization
timeline
of
the
product
candidate,
the
regulatory
approval
process
(FDA/EMA) and the final percentage to be applied
for future profits, the discretionary fees meet the
criteria of IAS 37 hence a provision must be
recognized:
The present obligation is a result of past events
The settlement is expected to result in an
outflow of resources (payment)
These uncertainties primarily affect timing and
amount of payment, rather than the existence of an
obligation. The expected timing of the payment is
between 2025 and 2035 if the commercialization of
the product candidate is out-licensed and between
2026 and 2033 if the commercialization is done by
Hyloris.
Valuation approach
The current portion of the provision is a fixed
amount and will be paid in the short term.
The non-current portion for the discretionary fee is
related to the variable part and the fair value is
determined by applying a discounted cash flow
approach with a discount rate of 13.38% and using
the business case of a product candidate which is
not yet commercialized.
This discretionary fee will be part the US litigation
costs to be recovered from API (see note 11). The
fair value of the receivable recognized as other
receivable for the discretionary fee amounts to
€196
thousand.
Sensitivity analysis
A sensitivity analysis shows that when the discount
rate increases or decreases by 1%, the non current
part of the provision would decrease by €5 thousand
or increase by €6 thousand. There is no material
impact on the current part of the provision.
p.153
Hyloris
: Annual report 2024
17
. Trade and other liabilities
(in € thousand)
December
31,
December
31,
2024
2023
Trade payables
3,166
3,195
Employee benefit liabilities
262
116
Deferred income
-
7
Trade
and
other
liabilities
3,428
3,318
- Current
The trade payables relate mainly to the R&D
activities, payables for lawyers for the litigation case
(
note 27
) and remuneration of different committees
and the executive management team, including the
accrued bonuses.
The fair value of trade payables approximates their
carrying amount.
Liquidity and currency risk are detailed in
note 4
.
18
. Deferred taxes
Deferred tax assets are recognized only if
management
assesses that these tax assets can be
offset
against
taxable
income
within
a
foreseeable future.
This judgment is made on an ongoing basis and
is based on budgets and business plans for the
coming years, including planned commercial
initiatives.
Although, no going concern issues have been
identified and significant profits are expected as
from the moment
more product candidates will
be
commercialized,
the
moment
of
commercialization and the amount
of revenue to
be generated from commercialization
remain
uncertain. Given the history of tax losses and the
fact
that there are at this moment, no agreements
yet
for
commercialization
of
additional
products that would
result in taxable profit in the
futur
e against which the tax losses or tax credits
can be utilized, no deferred tax asset has been
recognized as of 31 December 2024.
Deferred tax assets are reviewed at each
reporting date and will be recognised as from
and to the extent that it
is probable that taxable
profit will be available, against
which the unused
tax losses, unused tax credits and
deductible
temporary differences can be utilised.
Deferred tax assets and liabilities are offset
when there is a legally enforceable right to
offset and when the deferred taxes relate to
the same fiscal authority. The deferred tax
assets and liabilities are attributable to the
following items:
p.154
Hyloris
: Annual report 2024
December 31, 2024
December 31, 2023
in € thousand
Deferred tax
Deferred tax
Deferred tax
Deferred tax
asset
liability
asset
liability
Intangible assets
67
67
17
17
RoU Assets
413
431
Financial liabilities
413
431
Total deferred tax assets & liabilities
480
480
448
448
Offsetting
-480
-480
-448
-448
Total deferred tax assets & liabilities
0
0
0
0
Deferred tax assets have not been recognized in respect of the following items, because it is not probable
that future taxable profits are available against which the Group can use the benefits of therefrom:
In € thousand
2024
2023
Deductible temporary differences
15,074
16,673
Deductible temporary differences
related to investment in associates
550
469
Tax losses
56,097
53,155
Total
71,721
70,297
The deductible temporary differences disclosed above would reverse over a period ranging between 5 to 10
years. The tax losses carried forward, however, are available indefinitely.
19
. Revenue
The revenue can be detailed as follows:
(in € thousand)
2024
2023
Royalties
4,901
1,929
Out-license agreements
247
104
Milestones
3,310
54
Total revenues
8,458
2,087
Currently, more than half of the revenue of the Group consists of sales-based royalties. The increasing sales-
based royalties is income from the Group’s launched products, Sotalol IV, Maxigesic IV and Podofilox gel,
launched in December 2023, which had the biggest impact. Revenue from sales-based royalties is recognized
when the subsequent sale occurs
p.155
Hyloris
: Annual report 2024
A USD 2.1 million milestone related to the commercial launch of Maxigesic IV in the U.S. as well as, amongst
others, upfront and regulatory milestones payments related to the licensing and supply agreement on
Valacyclovir Oral Suspension, signed with Rosemont Pharmaceuticals in December 2024, contributed to the
strong growth of milestones revenue. Revenue from milestones is recognized when the performance obligation
has been met.
20
. Expenses by nature
Expenses by nature represent an alternative presentation for amounts included in the consolidated statement
of comprehensive income. They are classified under “Cost of sales”, “Research and development expenses”,
“General and administrative expenses” and “Other operating expenses” in respect of the years ended December
31:
In € thousand
2024
2023
Out-sourced R&D
(6,186)
(11,070)
Employee benefit expenses (Note 21)
(4,110)
(3,761)
Management consultancy fees
(1,092)
(1,137)
Board related expenses
(171)
(176)
Share based payments
584
(539)
Legal & paralegal fees
(2,561)
(2,205)
Audit and related consultancy fees
(853)
(125)
Hiring fees
(64)
(27)
Office equipment, rent and utilities
(433)
(290)
Travel expenses
(300)
(304)
Other expenses
(287)
(78)
Amortisation expense of intangible assets (Note 8)
(227)
(93)
Depreciation expense on PPE and Right-of Use
(421)
(255)
Total operating expenses
(16,119)
(20,060)
of which as:
Cost of sales
(227)
(93)
Research and development expenses
(10,265)
(14,421)
General and administrative expenses
(5,627)
(5,546)
1
The loss and the impairment on the investment in FHP are not included in the Operating expenses (€81 thousand and €972 thousand)
2
In the financial statements of 2023 Travel expenses were presented under Out-sourced R&D
p.156
Hyloris
: Annual report 2024
In accordance with IAS 38, we do not capitalize our research and development expenses until we file for
marketing authorization for the applicable product candidate. Research and development expenditures
incurred during the period were accounted for as operating expenses.
The Groups’ research and development expenses decreased by 29%, from €14,421 thousand in 2023 to €10,265
thousand in 2024. The decrease was principally driven by the timing and phasing of development projects.
Additionally, a $2 million investment (provided to cover R&D costs) in Vaneltix was booked as R&D expenses in
2023, whereas no additional investment was made in 2024 outside of contractual R&D funding, further
contributing to the overall reduction.
In 2024, the Group capitalized development costs for a total of €229 thousand (was €325 thousand in
2023).
(See
note 7
)
Hyloris’ General and administrative expenses remained elevated, totaling €5,627 thousand in 2024, compared
to €5,546 thousand in 2023. This was primarily driven by high legal and investigation costs of € 2,172 thousand,
including AltaThera arbitration costs, provisions for lawyers’ discretionary fees and forensic audit fees. This
amount of €5,627 thousand includes the reversal of share-based payments costs for 2019, 2020 and 2022
Warrants Plans (-€584 thousand), which is a non-cash item. Excluding shared based payments adjustments,
General and Administrative expenses would have amounted to €6,211, compared to €5,006 thousand in 2023.
With the arbitration now concluded, and all else being equal, General and Administrative expenses are expected
to be lower going forward.
21
. Employee benefit expenses
(in € thousand)
December
31,
December
31,
2024
2023
Wages and salaries
(3,588)
(3,277)
Social security costs
(274)
(247)
Defined contribution costs
(35)
(37)
Other employee Benefit
expenses
(213)
(200)
Total employee Benefit
expense
(4,110)
(3,761)
Average number of total employees
in full-time equivalents
40.46
34.70
Long-Term variable remuneration
A long-term variable remuneration will be rolled out starting January 1, 2025. This long-term variable
remuneration scheme will replace the long-term incentive plan that was approved in 2024 but is now
cancelled. (see note 3.3.4 in Corporate Governance)
p.157
Hyloris
: Annual report 2024
22
. OTHER OPERATING INCOME
(in € thousand)
December
31,
December
31,
2024
2023
Services rendered related
to co-developments
63
501
R&D tax credit
499
434
Government grants
576
578
Grants income related to exemption
on withholding taxes
164
159
Recoup US litigation costs
292
-
Other income
(10)
455
Other
operating
income
1,584
2,127
The decrease compared to last year is mainly
related to:
1) services rendered which primary consist of
strategic advice provided by the Group to Pleco
Therapeutics BV to support a co-developer and
recharge of services rendered. These strategic
advice and services are related to:
Business Development: advice on strategic
partnerships,
that
could
secure
additional
funding or distributor that could and expand the
market reach.
Market Entry Strategies: assistance in developing
effective plans to introduce the therapy to the
market and gain traction among healthcare
providers and patients.
Operational Efficiency: guidance on optimizing
their internal processes for maximum efficiency,
ensuring resources are strategically directed
towards achieving their goals.
Investor Relations: assistance on effectively
communicating with potential investors and
secure future funding rounds.
