549300VWY8KVDFKLDM592022-01-012022-12-31549300VWY8KVDFKLDM592021-01-012021-12-31iso4217:EURiso4217:EURxbrli:shares549300VWY8KVDFKLDM592022-12-31549300VWY8KVDFKLDM592021-12-31549300VWY8KVDFKLDM592020-12-31549300VWY8KVDFKLDM592020-12-31ifrs-full:IssuedCapitalMember549300VWY8KVDFKLDM592020-12-31ifrs-full:SharePremiumMember549300VWY8KVDFKLDM592020-12-31ifrs-full:AccumulatedOtherComprehensiveIncomeMember549300VWY8KVDFKLDM592020-12-31oxurion:OtherReservesExcludingOCIReservesMember549300VWY8KVDFKLDM592020-12-31ifrs-full:RetainedEarningsMember549300VWY8KVDFKLDM592020-12-31ifrs-full:EquityAttributableToOwnersOfParentMember549300VWY8KVDFKLDM592020-12-31ifrs-full:NoncontrollingInterestsMember549300VWY8KVDFKLDM592021-01-012021-12-31ifrs-full:IssuedCapitalMember549300VWY8KVDFKLDM592021-01-012021-12-31ifrs-full:SharePremiumMember549300VWY8KVDFKLDM592021-01-012021-12-31ifrs-full:AccumulatedOtherComprehensiveIncomeMember549300VWY8KVDFKLDM592021-01-012021-12-31oxurion:OtherReservesExcludingOCIReservesMember549300VWY8KVDFKLDM592021-01-012021-12-31ifrs-full:RetainedEarningsMember549300VWY8KVDFKLDM592021-01-012021-12-31ifrs-full:EquityAttributableToOwnersOfParentMember549300VWY8KVDFKLDM592021-01-012021-12-31ifrs-full:NoncontrollingInterestsMember549300VWY8KVDFKLDM592021-12-31ifrs-full:IssuedCapitalMember549300VWY8KVDFKLDM592021-12-31ifrs-full:SharePremiumMember549300VWY8KVDFKLDM592021-12-31ifrs-full:AccumulatedOtherComprehensiveIncomeMember549300VWY8KVDFKLDM592021-12-31oxurion:OtherReservesExcludingOCIReservesMember549300VWY8KVDFKLDM592021-12-31ifrs-full:RetainedEarningsMember549300VWY8KVDFKLDM592021-12-31ifrs-full:EquityAttributableToOwnersOfParentMember549300VWY8KVDFKLDM592021-12-31ifrs-full:NoncontrollingInterestsMember549300VWY8KVDFKLDM592022-01-012022-12-31ifrs-full:IssuedCapitalMember549300VWY8KVDFKLDM592022-01-012022-12-31ifrs-full:SharePremiumMember549300VWY8KVDFKLDM592022-01-012022-12-31ifrs-full:AccumulatedOtherComprehensiveIncomeMember549300VWY8KVDFKLDM592022-01-012022-12-31oxurion:OtherReservesExcludingOCIReservesMember549300VWY8KVDFKLDM592022-01-012022-12-31ifrs-full:RetainedEarningsMember549300VWY8KVDFKLDM592022-01-012022-12-31ifrs-full:EquityAttributableToOwnersOfParentMember549300VWY8KVDFKLDM592022-01-012022-12-31ifrs-full:NoncontrollingInterestsMember549300VWY8KVDFKLDM592022-12-31ifrs-full:IssuedCapitalMember549300VWY8KVDFKLDM592022-12-31ifrs-full:SharePremiumMember549300VWY8KVDFKLDM592022-12-31ifrs-full:AccumulatedOtherComprehensiveIncomeMember549300VWY8KVDFKLDM592022-12-31oxurion:OtherReservesExcludingOCIReservesMember549300VWY8KVDFKLDM592022-12-31ifrs-full:RetainedEarningsMember549300VWY8KVDFKLDM592022-12-31ifrs-full:EquityAttributableToOwnersOfParentMember549300VWY8KVDFKLDM592022-12-31ifrs-full:NoncontrollingInterestsMember
ANNUAL REPORT 2022
FINANCIAL INFORMATION
ANNUAL REPORT 2022
FINANCIAL INFORMATION
CONTENTS
1. GENERAL INFORMATION AND
RESPONSIBILITY FOR THE
ANNUAL REPORT AND FOR
THE AUDIT OF THE FINANCIAL
STATEMENTS 6
1.1 Responsibility for the contents of this
document 7
1.2 Responsibility for the audit of the
financial statements 7
1.3 Availability of the Annual Report 8
1.4 Forward-looking
information 8
2. MESSAGE FROM THE CEO 10
3. MANAGEMENT REPORT OF THE
BOARD OF DIRECTORS 14
3.1 Key Figures 15
3.2 Activities of Oxurion 15
3.3 Comments to Consolidated Financial
Statements 21
3.4 Comments to Statutory Accounts 22
3.5 Description of the Principal
Characteristics of the Company’s Risks 23
4. CORPORATE GOVERNANCE 44
4.1 General provisions 45
4.2 Compliance with the Corporate
Governance Code 45
4.3 Description of the Principal
Characteristics of the Company’s
Internal Controls and Risk Analysis 46
4.4 Fees to the Statutory Auditor 51
4.5 Notification of Important Participations 51
4.6 Composition and functioning of the
Company’s management 53
4.7 Policy regarding Transactions and other
Contractual Relationships between
the Company, including Affiliated
Companies, its Directors, and the CEO 59
4.8 Capital Increase by the Board of
Directors with Respect to the Authorized
Share Capital and Provisions that may
be triggered in the Event of a Public
Takeover on the Company (Article 8:2
of the Royal Decree of April 29, 2019
(Article 34 of the old Royal Decree of 14
November 2007)) 60
4.9 Remuneration Report Financial Year 2022 61
5. CONSOLIDATED FINANCIAL
STATEMENTS 70
5.1 Consolidated statement of profit and loss 71
5.2 Consolidated statement of financial position 72
5.3 Consolidated statement of cash flows 73
5.4 Consolidated statement of changes in equity 74
5.5 General notes to the consolidated
financial statements 75
5.6 Notes to the consolidated statement of
profit and loss 95
5.7 Notes to the consolidated statement of
financial position 99
5.8 Other clarification notes to the
statement of financial position 116
6. STATUTORY AUDITORS
REPORT TO THE GENERAL
SHAREHOLDERS’ MEETING
ON THE CONSOLIDATED
ACCOUNTS FOR THE YEAR
ENDED
31 DECEMBER 2022 124
7. ABBREVIATED STATUTORY
FINANCIAL STATEMENTS 133
7.1 Balance sheet of Oxurion NV 134
7.2 Income statement of Oxurion NV 135
7.3 Appropriation account of Oxurion NV 135
7.4 Key valuation principles 136
8. GLOSSARY 141
6
OXURION ANNUAL REPORT 2022
1. GENERAL INFORMATION AND
RESPONSIBILITY FOR THE
ANNUAL REPORT AND FOR
THE AUDIT OF THE FINANCIAL
STATEMENTS
7
OXURION ANNUAL REPORT 2022
1.1 RESPONSIBILITY FOR THE
CONTENTS OF THIS DOCUMENT
The board of directors of Oxurion NV (the “Company” or
“Oxurion) is responsible for the contents of this document.
The board of directors (the “Board of Directors) declares
that having taken reasonable care to ensure that such is the
case, the information contained in this year’s annual report
(theAnnual Report”) is, to the best of its knowledge, in
accordance with the facts and contains no omissions likely
to affect it materially.
Dr. Patrik De Haes, M.D., (as representative of MeRoNo BV),
Non-Executive Director and Chairman, and Tom Graney,
CFA, Executive Director and Chief Executive Officer of
Oxurion, declare on behalf of the Company that to their
knowledge:
The consolidated financial statements prepared in ac-
cordance with International Financial Reporting Standards
(“IFRS”) as adopted by the EU, give a true and fair view of
the net worth, financial position, and the results of opera-
tions of the Group (as defined hereinafter).
The Annual Report regarding the consolidated financial
statements gives a true and fair view of the development
and results of the Group (as defined hereinafter), as well as
the main risks and uncertainties.
This Annual Report was approved by the Board of Directors
on March 30, 2023.
1.2 RESPONSIBILITY FOR THE AUDIT OF
THE FINANCIAL STATEMENTS
PricewaterhouseCoopers Bedrijfsrevisoren BV, a limited
liability company incorporated under Belgian law, having
its registered office at Culliganlaan 5, 1J, 1831 Diegem, rep-
resented by Didier Delanoye, auditor, and a member of the
“Instituut van de Bedrijfsrevisoren”, has been appointed as
the statutory auditor of Oxurion (the “Statutory Auditor”)
for a term of three years ending immediately after the
closing of the annual general shareholders’ meeting
(AGM”) to be held in 2025, which will have deliberated
and resolved on the financial statements for the financial
year ending on December 31, 2024.
8
OXURION ANNUAL REPORT 2022
1.3 AVAILABILITY OF THE
ANNUAL REPORT
Oxurion published its Annual Report in Dutch. Oxurion has
also produced an English translation of this Annual Report.
In the event of differences of interpretation between the
English and the Dutch versions of the Report, the original
Dutch version has priority.
The Annual Report is available to the public on the
Company’s website (www.oxurion.com) and in hard copy
free of charge in both languages by request to:
Oxurion NV
for the attention of Michaël DILLEN
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32 16 75 13 10
Fax: +32 16 75 13 11
e-mail: IR@oxurion.com
The annual report presented here in PDF format is only
a supplementary document - the ESEF (European Single
Electronic Format) version is the only official version and
prevails.
1.4 FORWARD-LOOKING
INFORMATION
This Annual Report includes forward-looking statements,
expectations, and assessments regarding the expected
future performance of Oxurion and the market in which
it operates. Certain statements, expectations and assess-
ments can be recognized using words such as, but not
limited to, “believe”, “anticipate”, “expect”, “intend”, “plan”,
“strive”, “estimate”, “forecast”, “project”, “could”, “will” and
“continue” and comparable expressions. These relate to
future matters that are not historical facts. Such statements,
expectations and assessments are based on various as-
sumptions, expectations and assessments of known and
unknown risks, uncertainties and other factors that were
deemed to be reasonable when they were made, but
which may or may not prove to be correct. Actual events
are difficult to predict and depend on factors outside
the Company’s control. Consequently, the actual results,
financial condition, and the results of the sector, may
diverge substantially from any future results, performance
or achievements expressed or implied by such statements,
expectations, and assessments. Factors that can cause
such a divergence include, but are not limited to, the factors
that are discussed in the Chapter “Risk Factors”. Given
these uncertainties, absolutely no statement is made, nor
reassurance given regarding the correctness or reasona-
bleness of such forward-looking statements, expectations,
and assessments. Moreover, forward-looking statements,
expectations and assessments apply only on the date of
this Annual Report. The Company expressly disclaims any
obligation to adapt any of the forward-looking statements,
expectations, and assessments in this Annual Report to
reflect any change in the expectations and assessments
of the Company or any change in the facts, conditions or
circumstances on which such statements, expectations
and assessments are based, except to the extent that this
is required by Belgian law.
All statements and information relate to the period up to
December 31, 2022, unless expressly stated otherwise.
9
OXURION ANNUAL REPORT 2022
10
OXURION ANNUAL REPORT 2022
e.
2. MESSAGE FROM THE CEO
11
OXURION ANNUAL REPORT 2022
Key progress on potential therapy to
adress diabetic macular edema
Dear Fellow Shareholders,
Over the past year, we have continued to advance
our company’s mission to develop the next genera-
tion standard of care for retinal vascular diseases. In
February 2022, we presented the impressive post hoc
analysis of Part A of our Phase 2 KALAHARI trial for
THR-149, at the prestigious Angiogenesis scientific con-
ference, showing greater than a 9 letter improvement in
vision that persisted for four months after the last injection
(5 letters is considered clinically meaningful). On the back
of that encouraging data, we executed a timely financing
of over 10 million euro from a group of new, high quality
global healthcare investors, led by Fidelity Management
and Research and other important European investors,
along with support from current investors.
In light of the geopolitical and market unrest that
permeated our sector throughout the remainder of 2022,
marking the most difficult capital market environment for
biotech companies like ours since 2008, we realigned our
clinical operations to focus solely on one novel, differenti-
ated clinical-stage drug candidate, THR-149, that is being
evaluated as a potential treatment of Diabetic Macular
Edema (“DME”), and to pause further development of our
other clinical asset, THR-687, until our financial condition
improves, and then potentially to study THR-687 in a Phase
2 study in treatment-experienced patients. As a result of
pausing development of THR-687, in the second quarter,
we conducted a reduction in force to further extend our
cash runway.
We are currently completing Part B of our Phase 2
KALAHARI clinical trial supporting the development of
THR-149, as described below, and we are looking forward
to sharing the top-line results that are expected in the
fourth quarter of this year. We believe this program has
the potential to make a meaningful difference in the lives
of millions of patients and their caregivers worldwide, and
we’re grateful for the support we have received in progress-
ing this potential treatment from patients, physicians and
researchers. If successful, our THR-149 program would be
the first significant treatment for the target patient popula-
tion introduced in more than a decade.
High Unmet Need, Novel Approach To Grow
the Market
THR-149 is a potent bicyclic peptide that selectively inhibits
human plasma kallikrein (PKal) with an inhibition constant
of 0.22 nM. Through the inhibition of the kallikrein-kinin
system (KKS), which is an established mechanism of action,
THR-149 prevents the induction of retinal vascular perme-
ability, neurodegeneration, and inflammation. THR-149
is currently being evaluated in the KALAHARI Phase 2,
Part B clinical trial as a potential treatment for patients who
respond suboptimally to anti-VEGF (as defined below)
standard of care for treatment of DME.
At present, more than 20 million people worldwide suffer
from DME, with prevalence increasing due to the growing
global diabetic epidemic. DME is the leading cause of
progressive vision loss in working-aged people, and the
market for treatments is currently estimated at more than
$5 billion. People with DME have leaking vessels in the
back of the eye, leading to a thickening of the retina that
causes significant, life-changing vision problems such as
Clinical Progress
blurriness in the center of vision, the appearance of dark
spots or patches in the field of vision, and colors to look
THR-149 | Over the past year, our progress on Part B of
dull. Even worse, DME is the leading cause of blindness
our Phase 2 KALAHARI trial, which is designed to assess
in working-aged people. These symptoms may affect the
THR-149 for the treatment of DME against the anti-VEGF
ability to read, write, work, drive and recognize faces – all
market leader aflibercept, in more than 100 patients who
presenting a major patient and caregiver burden.
respond suboptimally to anti-VEGF therapy, has advanced
meaningfully. The trial is powered to demonstrate superi-
The scientific innovation behind our clinical asset THR-149
ority against aflibercept in these patients, with the primary
is meaningful, yet we believe that its path forward is sub-
endpoint of Best Corrected Visual Acuity, and secondary
stantially de-risked. Inhibiting vascular endothelial growth
endpoints including central subfield thickness and safety.
factor (“VEGF”) is now the mainstay of therapy, even
We are also measuring an experimental endpoint investi-
though up to 50% of patients with DME respond subop-
gating the potential synergy between THR-149 and afliber-
timally to anti-VEGF therapy. In addition, anti-VEGF treat-
cept used in a combination regimen. This trial builds upon
ments address only a subset of the disease hallmarks of
the compelling safety and efficacy profile demonstrated
DME. We continue to believe that we can do better, and
in patients with DME in Part A of the two-part Phase 2
patients deserve better.
KALAHARI trial.
While other companies are seeking to develop “better”
Working at more than 80 clinical trial sites worldwide,
anti-VEGF therapies by focusing solely on treatment
the trial recruitment was initially constrained by lower
burden (i.e., durability), Oxurion offers a significant and
participation in clinical trials in general associated with
distinct opportunity to grow and disrupt the estimated $5
the pandemic but began to increase in the second half
billion market for DME by improving efficacy with a pa-
of 2022. In December, we shared the recommendation
tient-friendly dosing regimen.
from an Independent Data Monitoring Committee that
the KALAHARI Phase 2, Part B should continue, based
upon the outcome of a pre-specified futility analysis that
Differentiated Mechanism of Action for
included an evaluation of interim efficacy and safety data
Improving Treatment Outcomes
from three-month data, in a total of 31 patients. After the
close of the financial year, in Q1 of 2023, we announced
We are confident that our differentiated molecule offers
that we have surpassed two-thirds of the total planned en-
a novel mechanism of action and significant potential.
rollment worldwide, giving us confidence that we will be
THR-149 aims to address the unmet need for the up to
able to share top-line data in the fourth quarter of this year.
50% of patients who respond suboptimally to anti-VEGFs
and for whom there are currently no suitable therapeutic
THR-687 | We elected not to proceed with continued
options.
development of this integrin antagonist considering both
resources available and the inconsistent top-line data from
the Phase 2, Part A INTEGRAL trial, which was designed
to evaluate THR-687 for the treatment of DME in treat-
ment-naïve patients. The Part A data showed THR-687 to
12
OXURION ANNUAL REPORT 2022
13
OXURION ANNUAL REPORT 2022
be safe and well tolerated with no serious adverse events
and none of the patients required rescue medication
through Month 3. At the same time, there was insufficient
evidence of efficacy on the key endpoints (Best Corrected
Visual Acuity and Central Subfield Thickness) to warrant
proceeding with Part B of the trial under the current design,
even though the Phase 1 results had indicated a rapid
onset of action, positive extent of effect and durability in
treatment-experienced patients.
While we had hoped for a better outcome for treat-
ment-naïve patients in the INTEGRAL trial, we continue
to believe that THR-687 has therapeutic potential.
Accordingly, we have paused development of THR-687
until we secure adequate financial resources to study the
THR-687 in a Phase 2 study in treatment-experienced
patients.
Operational Progress
As befits our realigned focus on continued development
of THR-149, we have also streamlined our management
team and employee base to lower our costs as we pursue
the most capital efficient path forward. Like many other
companies in the life sciences industry over the past year,
we have worked diligently to ensure that we advance our
clinical operations, despite the financial challenges, for the
benefit of our shareholders, our employees, prospective
patients, the community, and other stakeholders. We are
mindful of our opportunity to uncover meaningful innova-
tion no matter what the economic backdrop may be.
We ended 2022 with approximately 3 million euro in cash
and in early 2023, the funding program with the Negma
Group, of which we had drawn down 11 million euro, ended
and we entered into a new financial collaboration with
Atlas Special Opportunities. We appreciate the support of
both Negma and Atlas in enabling us to pursue our clinical
operations at this crucial time. In addition, we were able to
accelerate the repayment of our debt to our convertible
debt bondholders, Kreos Capital and Pontifax Ventures, to
put us on an even firmer financial footing.
Looking Ahead
For THR-149, Part B of the Phase 2 KALAHARI trial is
ongoing, and we are pleased by the recent increase in
enrollment of patients in sites in the US and Europe. We
expect topline results in the fourth quarter of 2023, which,
if positive, will enable us to move to pivotal trials that we
believe would be relatively de-risked.
Our progress in 2022 has offered important validation of
our decision in 2021 to focus our resources on our clinical
stage assets and further in 2022 to concentrate on the
clear market opportunity provided by THR-149 and
leverage our scientific and clinical leadership position in
the global retina community in its advancement.
I look forward to updating you on new developments as
we work to address the unmet needs of patients with
retinal vascular diseases, and generate value for patients,
payors, and shareholders. Our entire team appreciates the
continued support and confidence demonstrated by all
our shareholders.
Respectfully,
Tom Graney, CFA
Chief Executive Officer, on behalf of the entire Oxurion
Team
14
OXURION ANNUAL REPORT 2022
3. MANAGEMENT REPORT OF THE
BOARD OF DIRECTORS
15
OXURION ANNUAL REPORT 2022
3.1 KEY FIGURES
3.1.1 Consolidated statement of
financial position
IN '000 EURO (AS AT 31 DECEMBER) 2022 2021
Property, plant and equipment 99 120
Right-of-use assets 963 252
Intangible assets 0 1,000
Other non-current assets 40 95
Non-current tax credit 3,785 4,000
Inventories 5 60
Trade and other receivables 3,321 2,517
Current tax receivables 189 845
Investments 95 247
Cash and cash equivalents 3,496 9,740
Total assets 11,993 18,876
Total equity -4,583 -1,108
Non-current liabilities 4,227 9,071
Current liabilities 12,349 10,913
Total equity and liabilities 11,993 18,876
3.1.2 Consolidated statement of profit
and loss
IN '000 EURO (EXCEPT PER SHARE AMOUNTS)
(AS AT 31 DECEMBER)
2022 2021
Income 595 1,128
Operating result -22,946 -28,495
Finance income 639 171
Finance expense -9,379 -1,268
Result before income tax -31,686 -29,592
Taxes -7 -3
Result of the year -31,693 -29,595
Result per share
Basic earnings/(loss) per share (euro) -0.37 -0.77
Diluted earnings/(loss) per share (euro) -0.37 -0.77
3.2 ACTIVITIES OF OXURION
3.2.1 General
Oxurion was incorporated on May 30, 2006, under its
former name, ‘ThromboGenics’, and is a public limited liability
company (in Dutch: Naamloze Vennootschap).
The registered office is established at:
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32 16 75 13 10
Fax: +32 16 75 13 11
The Company is registered in the Register of Legal Entities of
Leuven under enterprise number 0881.620.924.
3.2.2 Mission
Oxurion is dedicated to developing new pharmacologic
treatments addressing important unmet clinical needs in
ophthalmology. Oxurion is focused on developing novel
medicines for vascular retinal disorders, with an initial
focus on DME, as well as compounds targeting other
vascular retinal disorders including in the areas of wet age-
related macular degeneration (“wet AMD”) and retinal
vein occlusion (“ME-RVO”).
3.2.3 History
In May 2006, the Company was incorporated, under its
former name ‘ThromboGenics’, as a public limited liability
company with headquarters in Leuven.
In July 2006, the Company raised 35 million euro through
a successful Initial Public Offering (IPO) and listed on the
Eurolist of Euronext Brussels.
16
OXURION ANNUAL REPORT 2022
The Company pioneered the new drug category of phar-
macological vitreolysis, developing and commercializing
JETREA® (ocriplasmin) (“JETREA®”), which has been
approved for the treatment of vitreomacular adhesion/
vitreomacular traction in 54 countries worldwide.
In 2015, the Company took a strategic decision to focus
its main resources on developing novel medicines for
vascular retinal disorders, with an initial focus on DME,
as well as compounds targeting other vascular retinal
disorders including in the areas of wet AMD and ME-RVO.
In 2018, the Company changed its name to Oxurion. To
focus its efforts on the development of new medicines
for vascular retinal disorders, Oxurion decided in 2019 to
move towards a distribution model for JETREA®. This was
completed in 2020 when Oxurion granted a worldwide
license to the Inceptua Group (“Inceptua) to commercial-
ize JETREA®.
Today, Oxurion is a biopharmaceutical company focused
on developing innovative treatments for vascular
retinal disorders, with two wholly owned subsidiaries –
ThromboGenics Inc. and Oncurious NV (“Oncurious),
Oxurion, ThromboGenics Inc. and Oncurious are collec-
tively referred to as the “Group.
1 Saaddine JB et al. Arch Ophthalmol 2008;126(12):1740-1747; Fong DS et al; Retinopathy in diabetes. Diabetes Care 2004;27(suppl_1):s84-s87.
3.2.4 Employees and
headcount development
As of December 31, 2022, the Group engaged 27 members
of personnel (including both employees and independent
contractors): Oxurion has 25 members of personnel
based in Belgium, 1 in France; and ThromboGenics Inc. has
1 member of personnel in the United States of America
(“US”). Nine members of the personnel hold doctoral
degrees and eleven hold master’s degrees.
3.2.5 Activities
Principal activities
The Company is engaged in the development of drugs to
treat back-of-the-eye diseases, more specifically, ophthal-
mologic pharmaceuticals to treat vascular retinal disorders,
specifically DME.
Oxurions disease focus
DME is caused by Diabetic Retinopathy (“DR”), which is a
complication of diabetes affecting the eye. DR is a chronic,
progressive, sight-threatening, and life-altering disease, and
is the leading cause of vision loss in working-aged adults
(20-65 years).
1
DME can present at any stage in the development of DR.
DME occurs when DR damages blood vessels in the eye,
allowing fluid to escape and to accumulate in the central
part of the retina, leading to vision loss.
17
OXURION ANNUAL REPORT 2022
DR and DME are growing public health concerns due to
the rapid growth in the number of people with diabetes
globally. More than one in three people living with diabetes
will develop some form of DR in their lifetime.
2
Along with
the development of diabetes as a global health issue, the
prevalence of DME is expected to rise for the foresee-
able future. The market value for drugs to treat DME is
estimated at approximately $5 billion annually.
3
The current standard of care therapy for the
treatment of DME is monthly injections in the eye
with anti-vascular endothelial growth factor compounds.
These intravitreal injections block the vascular
endothelial growth factor pathway, which is one of the
key causes in the development of DME. Scientifically
speaking, VEGF is a cytokine produced in conditions of
cellular stress, resulting in increased vascular permeability/
proliferation by binding to endothelial cell receptors.
Anti-VEGF agents work by binding to VEGF to inhibit
endothelial receptor binding.
However, anti-VEGFs have been shown to deliver subop-
timal results in a significant portion of the patient popula-
tion. Up to 50% of DME patients have an unsatisfactory
visual response with anti-VEGF therapy, and in many cases
anti-VEGFs fail to achieve a clinically meaningful visual
improvement.
4
Moreover, despite the significant success
of anti-VEGFs, physicians and patients constantly seek
improved therapies, not only to expand treatment capa-
bilities for the up to 50% of DME patients who respond
suboptimally to anti-VEGFs, but also to deliver faster
onset of action, better therapeutic effect, longer duration
of response to treatment, and improved convenience of
treatment through a simpler dosing regimen.
2 Yau JW et al. Diabetes Care 2012;35(3):556-564; Thomas RL et al. Diabetes ResClin Pract 2019;157:107840; Teo ZL et al. Ophthalmology
2021;128(11):1580-1591.
3 Market size estimates were derived from combination of datasets extracted from multiple sources including curative databases with subscription
(Datamonitor Healthcare 2017-2020, Decision Resources Group 2019, GlobalData 2020) and publicly available data from the annual reports of publicly
traded companies.
4 Sun JK and Kampol LM. Ophthalmic Res 2019;62:225-230.
This is driving the development of the Company’s clinical
asset, THR-149 (“THR-149” or the “Clinical Asset”), which
is designed to meet specific unmet needs in this market
by treating DME patients who do not respond well to
anti-VEGFs.
Alternative Treatments
The primary treatment for DME currently consists of IVT
anti-VEGF therapies and IVT sustained-release corticos-
teroids, with anti-VEGF therapies representing more than
90% of the market in value terms.
Oxurion is engaged in the development of alternatives to
anti-VEGF therapies to treat vascular retinal disorders in
the back-of-the-eye.
THR-149 is being developed as a possible alternative to
anti-VEGF therapy for the treatment of DME for those
patients who do not respond well to anti-VEGF therapies.
THR-149 is a bicyclic peptide and acts through inhibition of
the plasma kallikrein kinin (“PKaI-Kinin) system, which is
a recognized a target for DME.
Patients with DME have been shown to have elevated
levels of plasma kallikrein. THR-149 inhibits the PKaI-
kinin system, with the intent of hindering the further de-
velopment of DME (including symptoms including retinal
vascular permeability, inflammation, and angiogenesis).
THR-687 is an integrin antagonist for the treatment of
DME, but the development of this asset is currently on
pause.
Status and recruitment of the KALAHARI trial
After December 31, 2022, the Company announced
for THR-149
that two-thirds of the patients had been enrolled in the
KALAHARI trial. Topline data from Part B of the KALAHARI
THR-149 has already had positive safety results and
trial is expected in the fourth quarter of 2023.
promising efficacy from a Phase 1 safety trial and is
engaged in a Phase 2 clinical trial for the treatment of DME
INTEGRAL TRIAL for THR-687
(the “KALAHARI trial).
On May 9, 2022, the Company announced topline results
The KALAHARI trial is two-part randomized, multicenter
from Part A of its Phase 2 trial (“INTEGRAL) of THR-687,
Phase 2 clinical trial evaluating multiple IVT injections of
an integrin antagonist, for the treatment of DME.
THR-149 in DME patients previously showing a suboptimal
response to anti-VEGF therapy.
The Part A data showed THR-687 to be safe and well
tolerated with no serious adverse events and none of the
The first part, Part A, was successfully completed in
patients required rescue medication through Month 3.
September 2021, and the first patient was treated in Part B
However, there was insufficient evidence of efficacy on the
of the KALAHARI trial in October 2021.
key endpoints (Best Corrected Visual Acuity and Central
Subfield Thickness). As a result, Oxurion has decided not to
This study will be conducted in ~80 sites in eight countries.
advance THR-687 to Part B of the INTEGRAL trial in light
Approximately 108 subjects will be randomized in Part B
of both resources available and the inconsistent top-line
of the study.
data from the Phase 2, Part A INTEGRAL trial, which was
designed to evaluate THR-687 for the treatment of DME
The primary objective of Part B of the study is to assess
in treatment-naïve patients.
the difference in treatment effect between THR-149
0.13mg (selected dose level from Part A) and aflibercept
2mg in terms of increase in best corrected visual acuity
3.2.6 Intellectual property
from Baseline at Month 3.
The Company’s drug candidates are covered by several
The other study objectives of this part of the study are
patent families that are either owned by, or licensed to, the
to assess the efficacy of three monthly IVT injections of
Company.
THR-149, to further assess the safety of three monthly IVT
injections of THR-149, and to assess the efficacy and safety
The licenses granted to Oxurion are exclusive licenses
of a single flip-over injection (aflibercept or THR-149) when
with the right to sublicense and are subject to pre-agreed
administered one month after three monthly IVT injections
royalties. Oxurion has the rights to all intellectual property
of THR-149 or aflibercept.
(“IP”) that was developed in-house. The Company
engages a contracted European patent counsel from an IP
An interim analysis was completed in December 2022.
firm who works in collaboration with several leading inter-
The Independent Data Monitoring Committee rec-
national IP and patent law firms.
ommended continuation of the study based upon the
outcome of that interim analysis. The Independent Data
Monitoring Committee assessment included an evaluation
of interim efficacy and safety data from three-month data,
with a total of 31 patients.
18
OXURION ANNUAL REPORT 2022
19
OXURION ANNUAL REPORT 2022
THR-149. Oxurion has licensed composition-of-matter
patents related to THR-149 from Bicycle Therapeutics.
Oxurion has an exclusive license to these patents under
a research collaboration and license agreement (defined
below as the “Bicycle Collaboration Agreement”). As
further described in section 5.8, the license is subject to de-
velopment milestone payments and royalties. The patents
related to THR-149 have been granted in Australia, Canada,
China, Europe, Hong Kong, Japan, Russia, Singapore, and
US and are still pending in Brazil, India, and New Zealand.
The duration of patent protection lasts until 2034. This
may be extended up to five years in countries with patent
extension regimes, such as Europe and the US.
THR-687. Galapagos has transferred certain composi-
tion-of-matter patents relating to THR-687 to Oxurion. As
further described in Section 5.8, the license agreement
between Galapagos and Oxurion (defined below as the
“Galapagos License Agreement” or the “Galapagos
License”) foresees development milestone payments,
sales-based milestone payments and royalty rate.
THR-687 is an improved molecule created by Oxurion and
Oxurion has filed new composition-of-matter patent appli-
cations covering the THR-687 molecule. These patent ap-
plications are owned by Oxurion and have been granted in
Europe and the US and are still pending in Canada, Japan,
China, India, South Korea, Israel, Australia, New Zealand,
Brazil, Mexico, Eurasia, South Africa, Colombia, Indonesia,
Philippines, Singapore, Thailand, Vietnam, Malaysia. The
duration of patent protection lasts until 2039. This may be
extended up to five years in countries with patent extension
regimes, such as Europe and the US.
As security for the Kreos/Pontifax convertible bond, the
Group has granted Kreos-Pontifax a security interest over
its patents, however, the Company retains the express right
to license. The Group has created a pledge up to 10 million
euro over (i) the Company’s business, including its intellec-
tual property, and (ii) the patents and patent application in
families WO2020043533 and WO2005123734, relating
to THR 687, which have been registered in the Belgian
national pledge register. In addition, a pledge is registered
over the US patent 10,703,752 (application 16/554,259
filed on August 19, 2019), relating to THR 687, in the United
States Patent and Trademark Office.
3.2.7 Group structure
As of December 31, 2022, the Group consists of three
companies, Oxurion and its subsidiaries, (i) ThromboGenics
Inc., which is wholly owned and incorporated in New York,
US and (ii) Oncurious, which based in Leuven, Belgium,
and is also wholly owned.
3.2.8 Facilities
Since January 2009, all the Company’s laboratories have
been located at the “Bio-Incubator” building at Gaston
Geenslaan 1, 3001 Leuven.
The Company is GMP certified (EU Regulation 2003/94/
EC) by the Belgian Health Authorities (FAGG/AFMPS) for
both Commercial and Investigational Medicinal Product
batch certification.
3.2.9 Investment policy
Apart from investments in laboratory materials, hardware
and software, Oxurion has not made any other significant
investments, or any made commitments to make major
investments in the near future.
IP acquired from third parties is accounted for as invest-
ments and subject to impairment evaluation in accord-
ance with IFRS accounting policies.
Research and Development (“R&D”) expenses are directly
3.2.11 Corporate social responsibility
financed and as such are not considered as investments to
be capitalized on the balance sheet according to relevant
The Company is in contact with NGOs and patient
accounting rules. Under IFRS reporting and according to
advocacy organizations. Oxurion continuously aims to
the Company’s accounting policies, only development
reach out to the broader eye community to join forces
costs made in Phase 3, will be capitalized.
and to demonstrate its dedication to fulfilling our mission:
to prevent vision loss and fight blindness worldwide by
developing and delivering next-generation treatments for
3.2.10 Health, safety and
vascular retinal disorder.
environmental regulations
Oxurion is focused on creating a safe environment, not
only for the Company’s employees, but also for contrac-
tors, visitors, and the overall environment.
As a biotech Company, Oxurion must deal with biological
products daily. The environmental, health and safety policy
is a key element of the Company’s business strategy and
is part of the training of each employee. This policy implies
a continuous process through which improvements and
innovations are implemented.
While biotech research is inherently associated with high
waste production, where possible the Company selects
reusable or recyclable material: disposable protective
garments are replaced by a washable alternative, plastics
are replaced by glassware and waste flows are separated
in different fractions to allow recycling. Orders are placed
with local (European) providers and grouped to reduce
transportation impact. Our processes are optimized to
generate as few waste materials as possible.
Furthermore, Oxurion actively promotes the use of public
transportation or bicycle for the regular commute to work
and work-related travel is replaced by interactive video-
conference calls to maintain business contacts. Oxurion is
conscious of the environmental impact of its activities, and
continuously evaluates its needs in order to minimize its
environmental footprint.
20
OXURION ANNUAL REPORT 2022
21
OXURION ANNUAL REPORT 2022
3.3 COMMENTS TO CONSOLIDATED
FINANCIAL STATEMENTS
The consolidated financial statements were prepared in
accordance with IFRS as adopted by the EU and were
approved by the Board of Directors on March 30, 2023.
Statement of profit and loss
In 2022, Oxurion JETREA® income amounted to 0.6
million euro compared to 1.1 million euro in 2021.
Oxurions gross profit in 2022 amounted to 0.01 million
euro compared to 0.5 million euro in 2021.
R&D expenses in 2022 were 16 million euro compared to
20.7 million euro in 2021. The R&D expenses were mainly
related to clinical activities in THR-687 and THR-149.
In 2022, the selling expenses of Oxurion were 0.9 million
euro compared with 1.3 million euro in 2021.
General and administrative expenses of 6.0 million euro in
2022, compared to 7.2 million euro in 2021.
In 2022, Oxurion obtained other operating income of 0.8
million euro compared to 1.2 million euro in 2021.
In 2022, Oxurion incurred an operating loss of 22.9 million
euro compared to an operating loss of 28.5 million euro
in 2021.
The 2022 financial results were as follows: 0.6 million euro
in finance income compared to 0.2 million euro in 2021
and 9.4 million euro in finance expense in 2022 compared
to 1.3 million euro in 2021. The increase in finance expense
is due to the fair value adjustment on convertible bonds, a
non-cash item.
In 2022, Oxurion incurred a loss for the year of
31.7 million euro, compared to a loss for the year in 2021
of 29.6 million euro resulting in negative diluted earnings
per share of 0.37 euro in 2022 versus 0.77 euro in 2021.
Cash Flow
Oxurions cash position (including investments) at the end
of 2022 amounted to 3.6 million euro, in comparison to
10.0 million euro (including investments) at the end of
2021.
Statement of financial position
As of December 31, 2022, the Company’s statement of
financial position amounted to 12.0 million euro with cash,
cash equivalents and investments representing 30% of
the total balance sheet. This compares to the Company’s
December 31, 2021 balance sheet of 18.9 million euro with
cash, cash equivalents and investments representing 53%
of the total balance sheet.
As of December 31, 2022, the Group has convertible loans
for a total amount of 7.0 million euro, compared to 11.8
million euro in 2021.
Oxurion was incorporated on May 30, 2006, under its
former name ‘ThromboGenics’, with a share capital of
62,000 euro represented by 11,124 shares. As of December
31, 2022, the share capital of the Company amounted to
65.4 million euro represented by 411,071,559 shares.
3.4 COMMENTS TO
The financial results were as follows: 0.2 million euro in
STATUTORY ACCOUNTS
financial revenue in 2022 compared to 0.1 million euro in
2021, and 3.5 million euro in financial expenses in 2022
The 2022 financial year closed with a loss of 24.5 million
due to the impairment of Galapagos and the participation
euro compared to a loss of 36.7 million euro for the 2021
in ThromboGenics Inc. compared to 12.2 million euro in
financial year.
2021 due to the impairment of Oncurious assets.
The operating income for the 2022 financial year
Favorable adjustments of income taxes, tax credits,
amounted to 19.9 million euro compared to 26.5 million
amounted to 0.6 million euro in 2022 and 0.8 million euro
euro in 2021, consisting of:
in 2021.
0.4 million euro from product sales compared to 0.9
As a result, the 2022 financial year closed with a loss of
million euro in 2021.
24.5 million euro compared to a loss of 36.7 million euro
0.2 million euro from royalties compared to 0.2 million
for the 2021 financial year.
euro in 2021.
17.9 million euro in capitalized R&D expenses compared
In addition, for the financial year 2022, an amount of
to 23.7 million euro in 2021; and
0.06 million euro was invested, mostly in IT & laboratory
1.4 million euro from costs carried forward and other
equipment and office modelling, compared to 0.02 million
operational revenue compared to 1.7 million euro in
euro in 2021.
2021.
Going concern - material uncertainty
The operating expenses for the financial year 2022
amounted to 41.7 million euro compared to 51.9 million
According to Article 3:6, §1, 6° of the Belgian Code of
euro for the financial year 2021. These operating expenses
Companies and Associations (“BCCA) and after deliber-
break down as follows:
ation, the Board of Directors has decided to preserve the
valuation rules assuming continuation, for the following
3.3 million euro in purchases compared to 4.5 million
reason:
euro in 2021;
15.1 million euro in services and various goods
The Company cash balance at December 31, 2022 of 3.4
compared to 15.6 million euro in 2021.
million euro is not sufficient to fund the Company’s oper-
4.9 million euro in salaries and social security contribu-
ations during the next 12 months. However, post-closing,
tions compared to 7.4 million euro in 2021;
on March 1, 2023, the Company entered into a subscrip-
18 million euro in depreciation and amortization
tion agreement for convertible bonds with Atlas Special
compared to 24.0 million euro in 2021; and
Opportunities, LLC, providing for up to 20 million euro in
0.4 million euro in other operating expenses compared
financing (the Atlas Subscription Agreement”).
to 0.4 million euro in 2021.
This committed but conditional funding would be suffi-
Therefore, the operating loss amounts to 21.8 million euro,
cient to fund operations during the next twelve months
compared to a loss of 25.4 million euro a year earlier.
from the financial statement’s issue date. However, given
the contingent nature of this funding, the Company is
actively exploring the possibility of obtaining additional
22
OXURION ANNUAL REPORT 2022
23
OXURION ANNUAL REPORT 2022
funding through debt, equity, or non-dilutive funding,
including the licensing of THR-149, or alternatively
reducing its costs and investments so that there should
be sufficient cash to continue its operations during the
next twelve months.
As the net-assets of the Company are below 61,500
euro (the statutory minimum amount of share capital of
a Belgian public limited liability company), in accordance
with article 7:229 of the BCCA, each interested party is
entitled to request the competent commercial court to
dissolve the Company. In such instance the court may
order the dissolu tion of the Company or grant a grace
period within which the Company is allowed to remedy
the situation.
