BERGENBIO
Annual Report & Accounts 2023
Focused on advancing
selective AXL inhibition
to improve the lives of
lung cancer patients
ANNUAL REPORT & ACCOUNTS 2023
BERGENBIO
Annual Report & Accounts 2023
02
2023 Highlights
BerGenBio (OSE: BGBIO) is a clinical stage biopharmaceutical company developing selective AXL inhibitors to treat
aggressive diseases including cancer and severe respiratory infections.
02
BERGENBIO
Annual Report & Accounts 2023
Expanded 1L STK11m
NSCLC Ph1b/2a study
into 33 sites in 7 countries
33
Clinical Trial
Sites
Multiple data presentations
at prestigious medical
conferences
12
Scientific
Presentations
Focused strategy yielded
significant cost savings
37%
Reduction in
Cash Use
Executed Rights Issue
provided meaningful funding
250
NOK
BERGENBIO
Annual Report & Accounts 2023
BERGENBIO
GOVERNANCE
STRATEGIC REPORT
03
Annual Report & Accounts 2023
5-6
7-9
10
11-21
22
Board of Directors
A Focused Strategy to Improve the Lives
of Patients Living with Non-Small Cell
Lung Cancer
23
Management Team
NSCLC: Potential to Treat a Large Patient
Population with Poor Prognosis
24-36
Remuneration Report
Severe Respiratory Infections – Beyond
COVID-19: Setting the Stage for Indication
Expansion
38-45
Corporate Governance Report
Environmental, Social and Governance
46-53
Board of Directors’ Report
Table of
contents
FINANCIAL STATEMENTS
55-84
Financial Report
85-88
Independent Auditor’s report
89-91
WEF index and data summary
92-93
Definitions/About us
54
Confirmation from the Board of Directors
and CEO
BERGENBIO
Annual Report & Accounts 2023
Chair’s Statement
CEO Statement
Over the past year, we began to experience the clear
benefits of the intense, focused organizational strategy
that we implemented in the second quarter of 2023.
Most importantly, we made substantial progress in
developing an effective new therapy for late-stage lung
cancer, which we hope will make an significant impact
on the lives of patients suffering from this disease. We
are grateful for the faith that our investors have shown
in their support for our plan and mission to validate
the power of AXL inhibition with our lead candidate,
bemcentinib, by successfully treating Non-Small
Cell Lung Cancer (NSCLC) patients harboring STK11
mutations (STK11m).
I am extremely proud of our employees for maintaining
their focus during what was a transitional year for the
Company. They embraced the new streamlined strategy
and have been executing it at an impressive level. Their
dedication and expertise, along with the considerable
support of our investors, provide hope for a patient
population in desperate need of an answer.
BerGenBio is a leader in studying lung cancer patients
with some of the highest unmet needs today – those
who harbor a mutation in the STK11 gene. Patients
with STK11m comprise ~20% of non-squamous NSCLC
cases, are not currently eligible for targeted therapy and
face a very poor prognosis. STK11m NSCLC patients
widely express AXL, the target of bemcentinib, resulting
in the development of drug resistance, immune invasion
and metastasis. For these reasons, we are evaluating
bemcentinib in a first-line setting, before the cancer has
a chance to completely transform, giving patients their
greatest opportunity to triumph.
In addition to the new findings demonstrating the benefit
of the addition of bemcentinib to both immunotherapy
and chemotherapy that we reported at scientific
conferences throughout the year. The scientific
and medical communities also released a trove of
publications substantiating the potential of AXL inhibition
for STK11m NSCLC patients and the awareness of need
for new therapies for this underserved patient group.
During 2023 we enrolled patients in the Phase 1b portion
of our 1L study in STK11m NSCLC patients and we
recently expanded the study. We have great confidence
in bemcentinb’s potential to prove clinical benefits for a
large underserved patient population and we look forward
to announcing data from the study late 2024 and into
2025.
I wish to thank our employees, the patients and
physicians who are working with us to advance our goal
of improving the lives of cancer patients.
Anders Tullgren
Chair of the Board
of Directors
Martin Olin
CEO
Overview
›
04
BERGENBIO
Annual Report & Accounts 2023
A focused strategy to improve the lives of patients living with NSCLC
05
BerGenBio is the
only
company solely focused on exploiting the potential of selective AXL inhibition for therapeutic
purposes, providing it with a unique competitive position
Over the last decade, there has been growing recognition of the importance of the tyrosine kinase receptor AXL as a highly promising target for
new cancer therapies. This places BerGenBio in an enviable position as since its inception the Company has explored and validated the significant
role that AXL plays as a driver of serious diseases. Unlike companies pursuing less selective compounds - our approach of highly selective, potent
AXL inhibition has allowed us to establish a unique position in the clinical development of AXL inhibitors, with few direct competitors.
BerGenBio has studied its product candidates across several clinical trials to inform its development plans, in both company-sponsored trials and
in partnership with some of the leading academic centers in the US and Europe in Investigator Led Trials (ILTs). Data from these trials have been
analyzed to identify the indications in which selective AXL intervention has the most promise to treat patients with high unmet medical needs and
for which there is competitive “white space”.
These analyses have resulted in our focus on
clinical development in 1L STK11m NSCLC
and early preclinical exploration of severe
respiratory infections, where AXL has been
shown to play a significant role.
Strategic Report
In cancer, it is believed that bemcentinib
selectively inhibits the role of AXL in
maintaining and expanding cancers –
both through its activity on tumor and
immune cells.
BERGENBIO
Annual Report & Accounts 2023
Bemcentinib: a potentially 1st-in-class cancer treatment
Strategic Report
›
06
Bemcentinb was licensed from Rigel, Inc. and we hold exclusive rights to develop and commercialize the product world-wide.
High selectivity: precedent setting, reduces off-target toxicity
Monotherapy activity seen in multiple indications
Convenient oral daily dosing
FDA Fast Track Designations in 2L NSCLC and in STK11m NSCLC
Extensively studied in multiple indications in over 600 patients
Tolerable in combination with chemotherapy, targeted therapies and checkpoint inhibitors
Concentrates in lung (40x); crosses blood-brain-barrier
Extensive IP through 2042
BERGENBIO
Annual Report & Accounts 2023
In addition to bemcentinib, an AXL antibody developed by BerGenBio has been licensed to ADC Therapeutics for use in an antibody drug
conjugate format. ADC Therapeutics continued to advance its program in 2023 called ADCT-601 and expects to announce data from its Phase I
trial in 2024. Tilvestamab a second selective therapeutic antibody developed by BerGenBio is currently available for licensing world-wide.