Risk mitigation
2) a settlement agreement in 2023 with a partner of
€394
thousand
resulting
from
a
long-lasting
discussion on disputed costs incurred in the past
that was presented as Other income.
Furthermore the Other Operating Income consists
of:
the R
&D tax credit for a total of €515
thousand,
of
which
€499
thousand
is
recognised as other operating income, and
€15 thousand is recognised as a deduction
from the carrying amount of the related
assets, which are recognized in the profit or
loss statement in line with the amortization
or depreciation expense of the related assets
(note 11). In 2023 the Group recognized R&D
tax credits for a total of €445 thousand, of
which €434 thousand as other operating
income, and €11 thousand deduction from
the carrying amount of the related assets.
a
tax
credit
from
an
American
State
government for the clinical development of
TM
the Alenura
product
candidate of €576
thousand (note 11). In 2023 the tax credit from
an American State government for this product
candidate was €369 thousand.
p.158
Hyloris
: Annual report 2024
an exemption of withholding taxes on the
employee’s wages for €164 thousand. In 2023
the amount was €159 thousand.
the first-time recognition of the fair value (€292
thousand) of AltaThera litigation costs (classified
as financial assets under IFRS), which are to be
recouped from royalties payable to API once
several cardio assets are commercialized (
note
11
).
23
. FINANCIAL RESULT
The various items comprising the net finance cost are as follows:
(in € thousand)
2024
2023
Realized gain on FX forward contracts
-
29
Interest income on deposits
901
869
Exchange differences
259
-
Other
6
-
Total financial income
1,166
898
Interest expense on lease liabilities
(70)
(52)
Interest expense on other financial liabilities
(7)
-
Total interest expenses
(77)
(52)
Fair Value of API loan (note 11)
(241)
(173)
Bank fees
(58)
(48)
Exchange differences
-
(12)
Total financial expenses
(378)
(285)
p.159
Hyloris
: Annual report 2024
24
. Income tax expense
24.1
AMOUNTS RECOGNIZED TO PROFIT AND LOSS
The income tax (charged)/credited to the income statement during the year is as follows:
(in € thousand)
2024
2023
Tax
(expense)
/
income
-
-
Income
taxes
-
-
24.2
RECONCILIATION OF EFFECTIVE TAX
The income tax expense can be reconciled as follows:
(in € thousand)
2024
2023
Loss before income tax
(6,342)
(15,380)
Income tax expense calculated at
domestic tax rates (25%)
1,585
3,845
Tax
effect
of :
Share of Loss of equity-accounted investees
reported, net of tax
(20)
(37)
Tax incentives (R&D Tax Credit)
125
109
Non-deductible expenses
(413)
-
Effect of unused tax losses not recognized
as deferred tax assets
(1,277)
(3,916)
Total tax Expenses
0
0
24.3
CURRENT TAX ASSETS
The withholding tax on our deposits in Belgium can be fully recovered via the corporate income tax return.
The Group will get a refund for the difference between on one hand the recoverable Belgian withholding
tax, and on the other hand the corporate income tax due on the minimum taxable basis corresponding
to 40% of the benefit in kind for the private use of company cars. The refundable amount for 2024 is €508
thousand and booked on Current tax assets.
p.160
Hyloris
: Annual report 2024
25
. Earnings per share
Basic earnings per share amounts are calculated by
dividing net profit for the year attributable to ordinary
equity holders of the parent by the weighted average number of ordinary shares outstanding during the
year.
Diluted earnings per share amounts are calculated by dividing the net profit attributable to ordinary equity
holders of the parent (after adjusting for the effects of all dilutive potential ordinary shares) by the weighted
average number of ordinary shares outstanding during the year plus the weighted average number of
ordinary shares that would be issued on conversion of all the dilutive potential ordinary shares into ordinary
shares. No effects of dilution affect the net profit attributable to ordinary equity holders of the Group. The
table below reflects the income and share data used in the basic and diluted earnings per share
computations:
Number of shares
December
31,
2024
December
31,
2023
Weighted average number of ordinary
28,000,374
28,000,374
shares outstanding
during the period
Basic earnings per share
(0.23)
(0.55)
Diluted earnings per share
(0.23)
(0.55)
Earnings per share based on the existing number of ordinary shares:
(in € thousand)
December
31,
December
31,
2024
2023
Basic earnings
Profit
(Loss)
from
(6,342)
(15,380)
continuing operations
attributable to owners of the parent
Diluted earnings
Dilution effect of share-based payments
Profit from continuing operations at-
(6,342)
(15,380)
tributable to owners of the parent,
after dilution effect
As the Company is suffering operating losses, the stock options have an anti-dilutive effect. As such,
there is no difference between basic and diluted earnings per ordinary share. There are no other
instruments that could potentially dilute earnings per share in the future.
p.161
Hyloris
: Annual report 2024
26
. Share-based payments
The Company has a stock option scheme for the employees, consultants and directors of the Company
and its subsidiaries for rendered services. In accordance with the terms of the plan, as approved by
shareholders, employees may be granted options to purchase ordinary shares at an exercise price as
mentioned below per ordinary share.
Each employee share option converts into one ordinary share of the Company on exercise. No
amounts are paid or payable by the recipient on receipt of the option.
The options carry neither rights to dividends nor voting rights. Options may be exercised at any time
from the date of vesting to the date of their expiry.
The following share-based payment arrangements were in existence during the current and prior
periods, there is no new plan emitted in 2024:
Warrants
Warrants
Warrants
Warrants
Warrants
Warrants
outstanding
Warrants
outstanding
Warrants
Warrants
outstanding
Warrants
Warrants
authorised
cancelled
granted
31/12/2019
forfeited
31/12/2020
granted
forfeited
31/12/2021
forfeited
exercised
PLAN 2017
Warrants
1.200.000
1.200.000
1.200.000
1.200.000
1.200.000
-1.200.000
PLAN 2019
Warrants
363.300
-10.300
353.000
353.000
-20.000
333.000
-20.000
313.000
-6.875
PLAN 2020
400.000
-213.500
186.500
186.500
186.500
Warrants
-
69.500
69.500
Warrants
-
55.000
55.000
Warrants
-
60.000
60.000
Warrants
-
2.000
2.000
PLAN 2022
213.500
-71.500
142.000
Warrants
-
-
Warrants
-
-
Warrants
-
-
Total
Warrants
2.176.800
-295.300
1.881.500
1.553.000
-20.000
1.533.000
186.500
-20.000
1.699.500
-6.875
-1.200.000
p.162
Hyloris
: Annual report 2024
Weighted
Warrants
Warrants
Warrants
Average
Fair value at
outstanding
Warrants
Warrants
outstanding
Warrants
Warrants
outstanding
Expiry Date
Exercise Price
grant date
31/12/2022
forfeited
exercised
31/12/2023
forfeited
exercised
31/12/2024
per warrant
(€)
(€)
PLAN 2017
Warrants
0
0
0
04-05-22
2,36
1,11
PLAN 2019
Warrants
306.125
306.125
-306.125
0
31-12-24
5,34
2,47
PLAN 2020
186.500
186.500
185.500
11,89
5,40
Warrants
69.500
69.500
69.500
27-11-30
9,88
4,44
Warrants
55.000
55.000
55.000
27-11-30
12,04
5,68
Warrants
60.000
60.000
60.000
27-11-30
13,92
6,20
Warrants
2.000
2.000
-1.000
1.000
27-11-30
16,64
7,39
PLAN 2022
142.000
-7.354
134.646
123.813
14,12
5,36
Warrants
62.000
0
62.000
-10.833
51.167
30-06-29
15,20
6,06
Warrants
55.000
-7.354
47.646
47.646
30-06-29
12,92
4,76
Warrants
25.000
0
25.000
25.000
01-01-30
13,71
4,76
Total
Warrants
634.625
-7.354
0
627.271
-317.958
0
309.313
12,78
-
On 31 December 2019, the Company issued a plan
of 363,300 warrants in the context of an employee
stock ownership plan (ESOP warrants). The 2019
plan is subject to conditions so that it will vest
gradually over the next four years (25% after 1 year,
and 1/48 for every additional month during 3 years).
The Company offered in total 353,000 warrants. For
this plan, the expense in the profit or loss is €23
thousand in 2023. The plan expired on 31 December
2024 with no exercise of the (vested) ESOP warrants.
As a result, the expired warrants of this plan were
transferred from Other reserves to Retained
earnings for an amount of €633 thousand. The P&L
impact of the cancellation related to the resignation
of the CLO is -€124 thousand.
On 27 November 2020, the Company issued a plan
of 400,000 warrants. The 2020 plan is subject to
services conditions so that it will vest gradually
over the next four years (25% after 1 year, and 1/48
for every additional month during 3 years). In the
2020 plan, 191,500 warrants were offered to new
employees of which 186,500 warrants were
accepted. The remaining warrants of the 2020
plan
were cancelled. In 2024
1,000 warrants
additionally have forfeited due to the leave of a
participant. For the 2020 plan, the expense is €161
thousand in 2023 and -€282 thousand in 2024.