Based on the above, the Board of Directors considers
it may be reasonable to expect that there will be suf-
ficient cash to continue its operations during the next
twelve months, and therefore decided to continue its
valuation rules under the assumption of going concern.
However, there is a material uncertainty relating to going
concern of the Company because it is uncertain that the
above-mentioned committed but conditional funding will
be available when needed given the conditions related
to the funding, and because it is not certain whether the
Company will be able to timely obtain the necessary
additional funding through debt, equity, or non-dilutive
funding, partnering or to realize sufficient cost and invest-
ment reductions.
.
3.5 DESCRIPTION OF THE PRINCIPAL
CHARACTERISTICS OF THE
COMPANY’S RISKS
The risks and uncertainties that the Company believes to
be material are described below. The occurrence of one or
more of these risks may have a material adverse effect on
the Company’s cash flows, results of operations, financial
condition and/or prospects and may even endanger the
Company’s ability to continue as a going concern, which could
lead to its liquidation or bankruptcy, and which will have a
material adverse impact on the Company and its sharehold-
ers leading to the potential total loss of their entire investment.
Moreover, the Company’s share price could fall significantly
if any of these risks were to materialize. Further, these risks
and uncertainties may not be the only ones the Company
faces. Additional risks, including those currently unknown or
deemed immaterial, may also impair the Company’s business
operations.
The risk factors are presented in eight categories, depending
on their nature. In each category, the risk factor which in the
assessment of the Company is the most material, taking into
account the negative impact on the Company (including any
relevant mitigation measures) and the probability of its oc-
currence, is mentioned at the outset, and the remainder of
the risks in each category are listed in order of importance
based on the Company’s assessment, although prospective
investors should consider them all.
3.5.1 Risks related to insufficient funding,
The Company is of the opinion that it currently does not
continuation as a going Concern and
have sufficient working capital from fully committed sources
potential bankruptcy
to meet its capital requirements over the 12-month period
3.5.1.1 The Company is of the opinion that it currently
following the Issue Date. The shortfall over the 12-month
does not have sufficient working capital to meet
period from the Issue Date is estimated at approximately 16
its capital requirements from fully committed
million euro.
sources over the 12-month period starting from
the date this Annual Report was issued (“Issue
The Company included a statement in its 2020 Annual
Date”). The shortfall over the 12-month period
Report, its 2021 Annual Report and its 2022 Half Year
from the Issue Date is estimated at approxi-
Report that there is a material uncertainty with respect
mately 16 million euro. The Company’s ability
to the Company’s ability to continue as a going concern.
to complete the milestones in the development
Furthermore, the Board of Directors has established that the
of THR-149 will be put at risk if it is not able
net assets of the Company fell below one quarter of the share
to access available funding due to the condi-
capital and convened a special general shareholders’ meeting
tions attached to that funding, raise additional
that took place on November 9, 2021, in accordance with
funding and/or reduce its expenditures when
article 7:228 of the BCCA, at which the shareholders decided
required to do so during the 12-month period
(i) to continue the Company’s operations and (ii) to approve
starting from the Issue Date, all of which is
the recovery measures proposed by the Board of Directors
uncertain. Furthermore, if the Company is not
to improve the Company’s equity. This will be repeated at
able to access available funding due to the
the Annual General Meeting to be held on May 2, 2023. In
conditions attached to that funding, increase
accordance with article 7:229 of the BCCA, if the net-assets
its funding and/or reduce its expenditures when
of the Company would fall below 61,500 euro (the statutory
required to do so, all of which is uncertain, during
minimum amount of share capital of a Belgian public limited
the 12-month period starting from the Issue
liability company), each interested party would be entitled
Date, its ability to continue as a going concern
to request the competent commercial court to dissolve the
will be threatened, and could lead to its liqui-
Company. In such instance the court may order the dissolu-
dation or bankruptcy and which would have a
tion of the Company or grant a grace period within which the
material adverse impact on the Company and
Company is allowed to remedy the situation.
its shareholders leading to the potential total
loss of their entire investment. The Company’s
Concerning the possible sources of funding, after the close of
access to funds under the Atlas Funding
the financial year, the Company has entered into an issuance
Program is subject to certain conditions, such as
and subscription agreement with Atlas on March 1, 2023,
being able to obtain admission to listing of con-
pursuant to which Atlas has committed to subscribe to up to
version shares on a timely basis, the average
20 million euro in the Company’s equity through mandatory
market capitalization of the Company over a
convertible bonds to be issued in tranches of 2,000,000 euro
period of thirty days preceding the issue date
with a cool down period of 22 trading days between tranches
not having fallen below two times the amount
and subject to certain other conditions (herein referred to as
of the envisaged tranche call, and the total
the Atlas Funding Program”). The undertaking of Atlas to
trading value of the Company’s shares during
subscribe to a new tranche is, among other things, subject to
the preceding 22 trading days being at least
the fulfilment of (or waiver thereof) the conditions that (A)
equal to 1,500,000 euro
the total trading value of the Company’s shares during the
24
OXURION ANNUAL REPORT 2022
25
OXURION ANNUAL REPORT 2022
preceding 22 trading days is at least equal to 1,500,000 euro
(“Liquidity Condition) and (B) the average market capitaliza-
tion of the Company over a period of thirty days preceding
the issue date has not fallen below two times the amount
of the envisaged tranche call provided that if the Company’s
average market capitalization falls below 4,000,000 euro, the
Company shall be entitled to draw a Tranche of 1,000,000
euro, provided that its average market capitalization is at least
2,000,000 euro, and as soon as the Subscriber converts
those bonds, the Company shall be entitled to draw another
Tranche without a cool down period provided the other con-
ditions for drawing a Tranche are met (“Market Capitalization
Condition).
The Company’s access to funds under the Atlas Funding
Program is subject to certain conditions, such as the Liquidity
and Market Conditions described above, as well as the
Company’s ability to obtain admission to listing of conversion
shares in a timely manner. The inability for the Company
to draw under the Atlas Funding Program, a breach of the
Company’s contractual obligations under the Atlas Funding
Program or an event of default under the Loan Facility (such
as a breach of the minimum cash covenant under the Loan
Facility, i.e. requiring that the Company maintains a minimum
aggregate amount of 2 million euro cash on its bank account
(the “Minimum Cash Covenant”) could have a material
adverse impact on the Company’s cash position and could
lead to bankruptcy taking into account that the Company’s
cash position on December 31, 2022, was approximately
3.4 million euro.
Under the Atlas Funding Program, based on the amounts
drawn as of the Issue Date, the Company potentially has
access to up to another 16 million euro provided the Company
can and does draw the maximum tranche. The Company’s
ability to draw a tranche is subject to certain conditions such
that it may not be able to draw a tranche when it desires to do
so. Since the Liquidity and Market Capitalization Conditions
are expressed as an amount in euros and taking into account
the Company’s (reduced) stock price, it is currently uncertain
whether the Company would be able to meet these condi-
tions and draw under the Atlas Funding Program in the future
absent trading from Atlas, with the result that the Company
may depend on Atlas to meet this condition.
Therefore, if the Company’s stock price decreases, it is
uncertain whether the Company would be able to draw under
the Atlas Funding Program in the future, except to the extent
that such trading continues. The inability for the Company
to draw under the Atlas Funding Program, a breach of the
Company’s contractual obligations under the Atlas Funding
Program, or an event of default under the Loan Facility (such
as a breach of the Minimum Cash Covenant) could have a
material adverse impact on the Company’s cash position and
could lead to bankruptcy.
Furthermore, the Company may consider outlicensing
THR-149, which could reduce its costs because the licensor
could pay all or part of the relevant trial, and potential-
ly increase its revenues through upfront and milestone
payments (and eventually royalties). However, if due to cash
constraints, the Company enters into a license at an inoppor-
tune moment or on disadvantageous terms, this could have
a significant negative impact on the Company’s valuation and
on its shareholders.
The Company’s ability to complete the milestones in the
development of THR-149 will be put at risk if it is not able to
access available funding due to the conditions attached to
that funding, raise additional funding and/or reduce its expen-
ditures when required to do so, all of which is uncertain, during
the 12-month period starting from the Issue Date. Furthermore,
if the Company is not able to access available funding due to
the conditions attached to that funding, increase its funding
and/or reduce its expenditures when required to do so, all of
which is uncertain, during the 12-month period starting from
the Issue Date, its ability to continue as a going concern would
be threatened, which could lead to its liquidation or bank-
ruptcy which would have a material adverse impact on the
Company and its shareholders leading to the potential total
loss of their entire investment.
3.5.1.2 The Company is also of the opinion that,
Given the time required for completion of the KALAHARI
even if it manages to attract sufficient funding
trial for THR-149 in DME and that other development activi-
allowing it to cover its working capital needs
ties are expected to continue after the end of the 12-month
during the 12-month period starting from the
period following the date of the Issue Date, further funding
Issue Date, the Company will not have funds
will be required in the period starting 12 months after the
available at the end of this 12-month period,
Issue Date, the amount of which is uncertain and depends
unless it is able to attract additional funding,
on many factors, including the time required to complete
and will therefore continue to face working
the KALAHARI trial, whether the Company decides to
capital difficulties unless in the interim it is
undertake any Phase 3 trials itself or enter into a license
able to access available funding in light of the
with a third party for those trials and a myriad other factors
conditions attached to that funding, raise addi-
impacting the development of a clinical asset such as the
tional funds, and/or reduce its working capital
THR-149.
requirements when it is required to do so, all of
which is uncertain. If the Company is not able
As described in the preceding risk factor, after
to access available funding in light of the con-
December 31, 2022, the Company entered into the Atlas
ditions attached to that funding, increase its
Funding Program. As is the case for the Company’s funding
funding, and/or reduce its expenditures when
needs during the 12-month period following the Issue Date,
required to do so, all of which is uncertain, in
the Company is of the opinion that it does not have suffi-
the period starting 12 months after the Issue
cient working capital to meet its capital requirements over
Date, its ability to continue as a going concern
the period starting 12 months after the Issue Date and will
will be threatened, which could lead to its liqui-
continue to face working capital difficulties unless in the
dation or bankruptcy and will have a material
interim it is able to access available funding in light of the
adverse impact on the Company and its
conditions attached to that funding, raise additional funds,
shareholders leading to the potential total loss
and/or reduce its working capital requirements when it is
of their entire investment.
required to do so, all of which is uncertain.
In addition to the period of 12 months following the
The Company’s ability to meet its funding requirements
Issue Date, as described in the preceding risk factor, the
during the period starting 12 months after the Issue Date
Company is also of the opinion that, even if it manages
through a combination of debt and equity, accessing the
to attract sufficient funding allowing it to cover its working
debt markets and/or raising additional equity capital and/
capital needs during the 12-month period starting from the
or entering into licensing arrangements, is uncertain, in par-
Issue Date, the Company will not have funds available at
ticular taking into account the Company’s current market
the end of this 12-month period unless it is able to attract
capitalization. As described in Section 3.5.1.1 of Section 3.5
additional funding. The Company will therefore continue
‘Risk Factors’, the Company may also consider further out-
to face working capital difficulties unless in the interim it
licensing of THR-149 during the period starting 12 months
is able raise additional funds, and/or reduce its working
after the Issue Date to the extent the asset or territory
capital requirements when it is required to do so, all of
remains available for licensing.
which is uncertain, in particular taking into account the
Company’s current market capitalization.
26
OXURION ANNUAL REPORT 2022
27
OXURION ANNUAL REPORT 2022
The Company’s ability to complete the milestones in the
development of THR-149 will be put at risk if it is not able to
access available funding due to the conditions attached to
that funding, raise additional funding and/or reduce its ex-
penditures when required to do so, all of which is uncertain,
in the period starting 12 months after the Issue Date. If
the Company is not able to access available funding in
light of the conditions attached to that funding, increase
its funding, and/or reduce its expenditures when required
to do so, all of which is uncertain, in particular taking into
account the Company’s current market capitalization,
in the period starting 12 months after the Issue Date, its
ability to continue as a going concern will be threatened,
could lead to its liquidation or bankruptcy and will have a
material adverse impact on the Company and its share-
holders leading to the potential total loss of their entire
investment.
3.5.1.3 The Company is a clinical stage biotech with
no history of profitability due to substantial
investments in product development, and the
Company requires additional external funding
on a going forward basis to continue and
complete the development of THR-149, which,
if not available when needed, could threaten
the Company’s ability to continue as a going
concern, which could lead to its liquidation
or bankruptcy which would have a material
adverse impact on the Company and its
shareholders leading to the potential total loss
of their entire investment.
Oxurion is dedicated to developing and bringing new phar-
macologic treatments addressing important unmet clinical
needs for the treatment of vascular retinal disorders to a
commercial stage of development.
The Company only has one asset, THR-149, in active
clinical development, after the Company decided to pause
development of THR-687 due to capital constraints given
the disappointing results from the Phase 2 Part A results
in treatment naïve patients. Oxurion plans to continue
preclinical testing, product development, regulatory com-
pliance, and the KALAHARI trial for the THR-149 in DME,
which, together with anticipated general and administra-
tive expenses, will result in significant additional invest-
ments for several years before achieving any return. These
investments in THR-149 and related expenditures require
Oxurion to attract significant additional external funding in
order to realize the value of THR-149.
The extent of Oxurions future financing needs depends on
many factors, including the progress, costs and timing of
its research and development activities, preclinical studies,
the clinical trial design, the costs of managing its patent
and IP portfolio and obtaining regulatory approval, and
the terms and timing of its product supply arrangements,
commercial relationships, license agreements and other
partnerships, and/or re-establishing sales and marketing
capabilities. However, although the amount of additional
funding that is required is uncertain, it is certain that sub-
stantial additional funding will be necessary to complete
the Company’s existing and future drug development
programs. As of December 31, 2022, the Group had accu-
mulated losses of 73,404,000 euro.
The main cost will be the clinical trials for THR-149. The
Company is currently engaged in the KALAHARI trial
with THR-149 for DME, which the Company currently
estimates will have top-line results in the fourth quarter
of 2023. If that trial is successful, a number of Phase 3
clinical trials will be required before THR-149 is approved,
which are larger and more expensive trials, and which are
not expected to be completed until 2028. Oxurion does
not know if it will generate positive clinical data, receive
regulatory approval, or obtain reimbursement for THR-149.
Further, the Company may encounter unforeseen events
(potentially including expenses, difficulties, complications,
delays, and other unknown factors), all of which could
impair Oxurions ability to attract the additional funding
required to complete the clinical development.
This means that Oxurion will have to attract significant ad-
3.5.2 Risks related to clinical development
ditional funding from third parties to continue operations
until 2028 before it is able to generate revenues from the
3.5.2.1 The Company only has one product in active
marketing of THR-149. Alternatively, the Company could
development, which could fail, and which would
decide to outlicense THR-149 for further development or
threaten the Company’s ability to continue as
beyond Phase 2. This would reduce or eliminate future
a going concern, which could lead to its liq-
development costs and could generate revenues from
uidation or bankruptcy which would have a
milestone payments as early as this year.
material adverse impact on the Company and
its shareholders leading to the potential total
Should Oxurion not be able to secure adequate future
loss of their entire investment.
external funding to continue its development programs
for THR-149 in a timely manner and/or to enter into outli-
Oxurion cannot market or promote THR-149 until it
censing arrangements, this would have a material adverse
receives all necessary regulatory approvals, which may
effect on Oxurion as it may be forced to delay, reduce
never be received. Oxurion’s success therefore depends on
or terminate the development or commercialization of
the Company’s ability to successfully develop (or for a third
THR-149, out-license THR-149 prematurely, or not be able
party to successfully develop) THR-149 through comple-
to take advantage of future business opportunities, all of
tion of Phase 2 and Phase 3 clinical trials and regulatory
which could potentially impair Oxurions ability to sustain
marketing authorization.
operations or to continue as a going concern, which could
lead to its liquidation or bankruptcy which would have a
Oxurion only has one active clinical asset in the pipeline,
material adverse impact on the Company and its share-
which is in Phase 2 development, and a significant per-
holders leading to the potential total loss of their entire
centage of Phase 2 clinical trials fail. If the KALAHARI
investment.
trial also fails, this would threaten the Company’s ability to
continue as a going concern (please refer to Section 3.5.1.1
If the KALAHARI trial is significantly delayed, the risk
and Section 3.5.1.2 of this Section 3.5 ‘Risk Factors’, for
that it will be difficult to obtain additional funding for the
further information), which could lead to its liquidation or
KALAHARI trial increases substantially. If the KALAHARI
bankruptcy which would have a material adverse impact
trial fails, as was the case with Oxurions Part A of the
on the Company, and which could result in shareholders
Phase 2 INTEGRAL trial for THR-687 in DME, funding
losing the total value of their investment.
will become extremely difficult and potentially impossible,
and would threaten the Company’s ability to continue as
a going concern and potentially result in shareholders
losing the total value of their investment (please refer to
Risks 3.5.1.1 and 3.5.1.2 of this Section 3.5 ‘Risk Factors’ , for
further information).
28
OXURION ANNUAL REPORT 2022
29
OXURION ANNUAL REPORT 2022
3.5.2.2 The KALAHARI trial for THR-149 in DME could
be significantly delayed, which would threaten
the Company’s ability to continue as a going
concern, which could lead to its liquidation
or bankruptcy which would have a material
adverse impact on the Company and its
shareholders leading to the potential total loss
of their entire investment.
The KALAHARI trial for THR-149 in DME may be delayed for
a variety of reasons, including, but not limited to, delay in re-
cruiting a sufficient number of suitable patients to participate
in the KALAHARI trial and in having them complete the trial
or return for follow-up; the recruitment and retention of clinical
sites; the impact of COVID-19; maintaining the Company’s
relationships with its clinical research organizations (“CROs),
clinical investigators and clinical trial sites; the reliability of its
third-party manufacturing organizations; any possible safety
or efficacy issues that could be raised in the future; potential
delays in obtaining regulatory approval, and any supply
failures or delays with respect to the clinical trial materials.
COVID-19 did not directly impact the KALAHARI trial.
Indirectly, COVID-19 delayed the KALAHARI trial because
it impacted (i) potential patients for the trial, (ii) potential in-
vestigators for the KALAHARI trial, (iii) potential sites for the
KALAHARI trial, (iv) strained CRO resources and (v) increased
the time to obtain regulatory approvals. It is difficult to quantify
the costs of such delay, but a reasonable estimate is 5 million
euros.
Patient enrollment and the inclusion of sites and investiga-
tors is a particularly significant factor in the timing of clinical
trials and is affected by many factors including, but not
limited to, the number of patients available for the clinical trial,
competing trials and patient concerns about COVID-19, as
well as numerous other factors.
If Oxurion experiences lower/slower than expected enroll-
ment in the KALAHARI trial for THR-149 in DME, the trial
may be delayed, may not be completed as envisaged or may
become more expensive to complete, which would have an
adverse impact on Oxurions ability to raise funds (please refer
to Section 3.5.1.1 of this Section 3.5 ‘Risk Factors’, for further
information), as well as its business, prospects, financial
condition and results of operations.
A significant delay in the KALAHARI trial could cause the costs
of the trial to increase and seriously impact the Company’s
value and ability to raise additional funding. Delays in clinical
trials may be expected, but if it becomes significant, this would
be likely to have a material adverse impact on the Company’s
activities, costs, and ultimately on its valuation, which would
adversely impact shareholders, and eventually could threaten
the Company’s ability to continue as a going concern (please
refer to Risks 3.5.1.1 and 3.5.1.2 of this Section 3.5 ‘Risk Factors’’,
for further information), which could lead to its liquidation or
bankruptcy which would have a material adverse impact on
the Company and which could result in shareholders losing
the total value of their investment.
3.5.2.3 THR-149 may develop adverse side effects that
may delay or prevent marketing approval, which
could threaten the Company’s ability to continue
as a going concern given that THR-149 is the
only active clinical asset that Oxurion currently
has in the pipeline.
THR-149 may cause undesirable side effects or have other
properties that could delay or prevent further develop-
ment or regulatory approval, limit the commercial profile
of an approved label, or result in significant negative con-
sequences following marketing approval, if achieved.
At the clinical stage, adverse side effects could affect
patient recruitment or the ability of enrolled patients to
complete the trial or the completion of the KALAHARI trial
itself.
Both the Phase 1 clinical trial and Part A of the KALAHARI
3.5.3 Regulatory Risks
trial have shown THR-149 to be safe. However, undesirable
side effects could appear in subsequent clinical phases
3.5.3.1 The Company may not obtain marketing
and could cause Oxurion or regulators to interrupt, delay or
authorization for THR-149 in important terri-
halt the clinical trial or, even if the trial is completed, could
tories, which could have a significant adverse
cause delay or denial of regulatory approval by regulators
impact on shareholders given that THR-149 is
or result in a more restrictive label.
the only active clinical asset that Oxurion has
in the pipeline.
Although some adverse effects are expected in a clinical
trial, if THR-149 were to cause serious adverse effects,
THR-149 must receive marketing approval from the regula-
depending on their nature, this could have a significant
tors before it may be marketed and commercialized. Each
adverse impact on Oxurions ability to bring THR-149
regulator can impose its own requirements (thereby limiting
to market (please refer to Risks 3.5.1.1 and 3.5.1.2 of this
the market potential), can request additional data before
Section 3.5 ‘Risk Factors’, for further information). This
giving the marketing approval for the drug candidate, which
would impact the Company’s valuation and ability to
can cause delay, or can refuse to give approval, even if such
raise additional funding. Considering that THR-149 is the
approval was already given by other regulators.
only active clinical asset that Oxurion currently has in the
pipeline (please refer to 3.5.2.1 of this Section 3.5 ‘Risk
THR-149 is in a Phase 2 trial for DME, which may not be
Factors’, for further information), if it were to cause serious
successful, and even if it is, THR-149 will require additional
adverse effects, this could threaten the Company’s ability
Phase 3 clinical trials, and ultimately may not receive the
to continue as a going concern (please refer to Risks 3.5.2.1
required marketing approval to be sold. Furthermore, clinical
in this Section 3.5 ‘Risk Factors’, for further information),
data is often susceptible to varying interpretations and
which could result in shareholders losing the total value of
analyses and even a product that performed satisfactorily
their investment.
during clinical trials may nonetheless fail to obtain regulatory
approval for marketing. Due to the inherent risk in the de-
velopment of biopharmaceutical products, it is possible that
THR-149 will not be successfully developed and approved.
Once approved, products may also be subject to a post-au-
thorization safety trial or other pharmacovigilance or biovigi-
lance activities, may be subject to dosing or other limitations
on their uses, or may be withdrawn from the market for
various reasons, including if they are shown to be unsafe or
ineffective when used in a larger population, which may be
different from the trial population studied prior to introducing
the product on the market. It is also possible that regulatory
approval guidelines may change during the product develop-
ment and review process, making the current development
strategy suboptimal. These factors may result in significant
delays, increased development costs, substantial changes to
commercial assumptions or the failure of THR-149 to obtain
30
OXURION ANNUAL REPORT 2022
31
OXURION ANNUAL REPORT 2022
marketing authorization. Furthermore, even if a marketing
authorization is obtained, a regulator may impose ongoing
requirements such as a potentially costly post-approval trial
or post-market surveillance.
If THR-149 is not granted marketing authorization in important
markets, this is likely to have a materially adverse effect on
the Company’s ability to generate revenues. Furthermore, if
THR-149 were to be denied marketing authorization, funding
would become extremely difficult, and would threaten the
Company’s ability to continue as a going concern and po-
tentially result in shareholders losing the value of their invest-
ment (please refer to 3.5.1.1 and 3.5.1.2 of this Section 3.5 ‘Risk
Factors’’, for further information).
3.5.4 Market Acceptance Risk
3.5.4.1 THR-149 will have to compete against the
established market for anti-VEGFs, which are
widely accepted by physicians.
Anti-VEGFs have wide market acceptance with retina phy-
sicians for the treatment of DME (and wet AMD). Although
up to 50% of DME patients do not respond adequately
to anti-VEGF therapy
5
, retina physicians may resist trying
THR-149, which addresses an innovative pathway and
mechanism of action that may be perceived as untested.
Moreover, given its novelty, THR-149 may result in unex-
pected outcomes or the lack of efficacy that would not
be predicted based on the current standard of care, which
may have an adverse impact on market acceptance.
Furthermore, this type of advanced research sometimes
requires additional preclinical and clinical activities to
generate more extensive data and hence additional
costs, triggering increased time to market and funding
requirements.
5 Sun JK and Kampol LM. Ophthalmic Res 2019;62:225-230.
The market for treatments for vascular retinal disorders is
characterized by increased innovation, and major invest-
ments are being made in new therapies and improving
the existing standard of care, which is anti-VEGF therapy.
Although Oxurion is focused on a pathway that currently
does not have significant competition, competitors with
more financial wherewithal and other advantages may be
currently developing, or may in the future develop, technol-
ogies and products that are equally or more effective, safe
and/or economical than THR-149.
If THR-149 is not able to achieve market acceptance, this
will reduce Oxurions income and lower its valuation, which
could have a material adverse impact on the Company
and its shareholders, and could impact the Company’s
ability to continue as a going concern, which could lead to
its liquidation or bankruptcy which would have a material
adverse impact on the Company and potentially result in
shareholders losing the value of their investment (please
refer to Risk 3.5.2.1 of this Section 3.5 ‘Risk Factors’’, for
further information).
3.5.4.2 Price setting, availability, and level of reim-
bursement for THR-149 by third parties is
uncertain and may impede Oxurion’s ability to
be commercially successful.
THR-149’s commercial success will depend on the con-
ditions for setting the selling price and conditions of reim-
bursement by the health agencies, insurance companies,
health technology assessment agencies or other health-
care payers in the countries where THR-149 would be
marketed.
THR-149 is geared at creating an alternative to anti-VEGF
therapy. Considering THR-149’s innovative nature and the
lack of similar products, reimbursement levels are difficult
to predict and Oxurions ability to adopt an adequate
pricing strategy is uncertain. THR-149 may not fit within the
existing health technology assessment and reimbursement
3.5.5 Legal Risks
processes applied throughout the different jurisdictions
in which it would be sold. THR-149 may also be subject
3.5.5.1 THR-149 may be deemed to infringe on the
to different reimbursement mechanisms and amounts
patents or other intellectual property rights
depending on the jurisdiction in which it is being offered
of others, which could have a significant
for sale. Moreover, anti-VEGF therapies will lose market
adverse impact on shareholders and other
exclusivity, which is expected to create downward pressure
stakeholders.
on pricing and reimbursement. There is also a general
downward pressure on healthcare spending, including re-
Oxurions success depends on its ability to operate without
imbursement and price levels, in most countries, due to,
infringing on or misappropriating the intellectual property
among other things, the current environment of health-
rights of others. Oxurion cannot guarantee that its activities,
care cost control (e.g., international reference pricing) and
or those of its licensors, will not infringe on the patents or
increase in healthcare budgets caused by an aging popu-
other intellectual property rights owned by others.
lation, which budget pressure will be further expanded by
the impact of COVID-19.
There is significant litigation activity in the pharmaceutical
industry regarding patents and other intellectual property
If THR-149 fails to obtain favorable pricing and/
rights. Oxurion or its licensors may need to expend sig-
or adequate reimbursement by third parties, such as
nificant time and effort and may incur substantial costs
insurance companies, governmental and other healthcare
in litigation if the Company is required to defend patent
payers, this would impede Oxurions ability to generate
or other intellectual property rights claims regardless of
revenue from THR-149, which would have an adverse
whether the claims have any merit. Oxurion also cannot
impact on its revenue, which in turn would have an impact
predict whether it or its licensors will prevail in any litigation.
on its valuation in the market and reduce the benefit to
its shareholders to be derived from THR-149. If Oxurion is
If Oxurion or its licensors are found to have infringed the
unable to generate revenue from THR-149, the Company’s
patents or other intellectual property rights of others,
ability to continue as a going concern could be threat-
Oxurion or its licensors may be subject to substantial
ened, which would have a material adverse impact on
claims for damages, which could materially impact its cash
the Company and its shareholders and could lead to its
flow and financial position. Oxurion may also be required to
liquidation or bankruptcy which could potentially result in
cease development, use or sale of THR-149, or be required
shareholders losing the value of their investment (please
to obtain a license for the disputed rights, which may not
refer to Risk 3.5.2.1 of this Section 3.5 ‘Risk Factors’’, for
be available on commercially reasonable terms, if at all.
further information).
Although to date no patent infringement claim has been
made against Oxurion, if THR-149 were to be found to
infringe on the patents or other intellectual property of
others, Oxurion could be liable for significant damages,
potentially including a substantial unexpected royalty and
potentially even be required to withdraw THR-149 from
the market. This would have a material adverse impact on
Oxurions cash flow and reputation, which could result in
the shareholders losing the total value of their investment.
32
OXURION ANNUAL REPORT 2022
33
OXURION ANNUAL REPORT 2022
3.5.5.2 Product liability claims could be successfully
brought against Oxurion or its partners, which
could have a significant adverse impact on
shareholders and other stakeholders.
Product liability claims due to unpredicted adverse side
effects of THR-149 may be brought against Oxurion
or its partners by participants enrolled in clinical trials,
patients, practitioners, researchers, other health/research
professionals or others using, administering, or selling any
of Oxurions Clinical Asset once approved. Furthermore,
JETREA® is a product developed by Oxurion and marketed
by its partner, Inceptua, on its behalf, for the treatment of
vitreomacular traction (VMT), which could also lead to
product liability claims.
Oxurion is currently insured for product liability risks.
However, claims could be made that exceed this insurance.
Oxurion may incur substantial liability if it is found liable
for product liability to the extent that such claims are not
adequately covered by its insurance. Furthermore, a suc-
cessful product liability claim (or even an unsuccessful
one) could potentially harm the Company’s reputation and
hinder its ability to market other products, especially given
that the Company has only one product in active develop-
ment (please refer to Risk 3.5.2.1 of this Section 3.5 ‘Risk
Factors’’, for further information). To date, no such claims
or legal actions have been filed against Oxurion, but this
could happen in the future, in which case it could have
a material adverse impact on the Company depending
on the circumstances, resulting in a potential diminution
of the Company’s value and have an adverse impact on
shareholders.
3.5.5.3 Data protection violation or data breach claims
may have an adverse effect on Oxurions
business, prospects, financial condition and
results of operations and its ability to execute
the KALAHARI trial, which could have a sig-
nificant adverse impact on shareholders and
other stakeholders.
Oxurion is required to comply with applicable data pro-
tection laws, including the European Unions General Data
Protection Regulation (“GDPR”), which imposes strict
obligations and restrictions on the collection and use of
personal data. This includes cybersecurity measures
addressed to prevent loss or exposure of data, intrusion into
or blockage of Oxurions or its collaborators’ systems. Even
stricter requirements apply to sensitive data (including
data related to health).
Oxurion collects, uses, and stores personal data including
sensitive data during the ordinary course of its opera-
tions. Oxurions third-party vendors also have access to
and process personal data, including sensitive data, on its
behalf.
Oxurion has established processes and controls for com-
pliance with its data protection obligations and for the
proper prevention, detection, and response to cybersecu-
rity risk. This includes the fact that all data from its clinical
trial is pseudonymized before being transferred to Oxurion
or its vendors, which do not have access to any patient
details concerning the subjects taking part in its clinical
trials.
Oxurion has taken preventative measures and established
procedures regarding data processing and data security.
However, data protection violations, data breaches, loss
of data and unauthorized access could still occur. This
could result in legal claims or proceedings, liability under
the data protection and other laws, significant regulatory
penalties, disruption of Oxurion’s operations and damage
to its reputation.
A significant data protection violation or data breach could
Licenses. THR-149 is the result of a license agreement
have a material adverse effect on Oxurions business,
with Bicycle Therapeutics for the intellectual property
prospects, financial condition, and results of operations. As
that protects THR-149. The conditions under which the
a biopharmaceutical company engaged in clinical trials, if
Company may use this intellectual property include, but
the Company were to be considered a data protection risk
are not limited to, payments being due upon achievement
by competent authorities, the CROs, investigators, hospitals,
of certain milestones and royalties on net sales of relevant
patients or third parties, it would make it more difficult for
products, as well as the performance of other obligations.
the Company to recruit the clinical trial sites, clinical in-
vestigators, and patients required for its trials and hence
If Oxurion fails to comply with its obligations under the
more difficult to carry out the trials, potentially resulting
license agreement, the licensor may reduce the scope of
in delay. This would result in a potential loss of value for
the license or terminate the license, resulting in the loss of
the Company and its shareholders as the trials could
the use of the related intellectual property rights. Loss of
take longer and become more expensive (please refer to
the rights to the intellectual property protecting THR-149 is
Sections 3.5.2.2 ‘THR-149 could be significantly delayed
likely to mean that Oxurion is unable to develop, manufac-
and 3.5.3.1 ‘The Company may not obtain marketing
ture or sell THR-149 products or have them sold.
authorization for THR-149 in important territories’ of this
Section 3.5 ‘Risk Factors’, for further information).
Patent Protection. Oxurion and its licensors have a robust
patent portfolio protecting THR-149 in the most important
markets. However, Oxurion cannot guarantee that it or its
3.5.6 Risks related to intellectual
licensors will be able to obtain or maintain these patent
Property Protection
rights against third-party challenges to their validity, scope,
and enforceability, potentially enabling competitors to
3.5.6.1 THR-149 is licensed from third parties,
circumvent the patents and to use the patented intellec-
which creates risks of the loss of the license
tual property, thereby depriving Oxurion of the protection
rights, and THR-149 may not be adequately
it would expect against competitors. Moreover, Oxurion
protected by the patents and other intellectual
and its licensors have not sought to protect its intellectual
property rights, which could have a significant
property rights in all jurisdictions throughout the world and
adverse impact on shareholders and other
may not be able to adequately enforce their intellectual
stakeholders.
property rights in the jurisdictions where they have sought
or obtained protection.
THR-149 is covered by several patent families, which are
licensed to Oxurion. The Company’s success will depend
A biopharmaceutical company such as Oxurion that
in part on its and its licensors’ ability to obtain, maintain and
licenses rights from third parties relies on being able to
enforce these patents and other intellectual property rights.
exercise those rights and that they will be enforceable and
enforced, for its market and commercial value. Any diminu-
tion of those rights or that protection could have a material
adverse impact on the Company and its shareholders, and
therefore could result in a significant loss of investment.
If Oxurion were to lose the license rights to THR-149, the
Company’s ability to continue as a going concern could be
threatened which would have a material adverse impact
34
OXURION ANNUAL REPORT 2022
35
OXURION ANNUAL REPORT 2022
on the Company and its shareholders and could lead to
the Company’s liquidation or bankruptcy and the potential
total loss by the shareholders of their entire investment
(please refer to Section 3.5.1.1 of this Section 3.5 ‘Risk
Factors’, for further information).
In summary, if Oxurion were to lose the license rights
to THR-149, this would have a material impact on its
business and its shareholders (please refer to Section
3.5.2.1 of this Section 3.5 ‘Risk Factors’, for further infor-
mation). Furthermore, if Oxurion and its licensors would
be unsuccessful in enforcing their patents and other intel-
lectual property protection to protect THR-149, this could
have a material adverse effect on the Company’s ability
to maximize the market potential of THR-149, which also
could have a material impact on its business and its share-
holders and other stakeholders.
3.5.6.2 If Oxurion is not able to prevent disclosure of
its trade secrets, know-how, or other propri-
etary information, the value of its technology
and THR-149 could be significantly diminished,
which could have a substantial adverse impact
on shareholders and other stakeholders.
Oxurion relies on trade secret protection to protect its
interests in its know-how and other proprietary information
and processes for which patents are difficult to obtain or
enforce, all of which constitutes confidential information.
Oxurion may not be able to protect its confidential informa-
tion adequately. Oxurion has a policy of requiring anyone
to which it discloses confidential information, including for
example, its employees, actual or potential consultants,
contract personnel, advisers, some investors and potential
investors and third-party partners (“Receiving Parties”),
to enter into confidentiality agreements. However, there is
no assurance that such agreements will provide sufficient
protection of confidential information in the event of any
unauthorized use or disclosure of confidential information.
Furthermore, Oxurion cannot provide any assurance that any
of its Receiving Parties, either accidentally or through wilful
misconduct, will not cause serious damage to its programs
and/or its strategy, by, for example, disclosing confidential
information to its competitors. It is also possible that confi-
dential information could be obtained by third parties as a
result of breaches of physical or electronic security systems
of Oxurion, its Receiving Parties or other parties that have
had access to its confidential information.
Any disclosure of confidential data into the public domain
or to third parties could allow Oxurions competitors to learn
confidential information and use it in competition against
Oxurion. In addition, others may independently discover
Oxurions confidential information through intrusion on its
systems or those of third parties.
Enforcing Oxurions rights against any misappropriation or
unauthorized use and/or disclosure of confidential informa-
tion is time-consuming and expensive, and may ultimately
be unsuccessful, or may result in a remedy that is not com-
mercially viable. If Oxurion were unable to protect its confi-
dential information, this could significantly diminish the value
of THR-149 by allowing competitors to gain access to com-
petitive information, which could have a significant adverse
impact on Oxurion and its shareholders. A clinical stage bio-
pharmaceutical company such as Oxurion relies heavily on
the confidentiality of its information and trade secrets for its
market and commercial value and any loss of confidential-
ity with respect to THR-149 could have a material adverse
impact on the Company and its shareholders, and therefore
could result in a significant reduction in the Company’s value
and the shareholders’ investment.
3.5.7 Risks related to reliance on third
if the quality or accuracy of the clinical data they obtain is
parties, key personnel, grants, and tax
compromised due to their failure to adhere to Company’s
carry forwards.
clinical protocols, regulatory requirements or for other
3.5.7.1 Oxurion relies on third parties to conduct its
reasons.
clinical trials and to manufacture THR-149,
which creates interdependencies and risks.
There are a limited number of third-party service providers
that specialize in, or have the expertise required to,
Oxurion has relied upon and plans to continue to rely upon
undertake Oxurion’s preclinical and clinical trials in DME
third parties, including independent laboratories, clinical
and other vascular retinal disorders. If Oxurions relation-
investigators, CROs and third-party manufacturers, to
ships with these third-party CROs or clinical and preclini-
conduct its clinical trials and to manufacture THR-149.
cal investigators or laboratories would be compromised or
terminated, it may not be able to enter into alternative ar-
Clinical trials. Oxurion relies on third parties for the
rangements with alternative CROs or clinical investigators
execution of its preclinical trials and clinical trials and can
or to do so on commercially reasonable terms. Switching
control only certain aspects of their activities. However,
or adding additional CROs (or investigators or laborato-
Oxurions reliance on these third parties does not relieve
ries) involves additional cost and requires management
it of its regulatory responsibilities and it continues to
time and focus. In addition, the use of third-party service
be responsible for ensuring that the KALAHARI trial is
providers requires Oxurion to disclose its proprietary infor-
conducted in accordance with the applicable protocol,
mation to these third parties, which increases the risk that
scientific standards, and legal and regulatory obligations,
this information may be misappropriated.
such as Good Laboratory Practice (“GLP”), Good Clinical
Practice (“GCP”) and Good Clinical Manufacturing
If these third parties do not successfully carry out their
(“cGMP”) regulations. If Oxurion, third-party laboratories,
contractual duties or meet expected deadlines, Oxurion’s
clinical investigators or any of its CROs fail to comply with
results of operations and the commercial prospects for
applicable GLPs, GCPs or the tested products do not meet
THR-149 could be damaged, its costs could increase, and
cGMP regulations, the preclinical or clinical data may be
its ability to generate revenues could be delayed. Were this
deemed unreliable, and regulators may deny approval or
to occur, Oxurion may not be able to obtain regulatory
may require Oxurion to perform additional preclinical trials,
approval for, or commercialize THR-149 in a timely manner,
clinical trials or other activities before approving further
or at all, and as a result, the Company and its shareholders
trials or the marketing applications for THR-149.
and other stakeholders could be substantially harmed.
Further, with respect to the KALAHARI trial, the clinical in-
Third-Party Manufacturers. Oxurion also relies on third-par-
vestigators and CROs are not employees of Oxurion and
ty manufacturers to produce and supply trial medication
Oxurion will not be able to control, other than by contract,
for its clinical trials, drug discovery, and development
the quality and extent of resources, including time, which
process, as well as for the commercial supply of JETREA®.
they devote to THR-149 and the KALAHARI trial. The
trial therefore may be extended, delayed or terminated
Due to the size of Oxurions business, most goods and
if clinical investigators or CROs fail to devote sufficient
services are provided by only one and not several different
quality resources to the development of THR-149, do not
suppliers, which creates the risk of loss of key suppliers.
successfully carry out their contractual duties or obliga-
Expanding the supplier network would be time-consum-
tions or meet expected deadlines, need to be replaced, or
ing and expensive as all source suppliers are subject to
36
OXURION ANNUAL REPORT 2022
37
OXURION ANNUAL REPORT 2022
rigorous quality control standards. Oxurions suppliers are
required to adhere to strict contractual terms that include
regulatory, quality (including adherence to cGMP), as well
as anti-bribery and anti-corruption provisions.
