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2023
Annual Report
Reinventing
existing medications
This Annual Report 2023 includes the management report inaccordance 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.
Contents
Profile
                                                      4
Key Figures                                                  6
Letter to Shareholders
                                       8
Business Overview                                           11
Environmental, Social, and Governance
                       31
The Hyloris Share
                                           42
Corporate Governance
                                      44
Consolidated Financial Statements
                           84
Glossary and Other Info
                                    155
Hyloris
: Annual Report 2023
p 4
Hyloris: Unlocking Potential
for Underserved Patients
Hyloris is a specialty biopharmaceutical company dedicated to a single purpose:
improving the lives of patients facing unmet medical needs.
We achieve this by focusing on innovative treatments that offer significant added value.
We leverage our expertise and cutting-edge technologies to unlock the hidden potential of existing
pharmaceuticals. By reformulating and repurposing these drugs, we aim to address critical gaps in current
treatment options. This translates to a robust pipeline of proprietary, complex products with the potential to offer
substantial advantages over what’s currently available.
Currently, we have three commercially available products in partnership with other companies. Maxigesic® IV,
a novel dual-mode-of-action non-opioid analgesic, offers relief for post-operative pain. Podofilox gel - the first
generic of Condylox® gel in the U.S. - is an antimycotic drug for the topical treatment of external genital and
perianal warts caused by certain types of the Human Papilloma Virus (HPV). Our third commercial product is
Sotalol IV for the treatment of atrial fibrillation.
To accelerate development and minimize risks, Hyloris utilizes a focused strategy. We primarily rely on
the 505(b)(2) regulatory pathway in the U.S. and similar pathways in other countries. This approach is specifically
designed for pharmaceuticals where safety is already established, allowing us to streamline clinical trials and
significantly expedite the development process. This translates to lower development costs, faster product
launches, and ultimately, quicker access to these innovative treatments for the patients who need them most.
Hyloris employs 41 people
(20 women and 21 men) of 11 nationalities
Profile
Hyloris
: Annual Report 2023
p 5
Specialty biopharma
Adding value and innovation to existing drug assets for core unmet medical needs
Broad Pipeline
With 16 innovative product candidates, 3 marketed products, and 2 high barrier
generics
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)
Hyloris
: Annual Report 2023
p 6
Key Figures
2023
Year ended 31 December
(In € thousands)
2023
2022
1
Revenue
2,087
900
1
Other operating income
2,127
1,487
2
Total Revenue and Other operating income
4,214
2,387
Cost of sales
-93
-94
Research and development expenses
-14,421
-10,272
Selling, general and administrative expenses
-5,546
-3,517
Operating profit/(loss) (EBIT)
-15,993
-11,638
1
Financial result
613
-264
PROFIT/(LOSS) FOR THE PERIOD
-15,380
-11,906
1
Financial Highlights
1
See restatement for the year 2022 and press release dated 14 March 2024 relating to the restatement for additional information on HY-038 and HY-088
2
Reclassification of the withholding tax on R&D salaries (payroll tax rebates)
3
Excludes €10M short-term deposits
€4,2
€30,4
€0
million revenue
& other income
million cash & cash
equivalents
no financial
debt
Cash and cash equivalents
30,406
33,457
3
Hyloris
: Annual Report 2023
p. 7
19
Portfolio
Products*
Podofilox
Gel
(U.S.)
for the treatment of
genital & perianal warts
16
Product
s in
Development*
3
FDA Approved
Products
3
Commercial
Products
*Does not include 2 high barrier generics in development
Sotalol
IV
(U.S.)
for the treatment of
atrial fibrillation
Maxigesic
®
IV
(U.S. & ROW)
for the treatment of
post-operative pain
Hyloris
: Annual Report 2023
p 8
Letter to
Shareholders
Dear Shareholders,
Hyloris has made remarkable advances this past year while navigating the evolving dynamics of the
pharmaceutical industry. I am thrilled to share a comprehensive update with you about them, as
well as our exciting plans for the future.
We remain committed to repurposing and reformulating existing molecules, primarily utilizing the
U.S. FDA’s 505(b)(2) pathway and similar pathways globally. This innovative approach allows us to
bring critically needed products to market significantly faster and at a fraction of the cost of new
chemical entities, all while mitigating risk. Since our initial public offering (IPO) in 2020, we’ve been
intensifying our focus on “repurposing” with reformulated products, solidifying our position as a
unique player in the industry.
2023 was a year of marketing approvals for Hyloris’ products
Maxigesic
®
IV received approval in multiple countries. A significant milestone was achieved
in October with the U.S. FDA approval opening up the largest and most attractive market for
Maxigesic
®
IV globally. The U.S. marketing partner, Hikma Pharmaceuticals launched the product
under the tradename Combogesic
®
IV in February (2024).
The FDA also approved podofilox gel, the first generic ever of Condylox Gel. The approval was
obtained in December 2023 by our partner Padagis. This approval is not only a testament to
our skill in navigating regulatory pathways, but it also positions us at the forefront of providing
patients with cost-effective alternatives.
We also made progress in building our pipeline of innovative products. This year, we added two
innovative 505(b)(2) product candidates to our portfolio, solidifying our commitment to innovation
and addressing unmet medical needs. Notably, we announced the development of a possibly
pioneering treatment for Burning Mouth Syndrome (BMS), a currently underserved area with no
approved pharmaceutical treatment. The product candidate is a co-development with our long-
standing partner AFT Pharmaceuticals from New Zealand. Additionally, we expanded our portfolio
with a product candidate for Hypophosphatemia.
While initially focused solely on the U.S. market, we strategically licensed Atomoxetine oral liquid
in Canada. This liquid formulation offers several advantages, including easier administration,
individual and precise dosing as well as greater flexibility in tailoring treatment plans, ultimately
improving patient adherence and experience. This decision aligns with our commitment to providing
innovative solutions for better patient outcomes.
Despite challenging market conditions, Hyloris remains resilient and committed to keeping our
shareholders informed. We expect to submit several product candidates to the U.S. FDA within
the next 18 months, fueled by the recent positive clinical trial data for our Valacyclovir liquid
Hyloris
: Annual Report 2023
p. 9
formulation. Looking forward, we anticipate a robust year, targeting up to 30 product (candidates) in
development, or on the market. This translates to a significant number of announcements, making
2024 one of our busiest years yet in business development.
This ambitious goal is coupled with a commitment to focus on cost-efficiency. We aim to develop all
new products for an average cost of less than EUR 7 million (non-inflation adjusted) and within
7
years after announcement. This cost-effective approach, combined with our focus on shareholder
value, positions us for sustained growth and profitability. We are confident in our unique position,
holding one of the largest dedicated 505(b)(2) value-added development portfolios and maintaining
such stringent financial requirement.
In the spirit of full transparency, I acknowledge that the recent suspension of the trading of our
company’s shares, may have raised questions and created uncertainty for our investors. This
temporary measure is related to inquiries regarding the Qliniq product transactions about which
we communicated through various press releases. We understand this has caused concerns among
many of you and we apologize for any inconvenience. However, it is our
expectation that this matter will be resolved upon the publication of this
report.
We are committed to upholding the highest standards of corporate
governance and are confident in the integrity of our business
practice. We ensure you that we will work diligently to implement
the measures announced by our Board of Directors to improve
our governance practices in the interest of the Company and all its
stakeholders.
I’m also pleased to announce the appointment of Thomas Jacobsen as
Co-CEO, while we search for a new and independent CEO. Thomas and
I co-founded Hyloris and with our company expecting exciting
growth, I will be focusing more on strategic implementation
to guide us through this expansion. Together with new
and expanded leadership, I am confident we will
navigate this new chapter with continued success.
Your continued support is crucial as we shape the
future of Hyloris. Together, we are driving healthcare
advancements through innovation, patient
dedication, and a commitment to shareholder value.
Sincerely,
Stijn Van Rompay
Hyloris
: Annual Report 2023
p 10
Hyloris
: Annual Report 2023
p 11
Business
Overview
Solid Financial Position
Hyloris’ financial performance in 2023 was positive, with total revenue
and other income growing to €4.2 million. This trend is expected to
continue, with the company forecasting stronger growth in both sales
and gross margin for 2024. This optimism is fueled by the recent launch
of key products like Maxigesic
®
IV and Podofilox gel in the U.S. market,
along with planned global rollouts and additional commercial deals in the
pipeline.
Despite increased investments in research and development (R&D)
leading to higher operating expenses, Hyloris managed to maintain stable
net operating cash outflow compared to 2022. This demonstrates our
commitment to financial discipline while still prioritizing innovation.
Hyloris’ financial health remains robust. The Company boasts a solid
cash position with
€30.4 million and zero financial debt
. This strong
foundation positions Hyloris to capitalize on future growth opportunities.
Hyloris
: Annual Report 2023
p 12
COMMERCIAL PROGRESS
Hyloris saw progress across the
commercial portfolio in 2023.
This is demonstrated by the U.S.
FDA approval and subsequent
launches of Maxigesic® IV
and Podofilox gel, a rise in royalty contributions
from existing commercial partnerships, and strategic
out-licensing agreements for additional products in key
markets.
Maxigesic® IV is a patented, unique combination of
Paracetamol and Ibuprofen for intravenous infusion for
the treatment of post-operative pain and is currently
licensed to partners covering over 100 countries across
the globe. Maxigesic® IV is developed with our partner
AFT Pharmaceuticals.
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.
A marketing authorization was granted by the U.S.
FDA in October 2023. Hikma Pharmaceuticals (Hikma),
a leading supplier of complex injectable hospital
products, has launched the product in the U.S. under
the tradename Combogesic® IV. An exclusive license
and distribution agreement had previously been signed
between Hyloris’ partner AFT and Hikma.
Additional submissions for marketing authorization
were made in 13 countries in the Middle East, Africa,
Latin America, and Asia.
Additional marketing authorizations have been
granted in 8 countries including Poland, South Africa,
and Spain. In early 2024, Health Canada granted
approval bringing the total number of approvals to
50.
Launches occurred in 14 countries including Norway,
Singapore, Belgium, The Netherlands, the Czech
Republic, and Romania. Imminent launches are
expected in several additional countries, bringing
the total number of countries where Maxigesic® IV
will be available up to more than 30.
In December 2023, our partner Padagis US LLC (Padagis)
received marketing authorization for Podofilox gel
0.5% (previously referenced as HY-016) from the FDA.
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).
Padagis launched the product in December 2023. It is
the first generic approved for Condylox® Gel in the U.S.
Sotalol IV is a patented, intravenous formulation of
Sotalol for the treatment of atrial fibrillation, and life-
threatening ventricular arrhythmias developed for the
U.S. Sotalol IV potentially allows to significantly reduce
the length of hospital stay and the overall cost of care
and potentially improve patient outcomes. Hyloris
is taking further steps targeting to increase product
related revenues from the sale of Sotalol in the future
(see also:
Ongoing Legal Proceedings
in the financial
notes
).
Additional out-licensing agreements for Tranexamic
Acid (TXA) RTU – a ready-to-use formulation under
development of an established antifibrinolytic used in
emergency haemorrhaging situations – were made in
2023. These new agreements cover a large European
country and several major Asian countries. In 2023, our
licensing partner for Canada submitted an application
for approval by Health Canada. Additional regulatory
submissions in the partnered territories are in progress,
and more out-licensing agreements are expected going
forward. An Abbreviated New Drug Application (ANDA)
has been submitted to the U.S. FDA.
An out-licensing agreement was signed with Kye
Pharmaceuticals (Kye) in October 2023 for Atomoxetine
Oral Liquid. Kye will exclusively commercialize the
product in Canada where atomoxetine is currently not
available as an oral liquid formulation. The introduction
of an oral liquid formulation in the ADHD (Attention
Deficit Hyperactivity Disorder) medication category has
historically led to significant market share gains . This
suggests a strong potential for Atomoxetine Oral Liquid
in Canada, where an estimated 1.8 million people (or
4-6% of adults and 5-7% of children) are diagnosed with
ADHD . ADHD is a chronic condition, with symptoms
persisting into adulthood for 60-80% of patients.
Under the terms of the agreement, Hyloris will be
eligible to receive attractive sales-related milestone
payments (totaling up to USD 7.5 million), and a
substantial share of the generated revenue.
3
commercial
products
Hyloris
: Annual Report 2023
p 13
EXPANDED PIPELINE
Hyloris strengthened its product portfolio in 2023.
HY-088 was announced in January 2023. This novel, proprietary oral formulation will be
administered to patients with hypophosphatemia – a condition where the blood level of
phosphorus is lower than 2.5mg/dL. Patients can develop hypophosphatemia from either a
genetic abnormality (such as Cushing Syndrome or osteomalacia) or an acquired condition
(like long-term use of diuretics or phosphate binders).
HY-090, a promising new treatment candidate for Burning Mouth Syndrome (BMS) was announced in December
2023. BMS is a chronic condition affecting millions, primarily postmenopausal women, causing a burning, tingling,
or scalding sensation in the mouth for months at a time. While the mouth appears healthy, sufferers may also
experience dry mouth or taste alterations, the exact cause of BMS remains unknown. Studies suggest that 0.7% to
5% of individuals in the U.S. might be affected.
2
additional pipeline
products
HY-091, a novel topical treatment candidate for the management of Vulvar Lichen
Sclerosus (VLS), was announced in January 2024. VLS is a chronic inflammatory
condition affecting an estimated 3% of women, causing severe pain, itching, and
discomfort that significantly impacts their quality of life.
PTX-252, a novel chelating agent, received Orphan Drug Designation from the FDA in
January 2024 for the development of a potential treatment for Acute Myeloid Leukemia
(AML).
Hyloris and Purna Female Healthcare announced positive results from a Phase 2 clinical
trial evaluating a treatment for Acute Vulvovaginal Candidiasis (VVC) in January 2024.
Maxigesic
®
IV was launched in the U.S. and approved in Canada in February 2024.
Hikma Pharmaceuticals will commercialize the product as Combogesic
®
IV in the U.S.
The first patient was enrolled in a phase 3 clinical trial for a novel Tranexamic Acid Oral
Mouth Rinse (previously HY-004) in early 2024.
Maxigesic
®
IV expanded its global reach through licensing agreements in additional
markets, including Brazil.
POST-CLOSING BUSINESS EVENTS
(SEE ADDITIONAL INFORMATION IN NOTES 29)
Hyloris
: Annual Report 2023
p 14
COMMITTED TO ADDRESSING UNMET NEEDS
THROUGH INNOVATION
Strategy & Strengths
Hyloris is a company driven by a mission to improve lives. We focus on underserved medical needs
and aim to bring added value to the healthcare system through innovative reformulations and
repurposing of existing pharmaceuticals. Our goal is to change therapy outcomes for the better,
ultimately improving the lives of patients worldwide.
We’ve built a substantial portfolio of proprietary reformulated and repurposed product candidates.
This achievement is a result of our expertise and commitment to technological advancements.
Since our founding, we’ve strategically shifted our focus and now concentrate on complex,
reformulated, and repurposed products with patents. This strategic shift positions us further up the
value chain within the pharmaceutical industry.
Our development strategy hinges on a streamlined approach. We primarily utilize the 505(b)
(2) regulatory pathway in the U.S. and similar pathways in other countries. These pathways are
specifically designed for pharmaceuticals where safety and efficacy (in some instances) are already
established. This targeted approach significantly reduces the clinical development burden required
to bring a product to market. As a result, we can shorten development timelines, minimize costs,
and mitigate risks associated with bringing new drugs to market.
To achieve our ambitious goals, we maintain continuous dialogue with key stakeholders. This
includes healthcare professionals, patient groups, payers, universities, and potential corporate
partners. Additionally, we leverage our extensive sourcing network and robust R&D capabilities to
fuel our innovation engine.
We focus on value-added medicines —
pharma’s sweet spot
Hyloris
: Annual Report 2023
p 15
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, 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
Average development cost €7 million or less*
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 which
might include early stage product candidates.
This
will solidify our position as a leader in the development
of 505(b)(2) products.
Reduced Risks and Costs
: Development risks and costs associated
with reformulating existing drugs are substantially lower.
Lower Formulation Risk
: Developing new formulations of
well-documented drugs minimizes potential formulation issues.
Lower Clinical and Regulatory Risk
: Reformulating approved
drugs typically requires fewer studies, leading to a higher probabili-
ty of success and faster regulatory approval.
Shorter Timelines
: Development timelines are significantly short
-
er, averaging five years compared to eight to fifteen years for new
chemical entities (NCEs).
Lower Costs
: Development costs are expected to average €7 mil
-
lion per product*.
Lower Commercial Risk
: Since these products reference
established drugs, there is greater user awareness among
physicians and payers. We will leverage this awareness by demon-
strating the added value our products bring to the market.
Competitive Advantage
: While the chemical entity of 505(b)
(2) products typically cannot be patented, we file other patents
(formulation, process, method of use) to protect our products from
generic competition.
ADVANTAGES OF THE 505(B)2 PATHWAY
*Not adjusted for inflation
Hyloris
: Annual Report 2023
p 16
PROTECTING INNOVATION AND BUILDING
EXPERTISE
For all our 505(b)(2) candidates, we have a long-term
strategy to file and protect intellectual property
(IP) to maximize their commercial lifespan. Our
diverse patent portfolio provides broad protection,
encompassing dosages, formulations, medical
indications, and production methods.
TAILORED GO-TO-MARKET STRATEGIES
Our go-to-market strategy is flexible and adapts
to each product’s needs. In the U.S., for our
cardiovascular portfolio, we currently plan to leverage
a lean sales force to target specific sub-segments
such as electrophysiologists. This approach is cost-
effective given the high number of cardiologists
employed by hospitals. We will also consider potential
commercialization opportunities outside the U.S.
For existing products like Sotalol IV and Maxigesic®
IV, we maintain commercial partnerships with
AltaThera and AFT Pharmaceuticals for marketing,
sales, and distribution, respectively. Hyloris aims to
have most products in the Value Added portfolio
commercialized through regional marketing experts.
GENERATING REVENUE STREAMS FOR
SUSTAINABLE GROWTH
Sales from our current commercial products,
Maxigesic® IV, Podofilox gel, and Sotalol IV, will be
the primary drivers of short-term revenue growth. For
future products, we expect to out-license the majority
at a late stage of development. This strategy priori-
tizes product sales over upfront milestone payments
and allows us to retain a significant share of the net
product margin from our commercial partners.
Hyloris
: Annual Report 2023
p. 17
LOOKING AHEAD
Expectations for the next 15 months
Commercial
The Company is actively accelerating the growth of its product pipeline, aiming to reach 30 products by 2025.
The Business Development team will continue to actively seek out and evaluate products from multiple sources
(including early staged product candidates). They will also continue to find commercial partners for our late-stage
portfolio products.
Maxigesic
®
IV – We expect to see adoption in the U.S. market as Hikma recently started to promote the product.
Outside of the U.S. we anticipate additional marketing authorizations in the countries where submissions were
made followed by commercial launches.
R&D
With 16 reformulated and repurposed product candidates, and 2 high-barrier generics, several clinical trials are
expected to start and/or finish within 2024, including product candidates.
HY-074, a PK bridging study is estimated to start at the end of 2024
Dofetilide, results from pivotal clinical study are expected before end of 2024
Tranexamic Acid Oral Mouth Rinse, LPLV of the Phase 3 trial started in November 2023 is expected by year-
end with study results anticipated in H1 2025
Alenura™, a pivotal Phase 2 clinical trial comparing the effectiveness of Alenura™ against its individual
components and a placebo is expected to be completed (LPLV) in H1 2025
The company is also expecting several regulatory achievements in the next 15 months.
Hyloris
: Annual Report 2023
p 18
COMMERCIAL PORTFOLIO
MAXIGESIC
®
IV:
U.S. FDA APPROVED
FOR THE TREAT-
MENT OF POST-OPERATIVE PAIN
2023 H
ighlight: The U.S. FDA approved Maxigesic® IV for commercialization in the U.S. Hikma
Pharmaceuticals launched the product 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
1,2
.
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.
1
Coley K et al. J Clin Anesth. 2002
2
Wonuk Koh et al, Korean J Anesthesiol. 2015
Hyloris
: Annual Report 2023
p. 19
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 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)
1
.
Furthermore,
an additional exposure study has confirmed the
efficacy and safety of Maxigesic
®
IV in a broader patient
population over a longer treatment period
2
.
1
Daniels et al, 2019, Clinical Therapeutics