Reason for this credit amount in 2024 is the
revision of the vesting period. (see explanation
below)
On 22 June 2022, the Group issued a new plan of
213,500 warrants. The 2022 plan is subject to
services conditions so that it will vest gradually
over the next four years (25% after 1 year, and 1/48
for every additional month during 3 years). As of 31
December 2022, 142,000 warrants were accepted
p.163
Hyloris
: Annual report 2024
by new employees. In 2023, 7,353 warrants and in
2024, 10,833 warrants additionally have forfeited
due to the leave of a participant hence in total
89,687 warrants have forfeited. For the 2022 plan,
the expense is €356 thousand in 2023 and -€178
thousand in 2024. Reason for this credit amount in
2024 is the revision of the vesting period. (see
explanation below).
The ESOP schemes are structured with a vesting
period of 4 years (same for all warrant schemes)
with the specificity that participants lose their
vested warrants in the event of termination at the
initiative of the participant, even during the exercise
period which varies between 1 and 6 years,
depending on the warrant schemes. In light to this
specificity, the length of the vesting period is
variable depending on the estimated actual exercise
date of the warrants by the participants.
Until 31
December 2023, the Board of Directors had no
historical experience regarding the timing by which
the participants would exercise their warrants and
took the assumption that the participant would
exercise their warrant as soon as possible (just after
the end of the vesting period of 4 years) so that the
fair value at grant date was expensed over the 4
years. 2024 was the first year that warrants became
exercisable for one of the warrants schemes.
The Board of Directors noted that none of the
warrants have been exercised by the participants
which triggers a need to revise the assumption
regarding the length of the vesting period as
defined under IFRS2.
As included in the 2024 half year report, Hyloris’ CFO
and CLO have left their roles within the Company:
the CLO resigned and the CFO’s agreement was
terminated. The warrants accepted by the CLO
become null and void as a result of the resignation.
The fair value of the warrants has been determined
based on the Black Scholes model. For the plan
issued in 2019, the expected volatility is based on
the historical share price volatility over the past 5
years of listed peer companies. For the plan issued
on 27 November 2020, the expected volatility is
based on the historical share price volatility since
listing of the Company and bench marked
with
listed peer companies.
The warrants of the CFO which are vested, can be
exercised. As a result of this, in accordance with the
stipulations as included in the Plan(s) and IFRS 2
Share-based payments, the previously recognized
expense for the granted warrants was reversed for
an amount of €124 thousand (credit P&L).
In the 2024 year end report, the estimate of the
length of the expected vesting period has been
revised to the mid-range of the exercise period of
each plan. The cumulative share-based payment
costs with this new assumption (as it had always
been used) is significantly lower than the cumulative
cost recorded under ‘Other reserves’ so far and the
impact of the revision of the original estimate (€460
thousand) has been recognized in profit or loss
(deduction of ‘General and administrative costs’)
such that cumulative expense reflects the revised
estimate, with a corresponding adjustment to
equity-settled share-based payment reserve.
The total P&L impact in 2024 is a deduction in
expenses of €584 thousand:
Revised vesting period ESOP 2020 plan (including
forfeiture effect): €282 thousand
Revised vesting period ESOP 2022 plan (including
forfeiture effect): €178 thousand
CLO resignation: €124 thousand
p.164
Hyloris
: Annual report 2024
Below is an overview of all the parameters used in this model:
PLAN 2019
PLAN 2020
PLAN 2022
Average share price (€)
5.34
11.73
14.84
Average exercise price
(€)
5.34
11.89
15.2
Expected volatility of
the shares (%)
55%
40%
35%
Expected dividends
yield (%)
0%
0%
0%
Average risk free
interest rate (%)
0.10%
0.00%
2.66%
The Risk Free interest rate (%) is based on an OLO with
a maturity in relation to the exercise period of each
individual plan, which goes within a range between 5 and 10 years.
27
. Contingencies
Ongoing
legal
proceedings
Tax expense
In 2021, The Group recognized an additional Tax
Expense of €297 thousand related to a request for
payment of Taxes related to taxable income
realized in 2017, when the Company was still located
in Grand Duchy of Luxembourg. Although the
company filed
timely her Tax Return related to
income year 2016, the company did not receive
any Tax Assessments prior to the request for
payment.
Management
protested
to
the
relevant Authorities and decided to adopt a
cautious approach and recognized the Tax
Expense in 2021.
Payment has been done to the Authorities in 2022.
The current status is that the first hearing took place
before the Administrative Tribunal in first instance
in December 2024 and the ruling was confirmed in
early 2025 determining that the tax administration
should resume handling our case. The probability
criteria are still not met to recognize a receivable
given the current status of the procedure.
Concluded legal proceedings
In August 2022, AltaThera filed a lawsuit against
Hyloris and its development partner centered
around alleged misappropriation of trade secrets,
improper inventorship, unjust enrichment, and
breach of the licensing agreement governing the
distribution of Sotalol IV, a cardiovascular drug
licensed to AltaThera by Hyloris. AltaThera made
significant
claims
for
damages
and
rights
specifically relating to Hyloris’ intellectual property.
Hyloris
responded
by
initiating
arbitration
proceedings against AltaThera for breach of the
p.165
Hyloris
: Annual report 2024
same licensing agreement, including the failure of
AltaThera to use commercially reasonable efforts
in selling Sotalol IV and sought damages and
termination of the licensing agreement.
The American Arbitration Association denied all
AltaThera claims, except for a limited use of
confidential information, and imposed no financial
liabilities
on
Hyloris.
This
decision
was
an
endorsement of Hyloris’ position and a clear
rejection of the damages claims. In addition,
Hyloris’ ownership of its intellectual property was
confirmed.
The
arbitration
panel
confirmed
termination of the license agreement as requested
by AltaThera, confirming a perpetual survival of the
Sotalol IV license allowing AltaThera to continue
commercialization. Hyloris' claims were denied but
Hyloris will continue to receive sales related
royalties, as defined in the license agreement in
accordance with the royalty structure already
applied. Hyloris is pleased that the damages claims
from
AltaThera
have
been
rejected
by
the
arbitration
panel
and
remains
dedicated
to
safeguarding its intellectual property rights while
ensuring the continued development and growth
of its portfolio and product candidates.
28
. COMMITMENTS AND
CONTINGENT LIABILITIES
Hyloris has contractual commitments related to
asset
purchase,
licenses
and
development
agreements.
The
amounts
are
due
upon
reaching
certain
milestones
depending
on
successful completion of development
stages of
the different product candidates (including FDA
approval) or on meeting specified sales targets.
The
Company
disclosed
as
commitments
the
maximum that would be paid if all milestones
and sales targets
are achieved. The amounts are
not risk-adjusted or
discounted.
As at December 31, 2024, Hyloris has contractual
commitments and contingent liabilities for a
maximum amount of €45,902 thousand related to
asset
purchase,
licenses
and
development
agreements recorded under intangible assets and
R&D expenses.
Commitments are unconditional promises made
by
the Group to other parties resulting from legal
or contractual requirements and related to R&D
liabilities (i.e. a commitment to fund R&D activities
as part of a (co-)development agreement with a
partner).
Contingent
liabilities
are
possible
obligations of the Group which are dependent on
(future) sales milestones that will occur when the
product is commercialized (eg. If a certain sales
threshold is met). The table includes the contingent
liabilities if all sales milestones were reached
(maximum exposure).
The accounting treatment of the contractual
commitments and contingent liabilities will vary
per nature of triggering event. Development
milestones up until commercialization will be
expensed
or
capitalized.
Sales
related
commitments such as royalties, profit
sharing and
sales
milestones
will
be
expensed
when
incurred.
p.166
Hyloris
: Annual report 2024
The following table details the total maximum contractual commitments and contingent liabilities
(milestone payments only) at December 31, 2024 per product candidates if such products are successfully
marketed (in € thousand):
Maximum contractual commitments
Contingent Liabilities
Expected
Product Candidate
timing
In k$
In k€
Converted in k€
In k$
In k€
Converted in k€
HY-004
225
217
0
2025
125
120
2026
100
96
HY-029
300
300
0
2025
200
200
2026
100
100
Atomoxetine oral
75
71
0
2025
50
48
2026
25
24
Metolazone IV
325
313
1,300
1,251
2025
75
72
2026
100
96
2027
150
144
2028
100
96
2030
200
193
2032
1,000
963
Dofetilide IV
200
193
0
2025
50
48
2026
150
144
HY-073
6,940
6,680
28,000
26,952
2025
6,822
6,567
2026
118
114
2027
1,000
963
2029
2,000
1,925
2030
2,000
1,925
23,000
22,139
HY-074
100
96
2025
25
24
2027
75
72
Alenura (note 29.2)
1.780
1,713
2025
1,780
1,713
p.167
Hyloris
: Annual report 2024
HY-086 (note 10)
5,313
5,313
2025
4,813
4,813
2026
500
500
HY-088
200
200
2025
200
200
HY-095
2,705
2,603
2025
131
126
2026
1,123
1,081
2027
676
650
2028
625
602
2029
50
48
2030
100
96
TOTAL
12,350
5,813
17,699
29,300
0
28,203
For HY-073 the contingent liability is related to future sales milestones for which only the 3 first years can be estimated
that the sales threshold will be met.
Contingent liabilities attached to profit split and royalties which percentage varies based on achieved profit and/ or
sales are not considered in the above table as no maximum amount can be determined. The company believes that
the list of these candidate products should, in principle, generate more revenue compared to the total value of
€45,902 thousand (maximum commitments).