Notwithstanding these contractual requirements, a
third-party manufacturer may not comply with the required
quality standards or devote sufficient resources to the man-
ufacturing of Oxurions products or may otherwise fail in
the manufacturing of such compound, in which event the
development and commercialization of THR-149 could be
delayed (for example because of product reruns) or even
terminated. Were concerns to arise with the manufactur-
ing of THR-149, Oxurions business could be substantially
harmed.
In summary, Oxurions reliance upon CROs and third-party
manufacturers to conduct its clinical trials and to manufac-
ture THR-149, creates risk to the Company and its share-
holders. If these CROs and third-party manufacturers do
not successfully carry out their contractual duties or meet
expected deadlines, Oxurion may not be able to obtain
regulatory approval for, or commercialize THR-149 and its
business could be substantially harmed, which could have
a significant negative impact on its shareholders or other
stakeholders.
3.5.7.2 Oxurion is subject to competition for its skilled
personnel, and challenges in identifying and
retaining key personnel could impair Oxurions
ability to do business.
Oxurion is a small company with 27 members of
personnel. Oxurions success depends on the continued
contributions of Oxurions CEO and his direct reports
(“Executive Committee”), its scientific personnel, and on
the Company’s ability to develop and maintain important
relationships with leading academic institutions, scientists,
and companies in the face of intense competition for such
personnel, amongst institutions and companies.
Oxurions ability to compete in the highly competitive bio-
technology and pharmaceuticals market depends on its
ability to attract and retain highly qualified management,
scientific and medical personnel. Many of the other bio-
technology and pharmaceutical companies and academic
institutions that Oxurion competes against for qualified
personnel have greater financial and other resources and
different risk profiles than Oxurion does.
The Company’s CEO, Executive Committee members, and
its key clinical and scientific personnel may terminate their
employment or services with the Company at any time
with relatively short notice. The departure of the CEO or
certain Executive Committee members and clinical and
scientific personnel may seriously and adversely affect
Oxurions business prospects, its clinical and research and
development efforts, and its ability to obtain funding.
To the extent that Oxurion loses key members of its
personnel or is unable to attract and retain key personnel,
this lack of resources would create risks for the business
and THR-149 by preventing the Company from achieving
its objectives due to the lack of qualified resources, which
could have a significant negative impact on its sharehold-
ers and other stakeholders.
3.5.7.3 Oxurion has obtained grants and subsidies,
which would need to be reimbursed if it
breaches the conditions.
The terms of certain of Oxurion’s grant agreements may
significantly hamper Oxurion in its flexibility to choose a
different location for its activities.
As of the end of 2022, Oxurion received several techno-
logical innovation grants in an amount of approximately
7 million euro, to support various research programs from
an agency of the Flemish government that supports tech-
nological innovation in Flanders. If Oxurion fails to comply
with its contractual obligations under the applicable tech-
nological innovation grant agreements, Oxurion could be
forced to repay all or part of the grants received, which,
3.5.8 Risks relating to the Shares
for example, inhibit Oxurion’s ability to relocate its activities
without repaying the grants because certain of the grants
3.5.8.1 Conversions of convertible bonds issued by the
require Oxurion to be located in Flanders. A violation of
Company under the Negma Funding Program
these grant agreements creates a risk of being required to
and going forward under the Atlas Funding
repay 1.3 million euro in grants, which would result in a loss
Program has, and will continue, to significant-
of this amount to the Company and its shareholders.
ly dilute the interests of existing shareholders
and such dilution is exacerbated by the sharp
3.5.7.4 Oxurion has significant deductible carry-for-
decrease in the Company’s market price.
ward tax losses and potential tax benefits in
Belgium, which could be adversely affected by
The Company has issued convertible bonds that are
changes in Belgian legislation and regulation.
convertible for new shares in the context of the funding
program as set out in the issuance and subscription
Through the end of 2022, the Group had 360 million euro
agreement entered into by the Company with Negma
of deductible carry-forward tax losses in Belgium.
on 26 August 2021, as amended (the “Negma Funding
Program”) and will continue to do so going forward under
Being active in research and development in Belgium,
the Atlas Funding Program.
Oxurion benefits from a patent income deduction, tax
credit for R&D expenses, tax exemption for regional grants
The conversion of convertible bonds under the Negma
and subsidies and tax advantages for qualified personnel
Funding Program has caused significant dilution. Going
as well as the expatriate regime for foreign researchers
forward, the conversion of convertible bonds under the
and executives. The introduction of a minimum taxable
Atlas Funding Program is expected to continue to cause
base and any other future adverse changes of Belgian tax
significant dilution. Due to conversions at low prices, the
legislation in relation to the items detailed above may ma-
number of shares issued by the Company has risen from
terially adversely affect Oxurions future average corporate
53,054,271 in August 2022 to 584,702,740 on 20 February
tax rate, results of operations and financial position. The
2023 (i.e. a rise of more than 1000% over a period of six
Group considers that there is a considerable uncertain-
months). The significant dilution caused by the conversion
ty regarding the future use of the tax losses of Oxurion
of convertible bonds under the Negma Funding Program,
as it is very difficult to estimate the impact of the patent
and in the future under the Atlas Funding Program, is exac-
deduction on the future tax result at this moment. As the
erbated by the Company’s low market price.
Group can only use the abovementioned patent deduction
on the basis of a tax ruling, the expectation exists that the
3.5.8.2 The market price of the shares may fluctuate
future tax gains will be rather limited. There is also the un-
widely in response to various factors, including
certainty regarding the future use of the tax losses with
significant sales of new shares upon conver-
ThromboGenics.
sion of convertible bonds.
Publicly traded securities from time-to-time experience
significant price and volume fluctuations that may be
unrelated to the results of operations or the financial
condition of the companies that have issued them. This is
exacerbated by the effects of the Atlas Funding Program
38
OXURION ANNUAL REPORT 2022
39
OXURION ANNUAL REPORT 2022
because of the large number of shares that the Company
expects to issue to Atlas (likely to exceed one billion
shares if all tranches are drawn down unless the stock
price increases), and which for the most part Atlas intends
to sell. Moreover, these market shifts may be more pro-
nounced in the biotech market than in the broader market
because the biotech market is considered to be riskier and
may react more strongly to perceptions of market shifts.
In addition, the market price of the existing Shares has
historically been volatile, ranging from a high of 1.54 euro
on March 30, 2022, and a low of 0.01 euro on February
28, 2023. The market price of the shares may continue
to fluctuate significantly in response to a number of
factors, some of which are beyond the Company’s control,
including fluctuations caused by results of the Company’s
clinical trial, changes in estimates by securities analysts
and the potential or actual sales of the shares, in particular
by Atlas, and the fact that the Company has limited news
flow and analyst coverage with approximately five analysts
covering the stock.
The Company’s existing shares also have a relatively
limited trading volume. For example, the average daily
trading volume of the Company’s shares in September
2022 was 261,590 shares. An active trading market for
the New shares may not develop, and there is no guarantee
that the existing active trading market for the shares can
be sustained or that it will be sufficiently liquid. If an active
trading market is not developed or sustained, the liquidity
and trading price of the shares of the Company could be
adversely affected.
Any sale of a significant number of the shares on the
public markets, or the perception that such sales could or
will occur, may adversely affect the market price of the
shares. The Company cannot make any predictions as to
6 Bron: https://live.euronext.com/en/product/equities/BE0003846632-XBRU.
the sale of shares or the perception on the market price of
the shares. It is expected that the shares issued upon con-
version of the convertible bonds under the Atlas Funding
Program will largely be sold by Atlas, which is expected to
exceed 1 billion if all available tranches are drawn down
unless the stock price increases. Such share sales may
continue to exert significant pressure on the market price
as the Company continues to draw significant amounts
under the Atlas Funding Program, upon which the
Company relies for its financing in the short term absent
other funding sources, by issuing convertible bonds. The
chart below illustrates the evolution of the stock price over
the period of September 29, 2021 (i.e., start of the Negma
Funding Program) to March 17, 2023
6
.
In addition, stock markets have recently experienced signif-
icant price and volume fluctuations, especially with respect
to biotech stocks, including in the Company’s view as a
result of the ongoing COVID-19 pandemic on the macro-
economic outlook. These fluctuations and the Russian
invasion in Ukraine have not always been related to the
performance of the specific companies whose shares are
traded. These fluctuations, as well as general economic
and political conditions, could have an adverse effect
on the market price of the shares and the value of any
investment.
3.5.8.3 Future capital increases by the Company
3.5.8.4 The Company will not be able to pay dividends
could have a negative impact on the price of
in the near future and intends to retain all
the shares and could significantly dilute the
earnings.
interests of existing shareholders.
The Company is not allowed to declare any dividends as
The Company will need to raise additional funds for the
long as it does not have any distributable reserves in accor-
completion of the KALAHARI trial and is likely in the future
dance with article 7:212 of the BCCA and has not declared
to increase its share capital against cash or contributions
or paid dividends on the shares in the past. Any declaration
in kind to finance its further development of its products
of dividends will be based upon the Company’s earnings,
or to strengthen its balance sheet (see also Sections 3.5.1.1
financial condition, capital requirements and other factors
and 3.5.1.2 of this Section 3.5 ‘Risk Factors’). It is uncertain
considered important by the Board of Directors.
whether the Company will be able to raise such additional
funds and, if it manages to do so, such raise of additional
The Company is not required to declare dividends.
funds may well be under less favorable conditions, in par-
Currently, the Board of Directors expects to retain all
ticular taking into account the Company’s current market
earnings, if any, generated by the Company’s operations
capitalization (see also Section 3.5.8.1 of this Section 3.5
for the development and growth of its business and does
‘Risk Factors’).
not anticipate paying any dividends to the shareholders in
the near future as the Company expects losses to continue
The Company has and may continue to issue subscrip-
as a result of costs relating to the ongoing KALAHARI trial
tion rights that are exercisable for new shares, or raise
and for future R&D.
capital through public or private offerings of convert-
ible debt (potentially in the context of the Atlas Funding
The Company therefore will not be in a in a position to pay
Program, the loan facility entered into by the Company on
dividends in the near future and intends to retain all earnings.
November 21, 2021 with Kreos Capital VI (UK) Limited
(“Kreos) and Pontifax Medison Finance (Israel) L.P.
(“Pontifax Israel) and Pontifax Medison Finance (Cayman)
3.6 OTHER INFORMATION IN
L.P. (“Pontifax Cayman and together with Pontifax Israel,
ACCORDANCE WITH BELGIAN
“Pontifax”) (Pontifax together with Kreos, the “Lenders)
COMPANY LAW
(the “Loan Facility”) or otherwise) or equity securities, or
rights to acquire these securities. In connection with such
3.6.1 Events after the end of the
transactions, the Company may, subject to certain con-
financial year
ditions, limit or decide to cancel preferential subscription
rights of existing shareholders that would otherwise be
On January 25, 2023, the Company has further amended
applicable to capital increases through contributions in
its mandatory convertible bonds issuance and sub-
cash. In addition, preferential subscription rights do not
scription agreement with the Negma Group. Before the
apply to capital increases through contributions in kind.
amendment, Negma had subscribed to 11 million euro in
Such transactions could therefore dilute shareholders in
convertible bonds. Pursuant to the amendment, Negma
the Company’s share capital, potentially at a price below
agreed to subscribe to up to 4 million euro (1,600 bonds)
the stock price, which could have a negative impact on the
in three tranches to be called at Oxurions full discretion.
price of the shares and the shareholders.
Similar to Part B of the funding program with Negma, the
40
OXURION ANNUAL REPORT 2022
41
OXURION ANNUAL REPORT 2022
liquidity requirement was eliminated, and the conversion
price of the shares was 80% of the lowest closing VWAP
over the 15 consecutive trading days in advance of the
conversion notice.
On March 1, 2023, the funding program with Negma
ended according to the terms of the agreement.
On March 1, 2023, the Company entered into the Atlas
Subscription Agreement for mandatory convertible bonds
with Atlas Special Opportunities, LLC providing for up to
20 million euro in financing. Under the terms of the Atlas
Subscription Agreement, Atlas has committed to subscribe
to up to 20 million euro in mandatorily convertible bonds
over a 24-month period at Oxurions discretion. The conver-
sion price is set at an eight percent discount to the average
VWAP over the three lowest days in the ten consecutive
trading days prior to the conversion notice. The Company
will pay a fee of 800,000 euro in bonds, which will be
issued together with the first tranche. The funding will be
provided in nine tranches, with the first tranche including a
Part A of 2.8 million euro (including the fee) and Part B of
2 million euro, and subsequent tranches of 2 million euro
each with a cool-down period of 22 trading days between
tranches (except for between Part A and Part B of the first
tranche where there is no cool down period). Provided the
conditions precedent are met, the decision to issue one or
more tranches is at the discretion of the Company. Certain
of the conditions precedents are not within the Company’s
control, including that the Company’s total trading volume
in the prior 22 trading days exceeds 1.5 million euro and
that its average market capitalization exceeds 4 million
euro (or 2 million euro for a 1 million euro tranche).
In addition, on March 1, 2023, Oxurion amended the terms
of its convertible bond loan agreement with Kreos Capital
and Pontifax Ventures, originally signed on November 22,
2021, (as already amended on June 30, 2022), to reduce
the Company’s debt by approximately 1 million euro by
making a prepayment in exchange for a corresponding
reduction in its cash covenant and other benefits.
On March 14, 2023, Oxurion announced that given their
other commitments, Dr. David Guyer and Dr. Adrienne
Graves decided to resign from the Company’s Board of
Directors and that Dr. Anat Loewenstein, Director of the
Department of Ophthalmology at Tel Aviv University, and
Nathalie Laarakker, Chief Financial Officer at Intravacc B.V.
in the Netherlands, have agreed to be co-opted as inde-
pendent directors. The co-optation is subject to ratification
by the Company’s Annual General Shareholders Meeting
on May 2, 2023.
3.6.2 Major trends influencing evolution of
the Company
The assets potentially subject to impairment on the
balance sheet of Oxurion are the carrying value of the in-
tangible asset composed of the in-licensed THR-687 from
Galapagos under the Galapagos License and the value of
immuno-oncology assets in Oncurious in-licensed from
VIB.
The Company impaired the Galapagos License related
to program THR-687, for the development and commer-
cialization of integrin antagonists as it has decided not to
advance THR-687 to Part B of the INTEGRAL trial. The
total impact amounted to 1.0 million euro in the first half
of 2022.
With respect to the in-licensed immuno-oncology assets
from VIB, as of June 30, 2021, the Company concluded
there is a need for impairment as Oxurion would no
longer make direct investments in these assets and the
Company was unable to secure a transaction with an addi-
tional investor in Oncurious. The assets were therefore fully
impaired as of that date.
Provided the Company is able to access all of the Atlas
Funding, Oxurion will have sufficient funding to continue
clinical development to reach topline data for the Phase
2 trial of THR-149 in the fourth quarter of 2023. However,
as set forth in Risks 3.5.1.1 and 3.5.1.2, the Atlas funding
Oncurious NV
is conditioned on certain events outside the Company’s
control, and the Company continues to pursue additional
As of December 31, 2022, Oncurious NV is wholly owned
funding to ensure completion of the THR-149 trial, and its
subsidiary of Oxurion based in Leuven, Belgium.
further operation thereafter.
Oncurious was incorporated on April 3, 2015, as a
public limited liability company (in Dutch: Naamloze
3.6.3 R&D
Vennootschap) by Oxurion and ThromboGenics Inc.
Given the activities of Oxurion, R&D costs are very signifi-
Oncurious is an oncology company focusing on the
cant and represent more than 70% of total operating costs
development of innovative medicines. Upon incorpora-
in 2022 and 2021.
tion, Oxurion made a contribution in kind of the TB-403
patents, the TB-403 know-how and the rights and obli-
Starting from financial year 2014, the government grants
gations under the TB-403 contracts representing 1.375
and income from recharge of costs have been deducted
million euro. ThromboGenics Inc. made a contribution in
from the R&D expenses. These costs mainly consist of
cash of 1,000 euro.
costs for clinical trials paid to third parties, personnel costs,
and depreciation. In 2013, a first depreciation on the cap-
On August 6, 2015, VIB made a contribution in kind in
italized costs related to the Phase 3 development of ocri-
Oncurious of the potential future royalties of TB-403
plasmin for the treatment of vitreomacular adhesion was
(oncology) representing 125,000 euro. After this trans-
booked. The JETREA® asset was impaired as of June 30,
action, VIB became a minority shareholder in Oncurious
2019, and from that date substantially lowered the depre-
alongside Oxurion, holding 125 shares of a total of 1,501
ciations as shown in section 5.7.3.
shares.
On December 12, 2017, Oxurion exercised the right to
3.6.4 Going concern
convert a 3.0 million euro convertible loan granted by
Oxurion to Oncurious into 3,000 shares in the share
We refer to section 3.4.
capital of Oncurious.
On December 12, 2017, Oncurious made simultaneous
3.6.5 Subsidiary activity –
agreements with VIB and Oxurion in which VIB made a
business combinations
contribution in kind of the rights to five immuno-oncolo-
gy targets in exchange for 857 new shares. As a result of
ThromboGenics Inc.
these agreements, Oxurion held 4,376 shares or 81.67%
and VIB held 982 shares or 18.33% of the total number of
As of December 31, 2022, ThromboGenics Inc. is a wholly
5,358 outstanding shares of Oncurious.
owned subsidiary of Oxurion and is incorporated in New
York, US.
42
OXURION ANNUAL REPORT 2022
43
OXURION ANNUAL REPORT 2022
On July 23, 2020, by decision of an extraordinary general
shareholders’ meeting (“EGM”) of Oncurious, the share
capital of Oncurious was increased by several contributions
in kind of Oxurion and VIB receivables from Oncurious
and a contribution in cash, followed by a formal capital
decrease to absorb accumulated losses.
On March 31, 2021, Oxurion and VIB entered into a share
purchase agreement pertaining to the acquisition of 680
shares in the share capital of Oncurious following the
exercise of a call-option granted by Oxurion to VIB under
the call option agreement between VIB and Oxurion of
December 12, 2017.
On April 30, 2021, by decision of the EGM of Oncurious,
the share capital of Oncurious was increased by a con-
tribution in kind of a VIB receivable from Oncurious. As
a result thereof, on December 31, 2021, out of a total of
12,011 shares, Oxurion owned 10,093 shares (representing
83.34%) and VIB owned 2018 shares (or 16.66%).
On September 28, 2022, Oncurious entered into an
agreement with VIB concerning the assignment of intellec-
tual property rights and know-how, and the termination of
certain licenses. The assignment concerns Oncurious’ C-C
motif chemokine receptor 8 (CCR8) program, as well as
other undisclosed assets. The assignment does not include
Oncurious’ TB-403 asset. The agreement was concluded
following the decision of Oncurious not to further invest in
the foreground technology of several discovery stage and
preclinical programs. In consideration of Oxurions contri-
butions towards the development of foreground technol-
ogy by Oncurious, prior to Oncurious’ abandonment and
assignment to VIB thereof, the parties agreed on a revenue
sharing agreement with Oxurion upon VIB’s valorization of
such foreground technology.
Subsequently, on December 14, 2022, VIB sold its
remaining stake in Oncurious to Oxurion for 1 euro.
We refer to the information on key arrangements in note
5.8 for more details on terms and accounting treatment.
3.6.6 Financial instruments
We refer to section 5.5.6.
3.6.7 Financial risk management
We refer to section 5.5.7.
3.6.8 Independence and competence in the
Audit Committee
The Company’s audit committee is validly composed in
compliance with the 2020 Belgian Code on Corporate
Governance (the “Corporate Governance Code”) and
the BCCA. The audit committee is made up of INVESTEA
SRL, represented by Emmanuèle Attout, who chairs the
Audit Committee, Thomas Clay and Philippe Vlerick (the
Audit Committee”). All three Audit Committee members
qualify as independent directors. Investea SRL repre-
sented by Emmanuèle Attout, as former audit partner at
PricewaterhouseCoopers, has the necessary credentials to
bring the required accounting and auditing expertise in this
committee.
44
OXURION ANNUAL REPORT 2022
4. CORPORATE GOVERNANCE
45
OXURION ANNUAL REPORT 2022
4.1 GENERAL PROVISIONS
This section summarizes the rules and principles applica-
ble to the corporate governance of Oxurion. It is based on
the articles of association (the Articles of Association)
and on the corporate governance charter of the Company
(the “Corporate Governance Charter”) which was
drawn up on October 19, 2006, and which has been
updated since on a regular basis. The last update was
approved by the Board of Directors in March 2023 and is
published on Oxurions website (https://www.oxurion.com/
corporate-governance).
Board of Directors
Management Structure
Dealing Code – Rules for the prevention of insider
trading and market abuse
Audit Committee
Nomination and Remuneration Committee (as defined
hereinafter)
4.2 COMPLIANCE WITH THE
CORPORATE GOVERNANCE CODE
The Company notes that under principle 7.6 of the
Corporate Governance Code, Non-Executive Directors
should receive part of their remuneration in the form of
shares in the Company. The Company does not comply
with this provision of the Corporate Governance Code
because the Company has no distributable reserves and
therefore it cannot acquire its own shares to be granted to
its Non-Executive Directors.
The Company further notes that under principle 7.6 of
the Corporate Governance Code, Non-Executive Directors
should not receive subscription rights in the Company as
part of their remuneration. The Company does not comply
with this provision of the Corporate Governance Code
because the Company has no distributable reserves and
therefore it cannot acquire its own shares to be granted
to its Non-Executive Directors. Consequently, the Company
has decided to grant Non-Executive Directors a limited
number of subscription rights to allow them to acquire
shares of the Company following the exercise of their re-
spective subscription rights, as approved by the AGM of
Oxurion of May 7, 2019.
Principle 7.9 of the Corporate Governance Code requires
the Board of Directors to set a minimum threshold of
shares to be held by the Executives (as defined below). The
Company deviates from this provision of the Corporate
Governance Code because the Company has no distrib-
utable reserves and therefore it cannot acquire its own
shares to be granted to its Executives (as defined below).
Principle 7.11 of the Corporate Governance Code provides
that subscription rights should not vest and be exercisa-
ble within less than three years. The Company deviates
from this standard because it considers it to be necessary
to attract high quality biotech executives, where vesting
of less than three years is not exceptional and Oxurion
considers to be necessary to be competitive.
4.3 DESCRIPTION OF THE PRINCIPAL
The Company does not consider that it is necessary to
CHARACTERISTICS OF THE
apply claw back provisions and therefore deviates from
COMPANY’S INTERNAL CONTROLS
principle 7.12 of the Corporate Governance Code. The
only variable compensation the Company pays are
AND RISK ANALYSIS
bonuses based on the achievement of corporate targets,
which are paid only upon achievement of the objective.
The Corporate Governance Charter describes how the
Subject to one deviation described and justified in Section
Company addresses internal controls and risk analysis.
4.9.2.1 (D), the Company does not apply any other perfor-
mance-based remuneration or variable compensation as
The following paragraphs summarize the most relevant
the subscription rights granted to Executives generally vest
characteristics of the Company’s internal controls and risk
over time and are not performance related.
analysis which make up part of the roles of the statutory
bodies as described in the Corporate Governance Charter.
Internal control systems play a central role in directing the
activities and in risk management. They allow for better
management and control of the possible risks (strategic
risks, financial risks, compliance with rules and legislations),
in order to achieve the corporate goals. The internal control
system is based on five pillars:
Control environment
Risk analysis
Control activities
Information and communication
Supervision and modification
4.3.1 Control environment
Oxurions control environment includes both formal and
informal rules on which the functioning of the Company
relies.
Oxurion has defined Drive and Initiative, Teamwork,
Flexibility and Quality of Work as being the values driving
Oxurions team with the aim to create an open corporate
culture, in which communication and respect for patients,
suppliers and staff play a central role. Oxurions employees
46
OXURION ANNUAL REPORT 2022
47
OXURION ANNUAL REPORT 2022
are required to manage the Company’s resources with due
diligence and to act with the necessary common sense.
The informal rules are complemented by formal rules
where necessary.
Oxurions intent is to attract, motivate and retain qualified
employees, in a cooperative work environment and with
the possibility of personal development. Their expertise
and experience will contribute to the Company’s effective
management.
The control environment is further created and supported
by the Board of Directors, the committees within the
Board of Directors, being the Audit Committee, consisting
of INVESTEA SRL (represented by Emmanuèle Attout),
chairman; Thomas Clay; and Philippe Vlerick, the nomina-
tion and remuneration committee, consisting of Thomas
Clay (chairman), Dr. Adrienne Graves and Dr. David Guyer,
the CEO, the Executive Committee, and the staff.
Board of Directors
The Board of Directors consists of a majority of Non-
Executive, Independent Directors. The Board of Directors
undertakes the following functions in creating the control
environment:
The Board of Directors pursues sustainable value
creation by the Company, by setting the Company’s
strategy, putting in place effective, responsible, and
ethical leadership, and monitoring the Company’s
performance.
The Board of Directors supports the CEO in the fulfil-
ment of his duties and constructively challenges the
CEO whenever appropriate.
The Board of Directors decides on and regularly reviews
the Company’s medium and long-term strategy based
on the proposals from the CEO.
The Board of Directors approves the operational plans
and main policies developed by the CEO to give effect
to the approved Company strategy.
The Board of Directors determines the risk appetite
of the Company in order to achieve the Company’s
strategic objectives.
To achieve its duties, the Board of Directors relies on its
committees, as well as the CEO as follows:
Committees within the Board of Directors
The Audit Committee evaluates the strength of the
controls in place at regular intervals and assists the
Board of Directors in fulfilling its monitoring responsi-
bilities in respect of the financial reporting process, the
effectiveness of the internal control and risk manage-
ment systems and the Statutory Auditor’s work and
independence.
The Audit Committee also monitors the integrity of the
financial information provided by the Company. The
Audit Committee ensures that the financial reporting
provides a true, honest, and clear picture of the situation
and the prospects of the Company. For this moni-
toring, the Audit Committee in particular reviews the
relevance and consistency of the accounting standards
and the accuracy, completeness, and consistency of
the financial information.
The Nomination and Remuneration Committee
controls the quality and compensation for the Board of
Directors, the CEO, and the Executive Committee, and
evaluates the remuneration policy on a going forward
basis. Under the BCCA, any material changes to the
Remuneration Policy must be approved by the general
shareholders’ meeting of the Company.
CEO and Executive Committee
The day-to-day management is the responsibility of the
CEO who is supported by the Executive Committee,
which is made up of the CEO and some of his direct
reports. The CEO controls the operations and activities
of the Executive Committee and all other personnel.
For the sake of effective management, authority is
themselves in accordance with those principles and
partially delegated from the CEO to the various de-
seek to avoid even the appearance of improper behavior.
partments within Oxurion. The delegation of authorities
The Code of Business Conduct is also provided to, and
is not linked to a person, but rather to the position. The
followed by, Oxurions agents and representatives, including
CEO is responsible at a Group level and is finally re-
consultants.
sponsible for the activities that have been delegated.
All individuals concerned are informed of the extent of
The Code of Business Conduct seeks to deter wrongdoing
their authority (approval requirements and limitations
and to promote:
of authority).
In managing internal controls and risks, the CEO is
Honest and ethical conduct, including the ethical
entrusted with proposing, developing, implementing,
handling of actual or apparent conflicts of interest in
and monitoring the Company strategy, taking into
personal and professional relationships.
account Oxurions values, its risk profile and key policies.
Full, fair, accurate, timely and understandable disclosure
in reports and documents that Oxurion submits to the
Financial Services and Markets Authority (the “FSMA)
4.3.2 Risk analysis
and in other public communications made by Oxurion.
Compliance with all applicable governmental laws,
As set forth above, the Board of Directors decides on the
rules, regulations, and industry codes
Groups strategy, risk profile and its policies. The Board of
Accountability for adherence to the Code of Business
Directors is tasked with ensuring the Company’s long-term
Conduct
success by employing appropriate risk assessment and
Prompt internal reporting of violations of the Code of
management.
Business Conduct
The CEO is responsible for the development of systems
Oxurion divides its objectives into four categories:
that identify, evaluate, and monitor risks. The CEO under-
takes a risk analysis in all departments of the Group and
Strategic
takes relevant risks into account in developing the Groups
Operational
strategy. Implementation includes a set of means, codes of
Reliability of the internal and external information
conduct, procedures and measures that fit with the Groups
Compliance with rules and legislations and internal
structure, which are intended to maintain risks at an ac-
instructions
ceptable level.
Risk identification consists of examining the factors that
The control environment is supported by Oxurions code
could influence the objectives put forward in each category.
of business conduct (the “Code of Business Conduct”),
Internal or external factors may influence the realization of
which is part of the Corporate Governance Charter,
these objectives:
covering a wide range of business practices and proce-
dures. It does not cover every issue that may arise, but
Internal factors: are closely related to the internal orga-
rather establishes basic principles to guide the motives
nization and could have several causes (for example,
and actions of Oxurions directors, officers, and employees.
change in the Company or Group structure, staff, ERP
All directors, officers and employees must conduct
system).
48
OXURION ANNUAL REPORT 2022
49
OXURION ANNUAL REPORT 2022
External factors: can be the result of changes in the
economic climate, regulations or competition affecting
the Company or the Group and the sector.
The risks identified by the Company are detailed under
section 3.5.
4.3.3 Control activities
In order to properly manage the identified risks, Oxurion
takes the following control measures:
Establishment of internal operational and control
procedures.
Modifications and updates of the existing proce-
dures; use of a reporting tool that permits financial
data reporting on a regular basis (quarter, year). The
reporting tool also permits development of KPIs and
regular assessments thereof.
Installation of access and security systems at the
premises and offices.
The risk mitigation comprises numerous day-to-day activ-
ities such as:
Regular updates of the Company’s risk management
plans
Management by operational supervisors
Data exchange with third parties for confirmation
purposes (e.g. suppliers/customers)
Segregation of duties
4.3.4 Information and communication
The Board of Directors takes all necessary measures to
ensure the integrity and timely disclosure of the Company’s
financial statements and other material financial and
non-financial information in accordance with applicable
law.
In order to be able to present reliable financial information,
Oxurion makes use of a standardized reporting of accounts
and a global application of IFRS recognition criteria and
applies a uniform administration and implementation of
the same ERP system in all subsidiaries.
Oxurion has a robust information management system.
Depending on the type of data at issue, controls are in
place to ensure that the information is limited to autho-
rized persons. A back-up policy is available, and all data
is backed up centrally on a weekly basis and locally on a
daily basis.
4.3.5 Supervision and modification
Supervision of the Company’s activities is carried out
by the Board of Directors, the Audit Committee and the
Company’s CEO.
Role of the Board of Directors
The Board of Directors approves a framework of internal
control and risk management, proposed by the CEO. It
reviews the implementation of the framework, consider-
ing the evaluation made by the Audit Committee. The
Board of Directors is also responsible for describing the
main features of the internal control and risk manage-
ment systems of the Company and disclosing them in the
corporate governance statement in the Annual Report.
The Board of Directors ensures that there is a process
in place for monitoring the Company’s compliance with
laws and other regulations, as well as for the application of
internal guidelines relating thereto.
Role of the Audit Committee
The Audit Committee informs the Board of Directors of
the outcome of the statutory audit and explains how the
statutory audit contributed to the integrity of financial
reporting and the role that the Audit Committee played
in that process.
At least once a year, the Audit Committee reviews the
Role of the CEO
internal control and risk management systems es-
tablished by the CEO. It ensures that the main risks
The CEO is responsible for:
are properly identified, managed, and disclosed in ac-
cordance with the framework approved by the Board
Supervising compliance with the legislation and regu-
of Directors. The risks identified by the Company are
lations that apply to the Company.
detailed under Section 3.5.
Establishing internal controls (i.e., systems to identify,
The role of the Audit Committee also includes review
assess, manage and monitor financial and other risks)
and approval of the statements on internal control
without prejudice to the Board of Directors’ monitoring
and risk management included in the corporate gov-
role, based on the framework approved by the Board
ernance statement in the Annual Report, as well as
of Directors.
review of the specific arrangements in place which the
Presenting a complete, timely, reliable, and accurate
staff of the Company may use, in confidence, to raise
preparation of the Company’s financial statements to
concerns about possible improprieties.
the Board of Directors, in accordance with the applica-
The Audit Committee monitors the external auditor’s
ble accounting standards and policies of the Company;
work program and reviews the effectiveness of the
and
external audit process and the responsiveness of the
Presenting a balanced and understandable assess-
management to the recommendations made by the
ment of the Company’s financial situation to the Board
external auditor in his or her management letter. The
of Directors.
external auditor must report to the Audit Committee
on the key matters arising from the statutory audit of
Oxurion believes that periodic evaluations are necessary
the financial statements, and in particular on material
to assess the effectiveness of the internal control function
weaknesses in internal control in relation to the financial
and the implemented procedures. Oxurion thus far has not
reporting process, if any.
assigned an internal audit role as the size of the business
The Audit Committee annually reviews the need for
does not justify a permanent internal audit position. As
an internal audit function and advises the Board of
required, the Audit Committee outsources internal audit
Directors on the Audit Committee’s annual assessment
activities to cover selected and/or recurring topics.
whether an internal audit function is required.
External Audit
External auditing within Oxurion is performed by the Statutory
Auditor. This includes the auditing of the statutory financial
statements and the consolidated financial statements of
Oxurion and its subsidiaries.
50
OXURION ANNUAL REPORT 2022
51
OXURION ANNUAL REPORT 2022
4.4 FEES TO THE STATUTORY AUDITOR
IN '000 EURO (AS AT 31 DECEMBER)
2022
2021
Remuneration audit mandate
113
90
Other legal assignments of the auditor
18
48
Other services provided by the PwC/network
0
3
In 2022, fees totalling 113,000 euro were paid for the audit
mandates of Oxurion and Oncurious.
The 2021 fees involved other services provided by the
Statutory Auditor’s network related to tax services provided
in the UK and closing of the Irish Branch and were pre-ap-
proved by the Audit Committee.
4.5 NOTIFICATION OF
IMPORTANT PARTICIPATIONS
4.5.1 Share capital and shares
On December 31, 2022, the share capital of Oxurion was
75,856,161.32 euro, represented by 411,071,559 shares, all
with the same fractional value. Section 5.4 provides an
overview of the evolution of the Company’s share capital
over time. Section 5.7.7 also specifies the Board of Directors
powers with respect to authorized share capital.
During financial year 2022, Oxurion’s share capital has
been increased on several occasions following the conver-
sion of (in aggregate) 3,610 convertible bonds issued to
Negma:
DAT E
BONDS
CAPITAL (IN SHARE PREMI-
EURO)UM (IN EURO)
8 February 2022
200
483,219.36
16,780.64
23 March 2022
240
600,000.00
0.00
15 April 2022
230
575,000.00
0.00
18 May 2022
200
500,000.00
0.00
7 June 2022
180
450,000.00
0.00
6 July 2022
220
550,000.00
0.00
17 August 2022
200
500,000.00
0.00
5 September 2022
80
200,000.00
0.00
13 September 2022
80
200,000.00
0.00
12 October 2022
173
432,500.00
0.00
19 October 2022
164
410,000.00
0.00
24 October 2022
120
300,000.00
0.00
26 October 2022
123
307,500.00
0.00
2 November 2022
120
300,000.00
0.00
7 November 2022
130
325,000.00
0.00
17 November 2022
56
140,000.00
0.00
22 November 2022
172
430,000.00
0.00
24 November 2022
140
350,000.00
0.00
28 November 2022
242
605,000.00
0.00
30 November 2022
80
200,000.00
0.00
5 December 2022
80
200,000.00
0.00
9 December 2022
380
950,000.00
0.00
Total
3,610
9,008,219.36
16,780.64
In addition to the Negma funding, a capital increase also
4.5.3 Shareholders
took place in the context of the authorized capital by a
contribution in cash of 10,405,500 euro and with the
On December 31, 2022, based on all transparency decla-
issuance of 7,226,039 new Oxurion NV shares at 1.44 euro
rations and information received by the Company, Oxurion
per share through a private equity placement on March 7,
is not aware of participations exceeding any legal transpar-
2022.
ency threshold.
In accordance with Article 7:215 of the BCCA, the Board
of Directors is authorized to proceed on one or more
4.5.4 Notification of important participations
occasions with the acquisition, by purchase or exchange, of
its own shares for a price to be determined by the Board
Belgian law, in conjunction with the Articles of Association,
of Directors at the time of acquisition. This authorization
imposes disclosure requirements on any individual or entity
also applies to the acquisition of the Company’s shares
acquiring or transferring voting securities or securities which
by one of its directly controlled subsidiaries pursuant to
give a right to voting securities, as soon as the total number
Article 7:221 of the BCCA. This authorization is granted for
of voting rights directly or indirectly held by such individual
a period of five years starting from May 24, 2022.
or entity, alone or jointly with others, increases above, or
falls below, a threshold of three percent, five percent, or
any multiple of five percent, of the total number of voting
4.5.2 Subscription rights plans
rights attached to the Company’s securities. A shareholder
whose shareholding increases above or falls below any
As of December 31, 2022, Oxurion has the following sub-
such threshold must disclose this fact to the FSMA and to
scription rights plans in place:
the Company each time it occurs and submit the related
documentation to the FSMA. The Company is required to
Four subscription rights plans for personnel,
publicly disclose any transparency notifications it receives
including employees and consultants, being the 2017
within three business days and must mention these noti-
Subscription Rights Plan (formerly referred to as the
fications in the notes to its financial statements. Euronext
2017 warrants plan) and the three 2021 Subscription
Brussels also publishes details of the notifications. To this
Rights Plans (consisting of the 2021-1, 2021-2 and
end, the Company has created a dedicated section on its
2021-3 Subscription Rights Plans); and
website: Transparency Notifications | Oxurion NV.
One subscription rights plan for Non-Executive
Directors.
4.5.5 Financial service – paying
Paragraph 5.7.8 gives more detailed information on the
agent services
subscription rights plans and the outstanding number of
subscription rights as of December 31, 2022.
KBC Bank NV provides financial services related to the shares
in Belgium free of charge for the shareholders.
If shareholders prefer to use other intermediaries, they must
themselves solicit information with regards to costs relating to
the financial services.
52
OXURION ANNUAL REPORT 2022
53
OXURION ANNUAL REPORT 2022
4.6 COMPOSITION AND FUNCTIONING
OF THE COMPANY’S MANAGEMENT
4.6.1 Composition of the Board of Directors
The Company is led by a collegiate Board of Directors,
which is the Company’s most senior administrative body.
The Company establishes the Board of Directors’ internal
rules and regulations and publishes them in its Corporate
Governance Charter. The Board of Directors is charged with
achieving the Company’s long-term success by guarantee-
ing entrepreneurial leadership and ensuring that risks are
assessed and managed in an appropriate way. The Board
of Directors’ responsibilities are stipulated in the Articles of
Association and in the Board of Directors’ internal rules and
regulations. The Board of Directors is organized in view of an
effective execution of its tasks.
The Board of Directors decides upon the Company’s strategic
direction, policies geared towards achieving its objectives, and
its risk profile.
The Board of Directors ensures that the necessary leadership
and financial and human resources are available so that the
Company is able to realize its goals. Also, when determining
the values and strategies contained in the Company’s overall
business plan, the Board of Directors considers corporate
social responsibility, gender diversity and diversity in general.
MeRoNo BV (represented by Dr. Patrik De Haes, M.D.) was
appointed Chairman of the Board of Directors on May 15,
2021, replacing Thomas Clay who remains on the Board of
Directors as Non-Executive, Independent Director.
As of December 31, 2022, the Board of Directors consists of
seven members:
MeRoNo BV, represented by Dr. Patrik De Haes, M.D., Non-
Executive Director, Chairman
Thomas Clay, Non-Executive, Independent Director
Dr. David Guyer, M.D., Non-Executive, Independent Director
INVESTEA SRL, represented by Emmanuèle Attout, Non-
Executive, Independent Director
Baron Philippe Vlerick, Non-Executive, Independent
Director
Dr. Adrienne Graves, Non-Executive, Independent Director
Tom Graney, CFA, Executive Director, Chief Executive
Officer
The Board of Directors includes two female members and
five male members.
The following paragraphs contain a brief biography of each
director in function during the year 2022.
Dr. Patrik De Haes, M.D., (MeRoNo BV), Non-Executive
Director, Chairman
Dr. Patrik De Haes, M.D., has over 30 years of experi-
ence in the global healthcare industry, covering product
development, marketing, and general management. Patrik
joined Oxurion in 2008 and before taking up the role of
Chairman of the Board of Directors, he was Oxurions CEO
for 14 years. Prior to Oxurion, Patrik was head of Roche’s
Global Insulin Infusion business, as well as President and
CEO of Disetronic Medical Systems Inc., a medical device
company based in Minneapolis, US. He also led the global
development and commercialization of the first biotech
product at Sandoz Pharma (now Novartis) in Switzerland.
As past Chairman of FlandersBio, Patrik is an active
member of the local and regional biotech and life sciences
community in Belgium. Patrik holds a degree in Medicine
from the University of Leuven.