BERGENBIO
Annual Report & Accounts 2023
1L STK11m NSCLC - a significant unmet need
Strategic Report
›
07
Unique opportunity to establish a large biomarker driven NSCLC market segment
Lung cancer is the world’s second most common cancer and despite
recent advancements in treatment options, it remains the leading
cause of cancer-related mortality. NSCLC is the most common
type of lung cancer representing ~85% of patients. NSCLC is often
diagnosed late when patients already have metastatic disease,
limiting potential treatment options. NSCLC is a severe disease with
a 5-year survival for newly diagnosed patients of just 25% (Source:
SEER 2020). The activation of the cell surface protein AXL is a
recognized negative prognostic factor in lung cancer and has been
shown to be an important resistance mechanism in NSCLC patients.
Current treatment of 1L NSCLC is biomarker driven with patients
routinely screened for the presence of driver mutations to determine
the optimal treatment approach. Several mutations in 1L NSCLC
can be specifically addressed with targeted therapies including
EGFR, ALK/ROS1, ALK and MET. 2021 sales of lung cancer targeted
therapies were estimated at $6.2B USD and are expected to grow to
$18.5B USD by 2031 (Nature Reviews, April 2023).
STK11 mutations (STK11m) occur in up to 20% of 1L NSCLC
patients (~31,000 patients in the US and EU5) and extensive data
suggest that current standard of care treatment with immune
checkpoint inhibitors and chemotherapy results in a poor prognosis
when compared to patients without mutations in the STK11 gene.
No targeted therapies exist for this large population. The chart to the
right illustrates the high frequency of STK11 mutations in NSCLC.
In late 2021, BerGenBio received a US FDA Fast Track designation
for bemcentinib in NSCLC patients harboring a STK11 mutation
supporting the recognition of need for this patient population.
The Opportunity
COMMONLY REPORTED 1L NSCLC MUTATIONS
* Sources:Oncogenic driver mutations in non-small cell lung cancer: Past, present and future, World J Clin Oncol. 2021 Apr 24; 12(4): 217–237
Prognostic Impact of KRAS Mutation Subtypes in Metastatic Lung Adenocarcinoma, J.Thor.Onc. 2015; 10(3):431-437
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Indication Highlight – 1L STK11m NSCLC
›
08
Unique Role of AXL in 1L STK11m
NSCLC Patients
AXL plays a key role in cancer to ensure tumor survival and promote metastasis.
Our research in NSCLC patients indicates that AXL is almost universally
present on tumor and/or immune cells. STK11 mutations are known to create
a uniquely adverse tumor microenvironment (TME) in which AXL plays a key
role and which decrease the efficacy of current cancer therapies including,
immune checkpoint inhibition and chemotherapy. More than 1,300 mutations in
the STK11 gene have been identified making development of specific targeted
therapies difficult.
STK11m patients have the following hallmarks, all of which the Company
believes result in the expression/activation of AXL:
• High oxidative stress and elevated levels of Reactive Oxygen Species (ROS)
• High levels of epithelial to mesenchymal transition (EMT) driving tumor drug
resistance, immune evasion and metastasis
• Enhanced replication stress tolerance and resistance to DNA damage and
apoptosis
• No/low PDL1 expression and a highly immune suppressed TME
Through the administration of bemcentinib, we hypothesize that potent
inhibition of AXL will provide improved response to immune checkpoint
inhibition and delay/decrease of chemotherapy resistance in these highly
immuno-suppressed STK11m patients.
Extensive NSCLC Data
In 2022, the company completed a Ph2 trial (BGBC008) of bemcentinib
in combination with the immune checkpoint inhibitor pembrolizumab
(KEYTRUDA®) in 2L NSCLC patients. The Company announced on February 16,
2023, positive topline data from this study as shown in the graph to the right.
The company believes that these data represent clinically meaningful outcomes
when compared to what is achievable with existing therapies.
In addition, a Ph1b Investigator Sponsored Trial (BGBIL005) has been completed
studying bemcentinib in combination with the chemotherapy docetaxel in
2L NSCLC patients. Bemcentinib in combination with docetaxel provided
significantly improved median overall survival when compared with historical
survival data with docetaxel treatment alone in this patient population.
DATA FROM BGBC008 STUDY IN 2L NSCLC
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Indication Highlight – 1L STK11m NSCLC
›
9
Advancing into 1L NSCLC
While both 2L NSCLC studies resulted in encouraging signs of efficacy with
acceptable tolerability, BerGenBio has decided to prioritize 1L NSCLC STK11m
as its next step in clinical development of bemcentinib due to the expected
high level of AXL activation and high unmet medical need in this indication.
The Company initiated a Ph1b/2a study in 2022 (BGBC016) to study the
safety and efficacy of bemcentinib in combination with an anti-PD1 antibody
and chemotherapy in 1L STK11m NSCLC patients. The company believes
that bemcentinib’s unique mechanism of action works synergistically with
immunotherapies (such as anti-PD1/PDL1 mAbs) to increase a cancer’s ability
to be recognized and targeted by the immune system, while reducing its
immunosuppressive effects. In late 2021, the US FDA awarded a Fast Track
designation for the use of bemcentinib in 1L STK11m NSCLC patients.
BGBC016 Study in 1L STK11m NSCLC
Our focused study in 1L Non-Squamous NSCLC patients with mutations in the
STK11m gene is designed in two parts: 1) a Phase 1b study of the safety and
tolerability in cancer patients of bemcentinib when added to the standard of
care treatments [immuno- and chemo-therapy] and 2) a Phase 2a expansion
into 1L Non-Squamous NSCLC STK11m patients to study two doses of
bemcentinib in combination with standard of care treatments. The Company
announced initiation of the Phase 2a portion of the study in March 2024. The
Company expects to provide initial study data during 2024.
On-going Phase 1b/2a Study of
Bemcentinib + Anti-PD1/Chemotherapy in
1L Non-Squamous NSCLC patients with
STK11 Mutations
BGBC016 STUDY SCHEMATIC
PHASE 1B SAFETY & FEASIBILITY
(US) 3+3 DESIGN DOSE ESCALATION
N=9-30
PHASE 2A (US & EU) EXPANSION OF
2 DOSE(S) IN STK11M PTS
N=40+
1L Advanced/ Metastatic Non-
Squamous NSCLC pts without
actionable mutations
Newly diagnosed,
Any PDL1 status
1L Advanced/ Metastatic
Non-Squamous STK11m NSCLC
pts without actionable mutations
Compared to results in 40 pts in
Prospective Synthetic Control Arm
(Same Characteristics/Mutational
Status/Treatment)
BERGENBIO
Annual Report & Accounts 2023
Extensive data supports
the role of AXL in Severe
Respiratory Infections
Strategic Report
›
10
Clinical experience with bemcentinib in SRIs
Independent scientific evidence published by academic groups indicate
that AXL plays a unique role in the promotion of severe respiratory
infections. Bemcentinib was studied in combination with standard of
care in two completed hospitalized COVID-19 studies demonstrating
clinical response and biomarker improvement consistent with reduced
inflammatory response. Based on these data, in 2022 bemcentinib
was accepted into the EU funded EU-SolidAct Ph2b trial in hospitalized
COVID-19 patients. The EU-SolidAct and BerGenBio mutually decided
to discontinue the study; however, due to the changing nature of the
COVID-19 pandemic resulting in fewer patients developing severe
respiratory symptoms.