2
Maxigesic® IV Phase 3 exposure study. Study ID No AFT-MXIV-11.
NCT04005755. Submitted for publication
8
New
Marketing
Authorizations
13
Marketing
Applications
14
commercial
launches
MAXIGESIC
®
IV
2023 NUMBERS
Hyloris
: Annual Report 2023
p 20
COMMERCIAL PORTFOLIO
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
Atrial fibrillation
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.
Hyloris
: Annual Report 2023
p 21
Hyloris
: Annual Report 2023
p 22
DEVELOPMENT PORTFOLIO
Cardiovascular
Our cardiovascular development portfolio currently contains 6 product candidates at varying
stages of development. For the majority of the porfolio, we intend to commercialize the products
in the U.S. by ourselves. We plan to build a lean efficient commercial organization that focuses on
cardiology specialists in specialty care centers and hospitals.
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 after symptoms arise. However, clinical
research has shown that oral aspirin takes between
20 and 40 minutes to take effect and the amount of
aspirin absorbed is highly variable; often only half of the
administered dose is absorbed.
Potential Solution
Intravenous formulation of aspirin for faster onset of
action and decrease inter/intra-patient variability of
amount of aspirin absorbed.
Intellectual Property
’38, granted and pending applications.
Target Population
Every year about 850,000 in the U.S. experience a heart
attack
1
.
MILRINONE ER
Indication
The treatment of right heart failure due to Left
Ventricular Device (LVAD).
Unmet Need
Milrinone is currently only available as an intravenous
solution for continuous infusion. Patients must travel to
an infusion clinic where they are monitored closely
for
any significant adverse reactions. Their dose is adjusted
based on hemodynamic responses. IV milrinone is
currently limited to a 48-hour time period.
Potential Solution
An extended release oral solid formulation of milrinone
to allow for long term at-home use.
1
Tsao et al. Heart Disease and Stroke Statistics—2023 Update:
A Report From the American Heart Association. Circulation.
2023;147:e93–e621
Hyloris
: Annual Report 2023
p 23
Special Regulatory Designation
Orphan Drug Designation
Target Population
In 2020, there were about 20,000 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.
DOFETILIDE IV
Indication
A trial fibrillation.
Unmet Need
Patients that are unable to take an oral medication or
that require faster onset.
Potential Solution
An intravenous product administered in hospital setting
providing similar exposure as that of the approved oral
product.
Intellectual Property
‘39, 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.
Intellectual Property
Application filed.
Target Population
Every year about 1.6 million people in the U.S.
experience a heart attack or stroke
1
.
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
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
Granted & pending applications.
Target Population
Around 870,000 new cases par year in the U.S. and
8 million people in the U.S. expected to suffer from
CHF by 2030. By 2030, the total cost of heart failure is
forecasted to reach $69.8 billion.
Hyloris
: Annual Report 2023
p 24
HY-075 IV
Indication
Prevention and treatment of specific cardiovascular
diseases.
Unmet Need
The currently approved oral solid requires frequent
dosing changes and adjustments. The product is only
available in fixed-dose scored tablets that may have to
be cut.
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.
Hyloris
: Annual Report 2023
p 25
DEVELOPMENT PORTFOLIO
Other Value-Added
Our portfolio of other value-added products currently contains 10 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.
Unmet Need
Patients on blood thinners can experience significant
bleeding during dental procedures.
Potential Solution
A reformulated oral rinse developed for use in minor
surgical procedures with complications/bleedings to
used by dental care professionals for patients on anti-
coagulant therapies.
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.
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 relieve and
potentially aid in the regeneration of the bladder lining.
The product is being co-developed with Vaneltix.
Hyloris
: Annual Report 2023
p 26
Intellectual Property
‘28-’38; granted.
MICONAZOLE/DOMIPHEN BROMIDE CREAM
Indication
Treatment of recurrent vulvovaginal candidiasis (rVVC).
Unmet Need
rVVC is a chronic and debilitating vaginal infection
commonly caused by Candida albicans. Current
treatments include topical and systemic anti-fungals.
These products limited efficacy and severe side effects
when used chronically.
Potential Solution
A topical cream combination product containing
Miconazole (MCZ), a current standard antimycotic
treatment, and Domiphen Bromide (DB), a well-known
anti-septic currently used in some cough medicines.
We are co-developing the product with Purna Female
Healthcare.
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 have
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 aimed at decreasing elevated
blood levels of toxic metals. We are co-developing this
product with Pleco Therapeutics.
Hyloris
: Annual Report 2023
p. 27
Intellectual Property
Pending application.
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. Straterra® (atomoxetine
HCl) is the leading nonstimulant medication for ADHD
1
.
However, dosing for children and adolescents less
than 70 kg (154) lbs is weight-based and can be difficult
to titrate. Too small of a dose and the desired effect
may not occur. Too large of a dose and patients can
experience side effects ranging from dry mouth to
blurred vision. Atomoxetine is also notoriously bitter
tasting.
Potential Solution
A taste-masked oral solution of atomoxetine for precise
dosing and titration as well as palatability.
Intellectual Property
‘36-’43; 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
1
2022 IMS Sales Data
obstruction, rhinorrhoea (colloquially: a runny nose),
and/or sneezing. Approximately 19 million people in
the US and 25.8 million in Europe are affected with
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
septal corrections and/or inferior turbinate reductions.
Potential Solution
A proprietary formulation of a molecule with a well-
known mechanism of action 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 to replace compounded drugs which
have, by definition, not been submitted for regulatory
scrutiny regarding safety, efficacy, and quality.
Intellectual Property
Confidential.
Hyloris
: Annual Report 2023
p 28
HY-090
Indication
Treatment of Burning Mouth Syndrome (BMS).
Unmet Need
Burning mouth syndrome (BMS) is characterized by
burning pain in a normal-appearing 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 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 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 be affected. Advanced
condition severely affects the quality of life and is
associated with increases risk of vulvar squamous cell
carcinoma. It is a massively 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 the 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.
Outside our core strategic focus, we have 2 high barrier
generic products in development:
Fusidic Acid Cream
, a generic of an off-patent reference product
currently sold in Canada without generic competition
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 UK, Switerland, one major Asian
country, Canada, Australia and New Zealand.
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: Annual Report 2023
p. 29
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Environmental,
Social,
and Governance
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: Annual Report 2023
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Introduction
ESG (Environmental, Social, and Governance) is becoming increasingly
important for the pharmaceutical industry.
While developing life-saving
drugs is a social good, there’s a growing focus on how pharma companies
operate sustainably across a range of areas.
Environmental considerations
include reducing waste and emissions from manufacturing, while socially,
fair labor practices, access to medication, and responsible drug pricing
are crucial.
Strong governance ensures transparency and minimizes risks
like fraud or corruption. By prioritizing ESG, Hyloris can build trust with
our investors, development partners, and the public, all while ensuring a
sustainable and responsible approach to healthcare.
In 2023 Hyloris focused on its commitment towards the sustainability goals
it set in 2022. When defining these goals, the Company utilized the United
Nations Agenda for Sustainable Development (UNSD). This framework
contains 17 global goals for achievement by 2030. Under those goals
are 167 different targets each with their own set of metrics. Companies
can choose which of these goals and targets most closely align with their
priorities.
Hyloris
: Annual Report 2023
p 33
Review of Selected UNSD
Goals & Targets
Hyloris considered both our core mission and measurable targets when defining the
appropriate goals for its ESG strategy in 2022. The goals and targets we chose were
organized into 3 separate imperatives.
I
II
III
Commitment to the Good Health and Well-Being
of Society
Commitment to Environmental Sustainability
Commitment to Responsible Leadership
Hyloris
: Annual Report 2023
p 34
I
Commitment to the Good Health and Well-Being of Society
Access to safe, effective, quality, and affordable essential
medicines
Hyloris focuses on innovation through reformulation and repurposing existing,
approved medications. This approach tackles unmet medical needs in areas like
cardiovascular disease, the world’s largest therapeutic area. We currently have 18
value-added medicines in the portfolio, with two already commercially available.
Outside of our core portfolio, we also have in the portfolio the first commercially available Podofilox
Gel in the U.S. ensuring patients suffering from anogenital warts have access to affordable treatment.
By leveraging proven safety profiles, our strategy significantly reduces development time and cost,
potentially leading to more affordable treatments for patients and healthcare systems. Ultimately,
Hyloris aims to develop over 30 products.
Part of the Solution to the Opioid Crisis
The fight against drug abuse is taking a health-centered approach, as outlined by the UN’s Sustainable
Development Agenda. This is crucial considering the devastating impact of opioids, highlighted by the
World Health Organization (WHO). According to the WHO, drug abuse claims over half a million lives
annually, with opioids responsible for a staggering 70% of these deaths. Their report further reveals a
concerning rise in opioid overdoses, partly linked to the increased use of these drugs for post-operative
pain, chronic pain management, and the emergence of highly potent illicit opioids.
Our commercially available product Maxigesic® IV is a novel non-opioid analgesic for the treatment
of post-operative pain. In 2023 Maxigesic® IV was approved in the U.S. which has more than double
opioid-related deaths than other countries. The product is now approved in over 50 countries with plans
for additional marketing authorization submissions – including most developing nations.
A Portfolio Focused on the Leading Cause of Death
Cardiovascular diseases (CVDs) are a global health crisis, claiming millions of lives each year.
According
to the World Health Organization (WHO), CVDs were responsible for a staggering 17.9 million deaths
in 2019, representing over a third of all global deaths. Heart attacks and strokes make up a significant
portion of these fatalities, accounting for 85 percent. Recognizing this critical public health issue, Hyloris
dedicates a third of our product development pipeline to addressing cardiovascular diseases.
Our first commercial product, Sotalol IV for atrial fibrillation, prioritizes both patient safety and
cost-effectiveness. By significantly reducing hospital stays, particularly relevant in the US market with
its high overnight costs, Sotalol IV can dramatically lower the overall burden of care. This translates to
improved patient outcomes while minimizing healthcare system expenses.
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: Annual Report 2023
p 35
Location of Headquarters and Lab
Our headquarters are located in LégiaPark in Liege. LégiaPark is a top-rated green
building – a BREEAM-certified facility with an “Excellent” performance rating. BREEAM
(Building Research Establishment Environmental Assessment Method), the world’s
leading standard for sustainable buildings, recognizes this space as not only eco-
friendly but also designed for employee comfort and well-being. In 2023 we also relocated our R&D
laboratory facility to this complex.
Raising the Bar for Our Suppliers
Hyloris prioritizes responsible sourcing practices when selecting partners for drug development and
manufacturing. Our selection process goes beyond traditional metrics like product quality and supplier
capabilities. We also evaluate a partner’s environmental, social, and governance (ESG) practices to
ensure alignment with our commitment to sustainability.
Leading the Push for Electric Vehicles
Hyloris is proactively transitioning the company car fleet ahead of Belgian legal deadlines.
The
Company has significantly reduced combustible engine vehicles from our pre-approved leasing options
thereby doing its part to lower emissions. In their place, Hyloris has introduced a wide selection of plug-
in hybrid (PHEV) and battery electric vehicles (BEV), actively promoting the switch to electric cars.
II
Commitment to Environmental Sustainability
Hyloris is actively combating the environmental challenges of biodiversity
loss, pollution, and climate change through specific initiatives
Hyloris
: Annual Report 2023
p 36
A Virtual, Flexible Workspace
Hyloris fosters a collaborative global environment with a hybrid work model combining
in-office and remote-work. Our geographically diverse teams leverage virtual meetings
as the standard, with over 90% of recurring meetings held online. This reduces
commuting and fosters a flexible work-life balance for our employees with a minimum
2-day on site in the office. To further minimize travel burdens, Hyloris provides hotel
accommodations for colleagues needing to bridge in-person workdays.
Key Values, Accountability, and Leadership Culture
In 2023 Hyloris included four key values into employees’ annual review procedure:
Passion and drive
Entrepreneurship
Professional excellence
Integrity and accountability
The HR team continued to formalize the employee performance review process over 2023. Included in
this was incorporating empowerment and coaching to our colleagues in leadership positions.
Dedication to Workplace Safety
The company is committed to providing a safe and healthy workplace for all employees. Our HR team
has enacted a 5-year plan that encompasses several key areas:
Establishing clear processes, procedures, documentation, and registrations to promote the
general welfare of our employees;
Prioritizing work safety and ergonomics by providing safety trainings (fire response, first aid, etc)
and optimizing the physical environment;
Promote the physical and mental well-being of our employees by offering resources such as
regular medical checkups for lab personnel and dedicated maternity policies.
III
Commitment to Responsible Leadership
“At Hyloris, employee well-being isn’t a perk, it’s a priority. We believe a healthy,
safe, and supportive work environment fuels success for both individuals and the
company. Our flexible, location-independent work model reflects this commitment.
Looking ahead, we’re actively developing even more benefits to help our team
manage stress, achieve work-life balance, and thrive in their careers and in their
personal lives.”
Peter Mertens, HR Director
Hyloris
: Annual Report 2023
p. 37
Respect for Global Expertise
At Hyloris we believe in “looking for expertise where it
is available”. Our workforce can be found in 11 different
countries spanning 3 continents – Europe, North America, and
Asia.
Pursuit of Gender Equality
Hyloris is actively working to enhance diversity at all levels,
with a particular focus on increasing female representation
on our Board of Directors. Currently, we have one female
Director, and ongoing efforts are underway to attract more
women with valuable experience to contribute to our highest
decision-making body.
While our overall company gender balance is currently at
48% women and 52% men
, we remain
committed to achieving greater diversity in leadership positions. This includes the VP, director,
and manager levels, which currently reflect the global gender ratio.
Looking ahead, we aim to maintain a balanced workforce while actively seeking opportunities to
build a more diverse team across all levels, including leadership.
Hyloris employs 41 people of
11 different nationalities:
American
Austrian
Belgian
Danish
French
Greek
Indian
Portuguese
Slovenian
Spanish
Swiss
48%
52%
Ethical Business Practices
Hyloris prioritizes ethical behavior in all interactions, from customer and supplier relationships to
internal company culture. This commitment is reflected in our comprehensive ethical guidelines,
which all employees are required to follow. These core principles address essential areas like
personal conduct, conflict of interest, confidentiality, influence, and competition.
Hyloris
: Annual Report 2023
p 38
Furthermore, Hyloris has established a dedicated “Dealing Code” to ensure compliance with
market regulations. This code specifically addresses market abuse practices such as insider
trading, information disclosure violations, and market manipulation. It also outlines guidelines for
financial transactions by those with managerial responsibilities and their associates.
By implementing these clear standards, Hyloris fosters a culture of integrity and transparency
throughout the organization.
Checks & Balances in Place at the Highest Level
Hyloris adheres to the high standards of corporate governance expected of a publicly traded
company in Belgium. Our Board of Directors reflects this commitment, with four out of eight
members classified as Independent Directors in 2023.
Further strengthening transparency and
accountability, the Remuneration Committee is comprised solely of Non-Executive Directors, with a
majority being independent (See
note 29
).
Less Animal Testing
By leveraging the 505(b)(2) development pathway, Hyloris can
potentially reduce the need for extensive early-stage research
compared to traditional 505(b)(1) approaches for new drugs. This
allows us to focus our efforts on developing valuable medicines while
potentially minimizing the use of animal testing. We remain committed
to exploring alternative testing methods wherever possible.
Ethical Business Practices Continued...
Hyloris
: Annual Report 2023
p. 39
In 2022 Hyloris outlined four performance indicators to
track its medium-term progress towards sustainability.
In 2023 we took action to meet or exceed those targets.
At least one third of the members
of our Board must be of another
gender than the other members by
2026
Indicator
Actively sought women candidates
2023 Action
Increased focus on sustainability
factors in the selection procedure
for suppliers
Indicator
Increased focus on sustainability
factors in the selection procedure for
suppliers
Started a vendor database to track
approved vendors
2023 Action
Maintaining or improving diversity of
workforce with different nationalities
and cultural backgrounds
Indicator
Maintained the same number of
nationalities (11) from 2022 to
2023
2023 Action
Maintaining or improving gender
equality across all levels of the team
Indicator
Increased the percentage of
women in the company from
40% in 2022 to 48% in 2023
2023 Action
Hyloris
: Annual Report 2023
p 40
While we remain committed to the goals we set in 2022, we strive to create as sustainable a
business as possible and mitigate risk where we can. To that end, we plan to engage in 2024
a 3rd party consulting firm that specializes in ESG strategy and reporting.
We will partner
with them on a 3-stage project that critically examines all aspects of Hyloris’ business. The
project is expected to begin in H1 2024
.
Looking Ahead
Phase 2
Double Materiality A
A
double materiality asse
used by companies to dete
sustainability topics are mo
on. It takes into account tw
Impact Materiality
: This p
environmental and social i
operations. Essentially, it a
company’s business impac
This could include emission
labor practices, and comm
Financial Materiality
: Thi
on how sustainability issue
company’s financial perfor
do environmental and soci
company’s bottom line? Th
associated with climate cha
changes in consumer prefe
Our partner will evaluate H
internal and external persp
engaging with key stakeho
outside (wherever possible
allow them to prioritize ESG
business.
Phase 1
Gap Analysis
Our ESG partner will conduct a review of our current
plan to include:
Defining our specific sustainability goals;
Evaluating our current performance across
the various metrics relevant to our goals;
Identifying the gaps between our current
practices and our desired practices to show
where improvement is needed.
This work will produce a non-misleading score of
Hyloris’ current ESG performance.
Hyloris
: Annual Report 2023
p 41
Assessment
essment
is a framework
ermine which
ost important to report
wo key perspectives:
perspective considers the
impacts of a company’s
asks: How does the
ct people and the planet?
ns, waste generation,
munity engagement.
is perspective focuses
es can affect a
rmance. It asks: How
ial factors affect the
his could consider risks
ange, resource scarcity, or
erences.
Hyloris from both an
pective by actively
olders both inside and
e) the company. This will
G themes specific to our
Phase 3
Information Requirements & Reporting
Without the proper data capturing procedures, it
would be difficult to track and report our progress
towards the identified ESG goals. Our partner will
identify which sustainability disclosures Hyloris is
required to publish in the future along with which
data is needed to be able to do so. They will also
provide guidance on how to review our existing data
and document processes.
Hyloris
: Annual Report 2023
p 42
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
BREAKDOWN OF SHARE CAPITAL
Stijn Van Rompay
(Founder & CEO)
27.65%
Thomas Jacobsen
(Founder & CBDO)
13.78%
Scorpiaux BV
6.17%
Nick Reunbrouck
5.75%
Peter Van Rompay
3.27%
Other Holders
43.38%
Total number of outstanding voting rights (denominator)
28,000,374
Total number of securities carrying voting rights not yet issued
627,271
Share capital (excluding premium)
€140,001
Based on transparency notifications and latest denominator
Based on online notification (FSMA website) of managers’ transactions
Hyloris
: Annual Report 2023
p 43
PERFORMANCE TO DATE OF HYLORIS VERSUS BEL20 AND
NEXT BIOTECH SINCE IPO
Hyloris
Bel20
NEXT BIOTECH
Bank
Analyst
Rating
Van Lanschot Kempen
Suzanne van Voorthuizen
Buy
KBC Securities
Jacob Mekhael
Accumulate
Kepler Chevreux
Christophe Dombu
Buy
Degroof Petercam
David Seynnaeve
Buy
Berenberg
Beatrice Allen
1
Buy
1
Beatrice Allen is no longer with Berenberg but Hyloris is still covered
ANALYST COVERAGE
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 2023
p 44
Corporate
Governance
Contents
Introduction
                                   46
Compliance with the Corporate Governance Code
  46
Board of Directors
                              48
Executive Committee
                           60
Remuneration Report                            62
Appraisals
                                     