Thomas Clay, Non-Executive, Non-Executive,
Independent Director
Thomas Clay is the Managing Member of Epacria Capital
Partners, LLC, a single-family office managing public and
private investments for members of the Clay family. He
also serves as a Director of several private companies
and of the Clay Mathematics Institute, Inc. Thomas is
a graduate of Harvard College, Oxford University and
Emmanuèle Attout (INVESTEA SRL), Non-Executive,
Harvard Business School. Thomas replaced his father,
Independent Director
Landon Clay, on the board of directors, who led the first
external investment into Oxurion and resigned from the
Emmanuèle Attout was an audit partner at
Board of Directors in 2011.
PricewaterhouseCoopers from 1994 to 2014, in charge
of audits of a range of clients in various sectors, including
Dr. David Guyer, M.D., Non-Executive, Independent
listed companies and pharmaceutical and life sciences
Director (resigned on March 12, 2023)
companies, from which she brings substantial relevant
experience to the Board of Directors and to the Audit
Dr. David Guyer, M.D., is a long-standing member of the
Committee. Emmanuèle is an independent Non-Executive
US retina community and is currently the Co-founder,
Director, and chair of the Audit Committee, of Atenor SA,
President, and CEO of EyeBio. David is also a Venture
AG Insurance SA/NV and Schréder SA. She is a super-
Partner at SV Health Investors and is Co-Founder and
visory board member of Eurocommercial Properties NV.
former CEO and Executive Chairman of IVERIC bio
Since 2009, Emmanuèle is co-founder and former director
(formerly Ophthotech Corporation). He was previously
of the NGO Women on Board. Emmanuèle graduated in
the CEO of Ophthotech. Dr. Guyer is also on the board of
Applied Economic Sciences at the UC Louvain.
directors of iStar Medical and Eye-Point Pharmaceuticals.
He co-founded and served as CEO and a Director of
Baron Philippe Vlerick, Non-Executive, Independent
Eyetech Pharmaceuticals, Inc., where he led the company
Director
through private, public, and corporate financings, and
oversaw the rapid development and successful commer-
Philippe Vlerick is the owner, Chairman and CEO of several
cialization of Macugen® (pegaptanib sodium), the first
businesses in Belgium and abroad. He currently serves
FDA-approved anti-VEGF pharmacological treatment
as the Chairman and Chief Executive Officer of Vlerick
for the treatment of wet AMD. Dr. Guyer has also had a
Group (Belgium), and as Chairman and CEO of UCO
successful career in academic medicine as Professor and
NV, Chairman of Pentahold, Chairman of Smartphoto
Chairman of the Department of Ophthalmology at New
Group and Chairman of the Festival Van Vlaanderen.
York University School of Medicine. Dr. Guyer received
Baron Vlerick is also Vice-chairman of KBC Group and is
his Bachelor of Science (BSc) degree from Yale College
a member of the board of directors of Exmar, Besix Group,
summa cum laude and his medical degree (MD) from
Mediahuis, BMT and L.V.D. (Belgium). Mr Vlerick holds
Johns Hopkins Medical School. He completed his ophthal-
a Degree in Philosophy and Law from the University of
mology residency at Wilmer Ophthalmological Institute
Leuven, and an MBA General Management degree (PUB)
at Johns Hopkins Hospital and a retinal fellowship at the
(Ghent, Vlerick School of Management – 1979). He also
Massachusetts Eye and Ear Infirmary at Harvard Medical
holds a master’s degree in business administration from
School.
Indiana University, Bloomington (US – 1980). In 2006,
he was voted Manager of the Year by Trends, a leading
business magazine in Belgium. He was granted the title of
Baron in 2008 and became Commander of the Order of
Leopold in 2013.
54
OXURION ANNUAL REPORT 2022
55
OXURION ANNUAL REPORT 2022
Dr. Adrienne Graves, Non-Executive, Independent
Director (resigned on March 13, 2023)
Dr. Graves is a board member of multiple companies and
organizations including IVERIC bio, Nicox, the American
Society of Cataract and Refractive Surgery, the Glaucoma
Research Foundation, and the Foundation Fighting
Blindness. She was the president and chief executive
officer of Santen, Inc., the US arm of Japans largest oph-
thalmic pharmaceutical company, Santen Pharmaceutical
Co., Ltd. Before becoming the president and chief executive
officer, she was the vice president of clinical affairs and
senior vice president of worldwide clinical affairs for Japan,
US, and Europe at Santen, Inc. Prior to Santen, Inc., Dr.
Graves was the director of international ophthalmology
at Alcon Laboratories, Inc. She was also the co-founder
of Glaucoma 360 (Glaucoma Research Foundation) and
Ophthalmic Women Leaders (OWL). Dr. Graves received
her bachelor’s degree in psychology with honors from
Brown University, her Ph.D. from the University of Michigan
in psychobiology and completed a postdoctoral fellowship
in visual neuroscience from the University of Paris.
Tom Graney, CFA, Executive Director, Chief Executive
Officer
Tom Graney has extensive global finance and operational
experience that spans corporate development, commer-
cial strategy, portfolio management and supply chain
management, communications, and investor relations. He
is the former Chief Financial Officer of Generation Bio, was
Senior Vice President and Chief Financial Officer at Vertex
Pharmaceuticals Inc. and Chief Financial Officer and Senior
Vice President of Finance & Corporate Strategy at Ironwood
Pharmaceuticals. Prior to Ironwood Pharmaceuticals, Tom
spent 20 years working with Johnson and Johnson and its
affiliates, including four years as worldwide vice president
of finance and Chief Financial Officer of Ethicon. Tom is a
Charted Financial Analyst and holds a B.S. in accounting
from the University of Delaware and an M.B.A. in Marketing,
Finance, and International Business from the Leonard N.
Stern School of Business at New York University. Tom is an
independent director and member of the audit and com-
pensation committees of AC Immune (Nasdaq: ACIU) and
independent director and chair of the audit committee of
Mogrify, a private biotechnology company.
4.6.2 Evaluation of Board of Directors’
activity and members
The Board of Directors does not use a formalized process
for the assessment of its operation, the functioning of the
Committees or the involvement of each director in Board of
Directors’ activities. Rather, the Chairman, in consultation with
individual directors and with support from the Nomination
and Remuneration Committee, regularly conducts an evalua-
tion of all components of the Board of Directors. A global eval-
uation is further informally debated in the various Board of
Directors’ meetings and Committee meetings to ensure that
all components of the Board of Directors and interactions with
the CEO are functioning well. In particular, when proposing
the election or re-election of directors, the Board of Directors
ensures through its discussions that its composition delivers
the appropriate skills and diversity to the Company.
4.6.3 Board of Directors’ meetings in 2022
The Board of Directors met regularly and had fourteen
formal board meetings in 2022. With regard to its super-
visory responsibilities, the Board discussed, among other
things::
The Board of Directors decided not to advance
THR-687 to Part B of the INTEGRAL trial, and to focus
on its THR-149 program, following top-line results from
Part A of its Phase 2 trial of THR-687 in May 2022.
56
OXURION ANNUAL REPORT 2022
The Board of Directors decided to the conduct an
interim analysis of at least 25% of the patients for the
KALAHARI Phase 2, Part B THR-149 trial. The Board
of directors decided to continue the trial based on the
results of the interim analysis.
The Board of Directors ensures that the necessary
financial resources are in place so as to allow the
Company to meet its objectives. This included suc-
cessfully organizing a private equity placement on
March 7, 2022, by which it raised 10.4 million euro in
gross proceeds for 7,226,039 new shares issued at
1.44 euro. Moreover, it amended its mandatory con-
vertible bonds issuance and subscription agreement
with Negma, allowing the Company (at its discretion)
to access to 6 million euro in cash in four monthly
tranches, without application of a cooling off period or
liquidity requirement.
The Board of Directors was actively involved in discus-
sions regarding future funding opportunities.
The Board of Directors is responsible for the corporate
governance structure of the Company and compliance
with the corporate governance stipulations. The Board
of Directors has decided to adopt a one-tier gover-
nance structure and to have an Audit Committee and a
combined Nomination and Remuneration Committee.
The Board of Directors appointed Midico BV (represented
by Michaël Dillen) as Company Secretary in March 2020.
Below is the attendance grid at the formal 2022 Board of
Directors’ meetings:
BOARD OF DIRECTORS
MERONO BV,
CHAIRMAN (PATRIK
DE HAES)
THOMAS CLAY DR. DAVID GUYER
INVESTEA SRL
(Emmanuèle
Attout)
BARON PHILIPPE
VLERICK
DR. ADRIENNE
GRAVES
TOM GRANEY
27/01/2022
present present present present present present present
18/02/2022
present present present present present present present
24/03/2022
present present present present present present present
8/05/2022
present present present present present present present
2/06/2022
present present present present present present present
30/06/2022
present present present present excused excused present
30/08/2022 I
present present present present represented present present
30/08/2022 II
present present present present represented present present
5/09/2022
present represented represented represented represented represented present
6/09/2022
present present present present present excused present
5/10/2022
present present excused present present present present
20/10/2022
present present present present represented excused present
13/12/2022
present present present present present present present
16/12/2022
present excused present present present present present
57
OXURION ANNUAL REPORT 2022
4.6.4 Committees within the Board
of Directors
The Board of Directors has established an Audit Committee
and a combined Nomination and Remuneration
Committee. The Board of Directors appoints the members
and the chairman of each committee. Each committee
consists of at least three members. The composition of
the Committees for 2022 was as follows:
Audit Committee: INVESTEA SRL (represented by
Emmanuèle Attout), chairman; Thomas Clay; Philippe
Vlerick.
The Audit Committee held five meetings during 2022.
Nomination and Remuneration Committee: Thomas Clay,
chairman; Dr. Adrienne Graves; Dr. David Guyer.
The Nomination and Remuneration Committee held three
meetings during 2022.
The powers of these Committees are described in the
Company’s Corporate Governance Charter (Appendix
4 and 5), which is available on Oxurions website
(
www.oxurion.com
).
Below is the attendance grid at the 2022 Committee
meetings:
AUDIT COMMITTEE
INVESTEA SRL,
CHAIR
THOMAS CLAY PHILIPPE VLERICK
16/02/2022
present present present
14/03/2022
present present present
20/05/2022
present present present
30/08/2022
present present represented
7/12/2022
present present represented
NOM REM CO
THOMAS CLAY,
CHAIR
DR. DAVID GUYER
DR. ADRIENNE
GRAVES
19/01/2022
present present present
24/03/2022
present present excused
12/12/2022
present present excused
4.6.5 CEO
The CEO is appointed by the Board of Directors in ac-
cordance with Oxurions Corporate Governance Charter.
The CEO has the power to propose and implement the
corporate strategy, taking into account the Company’s
values, its risk tolerance and key policies. The CEO is,
among other things, entrusted with the day-to-day man-
agement of the Company.
The powers of the CEO are defined by the Board of
Directors in close consultation with the CEO. The CEO su-
pervises the Company’s on-going activities.
In 2022, the role of CEO was carried out by Tom Graney.
The details of the CEO’s remuneration is laid out in the
Remuneration Report.
This section provides a brief biography of the CEO in place
on December 31, 2022.
Tom Graney – Chief Executive Officer
We refer to section 4.6.1.
4.6.6 Executive Committee
In addition to the CEO, several managers are members
of the Executive Committee. The Executive Committee is
not mentioned in the Corporate Governance Charter. The
members of the Executive Committee provide support
and assistance to the CEO (members of the Executive
Committee together with the CEO are referred to herein as
“Executives). The Executive Committee has no statutory
delegated powers to represent the Company or to propose
or implement corporate strategy.
Executive Committee meetings are attended by the
following executives (December 31, 2022):
Julie Binon – Chief People Officer
Andy De Deene – Chief Development Officer
Tom Graney – Chief Executive Officer and Chief
Financial Officer
Midico BV represented by Michaël Dillen – Chief
Business Officer and Company Secretary
Paisley BV represented by Kathleen Paisley – Chief
Legal Officer and Compliance Officer
58
OXURION ANNUAL REPORT 2022
59
OXURION ANNUAL REPORT 2022
4.7 POLICY REGARDING
TRANSACTIONS AND OTHER
CONTRACTUAL RELATIONSHIPS
BETWEEN THE COMPANY,
INCLUDING AFFILIATED COMPANIES,
ITS DIRECTORS, AND THE CEO
4.7.1 Conflicts of Interest of Directors and
the CEO
Article 7:96 of the BCCA contains special provisions which
must be complied with whenever a director has a direct
or indirect conflict of interest of a patrimonial nature in a
decision or transaction within the authority of the Board of
Directors.
According to Appendix 1 and 2 of the Corporate
Governance Charter of the Company regarding transac-
tions or other contractual relations between the Company
including affiliated companies, and its directors and the
CEO, such transactions need to be submitted to the Board
of Directors.
In 2022, no conflicts of interest occurred.
4.7. 2 Transactions with Affiliated Companies
Article 7:97 of the BCCA provides for a special procedure
which must be followed for transactions with Oxurions
affiliated companies or subsidiaries. Such a procedure
does not apply to decisions or transactions that are
entered in the ordinary course of business under at arm’s
length conditions or for decisions and transactions whose
value does not exceed one percent of the Company’s
consolidated net assets. According to Appendix 2 of the
Corporate Governance Charter of the Company regarding
transactions or other contractual relations between the
Company including affiliated companies, and its directors
and members of the CEO, such transactions need to be
submitted to the Board of Directors.
In 2022, no such transactions occurred.
4.7. 3 Protocol regarding transactions with
Related Parties
Transactions with related parties are exclusively with
members of the Board of Directors.
We refer to section 4.9 for the remuneration report con-
cerning 2022.
4.7.4 Market Abuse regulations
Oxurions Corporate Governance Charter Appendix 3
as published on its website describes the rules in place
to prevent inside information being used illegally or the
impression of such illegal use being created by directors,
shareholders, members of the management and important
employees (insiders).
The precautionary measures against insider trading
include, among other things, the obligation to compose
lists of insiders, the requirements concerning investment
recommendations, the obligation to report insider trans-
actions, and the obligation for the intermediary to report
suspicious transactions. The measures are stipulated in
Regulation (EU) No 596/2014 of the European Parliament
and of the Council of April 16, 2014, on Market Abuse
(the “Market Abuse Regulation”) and repealing Directive
2003/6/EC of the European Parliament and the Council
and Commission Directives 2003/124/EC, 2003/125/EC
and 2004/72/EC.
In accordance with the Market Abuse Regulation, Oxurion
has drawn up a list of permanent insiders, including
persons in the Company who are employed or consulted
for the Company and who have regular or occasional
4.8 CAPITAL INCREASE BY THE BOARD OF
access to insider information directly or indirectly concern-
DIRECTORS WITH RESPECT TO THE
ing Oxurion. Moreover, the Company establishes ad hoc
AUTHORIZED SHARE CAPITAL AND
insider lists as required. These lists are updated frequently
and remain at the disposal of the FSMA for five years.
PROVISIONS THAT MAY BE TRIGGERED
IN THE EVENT OF A PUBLIC TAKEOVER
In accordance with the Market Abuse Regulation, the
ON THE COMPANY (ARTICLE 8:2 OF
members of the Board of Directors and the management
THE ROYAL DECREE OF APRIL 29,
are obliged to report their transactions involving shares of
2019 (ARTICLE 34 OF THE OLD ROYAL
Oxurion to the FSMA.
DECREE OF 14 NOVEMBER 2007))
The Company has established a disclosure committee
The Powers of the Board of Directors with Respect to the
and has a Chief Compliance Officer, Paisley BV (represent-
Authorized Share Capital
ed by Kathleen Paisley).
Article 46 of the Articles of Association contains the following
provisions with respect to the authorized share capital. The
Board of Directors’ powers with respect to the authorized
share capital were renewed at the EGM of Oxurion held on
May 24, 2022, for a period of five years starting from the
publication of the notary deed pertaining to the modification
of the Articles of Association in the Belgian Official Gazette
(May 24, 2022). The Board of Directors is authorized to
increase the share capital of the Company upon one or more
occasions up to an amount of 67,931,161.32 euro (less the
authorized capital which is used in view of the issuance of
convertible bonds) through contribution(s) in cash, contribu-
tion(s) in kind, or by conversion of the reserves in accordance
with the special report drawn up pursuant to Article 7:199 of
the BCCA. As a result, on December 31, 2022, the authorized
capital is 65,443,000 euro.
60
OXURION ANNUAL REPORT 2022
61
OXURION ANNUAL REPORT 2022
4.9 REMUNERATION REPORT FINANCIAL
YEAR 2022
In accordance with Belgian law, the Company has adopted
a new remuneration policy in 2021 (Article 3:6, §3 of the
BCCA), which was approved by the Board of Directors on
March 17, 2021, on the recommendation by the Nomination
and Remuneration Committee. At the AGM in May 2021, the
Company submitted its remuneration policy to the sharehold-
ers, which was approved. This policy applies for the next four
years unless materially modified by the Board of Directors and
approved by the shareholders (the “Remuneration Policy” or
the “Policy”).
The purpose of a remuneration policy is to provide the funda-
mental principles based on which the Company will remuner-
ate the members of its Board of Directors, CEO, and Executive
Committee on a going forward basis.
This section of the Annual Report first provides an overview of
the Remuneration Policy. This is followed by the remuneration
report for 2022 applying the Policy.
The purpose of the Remuneration Report is to report on the
remuneration paid by the Company in 2022 in accordance
with the Belgian legislation (Article 7:89/1 of the BCCA) and
the Policy.
4.9.1 Overview of Remuneration Policy
4.9.1.1 Executives
(A) Structure
The CEO is appointed by the Board of Directors in accor-
dance with Oxurions Corporate Governance Charter. The
CEO has the power to propose and implement corporate
strategy, taking into account the Company’s values, its risk
tolerance and key policies. The CEO is, among other things,
entrusted with the running of the Company.
The CEO is assisted by an Executive Committee, which
provides support and assistance to the CEO but has no
statutory delegated powers to represent the Company or to
propose or implement corporate strategy.
The CEO and other members of the Executive Committee are
all referred to in this Remuneration Report as the “Executives”.
(B) Remuneration of Executives
Oxurions approach to remuneration of its Executives is geared
at attracting, motivating, and retaining highly qualified individ-
uals with the necessary skill set and experience to ensure its
continuing sustainable and profitable growth. As such, the
Policy is designed to support the retention and motivation of
the Executives.
The total remuneration package for Oxurion Executives is
made up of three components:
Fixed compensation, including pension and other benefits.
Variable compensation which is based on achieving
corporate objectives.
Equity-based compensation in the form of subscription
rights.
Fixed Compensation. Each Oxurion Executive is entitled to a
to the expiry of a three-year period following their allocation.
fixed annual compensation package including pension, where
The decision to do so was not considered to be exceptional
applicable, and other benefits.
in the biotech and pharmaceutical industry where such plans
are common in order to ensure longevity.
Variable Compensation. Executives are also entitled to
variable compensation based on achieving annual corporate
Oxurion generally does not provide for any performance-re-
performance objectives.
lated premiums in shares, options, or other rights to acquire
shares. However, a deviation was made in 2021 to grant Mr.
This variable component is an incentive linked to the achieve-
Graney performance-based options when he was appointed
ment of annual corporate objectives. The level of achieve-
CEO, as set forth in the 2021 Remuneration Report.
ment of each of the corporate objectives defines the total
percentage of the target amount that is paid. As it is typically
Ownership of shares. The Company is not able to make
annual in nature, this component qualifies as a short-term
share grants as it does not have distributable reserves and
cash incentive.
therefore is not able to hold treasury shares and hence has
not put in place any requirements for share ownership by the
Share Subscription Rights. The Company offers subscription
Board of Directors or by Executives.
rights to Executives through various subscription rights plans
(previously referred to as warrants).
Claw backs. In line with its remuneration policy, Oxurion
does not operate any claw back arrangements in relation
Subscription rights are granted free of charge according
to remuneration paid to Executives. The Company does not
to rules set by the Board of Directors on the advice of the
consider that it is necessary to apply claw back provisions
Nomination and Remuneration Committee. The vesting of
and therefore deviates from principle 7.12 of the Corporate
subscription rights is generally not linked to individual perfor-
Governance Code on the basis that:
mance but rather is based on continued service to ensure
that Executives have a long-term commitment to maximizing
The pay out of the variable compensation, based on the
long-term shareholder value. Paragraph 4.9.2.1, D gives more
achievement of corporate targets as set by the Board of
detailed information on the subscription right plans and out-
Directors, is paid only upon achievement of the objective.
standing subscription rights at the end of 2022 including the
The Company does not apply any other perfor-
value per subscription right at the time of each grant applying
mance-based remuneration or variable compensation
the Black-Scholes-Merton valuation method.
as the subscription rights granted to Executives generally
vest over time and are not performance related.
The Company does not consider the subscription rights
granted to Executives to be variable remuneration as defined
Consequently, no claw back arrangements were applied
by the BCCA.
during 2022.
At the EGM of November 20, 2017, it was decided that
Conflicts of interest. The remuneration of the non-executive
Oxurion would expressly deviate from the specific provi-
directors is subject to approval by the general shareholders
sions of Art. 7:91 BCCA, according to which directors are not
meeting.
allowed to exercise subscription rights allocated to them prior
62
OXURION ANNUAL REPORT 2022
63
OXURION ANNUAL REPORT 2022
The CEO does not participate in the preparation and the
decision making regarding his own remuneration. Furthermore,
the Nomination and Remuneration Committee is composed
exclusively of non-executive board members and a majority
of its members qualify as independent directors. The CEO/
Executive Director only participates in the meetings of the
Nomination and Remuneration Committee in an advisory
capacity. He recuses himself and does not participate in the
discussions relating to his own remuneration in either the
Nomination and Remuneration Committee or the Board of
Directors.
4.9.1.2 Board of Directors
The procedure for establishing the remuneration policy and
setting remuneration for members of the Board of Directors is
determined by the Board of Directors on the basis of proposals
from the Nomination and Remuneration Committee, taking into
account relevant benchmarks with appropriate peer companies.
The remuneration of the Non-Executive Directors is submitted
by the Board of Directors to the shareholders’ meeting for
approval and is only implemented after such approval.
The fixed and variable remuneration of the CEO (who is a
member of the Board of Directors) is established by the Board
of Directors based upon an authorization from the sharehold-
ers’ meeting and described above. Executive Directors are not
separately remunerated for their board role.
(A) Non-Executive Directors
Based on a peer review of the compensation of the Board
of Directors against peer companies (Euronext listed biotech
companies), the AGM of Oxurion of May 7, 2019, approved a
new remuneration and compensation scheme and decided
to issue a subscription rights plan for Non-Executive Directors
with the objective of avoiding disadvantages compared to
competitors and peer companies. This was further imple-
mented in the Company’s Remuneration Policy.
In accordance with the policy terms approved by the share-
holders, Non-Executive Directors are entitled to the following
fees:
ROLES BOARD AUDIT CO NOM REM CO
Chairman
90,000 12,000 8,000
Board Member
30,000 6,000 4,000
The Chairman of the Board of Directors does not receive
any fees for any membership or chairmanship of any of the
Committees he may hold. If a director attends less than at
least 75% of the scheduled annual Board of Directors’ or
Committee meetings of which he or she is a member either
in person or by phone, the fees are reduced on a pro rata
basis. Where members attend Board of Directors’ meetings
in person, they are entitled to reimbursement of reasonable
out-of-pocket expenses actually incurred as a result of partic-
ipation in meetings of the Board of Directors.
Apart from the above remuneration, the shareholders decided
at the AGM in May 2019 that Non-Executive Directors should
be entitled to subscription rights for 7,500 shares in the
Company per year. This was implemented by decision of the
Board of Directors to adopt a Board of Directors’ Subscription
Rights Plan 2020 for 150,000 shares before the Public
Notary on December 23, 2020. These rights are not subject
to any vesting criteria and can be freely exercised during any
exercise period for the life of the Plan. The Company does not
consider them to be variable compensation.
The Company recognizes that the Corporate Governance
Code recommends against granting subscription rights to
Board of Directors’ members, but at the same time advises
companies that members of the Board of Directors should own
shares of the Company. Oxurion is not able to grant shares to its
directors because it does not have distributable reserves and
cannot own treasury shares. Therefore, the Company considers
that the grant of subscription rights to Non-Executive Directors
that vest on grant operates as closely as possible to a share.
64
OXURION ANNUAL REPORT 2022
The shareholders have already expressly agreed to the grant
of subscription rights to the Board of Directors at the 2019
AGM and again at the 2021 AGM as part of the approval of
the 2021 Remuneration Policy.
The Board of Directors’ remuneration structure encourages an
active participation in both Board of Directors’ and Committee
meetings. The fixed remuneration for the Non-Executive
Directors is justified by the fact that the proper operation of
these Committees requires adequate preparation by the
members. The grant of subscription rights to Non-Executive
Directors further aligns the Directors’ interests with those of
the shareholders and allows the Company to attract and
retain top quality directors.
The objective and independent judgment of the Non-
Executive Directors is further encouraged by the fact that they
do not draw any other remuneration from the Company other
than their fixed Directors’ remuneration and their subscription
rights, except for David Guyer who provides additional ad hoc
consultancy services.
The remuneration of the Non-Executive Directors does not
contain a variable component; hence no performance criteria
apply to the remuneration of the Non-Executive Directors.
The Directors’ mandate may be terminated “ad nutum” (at
any time) without any form of compensation.
(B) Executive Directors
Executive Directors are not compensated for their role on
the Board of Directors in addition to the compensation they
receive as Executives.
4.9.2 Remuneration report
4.9.2.1 Executives
(A) Total Remuneration Summary for Executives
This Remuneration Report covers Oxurion Executives,
including the CEO and the Executive Committee. During fiscal
year 2022, the Executive Committee was made up by the
following Executives (plus the CEO):
Julie Binon – Chief People Officer (until December 31,
2022)
Andy De Deene – Chief Development Officer
Tom Graney – Chief Executive Officer and Chief Financial
Officer
Midico BV represented by Michaël Dillen – Chief Business
Officer and Company Secretary
Paisley BV represented by Kathleen Paisley – Chief Legal
Officer and Compliance Officer
Hanne Callewaert – Chief Operating Officer (until
September 1, 2022)
Alan Stitt – Chief Scientific Officer (until August 31, 2022)
During the course of 2022, a number of changes were made
to the composition of the Executive Committee. The global
remuneration figures included in this Remuneration Report
for the Executive Committee for fixed compensation, other
benefits and pensions, where applicable, include amounts
paid to all members of the Executive Committee and relating
to the 2022 financial year in euro. The amounts included for
variable compensation are those relating to the financial year
regardless of when they were paid.
The overview below demonstrates the total remuneration of
the CEO and Executive Committee members in 2022 in euro:
NAME AND TITLE FIXED COMPENSATION OTHER BENEFITS PENSION
VARIABLE
COMPENSATION
TOTAL
RATIO OF VARIABLE TO
FIXED COMPENSATION
Tom Graney, CEO
502,000 35,000 24,000 0 562,000 N/A
Executive Committee
1,057,000 35,000 42,000
0
1,134,000 N/A
65
OXURION ANNUAL REPORT 2022
(B) Fixed Remuneration
We refer to the table above that reflects the base com-
pensation, pension and other benefits for the CEO and
Executive Committee members in 2022 in euro.
Base Compensation. Each Oxurion Executive is entitled to
base compensation in line with his/her position.
Other Benefits. Depending on their location and status,
Executives may be entitled to statutory benefits plus a
contribution to a healthcare plan, a company car, and/or
similar arrangements. These amounts can vary from year-
to-year but are reported here due to their recurring nature.
Pension. Depending on their location and status, Executives
may receive defined contribution benefits under Oxurions
group insurance plan or through matching arrangements
under 401 (k) plans in the US. These amounts can vary
from year-to-year but are reported here due to their
recurring nature.
(C) Variable Compensation
According to the Remuneration Policy, the performance
criteria are set at the beginning of the year together with
the Nomination and Remuneration Committee and the
Board of Directors to align with what they consider creates
the most shareholder value. They have four primary
components - (1) funding of the company in relation to
a specific plan, developed by the Board of Directors; (2)
delivery of the development programs via clinical trial
milestones; (3) enhancing the Company’s assets in key
strategic areas, for example, through in/out-licensing and
(4) a relevant people objective. Those four components
of the performance criteria are weighted in light of their
importance to the Company’s success and linked to the
specific year.
At year-end, the Nomination and Remuneration Committee
and the Board of Directors decide whether corporate ob-
jectives are achieved. The objectives are SMART, so they
are achieved or not achieved by the timeline set for the
period. In some cases, they are partially achieved. In the
latter case, the Nomination and Remuneration Committee
and the Board of Directors shall award a reduced target
incentive amount based on criteria for partial achievement
that have been established in advance.
For the year 2022, the objectives were set relating to
funding (both amount and timing), clinical trial timelines for
THR-149 and THR-687 and employee engagement. The
Nomination and Remuneration Committee and the Board
of Directors have decided not to grant a variable compen-
sation for the year 2022 in spite of the achievement of
some of the objectives.
66
OXURION ANNUAL REPORT 2022
(D) Subscription Rights
The Executives are also entitled to participate, free of charge, in the different subscription rights plans that Oxurion has in
place for its personnel.
No subscription rights were granted to or exercised by Executives in 2022.
The table below sets forth the subscription rights outstanding and exercisable as of December 31, 2022, for the Executives
including for our former CEO ViBio BV and former Chief Legal Officer Claude Sander:
NAME FIRST NAME DATE OF GRANT PLAN EXERCISE PRICE
N° OF SRS OUT-
STANDING AS OF
DECEMBER 31, 2022
N° OF SRS FORFEITED
IN 2022
NUMBER OF SRS
EXERCISABLE AS OF
DECEMBER 31, 2022
Binon
Julie 03 07 2019 2017 3.822 15,000 15,000
Binon
Julie 26 06 2020 2017 2.847 12,500 12,500 12,500
Binon
Julie 28 04 2021 2021-1 2.6 7,500 2,500 7,500
Binon
Julie 30 09 2021 2021-2 1.75 9,844 7,656 9,844
Binon
Julie 30 12 2021 2021-3 1.82 32,500 32,500 32,500
Callewaert
Hanne 29 06 2018 2017 6.549 10,000 10,000
Callewaert
Hanne 03 07 2019 2017 3.822 4,000 4,000
Callewaert
Hanne 28 04 2021 2021-1 2.6 7,500 5,156
Callewaert
Hanne 30 09 2021 2021-2 1.75 47,500 26,718
Callewaert
Hanne 30 12 2021 2021-3 1.82 90,000 45,000
De Deene
Andy 28 12 2018 2017 3.4 25,000 25,000
De Deene
Andy 27 12 2019 2017 2.64 25,000 25,000
De Deene
Andy 28 04 2021 2021-1 2.6 40,000 30,000
De Deene
Andy 30 09 2021 2021-2 1.75 150,000 84,375
De Deene
Andy 30 12 2021 2021-3 1.82 220,000 110,000
Graney
Tom 28 04 2021 2021-1 2.6 400,000 300,000
Graney
Tom 30 09 2021 2021-1 1.75 165,000 0
Graney
Tom 30 09 2021 2021-2 1.75 235,000 0
Midico BV
28 04 2021 2021-1 2.6 52,500 39,375
Midico BV
30 09 2021 2021-2 1.75 45,000 25,312
Midico BV
30 12 2021 2021-3 1.82 90,000 45,000
Paisley BV
28 04 2021 2021-1 2.6 52,500 39,375
Paisley BV
30 09 2021 2021-2 1.75 55,000 30,937
Paisley BV
30 12 2021 2021-3 1.82 90,000 45,000
Sander
Claude 28 12 2017 2017 3.38 25,000 25,000
Sander
Claude 28 12 2018 2017 3.4 25,000 25,000
ViBio BV
28 12 2017 2017 4.593 100,000 100,000
ViBio BV
28 12 2018 2017 4.593 100,000 100,000
ViBio BV
27 12 2019 2017 4.593 100,000 100,000
ViBio BV
28 04 2021 2021-1 2.6 200,000 150,000
67
OXURION ANNUAL REPORT 2022
(E) 2022 Executive Remuneration and
alignment with Remuneration Policy
The remuneration for 2022 is in line with the Remuneration
Policy and contributes to the long-term performance of the
Company as intended by the Remuneration Policy (as set out
above).
The Oxurion remuneration policy is defined in a manner that
remunerates the Company’s executives to drive and reward
actions, decisions and behavior that makes the Company suc-
cessful in the long run. Variable compensation at the Company
is directly linked to tangible corporate objectives, each one
contributing to the Company’s performance. Executives are
incentivized to focus on those actions or decisions that will
make the Company successful. This short-term incentive
plan is expressed as a percentage of base salary. Oxurion also
has a long-term incentive component, which is intended to
focus its executives on value creation for the shareholders,
employees, patients, and other stakeholders over the long run,
this via a subscription rights plan.
4.9.2.2 Directors
(A) Non-Executive Directors
Cash Compensation
The 2022 remuneration of the Non-Executive Directors
and the Chairman of the Board of Directors is set forth
in the chart below. Note that no benefits are provided to
members of the Board of Directors.
NAME
ANNUAL
FEES
AUDIT
CO
MEM-
BER
AUDIT
CO
CHAIR
NOM
REM
CO
MEM-
BER
NOM
REM CO
CHAIR
TOTAL
PAY-
MENTS
Chairman,
MeRoNo BV,
represented by
Patrik De Haes
90,000
90,000
22,500
Thomas Clay
30,000 6,000 4,000 4,000 44,000
Investea SRL,
represented by
Emmanuèle
Attout
30,000 6,000 6,000 42,000 21,000
Philippe
Vlerick
30,000 6,000 36,000
Dr. Adrienne
Graves
30,000 4,000 34,000
Dr. David
Guyer
30,000 4,000 34,000
David Guyer received, in addition to his Director’s remu-
neration, compensation of 35,000 USD for consultancy
services in 2022.
Share Subscription Rights
In 2022, no subscription rights were granted to members
of the Board of Directors.
(B) Executive directors
Executive director Tom Graney does not receive any com-
pensation for his Board of Director’s mandate. The com-
pensation paid in respect of his function as CEO is outlined
above.
68
OXURION ANNUAL REPORT 2022
4.9.2.3 Evolution of Executives remuneration and
average employee remuneration and pay ratio.
(A) Evolution of Executives remuneration and
average employee remuneration
The chart below shows the evolution of the Executive
Remuneration, share price (as a proxy for Company per-
formance) and average remuneration:
NAME AND TITLE TOTAL REMUNERATION
2019 2020 2021
2022
CEO (*)
557,000 455,000 652,000 562,000
Change year on year
-18.3% + 43.3% -13.8%
Non-Executive
Directors
206,000 196,949 252,250 280,000
Change year on year
-4.4% +28.1% +11%
Executive Committee
(**)
1,472,000 1,674,000 1,860,000 1,134,000
Change year on year
+13.7% +11% -39%
Share Price at YE
2.95 2.56 1.82 0.020
Change year on year
-13.2% -29% -99%
Average Compensation
per FTE (***)
107,000 102,000 159,000 110,000
Change year on year
-4.67% +56.9% -31%
(*) The decrease in the remuneration 2022 of the CEO is mainly due to the fact
that no variable compensation related to 2022 was granted.
(**) The decrease in the Executive Committee remuneration in 2022 is mainly due
to the fact that no variable compensation related to fiscal year 2022 was granted
and that the number of Executive Committee members was reduced.
(***) The decrease in average compensation per FTE is mainly due to the fact that
no variable compensation in 2022 was granted for corporate objectives and the
composition of the personnel changed due to restructuring and attrition.
For the calculation of the average compensation per
FTE, the fixed remuneration and employee benefits in
December 2022 have been taken into account. The com-
pensation data includes European employees, in full time
equivalent, employed in December 2022, and does not
include Executive Committee members.
(B) Ratio of the Total Remuneration of Highest
Paid versus Lowest Remunerated Personnel
The ratio of the 2022 remuneration of the lowest full time
FTE (in euro) to the highest fulltime FTE (in euro), was 1:9.
This compares to 1:15 in 2021.
For the calculation of this ratio, the compensation data
of US and European employees, full time equivalent, and
employed in December 2022, are considered and is based
upon the fixed remuneration and employee benefits in the
month of December 2022.
4.9.2.4 Extraordinary Items
Severance Payments
During 2022, three members of the Executive Committee
left the Company.
Hanne Callewaert, Chief Operating Officer, left the
company on August 31, 2022, however, she continues
to act as a part time consultant to the Company. No
severance payments were made. Her participation in
the different subscription rights plans that Oxurion has
in place for its personnel will end when Ms. Callewaert
no longer renders services to Oxurion as a consultant.
Alan Stitt, Chief Scientific Officer, left the company on
August 31, 2022. No severance payments were made.
Julie Binon, Chief People Officer, left the Company on
December 31, 2022, however, she continues to act as
a part time consultant to the Company. No severance
payments were made. Her participation in the different
subscription rights plans that Oxurion has in place
for its personnel will end when Ms. Binon no longer
renders services to Oxurion as a consultant.