While further study in COVID-19 has been discontinued, the need
continues for an effective new treatment for hospitalized patients who
develop Acute Respiratory Distress Syndrome (ARDS) from infections
including influenza and RSV. The Company is currently working with
prestigious academic collaborators to further develop preclinical data
supporting the expansion into treatment of ARDS.
BERGENBIO
Annual Report & Accounts 2023
Strategic Report
›
Environmental, Social and Governance
11
Environment, Social and Governance (ESG) is a key focus area for BerGenBio, and the following pages contain a
summary of the key policies, initiatives and impacts related to ESG
Since initiating our journey with ESG principles we have seen a
significant evolution within BerGenBio. What began as an initial
commitment has grown and deepened, firmly establishing ESG
considerations as a core pillar of our strategic vision and our values.
Emphasizing the importance of good governance, we have made
substantial progress in integrating these priorities throughout the
organization. This approach is anchored in our role as a responsible
corporate citizen, aligning with the United Nations’ Sustainable
Development Goals (SDGs) and Agenda 2030.
This section of the report consolidates ESG-related information.
We also refer to other parts of the annual report where the issues
in question are explained and presented in more detail. Governance
related topics are presented first before we turn to the social and
environmental aspects on the following pages. In addition, we have
included a table of key ESG-related indicators, combined with an
index referring to the most relevant ESG-related information at the
end of the annual report.
Introduction
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
ESG AT BERGENBIO
Cancer remains one of the most pressing
healthcare challenges, accounting for
the second most common cause of
death globally. Our vision is to improve
and save lives and thereby generate
a positive impact for patients, society
and shareholders through our work
in discovering and developing novel
medicines to treat aggressive diseases,
including advanced, treatment-resistant
cancers. ESG is therefore important to us,
as it is the foundation of our activities and
directly linked to our long-term success.
The CEO has the overall responsibility
for ESG at BerGenBio and our ESG
commitment is overseen by the Board
of Directors. Our governance structure
is elaborated upon in the Corporate
Governance report of the annual report.
Having engaged with ESG principles for
several years, we have identified a range
of ESG topics relevant for our activities
and our stakeholders. Moving forward, our
focus will be on refining our ESG ambitions
and KPIs, ensuring they are well integrated
with our strategy and governance.
This long-standing commitment to
ESG has laid a robust foundation that
will evolve alongside our Company,
ensuring sustainable value creation as we
continue to develop.
Progress and status on actions and
initiatives set out in the 2022 report:
• The revised Code of Conduct was put
into effect in March 2023
• Since its implementation in 2022,
we have successfully integrated a
supplier-assessment questionnaire,
aligned with the pharmaceutical sector
standard (Pharmaceutical Supply
Chain Initiative, PSCI), into our supplier
management system. For the past year
this questionnaire has been used both
in the selection of new vendors and the
evaluation of existing vendors.
• Our whistleblower policy was introduced
in 2022 and offers staff a independent
third-party reporting channel and a
confidential and transparent method
to report any conduct that may involve
wrongdoing, lead to illegal activity,
or breach of BerGenBio’s governance
standards.
• In compliance with the Norwegian
Transparency Act we took the necessary
steps and published the first inaugural
statement in June 2023.
THE SUSTAINABLE
DEVELOPMENT GOALS
We are committed to building our business
in line with international best practice on
Environmental, Social and Governance, in
particular Agenda 2030 and the Sustainable
Development Goals, as formulated by the
United Nations and launched in 2015.
Our vision is to develop innovative drugs
for aggressive diseases, and a key focus
for BerGenBio is consequently to innovate
(SDG 9) to enable SDG 3 – healthy lives
and promote well-being for all at all ages.
While this is our end goal, we are working
systematically at contributing to this goal
through our efforts to enable goals 8,
12 and 17. We believe that our positive
contribution to Agenda 2030 and the
SDGs will be largest if we become a role
model for responsible production (SDG 12)
and working in partnerships with others
(SDG 12 and SDG 17) in order to promote
innovation (SDG 9), and economic growth
and decent work (SDG 8).
12
BERGENBIO
Annual Report & Accounts 2023
SDG 9 AND 3
Innovation, research and development
are at the center of our business. Our
dedicated team and collaborators focus
on gaining a thorough understanding of
cellular mechanisms, therapy resistance,
disease-specific attributes and clinical
evidence through rigorous research with
state-of-the-art technologies. Our approach
to innovation and results are elaborated
under the Innovation and Economic
Performance heading of this ESG report
as well as in the strategic report.
As a biopharmaceutical company aiming
to provide drugs for some of our society’s
greatest health issues, our foundation is
built on delivering innovation for improved
health and well-being in line with SDG 3.
The future impact of our drug candidates
is potentially great, and we make efforts
to ensure that our drugs will be widely
available, and we adhere to international
agreements.
The safety and well-being of our patients
is imperative for our drug candidates to
deliver on BerGenBio’s vision and will
become even more important when we
get to a commercialization phase of
our drug development. We embed drug
safety considerations throughout the
drug development lifecycle. Our research
from pre-clinical studies is evaluated and
discussed with experts and regulators prior
to proceeding to the clinical trial phase.
Clinical trials are essential to ascertain the
efficacy, safety and effectiveness of drug
candidates and it is crucial that they are
conducted in accordance with our high
standards and regulatory requirements.
We examine the potential outcome of our
trials to ensure patients are subjected to
testing only when suitable. The primary
consideration of all our clinical trials is
to ensure the safety and effectiveness
of our medicines. We conduct detailed
studies on the safety profiles of our drug
candidates throughout the trial and testing
phase. Adverse effects and risks linked
to drug candidates are recorded and
reported to regulatory authorities (aligned
with regulations) on a periodic basis.
Ensuring the confidentiality and security
of our patient’s personal information is
of paramount importance to us. In 2023
there were no incidents or claims of data
breaches reported.