72
Internal Control and Risk Management Systems
   
73
Market Abuse Regulations
                       
76
Conflicts of Interest and Related Parties
           
76
Share Capital, Shares and Shareholders
           
78
Hyloris
: Annual Report 2023
p 45
Hyloris
: Annual Report 2023
p 46
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 July
31, 2020.
The Corporate Governance Charter and Articles of
Association can be consulted on the website of Hyloris
at:
https://hyloris.com/our-governance
COMPLIANCE WITH THE
CORPORATE GOVERNANCE
CODE
As a Belgian listed company, we are subject to the 2020
Belgian Code on Corporate Governance (the Corporate
Governance Code 2020). A copy of the Corporate
Governance Code 2020 can be found
here
or on the
Corporate Governance Committee’s
website
.
Companies are required to state the extent to which
they comply with the principles and best practice
provisions of the Corporate Governance Code 2020 in
their annual report and, where they do not comply with
them, why and to what extent they deviate from them.
Hyloris will apply the corporate governance principles
outlined in the Corporate Governance Code 2020,
which is reflected in a charter that complies with the
best practice provisions as stated in the Corporate
Governance Code 2020 (the Corporate Governance
Charter). 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 and Articles of
Association are available on our website.
Accordingly, this section of the annual report provides
more factual information on the Corporate Governance
policy pursued in the financial year 2023, with the aim
of applying the principles resulting from this Charter as
much as possible without affecting the unique character
of the Company.
Hyloris acknowledges the importance of good corporate
governance, and we fully endorse the underlying
principles of the Corporate Governance Code 2020,
in accordance with a ‘comply or explain’ approach,
pursuant to Article 3:6, §2, 1° CCA and the Royal Decree
of May 12, 2019 that specifies the corporate governance
code to be complied with by listed companies.
Hyloris
: Annual Report 2023
p. 47
Hyloris deviates from the best practice provisions in the areas set out below, for the reasons explained in this
section. These deviations mostly relate to our remuneration practices, which are in line with our remuneration
policy as approved by our annual general meeting of shareholders held in 2022. The Board of Directors is of the
opinion that these deviations from the provisions of the Corporate Governance Code 2020 are justified, in view of
our activities, our size and the specific circumstances in which we operate.
Provision 2.19
: the powers of the members of the
Executive Management other than the CEO are
determined by the CEO rather than by the Board
of Directors as the members of the Executive
Management perform their functions under the
leadership of the CEO, 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. 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
ESOP warrants (allocated prior to the IPO), 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
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 in any event
continue to safeguard that the contributions of
the Non-Executive Directors are made with the
company’s interest in the long term 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, i.a. through the implementation of a
long-term variable remuneration
. 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
Warrants Plans
).
Provision 7.10
: the Board believes that there is no
need to formally define a maximum for the variable
short-term remuneration for Executive Committee
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 2023, the variable remuneration
for all members of the Executive Committee
is maximum 17% of the 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.
What constitutes good corporate governance will evolve with the changing circumstances of the company
and with the standards of corporate governance globally and must be tailored to meet those changing
circumstances. The Board of Directors intends to update the Corporate Governance Charter as required
to reflect changes to the Company’s corporate governance.
Hyloris
: Annual Report 2023
p 48
BOARD OF DIRECTORS
COMPOSITION OF THE BOARD OF DIRECTORS
The Board of Directors consists of eight members, two of whom are Executive Directors (as members of the
Executive Committee) and six of whom are Non-Executive Directors, including three Independent Directors.
The Company’s Board currently counts one female Director. Hyloris is actively looking for new Non-Executive
Directors to meet the gender diversity requirements and to attract female Board Members in accordance with
Article 3:6 § 2, 6° of the Belgian Companies Code (and with the law of 28 July 2011) to assure that the appropriate
quorum and gender diversity will be reached by 2026 (i.e. first day of the sixth year after Initial Public Offering).
The intention of the Company is to reduce the number of Board Members to a total of seven, whereby at least 2
Non-Executive Directors would be female directors, meaning that only one additional (new) female Non-Executive
Directors should be appointed before 2026. Hyloris is comfortable that this requirement will be met. In the future,
the Company will continue taking gender diversity into consideration when renewing the members of its Board of
Directors and when filling new positions.
However, Hyloris relies on a relatively small team with a flat structure, so it is appropriate to consider diversity
across the entire group where there is a great diversity in terms of gender, nationality, age, seniority, and
educational background.
The table below gives an overview of the members of the Company’s Board of Directors and their terms as of the
date of this annual report:
Name
1
Age
Position
Start of Term
End of Term
Mr. Stefan Yee
62
Non-Executive Director
Chairman of the Board
2020
2024
Mr. Stijn Van Rompay
2
48
Executive Director
2020
2024
Mr. Thomas Jacobsen
3
49
Executive Director
2020
2024
Mr. Leon Van Rompay
4
74
Non-Executive Director
2020
2024
Mr. Marc Foidart
5
48
Independent Director
2020
2024
Dr. Carolyn Myers
65
Non-Executive Director (see
note 29
)
2020
2024
Mr. James Gale
75
Independent Director
2020
2024
Mr Chris Buyse
6
60
Independent Director
2021
2025
1
When a director is subsequently mentioned by name it will be assumed they are acting through their associated management company.
2
Acting through SVR Management BV
3
Acting through Jacobsen Management BV
4
Acting through Van Rompay Management BV
5
Acting through Noshaq Partners SCR BV
6
Acting through Pienter Jan BV
Hyloris
: Annual Report 2023
p. 49
Stefan Yee - Chairman of the Board, Non-Executive Director
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
Degrees 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 - Executive Director
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.
Thomas Jacobsen - Executive Director
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.
Hyloris
: Annual Report 2023
p 50
Leon Van Rompay - Non- Executive Director
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 is the former CEO of the Belgian women’s
health company, Mithra, a Euronext listed company.
Marc Froidart - Independent Director
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).of Antwerp.
James Gale - Independent Director
James (Jim) Gale is the founding partner of Signet Healthcare Partners. Jim has over
30 years of healthcare investing and finance experience. Jim is Managing Director of
Signet Healthcare Fund and is currently the Chairman of the Board of Bionpharma Inc,
is lead director of Knight Therapeutics Inc. (TSX: GUD) and also serves on the Board of
Directors of Ascendia Pharmaceuticals, Chr. Olesen Synthesis A/S, Juno Pharmaceutical Corp., Pharmaceutics
International (Pii), Lee’s Pharmaceutical Holdings (HKX:0950HK), and Pharma Nobis LLC. Prior portfolio
company boards include Arbor Pharmaceuticals, Amarin Corporation, eResearch Technologies Inc., and
Valera Pharmaceuticals. Prior to founding Signet, Jim was head of principal investment activities and head of
investment banking for Gruntal & Co., LLC. While at Gruntal, he made several investments including Andrx
Corporation, Royce Laboratories (merged with Watson Pharmaceuticals), Lifecell Corporation, Neurocrine
Biosciences, and BML Pharmaceuticals (acquired by Endo Pharmaceuticals).
Hyloris
: Annual Report 2023
p 51
Carolyn Myers - Non-Executive Director
- see note 29
Dr. Carolyn Myers is an accomplished senior executive with extensive experience
creating, growing, and leading health care businesses. She is currently CEO of FendX
Technologies Inc. (CSE:FNDX), a nanotechnology company developing products using a unique pathogen
repelling technology to reduce pathogen spread and infection. Carolyn is also a Principal of Bioensemble Ltd,
a business strategy consulting firm that provides a comprehensive range of drug development, commercial
and business development services to small and mid-size pharma. Carolyn currently serves as a board
member of EyeD Pharma SA and FendX Technologies (CSE:FNDX) and is a recently retired board member of
Mayne Pharma (ASX:MYX). Prior roles at Allergan (acquired by AbbVie) include Vice President of International
Business Development and Alliance Management and Vice President of CNS marketing. Prior to Allergan, she
held leadership positions at Mylan (now Viatris Pharmaceuticals) including President of Dey Laboratories and
President of Mylan Technologies. Carolyn earned a PhD in Genetics from the University of British Columbia
and an MBA from Rutgers University.
Chris Buyse - Independent Director
Chris Buyse is Managing Partner of the Belgian company Fund+ NV which he co-
founded in 2015. Fund+ is an open-end fund that invests in innovative life sciences
companies primarily active in therapeutics, as well as companies developing diagnostics
and medical devices.
He has more than 30 years of experience in international company finance and in running and establishing
best financial practice. He was previously CFO of ThromboGenics NV (currently Oxurion), CropDesign and
Keyware Technologies and he held several financial positions at Suez Lyonnaise des Eaux and Unilever. He
is currently serving as an independent Board Member of a few companies, mostly active in life sciences such
as Inventiva Pharma and IPA LTD. He is also member of the board of the Francqui Foundation (Brussels) and
trustee of the Louis-Jeantet Foundation (Geneva).
Hyloris
: Annual Report 2023
p 52
ACTIVITY REPORT
In 2023, in addition to discussing the financial reporting and the operational development of the Company,
the Board of Directors devoted a great deal of attention to product development and business development,
considering further expansion of the Company’s growth and strategy. The Board of Directors also closely monitored
the evolution of cash requirements of the Company and discussed at various occasions the possible remedies to be
implemented to meet these requirements.
The Executive and Non-Executive Members of the Board of Directors convened four times in 2023. All Directors
attended all Board Meetings, except for Mr. Leon Van Rompay, Mr. Chris Buyse and Mr. Marc Foidart, who were
excused once, and Mr. James Gale, who was excused two times.
Name
Attendance
Rate
Stefan Yee
Chairman
100%
Stijn Van Rompay
Executive Director
100%
Thomas Jacobsen
Executive Director
100%
Leon Van Rompay
75%
Marc Foidart
75%
Carolyn Myers
100%
James Gale
50%
Chris Buyse
75%
In 2023 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.
THE REAPPOINTMENT OF DIRECTORS
The Board of Directors will propose to the next General Shareholders’ Meeting to (re)-appoint new Directors to
replace those Directors whose mandates will terminate after the General Shareholders’ Meeting approving the 2023
financial statements, in accordance with applicable law and Corporate Governance regulations.
Hyloris
: Annual Report 2023
p 53
COMMITTEES OF THE BOARD OF DIRECTORS
The Board had already established two Board Committees: the Audit Committee and the Remuneration and
Nomination Committee.
At its meeting of February 28, 2024, the Board of Directors decided to install a new “Product Selection Committee”.
Currently, no Scientific Committee has been formally established within the Company.
BOARD OF
DIRECTORS
AUDIT
REMUNERATION
&
NOMINATION
PRODUCT
SELECTION
EXECUTIVE COMMITTEE
Hyloris
: Annual Report 2023
p 54
AUDIT COMMITTEE
Composition
The Audit Committee is a subcommittee of the
Board of Directors, composed of Board Members.
The Audit Committee’s authority is defined by law
and the Corporate Governance Code, with the Board
of Directors having the power to grant additional
responsibilities. It provides comprehensive support
to the Board of Directors, enabling them to fulfill their
monitoring responsibilities across all areas, including
risk management.
The Audit Committee is comprised of the following
members:
Mr. Marc Foidart
,
Independent Director, Chairperson of the Audit
committee
Mr. Stefan Yee
,
Non-Executive Director
Mr. James Gale
,
Independent Director
Mr Chris Buyse
,
Independent Director
The Audit Committee is composed of at least three
(3) Non-Executive Directors, and at least one-third
of independent directors. Members of the Audit
Committee have collective competence in the company’s
field of activities. At least one member of the Audit
Committee has the necessary competence in accounting
and auditing. The Chairman of the Board of Directors
proposes to the Board of Directors the names of the
candidates for membership of the Audit Committee.
The Chairman of the Audit Committee is chosen from
among its members by the Board of Directors. The
Chairman of the Board of Directors cannot chair the
Audit Committee.
The members of the Audit Committee have full access
to the Executive Committee and to any other employee
to whom they may require access to carry out their
responsibilities. The statutory auditor of the Company
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 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
Hyloris
: Annual Report 2023
p 55
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:
Financial information for shareholders and third
parties
The Audit Committee reviews, with the requested
assistance of the CFO, the annual and semi-annual
social and consolidated financial statements,
prospectuses, and other financial information before
submitting them to the Board of Directors. Regarding
financial data included in interim statements, these
are prepared under the responsibility of the CFO who
submits them to the Audit Committee for review by
the Board of Directors in the context of its general
oversight of the financial information preparation
process.
In reviewing the financial information preparation
process, the Audit Committee examines, in particular,
the relevance and consistency of the accounting
standards of the Hyloris Group. This includes the
criteria for consolidating accounts of companies
within the group. This review notably focuses on
assessing the completeness and consistency of the
financial information. The Audit Committee reviews,
with a view to providing an opinion to the Board
of Directors, any changes made, if applicable, to
accounting principles and valuation rules, particularly
considering their impact on financial statements.
The CFO informs the Audit Committee of the
methods used to account for significant and unusual
transactions for which accounting treatment is open
to different approaches, as well as the existence and
justification of activities carried out through specific
structures.
Internal control and risk management
The Audit Committee, at least once a year, reviews
the internal control and risk management systems
implemented by the CEO to ensure that the main
risks (including those related to compliance with
existing laws and regulations) are properly identified,
managed, and communicated in accordance with
the framework approved by the Board of Directors.
The Audit Committee reviews information related to
internal control and risk management published in
the Corporate Governance Statement of the annual
report.
External audit
The Audit Committee reviews reports prepared
by the auditor(s), including the report describing
all relationships between the auditor(s) and the
company and its group. The Audit Committee
examines the nature, quality, and scope of the
auditor(s)’ work, the coordination of missions
within the Hyloris Group, as well as the conclusions
(including management letters) resulting from their
work. The Audit Committee assesses to what extent
the CEO takes into account the recommendation
letter(s) addressed to him by the auditor(s).
The Audit Committee proposes to the Board of
Directors the appointment, possible renewal,
and remuneration of the auditor(s) for their
mission to certify the statutory accounts of Hyloris
Pharmaceuticals and the consolidated accounts of
the group. It verifies their independence within the
meaning of the Companies and Associations Code.
Any other mission, falling within Article 3:62 of the
Companies and Associations Code, performed by
the auditor(s) or by companies or persons related
to them, must be previously authorized by the Audit
Committee.
Hyloris
: Annual Report 2023
p 56
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 is called by its Chairman to meet
at least four times a year or whenever it deems it
necessary for the proper performance of its duties. It
is validly constituted when the majority of its members
are present or represented. The Audit Committee may
meet by telephone conference, video conference, or
Internet. Except for decisions for which this regulation
would exclude this possibility, decisions of the Audit
Committee may be taken by written consent of the
directors. The Chairman of the Audit Committee may
invite, depending on the items on the agenda:
the CFO, CEO, or any member of the management
and/or any senior executive of the company;
the auditor(s) who are its natural interlocutors and
are received by the Audit Committee at their request
and without prior justification. If necessary, these
interlocutors may be accompanied by an operational
manager. Subjects related to the audit plan and any
issues arising from the audit process are regularly
included on the agenda of the Audit Committee. Two
meetings are mainly dedicated to the annual and
semi-annual financial statements. At these meetings,
the auditor(s) is (are) invited to report on the result
of their work. These meetings also allow for an
exchange of views with the auditor(s) on any matter
within the competence of the Audit Committee and
any other issue highlighted by the audit process,
especially significant weaknesses in internal control.
The Chairman of the Audit Committee or two of
its members may convene a meeting whenever
deemed desirable. The Audit Committee may assign
the auditor(s) or other experts to specific tasks,
and ask them to report to it. The auditor(s) may
also address the Board of Directors, through its
Chairman, informing the Audit Committee.
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 4 times in 2023.
Name
Attendance
Rate
Marc Foidart
Chairman
100%
Stefan Yee
100%
James Gale
100%
Chris Buyse
100%
Hyloris
: Annual Report 2023
p. 57
REMUNERATION AND NOMINATION
COMMITTEE
The Remuneration and Nomination committee consists
of the following members:
Mr. Stefan Yee
,
Chairperson of the Renumeration and Nomination
Committee
Dr. Carolyn Myers,
Non-Executive Director
- see
note 29
Mr. Marc Foidart
,
Independent Director
The Remuneration and Nomination Committee is
composed exclusively of Non-Executive Directors and
independent directors within the meaning of Article 7:87
of the Belgian Code of Companies and Associations.
This composition helps to avoid conflicts of interest
regarding the structure design, adjustment and
implementation of the Remuneration Policy towards
Executive Committee Members. The CEO and Executive
Committee Members are not invited to participate in the
Remuneration Committee’s deliberations of their own
individual compensation. The chair-person of the Board
of Directors or another Non- Executive Director is the
Chair of the Remuneration and Nomination Committee.
The members of the Remuneration Committee must
have the necessary expertise in terms of remuneration
policy, which is evidenced by the experience and
previous roles of its current members (see also Board of
Directors, p. 48 for more information on their curriculum
vitae). The CEO may participate in the meetings of
the Remuneration Committee in an advisory capacity
every time the remuneration of another member of the
Executive Committee is discussed.
Mission
The role of the Remuneration and Nomination
Committee consists of making recommendations to
the Board of Directors regarding the appointment
and remuneration of Directors and members of the
Executive Committee and, and has the following tasks:
a) make recommendations to the Board of Directors
on the remuneration policy and other remuneration
proposals that the Board of Directors must submit to
the General Shareholders’ Meeting;
b) make recommendations to the Board of Directors
in line with the remuneration policy approved by
the General Shareholders’ Meeting on the individual
remuneration of the Directors and members
of the Executive Committee, including variable
remuneration and long-term performance bonuses,
whether or not linked to shares, in the form of stock
options (warrants) or other financial instruments, and
severance pay, and, where applicable, the resulting
proposals that the Board of Directors must submit to
the General Shareholders’ Meeting;
c) prepare the remuneration report, in line with
the remuneration policy approved by the General
Shareholders’ Meeting, that the Board of Directors
must include in its corporate governance statement,
which in turn forms a part of the Company’s annual
report; and
d) explain the remuneration report at the Annual
General Shareholders’ Meeting.
e) Pursuant to its function as Nomination Committee:
f) make recommendations to the Board of Directors
with regard to the appointment of Board Members
and members of Executive Committee;
g) prepare plans for the orderly succession of Board
Members;
h) lead the re-appointment process of Board
Members;
i) ensure that sufficient and regular attention is
paid to the succession of members of Executive
Committee; and
j) ensure that appropriate talent development
programmes and programmes to promote diversity
in leadership are in place.
Hyloris
: Annual Report 2023
p 58
Evaluation
At the end of each Board Member’s term, the
Remuneration and Nomination Committee shall
evaluate the relevant Board Member’s presence at
the meetings of the Board of Directors or Committee
meetings, their commitment and their constructive
involvement in discussions and decision-making and
shall also assess whether the contribution of each
Board Member is adapted to changing circumstances.
The Board of Directors shall act on the results of the
performance evaluation, and shall, where appropriate,
propose new Board Members for appointment, propose
not to re-appoint existing Board Members or take any
measure deemed appropriate for the effective operation
of the Board of Directors.
Meetings
The Remuneration and Nomination Committee shall
meet whenever it deems it necessary for the proper
performance of its duties and at least twice a year.
The Remuneration and Nomination Committee shall
regularly report to the Board of Directors on the
performance of its duties.
The Remuneration and Nomination Committee
convened only 1 time in 2023 as there were no major
changes or decisions that required additional meetings.
Name
Attendance
Rate
Stefan Yee
Chairman
100%
Carolyn Myers
100%
Marc Foidart
100%
PRODUCT SELECTION COMMITTEE
At its meeting of February 28, 2024, the Board of
Directors decided to install a new ‘Product Selection
Committee’. The Product Selection Committee consists
of at least 2 non-executive members of the Board of
Directors, the CEO, the COO and the CBDO
The Product Selection Committee shall prepare the
dossier for approval of new product candidates by the
Board of Directors. It shall discuss the new product
candidate(s) to be submitted for approval to the Board
of Directors and shall prepare a summary of its findings,
covering all aspects going from development stage and
regulatory pathway, the cost for further development,
registration and commercialization of the product
candidate(s), the market potential and positioning,
pricing, the financial return, etc. The Product Selection
Committee meets whenever it deems it necessary
for the proper performance of its duties. The Product
Selection Committee regularly reports to the Board of
Directors on the performance of its duties, and in any
event when a new product candidate is submitted to the
Board of Directors for approval.
The members of the Product Selection Committee have
full access to the Executive Committee and to any other
employee to whom they may require access to carry out
their responsibilities.
SCIENTIFIC COMMITTEE
A Scientific Committee has not yet been formally created
by the Company.
Hyloris
: Annual Report 2023
p. 59
Hyloris
: Annual Report 2023
p 60
EXECUTIVE COMMITTEE
The Board of Directors has established an “Executive
Committee” and appointed the members of the Executive
Committee in consultation with the CEO, based on the
recommendations
made
by the Remuneration and
Nomination
Committee.
The
Company’s
Executive
Committee is an advisory committee to the Board of
Directors and does not constitute a “conseil de direction”
/ “directieraad” per the definition of Article 7:104 CCA.
The Board of Directors considers the need for a balanced
Executive team.
In proposing candidates for the Executive Committee,
particular consideration is given to educational and
professional background, complementary skills,
knowledge, and experience, as well as to diversity in
age, gender, and nationality. All diversity requirements,
except for the gender requirement, are fully met. Hyloris’
members of the Executive Committee come from
diverse educational and multi-disciplinary professional
backgrounds. The 5 members of the Executive Committee
represent 3 different nationalities.
On 31 December 2023, the Executive Committee
consisted of the following members
1
:
Mr. Stijn Van Rompay
2
,
Chief Executive Officer
Mr. Thomas Jacobsen
3
,
Chief Business Development Officer
Mr. Jean-Luc Vandebroek
4
,
Chief Financial Officer
Mr. Dietmar Aichhorn
,
Chief Operating Officer
Mr. Koenraad Van der Elst
5
,
Chief Legal 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.
1
When a director is subsequently mentioned by name it will be
assumed they are acting through their associated management
company.
2
Acting through SVR Management BV
3
Acting through Jacobsen Management BV
4
Acting through Finsys Management BV
5
Acting through Herault BV
Stijn Van Rompay - CEO
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.
Thomas Jacobsen - CBDO
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.
Hyloris
: Annual Report 2023
p 61
Jean-Luc Vandebroek, CFO
Jean-Luc Vandebroek is a seasoned
executive who joined the Company
in 2021 from his role as CFO of Bone
Therapeutics, a publicly traded biotech
company based in Gosselies, Belgium. Prior to that, he
was CFO and CIO at Alcopa and Fluxys, and before that,
he held various senior financial positions at Delhaize
Group. Jean-Luc is an experienced Executive Board
member and has a track record of developing and
implementing financing strategies and transactions and
has a large, global network of investors and financial
institutions. Jean-Luc holds a Master in Business
Administration from the Louvain Management School.
He is Board member of BioSenic.
Dietmar Aichhorn, COO
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.
Koenraad Van der Elst, CLO
Koenraad Van der Elst has almost
40 of experience as in-house and
external legal and general counsel
of various listed companies and was
also involved in numerous capital market and M&A
transactions worldwide. Before joining Hyloris in 2020,
Koenraad served as General Counsel at Nikon Metrology
(previously Metris ) and acted as Secretary General
& General Counsel of Punch International and Punch
Graphix plc, a company listed on the London Stock
Exchange (AIM) and was President of the Supervisory
Board (“Raad van Commissarissen”) of Punch Technix, a
company listed on Euronext Amsterdam. Between 1995
and 2002, Koenraad was Director Legal Documentation
at the Investment Banking Department (Corporate
Finance and Capital Markets) of Generale Bank/Fortis
Bank. Koenraad was also an assistant Professor in
Financial Law at the University of Brussels (VUB).
Koenraad holds a Master of laws from the University of
Brussels (VUB) and holds an MBA from EHSAL Brussels.
Hyloris
: Annual Report 2023
p 62
REMUNERATION REPORT
REMUNERATION POLICY - GENERAL
A revised remuneration policy, as part of the
remuneration report, will be submitted for approval to
the next 2024 General Meeting of Shareholders.
INTRODUCTION
The remuneration policy of Hyloris Pharmaceuticals
SA (Remuneration Policy) has been established in
accordance with the Belgian Code of Companies and
Associations (BCCA), and with the recommendations of
the Belgian Corporate Governance Code (Code 2020).
This Remuneration Policy applies as from 1 January
2021.
The remuneration policy applies to all Non-Executive
Directors, Executive Directors of Hyloris and other
members of the Executive Committee. The Executive
Directors are part of the Executive Committee. At the
time of Board approval, Hyloris did not have other
persons who hold management positions according to
the definition of this term in Article 7:121of the BCCA.
Our remuneration policy is available on our website.
OBJECTIVE OF THE HYLORIS’ REMUNERATION
POLICY
Our remuneration policy rewards contributions
to achieving Company objectives and generating
stakeholder value. Hyloris wants to be a competitive
market player by benchmarking against appropriate
peer groups and by incentivizing and rewarding
performance at the highest level possible. The objective
of the Hyloris Remuneration Policy is to attract,
motivate and retain diverse, qualified, and expert
individuals whom Hyloris needs to achieve its corporate,
strategic and operational objectives. We aim to provide
competitive remuneration packages that align with
market practices in the key markets where we compete
for talent. The Remuneration Policy also aims to ensure
consistency between the remuneration of executives
and that of all staff members, while soundly and
efficiently managing risks and controlling wage-related
costs for Hyloris.
The Board requests the Remuneration Committee
to evaluate the overall remuneration packages of
Executive Directors, Non-Executive Directors, and
Hyloris’ employees. The Remuneration Committee
consults and engages the Board on this subject matter.
The Remuneration Committee takes into consideration
all the information on its workforce remuneration,
its knowledge and research data about the relevant
job market to ensure that all Hyloris employees are
remunerated in a market-conforming and sufficient
manner to motivate and retain its employees.
The Remuneration Policy will evolve and be updated
from time to time to align with the development of our
company in a competitive environment and is reviewed
regularly so that its contents are aligned with market
practice. Any proposed amendments will be subject to
the approval of our general shareholders meeting.
REFLECTING OUR MISSION AND VALUES
Our Remuneration Policy is designed to support our
mission, our identity, and our core values. We believe in
the intrinsic motivation of our entire team to contribute
to our mission and we know that maximum alignment
between the interests of our senior leadership team and
our stakeholders is supportive of our long-term success.
Our mission is to transform patients’ lives by providing
them with medicines for unmet needs. To achieve our
mission, we will need to be successful across a range
of challenging activities in an extremely competitive
environment. This includes the discovery, research,
and development of highly innovative pharmaceutical
product candidates, entering into and maintaining
successful collaborations with key industry experts
across the globe, managing our limited resources in
a disciplined manner to enable us to progress our