69
OXURION ANNUAL REPORT 2022
70
OXURION ANNUAL REPORT 2022
5. CONSOLIDATED FINANCIAL
STATEMENTS
71
OXURION ANNUAL REPORT 2022
5.1 CONSOLIDATED STATEMENT OF PROFIT AND LOSS
N '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
NOTE
2022
2021
Revenue5.6.1
595
1 ,128
Cost of sales
5.6.2
-513
-612
Gross profit
82
516
Research and development expenses
5.6.3
-15 ,986
-20 ,696
General and administrative expenses5.6.4
-5 ,980
-7 ,150
Selling expenses
5.6.5
-892
-1 ,27 4
Other operating income
5.6.6
830
1,2 45
Other operating expense
0
-9
Impairment losses
5.7.3
-1 ,000
-1,127
Operating result
-22,946
-28 ,495
Finance income
5.6.7
639
171
Finance expense5.6.8
-9 ,379
-1,268
Result before income tax
-31 ,686
-29 ,592
Taxes
5.6.10
-7
-3
Result of the year
-31 ,693
-29 ,595
Attributable to:
Equity holders of the company
-31 ,685
-29 ,158
Non-controlling interest
-8
-437
Result per share
Basic earnings / loss (-) per share (euro)
5.6.11
-0 .37
-0.77
Diluted earnings / loss (-) per share (euro)
5.6.11
-0 .37
-0.77
IN '000 EURO (AS AT 31 DECEMBER)
NOTE
2022
2021
Result of the year
-31 ,693
-29 ,595
Other comprehensive income:
Remeasurement of defined benefit pension schemes
5.7.9
361
566
Fair value gain/(loss) on investments designated as at FVTOCI
-5
-5
Other comprehensive income that will not be reclassified to profit or loss
356
561
Exchange differences arising on translation of foreign operations
101
122
Other comprehensive income that will or may be reclassified to profit or loss
101
122
Other comprehensive income, net of income tax
457
683
Total comprehensive loss (-) / income for the year
-31 ,236
-28,912
Attributable to:
Equity holders of the company
-31 ,228
-28,475
Non-controlling interest
-8
-437
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
72
OXURION ANNUAL REPORT 2022
5.2 CONSOLIDATED STATEMENT OF FINANCIAL POSITION
IN '000 EURO (AS AT 31 DECEMBER)
NOTE
2022
2021
ASSETS
Property, plant and equipment
5.7.1
99
120
Right-of-use assets
5.7.2
963
252
Intangible assets
5.7.3
0
1,000
Other non-current assets
40
95
Non-current tax credit
5.7.4
3 ,785
4,000
Non-current assets
4,887
5,467
Inventories
5.7.5
5
60
Trade and other receivables
5.7.4
3 ,321
2,517
Current tax receivables
5.7.4
189
845
Investments
5.7.6
95
247
Cash and cash equivalents
3 ,496
9 ,7 40
Current assets
7 ,106
13,409
Total assets
11 ,993
18,876
EQUITY AND LIABILITIES
Share capital
5.7.7
65 ,443
46 ,029
Share premium
5.7.7
250
234
Other comprehensive income
5.7.8
101
-356
Other reserves
5.7.8
3,027
-5,266
Retained earnings
-73 ,404
-4 1 ,719
Equity attributable to equity holders of the company
-4,583
-1,078
Non-controlling interest
0
-30
Total equity
-4,583
-1 ,108
Lease liabilities
833
44
Employee benefit liabilities
5.7.9
159
594
Convertible loans
5.7.11
3,235
8,433
Non-current liabilities
4,227
9 ,071
Trade payables
5 ,040
4,979
Lease liabilities
139
221
Convertible loans
5.7.11
3,809
3,401
Other short-term liabilities
5.7.10
3,361
2,312
Current liabilities
12,349
10 ,913
Total equity and liabilities
11 ,993
18,876
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
73
OXURION ANNUAL REPORT 2022
5.3 CONSOLIDATED STATEMENT OF CASH FLOWS
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
NOTE
2022
2021
Cash flows from operating activities
Loss for the period
-31 ,693
-29 ,595
Finance expense
5.6.8
1,555
896
Finance income
5.6.7
-203
-171
Depreciation of property, plant and equipment
5.7.1
63
77
Amortization and impairment of intangible assets
5.7.3
1 ,000
1 ,127
Amortization of right-of-use assets
5.7.2
290
600
Gain on sale of property, plant and equipment
-1
-344
Fair value adjustments of financial instruments
7 ,388
372
(Reversal of) impairment losses on current assets
0
629
Increase / Decrease (-) in provisions
-75
64
Equity settled share-based payment transactions
5.6.9
933
1 ,107
Increase (-) / Decrease in trade and other receivables and inventories
215
-2,037
Increase / Decrease (-) in short-term liabilities
1,149
297
Net cash flows generated / used (-) in operating activities
-19,379
-26,978
Cash flows from investing activities
Disposal of property, plant and equipment (following a sale)
5.7.1
18
394
Decrease / Increase (-) in investments
5.7.6
147
36
Interest received and similar income
5.6.7/8
5
9
Purchase of property, plant and equipment
5.7.1
-59
-32
Net cash flows generated / used (-) in investing activities
111
407
Cash flows from financing activities
Principal paid on lease liabilities
5.7.2
-294
-599
Proceeds from loans and borrowings
5.7.11
7 ,150
11,150
Repayment of loans and borrowings
5.7.11
-3,605
0
Other financial income / expense (-)
-7
-20
Interest paid on lease liabilities
5.7.2
-6
-3
Proceeds from capital increases in subsidiaries from non-controlling interest
0
86
Proceeds from capital and share premium increases, gross amount
5.7.7
10,405
1,350
Paid interests and other bank charges
5.6.8
-642
-186
Net cash flows used (-) / generated in financing activities
13,001
11,778
Net change in cash and cash equivalents
-6 ,267
-14 ,793
Net cash and cash equivalents at the beginning of the period
9 ,7 40
2 4,511
Effect of exchange rate fluctuations
23
22
Net cash and cash equivalents at the end of the period
3 ,496
9 ,7 40
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
74
OXURION ANNUAL REPORT 2022
5.4 CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
OTHER ATTRIBUTABLE
SHARE CAPITALSHARE COMPREHEN-OTHER RETAINED TO EQUITY NON-CONTROL-TOTAL
PREMIUMSIVE INCOME RESERVESEARNINGSHOLDERS OF LING INTEREST
RESERVETHE COMPANY
Balance as at 1 January 2021
44,913
0
-1,039
-6 ,133
-12,561
25 ,180
-132
25,048
Total comprehensive income of the year
Result of the year
0
0
0
0
-29 ,158
-29 ,158
-437
-29 ,595
Change to foreign currency translation
0
0
122
0
0
122
0
122
difference
Remeasurement of DBO
0
0
566
0
0
566
0
566
Net change in fair value of investments
0
0
-5
0
0
-5
0
-5
Total comprehensive income for the year
0
0
683
0
-29 ,158
-28 ,475
-437
-28 ,912
Contributions by and distributions to
owners
Issue of ordinary shares
1 ,116
234
0
213
0
1 ,563
0
1 ,563
Share-based payment transactions
0
0
0
1 ,107
0
1 ,107
0
1 ,107
Total contributions by and distributions
1 ,116
234
0
1,320
0
2,670
0
2,670
to owners
Transactions with non-controlling interests
0
0
0
-453
0
-453
539
86
Balance as at 31 December 2021
46 ,029
234
-356
-5,266
-41 ,719
-1 ,078
-30
-1 ,108
Balance as at 1 January 2022
46 ,029
234
-356
-5,266
-41 ,719
-1 ,078
-30
-1 ,108
Total comprehensive income of the year
Result of the year
0
0
0
0
-3 1,685
-31,685
-8
-3 1 ,693
Change to foreign currency translation
0
0
101
0
0
101
0
101
difference
Remeasurement of DBO
0
0
361
0
0
361
0
361
Net change in fair value of investments
0
0
-5
0
0
-5
0
-5
Total comprehensive income for the year
0
0
457
0
-3 1 ,685
-31 ,228
-8
-31 ,236
Contributions by and distributions to
owners
Issue of ordinary shares
19 ,4 14
16
0
7 ,398
0
26 ,828
0
26 ,828
Share-based payment transactions
0
0
0
933
0
933
0
933
Total contributions by and distributions
19 ,4 14
16
0
8,33 1
0
27 ,761
0
27 ,761
to owners
Transactions with non-controlling interests
0
0
0
-38
0
-38
38
0
Balance as at 31 December 2022
65 ,443
250
101
3,027
-73 ,404
-4,583
0
-4,583
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
75
OXURION ANNUAL REPORT 2022
5.5 GENERAL NOTES TO
THE CONSOLIDATED
FINANCIAL STATEMENTS
5.5.1 Reporting entity
Oxurion is a public limited liability company (in Dutch:
Naamloze Vennootschap) established under Belgian
law with its registered office at Gaston Geenslaan 1,
B-3001 Leuven, with two wholly owned subsidiaries
– ThromboGenics and Oncurious (wholly owned as
of December 14, 2022). Oxurion, ThromboGenics and
Oncurious are biopharmaceutical companies focusing on
the development of new drugs for the treatment of eye
diseases and cancer. The Group has built a pipeline of
drug candidates, one of which is actively in the clinic. The
Groups research and development facilities are located in
Belgium.
The consolidated financial statements of Oxurion for the
year ending December 31, 2022, include the entire Group.
These consolidated financial statements were approved
by the Board of Directors on March 30, 2023. Possible
changes to this Annual Report can be carried out until the
AGM of May 2, 2023 .
5.5.2 Application of new and revised
standards and interpretations to the
consolidated financial statements
New Standards, Interpretations and Amendments adopted
by the Group.
During 2022, the Group has adopted all the new and
revised Standards and Interpretations issued by the
International Accounting Standards Board (“IASB”) and
the IFRS Interpretations Committee (“IFRS IC”) of the
IASB as adopted by the European Union (“EU”) and
effective for the accounting year starting on January 1,
2022. The Group has not applied any new IFRS require-
ments that are not yet effective as of December 31, 2022 .
The following new Standards, Interpretations and
Amendments issued by the IASB and the IFRS IC as
adopted by the European Union are effective for the
financial period:
Amendment to IFRS 16 Leases: COVID-19-Related
Rent Concessions beyond 30 June 2021 (applicable
for annual periods beginning on or after 1 April 1, 2021)
Amendments to IAS 16 Property, Plant and Equipment:
Proceeds before Intended Use (applicable for annual
periods beginning on or after 1 January 1, 2022)
Amendments to IAS 37 Provisions, Contingent
Liabilities and Contingent Assets: Onerous Contracts
— Cost of Fulfilling a Contract (applicable for annual
periods beginning on or after 1 January 1,2022)
Amendments to IFRS 3 Business Combinations:
Reference to the Conceptual Framework (applicable
for annual periods beginning on or after 1 January 1,
2022)
Annual Improvements to IFRS Standards 2018–2020
(applicable for annual periods beginning on or after 1
January 1, 2022)
The adoption of these new standards and amendments
has not led to major changes in the Groups accounting
policies.
Standards and Interpretations issued but not yet effective
in the current year.
The Group elected not to early adopt the following new
Standards, Interpretations and Amendments, which have
been issued by the IASB and the IFRS IC but are not yet
mandatory for December 31, 2022, reporting periods and/
or not yet adopted by the EU as per December 31, 2022 :
IFRS 17 Insurance Contracts (applicable for annual
5.5.3 Basis of preparation and significant
periods beginning on or after January 1, 2023)
accounting policies
Amendments to IFRS 17 Insurance contracts: Initial
Application of IFRS 17 and IFRS 9 – Comparative
The main basis adopted when preparing these consolidat-
Information (applicable for annual periods beginning
ed financial statements are set out below.
on or after January 1, 2023)
Amendments to IAS 1 Presentation of Financial
(A) STATEMENT OF COMPLIANCE
Statements: Classification of Liabilities as Current or
Non-current (applicable for annual periods beginning
These consolidated financial statements were prepared
on or after January 1, 2024 or later, but not yet endorsed
in accordance with the IFRS as issued by the IASB and
in the EU)
adopted by the EU. The consolidated financial statements
Amendments to IAS 1 Presentation of Financial
are presented in thousands of euro except per share
Statements and IFRS Practice Statement 2: Disclosure
amounts which are in euro.
of Accounting Policies (applicable for annual periods
beginning on or after January 1, 2023)
(B) GOING CONCERN - MATERIAL
Amendments to IAS 8 Accounting policies, Changes
UNCERTAINTY
in Accounting Estimates and Errors: Definition of
Accounting Estimates (applicable for annual periods
The Groups cash balance at December 31, 2022, of 3.6
beginning on or after January 1, 2023)
million euro is not sufficient to fund the Groups operations
Amendments to IAS 12 Income Taxes: Deferred Tax
during the next twelve months. However, post-closing, the
related to Assets and Liabilities arising from a Single
Group entered into the Atlas Subscription Agreement.
Transaction (applicable for annual periods beginning
This committed but conditional funding would be
on or after January 1, 2023)
sufficient to fund operations during the next twelve months
Amendments to IFRS 16 Leases: Lease Liability in a
from the financial statement’s issue date. However, given
Sale and Leaseback (applicable for annual periods
the contingent nature of this funding, the Group is actively
beginning on or after January 1, 2024, but not yet
exploring the possibility of obtaining additional funding
endorsed in the EU)
through debt, equity, or non-dilutive funding, including the
licensing of THR-149, or alternatively reducing its costs
None of the new Standards, Interpretations and
and investments so that there should be sufficient cash
Amendments, which are effective for periods beginning
to continue its operations during the next twelve months.
after January 1, 2022, that have been issued by the IASB
and the IFRS IC but are not yet effective as per Decembe r
As the net-assets of the Company are below 61,500
31, 2022, and/or not yet adopted by the EU as per
euro (the statutory minimum amount of share capital of
December 31, 2022, are expected to have a material effect
a Belgian public limited liability company), in accordance
on the Groups current or future financial statements or on
with article 7:229 of the BCCA, each interested party is
foreseeable future transactions.
entitled to request the competent commercial court to
dissolve the Company. In such instance the court may
order the dissolution of the Company or grant a grace
period within which the Company is allowed to remedy
the situation .
76
OXURION ANNUAL REPORT 2022
77
OXURION ANNUAL REPORT 2022
Based on the above, the Board of Directors considers it
may be reasonable to expect that there will be sufficient
cash to continue its operations during the next twelve
months, and therefore decided to continue its valuation
rules under the assumption of going concern. However,
there is a material uncertainty relating to going concern
of the Group because it is uncertain that the above-men-
tioned committed but conditional funding will be available
when needed given the conditions related to the funding,
and because it is not certain whether the Group will be
able to timely obtain the necessary additional funding
through debt, equity, or non-dilutive funding, partnering or
to realize sufficient cost and investment reductions .
( C) BASIS OF CONSOLIDATION
Subsidiaries
The consolidated financial statements include all the
entities that are controlled by the Group. Control exists
when Oxurion directly or indirectly has the ability to direct
the relevant activities that significantly affect the entities
returns, has exposure or rights to variable returns and the
ability to use its power over the entity to affect investors
returns, Control is presumed to exist when Oxurion owns,
directly or indirectly, more than 50 percent of the voting
rights linked to the share capital. The existence and effect
of potential voting rights that are currently exercisable or
convertible are considered when assessing whether the
Group controls another entity. Applying this standard,
Oxurions subsidiaries ThromboGenics and Oncurious
have been consolidated.
Subsidiaries are fully consolidated from the date on which
control is transferred to the Group. They are deconsolidat-
ed from the date on which control ceases. A change in
the ownership interest of a subsidiary, without a change
in control, is accounted for as an equity transaction. Cash
flows from transactions relating to changes in ownership
that do not result in a change of control are classified as
financing activities.
Intra-group transactions, balances and unrealized profits
and losses on transactions between companies in the
Group are eliminated in preparing the consolidated
financial statements. Unrealized losses are eliminated in
the same way as unrealized profits unless the transaction
indicates an impairment loss on the assets transferred.
The accounting principles of the subsidiaries have been
adjusted where necessary to be consistent with the princi-
ples adopted by the Group.
( D) BUSINESS COMBINATIONS AND
GOODWILL
Business combinations are accounted for by applying
the acquisition method. The cost of an acquisition is
measured as the aggregate of the consideration trans-
ferred as measured at fair value on the acquisition date
and the amount of any non-controlling interests in the
acquiree. For each business combination, the Company
elects whether to measure the non-controlling interests
in the acquiree at fair value or at the proportionate share
of the acquiree’s identifiable net assets. Acquisition-related
costs are expensed as incurred. The cost is attributed to
the identifiable assets, liabilities and contingent liabilities of
the acquiree. These acquired identifiable assets and (con-
tingent) liabilities are initially measured at their fair value on
the date of acquisition.
Goodwill is initially measured at cost (being the excess
of the aggregate of the consideration transferred and the
amount recognized for non-controlling interests) and any
previous interest held over the identifiable assets acquired
and liabilities assumed. If the fair value of the net assets
acquired is in excess of the aggregate consideration trans-
ferred, the Company re-assesses whether it has correctly
identified all of the assets acquired and all of the liabilities
assumed and reviews the procedures used to measure
the amounts to be recognized at the acquisition date. If
the reassessment still results in an excess of the fair value
of net assets acquired over the aggregate consideration
transferred, then the gain is recognized in the profit or loss .
(E) FOREIGN CURRENCY TRANSLATION
(F) REVENUE RECOGNITION
Functional and presentation currency
Revenue recognition for Oxurion consists of JETREA® via l
sales to distributors, royalties for JETREA® vial sales fro m
The consolidated financial statements are presented in
licensees, occasional upfront and milestone payments
thousands of euro, which is the functional currency of
agreed through license or collaboration contracts whic h
Oxurion. All companies within the Group use the euro
could include recharging of incurred services of cost, an d
as their functional currency, except for the US subsidiary,
royalties.
whose functional currency is the US dollar (USD).
JETREA® sales
Transactions and balances in foreign currencies
Performance obligations
Transactions in currencies other than the functional
currency of the entities are recorded at the exchange rates
Oxurion has identified one performance obligation withi n
prevailing on the date of the transaction. On each balance
its customer contracts for the sale of JETREA® product, i.e .
sheet date, monetary assets and liabilities denominated
the delivery of goods to its customers.
in foreign currencies are translated into the functional
currency at the exchange rates prevailing on the balance
Timing of revenue recognition
sheet date.
Oxurion recognizes revenue upon delivery of the goods to
Non-monetary assets and liabilities that are measured
the customers as that is the moment the customer obtains
at historical cost in a foreign currency by the Company’s
control over the goods.
entities are translated using the exchange rates at the
dates of the initial transactions.
Transaction price – variable consideration
Gains and losses arising on retranslation using a foreign
The variable consideration is estimated at contrac t
currency are included in the net profit or loss for the period.
inception and constrained until it is highly probable that a
significant revenue reversal in the amount of cumulativ e
Foreign operations
revenue recognized will not occur when the associated
uncertainty with the variable consideration is subsequent-
On consolidation, the assets and liabilities including
ly resolved. The sales prices are fixed in the contract .
goodwill and fair value adjustments arising on consoli-
However, some contracts provide customers with a righ t
dation of the Groups foreign operations are translated at
of return and rebates.
the exchange rates prevailing on the balance sheet date.
Income and expense items are translated at the average
Oxurion accepts returns in certain limited cases, and the y
exchange rates for the period. Exchange rate differences
need to be approved by Oxurion in order to be processe d
arising, if any, are classified as equity and transferred to the
by the distributors. The amount of revenue recognized is
Groups translation reserve. Such translation differences
the amount allocated to the satisfied performance ob-
are recognized as income or expense items in the period
ligation taking into account variable consideration (incl.
in which the operation is disposed of.
expected returns). The estimated amount of variable con-
sideration is included in the transaction price only to th e
78
OXURION ANNUAL REPORT 2022
79
OXURION ANNUAL REPORT 2022
extent that it is highly probable that a significant reversal
in the amount of cumulative revenue recognized will not
occur and is estimated on the basis of historical experi-
ence and the specific terms in the individual agreements.
A liability is recognized for expected sales returns, rebates,
trade and cash discounts, chargebacks or other reimburse-
ments payable directly or indirectly to customers in relation
to sales made until the end of the reporting period. Oxurion
applies the ‘expected value method’ in order to estimate
such return accruals, and related asset.
Oxurion does not offer warranties, customer loyalty point
programs or any material financing component to its
customers. Oxurion has not received any non-cash consid-
eration. There are no costs to acquire customer contracts,
or costs to fulfil the customer contracts. Therefore, contract
balances are only recognized to the extent of accounts re-
ceivable, and refund liability (return accrual).
Royalty revenue on JETREA® sales
In the case of one distributor, royalties are generated
under license agreements based on licensee’s sales of
JETREA® products to the end-customers. As explained
above, revenue from the sale of goods is recognized at
the moment of delivery to the distributor. However, the
agreement stipulates that the royalty is earned once the
distributor subsequently sells the product to the end-cus-
tomer. Therefore, the royalty revenue is recognized once
the product is sold to the end-customer, based on quarterly
invoicing data. There is no specific performance obligation
for Oxurion to satisfy in order to be entitled to this royalty.
Occasional upfront, milestone and other payments
Revenue is only recognized at an amount that reflects the
consideration to which the Group expects to be entitled
in exchange for the satisfied performance obligation. A
performance obligation is satisfied when the control of
goods or services is transferred to a customer. Any upfront
payments or license fees for which there are subsequent
performance obligations, are initially reported as deferred
revenue and are recognized as revenue when perfor-
mance obligations are satisfied over the period of the de-
velopment, collaboration, or manufacturing obligation. We
refer to note 5.8 under key arrangements section ..
( G) RESEARCH GRANTS
On certain specific research projects, the research costs
incurred are partially reimbursed by Flanders Innovation
& Entrepreneurship (Vlaams Instituut Innoveren en
Ondernemen) (“VLAIO”), formerly known as IWT
(Agency for Innovation by Science and Technology in
Flanders – Agentschap voor Innovatie door Wetenschap
en Technologie in Vlaanderen). In line with IAS 20
“Government grants”, these grants are recognized as
government grant income over the term of the project
for which the grant was given when there is reasonable
assurance that the Group will comply with the conditions
attached to them and the grants will be received. Grants
that compensate the Company for expenses incurred are
deducted from the ‘Research and Development Expenses
on a systematic basis in the same period in which the
expenses are incurred.
Oxurion has a track record of more than 10 years with these
types of projects for which it receives grants from VLAIO.
Grants are provided to Oxurion in order to support certain
R&D activities. Activities, related budget, and types of costs
that will be paid are defined in the grant agreement. Over
the course of the project, Oxurion reports on the status of
activities and incurred expenditure to VLAIO on a regular
(quarterly) basis in order to receive grant advances. The
final assessment is performed by VLAIO at the end of
the project in order to determine the final grant amount.
Projects can take on average between two to five years.
Over the course of funded projects, Oxurion is confident
that all activities performed will not deviate from the agreed
scope, and that the final grant amount will not deviate from
the initially agreed amount (except in a limited number o f
cases when Oxurion had finalized the project earlier and did
Where the criteria for capitalization of the development
not spend the whole budget but has still received the grant
expenses are not met, these expenses are recorded as
based on actual expenditure). Overall, Oxurion is confident
incurred during the period.
that the reasonable assurance as defined in the standard
is reached over the course of the project for the amounts
After their initial recording on the statement of financial
spent up to that moment, as the only condition attached
position intangible assets are valued at cost less accumu-
to the grant is to perform R&D activities in line with the
lated depreciation and accumulated impairment losses.
agreed-upon scope and in line with the set budget. There
Amortization of capitalized development costs are recog-
are no other conditions attached to the grants and the
nized in the statement of profit and loss under ‘Research
outcome of R&D activities does not impact the decision
and Development Expenses’. We refer to note 5.6.3 on
of VLAIO whether the final grant will be received or not.
‘Research and Development Expenses’.
(H) INTANGIBLE ASSETS
The capitalized costs of the patent are amortized over the
life of the patent as of the moment that it would generate
Internally generated intangible assets
revenue.
Research costs are charged to statement of profit and loss
Software licenses are amortized over three years.
as incurred.
Externally acquired intangible assets and outsourced
An internally generated intangible fixed asset (see note
R&D costs
5.7.3) which arises from development activities undertak-
en in the Group is recognized only if all of the following
Payments made to third parties for subcontracted R&D,
conditions are met:
where there is no transfer of intellectual property to
Oxurion, are expensed as internal R&D expenses in the
Technical possibility of making the intangible asset
period in which they are incurred. Such payments are only
ready for use.
capitalized if they meet the criteria for recognition of an
The intention is to complete the intangible asset and
internally generated intangible asset, as indicated above.
use or sell it.
Possibility of using or selling the intangible asset.
Oxurion has entered into various contracts for the ac-
It is probable that the intangible asset will generate
quisition of licenses to intellectual property or third-party
future economic benefit or demonstrate the existence
know-how, as disclosed further in note 5.8 under the key
of a market.
arrangements section. These assets are typically acquired
Availability of adequate technical and financial
for consideration including upfront, milestone and royalty
resources to complete the development; and
payments.
Availability to reliably measure the attributed expenses
for the intangible asset during development.
Upfront payments made to third parties to in-license or
acquire intellectual property rights, patents, compounds,
The patent costs for protecting the intangible assets are
products, and know-how technologies to be used in R&D
recognized as an expense.
activities, are capitalized as costs paid for a separately
acquired intangible asset under IAS 38.
80
OXURION ANNUAL REPORT 2022
81
OXURION ANNUAL REPORT 2022
The related milestone payments can only be capi-
talized if they meet the criteria for recognition of an
internally generated intangible asset and is recognized at
the moment the milestone is achieved
Royalties paid/payable for acquired intellectual property
are accrued for in line with the underlying sales and recog-
nized under the cost of sales .
(I) PROPERTY, PLANT AND EQUIPMENT
Property, plant, and equipment are included at the histor-
ical cost (material costs only) less accumulated depreci-
ation and impairment. Subsequent costs are included in
the carrying amount for the asset or booked as a separate
asset as appropriate, but only when it is probable that
future economic benefits associated with the item will be
generated for the Group and the cost price of the item can
be measured reliably. All other repair and maintenance
costs are charged to the statement of profit and loss as
incurred. The cost of assets retired or otherwise disposed
of, and the related accumulated depreciation, are included
in the statement of profit and loss as part of the gain or
loss on disposal in the year of disposal. Gains and losses
on disposal of property, plant and equipment are included
in other income or expense.
Depreciation is calculated using the straight-line method to
allocate the cost of property, plant and equipment to their
estimated residual values over their estimated useful lives
as follows:
Property, plant and equipment: three to five years
Furniture and fittings: three to five years
The depreciation methods, useful life and residual value
are revalued on each reporting date.
We refer to the notes 5.6.3 until 5.6.5 for the disclosures
of where the depreciation charges are recognized in the
statement of profit and loss.
Subsequent costs
The cost of replacing part of an item of property, plant
and equipment is recognized in the carrying amount of
the item if it is probable that the future economic benefits
embodied within the item replaced will flow to the Group
and its cost can be measured reliably. The carrying amount
of the replaced item is derecognized. The costs of the day-
to-day servicing of property, plant and equipment are rec-
ognized in profit or loss as incurred .
(J) LEASED ASSETS
IFRS 16
The Group leases an office, copiers, and cars. Rental
contracts are typically made for fixed periods of 3 to 4
years but may have extension options as described below.
Lease terms are negotiated on an individual basis and
contain a wide range of different terms and conditions.
The lease agreements do not impose any covenants, but
leased assets may not be used as security for borrowing
purposes.
Leases are recognized as right-of-use assets and a cor-
responding liability at the date at which the leased asset
is available for use by the Group. Each lease payment
is allocated between the liability and finance cost. The
finance cost is charged to profit or loss over the lease
period so as to produce a constant periodic rate of interest
on the remaining balance of the liability for each period.
The right-of-use asset is depreciated over the shorter of
these asset’s useful life and the lease term on a straight-
line basis .
Assets and liabilities arising from a lease are initially
measured on a present value basis. Lease liabilities are
exclusively composed of fixed payments less any lease
incentives receivable .
The lease payments are discounted using the lessee’s in-
there are separately identifiable cash flows (cash-generat-
cremental borrowing rate, being the rate that the lessee
ing units). The impairment loss is allocated first to reduce
would have to pay to borrow the funds necessary to obtain
the carrying amount of any goodwill allocated to the
an asset of similar value in a similar economic environ-
cash-generating unit pro rata to the carrying amount of
ment with similar terms and conditions.
each asset in the unit. An impairment loss recognized for
goodwill cannot be reversed in a subsequent period. For
Right-of-use assets are measured at cost comprising the
assets other than goodwill, where an impairment loss is
amount of the initial measurement of the lease liability and
subsequently reversed, the carrying amount of the asset
any lease payments made at or before the commence-
(cash-generating unit) is increased to the revised estimate
ment date.
of its recoverable value, but in such a way that the increased
carrying amount does not exceed the carrying amount
Payments associated with short-term leases and leases of
that would have been determined had no impairment loss
low-value assets are recognized on a straight-line basis as
been included for the asset (cash-generating unit) in prior
an expense in profit or loss. Short-term leases comprise
years. The reversal of an impairment loss is included im-
some car leases and are leases with a lease term of twelve
mediately in the statement of profit and loss.
months or less. Low-value assets only comprise of one
copier.
(L) INCOME TAXES
We refer to note 5.7.2 for more information.
Income tax expenses in the statement of profit and loss
comprise the tax currently payable.
(K) IMPAIRMENT LOSSES ON GOODWILL,
INTANGIBLE ASSETS AND PROPERTY,
The tax currently payable is based on taxable profit for
PLANT AND EQUIPMENT
the year. Taxable profit differs from net profit as reported
on the statement of profit and loss because it excludes
Intangible assets with an indefinite useful life or not yet
items of income or expense that are taxable or deductible
available for use and goodwill are not subject to amortiza-
in other years, and it further excludes items that are never
tion but are tested annually for impairment or if there is an
taxable or deductible. The Groups liability for current tax
indication that an asset may be impaired.
is calculated using tax rates that have been enacted or
substantially enacted on the reporting date.
Assets that are subject to amortization or depreciation are
reviewed for impairment whenever events or changes in
Deferred tax is the tax expected to be payable or recov-
circumstances indicate that the carrying amount may not
erable on differences between the carrying amounts of
be recoverable.
assets and liabilities in the financial statements and the
corresponding tax bases used in the computation of
An impairment loss is recognized for the amount by which
taxable profit and is accounted for using the balance sheet
the carrying amount of the asset exceeds its recoverable
method.
amount. The recoverable amount is the higher of an asset’s
fair value less the costs to sell the asset and its value in use.
Deferred tax liabilities are generally recognized for all
These values are generally determined based on discount-
taxable temporary differences. Deferred tax assets are rec-
ed cash flow calculations. For the purpose of assessing im-
ognized to the extent that it is probable that taxable profits
pairment, assets are grouped at the lowest levels for which
will be available against which deductible temporary
82
OXURION ANNUAL REPORT 2022
83
OXURION ANNUAL REPORT 2022
differences can be utilized. Such assets and liabilities are
not recognized if the temporary difference arises from
goodwill (or negative goodwill) or from the initial recogni-
tion (other than in a business combination) of other assets
and liabilities in a transaction that affects neither the tax
profit nor the accounting profit.
Deferred tax liabilities are recognized for taxable temporary
differences arising on investments in subsidiaries and as-
sociates, and interests in joint ventures, except where the
Group is able to control the reversal of the temporary dif-
ference and it is probable that the temporary difference
will not reverse in the foreseeable future.
Deferred tax is calculated at the tax rates that are expected
to apply in the period when the liability is settled, or the
asset realized. Deferred tax is charged or credited in the
statement of profit and loss, except when it relates to items
charged or credited directly to equity, in which case the
deferred tax is also dealt with in equity.
Deferred tax assets and liabilities are offset when they
relate to income taxes levied by the same taxation authority
and the Group intends to settle its current tax assets and
liabilities on a net basis .
The Group also receives tax credits for R&D expenses.
These R&D expenses are recorded through P&L under
IFRS in the line item ‘Research and development expenses
as the expenses do not meet the requirements in IAS 38
to be capitalized. The tax credit is not subject to unfulfilled
conditions. In case there is insufficient tax against which
to set off the tax credit, the credit can be carried forward
during 5 consecutive assessment years. The tax credit re-
ceivable is presented for the non-current portion in the line
item ‘Non-current tax credit’ and for the current portion in
the line item ‘Current tax receivables’ of the consolidated
statement of financial position. At the end of 5 consecu-
tive assessment years, the balance of the unused tax credit
is received in cash from the government. The income
from those tax credits is included in the line item ‘Other
operating income’ in the statement of profit and loss .
(M) EMPLOYEE BENEFIT PLAN
Short-term employee benefits
Liabilities for wages and salaries that are expected to be
settled wholly within twelve months after the end of the
period in which the employees render the related service
are recognized in respect of employees’ services up to
the end of the reporting period and are measured at
the amounts expected to be paid when the liabilities are
settled. The liabilities are presented as current employee
benefit obligations in the statement of financial position.
Pension benefits
Starting July 1, 2009, the Group changed the defined
benefit pension plan into a new defined contribution
pension plan. All acquired rights up to June 30, 2009, are
retained. Therefore, the Group has two pension plans: (i)
the initial defined benefit plan and (ii) the pension plan,
which is a defined contribution plan in structure.
The assets of both plans are held in separate trustee-ad-
ministered funds.
According to the Belgian legislation applicable to the
second pillar pension plans (the minimum guaranteed
return under the so-called “Law Vandenbroucke”), all
Belgian pension plans that are structured as defined con-
tribution plans are considered defined benefit plans under
IFRS and therefore are accounted for as such.
Because of this minimum guaranteed return, the employer
is exposed to a financial risk since further contributions
could be required if the return on the assets is not suffi-
cient to reach the minimum benefits to be paid.
The Groups commitments under defined benefit plans,
and the related costs, are measured using the “projected
unit credit method” with actuarial valuations being carried
out at each balance sheet date by a qualified actuary. Past
service cost is included immediately to the extent that the
benefits are already vested, and otherwise the service is
of the revision of original estimates, if any, in the statement
amortized on a straight-line basis over the average period
of profit and loss, and a corresponding adjustment to equity
until the benefits become vested. Remeasurements of the
over the remaining vesting period. The proceeds received, net
net defined obligation are recognized directly within equity.
of any directly attributable transaction costs, are credited to
share capital (nominal value) and share premium when the
The retirement benefit obligation recognized in the
subscription rights are exercised.
statement of financial position represents the fair value of
plan assets at the reporting date, less plan liabilities calcu-
(N) FINANCIAL INSTRUMENTS
lated using the projected unit credit method discounted
to its present value using yields available on high quality
Financial assets
corporate bonds that have maturity dates approximating
to the terms of the liabilities and are denominated in the
INITIAL RECOGNITION AND MEASUREMENT
same currency as the post-employment benefit obliga-
Financial assets are classified, at initial recognition, and subse-
tions less the effect of minimum funding requirements
quently measured, at either amortized cost, fair value through
agreed with scheme trustees.
other comprehensive income (“OCI) or fair value through
profit or loss.
No other long- or short-term benefits are granted to
employees.
The classification of financial assets at initial recognition
depends on the financial asset’s contractual cash flow char-
Share-based compensation
acteristics and the Company’s business model for managing
them. With the exception of trade receivables that do not
The Group operates equity-settled, share-based compensa-
contain a significant financing component, the Company
tion plans through which it grants share subscription rights
initially measures a financial asset at its fair value plus, in the
(giving the holder the right to subscribe to a specific number
case of a financial asset not at fair value through profit or loss,
of shares in accordance with the share option plan, hereafter
transaction costs.
referred to as ‘subscription rights’) to the CEO, personnel,
and consultants as consideration in exchange for services
Trade receivables that do not contain a significant financing
performed. The fair value of the services received in exchange
component are measured initially at the transaction price de-
for the granting of the subscription rights is recognized as
termined under IFRS 15.
an expense over the vesting period with a corresponding
increase in equity.
In order for a financial asset to be classified and measured
at amortized cost or fair value through OCI, it needs to give
The total amount to be expensed over the vesting period
rise to cash flows that are ‘solely payments of principal and
is determined by reference to the fair value at the date on
interest’ (“SPPI) on the principal amount outstanding. This
which the subscription rights are granted, measured using
assessment is referred to as the SPPI test and is performed
the Black & Scholes model, taking into account the term and
at an instrument level.
conditions upon which the subscription rights were granted
excluding the impact of any non-market vesting conditions. At
The Company’s business model for managing financial
each balance sheet date, the entity revises its estimates of the
assets refers to how it manages its financial assets in order
number of subscription rights that are expected to become
to generate cash flows. The business model determines
exercisable except where forfeiture is only due to shares not
whether cash flows will result from collecting contractual cash
achieving the threshold for vesting. It recognizes the impact
flows, selling the financial assets, or both .
84
OXURION ANNUAL REPORT 2022
85
OXURION ANNUAL REPORT 2022
SUBSEQUENT MEASUREMENT
For purposes of subsequent measurement, the following cat-
egories of financial assets are relevant to the Company:
Financial assets at amortized costs (trade receivables,
term deposits); and
Financial assets at fair value through OCI (investments in
debt instruments (bonds)).
FINANCIAL ASSETS AT AMORTIZED COST
This category is the most relevant to the Company. The
Company measures financial assets at amortized cost if both
of the following conditions are met:
The financial asset is held within a business model with
the objective to hold financial assets in order to collect
contractual cash flows; and
The contractual terms of the financial asset give rise on
specified dates to cash flows that are solely payments of
principal and interest on the principal amount outstanding.
Financial assets at amortized cost are subsequently measured
using the effective interest rate (“EIR”) method and are subject
to impairment. Gains and losses are recognized in profit or
loss when the asset is derecognized, modified or impaired.
The Company’s financial assets at amortized cost mainly
includes trade receivables and term deposits .
FINANCIAL ASSETS THROUGH OCI (DEBT INSTRUMENTS)
The Company measures debt instruments at fair value
through OCI if both of the following conditions are met:
The financial asset is held within a business model with
the objective of both holding to collect contractual cash
flows and selling; and
The contractual terms of the financial asset give rise on
specified dates to cash flows that are solely payments of
principal and interest on the principal amount outstanding.
For debt instruments at fair value through OCI, interest
income, foreign exchange revaluation and impairment losses
or reversals are recognized in the statement of profit or loss
and computed in the same manner as for financial assets
measured at amortized cost. The remaining fair value changes
are recognized in OCI. Upon derecognition, the cumulative fair
value change recognized in OCI is recycled to profit or loss.
The Company’s debt instruments at fair value through OCI
includes investments in quoted debt instruments (bonds).
DERECOGNITION
A financial asset (or, where applicable, a part of a financial
asset or part of a group of similar financial assets) is primarily
derecognized (i.e., removed from the Company’s consolidated
statement of financial position) when:
The rights to receive cash flows from the asset have
expired; or
The Company has transferred its rights to receive cash
flows from the asset or has assumed an obligation to
pay the received cash flows in full without material delay
to a third party under a ‘pass-through’ arrangement and
either (a) the Company has transferred substantially all
the risks and rewards of the asset, or (b) the Company
has neither transferred nor retained substantially all the
risks and rewards of the asset but has transferred control
of the asset.
I MPAIRMENT OF FINANCIAL ASSETS
The Company recognizes an allowance for expected credit
losses (“ECLs) for all debt instruments not held at fair value
through profit or loss. ECLs are based on the difference
between the contractual cash flows due in accordance with
the contract and all the cash flows that the Company expects
to receive, discounted at an approximation of the original
effective interest rate. The expected cash flows will include
cash flows from the sale of collateral held or other credit en-
hancements that are integral to the contractual terms .
For trade receivables and term deposits, the Company applies
INITIAL RECOGNITION AND MEASUREMENT
a simplified approach in calculating ECLs. Therefore, the
Financial liabilities are classified, at initial recognition, at fair
Company does not track changes in credit risk, but instead
value through profit or loss, loans and borrowings, payables,
recognizes a loss allowance based on lifetime ECLs at each
or as derivatives designated as hedging instruments in an
reporting date.
effective hedge, as appropriate. All financial liabilities are
recognized initially at fair value and, in the case of loans
Upon impairment, the carrying amount of the financial assets
and borrowings and payables, net of directly attributable
is directly reduced by the impairment loss, with the exception
transaction costs.
of trade receivables. For trade receivables, the carrying amount
is reduced by means of a separate impairment account. If a
The Company’s financial liabilities include trade and other
trade receivable is considered uncollectible, it is written off in
payables and convertible loans.
the impairment account. Subsequent collection of amounts
that had previously been written off is credited in the impair-
SUBSEQUENT MEASUREMENT
ment account. Modifications in the carrying amount of the
impairment account are recognized in the statement of profit
For purposes of subsequent measurement, financial liabili-
and loss.
ties are classified in two categories:
CASH AND CASH EQUIVALENTS
Financial liabilities at fair value through profit or loss
Financial liabilities at amortized cost (loans and
Cash and cash equivalents comprise demand deposits
borrowings)
and other short-term, highly liquid investments (with less
than three months to maturity) that are readily convertible
Financial liabilities at fair value through profit and loss
into a known amount of cash and are subject to an insig-
include financial liabilities designated upon initial recogni-
nificant risk of fluctuations in value .
tion as at fair value through profit or loss and only if the
criteria in IFRS 9 are satisfied. The Group has designated
Financial liabilities
convertible loans at fair value through profit and loss, since
the convertible loans contain embedded derivatives for
DISTINCTION BETWEEN FINANCIAL LIABILITIES
which assessment of whether it is required to separate the
AND EQUITY
embedded derivative from the host contract to measure
Financial liabilities and equity instruments issued by the Group
the derivative at fair value, would be more complex or
are classified according to the substance of the contractual
result in less reliable measures than measuring the entire
arrangements entered into and the definitions of a financial
instrument at fair value through profit or loss As such the
liability and an equity instrument. An equity instrument is any
conditions in IFRS 9 4.3.5 are met and designation at fair
contract that evidences a residual interest in the assets of the
value through profit or loss is permitted.
Group after deducting all its liabilities. The accounting policies
adopted for specific financial liabilities and equity instruments
The convertible loans are measured at fair value through
are set out below.
profit or loss, using the valuation methods described in
note 5.7.11. Transaction costs in relation to these financial
liabilities at fair value through profit or loss are expensed as
incurred and included in the line item ‘Finance expense’ in
the consolidated statement of profit and los s.
86
OXURION ANNUAL REPORT 2022
87
OXURION ANNUAL REPORT 2022
Trade and other payables are subsequently measured at
amortized cost, using the effective interest rate metho d .
(O) EQUITY INSTRUMENTS
Equity instruments issued by the Group are recorded at
the proceeds received. Direct issue costs are processed as
a deduction on equity.
(P) FINANCIAL INCOME AND EXPENSES
Financial income includes interest income on invested
funds. Realized and unrealized exchange differences are
reported under financial income and expenses.
(Q) SEGMENT REPORTING
An operational segment is a component of an entity:
which exercises operating activities with which profits
are gained and costs can be made (including profits
and costs from transactions with other components of
the entity);
where the operational results are judged regularly by
the highest managerial function of the entity who can
take important operational decisions in order to make
decisions regarding the granting of resources and to
evaluate the financial results of the segment (chief
operating decision maker); and
for which separate financial information is available and
that is engaged either in providing specific products or
services (business segment), or in providing products
or services within a particular economic environment
(geographical segment), and which is subject to risks
and rewards that are different from those of other
segments.
The segment information is represented in a consistent
manner regarding the internal reporting to the chief
operating decision maker of the entity, i.e., the institu-
tion which takes the most important decisions, enabling
decision-making of allocating resources to the segment
and evaluating financial performances of the segment.
At this moment, reporting is being done at a global level
within Oxurion.
( R) INVENTORIES
Raw and ancillary materials and commodities are stated
at the lower of cost or net realizable value. The inventory
costing system is based on the FIFO-method.
Goods in process and finished goods are stated at the
standard manufacturing cost or net realizable value. The
inventory costing system is based on the FIFO-method.
The net realizable value test is performed for each reporting
period. Net realizable value is the estimated selling price in
the ordinary course of business less the estimated costs
of completion and the estimated costs necessary to make
the sale.
The standard manufacturing price of the goods in process
and of the finished goods, includes (i) the acquisition
value of the raw materials, (ii) consumables and ancillary
materials, (iii) the production costs that are directly attrib-
utable to the product, and (iv) the proportioned part of the
production costs that are only indirectly attributable to the
product, in so far that these costs cover the normal pro-
duction period.
The standard manufacturing price is compared to the
actual manufacturing price on an annual basis, and adjust-
ments are made to the value of the inventory.