Strategic Report | Environmental, Social and Governance
›
13
Annual Report & Accounts 2023
BERGENBIO
Annual Report & Accounts 2023
SDG 8, 12 AND 17
While BerGenBio is a clinical trial stage
company with moderate drug manufacturing
activity, we have still chosen to focus on SDG
12 and our role in supporting responsible
production and consumption. Key efforts
in this regard relate to our emphasis on
promoting sustainability in our supply chain
through our dialog and contracts with our
partners and suppliers. We have initiated
actions related to the 2022 Norwegian
Transparency Act. The new requirements
related to performing due diligence, and
working on fundamental human rights and
decent working conditions is in line with our
efforts to be a responsible actor, focusing
on a responsible supply chain. In line with
the requirements of the Transparency Act,
BerGenBio released its first report in
June 2023. You can read more about our
efforts related to responsible sourcing under
the Responsible Sourcing heading of this ESG
report.
Through our work we are also contributing
to SDG 8 – decent work and economic
growth, SDG 9 – industry, innovation and
infrastructure, and SDG 17 – partnerships
for the goals. Decent work relates to the
aforementioned efforts to secure human
rights and decent working conditions.
BerGenBio contributes economically to
society through our investments in research
and development, and our economic
performance sets the foundation for our
future contribution, as we further develop
our Company towards production and
commercialization. Our performance is
disclosed in our financial statements.
BerGenBio intends to develop drug candidates
ourself and through strategic partnerships in
multiple indications and retains all strategic
options for the future commercialization
of our products. While the research and
development strategy is designed in-house,
the Company leverages our network of
external contract research organizations
(CROs) to execute our development strategy.
BerGenBio also collaborates with academic
institutions to extend research in areas of
interest for the Company. This approach
allows BerGenBio to react quickly and nimbly
to industry changes.
Strategic Report | Environmental, Social and Governance
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14
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
15
Material topics
To ensure that our commitment towards
sustainability results in activities that positively
impact our key sustainability targets, we have
performed an initial materiality analysis which
have been reviewed annually. This analysis
involved mapping our value chain, as well as
reviewing industry standards, organizations,
and peers. More importantly, it has led us to
engage with key stakeholders and consulted
ESG experts, to gain insight into which topics
are most important to them, as well as their
expectations of us. These key stakeholders
include: our patients and their families,
employees, investors, regulators, suppliers,
and other business partners such as research
organizations and academic institutions.
This resulted in a mapping of the ESG
topics deemed important to our long-term
sustained value creation. The matrix to the
right provides an overview of these topics,
arranged according to the significance of their
ESG impacts, and the topics’ influence on
stakeholder assessments and decisions.
The topics in the top right corner are those
which are of most strategic importance
to BerGenBio and these are given detailed
descriptions in this report. A reference index of
the reporting is provided on page 78 for ease
of location.
Communicate decisions
& monitor development
Monitor & communicate
Strategic, active communication,
clear governance & follow-up
Active governance & communication
Protection of human &
labor rights
Occupational health & safety
Climate & environmental
management
Clinical trial
conduct
Wellbeing of
employees
Board
governance
Talent attraction
& retention
Responsible
sourcing
Economic
Patient health
& safety
Innovation
Business ethics
performance
Legend
Environment Social Governance
SIGNIFICANCE OF ENVIRONMENTAL, SOCIAL & GOVERNANCE IMPACTS
INFLUENCE ON STAKEHOLDER ASSESSMENTS & DECISIONS
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
BUSINESS ETHICS
To ensure that patients, research and
development partners, employees,
shareholders and other stakeholders
feel confident about our commitment to
operate in accordance with responsible,
ethical and sound corporate and business
principles, the Company has established a
set of ethical guidelines that are presented
in its Code of Conduct policy.
The Code of Conduct, implemented in 2023,
reflects our commitment to sustainability
and the guidelines provide a framework for
what the Company considers responsible
conduct and defines the individual
responsibilities of all employees and Board
members through a combination of broad
principles and specific requirements.
The Code of Conduct has been distributed
to all employees, managers and Board
members and is available on the BerGenBio
website.
BerGenBio takes a zero-tolerance stance
towards corruption, money laundering
and insider trading. All employees are
encouraged to report any breaches of
the Company’s policy. No incidents were
reported in 2023.
BOARD GOVERNANCE
For BerGenBio it is important that the
Board reflects the diversity of their
Company’s stakeholders to be adequately
aware of their needs. This will enable the
Board to assist the Company in making
robust strategic decisions, in addition
to controlling risks and ensuring legal
compliance. Furthermore, this enables
us to be well-positioned to deliver
long-term value for shareholders and
stakeholders. Our Board consists of
four non-executive members of whom
two are women. All of the members are
independent. The members of the Board
reflect different nationalities and a breadth
of competencies, including healthcare,
medicine, pharmacy, research, finance and
ESG.
Further information about the Board
of Directors and its Independence can
be found in section 8 of the Corporate
Governance report.
CLINICAL TRIALS
BerGenBio ensures strict conformity with
international, regional and local regulatory
requirements in all our sponsored studies.
All our clinical studies comply with the
principles elucidated in the Declaration
of Helsinki, the International Council for
Harmonization of Technical Requirements
for Pharmaceuticals for Human Use,
including Good Clinical Practice guidelines
E6 (R2) and International Ethical Guidelines
for Health-related Research Involving
Humans. In 2023, we had no critical
inspection findings from any regulators and
no monetary claims were received.
We make periodic disclosures of clinical
trial data in line with EFPIA-PhRMA
Principles for Responsible Clinical Trial
Data Sharing. We share information on the
outcomes of our clinical trial studies here
and through EUDRaCT, ClinicalTrials.gov
and other registries in accordance with
international legislation. We also support
academia by sharing clinical data upon
request pursuant to relevant regulations
and protocols.
16
Governance
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
PATIENT HEALTH AND SAFETY
As discussed in relation to SDG 3, the
safety and well-being of our patients is
imperative for our drug candidates to deliver
on BerGenBio’s vision and will become
even more important when we reach the
production and commercialization phase
of our drug development. We embed
drug-safety considerations throughout the
drug development lifecycle. Our research
from pre-clinical studies is evaluated and
discussed with experts and regulators prior
to proceeding to the clinical trial phase.
We examine the potential outcome of our
trials to ensure patients are subjected to
testing only when suitable. The primary
consideration of all our clinical trials is to
ensure the safety and effectiveness of our
medicines. We conduct detailed studies on
the safety profiles of our drug candidates
throughout the trial and testing phase.
Adverse effects and risks linked to drug
candidates are recorded and reported to
regulatory authorities in alignment with
regulations on a periodic basis. It is also of
paramount importance to us to ensure the
security and confidentiality of the personal
information of our patients. No personal
data privacy claims of any breaches or
incidents were received in 2023.