products all the way through to regulatory approval, and
finally to successfully commercialize our products by
bringing our innovative therapies to patients in need.
We strongly believe that our long-term success depends
on our ability to attract and retain exceptionally talented
people focused on the execution of our business
objectives while promoting and upholding our identity
and core values along the way. Our core values and
leadership competencies are:
Hyloris
: Annual Report 2023
p 63
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
This policy should allow us to:
attract, retain and motivate superior talent
by offering market competitive remuneration
packages that are strategically aligned in the
regions in which we operate;
promote long-term value creation over short-
term success through a combination of co-
ownership of our business in the form of ESOP
Warrants and both a short-term and long-term
variable remuneration scheme;
offer variable remuneration components to the
members of the Executive Committee based
on the achievement of challenging short-term
goals that are specifically designed to support
our long-term business objectives and our core
values.
In determining the remuneration packages offered to
our team, we strive to ensure that the remuneration
offered is competitive and in line with market practice.
We are committed to being transparent about our
remuneration practices and we strive to have a
meaningful dialogue with our stakeholders to help us
continually improve the quality of our disclosures.
Any decision that relates to the remuneration level
of members of the Executive Committee shall be
based on a recommendation from our Remuneration
and Nomination committee. The Remuneration
and Nomination committee shall justify why its
recommendations are competitive, reasonable, and
fair, based on the unique talents and expertise of the
individual concerned and the value they bring to the
Company.
DEVIATION FROM THE REMUNERATION
POLICY
In exceptional circumstances, the Board may decide to
deviate from any rule contained in this Remuneration
Policy, if deviation is deemed necessary to serve the
long-term interests and sustainability of the company
or to safeguard the viability of the company. In case the
Board intends to grant any remuneration in deviation
from this policy, the following procedural requirements
apply:
(i) the remuneration offered to any individual
shall be based on the value that individual
brings to the company, shall be competitive
in the relevant markets where we compete
for talent and shall for executives include a
significant variable component linked to specific
performance targets aligned with our company
strategy;
(ii) the Remuneration and Nomination
Committee will be consulted on the proposed
deviation;
(iii) we will report any deviations from this
policy in our annual remuneration report to our
shareholders, and such report will include an
overview of the key considerations for deviating
from the policy and the expected duration of the
deviation, and our shareholders will be asked to
provide an advisory vote on our remuneration
practices for the respective year.
CHANGES TO THE REMUNERATION POLICY
This 2024 remuneration policy is based on the principles
of the current (2021) policy.
Hyloris
: Annual Report 2023
p 64
The main difference between the 2021 and 2024
remuneration policy is the implementation of a
long-
term variable remuneration
and the proposal for
a new remuneration for the Board of Directors and
the various committees
(see proposed changes to
remuneration policy for non-executive directors)
.
Hyloris does not expect any material changes to this
Remuneration Policy to be made in the next two years.
EVOLUTION OF THE EVALUATION &
PERFORMANCE OF HYLORIS
(in € thousand)
2020
2021
2022
2023
Remunera-
tion of Excom
Members
Fix
199
800
991
1016
Variable
111
103
100
107
Remunera-
tion of CEO
Fix
162
180
186
191
Variable
55
30
22
22
Net profit
(7,2)
(11,6)
(11,7)
(15,8)
Average re-
muneration
of employ
-
ees
1
84,2
108
127
108
1 Includes consultants in a service agreement
REMUNERATION POLICY FOR
NON-EXECUTIVE DIRECTORS
Remuneration of Non-Executive Directors will be
adjusted as necessary based on regular benchmarking
exercises to ensure that we continue to offer fair
and competitive remuneration to attract, retain and
motivate the Non-Executive Directors. Fees for being
on special committees of the Board of Directors serve
as compensation for the significant additional time
commitment and responsibilities that come with
fulfilling these duties in addition to those generally
required for serving as Non-Executive Director on our
Board of Directors. A Non-Executive Director serving
multiple committee positions will receive appropriate
additional compensation for each of these committee
positions such as the Remuneration Committee and
the Audit Committee. The Board submits this proposal
for approval to the shareholders at the annual
Shareholders’ Meeting.
1
Includes consultants with a service agreement
The Remuneration and Nomination committee and the
Board share the view that all Non-Executive Directors -
including the independent directors within the meaning
of Article 7:87 of the BCCA - should be compensated
equally as set out hereafter.
The Non-Executive Directors are paid a fixed
remuneration per year plus a fixed remuneration per
year as a member of a Board committee (such as the
Remuneration Committee or the Audit Committee).
As from 2020, the remuneration for Non-Executive
Directors was as follows
(in € thousand)
:
Board of Directors
Audit
Committee
Remuneration &
Nomination Committee
Chair
Member
Member
Member
12.5
12.5
5
5
The Non-Executive Directors do not receive any fringe
benefits and do not receive any variable remuneration
i.e., performance-related pay such as bonuses.
Reasonable out-of-pocket (travel) costs incurred by Non-
Executive Directors in their duties are reimbursed.
Hyloris does not grant shares to Non-Executive
Directors. It considers that its general policy and modus
operandi already meet the objective of recommendation
7.6 of the Code 2020, which is to promote long-
term value creation. Taking into account the current
remuneration amounts and the independent nature of
the Non-Executive Directors, Hyloris is of the view that
providing part of the remuneration in shares would not
necessarily contribute to the objective of the 2020 Code
to have these Directors act with the perspective of a
long-term shareholder. 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 Non-Executive Director mandate can be revoked at
any time (ad nutum) without the Non-Executive Director
being entitled to an indemnity payment. There are no
employment or service agreements that provide for
notice periods or indemnities between the Company
and the members of the Board of Directors, who are not
members of the Executive Management Team.
Hyloris
: Annual Report 2023
p 65
PROPOSED CHANGES TO REMUNERATION
POLICY FOR NON-EXECUTIVE DIRECTORS
(in € thousand)
Board of
Directors
Audit
Committee
Remuneration
&
Nomination
Committee
Product
Selection
Committee
Chair
Member
Member
Member
Member
17.5
17.5
5
5
7.5
The Remuneration & Nomination Committee also
proposes to offer a certain number of shares in order
to meet the requirement of principle 7.6 of the Belgian
Corporate Governance Code. These shares will have to
be held at least one year after the Board Member has
left the Board of Directors and must be held at least
three years after granting.
REMUNERATION POLICY FOR EXECUTIVE
COMMITTEE MEMBERS
INTRODUCTION
Hyloris wants to offer market-competitive compensation
to be able to recruit, retain and motivate expert and
qualified professionals, while considering the scope of
their responsibilities.
The remuneration scheme that applies to the Chief
Executive Officer (CEO) and other Executive Committee
Members is designed to balance short-term operational
performance with the long-term objective of creating
sustainable value, while at the same time also
considering the interests of all stakeholders.
The remuneration scheme for Executive Committee
Members has a fixed part (i.e., a base annual
remuneration in cash) and a variable part that
comprises of a short-term variable remuneration (cash
bonus) and a long-term variable remuneration that
is construed as a retention bonus based on reaching
certain EBITDA levels by the Company. As for the long-
term remuneration elements, the Executive Committee
Members may receive ESOP Warrants (please see
Warrants and Other Share-Convertible Securities
).
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.” The Articles of Association of a company
can deviate from Article 7:91 of the BCCA, which is
what Hyloris has done. Article 7:91 also states that
the above principles do not apply if the variable part
of the remuneration does not exceed 25% of the total
yearly remuneration. Therefore, the rules on variable
remuneration laid down in Article 7:91 of the BCCA do
not apply.
Furthermore, our Board of Directors may decide to
adjust the total amount of variable remuneration
payable upward or downward if the remuneration
payable would otherwise not be fair or reasonable.
This means also that our Board of Directors may
decide to award an amount of the variable pay also if
the corresponding performance target was not (fully)
met, for example if the Board of Directors concludes
that unforeseen external circumstances prevented the
targets from being (fully) achieved.
In case of significant overachievement, the Board
of Directors may decide to award a higher variable
remuneration to fairly reflect the individual’s value
contribution to the Company.
FIXED REMUNERATION
The fixed annual remuneration consists of a fee
paid in cash. The amount of this fee is determined
by the Board, upon the recommendation by the
Remuneration Committee. The fee is paid in monthly
installments. Some Executive Committee Members
receive compensation for costs they incurred in the
performance of their duties. Hyloris will conduct
external salary-benchmarking exercises regularly to
ensure that the remuneration of Executive Committee
Members are
in line with market practices and is
sufficiently fair and reasonable to attract, retain and
motivate individuals with the most appropriate profile.
Hyloris
: Annual Report 2023
p 66
SHORT-TERM VARIABLE REMUNERATION
Short-term variable cash incentives are granted for
achieving predetermined specific performance targets.
At the start of each financial year, the Board of Directors
will determine the company’s key priorities and will set
specific, challenging performance targets in line with
these priorities. The Board of Directors will determine
the relative weight of each target and the metrics used
for measuring their achievement.
The principles that apply to granting any short-term
variable remuneration are the following:
(i) Granting allows for a certain part of the
remuneration to be linked to an individual’s
performance and to the performance of Hyloris
over the past calendar year. It also allows for
the individual’s interest to be aligned optimally
to that of Hyloris, the Shareholders and other
stakeholders.
(ii) Granting is driven by the individual’s merits
and based on the performance-rating system
at Hyloris, that is the achievement of individual
targets (Personal Targets) and the overall
performance of Hyloris (Corporate Targets) over
the past calendar year.
(iii) Corporate Targets include factors related
to progress in Hyloris’ research activities (OPS),
business development (BD) and finance. The
Corporate Targets focus on company growth
and value creation for all shareholders.
(iv) For the Executive Committee Members
(except for the CEO), the short-term variable
remuneration consists of two components:
the first component represents 60% of
the short-term variable remuneration and
is determined based on Personal Targets
achieved;
the second component represents 40% of
the short-term variable remuneration and is
determined based on the Corporate Targets
achieved by Hyloris;
(v) For the CEO, the short-term variable
remuneration also consists of two components:
the first component represents 25% of
the short-term variable remuneration and
is based on the average of the Personal
Targets achieved by the other members of
the Executive Committee;
the second component represents 75% of
the short-term variable remuneration and is
determined based on the Corporate Targets
achieved by Hyloris;
(vi) Both the Corporate and Personal Targets
are set annually. The Board sets the Corporate
Targets for all Executive Committee Members
and considers the recommendations made
by the Remuneration Committee. The CEO’s
Personal Targets are set by the Board upon the
Remuneration Committee’s recommendation,
which are made based on the Chairman’s
proposal. The Personal Targets of other
Executive Committee Members are set by
the CEO. 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)
may exceed 25% of the total fixed annual
remuneration of an Executive Committee
Member. However, the Remuneration and
Nomination Committee has currently set the
total target short-term variable remuneration
amount for the Executive Committee Members
at 17% of the total fixed annual remuneration.
(vii) The short-term variable remuneration for
Personal and Corporate Targets is paid only
when these targets are effectively wholly or
partially met. The extent to which the CEO has
achieved his Personal Targets is evaluated
by the Remuneration Committee when the
annual financial results are validated by the
Audit Commitee. The evaluation is subject
to deliberation and a final decision by the
Board. The extent to which the other Executive
Committee Members have achieved their
Personal Targets is evaluated by the CEO at
Hyloris
: Annual Report 2023
p. 67
the same time, which is deliberated by the
Remuneration Committee and finally decided
by the Board. Appraisal is based on a weighted
average of the achievement rate of the Personal
Targets.
(viii) Short-term variable remuneration, if any,
is paid after approval by the Board of Directors.
Usually during the first calendar quarter
following the year for which the targets were set,
the Board of Directors will determine the extent
to which the targets were met. Pay-out of the
variable cash incentive will usually occur also in
the first calendar quarter following the year for
which the targets were set.
LONG-TERM VARIABLE REMUNERATION
A long-term variable remuneration is 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 €20 million EBITDA (calculated on
a recurring basis) will be achieved by the Company and
this up to €80 million or 4 tranches of €20 million.
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.
THE 2024 CORPORATE TARGETS
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
30%
Business Development
30%
Finance
30%
Corporate
10%
Hyloris
: Annual Report 2023
p 68
FRINGE BENEFITS
Executive Committee members do not receive any fringe
benefits.
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
payments are described hereunder.
We will prevent ‘pay for failure’ and will therefore not
pay a severance arrangement in the event of seriously
culpable or negligent behavior on the part of an
Executive Committee member being dismissed. We will
also not pay severance if the agreement is terminated
at the initiative of Executive Committee member, other
than due to serious culpable conduct or neglect on the
part of the Company.
Mr. Stijn Van Rompay (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 a 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 a 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, 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
(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 (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 a 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 a compensation equivalent to the fixed
remuneration of such three-month period. The
agreement also provides for reasons for immediate
termination because of breach of 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 18 months after termination, against a payment
of 100% of the fixed fee over that 18 months’ 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. Jean-Luc Vandebroek (CFO)
The current services agreement with Mr. Jean-Luc
Vandebroek has been entered into between Mr.
Vandebroek’s Belgian incorporated management
company Finsys Management BV and the Company
effective as from 23 September 2021, for an indefinite
period. It can be terminated by the Company upon
three months’ notice or payment of a compensation
equivalent to the fixed remuneration of a three-
month period. It can be terminated by Finsys
Management BV upon three months’ notice or
payment of a compensation equivalent to the fixed
remuneration of such three- month period. The
Hyloris
: Annual Report 2023
p. 69
agreement also provides for reasons for immediate
termination because of breach of 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, Finsys 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 Finsys 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 a 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 a compensation equivalent to the
fixed remuneration of such 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. Koenraad Van der Elst (CLO)
The current services agreement with Mr. Koenraad
Van der Elst has been entered into between Mr.
Koenraad Van der Elst’s Belgian incorporated
management company Herault BV and the Company
effective as from 1 January 2020, for an indefinite
period. It can be terminated by the Company upon
six months’ notice or payment of a compensation
equivalent to the fixed remuneration of a three-
month period. It can be terminated by Herault BV
upon three months’ notice period or payment of a
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, 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,
Herault 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 Herault BV.
Hyloris
: Annual Report 2023
p. 70
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 the 4th year following the year
of the offer. No lock-up period applies to any shares
acquired after the exercise of such ESOP warrants.
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
5 Members of the Executive Committee already hold a
significant block of shares in the Company as co-founder
of the Company.
Hyloris
: Annual Report 2023
p. 71
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.
PENSION SCHEME
Hyloris does not have a complementary pension
scheme for any Non-Executive Director or any Executive
Committee member.
REMUNERATION
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
14, 2021 and consists of a fixed annual fee of €12,500
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 in the Board of
Directors.
For the remuneration of the Independent Directors
in 2023, the total remuneration amounted to €110
thousand. The table below provides an overview of the
remuneration per Non- Executive Director.
Name
Remuneration
Stefan Yee
€22,500
Leon Van Rompay
€12,500
Marc Foidart
€22,500
Carolyn Myers
€17,500
James Gale
€17,500
Chris Buyse
€17,500
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 at
December 31, 2023.
Warrants
Name
Number
%
Stefan Yee
100,000
15.94
Leon Van Rompay
0
0
Marc Foidart
0
0
Carolyn Myers
0
0
James Gale
0
0
Chris Buyse
0
0
The Non-Executive Members of the Board of Directors
do not hold any shares of the Company.
Hyloris
: Annual Report 2023
p. 72
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 2023, the following remuneration and compensation
was paid or accrued to the CEO (i.e., Mr. Stijn Van
Rompay) and the other members of the Executive
Management of Hyloris:
€ thousand
CEO
Other members
of Executive
Committee
Annual base salary
190,944
824,611
Annual variable salary
21,876
85,328
Supplementary pen-
sion plan (defined
contribution)
n.a.
n.a.
Car lease / transport
allowance
n.a.
n.a.
Medical plan
n.a.
n.a.
The 2023 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 6-to-1.
The ratio is calculated based on the lowest FTE pay per
31 December 2023, 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.
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, 2023.
Shares
ESOP Warrants
Name
Number
%
Number
%
Stijn Van Rompay
7,743,067
27.65
68,000
10.84
Thomas Jacobsen
3,857,838
13.78
0
0
Koenraad Van der
Elst
17,443
0.06
50,000
7.97
Jean-Luc
Vandebroek
9,000
0.03
40,000
6.38
Dietmar Aichhorn
32,500
0.12
40,000
6.38
APPRAISALS
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 regularly (and preferably
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,
Hyloris
: Annual Report 2023
p. 73
and that of its Committees, as well as of its interaction
with the Executive Committee, took place on April 18,
2024 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.
EXECUTIVE COMMITTEE
The CEO 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 CEO. For the CEO, 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 CEO 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 2023, the Remuneration and Nomination
Committee made its assessment and recommendation
on April 18, 2024.
The Board of Directors has taken note of the positive
assessment by the Remuneration and Nomination
Committee and determined that the corporate
objectives for 2023, which were aimed at supporting the
company’s long-term performance, had been achieved
at a rate of 65%. The variable remuneration for 2023 has
also considered the contributions of the members of
the Executive Committee towards these achievements
and their individual targets that were assessed between
76,5% and 85%. The Board of Directors approved the
recommendations of the Remuneration and Nomination
Committee on 26 July, 2024.
INTERNAL CONTROL AND
RISK MANAGEMENT SYSTEMS
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.
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.
See subsequent event related to Forensic Investigation.
RISK ANALYSIS
KEY RISK FACTORS RELATED TO THE
COMPANY’S BUSINESS
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.
Hyloris
: Annual Report 2023
p. 74
RISKS RELATED TO HYLORIS’ BUSINESS
ACTIVITIES AND INDUSTRY
Hyloris performance depends primarily on the success
of its product candidates, a majority of which are
in the early reformulation, repurposing 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.
In addition, Hyloris depends on the execution of its
partners AltaThera, AFT Pharmaceuticals, and Padagis
for successful roll-out and commercialisation 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.
Hyloris’ ability to successfully market its product
candidates will depend in part on the level of
reimbursement that healthcare organisations, including
government health administration authorities, private
health coverage insurers and other healthcare payors,
provide for the cost of Hyloris’ products and related
treatments.
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 commercialising its product
candidates in accordance with its business plan or result
in significant delays in doing so.
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.
The occurrence of a pandemic, epidemic, other health
crisis or geo-political imbalance, including the COVID-19
pandemic, 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.
The geopolitical situation in Eastern Europe intensified
on 24 February 2022, with Russia’s invasion of Ukraine.
The war between the two countries continues to evolve
as military activity proceeds and additional sanctions
are imposed. Although the Russia-Ukraine war is not
expected to cause disruption in the Hyloris’ operations.
If an external partner experience disruptions to their
business due to the military conflict, this could delay or
prevent it from executing its strategy as planned.
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.
Hyloris is dependent on third parties to supply
ingredients and manufacture its products, and
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.
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
Hyloris
: Annual Report 2023
p. 75
revenue and adversely affect Hyloris’ commercial
prospects.
Intellectual property rights are difficult and expensive
to obtain, maintain and protect and Hyloris may not be
able to fully ensure the protection of its rights, which
may adversely impact Hyloris’ financial performance and
prospects. Third parties may also claim an ownership
interest in Hyloris’ intellectual property.
RISKS RELATED TO BUSINESS ENVIRONMENT
Reference made to the US litigation - see
note 26
.
FINANCIAL RISKS
Hyloris has a limited operating history and has not
yet generated any substantial revenues. 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.
An inflation spike in the year 2022 reminded investors
of the risk of rising interest rates, which 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 2023 and has
limited exposure to exchange rates with non-European
countries.
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.
CONTROLS, SUPERVISION AND
CORRECTIVE ACTIONS
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 designated Tanguy Legein,
réviseur d’entreprises, as permanent representative.
In 2023, a total amount of €119K was paid to the
statutory auditor and its network. This amount includes
the following elements:
€91K thousand for audit fees,
and €28K for tax services.
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.
Hyloris
: Annual Report 2023
p. 76
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 (expenditures,
procurement, payroll, IT, investments, 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;
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 2023, the Company made the following improvements
in its internal processes:
a new enterprise resource ERP has been identified
and partialy implemented mainly for Finance;
a new reporting tool was developed and
implemented;
the internal budgeting and forecasting process was
further improved;
improvements were made to the handling of payroll
transactions;
A monthly financial reporting reconciliation was
developped and implemented.
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.
CONFLICTS OF INTEREST AND
RELATED PARTIES
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
: Annual Report 2023
p. 77
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
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
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.
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.
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.
Hyloris
: Annual Report 2023
p. 78
SHARE CAPITAL,
SHARES AND SHAREHOLDERS
HISTORY OF CAPITAL – CAPITAL
INCREASE AND ISSUANCE OF SHARES
SECURITIES ISSUED BY THE COMPANY
As of December 31, 2023, 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.
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 8, 2020, 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 8, 2020, the
authorisation to the Board of Directors to increase the
capital of the Company with a maximum amount of
€117,758.84 (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 8, 2020.
The Board has used its powers to increase the share
capital within the framework of the authorised capital
on November 27, 2020 by an amount of €2,000
(excluding any issue premiums) following the issuance
of the 400,000 ESOP 2020 Warrants.
On March 31, 2022, the share capital was increased
by contribution in cash, as the result of an accelerated
bookbuilding, for a total amount of €15 mio (including
issue premium) with issuance of 967,742 new shares,
also within the framework of the authorized capital. The
new shares were issued at a price of €15.5 per share
(including issue premium), increasing the capital of the
Company for an amount of €4,838.71 (excluding issue
premium).
Finally, a third ESOP Warrant 2022 plan was approved in
June 2022, using the authorised capital for an amount
of €1,067.50 (excluding issue premium) following
the issuance of the 213,500 ESOP 2022 warrants and
restoring also the amount of the authorized capital
corresponding to 213,500 cancelled ESOP 2020
Warrants.
Consequently, the Board is therefore still authorised to
increase the share capital of the Company within the
framework of the authorised capital for a maximum
amount of €110,920.13 (as of 1 April 2024, excluding
issue premium).
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.
WARRANTS PLANS
WARRANT PLANS ISSUED
The Company created four 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 and
the ESOP Warrants plans in December 2019, November
2020 and June 2022.
Hyloris
: Annual Report 2023
p. 79
SUMMARY OF THE OUTSTANDING WARRANT
PLANS
Transaction Warrants
On May 12, 2017, the Company issued 300,000 warrants
(before stock split - the transaction warrants). All
transaction warrants have been subscribed for. The
transaction warrants were granted free of charge.
Initially all transaction warrants were subscribed by
Mr. Stijn Van Rompay. Thereafter they have been
transferred at multiple occasions to other persons such
as shareholders in the Company.
In June 2022, the afore-mentioned transaction warrants
were exercised, resulting in the issuance of 1,200,000
new ordinary shares at a subscription price per share of
€2.3597, resulting in a capital increase of €2,831,640.
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. Following the Share
Split and considering a certain number of warrants that
have lapsed or have been cancelled, a total of 306,125
ESOP Warrants are currently granted and outstanding.
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, 186,500 ESOP Warrants are currently
granted and outstanding and 213,500 ESOP Warrants
were cancelled.
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, 134,646 ESOP Warrants are currently granted and
outstanding and 71,500 ESOP Warrants were cancelled
and 7,353 were forfeited.
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 determined for all ESOP Warrants
issued in 2019, taking into account the Share Split, is
equal to €5.3375 per ESOP Warrant.
The exercise price for the ESOP Warrants issued in 2020
and 2022 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, 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): i.e., a first tranche of 25%
vests on the first anniversary of the starting date and
subsequently 1/48th vests each month. ESOP Warrants
can only be exercised by the relevant holder of such
ESOP Warrants, provided that they have effectively
Hyloris
: Annual Report 2023
p 80
2019
2020
2022
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
5 years
10 years
7 years
Vesting Period
The 2019 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 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).
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.
HYLORIS ESOP SCHEMES
Hyloris has put in place the following warrant schemes (which are called inschrijvingsrechten/ droits
de souscription under the BCCA) 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 long-
term interests of Hyloris, its shareholders and other stakeholders.
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 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.
Hyloris
: Annual Report 2023
p 81
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 out- standing debt obligations
of the Company under such agreements.
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
Hyloris
: Annual Report 2023
p 82
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 to the right 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, 2023).
At December 31, 2023, 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) 363,300
ESOP warrants (December 2019) of which 57,175
warrants were forfeited, (ii) 400,000 ESOP warrants
(November 2020) of which 213,500 warrants were
forfeited, (iii) 213,500 ESOP Warrants (June 2022) of
which 78,854 ESOP Warrants were forfeited. All the
warrants give right to subscribe to an equal number of
shares. As per 31 December 2023, a total of 627,271
ESOP warrants were outstanding.
Stijn Van Rompay
(Founder & CEO)
27.65%
Thomas Jacobsen
(Founder & CBDO)
13.78%
Scorpiaux BV
6.17%
Nick Reunbrouck
5.75%
Peter Van Rompay
3.27%
Other Holders
43.38%
Based on transparency notifications and latest denominator
Based on online notification (FSMA website) of managers’ transactions
Hyloris
: Annual Report 2023
p 83
DIVIDENDS AND DIVIDEND POLICY
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.
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 2023
p 84
Contents
Consolidated Financial Statements as at 31 December 2023
      