Impairment losses are calculated on the goods in-process,
if their manufacturing cost, increased with the estimated
amount of the costs to be incurred is higher than the net
sales price at year-end .
Impairment losses on inventories are analyzed on a case-
As the net-assets of the Company are below 61,500 euro
by-case basis if the net realizable value is lower than the
(the statutory minimum amount of share capital of a
cost. The calculation of the net realizable value takes into
Belgian public limited liability company), in accordance with
account the specific characteristics of the inventories,
article 7:229 of the BCCA, each interested party is entitled
including the due date and if there are indications of a low
to request the competent commercial court to dissolve the
rotation.
Company. In such instance the court may order the disso-
lution of the Company or grant a grace period within which
the Company is allowed to remedy the situation.
5.5.4 Main accounting estimates,
assumptions and judgments
Based on the above, the Board of Directors considers it
may be reasonable to expect that there will be sufficient
Reporting the financial statements in accordance with IFRS
cash to continue its operations during the next twelve
requires management to rely on estimates, assumptions and
months, and therefore decided to continue its valuation
judgments that impact the amounts reported under assets
rules under the assumption of going concern. However,
and liabilities, the notes on the latent assets and liabilities on the
there is a material uncertainty relating to going concern
date of the financial statements, and the reported amounts of
of the Group because it is uncertain that the above-men-
income and expenditure in the course of the reporting period.
tioned committed but conditional funding will be available
The actual results may differ from these estimates.
when needed given the conditions related to the funding,
and because it is not certain whether the Group will be
The main assumptions relating to future developments and
able to timely obtain the necessary additional funding
the main sources of uncertainty regarding estimates on the
through debt, equity or non-dilutive funding, partnering or
reporting date are set out below:
to realize sufficient cost and investment reductions.
Going Concern - material uncertainty
Convertible loans
The consolidated financial statements were prepared on a
The Group has convertible loans with Negma and Kreos
going concern basis.
Capital / Pontifax Ventures. The convertible loans are
measured at fair value through profit and loss. In deter-
The Groups cash balance at December 31, 2022, of 3.6
mining the fair value, the Group makes certain judgments
million euro is not sufficient to fund the Groups operations
on the valuation model to be applied and the probability
during the next twelve months. However, post-closing, the
that certain scenarios will occur or not in the future. The
Group entered into the Atlas Subscription Agreement.
terms and conditions and further information is provided
This committed but conditional funding would be sufficient
in note 5.7.11.
to fund operations during the next twelve months from the
financial statement’s issue date. However, given the contin-
Revenue from Contracts with Customers
gent nature of this funding, the Group is actively exploring
the possibility of obtaining additional funding through debt,
Under the five-step model established by the IFRS 15
equity, or non-dilutive funding, including the licensing of
standard, the Groups main estimates and assessments relate
THR-149, or alternatively reducing its costs and invest-
to identifying the performance obligations under its contracts
ments so that there should be sufficient cash to continue
and allocating the transaction price according to the stand-
its operations during the next twelve months.
alone price of each of the performance obligations.
88
OXURION ANNUAL REPORT 2022
89
OXURION ANNUAL REPORT 2022
The majority of the Company’s sources of revenue are
derived from sales of JETREA® vials through our worldwide
license agreement with Inceptua and the tripartite agreement
with Eumedica. The Group has determined that there is
only one performance obligation for all contracts in place
with customers, that is to deliver the JETREA® product to
the customer. Therefore, the transaction price is equal to the
stand-alone selling price of each vial.
STEP REVENUE FROM SALE OF VIALS
Oxurion has a contract in place
with Inceptua and Eumedica for
1. Identification of the contract the commercialization of JETREA®
as disclosed in Note 5.8 under Key
Agreements.
2. Identification of performance In all distribution contracts, there is
obligations only one performance obligation:
supply of goods to a third party.
3. Identification of the transaction price Stand-alone price per vial is defined
in each agreement with the customer.
As there is only one performance
4. Allocation of the transaction price obligation, there is no allocation of the
price, and therefore stand-alone price
per vial is recognized.
Revenue is recognized upon delivery
to the customer. Returns are credited
strictly at discretion of Oxurion, and
5. Revenue recognition a provision for US returns is made
based on historical data. Rebate
provisions for sales made outside the
US, are made based on contractual
agreements and/or local regulations.
Share-based payment plans
The Group defines the cost of share-based payment plans
on the basis of the fair value of the equity instrument on
the grant date. Determining the fair value involves choosing
the most suitable valuation model for these equity instru-
ments, and the characteristics of the equity instrument and
its issue have a decisive impact. It also assumes the input
in the valuation model of a number of relevant assump-
tions, such as the estimated useful life of the right, volatility,
etc. The assessments and the model are specified in more
detail in note 5.7.8.
Capitalization and impairment of intangible assets
The Group accounts for as intangible assets only rights
and intellectual property if acquired from third parties and
costs of internal development only if the conditions for the
recognition of intangible assets are met, otherwise such
costs are included in the statement of profit and loss when
they arise. The costs are capitalized only if the product is in
Phase 3 and the chances of future success are estimated
as highly probable. Accounting estimates and assess-
ments of future business evolution, growth, sales, likelihood
of success and discount rate are factors used in valuing
the intangible asset to execute the annual impairment test.
Taxes
The Group considers that there is a considerable uncer-
tainty regarding the future use of the tax losses of Oxurion
as it is very difficult to estimate the impact of the patent
deduction on the future tax result at this moment. As the
Group can only use the abovementioned patent deduction
on the basis of a tax ruling, the expectation exists that the
future tax gains will be rather limited. There is also the un-
certainty regarding the future use of the tax losses with
ThromboGenic s .
5.5.5 Segment information
Segment information is represented in a consistent
manner regarding the internal reporting to the chief
operating decision maker of the entity, i.e., the person or
persons that takes the most important decisions, enabling
decision-making of allocating resources to the segment
and evaluating financial performances of the segment. At
this moment, reporting is being done at global level within
Oxurion .
5.5.5.1 Product sales information
5.5.6 Financial instruments
Product sales relate only to JETREA® and are reported in
The Company has the following financial instruments
note 5.6.1.
measured at amortized cost: trade receivables, cash and
cash equivalents, investments, trade payables, lease liabili-
5.5.5.2 Geographic information
ties and other short term liabilities.
The Global R&D, Clinical Operations and most of the
As of December 31, 2022, the majority of cash and cash
General and Administrative functions are located in
equivalents are cash at banks available on demand.
Leuven, Belgium. These operations represent approxi-
mately 95% of the operating result. In the context of the
Besides these financial instruments, the Company also
Company’s business, these activities do not lead to the
issued convertible bonds measured at fair value through
need for geographic information.
profit and los since 2021 with two parties as described in
note 5.7.11.
100% of intangible assets and almost all non-current
assets are located in Belgium.
Financial assets and financial liabilities are included in the
Groups statement of financial position when the Group
becomes a party to the contractual provisions of the
5.5.5.3 Business unit reporting
instrument.
Oxurion is a biotechnology company with focus on
Fair Values
diseases related to the retina.
There is no significant difference between the fair value
Our molecules, ocriplasmin on the market with brand
and carrying amount of the Groups cash and cash equiv-
name JETREA®, the plasma kallikrein inhibitor in a Phase
alents, investments, trade and other receivables, other
2 clinical trial and the pan-RGD integrin inhibitor which is
current assets, trade payables and other current liabilities.
currently on hold, represent more than 95% of the income
and expenses of the Company. As a consequence, the
The carrying amount of cash and cash equivalents and
consolidated statement of profit and loss and of financial
investments is equal to their fair value, given the short-
position are a valid representation of its business unit as a
term maturity of these financial instruments. Similarly, the
whole.
carrying amounts of receivables and payables, which are
all subject to normal trade credit terms, are equivalent to
5.5.5.4 Information about major customers
their fair values. Investments in bonds are measured at
fair value based on quoted market prices. The fair value
Oxurion has one customer that individually accounts for
movements are recorded in OCI.
more than 74% of the total income at the end of 2022
(2021: 73%).
The class A Negma convertible loan is measured at fair
value as the nominal amount of the convertible loan plus
8%, which is the difference between the share price and
the 92% of the lowest closing VWAP (8%) (level 1). The
90
OXURION ANNUAL REPORT 2022
91
OXURION ANNUAL REPORT 2022
class B Negma convertible loan is measured at fair value
as the nominal amount of the convertible loan plus 20%,
which is the difference between the share prices and 80%
of the closing VWAP (20%) (level 1).
The Kreos Capital / Pontifax Ventures convertible loan
is measured at fair value whereby fair value is estimated
considering probabilities of the occurrence of different
scenarios. The probabilities are estimated by the Group
and consist level 3 fair value assessments. A reasonable
change of the probabilities between the different scenarios
would not lead to a material change in the fair value .
5.5.7 Financial risk management
The financial department of the parent Company coor-
dinates access to the national and international financial
markets and considers and manages the financial risks
relating to the activities of the Group. The financial risks
related to the operating activities of the Group are confined
to a minimal currency exchange rate risk. There are no
risks worth mentioning, such as liquidity risks or interest
rate risks as the Group has no debts with variable interest
rates. The Group does not buy or trade in financial instru-
ments for speculative purposes.
(A) CAPITAL MANAGEMENT
The Group manages its capital with the aim of ensuring
that the Group can continue to operate. At the same
time, the Group wishes to generate a return for its stake-
holders via the results of its research activities, which in
turn are expected to lead to an increase in the value of
the Company’s shares. This strategy has not changed
compared to previous years.
The capital structure of the Group consists of investments,
cash, cash equivalents and restricted cash, and equity at-
tributable to the equity holders of the Company, including
capital, reserves and results carried over, as indicated in
notes 5.7.7 and 5.7.8 respectively.
The Group manages its capital structure and makes the
necessary adjustments in light of changes in economic
circumstances, the risk characteristics of the underlying
assets and the projected cash requirements of current
research activities. When assessing the capital structure,
the current cash position and projected cash burn are used
as the key parameters. Cash burn is defined as the net
result corrected for depreciation and amortization, stock-
based compensation, and less investments in fixed assets.
The Group wishes to maintain a capital structure that is
sufficient to fund research activities during a period of at
least twelve months. Any cash inflows from possible coop-
eration agreements or other cash generating activities are
not taken into account. To maintain the capital structure,
the Group can issue new shares or conclude new
(B) MAIN ACCOUNTING PRINCIPLES
Details of the main accounting principles and methods,
including the inclusion criteria, the valuation basis, and the
basis on which income and costs are recognized, for each
category of financial assets, liabilities, and equity instru-
ments, are explained under 5.5.3.
(C) CATEGORIES OF FINANCIAL
INSTRUMENTS
The financial instruments currently held by the Company
are:
Trade receivables and payables
Short-term financial liabilities
Cash, cash equivalents and investments (we refer to
note 5.7.6) amounting to 3.6 million euro (2021: 10.0
million euro). Investments are mainly in very low risk
bonds and term investments.
Convertible bonds (we refer to note 5.5.6 )
92
OXURION ANNUAL REPORT 2022
(D) MARKET RISK
The Groups activities are such that the Groups income is
exposed to financial risks arising from currency exchange
rate fluctuations because a substantial proportion of
the research expenditure is invoiced in USD and pound
sterling (GBP). The Group tries to compensate the inflows
and outflows in foreign currenc y.
Analysis of sensitivity to exchange rates
The Group is mainly exposed to fluctuations in GBP and
USD against the euro.
The sensitivity of loss to changes in the exchange rates
arises mainly from USD and GBP denominated financial
instruments.
N '000 EURO
IMPACT ON PAST TAX LOSS
2022
2021
USD/euro exchange rate increase 10%
163
-339
USD/euro exchange rate decrease 10%
-200
415
GBP/euro exchange rate increase 10%
7
6
GBP/euro exchange rate decrease 10%
-9
- 7
(E) INTEREST RISK MANAGEMENT
At the moment, the Group has external debt financing
with a fixed interest rate. The Group does not have any
contracts with a variable interest rate. Consequently, there
is currently no need for a specific interest risk manage-
ment policy in the Group.
(F) CREDIT RISK MANAGEMENT
Credit risk relates to the risk that a counterparty will fail to
fulfil their contractual obligations with the result that the
Group would suffer a loss. The Groups policy focuses on
only working with credit-worthy counterparties and, where
necessary, requiring adequate securities. Information about
the creditworthiness of counterparties is provided by inde-
pendent ratings agencies and, if this is not available, the
Group uses information that is publicly available as well
as its own internal records. Credit risk is managed by the
financial department of Oxurion by means of individual
follow-up of credit per counterparty.
The Group has a limited number of customers. Credit
risk is considered as remote due to a history of no issues
with payment collection. So far, the collection of payments
happened without any delay and with limited credit risk.
The credit risk on cash investments is limited given that the
counterparties are banks with high credit scores attributed
by international rating agencies .
93
OXURION ANNUAL REPORT 2022
(G) LIQUIDITY RISK MANAGEMENT
The Group manages its liquidity risk by ensuring adequate
reserves and by constantly checking the projected and
actual cash flows. At the moment, the Group is not subject
to any substantial liquidity risk.
Contractual undiscounted maturities of financial liabilities
at December 31, 2021 and 2022 are as follows:
IN '000 EURO (AS AT
LESS THAN 6 MONTHS
6 - 12 MONTHS
BETWEEN 1 AND 2 YEARS
BETWEEN 2 AND 5 YEARS
OVER 5 YEARS
TOTAL
31 DECEMBER 2021)
Lease liabilities
162
59
30
15
0
266
Convertible loans
300
1,910
4,464
5,187
0
11,861
Trade payables
4,979
0
0
0
0
4,979
Other short-term liabilities
628
0
0
0
0
628
Total financial liabilities
6,069
1,969
4,494
5,202
0
17,734
94
OXURION ANNUAL REPORT 2022
IN '000 EURO (AS AT
31 DECEMBER 2022)
LESS THAN 6 MONTHS 6 - 12 MONTHS BETWEEN 1 AND 2 YEARS BETWEEN 2 AND 5 YEARS OVER 5 YEARS TOTAL
Lease liabilities 88 78 144 389 394 1,093
Convertible loans 1,728 1,728 3,456 541 0 7,453
Trade payables 5,040 0 0 0 0 5,040
Other short-term liabilities 2,813 0 0 0 0 2,813
Total financial liabilities 9,669 1,806 3,600 930 394 16,399
5.5.8 Remuneration of Key
Management Personnel
Key management personnel were constituted in 2022 of:
Tom Graney – CEO
The key management personnel constitute the CEO as
per Company’s corporate chapter.
Remuneration of key management personnel was as
follows:
IN '000 EURO (EXCEPT FOR THE NUMBER OF STOCK
2022
2021
OPTIONS) (AS AT 31 DECEMBER)
Short-term benefits - consultancy fees / salary
562
652
Termination benefits
0
159
Cost of stock options granted in the year
0
662
Number of stock options granted in the year
0
600,000
No loans, quasi-loans or other guarantees have been given
to any of the executive directors .
5.5.9 COVID-19 impact and Russia’s
invasion of Ukraine
Covid-19 Impact
In 2022, the global covid-19 situation improved consider-
ably allowing business to be carried out in normal condi-
tions again.
Russias invasion of Ukraine
Russias invasion of Ukraine and sanctions towards Russia
does not have direct impact on Oxurions business as the
company has no direct relations with Russia, nor with
Ukraine.
95
OXURION ANNUAL REPORT 2022
5.6 NOTES TO THE CONSOLIDATED
STATEMENT OF PROFIT AND LOSS
5.6.1 Income
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Sales
442
967
Income from royalties
153
161
Total revenue
595
1,128
In 2020, Oxurion entered into a global license agreement with
Inceptua for the commercialization of JETREA®.
In 2022, Oxurion JETREA® sales amounted to 0.4 million euro
out of which 91% is attributed to Belgium and the remaining
to other countries. In 2021, Oxurion JETREA® sales amounted
to 1.0 million euro out of which 61% was attributed to Belgium
and the remaining to other countries.
For further details we refer to the Key Agreements’ section as
disclosed in note 5.8.
5.6.2 Cost of sales
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
License rights on sales
-46
-48
Cost of goods
-467
-564
Total cost of sales
-513
-612
The license rights on sales include the royalties that Oxurion
owes to the companies RCT and LSRP on the basis of
JETREA® sales.
5.6.3 Research and development expenses
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Employee benefits
-3,231
-5,900
Subcontracted R&D activities
-10,668
-11,451
Reagents and materials
-88
-419
Patent expenses
-107
-279
Consultancy fees
-1,246
-1,984
Other
-389
-260
Depreciation and amortization
-307
-584
Government grants
3
84
Income from recharge of costs
47
97
Total research and development expenses
-15,986
-20,696
The decrease in employee benefits in 2022 compared to
2021 is mainly the result of the decision of the Company
taken in 2021 to reduce the headcount to focus on its clinical
assets, hence the severance attributable to these reductions
were included in 2021.
The subcontracted R&D activities relate to the outsourced
services used to develop Oxurion’s projects in the preclinical
and clinical phase. The costs in 2021 and 2022 are mainly
the cost related to the THR-149 and THR-687 clinical studies.
In 2022, other expenses were 0.4 million euro compared to
0.3 million euro in 2021.
The government grants are grants received from the VLAIO,
formerly known as IWT. Oxurion currently has no grant
agreement with VLAIO. These grants are provided to Oxurion
to support certain R&D activities. We refer to the accounting
policy in note 5.5.3.
Over the course of the project, Oxurion reports on the status of
activities and incurred expenditure to VLAIO on a regular basis
to receive grant advances. As such Oxurion and VLAIO follow
up over the course of the projects that all activities performed
will not deviate from the agreed scope and that the final grant
amount will not deviate from the initially agreed amounts.
Overall, Oxurion is confident that the reasonable assurance
as defined in the standard is reached over the course of the
project for the amounts spent up to that moment, as the only
condition attached to the grant is
to perform R&D activities in
96
OXURION ANNUAL REPORT 2022
l ine with the agreed-upon scope and in line with the set budget
and maintain a presence in the same region. There are no
other conditions attached to the grants and the outcome of
R&D activities does not impact the decision of VLAIO whether
the final grant will be received or not.
Government grants that compensate the Company for
expenses incurred and income from the recharge of costs are
deducted from the research and development expenses on
a systematic basis in the same period in which the expenses
are incurred .
5.6.4 General and administrative expenses
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Employee benefits
-1,753
-2,653
Consultancy fees
-3,141
-3,470
Insurance
-361
-343
Other
-692
-622
Depreciation and amortization
-33
-62
Total general and administrative expenses
-5,980
-7,150
The most important piece of the general and administra-
tive expenses are ICT contractors, management, audit fees,
Board of Directors’ fees, investor relations contractors, legal
and funding fees and HR services.
5.6.5 Selling expenses
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Employee benefits
-608
-975
Distribution costs
-68
-91
Contractor and consultancy fees
-241
-296
Other
-183
-116
Depreciation and amortization
-15
-31
Income from recharge of costs
223
235
Total selling expenses
-892
-1,274
In 2022, the selling expenses of Oxurion were 0.9 million
euro compared to 1.3 million euro in 2021. The decrease is
mainly a continuing effect of the outlicensing of JETREA®
to Inceptua.
5.6.6 Other operating income
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Other operating income
830
1,245
Total other operating income
830
1,245
In 2022, Oxurion received other operating income of 0.8
million euro compared to 1.2 million euro in 2021. The accrued
tax credit amounts to 0.6 million euro in 2022 compared to
0.9 million euro in 2021 .
5.6.7 Finance income
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Interest
9
9
Fair value adjustment convertible bonds
436
0
Exchange rate gain (on USD and GBP)
194
162
Total finance income
639
171
As a result of USD revaluations, the unrealized exchange
gain in 2022 amounted to 0.177 million euro (2021: 0.146
million euro) whereas 0.017 million euro exchange gains were
realized (2021: 0.016 million euro).
The fair value adjustment convertible bonds relate for 0.436
million euro to the Kreos/Pontifax convertible bond (2021:
0.025 million euro finance expense). We refer to note 5.7.11
for more information.
5.6.8 Finance expense
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Bank costs
-21
-26
Impairment on short-term financial investments
-15
-5
Fair value adjustment convertible bonds
-7,824
-372
Other
-1,349
-713
Exchange rate loss (on USD and GBP)
-170
-152
Total finance expense
-9,379
-1,268
The fair value adjustment convertible bonds relate for 7.824
million euro to the Negma convertible bond (2021: 0.347
million euro). We refer to note 5.7.11 for more information .
97
OXURION ANNUAL REPORT 2022
The other financial expenses relate for 0.700 million euro
to the Negma convertible bond (2021: 0.525 million euro),
0.636 million euro to the Kreos/Pontifax convertible bond
(2021: 0.177 million euro) and 0.013 million euro to other
(2021: 0.011 million euro).
As a result of USD revaluations, the unrealized exchange
losses in 2022 amounted to 0.004 million euro (2021: 0.138
million euro) whereas 0.166 million euro exchange losses
were realized (2021: 0.014 million euro ) .
5.6.9 Employee benefits
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Wages, salaries and bonuses
-4,456
-8,030
Share-based compensation expenses
-933
-1,107
Pension costs
-203
-391
Total
-5,592
-9,528
The pension costs included in the table above consist for
0.149 million euro (2021: 0.374 million euro) of costs related
to defined benefit plans and for 0.054 million euro (2021:
0.017 million euro) of costs related to defined contribution
plans. We refer to note 5.7.9 for more information on the
defined benefit plans.
The average number of full-time equivalents (including
executive directors) was as follows:
IN NUMBERS
2022
2021
Research and development
27
45
General and administration
7
10
Selling
1
1
Total
35
56
The share-based compensation expense included in the
statement of profit and loss is given below:
N '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Research and development expenses
427
289
General and administrative expenses
495
798
Selling expenses
11
20
Total
933
1,107
We refer to note 5.7.8, for further information regarding the
share-based payment plans.
5.6.10 Taxes
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Current tax expense
-7
-3
Deferred tax expense
0
0
Tax expenses in income statement
-7
-3
Effective tax rate
0.0%
0.0%
The tax expense as shown above has been calculated in
conformity with local and international tax laws. The tax
on the Company’s loss (-)/ profit before tax differs from
the theoretical amount that would arise using the domestic
rate in Belgium on loss (-) / profit of the year and is as
follows:
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER)
2022
2021
Loss (-) / profit before tax
-31,686
-29,592
Expected tax based on tax rate of the parent
7,921
7,398
company (25% - theoretical)
Disallowed expenses
-231
-51
Tax deductions and non-taxable income
152
144
Change in unrecognized deferred taxes
-5,961
-9,947
Difference in tax rates from other jurisdictions
0
-6
Permanent differences
-1,888
2,459
Tax expense of the year (effective)
-7
-3
The main difference between the theoretical tax and the
effective tax for the year 2021 and 2022 can be primarily
explained by the unrecognized deferred taxes for which
the Company conservatively assesses that it is not likely
that these will be utilized in the foreseeable future .
98
OXURION ANNUAL REPORT 2022
5.6.11 Result per share
Earnings per share
The calculation of basic earnings/loss per share on
December 31, 2022, is based on the holders of ordinary
shares attributable loss (-) / profit from 2022 (31.693)
million euro (2021: (29.595) million euro) and a weighted
average number of ordinary shares outstanding during
2022 of 85,019,833 (2021: 38,410,532), calculated as
follows:
2022
2021
Issued ordinary shares per 1 January
39,067,284
38,291,950
Effect of capital increases through issue of
shares
45,952,549
118,582
Average number of ordinary shares per
85,019,833
38,410,532
31 December
IN '000 EURO, EXCEPT FOR RESULT PER SHARE
2022
2021
Result of the year
-31,693
-29,595
Basic/Diluted result per share
-0.37
-0.77
As consideration in exchange for services performed, the
Group has granted subscription rights to buy ordinary
shares to the CEO and personnel.
In addition, the Group also has convertible loans with
Negma and Kreos/Pontifax (see note 5.7.11) for which
potential ordinary shares can be issued upon conversion.
The effect of these potential ordinary shares is anti-dilutive
as there was a loss in 2022 and 2021. As such, the diluted
earnings per share are the same as the basic earnings per
share.
See note 5.7.8 for an overview of the number of outstand-
ing subscription rights at each year-end.
99
OXURION ANNUAL REPORT 2022
5.7 NOTES TO THE CONSOLIDATED STATEMENT OF FINANCIAL POSITION
5.7.1 Property, plant and equipment
IN '000 EURO MACHINES, PLANT FURNITURE AND TOTAL
AND EQUIPMENT FITTINGS
As at 1 January 2021
Cost 6,674
4,310
10,984
Accumulated depreciation and disposals -6,469
-4,276
-10,745
Exchange differences -26
17
-9
Net carrying amount
179
51
230
Year ended on 31 December 2021
Additions 25
7
32
Depreciation expenses -47
-30
-77
Disposals -60
-8
-68
Exchange differences 0
3
3
Net carrying amount
97
23
120
As at 31 December 2021
Cost
6,699
4,317
11,016
Accumulated depreciation and disposals
-6,576
-4,314
-10,890
Exchange differences
-26
20
-6
Net carrying amount
97
23
120
Year ended on 31 December 2022
Additions
28
31
59
Depreciation expenses
-45
-18
-63
Disposals
-9
-7
-16
Exchange differences
0
-1
-1
Net carrying amount
71
28
99
As at 31 December 2022
Cost
6,727
4,348
11,075
Accumulated depreciation and disposals
-6,630
-4,339
-10,969
Exchange differences
-26
19
-7
Net carrying amount
71
28
99
At December 31, 2022, property, plant and equipment with an original cost of 2.5 million euro (2021: 3.4 million euro) that
has already been fully depreciated is still in use. No property, plant and equipment is pledged or in limited use .
100
OXURION ANNUAL REPORT 2022
5.7. 2 Leases
IN ‘000 EURO LAND AND PROPERTY, PLANT TOTAL
BUILDINGS AND EQUIPMENT
Right-of-use assets
As at January 1, 2021
817
252
1,069
Additions
0
34
34
Amortization
-466
-134
-600
Modification*
-251
0
-251
As at December 31, 2021
100
152
252
As at January 1, 2022
100
152
252
Additions
924
77
1,001
Amortization
-171
-119
-290
Modification
0
0
0
As at December 31, 2022
853
110
963
Lease liabilities
As at January 1, 2021
842
254
1,096
Additions
0
34
34
Lease payments
-463
-136
-599
Modification*
-266
0
-266
As at December 31, 2021
113
152
265
Of which are:
current lease liabilities
113
108
221
non-current lease liabilities
0
44
44
total
113
152
265
As at January 1, 2022
113
152
265
Additions
924
77
1,001
Lease payments
-172
-122
-294
Modification
0
0
0
As at December 31, 2022
865
107
972
Of which are:
current lease liabilities
92
47
139
non-current lease liabilities
773
60
833
total
865
107
972
(*) Oxurion decided to focus on its clinical development strategy and decided to
terminate part of the lease agreement with Bio-Incubator
The lease payments in the table above of 0.294 million
euro (2021: 0.599 million euro) are reconciled to the line
item ‘Principal paid on lease liabilities’ in the consolidated
statement of cash flows.
The amortization of the right-of-use assets is reconciled
to the line item ‘Amortization of right-of-use assets’ in the
consolidated statement of cash flows.
On December 31, 2022, Oxurion had outstanding lease
obligations, which become due as follows:
UP TO 3 BETWEEN BETWEEN BETWEEN OVER 5
IN ‘000 EURO MONTHS 3 AND 12 1 AND 2 2 AND 5 YEARS
MONTHS YEAR(S) YEARS
Lease obligations
39
100
121
338
374
101
OXURION ANNUAL REPORT 2022
5.7. 3 Intangible assets
INTERNALLY
IN '000 EURO GENERATED
LICENSE NUVUE
LICENSE GRIFOLS
LICENSE
LICENSE VIB
LICENSES OTHER
TOTAL
MICROPLASMIN GALAPAGOS
PHASE III
As at 1 January 2021
Cost
53,597
12,019
9,935
1,000
1,252
168
77,971
Accumulated amortization expenses
-22,700
-6,578
-5,381
0
0
-168
-34,827
Accumulated impairment losses
-30,897
-5,441
-4,554
0
-125
0
-41,017
Net carrying amount
0
0
0
1,000
1,127
0
2,127
Year ended December 31, 2021
Additions
0
0
0
0
0
0
0
Disposals
0
0
0
0
0
0
0
Amortization expenses
0
0
0
0
0
0
0
Impairment losses
0
0
0
0
-1,127
0
-1,127
Net carrying amount
0
0
0
1,000
0
0
1,000
As at December 31, 2021
Cost
53,597
12,019
9,935
1,000
1,252
168
77,971
Accumulated amortization expenses
-22,700
-6,578
-5,381
0
0
-168
-34,827
Accumulated impairment losses
-30,897
-5,441
-4,554
0
-1,252
0
-42,144
Net carrying amount
0
0
0
1,000
0
0
1,000
For the period ended on December 31, 2022
Additions
0
0
0
0
0
0
0
Disposals
0
0
0
0
0
0
0
Amortization expenses
0
0
0
0
0
0
0
Impairment losses
0
0
0
-1,000
0
0
-1,000
Net carrying amount
0
0
0
0
0
0
0
As at December 31, 2022
Cost
53,597
12,019
9,935
1,000
1,252
168
77,971
Accumulated amortization expenses
-22,700
-6,578
-5,381
0
0
-168
-34,827
Accumulated impairment losses
-30,897
-5,441
-4,554
-1,000
-1,252
0
-43,144
Net carrying amount
0
0
0
0
0
0
0
Intangible assets with definite useful lives:
In the development of JETREA®, Oxurion has capital-
ized ocriplasmin clinical trial costs (internally generated
Microplasmin Phase 3), and two externally acquired
licenses that were used for development of JETREA®:
NuVue and Grifols. The capitalized costs were amortized
from the date of commercialization of JETREA® in 2013,
over the life of the patent, which was determined to be
11.8 years, but as there was an impairment indicator, they
were fully impaired before that date. We refer to the ac-
counting policy section for more details on ocriplasmin.
Intangible assets pledged:
In the context of the Kreos/Pontifax convertible bond, the
Group has created a pledge up to 10 million euro over (i)
the Company’s business, including its intellectual property,
and (ii) the patents and patent application in families
WO2020043533 and WO2005123734, relating to THR
687, which have been registered in the Belgian national
pledge register. In addition, a pledge is registered over the
US patent 10,703,752 (application 16/554,259 filed on
August 19, 2019), relating to THR 687, in the United States
Patent and Trademark Office .
102
OXURION ANNUAL REPORT 2022
Intangible assets with indefinite useful lives:
The Galapagos License relates to an externally acquired
license by Oxurion in relation to program THR-687, for the
development and commercialization of integrin antago-
nists. The Part A data showed THR-687 to be safe and
well tolerated with no serious adverse events and none of
the patients required rescue medication through Month 3,
however, there was insufficient evidence of efficacy on the
key endpoints (Best Corrected Visual Acuity and Central
Subfield Thickness). As a result, Oxurion has decided not
to advance THR-687 to Part B of the INTEGRAL trial. The
Galapagos License was there for fully impaired as per
December 31, 2022. For more details on the agreement
and accounting policy treatment, we refer to note 5.8
under key arrangements section.
The VIB license relates to an externally acquired license
by Oncurious for a portfolio of five unique next generation
immuno-oncology assets which are being used in further
development. This asset was given as a contribution in
kind by VIB and was capitalized based on fair value deter-
mined by an independent valuator. The license is impaired
as per June 30, 2021, as Oxurion would no longer make
direct investments in these assets. The Company also
explored the option of taking on an additional investor in
Oncurious, but was unable to secure a transaction under
acceptable terms. For more details on the agreement and
accounting policy treatment, refer to note 5.8 under key
arrangements section. Besides the portfolio of five immu-
no-oncology assets the VIB License column also contains
TB-403 with a gross book value of 0.125 million euro,
which was impaired during 2020.
Impairment test at December 31, 2022
Indefinite life intangible assets are tested for impairment
annually since these are not subject to amortization.
Definite lived intangible assets are tested for impairment
if indicators exist.
The Galapagos license was fully impaired (1 million euro)
given the announcement in the first half of 2022 that
Oxurion has decided not to advance THR-687 to part B
of the INTEGRAL trial.
The VIB IP license has been fully impaired as per June
30, 2021, as a result of the existence of an impairment
indicator given the announcement in the first half of 2021
that Oxurion would no longer make direct investments in
Oncurious (oncology), and as a result the oncology assets
were impaired in the amount of 1.127 million euro .
5.7.4 Trade and other receivables, non-
current tax credit and current
tax receivables
5.7.4.1 Trade and other receivables
IN '000 EURO (AS AT 31 DECEMBER)
2022
2021
Trade receivables
316
81
Other receivables
2,696
2,276
Prepaid expenses and other current assets
309
160
Total
3,321
2,517
Other receivables relate mainly to prepayments: 2.376
million euro in 2022, compared to 2.228 million euro in
2021. These advances were paid upfront to various CRO
partners mainly in relation to direct costs and pass-through
costs.
Allowance for bad debt is booked on the basis of an
estimate of lifetime credit losses at each reporting, taking
into account the payment history of the other party. As per
December 31, 2022, and 2021, there are no material aged
trade receivables.
The table below shows the evolution of key trade receiv-
able amounts on the reporting date:
IN '000 EURO (AS AT 31 DECEMBER) 2022 2021
Eumedica 90 25
Inceptua Group 85 56
103
OXURION ANNUAL REPORT 2022
VIB 119 0
Other trade receivables 22 0
Total 316 81
Management has sufficient confidence in the creditworthi-
ness of the counterparty that the trade receivable amounts
are considered collectable in full.
Aging balance of receivables that are due, but that are
still considered collectable based on contractual payment
terms:
IN '000 EURO (AS AT 31 DECEMBER)
2022
2021
0 - 60 days
316
81
60 - 90 days
0
0
90 - 120 days
0
0
more than 120 days
0
0
Total
316
81
When determining the collectability of a trade receivable,
the Group takes into account any change in the quality of
the receivable between the date on which the credit was
granted and the reporting date.
The Group has no securities linked to these receivables.
5.7.4.2 Taxes
Non-current tax receivables
IN '000 EURO (AS AT 31 DECEMBER)
2022
2021
Tax credit
3,785
4,000
Total
3,785
4,000
Oxurion receives tax credits for R&D expenses. In case in-
sufficient tax against which to set off the tax credit, the credit
can be carried forward during five consecutive fiscal years.
At the end of these five fiscal years, the balance of the
unused tax credit is received in cash from the government.
Current tax receivables
IN '000 EURO (AS AT 31 DECEMBER)
2022
2021
Recoverable VAT
154
242
Recoverable withholding tax
2
4
Tax credit
0
568
Other taxes
33
31
Total
189
845
The outstanding tax claims relate to recoverable VAT, re-
coverable withholding tax on interest, US corporate income
tax and short-term tax credit .
5.7.5 Inventories
N '000 EURO (AS AT 31 DECEMBER)
2022
2021
Raw and ancillary materials, goods in process and
5
60
finished goods
Total
5
60
The inventories of raw and ancillary materials, goods in
process and finished goods are based on the net value,
after impairment losses. The impairment losses on the
inventories recognized in cost of goods amount to 0.444
million euro in 2022, compared to 0.629 million euro in
2021 .
104
OXURION ANNUAL REPORT 2022
5.7.6 Investments
IN '000 EURO (AS AT 31 DECEMBER)
2022
2021
Other investments
95
247
Total investments
95
247
FINANCE ASSETS ACCORDING TO CATEGORIES INVESTMENTS AT INVESTMENTS
DEFINED IN IFRS 9 AMORTIZED COST AT FVOCI
Balance at 1 January 2021
0
288
Exchange rate differences
0
7
Additions
0
0
Retirements
0
-40
Impairments
0
-1
Appreciation at market value
0
-7
Balance at 31 December 2021
0
247
-/- of which taken in fixed assets
-
-
Taken in current assets
0
247
Composition
- Other bonds
0
247
- Term investments
0
0
Breakdown per currency
- in euro
0
140
- in other currency
0
107
Total
0
247
Balance at 1 January 2022
0
247
Exchange rate differences
0
9
Additions
0
0
Retirements
0
-152
Impairments
0
-4
Appreciation at market value
0
-5
Balance at 31 December 2022
0
95
-/- of which taken in fixed assets
-
-
Taken in current assets
0
95
Composition
- Other bonds
0
95
- Term investments
0
0
Breakdown per currency
- in euro
0
95
- in other currency
0
0
Total
0
95
The Group decided to invest mainly in saving accounts
and term deposits. The remaining bonds are held by KBC
and are distributed in two bonds of private and public insti-
tutions. The credit rating varies from A+ to BBB. Bonds are
measured at fair value at level 1 hierarchy based on quoted
market prices .
5.7.7 Share capital
Oxurion was incorporated on May 30, 2006, under its
former name ‘ThromboGenics’, with a share capital of
62,000 euro represented by 11,124 shares.
On December 31, 2022, the share capital of the Company
on a consolidated basis amounted to 65.4 million euro
represented by 411,071,559 ordinary shares without
indication of nominal value. All shares are fully paid up and
have the same rights.
NUMBER OF SHARES
31 December 2020
38,291,950
Capital increase due to conversion of convertible bonds
775,334
31 December 2021
39,067,284
Capital increase by contribution in cash
7,226,039
Capital increase due to conversion of convertible bonds
364,778,236
31 December 2022
411,071,559
IN '000 EURO
CAPITAL
SHARE
PREMIUM
31 December 2020
44,913
0
Capital increase due to conversion of
convertible bonds
1,116
234
31 December 2021
46,029
234
Capital increase by contribution in cash
10,405
0
Capital increase due to conversion of
convertible bonds
9,009
16
31 December 2022
65,443
250
The Board of Directors’ powers with respect to the author-
ized share capital were renewed at the EGM of Oxurion
held on May 24, 2022, for a period of five years starting
from the publication of the notary deed pertaining to
105
OXURION ANNUAL REPORT 2022
t he modification of the Articles of Association in the
Belgian Official Gazette (May 24, 2022). The Board of
Directors is authorized to increase the share capital of the
Company upon one or more occasions up to an amount
of 67,931,161.32 euro (less the authorized capital which is
used in view of the issuance of convertible bonds) through
contribution(s) in cash, contribution(s) in kind, or by con-
version of the reserves in accordance with the special
report drawn up pursuant to Article 7:199 of the BCCA.
As a result, on December 31, 2022, the authorized capital
is 65,443,000 euro.
During financial year 2022, Oxurion’s share capital and
share premium has been increased on several occasions
following the conversion of (in aggregate) 3,610 converti-
ble bonds issued to Negma:
DAT E
BONDS
CAPITAL SHARE PREMIUM
(IN EURO) (IN EURO)
8 February 2022
200
483,219.36
16,780.64
23 March 2022
240
600,000.00
0.00
15 April 2022
230
575,000.00
0.00
18 May 2022
200
500,000.00
0.00
7 June 2022
180
450,000.00
0.00
6 July 2022
220
550,000.00
0.00
17 August 2022
200
500,000.00
0.00
5 September 2022
80
200,000.00
0.00
13 September 2022
80
200,000.00
0.00
12 October 2022
173
432,500.00
0.00
19 October 2022
164
410,000.00
0.00
24 October 2022
120
300,000.00
0.00
26 October 2022
123
307,500.00
0.00
2 November 2022
120
300,000.00
0.00
7 November 2022
130
325,000.00
0.00
17 November 2022
56
140,000.00
0.00
22 November 2022
172
430,000.00
0.00
24 November 2022
140
350,000.00
0.00
28 November 2022
242
605,000.00
0.00
30 November 2022
80
200,000.00
0.00
5 December 2022
80
200,000.00
0.00
9 December 2022
380
950,000.00
0.00
Total
3,610
9,008,219.36
16,780.64
In addition to the Negma funding, a capital increase also
took place in the context of the authorized capital by a
contribution in cash of 10,405,500 euro and with the
issuance of 7,226,039 new Oxurion NV shares at 1.44 euro
per share through a private equity placement on March 7,
2022 .
106
OXURION ANNUAL REPORT 2022
5.7.8 Other comprehensive income and
other reserves
The other comprehensive income is detailed as follows:
CURRENCY REMEASURE- FAIR VALUE ADJUST-
IN '000 EURO TRANSLATION MENT DEFINED MENTS OF DEBT TOTAL
ADJUSTMENT BENEFIT INSTRUMENTS OCI
PLANS
31 December 2020
-378
-661
0
-1,039
Movements in OCI
122
566
-5
683
31 December 2021
-256
-95
-5
-356
Movements in OCI
101
361
-5
457
31 December 2022
-155
266
-10
101
The other reserves movement is detailed as follows:
SHARE- RETAINED FAIR VALUE
IN '000 EURO BASED EARNINGS ADJUST-
OTHER
TOTAL
PAYMENT RESERVE MENT
RESERVE FUND RESERVE
31 December
12,574
-18,706
-1
0
-6,133
2020
Movements in
other reserves
1,107
-453
213
0
867
31 December
13,681
-19,159
212
0
-5,266
2021
Movements in
other reserves
933
-38
7,398
0
8,293
Transfer*
-11,433
0
0
11,433
0
31 December
3,181
-19,197
7,610
11,433
3,027
2022
*As at December 31, 2022, the Group reclassed the recorded share-based payment
reserve of the expired and exercised subscription rights to a category ‘other’.