RESPONSIBLE SOURCING
We rely on third parties for clinical studies
(Contract Research Organizations), supply
of medicinal products, office supplies and
housekeeping services. We currently have
6 key suppliers. We consider engaging
with the right vendors and suppliers as
critical, and therefore seek to only partner
with third parties who share our values of
business ethics, social and environmental
consciousness.
We have successfully implemented a
supplier self-assessment questionnaire,
adhering to the Pharmaceutical Supply
Chain Initiative (PSCI) standards, into our
existing supplier management system.
Additionally, we have established routines
to comply with the new Transparency Act,
focusing on due diligence processes that
address the risks of human rights violations
within in our value chain. This topic is
further discussed in the next section.
Our CMO and CEO are responsible
for procurement and supply chain
management-linked activities, overseeing
the effective implementation of
management systems and vendor selection
process. As an important component of
our process we perform an analysis on ESG
criteria, helping us to identify our critical
suppliers based on risks and opportunities
associated with each vendor. We administer
a self-assessment questionnaire to
prioritized existing and potential new
vendors. This vendor self-assessment
process enables us to appraise our partners
based on their adherence to regulatory
norms as well as social and environmental
standards. It also provides insights into our
vendors’ practices in terms of ethics, labor
management, environmental conservation
and employee health and safety
management. The outcome of the self-
assessment exercise helps us in engaging
with them to strengthen their performance
on identified improvement areas.
PROTECTION OF HUMAN AND
LABOR RIGHTS
We are committed to the protection of
human and labor rights in all our operational
endeavors. We recognize the universal
and fundamental nature of human rights
and align all our operations with the
Universal convention on Human Rights
and conventions of the International Labor
Organization (ILO). Our commitment
to human rights protection has been
emphasized in our Code of Conduct that
was implemented in 2023, as well as in our
Transparency Act statement, both available
on our website under the Corporate
Governance section.
While having robust systems to ensure
the protection of human rights within our
operational bounds, we also expect all our
suppliers and value-chain partners to strictly
comply with relevant norms on human
rights protection. We have zero tolerance
to child labor, forced labor, discrimination
of any form and direct or indirect violation
of human rights. We have established
grievance redressal mechanisms to ensure
timely resolutions of any breaches in this
regard. We are not aware of any cases of
discrimination or any other human rights
breaches in our operations during 2023.
17
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
INNOVATION AND ECONOMIC
PERFORMANCE
BerGenBio´s goal is to have a positive
impact on the lives of patients with
aggressive diseases, including immune-
evasive, drug-resistant and metastatic
cancers. Through cutting-edge technologies,
partnerships and scientific expertise we
seek to transform the lives of such patients.
Over the years, our organization has gained
a deep insight into AXL biology to bring
value for patients by tailoring transformative
drugs targeting AXL signaling pathways.
We have made substantial research
& development (R&D) investments to
strengthen our pipeline. Our greatest R&D
assets are our staff and collaborators, and
the scientific know-how they represent.
In 2023, we issued four peer-reviewed
publications and 12 scientific presentations
that stand as a testament to our
organizational knowledge-base.
Over the years, by engaging in partnerships
with industry leaders, academic
institutions, pharmaceutical companies
and clinical research organizations, we
have strategically focused our capabilities
and impact. This has made us able to
accelerate our innovation-driven research
and development efforts.
Social
Our approach to social sustainability is
reflected in BerGenBio’s relationships with
people, communities, and society. Hence,
activities that improve social conditions
are important for us. By discovering
and developing novel medicines to treat
aggressive diseases, including advanced,
treatment-resistant cancers, we aim to
improve and save lives, which in turn creates
value for patients, society, and shareholders.
Therefore, sustainability is a foundation of
our activities and is directly linked to our
long-term success.
We also seek to maintain and improve the
social conditions at both BerGenBio and in
our partnering companies. We especially
focus on activities that affect the topics:
diversity and inclusion, pay equality and
wage level, talent attraction and retention,
skills for the future, well-being of employees,
and occupational safety.
DIVERSITY AND INCLUSION
We value and encourage the development of
a diverse and inclusive work environment.
BerGenBio promotes an open and strong
corporate culture with a healthy, safe and
fair work environment that enables free
exchange of ideas and fosters collaboration.
We are committed to being an equal-
opportunity employer and to fair treatment
for each of our employees throughout their
tenure with BerGenBio. We strictly prohibit
discrimination of any form based on gender,
age, race, ethnic background and sexual
orientation, among other diversity metrics.
BerGenBio recruits from environments
where the number of women and men is
relatively equally represented. At year-end,
we employed 16 people, of which 56% are
women. Two out of four executives in the
management team are women while two
out of the four members of our Board of
Directors are women. Our team represents
a variety of nationalities, and their different
backgrounds enhance our ability to innovate
and strengthen our work environment.
Our team of highly-educated employees
includes six colleagues with PhDs. We make
provisions to cater to the diverse needs
and aspirations of our employees. We also
support each of our employees with their
individual challenges depending on their
personal circumstances.
18
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
PAY EQUALITY AND WAGE LEVEL
BerGenBio’s Remuneration Policy aims to
support both the purpose and sustainability
of the Company, as well as the delivery of
our strategic priorities. With remuneration
components aligned with the interests
of shareholders and other stakeholders,
BerGenBio wants to attract, motivate, and
retain members of the Board of Directors
and the Executive Management Team. The
Remuneration Policy also intends to reward
members of the Executive Management
Team in line with corporate and individual
performance.
Our current remuneration policies are
based on the following principles: market
competitiveness, “pay for performance”,
transparency, business alignment and
consistency, and shareholder alignment.
In order to ensure the policy’s market
competitiveness, it is benchmarked with
an appropriate peer group of companies.
This is a key component in the process of
reviewing our Remuneration Policy. The
current Remuneration Policy was approved
by the Annual General Meeting 19 March
2021 and is available at the Company’s
website under the Corporate Governance
section. The policy was not materially
changed in 2021 but updated to reflect the
new formal requirements effective from
1 October 2021. See the Remuneration
Report in the Annual Report for further
details.
ATTRACTION AND RETENTION
OF TALENT
Our employees are at the core of
BerGenBio’s growth story. We aim to
engender an organizational culture which
appeals to employees with varied talent
and experience. Enabling the all-round
development and growth of our employees
plays a vital role in attracting and retaining
promising talent. Our hiring process focuses
on creating a diverse employee pool in
terms of culture, educational background
and skill sets, among other considerations.
In 2023 there was limited new hire of
employees caused by the reorganization as
part of the focused strategy. At the end of
2023 we had two PhD students employed.
All employees receive regular performance
and development evaluation.