29
. RELATED PARTY
TRANSACTIONS
As part of the business, the Company has entered into several transactions with related parties. Balances
and transactions between the Company and its subsidiaries, which are related parties of the Company,
have been eliminated on consolidation and are not disclosed in this note. Details of transactions between
the Group and other related parties are disclosed below.
The related parties presented below are identified as:
FHP, in which the Group has a control of 20% (
note 9
);
Vaneltix Inc and its affiliates, in which former non-executive independent member of the Board of directors,
Carolyn Myers her partner, Dr. Dan Vickery is CEO and over which Hyloris has significant influence (see
note9
);
p.168
Hyloris
: Annual report 2024
The shareholders; Mr. Stijn Van Rompay, and
executive member of the Board of the Company, Co-
CEO and reference shareholder of the Company;
Mr. Thomas Jacobsen, an Executive Member of the
Board of the Company and co-CEO;
The Executive Management Team; and
The Board of Directors (Non-Executive Directors).
29.1
TRANSACTIONS WITH FHP
The table below provides an overview as per December 31, 2024:
Transactions for the period
2024
Financial
Profit
€ thousand
position
Loss
Commitments
Equity accounted investees
2,748
Impairment on financial assets
(972)
Other financial liabilities
(note 15.2.)
(3,000)
Total
(252)
(972)
0
The table below provides an overview as per December 31, 2023:
2023
Transactions for the period
Financial
Profit
Commitments
€ thousand
position
Loss
Equity accounted investees
3,801
Impairment on financial assets
(3,000)
Other financial liabilities
(note 15.2.)
54
Total
801
54
0
29.2
TRANSACTIONS WITH VANELTIX, INC.
In 2021 the Group entered into a strategic collaboration with Vaneltix Pharma Inc. for the development
and commercialization of Alenura
TM
as first-line drug treatment for acute pain in interstitial cystitis
/bladder pain syndrome (IC/BPS). See note 3.2. and note 9
At 31 December 2024, , the costs incurred exceeded the current funding resulting in a trade payable
position of €421 thousand, presented as “Trade Payable” (current). The R&D expenses incurred during
the past year reached €789 thousand. Hyloris invested a total amount of €5,114 thousand since the
signing of the Collaboration Agreement, bringing the remaining commitment to €1,713 thousand
compared to €1,810 thousand last year.
p.169
Hyloris
: Annual report 2024
2024
Transactions for the period
Financial
(in € thousand)
Position
Profit / Loss
Commitments
Convertible loan
556
Shares (Equity investee)
(see
note 9)
0.0001
Accounts receivable
178
Trade payables
-421
R&D Expenses
(789)
Interest income
28
Commitments and
Contingent Liabilities (see
1,713
note 28
)
Total
313
(761)
1,713
2023
Transactions for the period
Financial
(in € thousand)
Position
Profit / Loss
Commitments
Convertible loan
499
Shares (Equity-investee)
(see
note 9
)
0.0001
Accounts receivable
174
Prepayments
155
R&D Expenses
(2,744)
Interest income
47
Commitments and
Contingent Liabilities
1,810
(see
note 28
)
Total
828
(2.697)
1,810
29.3
TRANSACTIONS WITH THE SHAREHOLDERS
In 2024 and 2023 there were no transactions
with the shareholders as defined in this section.
p.170
Hyloris
: Annual report 2024
29.5
TRANSACTIONS WITH THE EXECUTIVE
MANAGEMENT
TEAM
Executive management team personnel include those persons having authority and responsibility for
planning,
directing and controlling the activities of the Group
Members of the Executive Management Team
at 31 December 2024 are:
SVR Management BV, an entity controlled by Stijn Van Rompay, an executive member of the Board of the
Company, co-CEO and reference shareholder of the Company
Jacobsen Management BV, an entity controlled by Thomas Jacobsen, an executive member of the
Board of the Company and co-CEO
CMM&C BV, an entity controlled by Christophe Maréchal, Chief Financial Officer
D
r Dietmar Aichhorn, Chief Operating Officer
Finsys Management, represented by Jean-Luc Vandebroek, and Herault BV, represented by Koenraad
Vanderelst are no longer members of the Executive Committee.
The table below presents the compensation of all members of Executive Management Team by type of
compensation
1
.
In
thousand)
2024
2023
ST compensation (incl.
management fees)
1,092
1,137
Share-based payments
(238)
64
Total
854
1,201
At reporting date, there were outstanding trade payables related to transactions with the Executive
Management Team:
In
thousand)
2024
2023
Management fees
104
143
Total
104
143
1
The remuneration of Herault BV is included till August 2024, Finsys till November 2024
p.171
Hyloris
: Annual report 2024
As of December 31, 2024, members of the Executive Management Team owned the following securities of
the Company
2
:
December 31, 2024
Shares
Warrants
Number (#)
Pct
(%)
Number (#)
Pct
(%)
Mr. Van Rompay
7,743,400
27.65
-
0.00
Mr. Jacobsen
3,857,838
13.78
-
0.00
Mr. Maréchal
-
-
-
0.00
Mr. Aichorn
32,500
0.12
40,000
12.93
TOTAL
11,633,405
41.55
40,000
12.93
At 31 December 2023, members of the Executive Management Team owned the following securities of the
Company
3
:
December 31, 2023
Shares
Warrants
Number (#)
Pct
(%)
Number (#)
Pct
(%)
Mr. Van Rompay
7,743,400
27.65
68.000
10.84
Mr. Jacobsen
3,857,838
13.78
-
0.00
Mr. Vandebroek
9,000
0.03
40,000
6.38
Mr. Aichorn
32,500
0.12
40,000
6.38
Mr. Vanderelst
17,443
0.06
50,000
7.97
TOTAL
11,659,848
41.55
198,000
31.57
Compared to 31 December 2023, at reporting date there were 28,000,374 shares (unchanged) and 309,313
warrants (627,271 in 2023). During 2024, 306,125 warrants from the 2019 plan expired without any
exercised and 11,833 were forfeited because of participants leaving the Company (1,000 from 2020 plan,
10,833 from the 2022 plan). This makes a total of 317,958 warrants.
2
In the new warrant plan 2025,see note 30, the Management team accepted following number of warrants : Mr. Van
Rompay : 45,000; Mr. Jacobsen : 30,000; Mr. Maréchal : 60,000; Mr. Aichorn : 60,000.
3
Mr. Vandebroek kept his warrants, the warrants of Mr. Vanderelst were cancelled.
p.172
Hyloris
: Annual report 2024
29.6
TRANSACTIONS WITH THE BOARD OF DIRECTORS (NON-
EXECUTIVE DIRECTORS)
As of December 31, 2024, non-executive members of the Board of Directors are:
Stefan Yee, Chairman
Leon Van Rompay
Marc Foidart
Revital Rattenbach
Vincent Van Dessel
At September 30, 2024, the mandate of Chris Buyse, Jim Gale and Carolin Myers ended. They were
replaced by Vincent Van Dessel and Revital Rattenbach for a period of 4 years.
At December 31,2023, Stefan Yee held 100,000 warrants of the 2019 plan. As explained in note 29.4, all
of these expired at December 31, 2024, none were exercised
4
.
The table below presents the compensation of all non-executive members of the Board of directors by
type of compensation:
2024
2023
(In
thousand)
Board fees
112
110
Share-based payments
(247)
7
Total
(135)
117
At reporting date, there were outstanding trade payables related to transactions with the non-executive
members of the Board of directors:
(In
thousand)
December
31,
December
31,
2024
2023
Board fees
50
110
Total
50
110
4
In the 2025 warrant plan, Stefan Yee was offered and accepted 60,000 warrants
p.173
Hyloris
: Annual report 2024
30
. SUBSEQUENT EVENT (AFTER
THE END OF THE REPORTING
PERIOD)
22.01.2025: New warrant plan
Cancellation of 2020 and 2022 plan
Pursuant to the ESOP Warrants plan 2020:
124,500
subscription
rights
cancelled
and
61,000 remaining subscription rights giving right
to 61,000 ordinary shares. Pursuant to the ESOP
Warrants plan 2022: 99,000 subscription rights
cancelled and 28,813 remaining subscription
rights giving right to 24,813 ordinary shares.
The financial impact in 2025 related to the
partial cancellation of 2020 and 2022 plan is a
transfer from Other Reserves to Retained
Earnings for €507 thousand.
New warrant plan
Following the expiry of 306,125 warrants under
the ESOP Warrants plan 2019 on December 31,
2024, Hyloris announced that the Board of
Directors approved the issuance of 650,000
warrants on 20 January 2025. These new
warrants, issued under the ESOP Warrant plan
2025
are
intended
for
key
employees,
consultants, members of the management team
and certain directors. These new warrants were
issued on 20 January 2025 concomitantly with
the cancellation of 223,500 existing warrants.
The warrants issued under the ESOP Warrant
plan 2025 have a duration of six years as of the
date of issuance.
The warrants are subject to vesting conditions
over a four-year period. They are generally not
transferable
and,
in
principle,
cannot
be
exercised prior to the fourth anniversary of the
grant date (i.e. 20 January 2029). Each warrant
gives the right to subscribe to one new share of
Hyloris. Should the warrants be exercised,
Hyloris will apply for the listing of the resulting
new shares on Euronext Brussels. The warrants
as such will not be listed on any stock exchange
market.