86
Consolidated Statement of Financial Position
                                   
86
Consolidated Statement of Profit and Loss and Other Comprehensive Income
      
87
Consolidated Statement of Changes in Equity
                                   
88
Consolidated Statement of Cash Flows
                                         
89
Notes to the Consolidated Financial Statements
                    
90
Abbreviated Statutory Financial Statements
                       
142
Statutory Notes
                                                         
144
Statutory auditor’s report
                                             
146
Consolidated
Financial Statements
Hyloris
: Annual Report 2023
p 85
STATEMENT OF THE BOARD OF DIRECTORS
On 26 July, 2024
, 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.
Signed by Stijn Van Rompay (CEO) and Stefan Yee (Chairman) on behalf of the Board of Directors
Hyloris
: Annual Report 2023
p 86
Consolidated Financial Statements as
at 31 December 2023
ASSETS
(in € thousands)
Note
31 December 2023
31 December 2022
restated
1
Non-current assets
12,373
10,927
Intangible assets
7
3,828
3,607
Property, plant and equipment
429
176
Right-of-use assets
8
1,724
885
Equity accounted investees
9
3,801
3,948
Other investment, including derivatives
10
1,000
1,000
Trade and other receivables
11
1,591
1,311
Current assets
35,308
49,801
Trade and other receivables
11
3,565
4,127
Other investment, including derivatives
10
499
10,469
Current tax assets
233
244
-
Prepayments
12
594
1,748
Cash and cash equivalents
13
30,406
33,457
TOTAL ASSETS
47,681
60,728
EQUITY AND LIABILITIES
(in € thousands)
Note
31 December 2023
31 December 2022
restated
1
Equity
14
39,069
53,909
Share capital
140
140
Share premium
121,513
121,513
Retained earnings, excluding profit (loss) for the reporting period
(65,381)
(53,476)
Retained earnings, profit (loss) for the reporting period
(15,380)
(11,905)
Share based payment reserve
2,161
1,621
Cost of Capital
(4,460)
(4,460)
Other reserves
476
476
Liabilities
8,613
6,819
Non-current liabilities
1,853
1,047
Borrowings
15
1,510
747
Other financial liabilities
15
344
300
Current liabilities
6,759
5,772
Borrowings
15
241
138
Other financial liabilities
15
3,200
3,212
Trade and other liabilities
16
3,318
2,422
TOTAL EQUITY AND LIABILITIES
47,681
60,728
Consolidated Statement of Financial Position
1
See
note 31
regarding restated information
The accompanying notes on pages are an integral part of these consolidated financial statements.
Hyloris
: Annual Report 2023
p. 87
(in € thousand)
Note
2023
2022 restated
1
Revenues
18
2,087
900
Other operating income
21
2,127
1,487
Operating income
4,214
2,387
Cost of sales
19
(93)
(94)
Research and development expenses
19
(14,421)
(10,272)
General and administrative expenses
19
(5,546)
(3,517)
Share of result of equity-accounted investees, net of tax
9
(147)
(130)
Other operating expenses
19
-
(12)
Operating expenses
(20,207)
(14,024)
Operating profit/(loss) (EBIT)
(15,993)
(11,638)
Financial income
22
898
466
Financial expenses
22
(285)
(730)
Profit/(loss) before taxes
(15,380)
(11,901)
Income taxes
23
-
(4)
PROFIT/(LOSS) FOR THE PERIOD
(15,380)
(11,906)
Other comprehensive income
-
-
TOTAL COMPREHENSIVE INCOME OF THE PERIOD
(15,380)
(11,906)
Profit/(loss) for the period attributable to the owners of the Company
(15,380)
(11,906)
Profit/(loss) for the period attributable to the non-controlling interests
Total comprehensive income for the period attributable to the owners of the
company
Basic and diluted earnings/(loss) per share (in €)
24
(0.55)
(0.43)
Consolidated Statement of Profit or Loss and Other Comprehensive Income
1
See
note 31
regarding restated information
The accompanying notes are an integral part of these consolidated financial statements
Hyloris
: Annual Report 2023
p 88
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
reserves
Balance at 31 December 2021
129
103,693
2,391
(3,827)
476
(54,805)
48,056
Private Placement via an ABB
(
note 142
)
5
14,995
(634)
-
14,366
Transfer of SBP reserves to
retained earnings (
note 25
)
6
2,826
(1,329)
1,329
2,832
Share-based payments (
note 25
)
560
560
Total comprehensive income
(10,770)
(10,770)
Balance at 31 December 2022, as
previously reported
140
121,513
1,622
(4,460)
476
(64,246)
55,045
Impact of correction of errors
(
note 31
)
(1,136)
(1,136)
Balance at 31 December, 2022,
(restated)
140
121,513
1,622
(4,460)
476
(65,381)
53,909
Share-based payments (
note 25
)
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
Consolidated Statement of Changes in Equity
The accompanying notes are an integral part of these consolidated financial statements.
Hyloris
: Annual Report 2023
p. 89
(in € thousand)
Note
2023
2022
restated
1
CASH FLOW FROM OPERATING ACTIVITIES
Profit/(loss) for the period
(15,380)
(11,906)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation, amortisation and impairments
19
349
196
Share-based payment expense
25
540
560
Net finance result
22
(613)
264
Equity transaction costs
-
29
Share of profit of equity-accounted investees, net of tax
9
147
130
Losses on disposal of PPE
-
16
Other non-cash adjustments
15
16
Bank fees paid
(48)
-
Changes in working capital:
Trade and other receivables
11
29
(921)
Other investment, including derivatives
-
56
Prepayments
12
1,155
(650)
Trade and other liabilities
15
1,050
(468)
Cash generated from operations
(12,756)
(12,679)
Interest paid
15/22
(52)
7
Taxes paid
23
-
(349)
Net cash generated from operating activities
(12,808)
(13,020)
CASH FLOW FROM INVESTING ACTIVITIES
Interest received
22
638
Purchases of property, plant and equipment
(298)
(101)
Purchases of Intangible assets
7
(452)
(638)
Proceeds from settlement of derivatives
22
-
522
Acquisition in other investments
10
(0)
(500)
Loans made to third parties
11
-
(655)
Proceeds of other financial assets
10
10,000
(10,000)
Net cash provided by/(used in) investing activities
9,889
(11,373)
CASH FLOW FROM FINANCING ACTIVITIES
Reimbursements of borrowings and other financial liabilities
15
-
(7,376)
Proceeds from borrowings and other financial liabilities
15
51
-
Reimbursements of lease liabilities
15
(170)
(79)
Reimbursements of borrowings
-
-
Proceeds from Private Placement via ABB
14
-
14,337
Proceeds from Exercise of Warrants
14
-
2,832
Interests paid
15
(12)
(1,877)
Net cash provided by/(used in) financing activities
(131)
7,838
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
(3,051)
(16,555)
CASH AND CASH EQUIVALENTS at beginning of the period
33,457
50,012
CASH AND CASH EQUIVALENTS at end of the period, calculated
30,406
33,457
1
See
note 31
regarding restated information
The accompanying notes are an integral part of these consolidated financial statements.
Consolidated Statement of Cash Flows
Hyloris
: Annual Report 2023
p. 90
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 Conylox 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.
Armed conflict between Russia and Ukraine
The military action in Ukraine is an element of the
current uncertainty in the macroeconomic environment.
While we do not have operations in Russia or Ukraine,
sanctions and other measures taken in response to
the military action have adversely affected – and could
further affect – the global economy, financial markets
and the supply chain.
Current economic climate
The macroeconomic situation did not improve, the
inflation and interest rates continued to slightly increase
in 2023 impacting for example the internal discount
rates (higher risk free rate) used in the financial
valuation models. Furthermore, the fear of recession
and the geopolitical conflicts remained important and
continued to impact the energy prices in 2023. The
context of high interest rates combined with high energy
prices puts pressure on the costs in general as well as
on many APIs (active pharmaceutical ingredient). The
crisis in the Middle East, which disrupted supply chains
in the Suez Canal, did not impact the company because
it has diverse sources of supply. In general, the volatility
of interest rates introduces uncertainty into financial
markets and can influence investor behavior, company
finances, and consumer spending patterns. To mitigate
these risks, the company remains very cautious about
the level of its expenses and the size of its investments
without impacting the ongoing R&D development
programs.
The consolidated financial statements were authorized
for issue by the Board of Directors on 26 July, 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, 2023 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,
2023. 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. 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.
Hyloris
: Annual Report 2023
p. 91
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 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 to be
adopted as from 2023 onwards
In 2021 the IASB issued Disclosure of Accounting
Policies (Amendments to IAS 1) and updated IFRS
Practice Statement 2 Making Materiality Judgements.
IAS 1 Presentation of Financial Statements has been
amended to require companies to disclose ‘material’
rather than ‘significant’ accounting policies. Although
the amendments did not result in any changes to the
accounting policies themselves, they impacted the
accounting policy information disclosed in the financial
statements. Management reviewed the accounting
policies and made updates to the information disclosed
in certain instances in line with the amendments.
Other pronouncements issued by the IASB have not
been disclosed as the Company considers these as not
relevant to the business of the Group.
A number of new standards, amendments to standards
and interpretations are not yet effective for the year
ended 31 December 2023, and have not been applied in
preparing these consolidated financial statements:
Amendments to IAS 1 Presentation of Financial
Statements:
Classification of Liabilities as Current or Non-current
Date (issued on 23 January 2020);
Classification of Liabilities as Current or Non-current
- Deferral of Effective Date (issued on 15 July 2020);
and
Non-current Liabilities with Covenants (issued on 31
October 2022)
Amendments to IAS 1 Presentation of Financial
statements
: Classification of Liabilities as Current
or Non-current, issued on 23 January 2020, clarify a
criterion in IAS 1 for classifying a liability as non-current:
the requirement for an entity to have the right to defer
settlement of the liability for at least 12 months after the
reporting period.
The amendments:
specify that an entity’s right to defer settlement
must exist at the end of the reporting period;
clarify that classification is unaffected by
management’s intentions or expectations about
whether the entity will exercise its right to defer
settlement;
clarify how lending conditions affect classification;
and
clarify requirements for classifying liabilities an
entity will or may settle by issuing its own equity
instruments.
On July 15, 2020, the IASB issued
Classification of
Liabilities as Current or Non-current — Deferral of
Effective Date (Amendment to IAS 1)
deferring the
effective date of the January 2020 amendments with one
year.
On October 31, 2022, the IASB issued
Non-current
liabilities with Covenants, which amends IAS 1
and specifies that covenants (i.e. conditions specified
in a loan arrangement) to be complied with after the
reporting date do not affect the classification of debt as
current or non-current at the reporting date. Instead,
the amendments require a company to disclose
information about these covenants in the notes to the
financial statements.
All amendments are effective for annual reporting
periods beginning on or after 1 January 2024, with
early adoption permitted. The amendments have been
endorsed by the EU.
Amendments to IFRS 16 Leases: Lease Liability in a
Sale and Leaseback, issued on 22 September 2022,
introduce a new accounting model which will impact
how a seller-lessee accounts for variable lease
payments in a sale-and-leaseback transaction.
Hyloris
: Annual Report 2023
p. 92
Under this new accounting model for variable payments,
a seller-lessee will:
include estimated variable lease payments when it
initially measures a lease liability arising from a sale-
and-leaseback transaction; and
after initial recognition, apply the general
requirements for subsequent accounting of the
lease liability such that it recognizes no gain or loss
relating to the right of use it retains.
These amendments will not change the accounting for
leases other than those arising in a sale and leaseback
transaction. The amendments apply retrospectively for
annual periods beginning on or after 1 January 2024
with early application permitted. These amendments
have been endorsed by the EU.
Amendments to IAS 7 Statement of Cash Flows
and IFRS 7 Financial Instruments: Disclosures:
Supplier Finance Arrangements,
issued on 25 May
2023, introduce additional disclosure requirements
for companies that enter into supplier finance
arrangements. The amendments are effective for
periods beginning on or after 1 January 2024, with
early application permitted. However, some relief
from providing certain information in the year of initial
application is available. These amendments have not yet
been endorsed by the EU.
Amendments to IAS 21 The Effects of Changes in
Foreign Exchange Rates: Lack of Exchangeability,
issued on 15 august 2023, clarify when a currency 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
not yet 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, i
ssued 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
Hyloris
: Annual Report 2023
p. 93
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.
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.
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
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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 araising 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
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 currrency 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
December 31, 2022
1.0666
1.0530
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:
Hyloris
: Annual Report 2023
p. 95
(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
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 amortised 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
Hyloris
: Annual Report 2023
p. 96
databases and payments made to purchase generics
dossiers are also capitalized as the conditions
mentioned above are met upon acquisition, and
amortised 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 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;
(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 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 amortisation and
any accumulated impairment losses. Intangible assets
are amortised on a systematic basis over their useful
life, using the straight-line method. Amortisation begins
when the asset is capable of operating in the manner
intended by management.
The estimated useful life and amortisation 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 amortisation 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.
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: Annual Report 2023
p. 97
26
LEASES
Leases are recognized as a right-of-use asset and
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
amortised 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 amortisation, 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
amortisation 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 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.
Hyloris
: Annual Report 2023
p. 98
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 the Group has 3 commercialized products for
which royalties are recorded, i.e., Sotalol IV, Maxigesic®
IV and Podofilox (in 2022 there were 2 commercialized
products, i.e., Sotalol IV and Maxigesic® IV). 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
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 assess
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:
Hyloris
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p. 99
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, 2023, 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 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 amortised 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.
A financial asset is measured at amortised 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
amortised 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).
Hyloris
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p 100
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 amortised 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 amortised 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 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.
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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 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, ie. 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 investments,
including derivatives 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
amortisation 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.
Hyloris
: Annual Report 2023
p 102
Recoverable cash advances
With respect to recoverable cash advances (RCA –
“avances récupérables”), the RCA gives rise to a financial
liability in the scope of IFRS 9 – Financial Instruments.
This financial liability is initially measured at fair value
and any difference with the cash to be received from
the authorities is treated as a government grant in
accordance with IAS 20 – Accounting for Government
Grants and Disclosure of Government Assistance.
Subsequent to the initial recognition, the financial
liability is measured at amortised cost using the
effective interest method on the basis of the estimated
contractual cash flows with changes in value due to a
change in estimated cash flows recognized in profit or
loss, in accordance with IFRS 9.
R&D Tax Credit
In Belgium, companies that invest in environmental
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, 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 amortised together with
the underlying assets.
Exemption payroll taxes
The Group applies for the program of partial exemption
from payment of withholding tax for organizations
employing researchers.
This measure allows companies not to pay the tax
authorities up to 80% of the withholding tax on the
salaries of staff working on innovative and R&D projects.
As of 2023, these payroll tax rebates are recognized
in the line Other Operating Income in the financial
statements. See
note 31
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. 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.
Hyloris
: Annual Report 2023
p 103
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 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 r 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 amortised 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 amortised 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. Borrowings are
classified as current liabilities unless the Group has an
unconditional right to defer settlement of the liability for
at least 12 months after the end of the reporting period.
Hyloris
: Annual Report 2023
p 104
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 recognized at fair value.
When a financial liability measured at amortised 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.
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 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, 2023, its
audited consolidated statement of profit and loss and
other comprehensive income reflects a net loss as well
as a loss carried forward. On 26 July 2024, the Board
reviewed and approved the audited consolidated
financial statements and accounting policies. Taking
into account the cash and cash equivalents of €30.4
million on December 31, 2023, the evolution of the
expected cash generated by the commercial revenues
from the three products, the revenue from the out-
license agreements expected in 2024, the expected
R&D expenses and the risk assessment related to the
US litigation with Alta Thera (see
note 26
), the Board is
of the opinion that the audited consolidated financial
statements are prepared under the assumption of going
concern. Whilst the current cash position is sufficient
for the Company’s to continue the development of
the current portfolio of product candidates, the Board
pointed out that if the research and development
activities related to the new product candidates as from
2024 continue to deliver added value, the Company
may seek additional funding to support the continuing
development of its portfolio of new product candidates
or to be able to execute other business opportunities.
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.
Hyloris
: Annual Report 2023
p 105
Arrangement with Purna Female Healthcare
In February 2021, Hyloris and Purna Female Healthcare
(‘PFH’) entered into a partnership to develop and
commercialise an innovative combination therapy for
the treatment of severe and recurrent vulvovaginal
candidiasis (rVVC). PFH 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 PFH (of which EUR 1.3 million is
already paid). Hyloris holds 20% of the shares in PFH
(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 PFH 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 PFH
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 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.
Purna Female Healthcare is a related party, see n
ote
281
Arrangement with Pleco Therapeutics
In November 2021, Hyloris and Pleco Therapeutics
signed an agreement to co-develop and register PTX-
252, 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 will provide €1 million
(automatically convertible into Pleco Therapeutics
equity under certain conditions) in several tranches
over time (already converted at 100%) and has obtained
global exclusive co-development rights and future joint
commercialisation to the Pleco technology in AML and
SCLC. Hyloris may commit to fund
(not equity) up to
an additional €7.7 million in pre-defined R&D activities
through to submission for approval in AML, plus initial
exploratory development work in SCLC. Pleco will fund
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 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.
Hyloris agrees to transfer its co-ownership rights
on the patent and patent applications to Pleco in
order for Pleco to be able to provide a pledge to the
innovation credit (“Innovatiekrediet”) as a security
for the reimbursement of the innovation credit
(“Innovatiekrediet”). 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 as originally agreed
in the collaboration agreement. The innovation credit
will be reimbursed to the authorities with the first profit
share payments under the collaboration agreement and
payment of the profit share will be subordinated until
full reimbursement of the innovation credit.
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.
The nature of 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 innovation
credit
(“Innovatiekrediet”) made available to Pleco,
further invoicing will be postponed until additional
amounts are made available of the innovation credit
Hyloris
: Annual Report 2023
p 106
(“Innovatiekrediet”) 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 as discussed in
note 312
. 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.
End of December 2023, Hyloris held an ownership
interest of 4.50% in Pleco Therapeutics (corresponding
to 5.35% of the voting rights). Hyloris 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.
Arrangement with Vaneltix
In December 2021, Hyloris has entered into a strategic
collaboration with Vaneltix Pharma, Inc. (‘Vaneltix’) for
the development and commercialisation of Alenura
TM
as first-line drug treatment for acute pain in interstitial
cystitis/bladder pain syndrome (IC/BPS).
Until now, Hyloris has committed to provide a maximum
of $6.7 million for supporting development related
activities and a loan of $0.5 million.
Hyloris will be eligible to receive a tiered percentage
of the product margin generated by Vaneltix. The
arrangement constitutes a joint operation.
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 co-development agreement and are 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.
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.
End of December 2023 Hyloris:
Invested $2.8 million for supporting development
related activities;
Subscribed to series D convertible preferred stock in
October 2023 for an amount of $2.0 million.
Hyloris provided a loan of $0.5 million to Vaneltix. In
relation to the settlement of this loan we refer note 10.
Hyloris holds 4 shares of Vaneltix and is not represented
on the Board of Directors of Vaneltix.
Vaneltix is a related party, see
note 281
.
Although Hyloris is holding less than 1% of the 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
Hyloris
: Annual Report 2023
p. 107
Vaneltix primarily focused of the development of this
product only (other product candidates are in a very
early stage of development).
There is interchange of people as
Carolyn Myers
(non-executive director of Hyloris) has a limited role at
Vaneltix as head of commercial affairs. In addition, her
partner, Dr. Dan Vickery is CEO of Vaneltix.
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.
Arrangement with AFT
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.
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
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 during the year
is calculated using the Black-Scholes pricing model.
This pricing model requires the input of subjective
assumptions, which are detailed in
note 25
.
4. FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
4.1
OVERVIEW OF FINANCIAL INSTRUMENTS
    
IFRS 9 Category
Input Level
(in € thousand)
December
December 31,
31, 2023
2022 Restated
*
Investment in Pleco (
note 10
) (non current)
FVOCI
3
1,000
1,000
Loan to Vaneltix (
note 10
)
At amortised cost
499
469
Loan to API (
note 11
)
FVTPL
3
317
490
Trade receivables (
note 11
)
At amortised cost
2,970
3,527
Cash and cash equivalents
At amortised cost
30,406
33,457
Other investment, including derivatives – Deposits (
note 10
)
At amortised cost
-
10,000
Total financial assets
35,192
48,943
Borrowings (
note 151
)
At amortised cost
1,750
885
Other financial liabilities (
note 152
)
At amortised cost
3,543
3,512
Trade and other liabilities (
note 16
)
3,195
2,352
Trade payables
At amortised cost
3,195
2,302
Derivative
FVTPL
2
-
52
Total financial liabilities
1
8,488
6,749
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
*
See note 31 regarding restated information
Hyloris
: Annual Report 2023
p 108
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, 2022 and 2023. In 2023
and 2022 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 on product candidates
in 2029. The change compared to last year is mainly due
to the assumption that the offset of the loan will happen
in 2029 instead of 2024 and that the determination of
the fair value was impacted by a change in the risk-
adjusted rate from 10.71% to 11.6%.
FX forward contracts: Forward pricing: the fair value
is determined using the spot FX exchange rates at the
reporting date and FX forward price in the contract.
There are no outstanding FX forward contracts at
December 31, 2023.
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,
 
2023
2022* restated
Assets
3,466
4,153
Liabilities
(817)
(1,078)
See note 31.3: restatement of the API loan
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. Comparative information for 2022: 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 - €29 thousand and + €29 thousand
respectively.
By default, the company uses natural hedging 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 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
Hyloris
: Annual Report 2023
p. 109
collaboration partners. Credit risk refers to the risks that
counterparty will default on its contractual obligations
resulting in financial loss to the Company.
At the end of 2023, the Company operated with about
10 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 €2,970 million
as of December 31, 2023, and no allowance for expected
credit loss was recorded in 2023, neither the last years.
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 current
trade receivables exposure with AFT amounted to
€2,124 million at the end of 2023. This amount has been
reduced in first quarter 2024 with payments of €495
thousand leading to reduce the AFT’s trade receivables
to €1,629 thousand. In April 2024 AFT paid the
outstanding receivable for an amount of €921 thousand.
The remaining unpaid part is paid in the second quarter
of 2024.
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 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 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 capital increases and
revenues. See
Note 14.2 Capital Management
. 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
after the completion of the dose finding study which
is expected in Q3 2024 and the other €1.5 million is
after the process validation report and completion of
enrollment of the phase 3 studies.
Hyloris
: Annual Report 2023
p 110
   
31/12/2023
Within one
>1 and <5
>5 and <10
>10 years
Total
(In € thousand)
year
years
years
   
Borrowings
         
Lease liabilities
241
871
639
 
1,751
Other financial liabilities
         
Other financial liabilities
3,200
344
   
3,544
Trade and other liabilities
3,318
     
3,318
Total
6,759
1,215
639
 
8,613
   
31/12/2022
Within one
>1 and <5
>5 and <10
>10 years
Total
(In € thousand)
year
years
years
   
Borrowings
         
Lease liabilities
138
492
255
 
885
Other financial liabilities
         
Loans from shareholders
         
Other financial liabilities
3,212
300
   
3,512
Trade and other liabilities
2,422
     
2,422
Total
5,772
792
255
 
6,819
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.
Total revenue represents an amount of €2,1 million.
The revenue relates 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 to PFH for €54
thousand. In 2022 the revenue related to royalties is
€885 thousand for Sotalol IV and Maxigesic IV, and an
out-license agreement that provides a right to use for
€15 thousand.
In 2023 there are 3 customers individually exceeding
10% of total revenues: client A for an amount of €804
thousand, client B for an amount of €881 thousand and
client C for an amount of €244 thousand.
Those 3 customers are representing 92% of the total
recognized revenues.
In 2022 there were 2 customers individually exceeding
10% of total revenues: client A for an amount of €190
thousand and client B for an amount of €695 thousand,
representing 98% of the total revenues.
Hyloris
: Annual Report 2023
p 111
In € thousand
2023
2022
Royalties
1,929
885
Out-license agreements
104
15
Milestones
54
-
Total revenues
2,087
900
In the revenue recognition there are no material
contingencies nor amounts which are subject to
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: €1,125 thousand.
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, 2023
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 Supply 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, 2023
         
Opening carrying amount
1,678
685
1,125
119
3,607
Additions
325
     
325
R&D Tax Credit
(11)
     
(11)
Disposals
         
Reclassification
119
   
(119)
-
Amortisation expense
(50)
(43)
   
(93)
Impairment losses
         
Closing carrying amount
2,061
642
1,125
-
3,828
At December 31, 2023
         
Cost
2,640
4,247
1,148
 
8,036
Accumulated amortisation and impairment
(580)
(3,605)
(23)
-
(4,208)
Carrying amount
2,061
642
1,125
-
3,828
(in € thousand)
Development Costs
Assets Purchase
License fees
Prepayments
Total
Year ended December 31, 2022
         
Opening carrying amount
1,090
729
1,125
 
2,944
Additions
660
   
119
779
R&D Tax Credit
(22)
     
(22)
Disposals
       
-
Amortisation expense
(50)
(44)
   
(94)
Impairment losses
         
Closing carrying amount
1,678
685
1,125
119
3,607
At December 31, 2022
         
Cost
2,208
4,247
1,148
119
7,722
Accumulated amortisation and impairment
(530)
(3,561)
(23)
 
(4,115)
Carrying amount
1,678
685
1,125
119
3,607
Hyloris
: Annual Report 2023
p 112
In 2023, the Company acquired intangible assets for
a total of €325 thousand, of which (i) €74 thousand
related to the development costs of product-candidate
Maxigesic® IV and (ii) €249 thousand related to the
development costs of HY-078.
Grouping of intangible assets of a similar nature and use:
Capitalized development costs: external incurred
development costs. Sotalol 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 and Milrinone.
The 4 largest product or product candidates in terms of
intangible assets are Maxigesic® IV (carrying amount:
€1,188 thousand), Podofilox gel (carrying amount: €632
thousand), Aspirine IV U.S. (carrying amount: €623
thousand) and Tranexamic Acid Mouth Rinse (carrying
amount: €433 thousand). Only for Maxigesic® IV, the
intangible assets are amortised. Since the commercial
sales for Podofilox gel is launched in mid December
2023, the amortization will start in 2024.
The intangible assets are not amortised until the
moment they are available for use as intended by
management, i.e. ready for commercialisation. The
company is amortizing since 2014 the development
costs of Sotalol IV, an asset for which regulatory
approval had been obtained. The development costs
of Sotalol IV have a remaining useful life of 1 year. In
2022 the Company has started the amortisation of
the development costs of Maxigesic® IV for the 38
countries outside the United States of America where
market approval is obtained. In 2024 when the product
is available for use in the United States of America the
amortisation will start for that market as well.
The amortisation expenses are included in “Cost
of sales” in the consolidated statement of profit or
loss and other comprehensive income. The applied
amortisatization rate for all classes of assets is 10%.
As long as the assets are not fully amortised, they are
tested for impairment if specific indicators are 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 11.85%
(was 11.26% in 2022).
The main input that lead to a discount rate of 11.85%
are:
a risk free rate of 2.58% corresponding to the 10-
year OLO rate as of December 31, 2023 (3.18% last
year)
a beta factor of 0.96 (1.24 last year)
a market risk rate of 2.77% (2.07% last year);
a Company specific risk premium of 6.60% (no
change compared to last year)
a cost of debt before tax of 6% (no change
compared to 2022)
We tested the sensitivity analysis of the impairment
tests by increasing the discount rate by 4%, leading the
discount rate to 15.85%. 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.
Hyloris
: Annual Report 2023
p 113
8. RIGHT-OF-USE ASSETS
   
(in € thousand)
Land and buildings
Vehicles and equipment
Total
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
Year ended December 31, 2022
     
Opening carrying amount
102
71
173
Additions
825
32
857
Depreciation expense
(44)
(27)
(71)
Disposals
(75)
-
(75)
Closing carrying amount
809
76
885
At December 31, 2022
     
Cost
825
184
1,251
Accumulated depreciation and impairment
(16)
(109)
(367)
Carrying amount
809
76
885
The depreciation expenses are all presented as “General
and administrative expenses”.
The Group leases its headquarter building and all
company cars. In 2023 the Group started with a new
lease contract for the labs. The 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 Group signed a lease contract for equipment in the
lab which commences in February 2024. The total cash
flow for the period of 3 years is €153 thousand.
The amounts recognized in profit or loss can be
summarized as follows:
   
(in € thousand)
2023
2022
Depreciation expense of right-of-use
(194)
(71)
assets
   
Interest expense on lease liabilities
(52)
(10)
Total amount recognized in profit or
(220)
(83)
loss
   
of which as:
   
General and administrative expenses
(168)
(73)
(note 19)
   
Financial expenses (note 22)
(52)
(10)
9. EQUITY ACCOUNTED INVESTEES
On 5 February 2021, the Group entered into a
partnership with Purna Female Healthcare (“PFH”),
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 PFH
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 is included in the carrying
amount which is justified by the potential of the product
Hyloris
: Annual Report 2023
p 114
candidate. Hyloris committed to an investment of €4,270
thousand, of which €1,270 thousand is already 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 PFH (later payments 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 PFH. As long as there is no commercialization of the
product candidate, 20% presents the Group’s economic
interest in PFH’s net assets. Hence the future economic
interest of Hyloris in PFH will be changed and will be
driven by the profitability of the company.
   
(in € thousand)
December 31,
December 31,
 
2023
2022
Opening carrying value
3,948
4,078
Profit or loss of the period
(147)
(130)
Carrying amount at
3,801
3,948
December 31
   
The following tables summarize the financial
information of PFH as included in its own financial
statements, adjusted for fair value and differences in
accounting policies, if needed. The negative results of
2021, 2022 and 2023 are in line with the estimated R&D
costs for this specific project. No other impairment
indicators are identified. The table below is restated
for 2022 as the line Uncalled capital contribution was
presented in Amounts receivable within one year in
prior year figures.
   