SKILLS FOR THE FUTURE
Growing our employees by ensuring they
are developing themselves and providing
the right skills to support BerGenBio are
important parts of the annual development
process for employees.
All employees have development discussions
with their line managers as part of the annual
review cycle to support the development and
growth of each team member.
During the year our employees have
attended conferences and are encouraged
to discuss their continued development
with their line manager and to request any
appropriate training which may assist in the
advancement of their skills which can be
applied in their role.
We provide various training and
development programs for our employees
in the areas of Good Clinical Practice (GCP)
and Good Manufacturing Practice (GMP),
as well as a mandatory basic course in
the General Data Protection Regulation
(GDPR) and Information security. We also
encourage our employees to enroll in
external accredited learning programs with
relevant professional bodies such as The
Organization for Professionals in Regulatory
Affairs (TOPRA) and The Institute of Clinical
Research (ICR). In order to support the
career growth of our employees, we engage
with them through periodic performance
appraisals to help them reflect on their
progress and set professional goals. The
appraisal process also helps to align
an employee’s career aspirations with
BerGenBio’s goals. We also provide long
term incentives through our stock option
program to support long-term association of
employees with BerGenBio.
19
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
WELL-BEING OF EMPLOYEES
Employee well-being is important to boost
workplace satisfaction and productivity
levels. To ensure the well-being of our
employees, we consider it important to
focus on job satisfaction, financial security,
a healthy work environment and overall
engagement in organizational activities.
When the global pandemic during 2020
and 2021 required changes in working
arrangements with working from home and
sustained focus on employee well-being, we
introduced a hybrid working model in 2022
and involved employee representatives in
well-being and social activities for the entire
team. The hybrid working arrangements has
continued during 2023.
We periodically capture our workforce’s
sentiment and feedback through employee
engagement surveys and the feedback that
we receive from our employees helps us to
update our policies and design interventions
to enhance employee engagement and
satisfaction. We provide competitive
compensation for all our employees
commensurate with their level of experience,
qualification and expertise.
The Group has focused the clinical
development of bemcentinib into NSCLC in
patients harboring a mutation in the STK11
gene and in preclinical development in
severe respiratory infections. As a result, a
restructuring of the team was implemented
in 2023. Redundant employees have been
given outplacement support.
We had a sick-leave of 3.6% in 2023
compared to 2.3% in 2022.
All employees can take advantage of our
flexible hours and we have shower facilities
to enable our employees to exercise
comfortably around their working day.
OCCUPATIONAL HEALTH
AND SAFETY
We encourage our employees to embrace
a proactive approach to managing their
health. We focus holistically on the physical,
emotional and mental well-being of our
employees and provide them assistance to
cope with identified ailments.
All staff have access to private medical care
and we have employee assistance programs
which offer support with health (physical
and mental) and on general topics related
to well-being. We support a hybrid working
arrangement and occasionally review our
workstation assessments to ensure our
employees have safe work spaces and the
right equipment to work virtually as and
when required.
We believe that safe working conditions
are a fundamental right of each employee.
We ensure alignment of our occupational
safety management systems with globally
recognized standards and guidelines. A
systematic protocol is in place to record and
investigate any untoward incidents. In 2023,
no occupational safety-linked incidents
occurred at any of our facilities.
Environmental
At the current development stage,
BerGenBio’s direct environmental impact is
relatively small. However, we are proactive
in our environmental responsibility and
have initiated measures to better assess
our impact. This will enable us to effectively
manage environmental risks as the
Company progress.
20
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Environmental, Social and Governance
›
GREENHOUSE GAS EMISSIONS (GHG)
We recognize the importance of corporate engagement in
environmental conservation and climate action. Our approach to
carbon management currently focuses on tracking our energy
consumption and corresponding emissions.
As we are currently not engaged in any commercial drug supply
manufacturing activities, our direct environmental footprint stems
primarily from the resources consumed in our office spaces.
We account for the footprint arising out of our indirect business
activities such as employee travel and are conscious of the impact
of waste that we generate. Specifically bio-hazardous waste and
managing this risk is an important aspect of our supply chain
management. Currently we do not measure the environmental footprint
of the activities conducted by third parties. We are also cognizant of
the impact of pharmaceuticals on the environment and are developing
systems to manage this risk. Furthermore, we consider it imperative
to have stringent systems and initiatives in place to address our future
needs in terms of safe and responsible waste management.
We have started mapping our GHG-emissions to develop baselines
for setting emission targets. We consider this a first but crucial step
for understanding our carbon footprint and for identifying appropriate
actions for reducing this footprint. Our emissions are reported
according to the Greenhouse Gas Protocol’s standard for carbon
accounting, which categorizes emissions in three categories called
Scopes. Scope 1 represents direct emissions, Scope 2 covers indirect
emissions from purchased energy, and Scope 3 includes indirect
emissions from upstream and downstream activities.
Our total emissions in 2023 were 76.91 tons CO2e (2022: 54.63
tons CO2e). The results of our initial mapping of direct and indirect
emissions confirm that business travel is where we have our largest
impact, representing 97% (2022: 90%) of our total emissions. While our
office space and scope 2 CO2e consumption have reduced over the last
two years due to our focused strategy and reorganization, the impact
from travel activities has increased after the COVID-19 pandemic. In
order to secure the development of our projects and business, some
level of travel is required externally and between our offices. We will, in
general continue to conduct digital meetings, when possible, to limit
travel. The increase from 2022 to 2023 is primarily caused by improved
registration of CO2e consumption from travel.
BerGenBio does not own or lease any vehicles and no other fossil fuels
or greenhouse gases are consumed in our direct business activities,
hence no Scope 1 emission sources are reported. Within our offices
in Norway and the UK, use of electricity and district heating represent
3% (2022: 10%) of our total emissions. The scope 3 numbers recorded
in 2021 were significantly affected by travel restriction caused by the
pandemic and therefore represent an historic low.
We acknowledge that a large part of the emissions within our business
are found in Scope 3. Going forward we will take further steps to
identify the most relevant sources to develop our carbon account. This
will include conversations with our suppliers in order to collect data on
our indirect emissions generated by our impact on the activities of our
partners’ operations.
ESG actions for 2024
BerGenBio will not be required to adhere to the new sustainability
standards under CRSD until 2026. While there are no current
plans to voluntarily adopt these standards before their mandatory
implementation, we are committed to enhancing and aligning our ESG
reporting in the intervening years, ensuring alignment with the relevant
standards leading up to the adaptation of the CRSD framework.