The
Company
offered
626.500
warrants.
611.500 warrants were accepted of which
195.000 from the Executive Management Team
and 60.000 from the chairman of the Board of
Directors.
Parameters used in
this model:
TOTAL
611.500,00
Average Share price (€)
€ 5
.76
Average Exercise Price (€)
€ 5
.58
Expected volatility of the shares (%)
65,0%
Expected dividends yield (%)
0,00%
Risk free interest rate (%)
2.76%
Fair Value (€)
€ 3
.55
This new warrant plan is not considered as a
replacement as:
The
old
plans
are
formally
partially
cancelled
There
is
no
clear
link
between
the
employees' cancellation of participation in
the old plan and acceptance of the share-
p.174
Hyloris
: Annual report 2024
based payment under the new plan, eg.
number of offered warrants is not the same
for some participants
The financial impact in 2025 of the cancellation
is €506thousand in Other Reserves and the
Profit or Loss. The financial impact in 2025 of the
new warrant plan is €802 thousand.
03.02.2025: Hyloris Announces Partnership
with Colonis Pharma for XTRAZA in the UK
An exclusive licence and distribution agreement
has been signed with Colonis Pharma Limited
(“Colonis”) for XTRAZA.
XTRAZA
TM
is a proprietary oral rinse designed to
deliver
tranexamic
acid
(an
antifibrinolytic
agent) to patients on anticoagulant therapies
(blood thinners) undergoing dental procedures
with bleeding risks, such as tooth extractions.
Tranexamic acid has a long history of use in
other dosage forms to reduce or prevent
postoperative bleeding. XTRAZA represents a
novel application in a localised format for
optimal coagulation during or after dental
interventions.
Under the terms of the agreement Hyloris will
receive milestone payments, primarily tied to
regulatory achievements, and will exclusively
supply XTRAZA in the UK to Colonis.
Financial impact: under the terms of the
agreement, Hyloris is entitled to receive a total
of four milestone payments: at signature, upon
regulatory events, and in connection with
commercial launch events.
13.02.2025: Hyloris Broadens Pipeline with
Ready-To-Use Pantoprazole IV
Hyloris has entered into an exclusive licensing
agreement
to
develop
a
ready-to-use
formulation for intravenous (IV) administration
of pantoprazole, a molecule used to treat gastric
acid-related conditions.
The new ready-to-use
pantoprazole
formulation
represents
a
substantial
advancement
over the existing
lyophilized
(freeze-dried)
version,
which
requires reconstitution prior to administration.
Reconstitution is a more complex and resource-
intensive
process
that
adds
unnecessary
preparation
time,
effort,
and
cost
for
administration. In contrast, the ready-to use
formulation
eliminates
the
need
for
reconstitution,
offering
an
immediate
and
efficient solution for healthcare professionals.
Financial impact: under the terms of the
agreement,
Hyloris
shall
pay
development
milestones and a portion of any licensing fees
received from commercial partners.
25.02.2025: Hyloris Broadens Pipeline with
RedHill’s Ondansetron Extended-Release
Hyloris has entered into an exclusive licensing,
development and commercialization agreement
with RedHill Biopharma (Nasdaq: RDHL) for a
once-daily,
proprietary,
bimodal
extended-
release oral tablet formulation of ondansetron1.
The agreement grants Hyloris exclusive global
rights outside of North America. This extended-
release formulation of the 5-HT3 antagonist
ondansetron is designed to provide prolonged
relief from nausea and vomiting associated with
chemotherapy, radiotherapy (also known as
CINV/RINV), and post-operative recovery. It aims
to enhance patient convenience and facilitate
better
management
of
symptoms
during
intensive treatments. The global CINV/RINV 5-
HT3 antagonist market was estimated at USD 1.5
billion in 2024 and is growing at a compounded
annual growth rate (CAGR) of approximately
5.3%.
Hyloris
will
be
responsible
for
further
development and regulatory activities in its
p.175
Hyloris
: Annual report 2024
territories while leveraging RedHill’s clinical data
from its U.S. development program.
Financial impact: under the terms of the
agreement, Hyloris shall pay RedHill a fixed
license fee upon achievement of milestones and
a royalty of Hyloris’ share of any downpayments.
31.03.2025: Hyloris Announces a New Product
Candidate Targeting Iron Deficiency
Hyloris has entered into a late-stage research
and development program in collaboration with
AFT Pharmaceuticals (AFT) to introduce an
innovative injectable iron deficiency therapy
(HY-094) to the global market. As part of this
program, Hyloris and AFT have secured an
exclusive global IP license covering human use.
Iron deficiency remains a common condition
that affects 15% of the world population. The
global
intravenous
iron
drug
market
is
forecasted to grow from around USD 3.2 billion
in 2023 to more than USD 7.41 billion by 2033
2
.
Existing
iron
treatments
often
present
significant challenges and frequently require
multiple infusions. The new innovative product
candidate, which has completed Phase 2b trials,
aims to address limitations of current options by
offering a more patient–friendly treatment.
Under the terms of the agreement, Hyloris and
AFT
will
co-develop
the
candidate
for
registration
and
global
commercialization.
Hyloris
will
oversee
product
formulation,
manufacturing,
and
the
commercialization
efforts in Europe. AFT will manage the clinical
trials, execution and the commercialization
outside Europe. Parties are jointly responsible
for commercialization in the United States. A
Phase 3 clinical trial(s) involving approximately
1,000 or more patients will be conducted for
investigation of efficacy and safety.
Development costs, as well as all net margin
from sales and licensing, will be distributed
equally between AFT and Hyloris, after a tiered
profit participation for the licensor.
An estimate of the financial impact for the Group
cannot be made.
31
. AUDIT FEES
During 2023 and 2024, the statutory auditor provided services for the group Hyloris which fees were as
follows:
(In
thousand)
2024
2023
Audit services
104
91
Audit related services - legal
engagements
7
-
Tax services
-
28
Total
111
119
p.176
Hyloris
: Annual report 2024
Abbreviated
Statutory Financial Statements
of Hyloris Pharmaceuticals SA
The following information is extracted from the
separate standalone annual accounts of Hyloris
Pharmaceuticals SA (“the Company”) and is
included as required by article 3:17 of the
Belgian Company and Association Code.
The statutory auditor’s report is qualified and
certifies that the standalone annual accounts of
Hyloris
Pharmaceuticals
SA
prepared
in
accordance
with
the
financial
reporting
framework applicable in Belgium for the year
ended December 31, 2024 give a true and fair
view of the Company’s equity and financial
position as at December 31, 2024 and of its
financial performance for the year then ended in
accordance
with
the
financial
reporting
framework applicable in Belgium with the
exception of the matter described in the “Basis
for qualified opinion” section of the audit report
relating
to
an
agreement
with
Pleco
Therapeutics BV and a partial recovery of legal
costs relating relating to the Alta Tera arbitration
proceedings which is also included in the
statutory auditor’s report on the consolidated
financial statements.
The standalone financial statements, together
with the annual report of the Board of Directors
to the general meeting of shareholders as well
as the auditors’ report, will be filed with the
National Bank of Belgium within the legal
deadline.
These documents are also available on request,
addressed to:
Hyloris Pharmaceuticals SA
Boulevard Patience et Beaujonc, N°3/1, 4000
Liège, Belgium
p.177
Hyloris
: Annual report 2024
Statement of Financial Position
(In
€)
2024
2023
ASSETS
FIXED
ASSETS
62,839,120
76,097,212
Intangible
fixed
assets
178,117
121,042
Tangible
fixed
assets
Financial
fixed
assets
62,661,003
75,976,170
Affiliated companies - Participations
61,661,002
73,161,002
Affiliated companies - Receivables
-
1,815,167
Investment
1,000,001
1,000,001
CURRENT
ASSETS
32,824,107
38,607,279
Receivables
over
one
year
664,387
634,434
Trade receivables
-
0
Others amounts receivable
664,387
634,434
Amounts
receivable
within
one
year
9,652,523
7,054,248
Trade receivables
3,595,091
5,695,222
Others amounts receivables
6,057,472
1,359,026
VIII. Cash Investment
0
10,000,000
IX. Cash at bank and in hand
22,390,031
18,817,284
X. Deferred charges and accrued income
117,166
2,101,313
TOTAL
ASSETS
95,663,227
114,704,491
p.178
Hyloris
: Annual report 2024
(In
€)
2024
2023
CAPITAL
AND
RESERVES
88,360,668
102,751,874
Capital
140,002
140,002
Share Premium
121,513,447
121,513,447
Reserves
5,000
5,000
Accumulated profits (losses)
(33,297,781)
(18,906,575)
PROVISIONS AND DEFERRED TAXES
385,023
0
CREDITORS
6,917,536
11,952,617
Amounts
payable
after
more
than
one
year
300,000
300,000
Other financial loans
Other debts
300,000
300,000
IX.