(in € thousand)
31-Dec-23
31-Dec-22
   
Restated
FIXED ASSETS
   
CURRENT ASSETS
834
1,495
Amounts receivable within one year
36
26
Cash at bank and in hand
798
1,469
TOTAL ASSETS
834
1,495
CAPITAL AND RESERVES
758
1,495
Capital
6,103
6,103
Uncalled capital contribution
(3,000)
(3,000)
Accumulated profits (losses)
(2,345)
(1,608)
PROVISIONS AND DEFERRED TAXES
   
CREDITORS
76
0,35
Amounts payable within one year
76
0,35
TOTAL LIABILITIES
834
1,495
   
(in € thousand)
2023
2022
Operating income
-
-
Operating charges
-737
-651
Services and other goods
-736
-649
Other operating charges (-)
-1
-2
Operating profit (loss)
-737
-651
Profit (Loss) for the period before
-737
-651
taxes (-)
   
Profit (loss) for the period
-737
-651
available for appropriation
   
Hyloris’ % of interest
20
20
Profit (loss) for the period
-147
-130
available for appropriation (20%)
   
Reconciliation between (a) the 20% of rights to net
assets applied to PFH’s equity/net assets and (b) the
carrying amount of Hyloris’ interest in PFH:
(a) 20% of 4,200 shares: 840 shares
The total equity of PFH 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, €1,500 thousand after the completion
of the dose finding study required for being able
to start a phase 3 study, expected in Q3 2024
and another €1,500 thousand after process the
validation report for 6 months stability data on
regristration batches and completion of enrollment
of the phase 3 studies (see
note 46
).
(b) 3,801 thousand
Committed investment of Hyloris:
€4,270 thousand
- 20% of Retained earnings of PFH (loss): €469
thousand
= Hyloris’ carrying amount in PFH:
€3,801 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 PFH. Before a commercial launch no
Hyloris
: Annual Report 2023
p 115
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 shareholder’s agreement. When PFH 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 PFH 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 PFH
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).
Transactions with PFH
In 2023 Hyloris invoiced PFH for a total amount of
€55 thousand related to PIND/IND services (€45k) and
CRO selection and qualification services (€9k)
Vaneltix
On 17 October 2023, the Group has subscribed to a
capital increase of Vaneltix for an amount of $2 million
in Vaneltix. The capital increase is against 4 fully paid
and non-assessable shares of the Series D Preferred
Stock of Vaneltix for $500 thousand. The 2 mio was
provided to cover R&D costs and has been recognized as
R&D expenses.
The following tables summarize the financial
information of Vaneltix as included in its own financial
statements.
(in € thousand)
31-Dec-23
FIXED ASSETS
6
CURRENT ASSETS
800
Amounts receivable within one year
271
Cash at bank and in hand
491
Prepayments
38
NON CURRENT ASSETS
126
Right-of-use assets
108
Other non current assets
18
TOTAL ASSETS
932
CAPITAL AND RESERVES
(3,243)
Capital
30,712
Accumulated profits (losses)
(-33,955)
CURRENT LIABILITIES
3,394
Provisions
1,355
Creditors
2,039
NON CURRENT LIABILITIES
781
Creditors
781
TOTAL EQUITY + LIABILITIES
932
(in € thousand)
2023
OPERATING INCOME
11
Licensing fees
11
OPERATING EXPENSES
1,832
Research and development
1,433
General and administrative
399
Operating profit (loss)
(1,821)
Other income and expenses, net
94
Profit (Loss) for the period before taxes (-)
(1,727)
Profit (loss) for the period available for appro
-
(1,727)
priation
Transactions with Vaneltix
In 2023 there were services provided to Vaneltix
for
a total amount of €145 thousand. 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 co-development
agreement and are 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.
The Group applies the Equity method in the
consolidated financial statements as the Group has
Hyloris
: Annual Report 2023
p 116
significant influence over Vaneltix (refer to note 3.2).
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.
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 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), the carrying amount would be zero.
10. OTHER INVESTMENT, INCLUDING
DERIVATIVES
The other investment, including derivatives can be
detailed as follows:
(in € thousand)
December
December
31, 2023
31, 2022
Restated
1
Term Deposits
-
10,000
Shares Pleco Therapeutics BV
1,000
1,000
Optional convertible loan
499
469
Other Investment,
1,499
11,469
including derivatives
of which as:
Non-current
1,000
1,000
Current
499
10,469
1
See
note 31
regarding restatement information
Term Deposits
At the end of 2022, two deposits for a total amount
of €10 million are reclassified from cash and cash
equivalents to other investments as they don’t meet the
criteria to be presented as cash equivalents. The term of
1 deposit was from December 13 2022 till June 13 2023
and the term of the other deposit is from December
13 2022 till September 13 2023. They could not be
withdrawn, in whole or in part, prior to the due date of
the term deposit.
Shares: Pleco Therapeutics BV
In 2021, the Group entered into a partnership with Pleco
Therapeutics to develop PTX-252, a novel combination
product of chelating agents 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 €2,216 million have been
already financed.
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 2023 the Group had a few purchase and sale
transactions with Pleco Therapeutics. The sales are
related to billed strategic advice for an amount of €500
thousand (see
note 32
) and the purchases are for
product development related services regarding pre-
clinical, clinical and CMC-related activities for a total
amount of €2,216 thousand. At 31 December 2023 the
outstanding commitment is €5,484 thousand (€7,700
thousand - €2,216 thousand).
Optional convertible loan
On 13 December 2021, the Group entered into a
collaboration with Vaneltix Pharma, Inc. (a related party
of Hyloris) for the development and commercialisation
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”).
Hyloris
: Annual Report 2023
p. 117
A loan amendment dated 17 October 2023 extended
the reimbursement date from 31 December 2023 to 31
August 2024. 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 $4,700 thousand has already
been provided.
In 2023, Hyloris incurred 2,744 thousand of R&D
expenses.
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, 2023
31, 2022
1
Trade receivables
2,970
3,527
API
317
490
Alter Pharma
-
395
R&D Tax Credits
1,256
811
TM
Tax Credit - Alenura
368
-
Interests on deposits
-
57
VAT
218
148
Other amounts receivable
26
10
Total trade and other receivables
5,156
5,438
or which as:
Current
3,565
4,127
Non Current
1,591
1,311
1
See
note 31
regarding restated information
The carrying amount of the Group’s trade receivables
(gross) is mainly denominated in USD resutling from
royalties and milestones.
After the closing period of December 31, 2023 AFT has
paid €1,440 thousand.
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.
Other amounts receivable mainly includes guarantees.
API
A loan to API of of €633 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 an interest
market rate and appropriate credit risk resulting in the
recognition of a loss of €173 thousand recognized as
financial expenses in 2023. For comparative information,
the financial expense in 2022 was €167 thousand. The
decrease of the fair value in comparison with 2022 is
due to the increase of the discount rate and the changed
assessment of term of the loan (6 years vs 3 years) and
the unrealized FX difference impact (€30 thousand).
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. The discount rate has been determined
by using the market rate and the company risk premium
(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 with €37 thousand or decreases
with €34 thousand. When the discount rate increases or
decreases with 1%, the fair value of the loan decreases
with 6% €20 thousand or increases with €21 thousand.
Alter Pharma
The balance sheet as at 31 December 2022 held a
current receivable from the Alter Pharma Group
for €395 thousand which has been paid in 2023 in
accordance to the settlement agreement signed by
Alter Pharma in 2021. The receivable is related to a
prepayment of R&D expenses to Alter Pharma Group.
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
Hyloris
: Annual Report 2023
p 118
grant and that the grant will be received. The Group
recognized R&D tax credits for a total of €434 thousand
in Other Operating Income (see
note 21
) and €11
thousand in Intangible assets (see
note 7
). No cash is
expected before 2025 based on the tax regulation.
Tax Credit - Alenura
TM
A Tax Credit of €368 thousand was granted from an
American state government for the clinical development
costs of the Alenura
TM
product candidate which were
incurred in 2022. The Tax Credit is recognized when the
approval of the grant request has been confirmed by the
authorities. Two other requests for a Tax Credit related
to development costs of the Alenura
TM
product for an
amount of approximately €724 thousand are being
assessed by the American state authorities and have not
been recognized.
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.
Pre-paid R&D expenses of €1,089 thousand were
incurred in 2023 and released in the profit and loss and
related to the development agreement with Vaneltix (a
related party of Hyloris) to run the development of the
Alenura
TM
product candidate (see
note 27
) and is the
main driver of the decrease compared to December 31,
2022 (€ 1,748 thousand).
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.
13. CASH AND CASH EQUIVALENTS
The net cash position as presented in the consolidated
statement of cash flows is as follows:
(in € thousand)
December 31,
December 31,
2023
2022 restated
*
Cash at bank
20,196
13,457
Short-term deposit
10,210
20,000
Total cash
30,406
33,457
and cash
equivalents
*
See
note 31
regarding restated information
The term of the only deposit outstanding is from
January 3, 2023 to January 3, 2024. It is classified as
cash equivalent as the nominal value of €10 million can
be withdrawn considering a notice period of 32 days.
A penalty is due if the amounts are withdrawn during
the entire term. The penalty due depends on when the
deposit is withdrawn, during the initial 180 days the
penalty amounts to 50% of the already earned interest
and after the initial 180 days the penalty amounts to
25% of the already earned interest. The term of the
deposit at year-end 2022 is from September 1, 2020 to
September 1, 2023. The nominal value of €20 million can
be withdrawn considering a notice period of 32 days.
There is no additional penalty stipulated in the contract,
however, no interest will be earned during the notice
period of 32 days.
14. EQUITY
14.1
OVERVIEW
(in € thousand)
December 31,
December 31,
2023
2022
*
Share capital
140
140
Share premium
121,513
121,513
Retained earnings
(80,761)
(65,381)
Other reserves
(1,823)
(2,363)
Total Equity
attributable
39,069
53,909
to
owners of the
parent
*
See
note 31
regarding restated information
14.2
CAPITAL MANAGEMENT
The Group manages its capital to maintain a strong level
of capital in order to sustain development of the business
and confidence of creditors while optimizing return
on capital for shareholders. This ensures that entities
Hyloris
: Annual Report 2023
p. 119
in the Group will be able to continue as going concern
while maximizing the return to stakeholders through the
optimization of its debt and equity balance. 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 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.
On March 31, 2022, the Company has successfully raised
an amount of €15 million in gross proceeds, from new
and existing, local and international investors, through
an equity offering by means of a private placement via
an accelerated bookbuild offering of 967,742 new shares
(being approximately 3.7% of the Group’s outstanding
shares (pre-transaction) at an issue price of EUR 15.50
per share (the “Offering”), representing a discount of
1.6% to the 30-day VWAP.
On June 20, 2022 Hyloris increased Capital and Share
Premium with respectively €6 thousand and €2,826
thousand through the issuance of 1.200.000 new shares
resulting from outstanding Transaction Warrants
exercised.
The Group uses the net proceeds of the Offering
primarily to fund the development of new products and
accelerate in-house R&D activities.
Equity transactions
Gross proceeds
Equity transaction costs
Expensed in P&L
Net proceeds
(In € thousand)
Accelerated
Bookbuilding
15,000
(634)
(29)
14,337
Exercise of warrants (see
note 25
)
2,832
(14)
2,818
Total
17,832
(634)
(43)
17,155
14.3
SHARE CAPITAL AND SHARE PREMIUM
Share Capital
As per December 31, 2022 and December 31, 2023, 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.
As per December 31, 2023, the remaining authorized
capital amounted to €110,920.13 (no change with
December 31, 2022).
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).
Hyloris
: Annual Report 2023
p 120
The following capital transactions have taken place since January 1, 2017:
Increase of share
Number of
Issue price / share
Number of
Date
Transaction
capital (incl. share
securities
(rounded, incl.
shares after the
premium) (€)
issues
share premium) (€)
transaction
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
to 4)
-
17,801,768
30 June 2020
IPO on Euronext
61,821,500
5,750,000 shares
10.75
23,551,768
30 June 2020
Conversion of convertible bonds
15,358,025
2,040,864 shares
10.75
25,592,632
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 exercised
2,832,000
1,200,000 shares
2.36
28,000,374
2
Accounting wise, the share issue of December 2019 was accounted for as from the date of establishment of common control in Dermax.
Share premium
As per December 31, 2022 and December 31, 2023,
the share premium of the Group amounts to €121,513
thousand.
Other reserves
(in € thousand)
December 31,
December 31,
2023
2022
Share based payment
2,161
1,622
Cost of Capital
(4,460)
(4,460)
Other
476
476
Total Other reserves
(1,824)
(2,362)
The movement of the other reserves over the period can
be explained by the increase of €539 thousand resulting
from the share based payment expenses associated
with the ESOP warrants (see
note 25
).
15. BORROWINGS AND OTHER
FINANCIAL LIABILITIES
15.1
BORROWINGS
(in € thousand)
December 31,
December 31,
2023
2022
Lease liabilities
1,751
885
Total borrowings
1,751
885
of which as:
Non-current borrowings
1,510
747
Current borrowings
241
138
For more details on the leases, we refer to
note 8
on
“Right-of-use assets”.
The main increase in the lease liabilities is mainly due
to the leasing of the new lab which is in use since June
2023.
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 3.12%. 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,
2023
2022
Recoverable cash advance
44
-
Other financial liabilities
3,500
3,512
Other financial liabilities
3,544
3,512
of which as:
Non-current other financial
344
300
liabilities
Current other financial
3,200
3,212
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
Hyloris
: Annual Report 2023
p 121
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 when the related costs are incurred. 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. The variable
part of the refundable advance will be reimbursed via
royalties to be paid as of commercialization.
Other financial Liabilities
With no change with last year, The Group has license
agreements with Alter Pharma Group, for which a
non-current other financial liability of €300 thousand
and a current financial liability of €200 thousand is
outstanding. The payments are are due when certain
milestones are reached: €200 thousand is due upon the
first commercial launch of Maxigesic® IV in the United
States and €300 thousand is payable upon reaching
a worldwide annual sales threshold of €50 million for
Maxigesic® IV.
Committed to milestone related investments
(contributions to the equity) in Purna Female Healthcare
(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
31/12/2023 (in € thousand)
Opening
carrying
amount
Cash flows
Acquisition
Interest ex
-
penses leases
Modification
Termination
Re-classes
Accrued
interests and
exchange
differences
Closing
carrying
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 liabilities
(170)
Financing activities - proceeds from borrowings and other
51
financial liabilities
Operating activities - interest paid
(52)
Hyloris
: Annual Report 2023
p 122
Non-cash movements
31/12/2022 (in € thousand)
Opening carrying
amount
Cash flows
Acquisition
Interest expenses
leases
Modification
Termination
Re-classes
Accrued interests
and exchange
differences
Closing carrying
amount
Non-current financial liabilities
Lease liabilities
109
-
747
(18)
(91)
-
747
Other financial liabilities
300
300
Current financial liabilities
Lease liabilities
65
(79)
102
(44)
91
134
Other financial liabilities
11,812
(9,253)
0
482
0
168
3,212
Total liabilities from financing activities
12,290
(9,332)
848
482
(62)
0
168
4,394
Presented in the statement of cash flows
as follows:
Reimbursement of borrowings and other financial liabilities
(9,253)
and interest paid
Reimbursement of lease liabilities
(79)
16. TRADE AND OTHER LIABILITIES
(in € thousand)
December 31,
December 31,
2023
2022
Trade payables
3,195
2,302
Employee benefit liabilities
116
68
Other payables
-
52
Deferred income
7
-
Trade and other liabilities
3,318
2,422
- Current
The trade payables relate mainly to the R&D activities
,
payables for lawyers for the litigation case (
note 26
) 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
.
17. 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 future against which the
tax losses or tax credits can be utilized, no deferred tax
asset has been recognized as of 31 December 2023.
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:
Hyloris
: Annual Report 2023
p 123
31-Dec-23
31-Dec-22 restated
1
(in € thousand)
Deferred tax
Deferred tax
Deferred tax
Deferred tax
asset
liability
asset
liability
Intangible assets
17
17
17
17
RoU Asset
-
431
221
Financial liabilities
431
221
Total deferred tax assets and liabilities
448
448
238
238
Offsetting
(448)
(448)
(238)
(238)
Total deferred tax assets and liabilities
0
0
0
0
1
Restated to present only recognized deferred tax assets and deferred tax liabilities.
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)
December 31,
December 31,
2023
2022
Deductible temporary
16,673
11,344
differences
Deductible temporary differ
-
469
-
ences related to investment
in associates
Tax losses
53,155
37,248
Total
70,297
48,592
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.
18. REVENUE
The revenue can be detailed as follows:
(in € thousand)
December 31,
December 31,
2023
2022
restated
1
Royalties
1,929
885
Out-license agreements
104
15
Milestones
54
-
Revenue
2,087
900
1
See
note 31
regarding restated information
Currently, the Group generates only limited sales-based
royalties as its main projects are in the development
pipeline and are not yet commercialized.
The
continuously increasing sales-based royalties is income
mainly from the Group’s launched products, Sotalol IV
and Maxigesic
®
IV. In December 2023 a third product
was commercialized: Podofilox gel. Royalty revenues
for Podofilox gel are recognized through our partner
Padagis US LLC.
Revenue from sales-based royalties is
recognized when the subsequent sale occurs.
Revenue from sales milestone is recognized when
the performance obligation has been met (i.e. sales
threshold reached). Income from Milestone payments in
2023 is driven by our joint collaboration with PFH after
the positive results from the Phase 2 clinical study.
19. 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)
2023
2022 Restated
1
Out-sourced R&D
(11,374)
(7,163)
Employee benefit expenses
(3,761)
(3,116)
(
note 20
)
Management consultancy fees
(1,137)
(1,091)
Board related expenses
(176)
(178)
Share based payments
(539)
(560)
Legal & paralegal fees
(2,205)
(645)
Audit and related consultancy
(125)
(91)
fees
Hiring fees
(27)
(84)
Office equipment, rent, and
(290)
(337)
utilities
Other expenses
(78)
(433)
Amortisation expense of intan-
(93)
(94)
gible assest (
Note 7
)
Depreciation expense on PPE
(255)
(102)
and Right of Use
(Note 8
)
Hyloris
: Annual Report 2023
p 124
Total operating expenses
2
(20,060)
(13,894)
of which as
Cost of sales
(93)
(94)
Research and development
(14,421)
(10,271)
expense
General and administrative
(5,546)
(3,517)
expenses
Other operating expenses
-
(12)
1
See
note 31
regarding restated information
2
The loss in PFH is not included in the Operating expenses (€147 K)
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
increased by 40%, from €10,271 thousand in 2022 to
€14,421 thousand in 2023. The increase was principally
driven by the progress made in the development of our
existing product candidates and the related additional
out-sourced R&D expenses and the enlargement of the
R&D team.
In 2023, the Group capitalized development costs for
a total of €325 thousand (was €661 thousand in 2022).
(See
note 7
)
Hyloris’ General and administrative expenses increased
by 58% (or €2,028 thousand), from €3,517 thousand
in 2022 to €5,545 thousand in 2023. The increase
was mainly driven by higher legal costs related to the
AltaThera’s litigation compared to last year (see
note 26
).
20. EMPLOYEE BENEFIT EXPENSES
(in € thousand)
December 31,
December 31,
2023
2022
Wages and salaries
(3,277)
(2,562)
Social security costs
(247)
(146)
Defined contribution costs
(37)
(20)
Other employee Benefit
(200)
(258)
expenses
Total employee Benefit
(3,761)
(2,987)
expense
in full-time equivalents
Average number of total em-
34.7
23.6
ployees
21. OTHER OPERATING INCOME
(in € thousand)
December 31,
December 31,
2023
2022 restated
*
Services rendered related to
501
1,052
co-developments
R&D tax credit
434
315
Government grants
578
-
Grants income related to
159
120
exemption on withholding taxes
Other income
455
-
Other operating income
2,127
1,487
*
See
note 31
regarding restated information
Services rendered in 2023 and 2022 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 advices 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
The big increase compared to last year is mainly related
to:
a tax credit from an American State government for
the clinical development of the Alenura
TM
product
candidate of €369 thousand
a recoverable cash advance from the Walloon region
related to a grant for the research and development
of product candidate HY-083 of €207 thousand (see
note 152
).
a Settlement agreement with a partner of €394
thousand resulting from long lasting discussion on
disputed costs incurred in the past.
the increase of the R&D tax credit compared with
last year. The Group recognised R&D tax credits for
a total of €445 thousand, of which €434 thousand
as other operating income, and €11 thousand
Hyloris
: Annual Report 2023
p 125
deduction from the carrying amount of the
related assets, which are recognised in the profit
or loss statement in line with the amortisation or
depreciation expense of the related assets (
note 11
).
22. FINANCIAL RESULT
The various items comprising the net finance cost are as
follows:
(in € thousand)
December 31,
December 31,
2023
2022
restated*
Realized gain on FX forward
contracts
29
525
Interest income on deposits
869
67
Exchange differences
-
(126)
Financial income
898
466
Interest expense on lease
liabilities
(52)
(11)
Interest expense on
shareholders loans
-
(164)
Other interest expense
-
(44)
Total interest expenses
(52)
(219)
Loss related to substan
-
tial modification of the
-
(226)
shareholders loans
FV adjustment on FX for
-
ward instruments
-
(52)
Fair Value of API loan (
note
11
)
(173)
(167)
Bank fees
(48)
(38)
Exchange differences
(12)
-
Other
-
(28)
Total financial expenses
(233)
(511)
*
See
note 31
regarding restated information
Modification of the shareholders loans
In 2022, the Group successfully renegotiated its
Shareholders loans. The changes in the terms of the
loan agreements qualified for substantial modifications
of the terms resulting in the derecognition of the
carrying value of former loans replaced by the carrying
value of the loans under the new terms. The loans
from shareholders, were unsecured, bear as from 1
January 2022 a fixed nominal interest rate of 0.75% (4%
previously) and were payable the earlier of December
31, 2022 or, if and when, the Group will generate a
positive EBIT.
At December 31, 2022 all Shareholders loans including
the accumulated interests were reimbursed.
Decrease of the Loans from Shareholders can be
explained by (i) the reimbursement of the principal
amount of one Shareholder, (ii) payment of incurred
interest (€ 1,877 thousand), partly compensated
by (iii) the FX impact on the conversion of the loans
denominated in USD into EUR (€ 256 thousand), and (iv)
the loss resulting from the derecognition of the former
carrying value of the loan (€ 226 thousand).
23. INCOME TAX EXPENSE
23.1
AMOUNTS RECOGNIZED TO PROFIT
AND LOSS
The income tax (charged)/credited to the income
statement during the year is as follows:
(in € thousand)
December 31,
December 31,
2023
2022
Tax (expense) / income
-
(4)
Income taxes
-
(4)
23.2
RECONCILIATION OF EFFECTIVE TAX
The income tax expense can be reconciled as follows:
(in € thousand)
2023
2022
*
restated
Loss before income tax
(15,380)
(11,901)
Income tax expense calculated at
domestic tax rates (25%)
3,845
2,975
Tax effect of
Share of Loss of equity-accounted
investees reported, net of tax
(37)
(33)
Tax incentives (R&D Tax Credit)
108
79
Changes in estimates related to prior
years
-
(4)
Effect of unused tax losses not recog
-
nized as deferred tax assets
(3,917)
(3,022)
Total tax Expenses
-
(4)
*
See
note 31
regarding restated information
23.3
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 2023 is €245 thousand and
booked on Current tax assets.
Hyloris
: Annual Report 2023
p 126
24. 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:
(in € thousand)
December
December
31, 2023
31, 2022
restated*
Basic earnings
Profit (Loss) from
(15,380)
(11,906)
continuing operations
attributable to owners of the parent
Diluted earnings
Dilution effect of share-based payments
Profit from continuing operations at
-
(15,380)
(11,906)
tributable to owners of the parent, after
dilution effect
*
See
note 31
regarding restated information
Earnings per share based on the existing number of
ordinary shares
Number of shares
December
December
31,
2023
31, 2022
Weighted average number of ordinary
28,000,374
27,198,925
shares outstanding during the period
Basic earnings per share
(0.55)
(0.43)
Diluted earnings per share
(0.55)
(0.43)
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.
25. 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 in 2023:
Hyloris
: Annual Report 2023
p. 127
Total warrants authorised and
granted
Movements per year
Warrants authorised
Warrants cancelled
Warrants granted
Warrants outstanding
31/12/2019
Warrants forfeited
Warrants outstanding
31/12/2020
Warrants granted
Warrants forfeited
Warrants outstanding
31/12/2021
Warrants forfeited
Warrants exercised
Warrants outstanding
31/12/2022
Warrants forfeited
Warrants exercised
Warrants outstanding
31/12/2023
Expiry Date
Weighted Average Exercise
Price per warrant (€)
Fair value at grant date (€)
PLAN 2017
Warrants
1,200,000
1,200,000
1,200,000
1,200,000
1,200,000
(1,200,000)
0
4/05/22
236
111
PLAN 2019
Warrants
363,300
(10,300)
353,000
353,000
(20,000)
333,000
(20,000)
313,000
(6,875)
306,125
306,125
31/12/24
5.34
2.47
PLAN 2020
400,000
(213,500)
186,500
186,500
186,500
186,500
186,500
11.89
540
Warrants
-
69,500
69,500
69,500
69,500
27/11/30
9.88
4.44
Warrants
-
55,000
55,000
55,000
55,000
27/11/30
12.04
5.68
Warrants
-
60,000
60,000
60,000
60,000
27/11/30
13.92
6.20
Warrants
-
2,000
2,000
2,000
2,000
27/11/30
16.64
7.39
PLAN 2022
213,500
(71,500)
142,000
142,000
(7,354)
134,646
1412
536
Warrants
-
-
62,000
0
62,000
30/06/29
15.20
6.06
Warrants
-
-
55,000
(7,354)
47,646
30/06/29
12.92
4.76
Warrants
-
-
25,000
0
25,000
1/01/30
13.71
4.76
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)
634,625
(7,354)
0
627,271
9.17
-
The 2017 plan was fully vested immediately as no
vesting conditions were required. The 1,200,000
Transaction warrants were exercised on 22 June 2022
(
note 14
).
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). The Company offered in total 353,000
warrants. For this plan, the expense in the profit or loss
is €23 thousand in 2023 and €67 thousand in 2022.
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). 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. For the 2020 plan, the expense is €161
thousand in 2023 and €382 thousand in 2022
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). As of 31 December 2022, 142,000
warrants were accepted by new employees. In 2023
7,353 warrants additionally have forfeited hence in total
78,854 warrants have forfeited. For the 2022 plan, the
expense is €356 thousand in 2023 and €111 thousand in
2022.
The fair value of the warrants has been determined
based on the Black Scholes model. For the plans issued
in 2017 and 2019, the expected volatility is based on
the historical share price volatility over the past 5 years
of listed peer companies. For the new 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.
Below is an overview of all the parameters used in this
model:
Hyloris
: Annual Report 2023
p 128
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
55%
40%
35%
shares (%)
Expected dividends yield
0%
0%
0%
(%)
Average risk free interest
0.10%
0.00%
2.66%
rate (%)
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.
26. CONTINGENCIES
Ongoing legal proceedings