21
2023 2022
SOURCE tCO2e
Share of
emissions
tCO2e
Share of
emissions
SCOPE 2
Total electricity & heat 2.03 3% 5.63 10%
SCOPE 3
Total flights 74.88 97% 49.00 90%
Total 76.91 100% 54.63 100%
BERGENBIO
Annual Report & Accounts 2023
Board of Directors
22
Governance
ANDERS TULLGREN Independent Chair
Anders Tullgren has over 35 years of global experience in both large pharmaceutical
and small/mid-size biotech environments, with senior leadership roles in the United
States, Germany, France, the United Kingdom and the Nordic region. He spent
over 20 years at Bristol Myers Squibb, most recently as President Intercontinental
Region. Anders Tullgren has in his career worked with several oncology products
and was leading the successful launch of BMS immuno-oncology portfolio in the
intercontinental region. Mr Tullgren is an experienced Non-Executive Director with
several international Board and Chair positions. He holds an MSc in Pharmaceutical
Studies from Uppsala University (Sweden) and a Diploma in Marketing & Business
Administration from MIS (Sweden).
Mr. Tullgren joined the Board of Directors on 6 January 2022 as Chairman. He is a
Swedish citizen and resides in Portugal. He attended 16 Board meetings in 2023.
SVEINUNG HOLE Independent Non-Executive Director
Sveinung Hole is a seasoned PE/Venture Capital/Investment Management executive
and has extensive leadership-, board- and chair experience from PE/VC-funds, listed
companies, private companies and foundations. Mr Hole is currently Managing
Partner/CEO of Sarsia Management AS, which has approximately NOK 1.3 billion
AUM in three venture funds. The last seven years Mr Hole has been the CEO of
the largest foundations in Norway funding research; Trond Mohn Foundation and
Stiftelsen Kristian Gerhard Jebsen with investment portfolios of approximately NOK
4 billion. Mr Hole also headed the Health & Care21 Strategy Council appointed by
the Norwegian Minister of Health (2019–2021) and was Member of the Steering
Committee of National Knowledge Program for Covid-19 (Norwegian Institute of
Public Health). Mr Hole has previously been board member of Norwegian Venture
Capital Association and Bergen Hospital Trust (Helse Bergen). Mr Hole has held
various top management positions in the Nordic and US and holds a Master of
International Management from BI Norwegian Business School.
Mr. Hole joined the Board of Directors on 1 September 2010 and served as Chairman
from 13 March 2019 to 6 January 2022. He is a Norwegian citizen and resides in
Norway. He attended 16 Board meetings in 2023.
DR DEBRA BARKER Independent Non-Executive Director
Debra Barker is a seasoned clinical development executive with experience from
Novartis, Roche, SmithKline Beecham and Knoll and serves as Chief Medical Officer
in Destiny Pharma PLC (UK). Dr Barker has a Diploma in Pharmaceutical Medicine
and received a MSc in immunology from King’s College in London and a medical
degree from Queens College, Cambridge.
Dr Barker joined the Board of Directors on 13 March 2019. She is a UK citizen and
resides in Switzerland. She attended 15 Board meetings in 2023.
DR SALLY BENNETT Independent Non-Executive Director
Dr Sally Bennett has a career spanning medicine, equity & capital markets and
investment management. She brings 25 years industry experience in senior roles
across the financial sector within the life science and biopharmaceutical space.
She currently serves as a senior advisor to Catalio Capital Management, a multi
strategy investment firm. Prior to Catalio she spent 15 years as a senior member of
the investment team at HealthCor, a global healthcare investment manager. Prior
to HealthCor she spent a decade in senior analyst roles at ING Financial Markets
and latterly Piper Jaffray. She currently serves on the Board of several other publicly
listed and private biotech companies. Dr Bennett is a member of the Institute of
Directors (IoD) and has been awarded the CertIoD qualification. She received a BSc
in Anatomical Sciences and a Medical Degree, awarded with Honours, both from the
University of Manchester.
Dr Bennett joined the Board of Directors on 9 December 2020. She is a UK citizen
and resides in the UK. She attended 16 Board meetings in 2023.
BERGENBIO
Annual Report & Accounts 2023
23
MARTIN OLIN Chief Executive Officer
Martin Olin joined BerGenBio as Chief Executive Officer in 2021. Mr Olin has more
than 20 years of experience as an executive in the pharmaceutical and biotechnology
industries. He previously served as CEO of Symphogen, a biotechnology company
focused on the development of protein drugs based on recombinant monoclonal
antibody mixtures, acquired by Servier in 2020. Before joining Symphogen in 2012,
Mr. Olin was a senior partner with SLS Invest, a Scandinavian-based healthcare-
focused private equity fund. During his career he has held managerial positions in
Novo Nordisk including Finance Director, EMEA. Prior to joining BerGenBio he served
as Managing Partner of Nordic Eye, a Copenhagen-based Venture Capital Firm.
CRISTINA OLIVA Chief Medical Officer
Cristina Oliva, MD, joined BerGenBio as Chief Medical Officer in 2022. Cristina brings
over 20 years of senior clinical development experience across large pharmaceutical,
biotechnology and Clinical Research Organizations (CROs). Most recently Cristina
was Vice President, Oncology and Head of Oncology Centre of Excellence at IQVIA
Ltd, where she supported customers with their oncology development plans and
established and led the IQVIA Oncology Global Scientific Advisory Board. Prior
to her role at IQVIA, Cristina held senior positions leading oncology development
programs for Nordic Nanovector, Takeda Pharmaceuticals, GlaxoSmithKline and
Eli Lilly. Cristina is a Board-certified oncologist and has global experience in drug
development in oncology and onco-haematology compounds.
RUNE SKEIE Chief Financial Officer
Rune Skeie joined BerGenBio as Chief Financial Officer in 2018. He has over 25
years of financial management, corporate development, corporate governance and
advisory experience with public and private companies across multiple industry
sectors. The majority of his career was spent at EY (formerly Ernst & Young), where
he held the role of Executive Director, before joining REMA Franchise Norge AS, the
multinational supermarket business. Mr Skeie has been awarded as Registered
Accountant and a State Authorized Public Accountant.
GAYLE MILLS Chief Business Officer
Gayle Mills joined BerGenBio as Chief Business Officer in 2021. Ms Mills has held a
variety of positions at senior levels in both major pharmaceutical and biotechnology
firms. Her most recent position was as Chief Business Officer at Symphogen A/S,
where she executed major collaborators with Merck KGaA and Baxalta.
Prior to Symphogen she was in senior business development positions at Abgenix,
Inc., Roche Bioscience and Syntex USA. In addition to leading the execution and
management of significant partnerships with several major pharmaceutical firms,
she has been actively involved in the negotiation and execution of the acquisitions of
Symphogen A/S, ROXRO Pharma and Abgenix, Inc.