Amounts
payable
within
one
year
6,585,530
10,624,769
Current portion of amounts payable after one year
-
-
Other financial loans
-
3,072,421
Suppliers
3,108,840
3,122,209
Taxes, remuneration and social charges
44,917
15,100
Other debts
3,431,773
4,415,039
X. Accrued charges and deferred income
32,006
1,027,848
TOTAL
LIABILITIES
95,663,227
114,704,491
Income
Statement
(In
€)
2024
2023
Operating
income
6,219,903
3,639,978
Turnover
5,966,698
1,120,551
Other operating income
253,205
709,473
Non-recurrent income
-
1,809,954
Operating
charges
(10,778,311)
(5,777,848)
Services and other goods
(10,083,206)
(5,409,842)
Other operating charges (-)
(5,956)
(1,859)
Remunerations, social charges and pensions
(189,483)
(346,393)
Depreciations
(114,643)
(19,754)
Provisions for liabilities and charges
(385,023)
-
Non-recurring operating expenses
-
-
Operating
profit
(loss)
(4,558,408)
(2,137,870)
Financial
income
1,831,611
1,159,948
Income from financial fixed assets
-
-
Income from current assets
1,521,112
1,094,291
Other financial income
310,499
65,657
p.179
Hyloris
: Annual report 2024
Financial
charges
(-)
(11,671,555)
(2,446,796)
Interest on financial debts
(145,699)
(360,181)
Other financial charges
(25,856)
(276,661)
Non-recurring financial charges
(11,500,000)
(1,809,954)
Profit (Loss) for the period before taxes (-)
(14,398,352)
(3,424,718)
Income
taxes
(-)
7,146
22,406
Profit
(loss)
for
the
period
available
for
appropriation
(14,391,206)
(3,402,312)
p.180
Hyloris
: Annual report 2024
Statutory Notes
Statement
of
financial
fixed
assets
In €
2024
2023
Affiliated companies - Participations
Acquisition value at the end of the preceding period
73,161,002
73,161,002
Movements during the period
Acquisition, included produced fixed assets
Acquisition value at the end of the period
73,161,002
73,161,002
Depreciation and amounts written down at the end of the preceding period
Movements during the period
Recorded
(11,500,000)
Depreciation and amounts written down at end of the period
(11,500,000)
Net book value at the end of the period
61,661,002
73,161,002
Affiliated companies - Receivables
Net book value at the end of preceding period
1,815,167
2,101,122
Movements during the period
Additions
Reimbursement
(1,815,167)
-285,855
Net book value at the end of the period
0
1,815,167
In €
2024
2023
Investment
Acquisition value at the end of the preceding period
2,809,955
1,000.000
Movements during the period
Acquisition, included produced fixed assets
1,809,955
Acquisition value at the end of the period
2,809,955
2,809,955
Depreciation and amounts written down at the end of the preceding period
(1,809,954)
Movements during the period
Recorded
Depreciation and amounts written down at end of the period
(1,809,954)
(1,809,954)
Net book value at the end of the period
1,000,001
1,000,001
p.181
Hyloris
: Annual report 2024
Participation held
Data extracted from last available annual accounts
Company
Company
code
Nature
Number
Direct
By
Subsidi
aries
Annual
accounts
at
Curre
ncy
Capital and
reserves
Net profit
(loss)
%
%
Hyloris Developments
SA
542.737.368
Shares
74,066
99.99%
0%
31-12-23
EUR
7,853,337
(12,069,087)
Boulevard Patience et
Beaujonc 3
4000 Liège - Belgium
Hyloris Supply SA
669.738.676
Shares
62,000
100%
0%
31-12-23
EUR
(1,716,017)
(146,630)
Boulevard Patience et
Beaujonc 3
4000 Liège - Belgium
Dermax SA
667.730.677
Shares
65,875
100%
0%
31-12-23
EUR
3,164,916
1,116,681
Boulevard Patience et
Beaujonc 3
4000 Liège - Belgium
FHP BV
762.693.578
Shares
840
20%
0%
31-12-23
EUR
758,157
(736,656)
Schaldestraat 31
2880 Bornem - Belgium
Vaneltix Pharma Inc.
Shares
4
<0.1%
0%
31-12-23
EUR
30,712
(33,955)
317 George Street
400 New Brunswick
NJ 08901 - United States
Deferred Charges and Accrued Income
(In
€)
2024
2023
Deferred charges and accrued
income
Interest earned on receivables from related companies
74,706
1,725,351
Statement
of
Amounts
Payable
(in €)
December 31,
2024
December 31,
2023
Analysis by current position of amounts initially payable after
more than 1 year, maturing in 1 year
-
-
Analysis by current position of amounts initially payable after
more than 1 year, maturing in max. 5 years
Other debts
300,000
300,000
Taxes payable
7,167
0
Other salary and social debts
22,650
15,100
Accrued bonuses
14,217
10,379
AFT - Milestone due at the start of the first commercial
manufacturing batch of Maxigesic IV
-
904,977
p.182
Hyloris
: Annual report 2024
Auditors’ Report
Statutory auditor’s report to the general meeting of
Hyloris Pharmaceuticals SA on the
consolidated financial statements as of and for the year ended 31 December 2024
In the context of the statutory audit of the consolidated financial statements of Hyloris Pharmaceuticals
SA
(“the Company”) and its subsidiaries (jointly “the Group”), we provide you with our statutory auditor’s
report. This includes our report on the consolidated financial statements and the other legal and
regulatory requirements. Our report is one and indivisible.
We were appointed as statutory auditor by the general meeting of 14 June 2022, in accordance with the
proposal of the board of directors issued on the recommendation of the audit committee. Our mandate
will expire on the date of the general meeting deliberating on the annual accounts for the year ended 31
December 2024. We have performed the statutory audit of the consolidated financial statements of the
Group for 6 consecutive financial years.
Report on the consolidated financial statements
Qualified opinion
We have audited the consolidated financial statements of the Group as of and for the year ended 31
December 2024, prepared in accordance with IFRS Accounting Standards as issued by the International
Accounting Standards Board, as adopted by the European Union, and with the legal and regulatory
requirements applicable in Belgium. These consolidated financial statements comprise the consolidated
statement of financial position as at 31 December 2024, the consolidated statements of profit or loss and
other comprehensive income, changes in equity and cash flows for the year then ended and notes,
comprising material accounting policies and other explanatory information. The total of the consolidated
statement of financial position amounts to 41.335 KEUR and the consolidated statement of profit or loss
and other comprehensive income
shows a loss for the year of 6.342 KEUR.
In our opinion, except for the possible effect (Strategic Advice to Pleco) and except for the effect
(Recovery of legal costs)
(hereafter “the (possible) effect”)
of the matters
described in the “Basis for
qualified opinion” section of our report,
the consolidated financial statements give a true and fair view of
the Group’s equity and financial position as at
31 December 2024 and of its consolidated financial
performance and its consolidated cash flows for the year then ended in accordance with IFRS Accounting
Standards as issued by the International Accounting Standards Board, as adopted by the European
Union, and with the legal and regulatory requirements applicable in Belgium.
Basis for our qualified opinion
Strategic Advice to Pleco
As described in note 3.2 to the consolidated financial statements, the Group entered into an agreement
with Pleco
Therapeutics BV (“Pleco”)
in July 2022. Under the terms of this agreement the Group agreed
to provide strategic advice to Pleco until 31 December 2024 for a maximum consideration of EUR 2,5
million. The Group recognized cumulatively an amount of 1.562 KEUR in retained earnings and an
amount of EUR 0,5 million and 62 KEUR as other operating income in the consolidated financial
statements for the years ended 31 December 2023 and 2024 respectively.
p.183
Hyloris
: Annual report 2024
This agreement is written in a general way (“provision of strategic advice”) and does not specify the
different performance obligations to be provided by the Group to Pleco. The Group has recognized
income from this agreement based on a contractual payment schedule, without analyzing specific agreed-
upon performance obligations, milestones, or other objective allocation methods. In the absence of such
an analysis, it is impossible for us to assess whether the accounting treatment of this agreement meets
the requirements of IFRS Accounting Standards as issued by the International Accounting Standards
Board and as adopted by the European Union. There were no alternative procedures we could have
performed to assess whether the income related to this agreement was correctly accounted for and
disclosed in note 3.2 to the consolidated financial statements in accordance with the applicable
accounting standards.
Recovery of legal costs
As described in note 11, the Company is contractually entitled to offset a substantial part of legal
expenses incurred related to the arbitration proceedings against Alta Thera Pharmaceuticals LLC by the
future royalties that it will owe to its development partner who was part of the proceedings. In 2024 a first-
time recognition of a receivable for an amount of 292 KEUR has been accounted for whereas the first-
time recognition of a receivable should have been recognized in the consolidated financial statements
for the year ended 31 December 2023 for an amount of 510 KEUR. The Group has corrected the error
by recording the net impact in the consolidated financial statements for the year ended 31 December
2024. However, in accordance with IAS 8
Accounting Policies, Changes in Accounting Estimates and
Errors
, the Group should have corrected the error retrospectively by restating the comparative
consolidated information for the year ended 31 December 2023. Not restating comparative consolidated
information has understated the Operating loss for the year ended 31 December 2024 by 510 KEUR.
The Trade and Other receivables and the corresponding Other income for the year ended 31 December
2023 are also understated for an amount of 510 KEUR.
We conducted our audit in accordance with International Standards on Auditing (“ISAs”) as adopted in
Belgium. In addition, we have applied the ISAs as issued by the IAASB and applicable for the current
accounting year while these have not been adopted in Belgium yet. Our responsibilities under those
standards are further described in the “Statutory auditors’ responsibility for the audit of the consolidated
financial statements” section of our report. We have complied with the ethical requirements that are
relevant to our audit of the consolidated financial statements in Belgium, including the independence
requirements.