The category ‘Share-based reserve’ expresses now the outstanding share-based
payment liability.
On August 24, 2020, by decision of an EGM of Oxurion, a
capital decrease was initiated and transferred within equity
to create a reserve fund classified as other reserves for an
amount of 5,532,596.62 euro to be able to absorb future
losses within the other reserves. For the movement in the
share-based payment reserve we also refer to note 5.6.9
where the share-based payment expense of the period is
disclosed as employee benefit expense.
Share-based payment plans
The Group has created various subscription rights plans
that can be granted to personnel and a subscription rights
plan for Non-Executive Directors.
Since the public listing, all subscription rights plans have
been created in respect of Oxurion.
At December 31, 2022, there are five outstanding sub-
scription rights plans, as follows:
CREATION DATE OF PLAN DATE GRAN- EXERCISE PRICE BENEFICIARY
TED (IN EURO)
Employees, key
Subscription Rights Plan 2017
2017-2020
Between 2.64 consultants and
and 6.55 directors of the
Group
Subscription Rights Plan Non-Executive
2020
2021
2.57
Directors of the
Group
Subscription Rights Plan Between 1.75 Employees and
2021-1 2021 and 2.60 key consultants
of the Group
Subscription Rights Plan Employees and
2021-2
2021
1.75
key consultants
of the Group
Subscription Rights Plan Between 0.444 Employees and
2021-3 2021-2022 and 1.82 key consultants
of the Group
Brief overview of all outstanding subscription rights granted
between 2017 and December 31, 2022 .
107
OXURION ANNUAL REPORT 2022
Subscription Rights Plan 2017
On November 20, 2017, the EGM of Oxurion decided to
issue the Subscription Rights Plan 2017 (formerly referred
to as the warrants plan 2017). Under this Subscription
Rights Plan 2017, which has a term of ten years and all
will lapse in 2027, a maximum of 1,440,000 subscription
rights can be issued and granted to employees, directors,
and consultants of the Group. Each subscription right
entitles the holder to subscribe to one Oxurion share.
Subscription rights are granted under this plan by the
Board of Directors or the Nomination and Remuneration
Committee, except for directors. Authority to grant sub-
scription rights to directors is held by the general meeting
of shareholders. Subscription rights are offered free of
charge. The exercise price is equal to the lower of (i) the
average of the closing prices of the share on the stock
market during the 30 days prior to the offering of a sub-
scription right or (ii) the closing price on the last stock
market day prior to the offer. Subscription rights granted
under this plan have a three year graded vesting (50%
after 2 years and 50% after 3 years) with no performance
conditions. The conditions under which a subscription right
holder is entitled to exercise a subscription right are estab-
lished by the Nomination and Remuneration Committee.
Subscription Rights Plan 2020
On December 23, 2020, the Board of Directors proposed
to issue the Oxurion 2020 Subscription Rights Plan, which
was decided by the AGM held in May 2019. Under this
Subscription Rights Plan 2020, which has a term of ten
years and all subscription rights will lapse in 2030, a
maximum of 150,000 subscription rights can be issued
and granted to Non-Executive Directors of Oxurion. Each
subscription right entitles the holder to subscribe to one
Oxurion share subject to the payment of the exercise price.
The exercise price is equal to the lower of (i) the average
of the closing prices of a share on the stock market during
the 30 days prior to the offering of a subscription right or
(ii) the closing price on the last stock market day prior to
the offer. Subscription rights granted under this plan have a
contractual term of ten years and vest immediately.
Subscription Rights Plans 2021
On April 14, 2021, the Board of Directors of Oxurion
decided to issue the Subscription Rights Plan 2021-1.
Under this Subscription Rights Plan 2021-1, which has a
term of ten years, and all subscription rights will lapse in
2031, a maximum of 1.085 million subscription rights can
be issued and granted to employees i and consultants of
the Group. Each subscription right entitles the holder to
subscribe to one Oxurion share.
On September 22, 2021, the Board of Directors of Oxurion
has decided to issue the Subscription Rights Plan 2021-2.
Under this Subscription Rights Plan 2021-2, which has
a term of ten years, and all subscription rights will lapse
in 2031, a maximum of 550,000 subscription rights can
be issued and granted to employees and consultants of
the Group. Each subscription right entitles the holder to
subscribe to one Oxurion share.
On December 30, 2021, the Board of Directors of Oxurion
has decided to issue the Subscription Rights Plan 2021-3.
Under this Subscription Rights Plan 2021-3, which has a
term of ten years, and all will lapse in 2031, a maximum of
862,000 subscription rights can be issued and granted to
employees and consultants of the Group. Each subscrip-
tion right entitles the holder to subscribe to one Oxurion
share. These plans are collectively referred to as the
Subscription Rights Plans 2021.
Subscription rights are granted under the Subscription
Rights Plans 2021 by the Board of Directors or the
Nomination and Remuneration Committee. Subscription
rights are offered free of charge. The exercise price is
equal to the lower of (i) the volume weighted average price
108
OXURION ANNUAL REPORT 2022
(VWAP) of the Company’s shares on the stock exchange
over a period of thirty calendar days prior to the date of
the offer or (ii) the closing price of the Company’s shares
on the last business day prior to the date of the offer. In
general, half of the subscription rights under these plans
vest after one year and the other half vest quarterly over
the following two years. For the subscription rights granted
in April 2021 under the Subscription Rights Plan 2021-1, the
vesting period exceptionally commenced on December
28, 2020. The conditions under which a subscription rights
holder is entitled to exercise a subscription right are estab-
lished by the Nomination and Remuneration Committee.
The grant date fair values of the subscription rights granted
under the different Subscription Plans have been deter-
mined by using the Black & Scholes model, taking into
account the following assumptions:
2017 SUBSCRIPTION PLAN ASSUMPTIONS
GRANT DATE DEC 17 DEC 17 JUN 18 DEC 18 DEC 18 JUL 19 DEC 19 DEC 19 JUN 20 AUG 20
Number of warrants granted 251,000 150,000 33,500 208,000 150,000 44,300 136,000 125,000 43,500 10,000
Current share price on grant
date (in euro)
3.38 3.38 7.07 3.52 3.52 4.65 2.875 2.875 3.07 2.72
Exercise price 3.38 4.593 6.549 3.4 4.593 3.822 2.64 4.593 2.847 2.8
Expected dividend yield - - - - - - - - - -
Expected stock price volatility 40% 40% 40% 40% 40% 40% 60% 60% 60% 60%
Risk-free interest rate 0.59% 0.59% 0.73% 0.69% 0.69% -0.25% -0.12% -0.12% -0.23% -0.38%
Expected duration 10 10 9.5 9 9 8.5 8 8 7.5 7.5
Fair value 1.56 1.29 3.33 1.58 1.3 2.23 1.75 1.43 1.83 1.56
2021 SUBSCRIPTION PLANS ASSUMPTIONS
GRANT DATE APR 21 JUN 21 SEP 21 SEP 21 DEC 21 JUN 22
Number of warrants granted 888,500 7,500 550,000 165,000 804,000 1,000
Current share price on grant
date (in euro)
2.6 2.505 1.928 1.928 1.82 0.45
Exercise price 2.6 2.52 1.75 1.75 1.82 0.44
Expected dividend yield - - - - - -
Expected stock price volatility 45% 45% 45% 45% 45% 65%
Risk-free interest rate 0.09% 0.08% -0.06% -0.06% 0.03% 2.08%
Expected duration 10 10 10 9.5 10 9.5
Fair value 1.3 1.27 1.01 1.00 0.91 0.32
109
OXURION ANNUAL REPORT 2022
2020 SUBSCRIPTION PLAN ASSUMPTIONS
GRANT DATE MAR 21
Number of warrants granted 75,000
Current share price on grant date
(in euro)
2.55
Exercise price 2.57
Expected dividend yield -
Expected stock price volatility 45%
Risk-free interest rate -0.16%
Expected duration 9
Fair value 1.23
The assumptions used in determining the fair value of the subscription rights granted are based on the following data:
Current share price on grant date – the closing price
on the stock market of Euronext Brussels.
Expected stock price volatility – the historical volatility
of Oxurions share price.
Expected duration – calculated as the estimated
duration until exercise, taking into account the specific
features of the plans.
Risk-free interest rate – based on the Belgian govern-
ment bond rates at the date of granting with a term
equal to the expected life of the subscription rights.
Movements in the number of subscription rights outstand-
ing and their related weighted average exercise prices are
as follows:
2022
2021
AVERAGE SUB- AVERAGE SUB-
EXERCISE SCRIPTION EXERCISE SCRIPTION
PRICE IN EUR RIGHTS PRICE IN EUR RIGHTS
As at 1 January
2.52
3,131,250
3.84
893,800
Granted, accepted
0.44
1,000
2.11
2,431,000
Forfeited
2.46
-172,970
3.30
-193,550
Exercised
0.00
0
0.00
0
As at 31 December
2.54
2,959,280
2.52
3,131,250
Outstanding vested subscription rights at December 31,
2022, have the following earliest exercise date, maturities
and exercise prices:
EARLIEST EXERCISE
DAT E
EXPIRY DATE
EXERCISE PRICE (IN
EURO)
NUMBER
(THOUSANDS)
2023 2027 3.95 692
2023 2030 2.57 60
2023 2031 2.23 1,171
Total weighted
average
2.86 1,923
110
OXURION ANNUAL REPORT 2022
5.7.9 Employee Benefit Obligations
Oxurion offers its employees retirement benefits that are
funded through a group insurance plan managed by an
insurance fund. Until June 30, 2009, the insurance group
plan was based on a “defined benefit” system. In a defined
benefit pension plan, an employer commits to paying its
employee a specific benefit for life beginning at his or her
retirement. The amount of the benefit is known in advance,
and is usually based on factors such as age, earnings, and
years of service. Defined benefit plans do not have con-
tribution limits, but they do have a limit on the maximum
annual retirement benefit.
Since July 1, 2009, the defined benefit plan was changed
into a pension plan that is structured as a defined con-
tribution plan, but that should be accounted for as a
defined benefit plan in accordance with IFRS, since the
company offers a minimum guaranteed return to the plan
participants.
The amounts recognized in the statement of financial
position can be broken down as follows:
2022
2021
Defined benefit obligation
4,707
5,015
Fair value of plan assets
-4,548
-4,421
Net defined benefit liability
159
594
The amounts recognized in the statement of financi al
position and the movements in the net defined benef it
obligations are as follows:
PRESENT FAIR VALUE OF
IN '000 EURO VALUE OF PLAN ASSETS TOTAL
OBLIGATION
As at 1 January 2021
5,361
-4,265
1,096
Current service cost
369
0
369
Past service cost
0
0
0
Interest expense/(income)
31
-26
6
Total amount recognized in profit
400
-26
374
or loss
Actuarial gains/(losses) on
DBO due to change in financial
-165
0
-165
assumptions
Changes in return of plan assets
0
-66
-66
Actuarial gains/(losses) on DBO
-335
0
-335
due to experience adjustments
Total amount recognized in other
comprehensive income
-500
-66
-566
Employer contributions
0
-310
-310
Employee contributions
67
-67
0
Benefit payments
-214
214
0
Taxes on contributions
-39
39
0
Insurance premiums related to
risk coverages
-61
61
0
As at 31 December 2021
5,015
-4,421
594
Current service cost
185
0
185
Past service cost
0
0
0
Interest expense/(income)
53
-47
7
Total amount recognized in profit
238
-47
191
or loss
Actuarial gains/(losses) on
DBO due to change in financial
-245
0
-245
assumptions
Changes in return of plan assets
0
-45
-45
Actuarial gains/(losses) on DBO
-283
0
-283
due to demographic adjustments
Actuarial gains/(losses) on DBO
213
0
213
due to experience adjustments
Total amount recognized in other
comprehensive income
-315
-45
-361
Employer contributions
0
-266
-266
Employee contributions
60
-60
0
Benefit payments
-202
202
0
Taxes on contributions
-34
34
0
Insurance premiums related to
risk coverages
-54
54
0
As at 31 December 2022
4,707
-4,548
159
111
OXURION ANNUAL REPORT 2022
The significant actuarial assumptions used to calculate the
net defined benefit liability were as follows:
2022
2021
Discount rate
3.80%
1.10%
Inflation rate short term
9.30%
1.80%
Inflation rate long term
2.50%
Salary increase rate on top of
inflation rate
2.00%
1.20%
Mortality tables MR/FR with age MR/FR with age
correction of 3 years correction of 3 years
Sensitivity analysis considering a change of 0.25% in the
discount rate (positive = increase net defined benefit liability
/ negative = decrease of net defined benefit liability):
IN '000 EURO TOTAL
DBO considering an increase of 0,25% in the discount rate -15
DBO considering a decrease of 0,25% in the discount rate +14
The expected future benefits to be paid are as follows:
IN '000 EURO
2023
120
2024
54
2025
101
2026
165
2027
233
5.7.10 Other short-term liabilities
IN '000 EURO (AS AT 31
2022
2021
DECEMBER)
Employee benefits
548
1,684
Other current liabilities
2,813
628
Total other short-term
3,361
2,312
liabilities
Oxurions Defined Benefit Obligation (“DBO”) is a non-cur-
rent liability.
Employee benefits include holiday pay, bonus, and out-
standing employee taxes.
The other current liabilities consist of commitments that
expire before year-end, but for which an invoice was not
yet received.
5.7.11 Convertible loans
The convertible loans include the following:
IN '000 EURO KREOS /
NEGMA
TOTAL
PONTIFAX
31 December 2020
0
0
0
Proceeds from loans and
borrowings
10,000
2,500
12,500
Commitment fee
0
525
525
Converted into capital
0
-1,350
-1,350
Fair value adjustment
25
134
159
31 December 2021
10,025
1,809
11,834
Proceeds from loans and
borrowings
0
7,150
7,150
Commitment fee
0
700
700
Converted into capital
0
-9,025
-9,025
Repayment of loans and borro-
wings
-3,605
0
-3,605
Fair value adjustment
-436
426
-10
31 December 2022
5,984
1,060
7,044
Of which current
2,749
1,060
3,809
Of which non-current
3,235
0
3,235
The Company issued convertible bonds since 2021 with
two parties as described below:
Negma Group Ltd.
On August 26, 2021, Oxurion (the Company or the Issuer)
entered into an agreement whereby Negma as investor
is willing to subscribe to, up to 12,000 zero coupon au-
tomatically convertible bonds with each a nominal value
of 2,500 euro, in several tranches of minimum 200 and
bonds) through several Tranches (“Part B Commitment”),
maximum 1,000 bonds for a total committed amount up
to be called by the Issuer at its discretion over the period
to 30 million euro. The Company as issuer controls the
between September 2, 2022 up to December 31, 2022
timing and amount of the tranche calls.
(“Part B Commitment Period).
The Investor is entitled to a commitment fee for an
The initial terms and conditions as set forth in the Issuance
amount equal to up to 3.5% of the total commitment, i.e.,
and Subscription Agreement remain unchanged for Part
up to 1.050 million euro, payable, at the option of the Issuer,
A of the Funding Program. Part A of the Funding Program
either in cash or in commitment fee convertible bonds.
was suspended during the Part B Commitment Period.
50% of the commitment fee is due upon signing of the
Upon expiry of the Part B Commitment Period, Part A
agreement, the remaining 50% is due only if a tranche call
of the Funding Program was automatically reactivated
is exercised by the Issuer, as a result of which in total half of
(including that part of the Part B Commitment for which
the commitment will have been called by the Issuer.
no Part B Convertible bonds shall have been issued and
subscribed to during the Part B Commitment Period).
The conversion price is 92% of the lowest closing vol-
ume-weighted average price (VWAP) over a period of
For the Part B Commitment, the Investor is entitled to a
15 consecutive trading days expiring on the trading day
further waiver and commitment fee equal to 0,7 million
immediately preceding the date of issuance of a con-
euro, payable in 280 convertible bonds for the Part B
version notice. Each convertible bond and commitment
Commitment together with the first tranche of the Part B
fee convertible bond has a duration of twelve months as
Commitment .The waiver and commitment fee convert-
from its date of issuance and shall accrue no interest. Any
ible bonds have a nominal value of 0,0025 million euro
convertible bond and commitment fee convertible bond
each.
not converted into shares prior to the maturity date, shall
convert automatically into shares at maturity date. The
The conversion price of the Part B convertible bonds is
Investor has the right to convert all or any of the convert-
80% of the lowest closing volume-weighted average
ible bonds and commitment fee convertible bonds into
price (VWAP) over a period of 15 consecutive trading
new shares at any time.
days expiring on the trading day immediately preceding
the date of issuance of a conversion notice. There is no
The number of shares to be issued upon conversion shall
liquidity condition or cool down period.
be equal to the conversion amount divided by the appli-
cable conversion price, provided that it shall not exceed
The number of shares to be issued upon conversion shall
a maximum of 38,291,950 shares. If the Investor does
be equal to the conversion amount divided by the appli-
not receive the relevant shares, the Issuer shall pay to the
cable conversion price. The cap of 38,291,950 shares is
Investor an amount in cash (“Part A of Funding Program”)
deleted from the terms and conditions of the agreement.
On September 2, 2022, the parties amended the terms
The convertible bonds described above meets the defini-
and conditions of part of the funding program (“Part B”)
tion of a financial liability given that the conversion price
for an amount of up to 6 million euro of the total com-
is not fixed and upon conversion, will result in a variable
mitment through the issuance and subscription of up
number of shares being issued, being the nominal amount
to 2.400 of the convertible bonds (“Part B Convertible
of the convertible loan divided by the conversion price. The
112
OXURION ANNUAL REPORT 2022
113
OXURION ANNUAL REPORT 2022
convertible bond is also a derivative financial liability as the
conversion feature is an embedded derivative of the loan
host. The host and the derivative will not be separated and
are accounted for as one hybrid financial liability.
The financial liability is measured at fair value through
profit or loss. The initial fair value of the convertible loan
equals an amount of cash received in the amount of
9.650 million euro of which 2.5 million euro was received
in 2021 and 7.150 million euro was received in 2022
(5 million euro Part A and 4.650 million euro Part B).
A total of 1.350 million euro was already converted into
shares before December 31, 2021. During 2022 another
9.025 million euro has been converted into shares before
December 31, 2022, following the conversion of (in
aggregate) 3.610 convertible bonds that were issued.
Subsequently, the fair value of the convertible loan related
to the Part A convertible bonds as per December 31, 2021,
is determined as the nominal amount of the convertible
loan plus 8%. The 8% represents the difference between
the share price and the 92% of the lowest closing VWAP.
Given the volatility of the share prices as per year ending
December 31, 2022, the fair value of the convertible loan
related to the Part B Convertible bonds is based on the
intrinsic value approach. Considering the term of the
convertible loan to be less than twelve months, no option
pricing model is used. The outstanding convertible loan has
a nominal value of 0.5 million euro as per 31 December
2022 and the fair value is determined at 1.06 million euro
with changes in the fair value recorded in profit and loss
as fair value gains and losses on the convertible loan.
The fair value loss in the amount of 0.426 million euro
as per December 31, 2022, is included in the line item
‘Finance expense’ in the consolidated statement of profit
and loss.
The fair value of the converted bonds during 2022 was
16.423 million euro. The difference between the fair value
and the nominal amount was recorded in profit and loss
as fair value loss included in the line finance expense for
an amount of 7.824 million euro and 0.426 million euro in
other reserves upon conversion.
Upon conversion, the financial liability measured at fair
value at date of conversion will be reclassified to share-
holders’ equity.
The liability for the first instalment of the Part A commit-
ment fee of 0.525 million euro (50% upon signing of the
agreement) is made once the first Tranche Call is called
by the Company. The commitment fee is recorded in
profit and loss as transaction cost due, given the Company
cannot avoid cash settlement if the Investor requests
eventual payment in cash. These transaction costs are
included in the line item ‘Finance expense’ in the consoli-
dated statement of profit and loss.
The second instalment of the Part A commitment fee of
0.525 million euro is recognized if and only if a tranche
call is exercised by the Issuer, as a result of which in total
more than half of the total commitment will have been
called. This commitment fee is considered as a transaction
cost in accordance with IFRS 9 and expensed as incurred
as financial expense, given it is an incremental cost that
the Company would not incur if the triggering condition is
not met. This second instalment has not been accounted
for as per December 31, 2022, since there is no present
obligation yet.
The Part B waiver and commitment fee of 0.7 million euro
payable in 280 convertible bonds with a nominal value of
0.0025 million euro became due upon the payment of
the first tranche under Part B pursuant to the addendum
and is recorded as financial expense in the consolidated
statement of profit and loss given these are considered as
transactions costs. The corresponding liability is measured
2. The conversion price may be adjusted from time to
at fair value through profit and loss. Upon conversion the
time upon the occurrence of corporate actions, such
financial liability measured at fair value at the date of con-
as merger, demerger, stock splits or reverse stock split,
version, will be reclassified to shareholders equity.
in accordance with the adjustment policy set out in the
Euronext Corporate Action Policy
Kreos Capital / Pontifax Ventures
3. In the event that, between the issue date of the Kreos
Bonds and the date falling twelve months after the
On November 21, 2021, Oxurion (the Company or the
Loan Facility (i.e. 22 November 2022, the Company
Issuer) entered into the Loan Facility whereby Kreos
issued any shares in the context of an equity financing
Capital VI Limited together with Pontifax Medison
at an issue price per share which represents a
Finance L.P. (the Investors) as investors are willing to
discount of more than 20% to the VWAP (volume-
subscribe to convertible bonds with each a nominal value
weighted average price) over the thirty trading days
of 0.1 million euro, in an amount of 10.0 million euro.
period preceding the date of such issuance of shares,
The Investors are entitled to a transaction fee of 0.125
the Kreos Conversion Price shall be adjusted to 140%
million euro and an end of loan payment equal to 3.5%
of the average issue price of all shares issued by the
that shall accrue on the amount drawn under each tranche.
Company in the context of any equity financing since
The convertible bonds accrue interest in the amount of
the issue date of the Kreos Bonds (if lower than the
7.95% per year.
Kreos Conversion Price). As a result, the strike price
was reset at 0.28 euro per share.
The convertible bonds may be either:
On June 21, 2022, the Company, Kreos Capital VI
1. Converted in shares at the option of the Investors at
Limited and Pontifax Medison Finance L.P. executed an
any time.
amendment to the convertible bond facility, pursuant
2. Converted in shares at the option of the Issuer when
to which a repayment of 3.0 million euro (30%) of the
certain conditions are met.
principal amount (excluding capitalized interest) of the
3. Repaid based on the amortization schedule without
first tranche of 10.0 million euro was made. As part of the
extension.
amendment, it was agreed that the cash covenant would
4. Repaid based on the amortization schedule with
be reduced from 4.0 million euro to 3.0 million euro, the
extension.
repayment schedule was revised and the interest only
5. Prepaid when certain conditions are met.
period was extended to September 30, 2022. At the same
6. Paid in full in case of events of default or change in
time, Kreos/Pontifax agreed not exercise any rights they
control.
might have had to recover amounts owed to them under
the Loan Agreement provided that certain conditions are
The number of shares to be issued upon conversion shall
met, the fulfilment of which is uncertain.
be equal to the conversion amount divided by the applica-
ble conversion price:
The convertible bond described above meets the definition
of a financial liability given that the Company cannot avoid
1. The initial conversion price of the Bonds was equal to
delivering cash to the investors and the conversion price
2.90 euro.
is not fixed. The Company cannot avoid delivering cash as
they do not have control over the different scenarios. The
conversion price can also change upon certain scenario’s
114
OXURION ANNUAL REPORT 2022
115
OXURION ANNUAL REPORT 2022
as described above and as such the number of shares
being issued will vary based on the conversion price. The
convertible bond is also a derivative financial liability as the
conversion feature is an embedded derivative of the loan
host. The host and the derivative will not be separated.
The financial liability is measured at fair value through
profit or loss. In determining the fair value, the company
makes certain judgements on the valuation model to be
applied and the probability that certain scenarios will occur
or not in the future. The fair value of the convertible bonds
has been measured considering the following scenarios
that may impact the term of the bond:
1. No extension
2. With extension
3. Prepaid when certain conditions are met.
4. Paid in full in case of events of default or change in
control.
The initial fair value of the convertible loan equals the
amount of cash received which is 10.0 million euro as
per December 31, 2021. Subsequently the fair value is de-
termined as the probability weighted average of the fair
values of the different scenarios described above consid-
ering the pre-payment agreed on June 21, 2022. The fair
value of the scenarios has been determined by application
of the effective interest rate method and the Black-Scholes
model. The payment by the Company to Pontifax Medison
Finance L.P is paid in USD by converting the relevant due
amount in euro into the USD at a fixed exchange rate. For
Pontifax, the fair value of the convertible loan is deter-
mined based on the application of the effective interest
rate method considering the USD loan payment at the
spot rate at valuation date.
The above fair value measurement is a level 3 as a result
of the unobservable input for the probabilities. A reason-
able change of the probabilities between the different sce-
narios would not lead to a material change in the fair value.
The fair value as per December 31, 2022, is determined
at 5.984 million euro, taking into account the repayment
of 3 million euro, with changes in the fair value recorded
in profit and loss as fair value gains and losses on the con-
vertible loan. The fair value gain in the amount of 0.436
million euro as per December 31, 2022, are included in the
line item ‘Finance income’ in the consolidated statement of
profit and loss. No amounts have already been converted
into shares as per December 31, 2022.
Upon conversion, the financial liability measured at fair
value at date of conversion will be reclassified to share-
holders’ equity, being share capital and share premium and
other reserves for the fair value adjustment portion.
The Loan Facility is subject to a financial covenant whereby
the Group is required to maintain at all times a minimum
aggregate amount of cash in the bank of an amount equal
to the lower of 3 million euro and the principal amount
outstanding. The Group has complied with the financial
covenant at December 31, 202 2 .
5.7.12 Deferred taxes
Deferred tax assets have not been recognized in respect
of the items below because it is not probable that future
taxable profits will be available against which the Group
can utilize the loss carryforwards or deductible temporary
differences. The losses available for offsetting future
taxable income are mainly related to Belgium.
In '000 euro (as at 31 December) 2022 2021
Losses available for offsetting against
future taxable income
361,140 342,145
Deductible temporary differences 18,056 24,518
Taxable temporary differences 0 -46
116
OXURION ANNUAL REPORT 2022
Total unused tax losses and other
deductible temporary differences not
379,196
366,617
recognized
No deferred tax liability is recognized on the unremitted
earnings of subsidiaries since no tax is expected to be
payable on them in the foreseeable future .
5.8 OTHER CLARIFICATION NOTES
TO THE STATEMENT OF
FINANCIAL POSITION
Subsidiaries and branches
NAME OF THE PLACE OF PRINCIPAL
SUBSIDIARY INCORPORATION
2022
2021
ACTIVITY
AND OPERATION
Thrombo-
Genics, Inc.
US
100%
100%
Distributor
Oncurious
BE
100%
83.34%
Research
NV (oncology)
At year-end 2021, out of a new total of 12,111 shares in the
share capital of Oncurious, Oxurion owned 10,093 shares
or 83.34%.
Due to a capital increase in Oncurious by VIB through a
contribution in kind of a receivable from VIB to Oncurious
for 86,299 euro, VIB’s non-controlling interest increased
with 0.5 million euro and the equity attributable to equity
holders of the company decreased with 0.5 million euro.
The effect of which is presented in the line item ‘trans-
actions with non-controlling interests’ in the statement of
changes in equity.
In the line item ‘transactions with non-controlling interests
presented in the statement of changes in equity, the
effect of the transfer between equity attributable to equity
holders of the company and the non-controlling interest
is presented resulting from the exercise of the call option
by VIB leading to the transfer of 680 shares in the share
capital of Oncurious from Oxurion to VIB. We refer to note
5.8 under the heading Flanders Institute for Biotechnology
for more information on the exercise of the call options
which were granted by Oxurion to VIB.
On December 14, 2022, Oxurion purchased 2,018 shares
from VIB for 1 euro. As of this date, the ownership of the
shares transferred and Oxurion owned 12,111 shares or
100% .
117
OXURION ANNUAL REPORT 2022
Key Agreements, Commitments and Contingent
Liabilities
In addition to the convertible loan agreements described
in the preceding section, the Group has a number of other
material agreements with third parties.
Please find below an overview of Oxurion’s material agree-
ments. An agreement is considered as “material” when the
contractual commitments reach over 1 million euro, or in
case of a new agreement, when such an impact is expected
in the twelve-month period after the reporting date.
Note that certain agreements may include sharing of R&D
costs and/or sharing of revenue. Although these agreements
may include the establishment of a joint committee which
monitors the joint activities, these arrangements are out of
the scope of IFRS 11 “Joint Arrangements”, as the Company
has concluded that no joint control exists. The main indica-
tors found in the multiple arrangements that resulted in the
conclusion that Oxurion has control over the operations and
relevant activities and therefore is the decision-making party
in the agreements are as follows:
Oxurion has sole and exclusive decision-making
authority on the development activities, including but
not limited to the development plan.
Oxurion bears the costs and expenses for all activities
under the development plan.
Oxurion is responsible for preparing, filing and main-
taining regulatory approvals.
Oxurion has the sole responsibility and decision-mak-
ing authority for manufacturing and commercialization.
Oxurion shall be the sole and exclusive owner of all
intellectual property in most agreements .
Research and Development Agreements
Bicycle Therapeutics
In August 2013, Oxurion entered into a research collabora-
tion and license agreement with Bicycle Therapeutics (the
“Bicycle Collaboration Agreement”). Under this agreement,
Bicycle is responsible for identifying Bicycle-peptides related
to the collaboration target, human plasma kallikrein, for use
in various indications. Oxurion is responsible for further de-
velopment and product commercialization after the defined
research screening is performed by Bicycle.
The collaboration includes two stages. During Stage 1, which
has been completed, Bicycle was obligated to perform
specific research activities in accordance with the research
plan focused on screening the target using the Bicycle
platform to identify compounds that meet the criteria set
by the parties. During Stage 2, which is ongoing, Oxurion has
continued research activities on selected Bicycle-peptides
with the goal of identifying compounds for further develop-
ment and commercialization. THR-149 has been selected as
a development compound under the Bicycle Collaboration
Agreement.
Bicycle granted certain worldwide intellectual property rights
to Oxurion for the development, manufacture and commer-
cialization of licensed compounds associated with plasma
kallikrein.
The Bicycle Collaboration Agreement provided an upfront
payment of 1.0 million euro and potential additional research
and development funding, at an agreed upon FTE rate,
should the research effort require more than one FTE, or the
research plan be amended or extended by Oxurion .
Oxurion is also required to make certain milestone payments
Based on IAS 38 “Intangible assets”, Oxurion has not
to Bicycle upon the achievement of specified research, de-
acquired a separate intangible asset that meets the defini-
velopment, regulatory and commercial milestones of up to
tion of IAS 38, and therefore these expenses are recorded
21 million euro (e.g., 3 million euro related to the first Phase
under R&D expenses. So far, the following upfront and
3 trial if the Company decides to do one, and 5 million euro
milestones payments to Bicycle were recognized: 1.0 million
when the first regulatory approval in either the United States
euro in 2013, 0.750 million euro in 2017, 1.0 million euro in
or the European Union is granted for the first indication).
2018 and 2.0 million in 2020. These were all expensed as
R&D costs.
Under the terms of the Bicycle Collaboration Agreement,
to date Oxurion has paid milestones of approximately 5
Galapagos
million euro. In addition, to the extent any of the collabora-
tion products covered by the licenses granted to Oxurion
Oxurion has entered into the Galapagos License, which is a
are commercialized, Bicycle would be entitled to receive
global and exclusive in-licensing agreement with Galapagos
tiered royalty payments of mid-single digits based on a
to develop and commercialize integrin antagonists for the
percentage of net sales. Royalty payments are subject to
treatment of diabetic eye disease. The company’s THR-687
certain reductions. Also, if Oxurion grants a sublicense to
asset for which development has been paused is a result of
a third party for rights to the program for non-ophthalmic
this agreement. Oxurion has obtained the exclusive rights for
use, Bicycle would be entitled to receive tiered payments
the clinical development, manufacturing and commercial-
of mid-single digits to low-double digits (no higher than first
ization under this agreement, while Galapagos is entitled to
quartile) based on a percentage of non-royalty sublicensing
receive a non-refundable upfront fee for technology access,
income. In line with IFRS principles, no provisions have been
development milestone payments of up to 12.5 million
made in the Company’s books for these payments.
euro (e.g., 1.5 million euro related to the first Phase 3 if the
Company decides to do one, and 5 million euro when the
In November 2017, the parties entered into an amendment
first regulatory approval in either the United States or the
to the Bicycle collaboration agreement. This amendment
European Union is granted for the first indication).
provides for additional research services to be performed
by Bicycle related to the identification of additional Bicycle
In addition, to the extent any of the collaboration products
peptides binding to the target for Oxurion, in its discretion, to
covered by the licenses granted to Oxurion are commercial-
select as development compounds. Bicycle was obligated to
ized, Galapagos would be entitled to receive certain sales-
perform the work in accordance with an amended research
based milestone payments and tiered royalty payments of
plan under Stage 1 of the collaboration and was funded at a
mid-single digits based on a percentage of net sales, except
specified FTE rate, plus any direct out of pocket expenses, and
in the case of annual sales exceeding 500 million euro, in
Oxurion was responsible for Stage 2 research and any de-
which case the royalty is higher.
velopment after the selection of a development compound.
Bicycle has completed Stage 1 of the research plan. Additional
In September 2017, the parties entered into an amendment
milestones were added for the potential additional licensed
to the Galapagos License Agreement. According to this
compounds, consistent with those of the initial Bicycle
amendment, Oxurion has taken over the prosecution and
Collaboration Agreement. This does not impact THR-149.
maintenance of the licensed patents and consequently has
acquired all rights in the licensed patents with effective date
as of September 25, 2017. Oxurion will be entitled to deduct
its documented and reasonable costs for prosecution and
118
OXURION ANNUAL REPORT 2022
119
OXURION ANNUAL REPORT 2022
maintenance for the licensed patents from the royalty due
and payable to Galapagos under the Galapagos License
Agreement. In line with IFRS principles, no provisions have
been made in the Company’s books for these payments.
Oxurion has paid to Galapagos an upfront fee of 1.0 million
euro in April 2016, upon Galapagos supplying to Oxurion
the licensed compounds, including THR-687, and all data
and manufacturing know-how related to the licensed
compounds, which was capitalized as an intangible asset
as it meets the conditions of a separately acquired intan-
gible asset under IAS 38, par. 25. Galapagos has no further
performance obligations for development services. Since
no commercialization was achieved and no profit was
generated, no amortization was recorded so far. Until now,
no other advance payments have been made to Galapagos.
In the first half of 2022, the Galapagos license was fully
impaired (1 million euro) given the announcement that
Oxurion has decided not to advance THR-687 to part B of
the INTEGRAL trial.
The future milestones must be assessed to determine if
they meet the capitalization criteria under IAS 38, once they
are paid. We refer to the accounting policy section on intan-
gible assets for more details.
Clinical Trial Agreement
Syneos Health
Syneos Health (“Syneos) provides clinical research
services for the development of THR-149. Services are
billed on a project basis by way of work orders (“Work
Orders) entered into based on a Master Services
Agreement (the “MSA) for Clinical Research and Related
Services dated as of August 19, 2016.
The MSA obligates the parties to use commercially rea-
sonable efforts to progress the study in a timely manner
and to meet any timelines for study milestones and target
dates applying professional standards consistent with GCP
and in adherence to applicable laws and regulations.
The major study milestones and target dates are described
in the binding Work Orders that are entered into under the
MSA. Subject to mutually agreed change orders, the Work
Order constitutes a binding agreement, and the parties
are obligated to use commercially reasonable efforts to
comply with the timelines and budgets set in the Work
Orders, unless a change order is agreed.
The Work Order for THR-149 specifies the basic parame-
ters of the THR -149 study, including, without limitation, the
scope of work, study-specific assumptions, estimated time
period for completing services, estimated budget, payment
and currency schedules, resource allocation and/or, as ap-
plicable, other specific services to be performed by Syneos.
The budget contained in the THR-149 Work Order can be
changed by way of a change order if there are changes
in the scope of the work or the assumptions underlying
the Work Order, provided that the change order must be
agreed between the parties.
Syneos also provided services for the INTEGRAL study
of THR-687 in treatment naïve patients, which has been
terminated and is in the process of being wound down
pursuant to the terms of the Work Order for THR-687.
Based on IAS 38 “Intangible assets”, the costs paid to
Syneos Health are not made in order to acquire an asset,
or to increase economic benefits already embodied into an
asset. Rather, they are an outsourced R&D cost. Therefore,
such costs are expensed to the statement of profit and
loss as R&D expenses, as incurred. In case of prepayments,
an asset is recognized for such prepayment, and prepay-
ment is released to statement of profit and loss as costs
are incurred. In 2022 and 2021, 7.4 million euro and 6.5
million euro were paid respectively to Syneos Health and
For 2022, Oxurion paid 0.067 million euro (2021: 0.072
recognized as R&D expenses. At year-end 2022, a prepay-
million euro) for distribution costs, 0.204 million euro (2021:
ment in the amount of .2.3 million euro is recorded on the
0.225 million euro) for selling expenses and received
statement of profit and loss.
0.403 million euro (2021: 0.588 million euro) revenue for
the select number of markets served by Eumedica.
License, Development and Commercial Agreement
On March 12, 2020, Oxurion entered into an exclusive
Eumedica and Inceptua
license with Inceptua for the commercialization and
marketing of JETREA® outside of the US in certain transfer
In June 2018, Oxurion and Eumedica entered into an
countries. Transfer countries include all countries of the
exclusive commercial agreement, pursuant to which
European Union, Norway, Liechtenstein, Switzerland, the
Eumedica agreed to provide distribution services for
UK and Australia and sales may also be made in non-ap-
JETREA® (the “2018 Agreement”). Eumedica acts as an
proved countries on a named patient basis under respect
agent of Oxurion, as Oxurion takes primary responsibility
of applicable law. The parties further agreed that Oxurion
for product quality, inventory risk, and has discretion in es-
would withdraw the marketing authorizations in the US
tablishing the sales price. The arrangement has the char-
and Canada and would transfer the EMEA marketing au-
acteristics of a consignment where Eumedica does not
thorization to Inceptua. The license became effective on
have control of the product, and Oxurion can direct its use
September 15, 2020, when the EMEA market authoriza-
and ask for its return. Eumedica collects payments from
tion was transferred. Under the terms of the agreement,
end-customers for Oxurion. Eumedica charges a monthly
Inceptua purchases JETREA® from Oxurion in final product
distribution fee that covers the services provided including
form for a fixed amount per vial and pays Oxurion a market
customer service, shipment preparation, packaging,
rate royalty on sales based on quarterly royalty reports.
storage, labeling/repackaging, administration, destruction
& waste handling, etc.
As a result of its agreement with Inceptua, Oxurion entered
into a tripartite agreement with Eumedica and Inceptua
Under IFRS 15, Oxurion has only one performance obliga-
pursuant to which Eumedica provides certain packaging,
tion, which is to deliver the product to the end-customer.
labelling and storage services directly to Oxurion and
This performance obligation is satisfied when Eumedica
purchases the finished product from Oxurion and sells its
transfers (delivers) the product to the end-customer, as this
to Inceptua (the “Tripartite Agreement”). The Tripartite
is the moment when the customer obtains control over the
Agreement replaces the 2018 Agreement. Eumedica also
product. Therefore, revenue is recognized for the price of
provides certain services to Oxurion on behalf of Inceptua,
the product at the point in time when it is delivered by
including storage, customer services and delivery, which
Eumedica to the end-customer. While inventory is located
are re-charged to Inceptua.
at Eumedica, it is recognized as inventory of Oxurion due to
consignment terms. Eumedica fees are recognized partly
After a transition period which was completed in December
under distribution costs and partly under selling expenses,
2020, Oxurions obligations under the Tripartite Agreement
as they are charged on a monthly basis.
will be limited to supply of the JETREA® product to
Inceptua until 2023. All other activities related to JETREA®
will be transferred to Inceptua or will cease .
120
OXURION ANNUAL REPORT 2022
121
OXURION ANNUAL REPORT 2022
Under IFRS 15, Oxurions only performance obligation
is to deliver final products to Inceptua. This obligation is
completed when Eumedica sells the products to Inceptua.
Oxurion therefore recognizes the revenue from the sale
of the goods when the assets are sold by Eumedica to
Inceptua. Royalties are recognised quarterly upon reception
of royalty report from Inceptua.
Oxurion received 0.153 million euro royalties (2021: 0.159
million euro) for the select number of markets served by
Inceptua.