In August 2022, AltaThera Pharmaceuticals LLC filed a
complaint before the District Court for the Northern
District of Illinois against Academic Pharmaceuticals
Inc, Dr. Somberg and Hyloris Pharmaceuticals, for (a.o.)
alleged misappropriation of AltaThera’s trade secrets
and confidential information, improper inventorship,
and breach of contract, which seeks (punitive) damages
and termination of the agreement whereby Hyloris
licenses Sotalol IV to AltaThera (the “Litigation”). Hyloris
moved to dismiss the complaint for improper service of
process and lack of jurisdiction.
Further, in November 2022, Hyloris initiated an
arbitration against AltaThera for breach of the same
licensing agreement between Hyloris and AltaThera in
relation to Sotalol IV, including the failure of AltaThera to
use commercially reasonable efforts in selling Sotalol IV
as required under the licensing agreement, which seeks
damages and termination of the licensing agreement
(the “Arbitration”). AltaThera responded and counter-
demanded, reasserting its claims from the Litigation.
At the end of August 2023, all parties agreed to stipulate
to the dismissal of the Litigation and to consolidate
the Litigation and the Arbitration before the American
Arbitration Association (“AAA”) in New York.
Hyloris contests the claims asserted by AltaThera and,
based upon Hyloris’ assessment of the documents
and expert reports put forward to date by AltaThera to
support its claims, Hyloris is of the view that there is no
convincing evidence supporting AltaThera’s claims for
liability or damages. On the other hand, Hyloris believes
strongly in the merits of its claims against AltaThera, and
that its position is well supported by its expert reports
and other documents and evidence submitted to the
arbitration panel.
After the arbitration hearings that took place in April
2024, Hyloris remains fully confident about the outcome
of this litigation in its favor. A final decision is expected
before the end of August 2024. Hyloris however cannot
guarantee that the outcome of the litigation, even if in
its favor, may not have a negative impact on future sales
of Sotalol IV. AltaThera is seeking significant damages,
including for lost profits related to future sales of
Dofetilide IV and Sotalol IV and for unjust enrichment
premised on a perceived value of investment tied to the
IPO raise in 2020. While these claims, if fully or partially
granted, would potentially jeopardize Hyloris as a going
concern, Hyloris believes such an outcome is improbable
and that either Hyloris will succeed in its defense or will
be subject to damages below an amount that would
impact Hyloris’ ability to function as a going concern.
Conversely, Hyloris believes it has a strong case against
AltaThera for the latter’s failure to exert commercially
reasonable efforts to sell Sotalol IV and has requested
a Panel award of significant damages. However, Hyloris
cannot assure that a judgment in this matter will not
adversely affect future Sotalol IV sales.
A final decision is expected before the end of August
2024.
The Group is unable to disclose the estimate of the
financial effects of the ongoing legal proceedings as
under the rules of the International Center for Dispute
Resolution and the American Arbitration Association, the
Panel in the Consolidated Arbitration has sealed these
proceeding with an Agreed Confidentiality Order such
that information that is designated “Confidential” or
“Highly Confidential—Attorneys’ Eyes Only” and cannot
be shared with the public.
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
Hyloris
: Annual Report 2023
p. 129
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. The
probability criteria are not met to recognize a receivable
given the current status of the procedure.
27. 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, 2023, Hyloris has contractual
commitments and contingent liabilities for a maximum
amount of €41,523 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.
The following table details the total maximum
contractual commitments and contingent liabilities
(milestone payments only) at December 31, 2023 per
product candidates if such products are successfully
marketed (in € thousand):
Maximum
contractual
Contingent
commitments
liabilities
Product Candidate
Expected timing
In $ thousand
In € thousand
Converted in €
(in € thousand)
In $ thousand
In € thousand
Converted in €
(in € thousand)
HY-004
225
204
0
2025
125
113
2026
100
90
HY-029
300
300
0
2024
100
100
2025
100
100
2026
100
100
Atomoxetine oral
75
68
0
2024
25
23
2025
25
23
2026
25
23
Metolazone IV
325
294
1 300
1 176
2025
75
68
2026
100
90
2027
150
136
2028
100
90
2030
200
181
2032
1000
905
Dofetilide IV
300
271
0
2024
100
90
2025
50
45
2026
150
136
HY-073
7 115
6 439
28 000
25 339
2024
3376
3 055
2025
3621
3 277
2026
118
107
2027
1000
905
2029
2000
1 810
2030
2000
1 810
23000
20 814
HY-074
150
136
2024
50
45
2025
25
23
2027
75
68
Hyloris
: Annual Report 2023
p 130
Alenura
TM
(note 29.2)
2 000
1 810
2024
2000
1 810
HY-086 (note 10)
5 285
5 285
2024
2363
2 363
2025
2422
2 422
2026
500
500
HY-088
200
200
2025
200
200
TOTAL
10 190
5 785 15 007
29 300
0
26 516
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 €41,523 thousand (maximum
commitments).
28. 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:
Purna Female helthcare, in which the Group has a
control of 20% (
note 9
);
Vaneltix Inc and its affiliates, in which 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
note 9
);
The shareholders; Mr Stijn Van Rompay, an
executive member of the Board of the Company,
CEO and reference shareholder of the Company;
Mr Thomas Jacobsen, an Executive Member of the
Board of the Company;
The Executive Management Team; and
The Board of Directors (Non-Executive Directors).
28.1 TRANSACTION WITH PURNA FEMALE
HEALTHCARE
The table below provides an overview as per December
31, 2023:
Financial
Transactions for the period
In € thousand
Position
Profit Loss
Commitments
Equity accounted
investees
3.801
-
-
Other financial lia
-
bilities (
note 152
)
(3.000)
-
-
Milestones revenue
-
54
-
Total
801
54
0
The table below provides an overview as per December
31, 2022:
Transactions for the period
In € thousand
Financial
Profit Loss
Commitments
Equity accounted
Position
investees
3.948
-
-
Other financial li
-
abilities (
note 15.2)
(3.000)
-
-
Total
948
54
0
28.2
TRANSACTIONS WITH VANELTIX, INC.
In 2021 the Group entered into a strategic collaboration
with Vaneltix Pharma Inc. for the development and
commercialisation of Alenura
TM
as first-line drug
treatment for acute pain in interstitial cystitis /bladder
pain syndrome (IC/BPS).
See
note 32
.
The outstanding commitment to Vaneltix as of
December 31, 2023 is $2 million:
$6,7 million commitment
- $1,6 million payment March 2022
- $1,2 million payment December 2022
- $1.9 million equity contribution October 2023
(excluding 100k for market study)
= $2 million commitment at end of 2023
Hyloris
: Annual Report 2023
p 131
The table below provides an overview as per December
31, 2023:
Transactions for the period
Financial
Profit Loss
Commitments
In € thousand
Position
Optional
convertible loan
499
(
note 10
)
Shares (Non
Current)
0.001
(
note 10
)
Accounts
Receivable
174
Prepayments
155
R&D expenses
(2,744)
Interest income
47
Commitments
and Contin-
gent Liabilities
1,810
(
Note 27
)
Total
654
(2,697)
1,810
The table below provides an overview as per
December31, 2022:
Transactions for the period
Financial
Profit Loss
Commitments
In € thousand
Position
Optional
convertible loan
494
(
note 10
)
Accounts
Receivable
29
Prepayments
1,108
R&D expenses
(1,422)
Interest income
25
Commitments
and Contingent
Liabilities (N
ote
3,656
27
)
Total
1,602
(1,398)
3,656
28.3
TRANSACTIONS WITH THE
SHAREHOLDERS
In 2023 there were no transactions with the
shareholders.
Capital increase dated June 22, 2022
On 22 June 2022 Hyloris increased her Capital and
accompanied her Share Premium with respectively
€6 thousand and €2,826 thousand via the exercise of
1,200,000 outstanding Transactions Warrants.
In 2022 the following number of warrants from the 2017
ESOP plan were exercised:
Number of
Related Party
transactions
Exercise price (in €)
warrants exercised
Stijn Van Rompay
852,096
2.36
Thomas Jacobsen
163,512
2.36
Total
1,015,608
236
28.4
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.
As of December 31, 2023 and December 31, 2022,
members of the Executive Management Team are:
SVR Management BV, an entity controlled by Stijn
Van Rompay, an executive member of the Board of
the Company, 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 CBDO
Finsys Management BV, an entity controlled by Jean-
Luc Vandebroek, Chief Financial Officer
Dr Dietmar Aichhorn, Chief Operating Officer
Herault BV, an entity controlled by Koenraad Van der
Elst, Chief Legal Officer
The table below presents the compensation of all
members of Executive Management Team by type of
compensation:
(In € thousand)
December 31,
December 31,
2023
2022
ST compensation (incl.
management fees)
1,137
1,045
Share-based payments
64
154
Total
1,201
1,199
Hyloris
: Annual Report 2023
p 132
At reporting date, there were outstanding trade
payables related to transactions with the Executive
Management Team:
(In € thousand)
December 31,
December 31,
2023
2022
Management fees
143
160
Total
143
160
As of December 31, 2023, members of the Executive
Management Team owned the following securities of
the Company:
Shares
Warrants
Number
Pct (%)
Number
Pct (%)
(#)
(#)
Mr. Stijn Van
Rompay
7,743,067
27.65
68,000
10.84
Mr. Thomas
Jacobsen
3,857,838
13.78
-
0.00
Mr. Jean-Luc
Vandebroek
9,000
0.03
40,000
6.38
Mr. Dietmar
Aichhorn
32,500
0.12
40,000
6.38
Mr. Koenraad
Vanderelst
17,443
0.06
50,000
7.97
TOTAL
11,659,848
4164
198,000
31.57
Compared to 31 December 2022, the members of the
Executive Management Team owned the following
securities of the Company:
Shares
Warrants
Number
Pct (%)
Number
Pct (%)
(#)
(#)
Mr. Stijn Van
Rompay
7,676,400
27.42
68,000
10.71
Mr. Thomas
Jacobsen
3,657,505
13.06
-
0.00
Mr. Jean-Luc
Vandebroek
3,000
0.01
40,000
7.88
Mr. Dietmar
Aichhorn
20,000
0.07
40,000
6.3
Mr. Koenraad
Van der Elst
27,443
0.10
50,000
6.3
TOTAL
11,374,348
4066
198,000
31.19
Total outstanding shares and warrants existing as of
December 31, 2023 are respectively 28,000,374 and
627,271.
28.5
TRANSACTIONS WITH THE BOARD
OF DIRECTORS (NON-EXECUTIVE
DIRECTORS)
As of December 31, 2023, non-executive members of the
Board of Directors are:
Stefan Yee, Chairman
Leon Van Rompay
Marc Foidart
Carolyn Myers
James Gale
Chris Buyse
The table below presents the compensation of all non-
executive members of Board of directors by type of
compensation:
December 31,
December 31,
(In € thousand)
2023
2022
Board fees
110
110
Share-based payments
7
30
Total
117
140
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,
2023
2022
Board fees
110
0
Total
110
0
As of 31 December 2022 and 31 December 2023, non-
executive members of the Board of directors owned the
following securities of the Company:
Shares
Warrants
Number
Pct (%)
Number
Pct (%)
(#)
(#)
Stefan Yee
-
-
100,000
15.94
Leon Van
Rompay
-
-
-
Mark Foidart
-
-
-
Carolyn Myers
-
-
-
James Gale
-
-
-
Chris Buysse
-
-
-
TOTAL
-
-
100,000
15.94%
Hyloris
: Annual Report 2023
p 133
29. SUBSEQUENT EVENT (AFTER THE END
OF THE REPORTING PERIOD)
16.01.2024: Orphan Drug Designation granted to PTX-
252 by U.S. FDA for the treatment of Acute Myeloid
Leukaemia (AML)
This product candidate, developed in collaboration
with Pleco Therapeutics BV incorporates a novel
molecular entity that is a derivative of a known
established molecule and is designed to enhance the
responsiveness of cancer cells to chemotherapy.
Obtaining an Orphan Drug Designation provides
incentives and benefits to encourage the development
of treatments for rate diseases. These include financial
incentives, market exclusivity and support in navigating
regulatory processes. An estimate of the financial impact
for the Group cannot be made.
18.01.2024:
Hyloris broadens pipeline with new
product candidate for Vulvar Lichen Sclerosus (VLS)
The Group has entered into a partnership with AFT to
develop a novel mucoadhesive film for the treatment
of Vulvar Lichen Sclerosus. Hyloris and AFT 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 commercialisation
in Europe. AFT is responsible for managing the clinical
trials, overseeing all aspects to ensure effective
planning, execution and monitoring throughout the trial
lifecycle, and the coordination of the commercialisation
outside of Europe. Parties are jointly responsible for
commercialisation in the United States.
Hyloris and AFT will share the net profit and will split all
external costs related to the collaboration. An estimate
of the financial impact for the Group cannot be made.
30.01.2024: Hyloris and Purna Female Healthcare
announce positive results from Phase 2 trial in
patients with Acute Vulvovaginal Candidiasis (VVC)
The phase 2 trial of product candidate Miconazole
Domiphen-Bromide (MCZ-DB) was a 12-week trial
evaluating the safety and efficacy of two doses of
MCZ-DB. The study has been conducted in Belgium
with a total of 102 patients enrolled. Topline results are
superior efficacy, positive safety and tolerability without
significant superiority over the active control.
With these positive results, the Group is prepared to
engage in discussions with relevant authorities for
further clinical investigations. The financial impact for
the Group is that a financial liability of €3 million (see
note 9
) €1.5 million is payable after the completion
of the dose finding study required for being able to
start a phase 3 study and another €1.5 million is due
after processing the validation report for 6 months
stability data on registration batches and completion of
enrollment of phase 3 studies
14.02.2024: Hyloris enrolls first patient in Phase
3 Clinical trial for its Proprietary Mouth Rinse to
control incidences of bleeding related to dental
procedures.
This Phase 3 trial is designed to demonstrate efficacy,
safety and acceptability of the oral solution containing
tranexamic acid to prevent possible oral hemorrhaging
in patients treated with anticoagulants and undergoing
extraction of one or more teeth. This study will measure
and compare efficacy of the proprietary oral solution
containing tranexamic acid against placebo in reducing
the number of both clinically relevant and irrelevant
bleeds in these patients.
An estimated 280 patients will be recruited at
approximately 20 clinical sites across Europe and
the United States. Recruitment of eligible patients is
expected to be completed around the end of 2024
with final results available in the first half of 2025. An
estimate of the financial impact for the Group cannot be
made.
27.02.2024: Hyloris announces launch of Maxigesic®
IV in the U.S. and approval in Canada
launch in the United States: Hikma has launched
Maxigesic
®
IV in the United States under the
tradename Combogesic
®
IV. Hyloris is entitled to a
milestone payment of $2.1 million.
approval in Canada: Maxigesic® IV has recently been
granted marketing authorization by Health Canada.
Hyloris
: Annual Report 2023
p 134
18.04.2024: Long-term incentive plan
A long-term incentive plan was approved. The long-term
variable remuneration is based on the achievement by
the Company of certain pre-set cash-based financial
results. For each member of the Executive Committee,
a one-time payment will be made for each €20 million
EBITDA realized annual basis, capped at €80 million or
four tranches of €20 million.
11.6.2024: Decision of the General Assembly
regarding the authorized capital.
See
Note 143
Events after the reporting period with respect to the
QliniQ transactions
Hyloris announced on 20 January 2023 that it had
successfully concluded agreements regarding (i) the in-
licensing by Hyloris from QliniQ BV (
“QliniQ
”) of HY 088
and (ii) the divestment by Hyloris to QliniQ of HY 038.
These transactions and their accounting treatment were
scrutinized by the Belgian Financial Services and Markets
Authority (“
FSMA
”). The inquiries from and exchanges
with the FSMA initially led the Company to restate its
fiscal year 2022 and fiscal year 2023 results in March
2024.
In the second half of April 2024, a few days before the
annual report for the fiscal year 2023 was due to be
published, KPMG replaced its permanent representative
for the Company and informed the Company’s Audit
Committee that additional audit work was required.
Following further exchanges with the Company’s auditor
and, subsequently, the FSMA, the Company initiated a
forensic independent review on the matter in April 2024.
On 29 April 2024 the FSMA suspended trading of the
Company’s shares.
The forensic independent review was carried out by a
reputable international law firm as independent legal
expert, appointed by and under the supervision of
an ad hoc committee of independent directors of the
Company. The work included a forensic data review
concerning the QliniQ transactions, interviews with
Hyloris’ executive management team concerning the
QliniQ transactions, as well as obtaining an independent
valuation expert opinion on the purchase price paid for
HY-088.
During and after the review process, the Company
was formally informed of the executive management
team’s opinion that the forensic independent review is
affected by procedural, methodological and substantive
deficiencies. Management disputes the findings and
believes inter alia that the independent legal expert
lacked impartiality, has not considered their explanations
and comments properly, and that the findings give an
incomplete and distorted picture. The management
team also pointed out that there was regular interaction
with the Company’s statutory auditor on the accounting
treatment of the transactions. Finally, the management
team also insisted in particular on the actual substance
of the HY-038 and HY-088 transactions and reiterated
their firm belief that the HY-088 deal will create value for
the Company.
The forensic independent review was completed early
June 2024 and established a number of irregularities
concerning the transactions with QliniQ and the
documentation practices and communication with the
FSMA related thereto which are further described in the
FSMA communication of 5 July 2024 (see below) and the
Company’s press release of 8 July 2024 containing its
reaction on the FSMA communication.
In the first half of June 2024, the Board has deliberated
on multiple occasions on the findings of the forensic
independent review, the recommendations of the
ad hoc committee (as also described in the FSMA
communication of 5 July 2024 – see below), and the
comments by the executive management team. Where
appropriate, meetings were held in closed session
with non-executive directors only. During this time,
the Board was also informed that the Company’s CEO
has offered to step down as CEO and transition into a
dedicated strategy-focused role concentrating on long-
term company objectives and direction, and that the
Company’s CFO and CLO have offered to resign and
leave their roles within the Company in mutual consent
after an appropriate transition period.
As a result, taking into account a.o (i) the findings of the
forensic independent review, (ii) the recommendations
Hyloris
: Annual Report 2023
p 135
of the ad hoc committee (as detailed in the (as detailed
in the FSMA’s communication of 5 July 2024) FSMA’s
communication of 5 July 2024), (iii) the views of the
executive management team (and the abovementioned
proposals by the CEO, CFO and CLO to leave their
current roles) and (iv) the Company’s corporate interest,
the Board has taken the following decisions:
The Company will initiate a transition process to
an independent CEO, with a view to the current
CEO, Mr. Stijn Van Rompay, assuming a dedicated
role focussed on driving and implementing the
Company’s global strategy. During the interim
period, Mr. Thomas Jacobsen (Hyloris’ Chief Business
Development Officer and co-founder) will be
appointed as co-CEO alongside the current CEO and
all major decisions shall be made jointly by the co-
CEOs.
Subject to a transition period, Hyloris’ CFO and CLO
will leave their roles within the Company in mutual
consent in the interest of the Company (but without
acknowledging any of the principal findings of the
review). At the request of the Board, the CFO will
remain with the Company to finalize the annual
accounts for the fiscal year 2023 and (if needed) the
half-year results, and hand over to the new CFO.
The Company’s governance will be strengthened by
(i) having the internal control systems reviewed by an
independent third party, (ii) creating an internal audit
function, and (iii) implementing written compliance
policies and clear internal reporting lines (including
to the Audit Committee).
The Company is evaluating continuously how and when
these decisions will be implemented considering the
corporate interest and the developments in this matter.
Following the decisions of the Board, the Company
has informed the FSMA of the findings of the forensic
independent review, the comments of the executive
management team, and the Board’s decisions. Since
then, the Company has had ongoing contacts with the
FSMA (including with regard to the content of the press
release to be issued concerning the findings of the
forensic independent review).
While these contacts were ongoing, on 5 July 2024,
the FSMA decided to release a public communication
regarding the Company
1
, setting out a.o. the FSMA’s
1
The full text of the FSMA communication is published in French and
Dutch on the website of the FSMA.
views of the QliniQ transactions and stating that the
FSMA has serious doubts about the reliability of the
information that Hyloris has provided to the market. The
FSMA expressed the view that this information does not
allow investors to assess the risk of an investment in
Hyloris shares.
The conclusions of the FSMA’s
1
warning are as follows
2
:
“On the basis of its own findings and the independent
forensic review, the FSMA has serious doubts as to the
economic reality of the transactions with QliniQ. The
independent forensic review indeed did not permit to
identify any objective element confirming the economic
reality of the transactions with QliniQ.
On the contrary, the conclusions of the independent
forensic review refer, inter alia, to:
indications that QliniQ had no interest in HY 038;
the absence of elements demonstrating that due
diligence had been carried out in relation to HY-
088 and the lack of substance for the payment of
EUR 1 million by Hyloris to QliniQ on 13 February
2023 as compensation for internal research and
development costs already incurred by QliniQ in
relation to HY 088;
multiple indications that the two transactions were
interrelated, which is an indication of the circular
nature of the transactions and the related payments;
the finding that the agreements with QliniQ were
prepared - and further amended after execution -
on the basis of accounting and market disclosure
objectives.
In addition, the independent forensic review identifies,
among other things, the following elements
strong indications that the documentary practices
do not reflect reality but are intended to achieve the
desired objectives (i.e. to be able to book revenue in
2022), as well as strong indications of a deliberate
attempt to backdate the HY 038 agreement to
31/12/2022;
evidence of multiple misrepresentations by Hyloris’
management to the FSMA
evidence of management filtering information from
the Board of Directors and the Audit Committee.
2
Free translation of the original French/Dutch text.
Hyloris
: Annual Report 2023
p 136
The independent forensic review also contains
observations regarding the governance and corporate
culture of Hyloris
1
As a result of the findings of the independent forensic
review, the independent directors have recommended to
the Board of Directors of Hyloris that the internal control
systems be reviewed by an independent third party
(including with a view to establishing an internal audit
function), that the company’s compliance policies be
reviewed, and that the CEO, CFO and CLO be replaced by
strong, independent and qualified candidates.
Hyloris’ management has indicated that it strongly
opposes the conclusions of the independent forensic
review.
Trading in the shares remains suspended pending
publication of the 2023 annual financial report and the
accompanying report of the statutory auditor.”
Further to the FSMA’s communication, the Company
has issued a press release on 8 July 2024. Therein it has
stated that the Company has taken note of the FSMA’s
communication. The Company is of the view that it has
made available (and intended to make available through
a press release concerning the forensic independent
review drafted in consultation with the FSMA) to the
public all information that is relevant for investors. The
Company is committed to inform the market correctly
and it will continue discussions with the FSMA in a view
to agree on a communication policy which meets the
concerns of the FSMA.
The Company’s 8 July 2024 press release also contains
detail on the business rationale and development
status of HY-088. In this respect, the Company’s
executive management team refers to the report of
the independent valuation expert which contributed to
the forensic independent review and which concludes
as follows with regard to the consideration paid for HY
088: “Based on (i) the limited procedures performed,
as described above, on the business plan prepared by
Management as of the date of the Transaction, (ii) the
use of the generally accepted valuation methods under
the income approach, and (iii) pursuant to the conditions
and limitations contained herein,
it is our preliminary
view that nothing leads us to believe that the
Transaction Price is not within an acceptable range
of preliminary values”
. The Company further notes that
the forensic independent review has not conclusively
established the absence of substance of the HY-088
and HY-038 transactions and that, even though the
forensic independent review concluded that there are
strong indications that the two QliniQ transactions were
apparently linked, both transactions were aligned with
Hyloris’ strategic objectives.
The development of HY-088 remains on track for
European market access by the second half of 2026,
with the total cost of acquisition and development,
including licensing fees and external development
expenses, staying (well) under €2 million as previously
announced. After development completion, Hyloris
will not incur any further financial obligations to the
original developer. Development began in late 2022
and by early 2023 an external development company
identified candidate formulations through product
design planning, ingredient selection activities, and
testing. Further work throughout 2023 ensured stability,
refinement, and successful lab-scale production. GMP
batch manufacturing is anticipated for late 2024.
18.7.2024: Expansion of Maxigesic
®
IV into Brazil
See the press release.
26.7.2024: Carolyn Myers, a non Executive Director
Ms. Carolyn Myers is an independent director of the
Company since 8 June 2020. She is also a member of the
Company’s Remuneration and Nomination Committee.
Directors in a listed company are considered
independent if they do not maintain a relationship
with the company or a major shareholder thereof
that compromises their independence. To determine
whether a (candidate) director satisfies this condition, at
least the criteria set out in the 2020 Belgian Corporate
Governance Code are applied.
One of these criteria is that independent directors
do not maintain, or have maintained in the past year
before their appointment, a significant business
relationship with the Company or a related company
or person, either directly or as a partner, shareholder,
board member, member of the senior management (as
Hyloris
: Annual Report 2023
p. 137
defined in article 19, 2° of the law of 20 September 1948
regarding the organisation of the business industry) of a
company or person who maintains such a relationship.
The Company has an ongoing business relationship with
Vaneltix Pharma, Inc. (“Vaneltix”) for the development
and commercialisation of AlenuraTM as first-line drug
treatment for acute pain in interstitial cystitis /bladder
pain syndrome (IC/BPS). [The Company also has a
shareholding of less than 1% in Vaneltix.]
Ms. Carolyn Myers is associated with Vaneltix due
to her relationship with Mr. Dan Vickery, CEO, board
member and shareholder of Vaneltix. Based on recent
information, Ms. Carolyn Myers also performs an
executive function within Vaneltix as Commercial Head.
Because of the business relationship between the
Company and Vaneltix on the one hand, and the
association of Ms. Carolyn Myers with Vaneltix on the
other hand, Ms. Carolyn Myers possibly no longer
fulfils the aforementioned criterion of the 2020 Belgian
Corporate Governance Code and, consequently, the
general condition to be considered an independent
director. For this reason, Hyloris’ Board of directors has
decided on 26 July 2024 that Ms. Carolyn Myers will be
considered a non-executive director (but no longer as an
independent director) for the remainder of her mandate.
Due to Ms. Carolyn Myers no longer being considered
an independent director, the Company’s Remuneration
and Nomination Committee no longer meets the
requirement set out in the Company’s corporate
governance charter, that a majority of the committee’s
members must be independent. As previously