Except for the matter described above (Strategic advice to Pleco), we have obtained from the board of
directors
and the Company’s
officials the explanations and information necessary for performing our
audit.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for
our qualified opinion.
Key audit matter
Key audit matters are those matters that, in our professional judgement, were of most significance in our
audit of the consolidated financial statements of the current period. These matters were addressed in the
context of our audit of the consolidated financial statements as a whole, and in forming our opinion
thereon, and we do not provide a separate opinion on these matters. In addition to the matters described
in the “Basis for our qualified opinion” section of our report we have determined the matter d
escribed
below to be a key audit matter to be communicated in our report.
Collaboration agreements between the Group and its partners for product candidates
Description
p.184
Hyloris
: Annual report 2024
We refer to note 3.2 of the consolidated financial statements in which the Group describes that they
have entered into several collaboration agreements with partners for the development of product
candidates. These agreements can take various forms such as equity investments, loans (convertible
or non-convertible), research & development (R&D) funding, strategic advice, etc., and can be subject
to contract amendments.
The existence of such collaboration agreements is considered to be a key audit matter due to the
complexity in determining the appropriate accounting based on i) their nature including the existence
of multiple or mutual obligations with the same party, ii) the existence of contract amendments that
could affect their subsequent accounting, iii) the level of judgment required to assess whether the
collaboration agreements give rise to significant influence by the Group over the partners and iv) the
absence of effective internal controls related to the identification, structuring, modification of and
accounting for collaboration agreements.
Our audit procedures
We performed the following audit procedures, amongst others:
-
We evaluated the substance of the various elements of significant collaboration agreements and
discussed the contract terms with management and those charged with governance.
-
For a sample of R&D costs recharged by the Group’s partners, we traced these costs back to the
underlying invoices originating from the partners’ subcontractors to verify their existence and
accuracy. When deemed necessary, we obtained direct confirmation
from the Group’s partner as
to the existence, completeness and accuracy of R&D costs recharged.
-
We evaluated the substance of revenue/other operating income charged by the Group to its
partners by obtaining supporting evidence on the performance obligations. In this respect, we also
refer to the matter
described in the “Basis for our qualified opinion” section of our report.
-
We analyzed the level of influence the Group has over its partners by considering amongst others
the significance of the Group’s relationships to the partners and
challenged the judgment made
by management. For partners where the Group was determined to have significant influence, we
evaluated the appropriateness of the accounting treatment.
-
We evaluated
management’s assessment of impairment for the equity accounted investee FHP
and challenged, together with the assistance of our internal valuation specialists, the applied
methodology, its mathematical accuracy and the key assumptions used such as weighted average
cost of capital.
-
We assessed the adequacy of the disclosures in the consolidated financial statements, particularly
under note 3.2 "Joint collaborations"
, note 9 “
Equity accounted investees
and note 22
Other
operating income” with respect to the collaboration agreements.
In this respect, we also refer to
the matter described in the “Basis for our qualified opinion” section of our report.
Board of directors’
responsibilities for the preparation of the consolidated financial statements
The board of directors is responsible for the preparation of these consolidated financial statements that
give a true and fair view in accordance with IFRS Accounting Standards as issued by the International
Accounting Standards Board, as adopted by the European Union, and with the legal and regulatory
requirements applicable in Belgium, and for such internal control as board of directors determines, is
necessary to enable the preparation of consolidated financial statements that are free from material
misstatement, whether due to fraud or error.
In preparing the consolidated financial statements, the board of directors is responsible for assessing the
Group’s ability to continue as a going concern, disclosing, as applicable, matters related to going concern
p.185
Hyloris
: Annual report 2024
and using the going concern basis of accounting unless the board of directors either intends to liquidate
the Group or to cease operations, or has no realistic alternative but to do so.
Statutory auditor’s
responsibilities for the audit of the consolidated financial statements
Our objectives are to obtain reasonable assurance as to whether the consolidated financial statements
as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s
report that includes our opinion. Reasonable assurance is a high level of assurance but is not a guarantee
that an audit conducted in accordance with ISAs will always detect a material misstatement when it exists.
Misstatements can arise from fraud or error and are considered material if, individually or in the
aggregate, they could reasonably be expected to influence the economic decisions of the users taken on
the basis of these consolidated financial statements.
When performing our audit, we comply with the legal, regulatory and professional requirements applicable
to audits of the consolidated financial statements in Belgium. The scope of the statutory audit of the
consolidated financial statements does not extend to providing assurance on the future viability of the
Group nor on the efficiency or effectivity of how the board of directors has conducted or will conduct the
business of the Group. Our responsibilities regarding the going concern basis of accounting applied by
the board of directors are described below.
As part of an audit in accordance with ISAs, we exercise professional judgement and maintain
professional skepticism throughout the audit. We also perform the following procedures:
Identify and assess the risks of material misstatement of the consolidated financial statements,
whether due to fraud or error, design and perform audit procedures responsive to those risks, and
obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of
not detecting a material misstatement resulting from fraud is higher than for one resulting from error,
as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of
internal control;
Obtain an understanding of internal controls relevant to the audit in order to design audit procedures
that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the
effectiveness of the Group’s internal control;
Evaluate the appropriateness of accounting policies used and the reasonableness of accounting
estimates and related disclosures made by board of directors;
Conclude on the appropriateness of
board of directors’
use of the going concern basis of accounting
and, based on the audit evidence obtained, whether a material uncertainty exists related to events or
conditions that may cast significant doubt on the Group’s ability to continue as a going concern. If we
conc
lude that a material uncertainty exists, we are required to draw attention in our auditors’ report to
the related disclosures in the consolidated financial statements or, if such disclosures are inadequate,
to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our
auditors’ report. However, future events or conditions may cause the Group to cease to continue as
a going concern;
Evaluate the overall presentation, structure and content of the consolidated financial statements,
including the disclosures, and whether the consolidated financial statements represent the underlying
transactions and events in a manner that achieves fair presentation;
Obtain sufficient appropriate audit evidence regarding the financial information of the entities or
business activities within the Group to express an opinion on the consolidated financial statements.
We are responsible for the direction, supervision and performance of the group audit. We remain
solely responsible for our audit opinion.
p.186
Hyloris
: Annual report 2024
We communicate with the audit committee regarding, among other matters, the planned scope and timing
of the audit and significant audit findings, including any significant deficiencies in internal control that we
identify during our audit.
We also provide the audit committee with a statement that we have complied with relevant ethical
requirements regarding independence, and to communicate with them all relationships and other matters
that may reasonably be thought to bear on our independence, and where applicable, related safeguards.
For the matters communicated with the audit committee, we determine those matters that were of most
significance in the audit of the consolidated financial statements of the current period and are therefore
the key audit matters. We describe these matters in our auditor’s report unless law or regulation preclu
des
public disclosure about the matter.
Other legal and regulatory requirements
Responsibilities of the Board of directors
The board of directors is responsible for the preparation and the content of the
board of directors’
annual
report on the consolidated financial statements and the other information included in the annual report
on the consolidated financial statements.
Statutory
auditor’s
responsibilities
In the context of our engagement and in accordance with the Belgian additional standard which is
complementary to the International Standards on Auditing as applicable in Belgium, our responsibility is
to verify, in all material respects, the
board of directors’ annual
report on the consolidated financial
statements, and the other information included in the annual report, and to report on these matters.
Aspects concerning the
board of directors’ annual
report on the consolidated financial
statements and other information included in the annual report
on the consolidated financial
statements
Based on specific work performed on the
board of directors’
annual report on the consolidated financial
statements
and except for the (possible) effect
of the matters described in the “Basis for our qualified
opinion” section of our report,
we are of the opinion that this annual report is consistent with the
consolidated financial statements for the same period and has been prepared in accordance with article
3:32 of the Companies’
and Associations’
Code.
In the context of our audit of the consolidated financial statements, we are also responsible for
considering, in particular based on the knowledge gained throughout the audit, whether the
board of
directors’
annual report on the consolidated financial statements
and other information included in the
annual report
on the consolidated financial statements
, being:
Business overview;
Key figures; and
Corporate Governance.
contain material misstatements, or information that is incorrectly stated or misleading. In the context of
the procedures carried out
and except for the (possible) effect
of the matters
described in the “Basis for
our qualified opinion” section of our report,
we did not identify any material misstatements that we have
to report to you.
Information about the independence
Our audit firm and our network have not performed any engagement which is incompatible with the
statutory audit of the consolidated accounts and our audit firm remained independent of the Group
p.187
Hyloris
: Annual report 2024
during the term of our mandate.
The fees for the additional engagements which are compatible with the statutory audit referred to in
article 3:65 of the
Companies’ and Associations’ Code
were correctly stated and disclosed in the
notes to the consolidated financial statements.
European Single Electronic Format (ESEF)
In
accordance
with the draft standard on the audit of compliance of the annual report with the European
Single Electronic Format (hereafter “ESEF”), we have also audited whether the ESEF
-format is in
accordance with the regulatory technical standards as laid down in the EU Delegated Regulation nr.
2019/815 of 17 December 2018 (hereafter “Delegated Regulation”) and the Royal Decree of 14
November 2007 on the obligations of issuers of financial instruments admitted to trading on a regulated
market (hereafter
the “Royal Decree of 14 November 2007”).