Academic Agreements
The Company has concluded agreements with various
academic institutions that are interested in the study of
drug candidates, including the following:
Flanders Institute for Biotechnology
The Company has entered into several agreements
with the Vesalius Research Centre (formerly the Dept. of
Transgene Technology and Gene Therapy), a department
of VIB, relating to the preclinical characterization of two of
the programs under license with the Vesalius Research
Centre, i.e., Anti-PlGF and PlGF.
On December 12, 2017, Oncurious and VIB entered into
a research collaboration and license agreement on the
basis of which Oncurious acquired exclusive licenses on a
portfolio of five unique next generation immuno-oncology
assets, based on seminal work originating from the VIB-KU
Leuven labs of Massimiliano Mazzone and Gabriele
Bergers, and from the VIB-VUB lab of Jo Van Ginderachter.
In the context of the abovementioned research collabora-
tion and license agreement, VIB has been granted two call
options from Oxurion for an aggregate maximum of 1,230
shares in Oncurious, subject to the achievement of certain
milestones linked to the achievement of one or two proof
of concepts (call option agreement of December 12, 2017).
On October 22, 2021, Oncurious announced the achieve-
ment of a second preclinical proof of concept for its im-
muno-oncology program aimed at depleting regulatory T
cells (Tregs) by targeting C-C motif chemokine receptor
8 (CCR8). Consequently, at year end 2021, VIB is entitled
to execute its remaining call option of 550 shares. Post-
closing VIB indicated it is executing this remaining call
option in full.
As per June 30, 2021, the VIB IP license has been impaired,
compared with a net carrying amount of 1.127 million euro
in 2020.
During 2021, Oxurion has paid 0.211 million euro of
R&D costs respectively to VIB in relation to this research
program.
On September 28, 2022, Oncurious entered into an
agreement with VIB concerning the assignment of intellec-
tual property rights and know-how, and the termination of
certain licenses. The assignment concerns Oncurious’ C-C
motif chemokine receptor 8 (CCR8) program, as well as
other undisclosed assets. The assignment does not include
Oncurious’ TB-403 asset. The agreement was concluded
following the decision of Oncurious not to further invest in
the foreground technology of several discovery stage and
preclinical programs. In consideration of Oxurions contri-
butions towards the development of foreground technol-
ogy by Oncurious, prior to Oncurious’ abandonment and
assignment to VIB thereof, the parties agreed on a revenue
sharing agreement with Oxurion upon VIB’s valorization of
such foreground technology.
On December 14, 2022, Oxurion purchased 2,018 shares
in Oncurious from VIB for 1 euro .
Other Commitments
in three tranches to be called at Oxurions full discretion.
Similar to Part B of the funding program with Negma, the
Research and development commitments
liquidity requirement was eliminated, and the conversion
price of the shares was 80% of the lowest closing VWAP
At December 31, 2022, the Group had commitments
over the 15 consecutive trading days in advance of the
outstanding in the context of research and development
conversion notice.
agreements amounting to 11.0 million euro compared to
18.0 million euro in 2021, payable over the course of the
On March 1, 2023, the funding program with Negma
following twelve months to various research subcontrac-
ended according to the terms of the agreements.
tors, but primarily to Syneos.
On March 1, 2023, the Company entered into the Atlas
Contingent liability
Subscription Agreement for mandatory convertible
bonds with Atlas Special Opportunities, LLC providing
The expenses incurred in several of the Groups research
for up to 20 million euro in financing. Under the terms
and development programs have been reimbursed by
of the Subscription Agreement, Atlas has committed to
VLAIO, formerly known as IWT, as a government grant.
subscribe to up to 20 million euro in mandatorily convert-
Contracts with VLAIO generally include a clause that
ible bonds over a 24-month period at Oxurions discretion.
defines the need for validation of the project results in
The conversion price is set at an eight percent discount
order for the grant to be effectively earned. Should this
to the average VWAP over the three lowest days in the
validation not occur, VLAIO has the right to reclaim the
ten consecutive trading days prior to the conversion notice.
funds previously granted. The Group considers this as a
The Company will pay a fee of 800,000 euro in bonds,
remote possibility. Please refer to the accounting policy
which will be issued together with the first tranche, raising
described in section 5.5.3 (G) and the rationale used in
the total amount of the available bonds to 20.8 million
order to recognize grant income over the course of the
euro. The funding will be provided in nine tranches, with
project. Total amounts received in 2021 with respect to
the first tranche including a Part A of 2.8 million euro
government grants from VLAIO amount to 0.228 million
(including the fee) and Part B of 2 million euro, and sub-
euro. No amounts were received in 2022.
sequent tranches of 2 million euro each with a cool-down
period of 22 trading days between tranches (except for
Related parties
between Part A and Part B of the first tranche where there
is no cool down period). Provided the conditions precedent
Other than members of the Board of Directors, no other
are met, the decision to issue one or more tranches is at
related parties have been identified.
the discretion of the Company. Certain of the conditions
precedents are not within the Company’s control, including
Subsequent events
that the Company’s total trading volume in the prior 22
trading days exceeds 1.5 million euro and that its average
On January 25, 2023, the Company has further amended
market capitalization exceeds 4 million euro (or 2 million
its mandatory convertible bonds issuance and sub-
euro for a 1 million euro tranche).
scription agreement with the Negma Group. Before the
amendment, Negma had subscribed to 11 million euro in
convertible bonds. Pursuant to the amendment, Negma
agreed to subscribe to up to 4 million euro (1,600 bonds)
122
OXURION ANNUAL REPORT 2022
123
OXURION ANNUAL REPORT 2022
In addition, on March 1, 2023, Oxurion amended the terms
of its convertible bond loan agreement with Kreos Capital
and Pontifax Ventures, originally signed on November 22,
2021, (as already amended on June 30, 2022), to reduce
the Company’s debt by approximately 1 million euro by
making a prepayment in exchange for a corresponding
reduction in its cash covenant and other benefits.
On March 14, 2023, Oxurion announced that given their
other commitments, Dr. David Guyer and Dr. Adrienne
Graves decided to resign from the Company’s Board of
Directors and that Dr. Anat Loewenstein, Director of the
Department of Ophthalmology at Tel Aviv University, and
Nathalie Laarakker, Chief Financial Officer at Intravacc B.V.
in the Netherlands, have agreed to be co-opted as inde-
pendent directors. The co-optation is subject to ratification
by the Company’s Annual General Shareholders Meeting
on May 2, 2023.
Done on March 30, 2023,
On behalf of the Board of Directors
124
OXURION ANNUAL REPORT 2022
6. STATUTORY AUDITORS REPORT
TO THE GENERAL SHAREHOLDERS
MEETING ON THE CONSOLIDATED
ACCOUNTS FOR THE YEAR ENDED
31 DECEMBER 2022
125
OXURION ANNUAL REPORT 2022
We present to you our statutory auditor’s report in the context of our statutory audit of
the consolidated accounts of Oxurion NV (the “Company”) and its subsidiaries (jointly
“the Group”). This report includes our report on the consolidated accounts, as well as
the other legal and regulatory requirements. This forms part of an integrated whole and
is indivisible.
We have been appointed as statutory auditor by the general meeting d.d. 3 May 2022,
following the proposal formulated by the board of directors and following the
recommendation by the audit committee. Our mandate will expire on the date of the
general meeting which will deliberate on the annual accounts for the year ended 31
December 2024. We have performed the statutory audit of the Groups consolidated
accounts for 1 consecutive year.
REPORT ON THE CONSOLIDATED ACCOUNTS
Unqualified opinion
We have performed the statutory audit of the Groups consolidated accounts, which comprise the consolidated statement
of financial position as at 31 December 2022, the consolidated statement of profit or loss, the consolidated statement of
changes in equity and the consolidated statement of cash flows for the year 31 December 2022 then ended, and notes to the
consolidated financial statements, including a summary of significant accounting policies and other explanatory information,
and which is characterised by a consolidated statement of financial position total of EUR ‘000 11.993 and a loss for the year
of EUR ‘000 31.693.
In our opinion, the consolidated accounts give a true and fair view of the Groups net equity and consolidated financial position
as at 31 December 2022, and of its consolidated financial performance and its consolidated cash flows for the year then ended,
in accordance with International Financial Reporting Standards as adopted by the European Union and with the legal and regu-
latory requirements applicable in Belgium.
Basis for unqualified opinion
Based on the above, the Board of Directors considers it may
be reasonable to expect that there will be sufficient cash to
We conducted our audit in accordance with International
continue its operations during the next twelve months, and
Standards on Auditing (ISAs) as applicable in Belgium.
therefore decided to continue its valuation rules under the
Furthermore, we have applied the International Standards
assumption of going concern. However, there is a material
on Auditing as approved by the IAASB which are applica-
uncertainty relating to going concern of the Group because
ble to the year-end and which are not yet approved at the
it is uncertain that the above-mentioned committed but
national level. Our responsibilities under those standards are
conditional funding will be available when needed given
further described in the “Statutory auditor’s responsibilities
the conditions related to the funding and because it is not
for the audit of the consolidated accounts” section of our
certain whether the Group will be able to timely obtain the
report. We have fulfilled our ethical responsibilities in accor-
necessary additional funding through debt, equity, or non-di-
dance with the ethical requirements that are relevant to our
lutive funding, partnering or to realize sufficient cost and
audit of the consolidated accounts in Belgium, including the
investment reductions.
requirements related to independence.
These events or conditions as set forth in Note 5.5.3.(B)
We have obtained from the board of directors and Company
indicate that a material uncertainty exists that may cast sig-
officials the explanations and information necessary for per-
nificant doubt on the Groups ability to continue as a going
forming our audit.
concern. Our opinion is not modified in respect of this matter.
We believe that the audit evidence we have obtained is suf-
Key audit matters
ficient and appropriate to provide a basis for our opinion.
Key audit matters are those matters that, in our profession-
Material Uncertainty Related to Going Concern
al judgment, were of most significance in our audit of the
consolidated accounts of the current period. These matters
We draw attention to Note 5.5.3 (B) in the consolidated
were addressed in the context of our audit of the consol-
accounts, which indicates that the Groups cash balance at
idated accounts as a whole, and in forming our opinion
31 December 2022 is not sufficient to fund the Groups op-
thereon, and we do not provide a separate opinion on these
erations during the next twelve months.
matters. In addition to the matter described in the “Material
Uncertainty Related to Going Concern” section, we have de-
Post-closing, the Group entered into a subscription agreement
termined the matters described below to be the key audit
for convertible bonds with Atlas Special Opportunities LLC.
matters to be communicated in our report.
This committed but conditional funding would be sufficient
to fund operations during the next twelve months from the
financial statements’ issue date. However, given the contin-
gent nature of this funding, the Group is actively exploring
the possibility of obtaining additional funding through debt,
equity or non-dilutive funding, including the licensing of
THR-149, or alternatively reducing its costs and investments
so that there should be sufficient cash to continue its opera-
tions during the next twelve months.
126
OXURION ANNUAL REPORT 2022
127
OXURION ANNUAL REPORT 2022
Issuance and valuation of convertible bonds under
the Negma Group Ltd Issuance and Subscription
agreement – Note 5.7.11
Description of the Key Audit Matter
As described in Note 5.7.11 to the consolidated financial
statements, the Company entered into an agreement
whereby Negma Group Ltd. as investor can subscribe to up
to 12.000 mandatory convertible bonds (class A) with each
a nominal value of €2.500, in several tranches of minimum
200 and maximum 1.000 bonds for a total committed
amount up to €30 million.
On 2 September 2022, the parties amended the terms and
conditions of part of the above funding program (part B)
for an amount of up to €6 million of the total commitment
through issuance and subscription of up to 2.400 convert-
ible bonds (class B) through several tranches, to be called
by the issuer at its discretion over the period between 2
September 2022 up to 21 December 2022.
The initial fair value of the convertible loan equals an amount
of cash received in the amount of €9,650 million of which
€2,5 million was received in 2021 and €7,150 million was
received in 2022 (€5 million class A and €4,650 million
class B). A total of €1,350 million was already converted
into shares before 31 December 2021. During 2022 another
€9,025 million has been converted into shares before 31
December 2022, following the conversion of in aggregate
3.610 convertible bonds issued.
The Company evaluated and determined that the con-
vertible bonds described meet the definition of a derivative
financial liability and designated the entire instrument at fair
value through profit and loss. The outstanding convertible
loan has a nominal value of €0,5 million as per 31 December
2022 and the fair value is determined at €1,06 million with
changes in the fair value recorded in profit and loss as fair
value gains and losses on the convertible loan.
We identified the accounting and the valuation of the
issuance of the convertible bonds as a key audit matter.
Auditing the following elements involved especially chal-
lenging and complex auditor judgment with respect to (i) the
Company’s accounting assessment related to the financial
instrument and (ii) the calculation of the valuation related to
the financial liability.
How our Audit addressed the Key Audit Matter
We have assessed the accuracy, existence and com-
pleteness of the financial liability as per 31 December
2022. This assessment included:
Analysing and reading the convertible transaction,
issuance and subscription agreement to create an
understanding of the impact on the financial state-
ments and its disclosures.
Inquiries of management and in-house legal
counsel.
Recalculation of impacts through profit and loss
and equity.
Tracing of corroborative evidence of the amounts
paid due to issuance of the convertible bonds and
to the amounts converted.
Checking the classification of the liability in the
financial statements.
We have utilised our internal IFRS accounting special-
ists’ knowledge and evaluated the appropriateness of
management’s application of accounting guidance
for complex financial instruments as adopted by the
Company in accordance with IFRS as adopted by the
European Union (“EU”).
We have utilised our internal valuation specialists
knowledge and evaluated the appropriateness of the
methodology and the reasonableness of assump-
tions used by the Company’s valuation of the financial
liability. A Monte Carlo approach was used to reflect
the Asian tail character of the option (conversion price
128
OXURION ANNUAL REPORT 2022
is lowest VWAP of the last 15 days x 80%). The impact
of the volatility and interest rate was limited as the
options were deep in the money due to the evolution
of the share price.
We have assessed the adequacy of the Company’s
disclosures in the notes of the Consolidated
Financial Statements.
Issuance and valuation of convertible bonds under
the Kreos Capital VI Ltd and Pontifax Medison
Finance LP loan facility agreement – Note 5.7.11
Description of the Key Audit Matter
As described in Note 5.7.11 to the consolidated financial
statements, the Company entered into an agreement
whereby Kreos Capital VI Ltd. together with Pontifax Medison
Finance L.P. as investors can subscribe to convertible bonds
with each a nominal value of €0,1 million, in two tranches of
each €10 million for a total committed amount up to €20
million. The convertible bonds accrue interest in the amount
of 7.95% per year.
The initial fair value of the convertible loan equals to an
amount of cash received which is €10 million as per 31
December 2021. The Company evaluated and determined
that the convertible bonds described meets the definition
of a derivative financial liability and designated the entire
instrument at fair value through profit and loss.
Subsequently the fair value is determined as the probability
weighted average of the fair values of different scenarios
considering the pre-payment agreed on 21 June 2022.
The fair value as per 31 December 2022, is determined
at €5,984 million, taking into account the repayment of
€3,6 million (consisting of €3 million early repayment and
€0,605 million repayment following the payment schedule),
with changes in the fair value recorded in profit and loss as
fair value gains and losses on the convertible loan.
We identified the accounting and the valuation of the
issuance of the convertible bonds as a key audit matter.
Auditing the following elements involved especially chal-
lenging and complex auditor judgment with respect to (i) the
Company’s accounting assessment related to the financial
instrument and (ii) the calculation of the valuation related to
the financial liability.
How our Audit addressed the Key Audit Matter
We have assessed the accuracy, existence and com-
pleteness of the financial liability as per 31 December
2022. This assessment included:
Analysing and reading the convertible transaction,
issuance and subscription agreement to create an
understanding of the impact on the financial state-
ments and its disclosures.
Inquiries of management and in-house legal
counsel.
Recalculation of impacts through profit and loss
and equity.
Tracing of corroborative evidence of the amounts
repaid.
Checking the classification of the liability in the
financial statements.
We have utilized our internal IFRS accounting special-
ists’ knowledge and evaluated the appropriateness of
management’s application of accounting guidance
for complex financial instruments as adopted by the
Company in accordance with IFRS as adopted by the
European Union (“EU”).
We have utilized our internal valuation specialists
knowledge and evaluated the appropriateness of the
methodology and the reasonableness of assump-
tions used by the Company’s valuation of the financial
liability. A standard option valuation model was used to
estimate the value of the conversion option at the date
of issuance of the bond and at the end of the year. The
key market parameters for this valuation were the level
of the share price, the volatility of the underlying option
and the level of interest rate.
129
OXURION ANNUAL REPORT 2022
We have assessed the adequacy of the Company’s
disclosures in the notes of the Consolidated Financial
Statements.
Responsibilities of the board of directors for the
preparation of the consolidated accounts
The board of directors is responsible for the preparation of
consolidated accounts that give a true and fair view in ac-
cordance with International Financial Reporting Standards
as adopted by the European Union and with the legal and
regulatory requirements applicable in Belgium, and for
such internal control as the board of directors determine
is necessary to enable the preparation of consolidated
accounts that are free from material misstatement, whether
due to fraud or error.
In preparing the consolidated accounts, the board of directors
is responsible for assessing the Groups 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 intend to
liquidate the Group or to cease operations, or has no realistic
alternative but to do so.
Statutory auditor’s responsibilities for the audit of the
consolidated accounts
Our objectives are to obtain reasonable assurance about
whether the consolidated accounts 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 users taken on the basis of these consolidated
accounts.
In performing our audit, we comply with the legal, regulatory
and normative framework applicable to the audit of the con-
solidated accounts in Belgium. A statutory audit does not
provide any assurance as to the Groups future viability nor
as to the efficiency or effectiveness of the board of directors
current or future business management at Group level. Our
responsibilities in respect of the use of the going concern
basis of accounting by the board of directors are described
below.
As part of an audit in accordance with ISAs, we exercise
professional judgment and maintain professional skepticism
throughout the audit. We also:
Identify and assess the risks of material misstatement
of the consolidated accounts, whether due to fraud or
error, design and perform audit procedures responsive
to those risks, and obtain audit evidence that is suffi-
cient 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, in-
tentional omissions, misrepresentations, or the override
of internal control;
Obtain an understanding of internal control 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 Groups internal control;
Evaluate the appropriateness of accounting policies
used and the reasonableness of accounting estimates
and related disclosures made by the board of directors;
Conclude on the appropriateness of the 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 condi-
tions that may cast significant doubt on the Groups
ability to continue as a going concern. If we conclude
that a material uncertainty exists, we are required to
draw attention in our statutory auditor’s report to the
related disclosures in the consolidated accounts or, if
such disclosures are inadequate, to modify our opinion.
130
OXURION ANNUAL REPORT 2022
Our conclusions are based on the audit evidence
obtained up to the date of our statutory auditor’s 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 accounts, including the disclosures,
and whether the consolidated accounts represent the
underlying transactions and events in a manner that
achieves fair presentation;
Obtain sufficient and 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 per-
formance of the Group audit. We remain solely respon-
sible for our audit opinion.
We communicate with the board of directors and 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 board of directors and with 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 in-
dependence, and where applicable, related safeguards.
From the matters communicated with the board of directors
and with the audit committee, we determine those matters
that were of most significance in the audit of the consoli-
dated accounts 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 directors’ report on the consolidated
accounts, and the other information included in the annual
report on the consolidated accounts.
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 (ISAs) as applicable in
Belgium, our responsibility is to verify, in all material respects,
the directors’ report on the consolidated accounts, and the
other information included in the annual report on the con-
solidated accounts and to report on these matters.
Aspects related to the directors’ report on the
consolidated accounts and to the other information
included in the annual report on the consolidated
accounts
In our opinion, after having performed specific procedures in
relation to the directors’ report on the consolidated accounts,
this directors’ report is consistent with the consolidated
accounts for the year under audit and is prepared in accor-
dance with article 3:32 of the Companies’ and Associations
Code.
In the context of our audit of the consolidated accounts, we
are also responsible for considering, in particular based on
the knowledge acquired resulting from the audit, whether the
directors’ report on the consolidated accounts and the other
information included in the annual report on the consolidat-
ed accounts is materially misstated or contains information
which is inadequately disclosed or otherwise misleading. In
light of the procedures we have performed, there are no
material misstatements we have to report to you.
131
OXURION ANNUAL REPORT 2022
Statement related to independence
Our registered audit firm and our network did not
provide services which are incompatible with the
statutory audit of the consolidated accounts, and our
registered audit firm remained independent of the
Group in the course of our mandate.
The fees for additional services which are compatible
with the statutory audit of the consolidated accounts
referred to in article 3:65 of the Companies’ and
Associations’ Code are correctly disclosed and itemized
in the notes to the consolidated accounts.
European Uniform Electronic Format (ESEF)
We have also verified, in accordance with the draft standard
on the verification of the compliance of the financial state-
ments with the European Uniform Electronic Format (here-
inafter “ESEF”), the compliance of the ESEF format with the
regulatory technical standards established by the European
Delegate Regulation No. 2019/815 of 17 December 2018
(hereinafter: “Delegated Regulation”).
The board of directors is responsible for the preparation, in
accordance with ESEF requirements, of the consolidated
financial statements in the form of an electronic file in ESEF
format (hereinafter “digital consolidated financial state-
ments”) included in the annual financial report.
Our responsibility is to obtain sufficient appropriate evidence
to conclude that the format and marking language of the
digital consolidated financial statements complies in all
material respects with the ESEF requirements under the
Delegated Regulation.
Based on the work we have performed, we believe that the
format of and marking of information in the digital consoli-
dated financial statements included in the annual financial
report of Oxurion NV per 31December 2022 complies in
all material respects with the ESEF requirements under the
Delegated Regulation.
Other statements
This report is consistent with the additional report to the
audit committee referred to in article 11 of the Regulation
(EU) N° 537/2014.
Diegem, 31 March 2023
The statutory auditor
PwC Reviseurs d’Entreprises SRL / PwC Bedrijfsrevisoren BV
Represented by
Didier Delanoye
Réviseur d’Entreprises / Bedrijfsrevisor
132
OXURION ANNUAL REPORT 2022
133
OXURION ANNUAL REPORT 2022
7. ABBREVIATED STATUTORY FINANCIAL
STATEMENTS
.
The financial statements of Oxurion are presented in an
abbreviated form.
The The Annual Report, the financial statements and the
opinion of the Statutory Auditor are filed at the National
Bank of Belgium in accordance with Articles 3:10 and 3:12
of the BCCA.
The full version of the statutory financial statements and
the reports are available free of charge for the public in
English and Dutch upon request to:
Oxurion NV
to the attention of Michaël DILLEN
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32 16 75 13 10
Fax: +32 16 75 13 11
e-mail: IR@oxurion.com
There is also an electronic version of the full statutory
Annual Report and the reports which can be obtained
via Oxurions website (www.oxurion.com). The statutory
financial statements as filed with the National Bank of
Belgium are based upon Belgian GAAP. An unqualified
audit opinion was issued by the Statutory Auditor.
134
OXURION ANNUAL REPORT 2022
7.1 BALANCE SHEET OF OXURION NV
IN '000 EURO (AS AT 31 DECEMBER) 2022 2021
ASSETS
Fixed Assets 338 2,084
Intangible fixed assets 0 1,000
Tangible fixed assets 98 118
Financial fixed assets 240 966
Current assets 8,107 14,666
Amounts receivable after more than
one year
3,473 3,647
Inventories and work in progress 5 60
Amounts receivable within one year 927 1,142
Current investments 95 242
Cash and banks 3,307 9,426
Deferred charges and accrued income 300 149
TOTAL ASSETS 8,445 16,750
LIABILITIES
Equity -6,418 -1,389
Capital 75,856 56,442
Share premium account 250 234
Reserves 5,533 5,333
Accumulated profits (losses) -88,057 -63,597
Amounts payable 14,863 18,139
Amounts payable after more than one
year
3,576 8,412
Amounts payable within one year 10,686 9,283
Accrued charges and deferred income 601 444
TOTAL LIABILITIES 8,445 16,750
7. 2 INCOME STATEMENT OF
OXURION NV
IN '000 EURO (FOR THE YEAR ENDED
31 DECEMBER)
2022 2021
Operating income and charges
Gross margin 1,454 6,069
Remuneration, social security costs and
pensions
-4,851 -7,376
Depreciation of and amounts written off
formation expenses, intangible and tangible
fixed assets
-17,919 -23,744
Amounts written down stock, contracts in
progress and trade debtors - Appropriations
(write-backs)
-35 -283
Other operating charges -415 -431
Non-recurring operating charges / operating
income
-1,780 -10,991
Operating profit (loss) -23,546 -36,756
Financial income 233 138
Financial charges -1,746 -875
Profit (loss) for the period before taxes -25,059 -37,493
Income taxes 599 799
Profit (loss) for the period -24,460 -36,694
Profit (loss) for the period available for
appropriation
-24,460 -36,694
135
OXURION ANNUAL REPORT 2022
7.3 APPROPRIATION ACCOUNT OF
OXURION NV
IN '000 EURO (FOR THE YEAR ENDED AT
31 DECEMBER)
2022 2021
Profit (loss) to be appropriated -88,057 -63,597
Gain (loss) to be appropriated -24,460 -36,694
Profit (loss) to be carried forward -63,597 -26,903
Transfers from capital and reserves 0 0
from capital and share premium
account
0 0
from reserves 0 0
Profit (loss) to be carried forward -88,057 -63,597
7.4 KEY VALUATION PRINCIPLES
INTANGIBLE ASSETS
Internally generated intangible assets
Research costs are charged to the income statement as
incurred.
An internally generated intangible fixed asset (see note
5.7.3) which arises from development activities undertak-
en in the Group is recognized only if all of the following
conditions are met:
Technical possibility of making the intangible asset
ready for use.
Intention is to complete the intangible asset and use
or sell it.
Possibility of using or selling the intangible asset.
Probability that the intangible asset will generate future
economic benefit or demonstrate the existence of a
market.
Availability of adequate technical, sufficient financial
resources to complete the development; and
Availability to reliably measure the attributed expenses
for this intangible asset during development.
Patent costs for protecting intangible assets are recognized
as an expense.
After their initial recording on the balance sheet, intangible
assets are valued at cost less accumulated depreciation
and accumulated impairment losses. Depreciation of cap-
italized development costs are recognized in the income
statement under ‘Research and Development Expenses’.
The capitalized costs are amortized over the life of a patent
as of the moment that it will generate revenue.
Where the criteria for capitalization of the research and
development expenses are not met, these expenses are
recorded as incurred during the period.
Oxurion has capitalized ocriplasmin clinical trial costs since
Depreciation is calculated using the straight-line method to
2008 due to the fact that this project was at that moment
allocate the cost of property, plant and equipment to their
in Phase 3 and future commercialization was estimated
estimated residual values over their estimated useful lives
to be highly probable. The intangible assets consist of
as follows:
external trial and production costs with subcontractors and
internal development costs regarding all projects in Phase
Property, plant and equipment: 3 to 5 years
3. An impairment test determined that the value of these
Furniture and fittings: 3 to 5 years
assets was no longer justified and as a consequence these
assets were written off on June 30, 2019.
The depreciation and amortization methods, useful life and
residual value are re-valued on each reporting date.
Intangible assets purchased
Subsequent costs
Computer software licenses acquired are capitalized on
the basis of the costs incurred to acquire and bring to use
The cost of replacing part of an item of property, plant
the specific software. These costs are amortized over their
and equipment is recognized in the carrying amount of
estimated useful life which is typically considered to be
the item if it is probable that the future economic benefits
three years.
embodied within the part will flow to the Group and its
cost can be measured reliably. The carrying amount of the
Knowledge acquired in the form of licenses is recorded
replaced part is derecognized. The costs of the day-to-day
at cost less accumulated amortization and impairment.
servicing of property, plant and equipment are expensed
These amounts are amortized on a straight-line basis over
as incurred.
their estimated useful life, which is the period over which
the Group expects to receive economic benefits from such
INVENTORIES
licenses.
Raw and ancillary materials and commodities are stated
TANGIBLE ASSETS
at the lower of cost or net realizable value. The inventory
costing system is based on the FIFO-method.
Property, plant, and equipment are included at the histori-
cal cost (material costs only) less accumulated deprecia-
Goods in process and finished goods are stated at the
tion. Subsequent costs are included in the carrying amount
standard manufacturing cost or net realizable value. The
for the asset or booked as a separate asset as appropriate,
inventory costing system is based on the FIFO-method.
but only when it is probable that future economic benefits
associated with the item will be generated for the Group
Net realizable value test is performed each reporting
and the cost price of the item can be measured reliably.
period. Net realizable value is the estimated selling price
All other repair and maintenance costs are charged to the
in the ordinary course of business less the estimated costs
income statement as incurred. The cost of assets retired or
of completion and the estimated costs necessary to make
otherwise disposed of and the related accumulated depre-
the sale.
ciation are included in the income statement as part of the
gain or loss on disposal in the year of disposal. Gains and
losses on disposal of property, plant and equipment are
included in other income or expense.
136
OXURION ANNUAL REPORT 2022
137
OXURION ANNUAL REPORT 2022
The standard manufacturing price of the goods in process
and of the finished goods, includes (i) the acquisition value
of the raw materials, consumables and ancillary materials,
(ii) the production costs which are directly attributable
to the product, and (iii) the proportioned part of the pro-
duction costs which are only indirectly attributable to the
product, in so far that these costs cover the normal pro-
duction period.
The standard manufacturing price is compared to the
actual manufacturing price on an annual basis. The differ-
ence results in an adjustment of the value of the inventory.
TRADE RECEIVABLES
When initially recognized, trade receivables are measured
at fair value, and are subsequently measured at amortized
cost using the effective interest rate method. Appropriate
allowances for estimated irrecoverable amounts are
included in the income statement when there is objective
evidence that the asset is impaired. Allowance for bad
debts are booked on the basis of an estimate of lifetime
credit losses at each reporting date, taking into account
the payment history of the other party. An allowance for
impairment of trade and other receivables is established
when there is objective evidence that the Company will
not be able to collect all amounts due according to the
original terms of the receivables. Impairment losses are
generally recorded on receivables in the event of insolven-
cy or similar proceedings being launched, financial restruc-
turing at business partners, or the initiation of enforcement
measures. Payment history and past-due receivables are
also analyzed, with customer-specific facts assessed in
each case.
INVESTMENTS
The investments are held as available for sale and annual
closing date stated at market value. The fair value adjust-
ment is included in other reserves until the investment is
derecognized or has been impaired. The impairment is
included in the income statement.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents comprise demand deposits
and other short-term, highly liquid investments (with less
than three months to maturity) that are readily convertible
into a known amount of cash and are subject to an insig-
nificant risk of fluctuations in value.
FINANCIAL LIABILITIES AND EQUITY
Financial liabilities and equity instruments issued by the
Group are classified according to the substance of the con-
tractual arrangements entered into and the definitions of a
financial liability and an equity instrument. An equity instru-
ment is any contract that evidences a residual interest in
the assets of the Group after deducting all its liabilities. The
accounting policies adopted for specific financial liabilities
and equity instruments are set out below.
TRADE PAYABLES
Trade payables are initially measured at fair value, and
are subsequently measured at amortized cost, using the
effective interest rate method.
CONVERTIBLE LOANS
The convertible loans are - in line with the CBN advice
2019/07 of July 3, 2019 - valued at issue value. The costs
associated with the issuance of these loans are recognized
in the income statement.
The Company currently has 2 convertible loans:
Repaid based on the amortization schedule with
extension.
Negma Group Ltd.
Prepaid when certain conditions are met.
Paid in full in case of events of default or change in
On August 26, 2021, Oxurion (the Company or the Issuer)
control.
entered into an agreement whereby Negma as investor
is willing to subscribe to, up to 12,000 zero coupon au-
For the classification as of December 31, 2022, the amor-
tomatically convertible bonds with each a nominal value
tization schedule without extension has been taken into
of 2,500 euro, in several tranches of minimum 200 and
account to divide the loan into “Amounts payable after
maximum 1,000 bonds for a total committed amount up
more than one year” and “Amounts payable within one
to 30 million euro. The Company as issuer controls the
year”.
timing and amount of the tranche calls.
As of December 31, 2022, the Company has received 10
Since the term of the convertible loan is less than twelve
million euro and has repaid 3.385 million euro.
months, it is included in “Amounts payable within one year”.
TAX CREDIT RECEIVABLES AFTER MORE THAN ONE
As of December 31, 2022, the Company has received
YEAR
9.650 million euro of which a total of 9.150 million euro
has already been converted into shares.
As from 2018, based on the CBN opinion 2018/02
published on March 21, 2018, the tax credit to be received
Kreos Capital / Pontifax Ventures
within one year is recorded under taxes and withhold-
ing taxes to be recovered (#412). To the extent that the
On November 21, 2021, Oxurion (the Company or the
repayment is estimated to occur only after more than one
Issuer) entered into the Loan Facility whereby Kreos
year, this receivable is recorded as other receivables after
Capital VI Limited together with Pontifax Medison Finance
more than one year (#291).
L.P. (the Investors) as investors are willing to subscribe to
convertible bonds with each a nominal value of 0.1 million
euro, in an amount of 10.0 million euro. The Investors are
entitled to a transaction fee of 0.125 million euro and an
end of loan payment equal to 3.5% that shall accrue on
the amount drawn under each tranche. The convertible
bonds accrue interest in the amount of 7.95% per year.
The convertible bonds may be either:
Converted in shares at the option of the Investors at
any time.
Converted in shares at the option of the Issuer when
certain conditions are met.
Repaid based on the amortization schedule without
extension.
138
OXURION ANNUAL REPORT 2022
139
OXURION ANNUAL REPORT 2022
140
OXURION ANNUAL REPORT 2022
8. GLOSSARY
141
OXURION ANNUAL REPORT 2022
Atlas Atlas Special Opportunities, LLC
AGM Annual General Shareholders’ Meeting
Annual Report Has the meaning given to it in Section 1.1.
Anti-VEGF Anti-vascular endothelial growth factor
Articles of Association The Company’s coordinated articles of association
Atlas Funding Program Funding program pursuant to the Atlas Subscription Agreement according to which Atlas has
committed to subscribe to up to 20 million euro in the Company’s equity through mandatory
convertible bonds.
Atlas Subscription
Agreement
Subscription Agreement entered into on March 1, 2023, between Oxurion and Atlas Special
Opportunities, LLC (“Atlas”), providing for up to 20 million euro in financing through mandatory
convertible bonds
Audit Committee Has the meaning given to it in Section 3.6.8.
BCCA The Belgian Code of Companies and Associations of March 23, 2019 (as amended from time
to time)
Bicycle Collaboration
Agreement
Collaboration agreement entered into between Oxurion and Bicycle Therapeutics in August
2013
Board of Directors Has the meaning given to it in Section 1.1.
CEO Chief Executive Officer
CFO Chief Financial Officer
cGMP Good Clinical Manufacturing
Clinical Asset Means THR-149
Code of Business
Conduct
Has the meaning given to it in Section 4.3.2.
Company Oxurion NV, having its registered office at Gaston Geenslaan 1, 3001 Leuven, registered in the
register of legal entities (Leuven) under number 0881.620.924
Corporate Governance
Charter
Oxurions Corporate Governance Charter
Corporate Governance
Code
The 2020 Belgian Code on Corporate Governance
CROs Clinical Research Organizations
DBO Defined Benefit Obligation
DME Diabetic Macular Edema
DR Diabetic Retinopathy
ECLs Expected credit losses
EGM Extraordinary general shareholders’ meeting
EIR Effective interest rate
EMA European Medicines Agency
ERP Enterprise resource planning
EU European Union
142
OXURION ANNUAL REPORT 2022
Executives Members of the Executive Committee
Executive Committee Has the meaning given to it in Section 3.5.7.2.
FDA US Food and Drug Administration
FSMA Financial Services and Markets Authority (Belgium)
Galapagos License
Agreement or the
Galapagos License
Global and exclusive in-licensing agreement entered into between Oxurion and Galapagos NV
GCP Good Clinical Practice
GLP Good Laboratory Practice
GDPR General Data Protection Regulation
Group Has the meaning given to it in Section 3.2.3.
Half Year Report The (unaudited) interim financial report of the Company on the half-year results as at 30 June
2022
IAS International Accounting Standard
IASB International Accounting Standards Board
IFRS International Financial Reporting Standards
IFRS IC IFRS Interpretations Committee
Inceptua Has the meaning given to it in Section 3.2.3.
INTEGRAL trial Has the meaning given to it in Section 3.2.5.
IP Intellectual Property
Issue Date The date of issuance of this Annual Report
IT Information Technology
IVT Intravitreal
IWT Agency for Innovation by Science and Technology in Flanders
JETREA® Has the meaning given to it in Section 3.2.3.
KALAHARI trial Has the meaning given to it in Section 3.2.5.
Kreos Kreos Capital VI (UK) Limited
KU Leuven Catholic University of Leuven
Liquidity Condition Has the meaning given to it in Section 3.5.1.1
Lenders Pontifax and Kreos, collectively
Loan Facility Has the meaning given to it in Section 3.5.8.3.
Market Abuse
Regulation
Regulation (EU) No 596/2014 of the European Parliament and of the Council of April 16, 2014,
on Market Abuse
Market Capitalization
Condition
Has the meaning given to it in Section 3.5.1.1
Minimum Cash
Covenant
Has the meaning given to it in Section 3.5.1.1
MBA Master of Business Administration
ME-RVO Retinal Vein Occlusion
143
OXURION ANNUAL REPORT 2022
MSA Has the meaning given to it in Section 5.8.
Negma Negma Group Ltd.
Negma Funding
Program
Funding program as set out in the issuance and subscription agreement entered into by the
Company with the Negma Group Ltd. on 26 August 2021, as amended
NGO Non-Governmental Organization
Nomination and
Remuneration
Committee
Has the meaning given to it in Section 4.3.1.
NV Public limited liability company (in Dutch: Naamloze Vennootschap)
OCI Other Comprehensive Income
Oncurious Oncurious NV, having its registered office at Gaston Geenslaan 1, 3001 Leuven, registered in the
register of legal entities (Leuven) under number 0627.952.462
Ophthalmology The branch of medicine that deals with the diagnosis, prevention, and treatment of disorders of
the eye
Oxurion Oxurion NV, having its registered office at Gaston Geenslaan 1, 3001 Leuven, registered in the
register of legal entities (Leuven) under number 0881.620.924
PKal-Kinin Plasma kallikrein kinin
Policy Has the meaning given to it in Section 4.9.
Pontifax Cayman Pontifax Medison Finance (Cayman) L.P.
Pontifax Israel Pontifax Medison Finance (Israel) L.P.
Pontifax Pontifax Israel and Pontifax Cayman, collectively.
Receiving Parties Has the meaning given to it in Section 3.5.6.2.
Regulator(s) FDA, EMA and other similar regulatory agencies
Remuneration Policy Oxurions remuneration policy, as adopted in 2021
R&D Research and Development
SPPI Solely payments of principal and interest
Statutory Auditor PricewaterhouseCoopers Bedrijfsrevisoren BV, a limited liability company incorporated under
Belgian law, having its registered office at Culliganlaan 5, 1J, 1831 Diegem, represented by Didier
Delanoye, auditor
Subscription Rights
Plan 2021-1
Has the meaning given to it in Section 4.9.2.1 (C).
Subscription Rights
Plan 2021-2
Has the meaning given to it in Section 4.9.2.1 (C).
Subscription Rights
Plan 2021-3
Has the meaning given to it in Section 4.9.2.1 (C).
Subscription Plans
2021
Means the Subscription Rights Plan 2021-1, 2021-2 and 2021-3 collectively
Syneos Has the meaning given to it in Section 5.8
Thromb-X Has the meaning given to it in Section 3.2.3.
ThromboGenics Inc. Has the meaning given to it in Section 3.2.3.
144
OXURION ANNUAL REPORT 2022
Trials The KALAHARI trial and the INTEGRAL trial
Tripartite Agreement Has the meaning given to it in Section 5.8.
UC Louvain Université Catholique de Louvain
US United States of America
VEGF Vascular Endothelial Growth Factor
VIB or Flanders Institute
for Biotechnology
Flanders Institute for Biotechnology VZW, having its registered office at Rijvisschestraat 120,
9052 Zwijnaarde, registered in the register of legal entities (Ghent – Division Ghent) under
number 0456.343.923
VLAIO Flanders Innovation & Entrepreneurship
Work Orders Has the meaning given to it in Section 5.8.
wet AMD Wet age-related macular degeneration
2018 Agreement Exclusive commercial agreement entered into between Oxurion and Eumedica in view of
JETREA®
Headquarters
Oxurion NV
Gaston Geenslaan 1
3001 Leuven
Belgium
T +32 16 75 13 10
F +32 16 75 13 11
United States subsidiary
ThromboGenics, Inc.
Belgian subsidiary
Oncurious NV
145
OXURION ANNUAL REPORT 2022
146
OXURION ANNUAL REPORT 2022