announced, the Company currently is in a process to
strengthen its governance. The Company will address
this as part of the ongoing evaluation, at the upcoming
annual general meeting. For the avoidance of doubt, this
change does not affect the validity of previous meetings
and decisions of the Remuneration and Nomination
Committee.
30. AUDIT FEES
During 2022 and 2023, the statutory auditor provided
services for the group Hyloris which fees were as follows:
December 31,
December 31,
(In € thousand)
2023
2022
Audit services
91
82
Audit related services -
legal engagements
-
15
Tax services
28
18
Total
119
115
31. RESTATEMENT OF 2022 STATEMENTS
31.1
QLINIQ TRANSACTION
Following discussions with the Belgian Financial
Services and Markets Authority (FSMA) and Hyloris‘
statutory auditor, the Board of Directors has revised the
financial statements due to the correction of a non-cash
accounting error regarding the divestment of HY-038 and
acquisition of HY-088.
Clarification on the press release of 20 January 2023 on
the transactions with Qliniq
On 20 January 2023 Hyloris announced that the
global rights of the ongoing development of HY-088
was licensed-in from a Dutch company, Qliniq, who
maintained the rights to commercialize the product
candidate in its home country, and a selected number
of Middle Eastern and developing countries. In the same
press release, Hyloris announced that it had divested
HY-038 to the same company, Qliniq, for a price of
€1 million.
As detailed in the 2022 Annual Report, HY-038 falls
under the category of high-barrier generics and thus
lies beyond Hyloris’ core portfolio of assets. Limited
development activities had occurred for HY038 since
the IPO. Hyloris encountered challenges in identifying
a suitable Contract Manufacturing Organization (CMO)
capable of producing HY-038 at a desired cost.
The transaction price of € 1 million was received on
16 February 2023.
HY-088 is a ready-to-administer
oral liquid formulation designed for addressing
hypophosphatemia. Presently, physicians utilize
compounded products for treating this condition, which
have not undergone regulatory evaluation regarding
their safety, effectiveness, and quality. At the time of the
transaction, QliniQ held no exclusive rights to develop
the oral liquid formulation.
Hyloris
: Annual Report 2023
p 138
It is expected that Hyloris will submit HY-088 for
registration in the course of 2025. The transaction price
of €1.2 million (including €200 thousand designated as
prepaid expenses), was paid by Hyloris on 13 February
2023.
QliniQ is a Dutch company which develops and
in-licenses drugs and medical supplies in various
therapeutic domains and commercializes these in
the Netherlands. QliniQ nurtures cooperation and
long-lasting business relationships with international
companies as part of its successful market approach. At
December 31, 2022, Qliniq had a balance sheet total of
€ 0.8 million, a cash balance of € 0.2 million and 2 FTE’s.
Qliniq’s shareholders have previously successfully build
and sold several pharmaceutical companies.
Accounting treatment of the transactions with Qliniq
Hyloris initially recognized (a) €1 million in revenue in
2022 from the divestment of HY-038, and (b) €1 million
in R&D expenses and € 0,2 million in intangible assets
in H1 2023 for the purchase of HY-088. A reassessment
determined that both transactions qualify as a non-
monetary exchange because negotiations and valuations
occurred simultaneously. Due to the development stage
of the products exchanged, the fair value of neither the
asset received, nor the asset given up can be reliably
determined. As highlighted in ‘Note 29 – Forensic
investigation outcome’, the transfer of control HY-038
occurred in 2023. As a result of this reassessment, the
restated financials for 2022 have reversed the €1 million
revenue from the divestment of HY-038.”
The following tables present the restatements performed
on the comparative periods:
Consoldated statement of financial position
Impact of correction of error
only for Qliniq
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Current assets
50,801
(1,000)
49,801
Trade and other receivables
5,127
(1,000)
4,127
Total assets
61,864
(1,000)
60,728
1
Equity
55,045
(1,000)
53,909
1
Result of the period
(10,770)
(1,000)
(11,906)
1
Total equity and liabilities
61,864
(1,000)
60,728
1
1
Including restatement of the API loan (refer to note 31.3)
Consolidated statement of profit or loss and other
comprehensive income
Impact of correction of error
only for Qliniq
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Revenues
2,951
(1,000)
900
1
Gross profit
2,857
(1,000)
805
1
Operating profit/(loss) (EBIT)
(10,638)
(1,000)
(11,638)
Profit (loss) before taxes
(10,766)
(1,000)
(11,901)
2
PROFIT (LOSS) FOR THE PERIOD
(10,770)
(1,000)
(11,906)
2
TOTAL COMPREHENSIVE
INCOME FOR THE PERIOD
(10,770)
(1,000)
(11,906)
2
1
Including reclass from revenue towards other operating income, see
note 31.2
2
Including
restatement of the API loan, see note 31.3
Consolidated statement of cash flows
Even though there was an actual cash inflow of €1 million
from the divestment of HY-038 and a cash outflow of €
1.2 million resulting from the in-licensing of HY-088, the
transactions are presented in the net consolidated cash
flow statement for the year ended per December 31,
2023 (i.e., €200 thousand prepaid expenses), as this most
faithfully presents the substance of the transactions. The
impact on the consolidated statement of cash flows for
the year ended on December 31, 2022 is the decrease of
the Trade and other receivables.
Hyloris
: Annual Report 2023
p. 139
31.2. RECLASSIFICATION OF REVENUE FOR
SERVICES RENDERED
Revenues for services rendered in connection with
the Management Consultancy Agreement concluded
with Pleco Therapeutics (see
note 32
) has been
reclassified from Revenue to Other income as they are
not considered as part of the ordinary activities of The
Group.
The impact on the consolidated financial statement of
profit or loss and other comprehensive income:
Per 31 December 2022
Impact of correction of error
(In € thousand)
As previously
reported
Adjustment
As restated
Revenue
2,951
(1,052)
900
1
Other operating income
315
1,052
1,487
2
1
Including restatement of Qliniq, see note 31.1
2
Including reclass for grants on payroll withholding taxes, see note
31.4B
31.3 RECLASS RELATED TO API LOAN
The loan made to third parties has been reclassified
in the statement of cash flow from Trade and other
receivables to Investing activities. In accordance with
IAS 7, par. 16(e) cash advances and loans made to
other parties are part of cash flows from investing
activities. Furthermore, in prior year the fair value of the
outstanding loan was incorrectly calculated and not in
compliance with IFRS 9 as an appropriate risk premium
was included. The discount rate was revised impacting
the statement of financial position (Trade and other
receivables) and statement of profit and loss and other
comprehensive income (financial expenses).
The impact on the consolidated financial statement of
cash flow:
Impact of correction of
error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Trade and other receivables
(2,261)
655
(921)
1
Cash generated from operations
(12,812)
655
(12,679)
2
Net cash generated from operating
activities
(13,154)
655
(13,020)
2
Loans made to third parties
-
(655)
(655)
Net cash provided by investing
activities
(1,239)
(655)
(11,373)
3
1
Including restatement for the R&D Tax Credit, see note 31.4B and
restatement for Qliniq transaction, see note 31.1
² Including restatement for the R&D Tax Credit, see note 31.4B and
restatement for Qliniq transaction, see note
31.1 and restatement
for the API loan, see note 31.3 and the netting of the finance result
³ Including restatement for cash and cash equivalents, see note 31.4A
and the netting of the finance result
The impact on the consolidated financial statement of
financial position:
Impact of correction of error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Non Current assets
11,063
(136)
10,927
Trade and other receiv-
ables (Non current)
1,447
(136)
1,311
Total assets
61,864
(136)
60,728
1
Equity
55,045
(136)
53,909
1
Result of the period
(10,770)
(136)
(11,906)
1
Total equity and
liabilities
61,864
(136)
60,728
1
1
Including restatement of Qliniq, see note 31.1
Hyloris
: Annual Report 2023
p 140
The impact on the consolidated financial statement of
profit or loss and other comprehensive income:
Impact of correction of error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Financial expenses
(594)
(136)
(730)
Profit (loss) before taxes
(10,766)
(136)
(11,901)
1
PROFIT (LOSS) FOR THE
PERIOD
(10,770)
(136)
(11,906)
1
TOTAL COMPREHENSIVE
INCOME FOR THE PERIOD
(10,770)
(136)
(11,906)
1
1
Including restatement of Qliniq, see note 31.1
31.4
OTHER RESTATEMENTS IN THE
FINANCIAL STATEMENTS
Next to the above restatement with impact on the
income statement and statement of financial position
of the comparative period, the Company has also made
following reclasses without net impact on the net result.
A. Cash and cash equivalents
Two term deposits for a total amount of
10 million
have been reclassified from “Cash and cash equivalents”
to “Other investment including derivatives” as the term
deposit does not meet the definition of cash equivalents
in accordance with IFRS. The term of 1 deposit is from
December 13, 2022 until June 13, 2023 and the term
of the other deposit is from December 13 2022 until
September 13, 2023. They cannot be withdrawn, in
whole or part, prior to the due date of the term deposit.
See
note 13
.
The impact of the restatement on the consolidated
financial statement:
Impact of correction of error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Other investment,
including derivatives
469
10,000
10,469
Cash and cash equivalents
43,457
(10,000)
33,457
The impact of the restatement on the consolidated
financial statement of cash flow:
Impact of correction of error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Proceeds of other financial
assets
-
(10,000)
(10,000)
Cash flow from investing
activities
(1,239)
(10,000)
(11,373)
1
Net (decrease) in cash
and cash equivalents
(6,555)
(10,000)
(16,555)
Cash and cash equiva
-
lents at end of year
43,457
(10,000)
33,457
1
Including restatement of the API loan, see note 31.3
B. Grants related to payroll withholding taxes and R&D
Tax Credit
As from 2023, the grants on payroll withholding taxes for
scientific personnel are presented as ‘Other operating
income’ while per December 31, 2022 they were
presented as a deduction from the related employee
benefit expenses within the ‘Research and development
expenses’. In order to guarantee comparability, the 2022
statement of profit and loss has been restated to reflect
this reclass (impact of €120 thousand). This is now also
consistent with the presentation of the Half Year figures.
The grant related to the R&D Tax Credit has been
reclassed in the 2022 statement of cash flow from R&D
Tax Credit to Trade and other receivables.
Hyloris
: Annual Report 2023
p 141
The impact on the consolidated statement of profit or
loss and other comprehensive income:
Impact of correction of error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Other operating income
315
120
1,487
1
Operating income
315
120
2,387
2
Research and development
expenses
(10,151)
(120)
(10,272)
Operating expenses
(13,905)
(120)
(14,024)
1
Including reclass from revenue towards other operating income, see
note 31.2
² Including reclass from revenue towards other operating income, see
note 31.2 and restatement for Qliniq transaction, see note 31.1
The impact on the consolidated financial statement of
cash flow:
Impact of correction of error
Per 31 December 2022
(In € thousand)
As previously
reported
Adjustment
As restated
Trade and other
receivables
(2,261)
(315)
(921)
1
R&D Tax Credit
(315)
315
-
1
Including restatement of Qliniq, see note 31.1 and restatement of the
API loan, see note 31.3
C. Other reclasses in the statement of cash flow
In the statement of cash flows, fair value gains and
losses on derivatives, interest expenses on shareholder’s
loans and losses on the derecognition of shareholder
loans have been reclassified to net financial result.
D Revised presentation of the consolidated statements
of Profit or Loss and Other Comprehensive Income in
general
In order to improve the readability of the consolidated
financial statement of Profit or Loss and Other
Comprehensive income there is a revised presentation
of the lines as from 2023 including the comparative of
2022.
In the new presentation, Other operating income is put
below Revenue. The sum of both is Operating Income.
Cost of sales is put together with Research and
development expenses, General and administrative
expenses, share of result of equity-accounted investees
and other operating expenses under the new line
Operating expenses.
Hyloris
: Annual Report 2023
p 142
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, 2023 give a true and fair
view of the Company’s equity and financial position as
at December 31, 2023 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 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
Statement of Financial Position
(In €)
2023
2022
ASSETS
FIXED ASSETS
76,097,212
76,374,779
Intangible fixed assets
121,042
112,655
Tangible fixed assets
Financial fixed assets
75,976,170
76,262,124
Affiliated companies - Participations
73.161.002
73,161,002
Affiliated companies - Receivables
1,815,167
2,101,122
Investment
1,000,001
1,000,000
CURRENT ASSETS
38,607,279
41,456,011
Receivables over one year
634,434
656,291
Trade receivables
-
Others amounts receivable
634,434
656,291
Amounts receivable within one year
7,054,248
3,893,442
Trade receivables
5,695,222
2,958,075
Others amounts receivables
1,359,026
935,367
VIII. Cash Investment
10,000,000
30,000,000
IX. Cash at bank and in hand
18,817,284
4,589,023
X. Deferred charges and accrued income
2,101,313
2,317,255
TOTAL ASSETS
114,704,491
117,830,790
CAPITAL AND RESERVES
102,751,874
106,154,186
Hyloris
: Annual Report 2023
p 143
(In €)
2023
2022
Capital
140,002
140,002
Share Premium
121,513,447
121,513,447
Reserves
5,000
5,000
Accumulated profits (losses)
(18,906,575)
(15,504,263)
PROVISIONS AND DEFERRED TAXES
CREDITORS
11,952,617
11,676,604
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
10,624,769
11,153,196
Current portion of amounts payable after one year
-
-
Other financial loans
3,072,421
6,633,479
Suppliers
3,122,209
1,291,575
Taxes, remuneration and social charges
15,100
28,142
Other debts
4,415,039
3,200,000
X. Accrued charges and deferred income
1,027,848
223,408
TOTAL LIABILITIES
114,704,491
117,830,790
Income Statement
(In € thousand)
2023
2022
Operating income
(3,639,978)
1,249,949
Turnover
1,120,551
204,885
Other operating income
709,473
1,045,064
Non-recurrent income
1,809,954
-
Operating charges
(5,777,848)
(3,750,126)
Services and other goods
(5,409,842)
(3,675,309)
Other operating charges (-)
(1,859)
(5,219)
Remunerations, social charges and pensions
(346.393)
(69,598)
Depreciations
(19,754)
-
Non-recurring operating expenses
-
-
Operating profit (loss)
(2,137,870)
(2,500,177)
Financial income
1,159,948
1,928,732
Income from financial fixed assets
-
363,784
Income from current assets
1,094,291
-
Other financial income
65,657
1,564,948
Financial charges (-)
(2,446,796)
(482,131)
Interest on financial debts
(360,181)
(286,159)
Other financial charges
-
(195,972)
Profit (Loss) for the period before taxes (-)
(3,424,718)
(886,786)
Income taxes (-)
22,406
(16,659)
Profit (loss) for the period available for appropriation
(3,402,312)
(1,070,235)
Hyloris
: Annual Report 2023
p 144
Statutory Notes
Statement of financial fixed assets
(In €)
2023
2022
Affiliated companies - Participations
Acquisition value at the end of the preceding period
73,161,002
44,944,782
Movements during the period
Acquisitions, included produced fixed assets
-
28,216,220
Acquisition value at the end of the period
73,161,002
73,161,002
Depreciation and amounts written down at end of the preceding period
Movements during the period
Recorded
Depreciation and amounts written down at end of the period
Net book value at the end of the period
73,161,002
73,161,002
Affiliated companies - Receivables
Net book value at the end of preceding period
2,101,122
12,232,733
Movements during the period
Additions
19,328,396
Reimbursement
(285,955)
(29,460,007)
Net book value at the end of the period
1,815,167
2,101,122
(In €)
2023
2022
Investment
Acquisition value at the end of the preceding period
1,000,000
-
Movements during the period
Acquisitions, included produced fixed assets
1,809,955
1,000,000
Acquisition value at the end of the period
2,809,955
1,000,000
Depreciation and amounts written down at end of the preceding period
Movements during the period
Recorded
Depreciation and amounts written down at end of the period
1,809,954
Net book value at the end of the period
1,000,001
1,000,000
Company
Participation held
Data extracted from last available annual
accounts
Nature
Direct
By
subsidiaries
Annual
accounts at
Currency
Code
Capital
Net profit
or (loss)
Number
%
%
Hyloris Developments SA
Boulevard Patience et
Beaujonc 3
4000 Liège
Belgium
542,737,368
Shares
74,066
99.99%
0%
12/31/2023
EUR
7,853,337
(12,069,087)
Hyloris Supply SA
Boulevard Patience et
Beaujonc 3
4000 Liège
Belgium
669,738,676
Shares
62,000
100 %
0%
12/31/2023
EUR
(1,716,017)
(146,630)
Hyloris
: Annual Report 2023
p 145
Deferred Charges and Accrued Income
(In €)
2023
2022
Deferred charges and accrued
income
Interest earned on receivables
from related companies
1,725,351
1,946,679
Statement of Amounts Payable
(In €)
2023
2022
Analysis by current position of
amounts initially payable after
more than one year, maturing in 1
year
Other debts (Shareholder loans)
-
Analysis by current position of
amounts initially payable after
more than one year, maturing in
max 5 years
Other debts
300,000
300,000
Tax, wage and social amounts
payable
Taxes payable
0
8,309
Other salary and social debts
15,100
19,833
Accrued charges and deferred
income
Accrued FX forward contracts
0
51,832
Accrued bonuses
10,379
4,390
AFT - Milestone due at the start of
the first commercial manufacturing
batch of Maxigesic IV
904,977
-
Dermax SA
Boulevard Patience et
Beaujonc 3
4000 Liège
Belgium
667,730,677
Shares
65,875
100%
0%
12/31/2022
EUR
3,164,916
1,116,681
Purna Female Healthcare
BV
Schaldestraat 31
2880 Bornem
Belgium
762,693,578
Shares
840
20%
0%
12/31/2023
EUR
758,157
(736,656)
Vaneltix Pharma Inc.
317 George St., Ste. 400
New Brunswick, NJ 08901
United States
Shares
4
<0.1 %
0%
12/31/2023
EUR
30,712
(33,955)l
Hyloris
: Annual Report 2023
p 146
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 2023
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 for the year ended 31 December
2023, as well as other legal and regulatory requirements. Our report is one and
indivisible.
We were appointed as statutory auditor by the general meeting 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 ending
31 December 2024. We have performed the statutory audit of the consolidated
financial statements of the Group for 5 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 2023, prepared in accordance with IFRS
Accounting Standards as issued by the International Accounting Standards
Board and 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 of 31 December
2023, 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
EUR 47.681.000 and the consolidated statement of profit or loss and other
comprehensive income shows a loss for the year of EUR 15.380.000
In our opinion, except for the possible effect of the matter 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 of
31 December 2023 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 and as adopted by the European Union, and with the legal and regulatory
requirements applicable in Belgium.
Statutory auditor’s report
Hyloris
: Annual Report 2023
p. 147
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 2023
Basis for our qualified opinion
As described in note 3.2 to the consolidated financial statements, the Group
entered into an agreement with Pleco Therapeutics BV (“Pleco”) on 8 July 2022.
Under the terms of this agreement the Group agreed to provide strategic advice
to Pleco from 1 January 2022 to 31 December 2024 for a maximum
consideration of EUR 2,5 million. The Group recognized an amount of EUR 1,0
million and EUR 0,5 million as other operating income in the consolidated
financial statements for the years ended 31 December 2022 and 2023,
respectively.
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 recognized income related to this agreement based
on a contractual payment schedule, and not based on an analysis with reference
to 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 income of EUR 1,5 million recognized as other operating
income in financial years 2022 and 2023 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.
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, 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.
Hyloris
: Annual Report 2023
p 148
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 2023
Emphasis of matter – Restatement of the consolidated financial
statements for the year ended 31 December 2022
We refer to note 31 ”Restatement of the 2022 statements” to the consolidated
financial statements in which the board of directors discloses the correction of
material errors identified in the current year with respect to the prior year
consolidated financial statements in accordance with IAS 8
Accounting Policies,
Changes in Accounting Estimates and Errors
.
Our audit opinion is not modified in respect of this matter.
Key audit matters
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 matter described in the “Basis for our qualified opinion” section of our
report we have determined the matters described below to be key audit matters
to be communicated in our report.
Collaboration agreements between the Group and its partners for product
candidates
Description
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, including the monitoring of
underlying costs.
Hyloris
: Annual Report 2023
p. 149
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 2023
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 examined the transactions between the Group and its partners to
identify the existence of circular transactions.
-
We assessed the adequacy of the disclosures in the consolidated
financial statements, particularly under note 3.2 "Joint collaborations" and
note 21 “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.
Impact of the outcome of the independent forensic review on the QliniQ
transactions on our audit
Description
We refer to note 29 "Subsequent Event (After the End of the Reporting
Period)" in which the Group discloses that, starting in April 2024, an
independent forensic review was carried out by an international law firm as
independent legal expert, appointed by and under the supervision of an ad
hoc committee of independent directors of the Company, with respect to two
transactions with Qliniq BV (“the Qliniq transactions”). We have considered
the observations of the independent forensic review as a key audit matter,
as such observations may impact other aspects of our audit.
Hyloris
: Annual Report 2023
p 150
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 2023
Our audit procedures
In accordance with ISAs, we have reevaluated our assessment of the risks
of material misstatement due to fraud or error and its resulting impact on the
nature, timing and extent of audit procedures to respond to the assessed
risks and reconsidered the reliability of evidence previously obtained.
Our incremental procedures as a result of this reevaluation of the risks of
material misstatement included amongst others:
-
We reevaluated the audit evidence obtained during the audit to assess
the reliability of the supporting evidence initially received.
-
We evaluated the nature of the other restatements identified and
corrected in the current year consolidated financial statements (see note
31 ”Restatement of the 2022 statements”).
-
We inspected the report prepared by and inquired the independent legal
expert appointed by the board of directors who carried out the forensic
independent review with respect to the QliniQ transactions.
-
We obtained specific representations from those charged with
governance.
-
We assessed the adequacy of the information provided in note 29
"Subsequent Event (After the End of the Reporting Period)".
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
Standards as issued by the International Accounting Standards Board and 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 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.
Hyloris
: Annual Report 2023
p 151
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 2023
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.
Hyloris
: Annual Report 2023
p 152
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 2023
If we conclude 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.
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 precludes
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.
Statutory auditor’s responsibilities
In the context of our engagement and in accordance with the Belgian 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.
Hyloris
: Annual Report 2023
p 153
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 2023
Aspects concerning the board of directors’ annual report on the
consolidated financial statements and other information included in the
annual report
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 matter
described in the “Basis for our qualified opinion” section of our report,
we are of
the opinion that this 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:
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 matter 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 that
compromises our independence with respect to the statutory audit of the
consolidated financial statements and our audit firm remained in substance
independent of the Group during the term of our mandate.
The fees for the additional engagements which were assessed not to impair our
independence with respect to the statutory audit of the consolidated financial
statements 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 Financial
Statements with the European Single Electronic Format (hereafter “ESEF”), we
have audited as well 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”).
Hyloris
: Annual Report 2023
p 154
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 2023
The Board of Directors is responsible for the preparation, in accordance with the
ESEF requirements, of the consolidated financial statements in the form of an
electronic file in ESEF format (hereafter “digital consolidated financial
statements”) included in the annual financial report.
It is our responsibility to obtain sufficient and appropriate information to conclude
whether the format and the tagging of
the
digital consolidated financial
statements comply, in all material respects, with the ESEF requirements under
the Delegated Regulation.
At the date of this report, we have not yet received the annual financial report
and the digital consolidated financial statements prepared by the Board of
Directors. We have reminded the Board of Directors of their legal responsibility
to provide the documents to the statutory auditor and the shareholders within the
deadlines stipulated in the Belgian Companies’ and Associations’ Code. As a
result, we were unable to conclude
whether the format and the tagging of the
digital consolidated financial statements comply, in all material respects, with the
ESEF requirements under the Delegated Regulation.
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
9
July 2024
KPMG Bedrijfsrevisoren - Réviseurs d’Entreprises
Statutory Auditor
represented by
Tanguy Legein
Bedrijfsrevisor / Réviseur d’Entreprises
Digitally signed by Tanguy
Legein
Date: 2024.07.29 00:10:39
+02'00'
Adobe Acrobat version:
2020.005.30636
Hyloris
: Annual Report 2023
p 155
Glossary and
Other Info
Hyloris
: Annual Report 2023
p 156
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
Glossary of Terms
Hyloris
: Annual Report 2023
p. 157
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
FINANCIAL CALENDAR
September 30, 2024
Half year results
CONTACT
Hyloris Pharmaceuticals SA
Boulevard Patience et Beaujonc N°3/1
4000 Liège, Belgium
Stijn Van Rompay
CEO Hyloris
Jean Luc Vandebroek
CFO Hyloris
: +32 (0)4 346 02 07
: investorrelations@hyloris.com
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”.
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.
This report, including the statutory
financial statements of Hyloris
Pharmaceuticals SA, is available on the
Company’s website, www.hyloris.com.
Certain statements in this annual
report are “for- ward-looking
statements.” These forwardlooking
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 foward-
looking statements.
The Company undertakes no
obligation to publicly update or revise
forwardlooking statements, except as
may be required by law. You should
not place undue reliance on foward-
looking statements. Certain monetary
amounts and other figures included
in this annual report have been
subject to rounding adjustments.
Accordingly, any discrepancies in any
tables between the totals and the
sums of amounts listed are due to
rounding.
Forward Looking Statements
DISCLAIMER & OTHER INFORMATION
Hyloris Pharmaceuticals SA
Boulevard Patience et Beaujonc N°3/1
4000 Liège, Belgium