The Board of Directors is responsible for the preparation of an annual report, in accordance with the
ESEF requirements, including the consolidated financial statements in the form of an electronic file in
ESEF format (hereafter “digital consolidated financial statements”).
It is our responsibility to obtain sufficient and appropriate information to conclude whether the format of
the annual report and the XBRL tagging of
the
digital consolidated financial statements comply, in all
material respects, with the ESEF requirements under the Delegated Regulation and the Royal Decree of
14 November 2007.
In our opinion, based on our work performed, the digital format of the annual report and the tagging of
information in the English version of the consolidated financial statements included in the annual report
of
Hyloris Pharmaceuticals SA
as per 31 December 2024, and which will be available in the Belgian
official mechanism for the storage of regulated information (STORI) of the FSMA, are, in all material
respects, in compliance with the ESEF requirements under the Delegated Regulation and the Royal
Decree of 14 November 2007.
For the annual report with the consolidated financial statements relating to the prior financial year, we
have concluded in a separate report prepared in accordance with ISAE 3000 (Revised) "
Assurance
engagements other than audits or reviews of historical financial information
" that the format of the annual
report and the XBRL tagging of the digital consolidated financial statements comply in all material
respects with the ESEF requirements under the Delegated Regulation and the Royal Decree of 14
November 2007.
Other aspect
This report is consistent with our additional report to the audit committee on the basis of Article 11 of
Regulation (EU) No 537/2014.
Zaventem, 2 May 2025
KPMG Bedrijfsrevisoren -
Réviseurs d’Entreprises
Statutory Auditor
represented by
Tanguy Legein
Bedrijfsrevisor / Réviseur d’Entreprises
Hyloris
: Annual report 2024
p.2
Hyloris
: Annual report 2024
p.189
Glossary
and
Other
Info
Hyloris
: Annual report 2024
p.190
Glossary of Terms
Active pharmaceutical ingrediant (API)
The biologically active component in a medication that pro-
duces the intended effect on the body
Atrial
fibrillation
(AF)
An abnormal heart rhythm (arrhythmia) characterised by
the rapid and irregular beating of the atrial chambers of the
heart. It often begins as short periods of abnormal beating,
which become longer or continuous over time
Attention
Deficit
Hyperactivity
Disorder
One of the most common neurodevelopmental disorders of
childhood. It is usually first diagnosed in childhood and
often lasts into adulthood. Children with ADHD may have
trouble paying attention, controlling impulsive behaviours
(may act without thinking about what the result will be), or
be overly active
Bioavailability
Assessment of the amount of product candidate that reach-
es the
body’s
systemic circulation after administration
Burning
Mouth
Syndrome
(BMS)
A chronic condition characterized by a burning or scalding
sensation in the mouth, often without any visible cause
Cardiovascular
(CV)
Refers to the heart, blood vessels, and the circulatory sys-
tem as a whole
Chemistry,
Manufacturing,
and
Controls
(CMC)
To appropriately manufacture a pharmaceutical or biologic,
specific manufacturing processes, product characteristics,
and product testing must be defined in order to ensure
that the product is safe, effective and consistent between
batches.
EBITDA
Earnings Before Interest, Taxes, Depreciation, and Amor-
tization is a financial metric used to assess a company’s
operating profitability
Food
and
Drug
Administration
(FDA)
The agency responsible for protecting and promoting public
health and in charge of American market approval of new
medications
FSMA
The Belgian market authority: Financial Services and Mar-
kets Authority, Or Autoriteit voor Financiele Diensten en
Markten; Autorité des Services et Marchés Financiers
Full-Time Equivalent
A way to measure an
employee’s
involvement in a project.
For example, an FTE of 1.0 means that the equivalent work
of one full-time worker was used on the project
HY-
029
A liquid formulation of an existing anti-viral drug that is
currently only available in oral solid form to treat a non-dis-
closed viral infection
HY-
038
A prefilled syringe of a commonly used product to treat a
specific, non-disclosed deficiency
HY-
074
IV formulation of oral antiplatelet drug, offering faster onset
of action in patients suffering from coronary heart disease
HY-
075
a liquid formulation of a commonly used drug for the treat-
ment of coronary heart disease requiring frequent dose
adjustments
Hyloris
: Annual report 2024
p.191
Initial
Public
Offering
(IPO)
Refers to the process of offering shares of a private corpo-
ration to the public in a new stock issuance. A public share
issuance allows a company to raise capital from public
investors. The transition from a private to a public company
can be an important time for private investors to fully real-
ise gains from their investment as it typically includes share
premiums for current private investors. Meanwhile, it also
allows public investors to participate in the offering.
Intellectual
Property
(IP)
Creations of the mind that have commercial value and are
protected or protectable, including by patents, trademarks
or copyrights
Intravenous
(IV)
Administration of medications directly into the veins using a
needle or tube
Key Opinion Leader (KOL)
An influential physician or researcher who is held in high
esteem by their colleagues
Investigational
New
Drug
(IND)
A drug that is ready for clinical trials in humans. When a
drug reaches this point, the drug developer submits an
application to get the consent of the FDA to begin the trials
Net Present Value (NPV)
A tool of capital budgeting to analyse the profitability
of a project or investment. It is calculated by taking the
difference between the present value of cash inflows and
present value of cash outflows over a certain period
New Chemical Entity (NCE)
A compound, without any precedent among the regulated
and approved drug products
Pharmacokinetics
(PK)
The study of drug absorption, distribution, metabolism,
and excretion. A fundamental concept in pharmacokinetics
is drug clearance, i.e., elimination of drugs from the body,
analogous to the concept of creatinine clearance
Phase
1
Study
First stage of clinical testing of an investigational
drug designed to assess the safety and tolerability,
pharmacokinetics of a drug, usually in a small number of
healthy human volunteers
Phase
2
Study
Second stage of clinical testing of a investigational drug,
usually performed in <several hundreds patients in order to
determine efficacy, tolerability and drug dose
Phase
3
Study
Large clinical studies, usually conducted in hundred (and
in some indications, thousand) patients to gain a definitive
understanding of the efficacy and tolerability of the drug
candidate
serves as a basis for approval
Pivotal
Study
Registrational clinical study
Ready-to-Use (RTU)
Pre-
diluted medicines for intravenous use, known as “ready
to
use”
preparations, help to reduce the amount of errors
associated with the preparation and administration of
medicines
Return
on
Investment
(ROI)
A performance measure used to evaluate the efficiency
or profitability of an investment or compare the efficiency
of a number of different investments. ROI tries to directly
measure the amount of return on a particular investment,
relative to the investment’s cost
Vulvar
Lichen
Sclerosis
(VLS)
A chronic inflammatory skin condition that affects the vulva,
the external genitalia in females
Hyloris
: Annual report 2024
p.192
DISCLAIMER & OTHER INFORMATION
This report contains all information required by Belgian
law. Hyloris Pharmaceuticals SA is a limited liability
company organised under the laws of Belgium and has
its registered office at Boulevard Patience et Beaujonc
N°3/1, 4000 Liège.
Throughout this report, the term “Hyloris
Pharmaceuticals” refers solely to the non-consolidated
Belgian company and references to “we,” “our,” “the
group” or “Hyloris”.
All references in this Annual Report to “$”, “US$”, “U.S.
dollars”, “dollars” and “USD” mean U.S. dollars and all
references to “€”, “EUR” and “euros” mean euros, unless
otherwise noted.
The Company has prepared its Annual Report in
English and provided a French translation
of the
Annual Report, in accordance with Belgian laws. Hyloris is
responsible for the translation and conformity between
the French and English versions. In case of inconsistency
between the French and the English versions, the English
version shall prevail.
The
ESEF version
of the annual financial report (
official
version
) takes precedence over any other versions (PDF,
etc.) in the event of a conflict between these different
versions.
This report, including the statutory financial statements of
Hyloris Pharmaceuticals SA, is available on the Company’s
website www.hyloris.com.
Forward Looking Statements
Certain statements in this annual report are “for- ward-
looking statements.” These forward looking statements
can be identified using forward-looking terminology,
including the words “believes”, “estimates,” “anticipates”,
“expects”, “intends”, “may”, “will”, “plans”, “continue”,
“ongoing”, “potential”, “predict”, “project”, “target”, “seek” or
“should”, and include statements the Company makes
concerning the intended results of its strategy.
These statements relate to future events or the
Company’s future financial performance and involve
known and unknown risks, uncertainties, and other
factors, many of which are beyond the Company’s
control, that may cause the actual results, levels of activity,
performance or achievements of the Company or its
industry to be materially different from those expressed
or implied by any forward looking statements.
The Company undertakes no obligation to publicly
update or revise forward looking statements, except as
may be required by law. You should not place undue
reliance on forward looking statements. Certain
monetary amounts and other figures included in this
annual report have been subject to rounding
adjustments.
Accordingly, any discrepancies in any table between the
totals and the sums of amounts listed are due to
rounding.
FINANCIAL CALENDAR
September 25, 2025:
Half year results
CONTACT
investorrelations@hyloris.com
Hyloris Pharmaceuticals SA
Boulevard Patience et Beaujonc N°3/1
4000 Liège, Belgique
Hyloris Pharmaceuticals SA
Boulevard Patience et Beaujonc N°3/1
4000 Liège, Belgium