Management Team
Governance/Management
›
BERGENBIO
Annual Report & Accounts 2023
24
Remuneration Report
Governance/Remuneration report
›
With this report, we are providing
greater insight and transparency into the
remuneration outcomes for 2023 and
our Executive remuneration practices.
The current Remuneration Policy was
approved by the Annual General Meeting in
2021. The policy is in compliance with the
Shareholder Rights Directive (SRD II) and
serves our current business needs.
Our core focus is inhibition of AXL,
which is known to play a central role in
the mediation of aggressive diseases.
Our strategic priorities are diseases in
which the scientific rationale, pre-clinical
and clinical data confers a clear rationale
for advancing our highly selective AXL
inhibitor bemcentinib towards potential
treatment modalities addressing unmet
medical needs.
During 2023 the Company focused its
strategy into the following activities:
• Clinical development of our main AXL
inhibitor, bemcentinib, in 1L NSCLC
STK11 mutated patients in our Ph 1b/2a
BGBC016 clinical study.
• Pre-clinical development of bemcentinib
in Severe Respiratory Infections.
The implementation of the focused
strategy implied a significant change of
the organization, including a reduction of
members the Executive management and
the Board of Directors. These changes
were implemented during 2023 and the
impact of the reduced remuneration to
the Executive management and Board of
Directors will materialize with full effect in
2024. This report shows a reduction of the
total remuneration of the Board of Directors
of 20% from 2022 to 2023 and a reduction
of the total remuneration of the Executive
management of 19% from 2022 to 2023 in
nominated currencies. The majority of the
Executives are remunerated in a different
currency than NOK and when translated
into NOK in table 7.1., the numbers are
affected by weakness of NOK from 2022
to 2023 by more than 10%. The full effect
of the reduction in remuneration to the
Executive management and the Board of
Directors from 2023 to 2024 is expected to
represent a reduction of approximately 30%
in nominated currencies.
The Board of Directors has cautiously
applied its remuneration practices, while
retaining the ability to develop the business,
recruit and retain key personnel to pursue
our strategic goals.
This statement regarding remuneration of
the management of BerGenBio ASA has
been adopted by the Board of Directors
of BerGenBio ASA pursuant to section
6–16a of the Norwegian Public Limited
Companies Act.
1. Chair’s Letter
ANDERS TULLGREN
Chairman of the Remuneration Committee
30 April 2024
BERGENBIO
Annual Report & Accounts 2023
25
Governance/Remuneration report
›
2.1 REMUNERATION POLICY &
OBJECTIVES
The remuneration principles for the Board
and Executive Management are governed
by our Remuneration Policy, which was
adopted at the Annual General Meeting held
on 19 March 2021. The Remuneration Policy
is available in the Corporate Governance
section at www.bergenbio.com.
The objective of the remuneration
principles for the Board and Executive
Management are to:
• Support the purpose and sustainability
of BerGenBio
• Align the remuneration components
with the interests of our stakeholders
• Support delivery of BerGenBio’s
strategic priorities
• Attract, motivate and retain members of
the Board of Directors and the Executive
Management Team of the appropriate
calibre, given the size and complexity of
the business
• Reward members of the Executive
Management Team in line with
corporate and individual performance
This Remuneration Report discloses all
the Group’s remuneration of members
of the Board of Directors of BerGenBio
ASA (“the Company”) and the Executive
Management of BerGenBio in 2023,
inclusive of remuneration received from
the subsidiaries BerGenBio Limited and
BerGenBio ApS.
The disclosures are primarily derived from
the audited financial statements, which
are available at www.bergenbio.com in
the Investor/Financial report section. The
Remuneration Report has been compiled
in accordance with section 6–16a of the
Norwegian Public Limited Companies Act
and to align with the amended Shareholder
Rights Directive.
2.2 NOMINATION &
REMUNERATION COMMITTEES
The Board has established both a
Nomination Committee and a Remuneration
Committee to assist the Board with
all matters related to establishing,
implementing, and executing the principles
set out in the Remuneration Policy.
2.2.1 NOMINATION COMMITTEE
The objectives for the Nomination
Committee are to recommend candidates
for the election of member and Chairman
to the Board of Directors; and remuneration
for the Board of Directors and board
Committees. The Nomination Committee
issues a report to the Annual General
Meeting on the work of the Nomination
Committee and the recommendation of
remuneration of the Board of Directors and
Committees. The Nomination Committee of
BerGenBio ASA consists of three members:
Hans Peter Bøhn (Chairman), Ann-Tove
Kongsnes and Shantrez Miller Gillebo.
2.2.2 REMUNERATION
COMMITTEES
The objective for the Remuneration
Committee is to act as a preparatory and
advisory body in relation to the Company’s
remuneration of Executive Management.
The Remuneration Committee shall review
the remuneration and benefits strategy,
review the performance and prepare matters
relating to other material employment issues
in respect of the Executive Management,
including Short Term Incentive (STI) and
Long Term Incentive (LTI) principles.
2. Introduction
BERGENBIO
Annual Report & Accounts 2023
26
Governance/Remuneration report
›
In 2023, the Remuneration Committee held three meetings and consisted of three members: Andes Tullgren (Chairman), Sveinung Hole and Debra
Barker.
The Remuneration Committee reviews the approach to remuneration based on the following principles:
PRINCIPLES SUMMARY
Market competitive remuneration
BerGenBio offers market-competitive remuneration opportunities to attract, retain, and motivate the talent needed to achieve BerGenBio’s vision, business
strategy and other Company objectives. BerGenBio shall balance the need to provide competitive levels of reward against a desire to be cost effective when
determining reasonable and responsible reward outcomes.
Pay for performance
A proportion of the remuneration package, the short-term incentive program, is performance based to link remuneration outcomes with the achievement
of key financial and non-financial targets that are aligned with BerGenBio’s strategy. Each element of remuneration is weighted to ensure continuous and
further positive development of BerGenBio.
Transparency Remuneration programs are designed and communicated in a manner that reinforces the link between vision, business objectives and culture.
Business alignment and consistency
Remuneration decisions are made to ensure local practices are aligned and consistent with BerGenBio´s principles and policies. The remuneration practices
will remain flexible enough to evolve as BerGenBio’s business priorities change.
Shareholder and strategic alignment
The remuneration programs will align the interests of all employees in driving value creation for shareholders. BerGenBio’s strategy is focused on developing
novel medicines for aggressive diseases. To sustain BerGenBio’s position as a world leader in this field, BerGenBio’s strategy hinges upon actionable
strategic priorities. Each of these strategic priorities consists of several themes where BerGenBio has defined specific financial and non-financial goals and
related actions to execute over time.
3. Overall Company financial performance in 2023
In 2023 BerGenBio sharpened its strategy to focus on NSCLC STK11m and severe respiratory infections for its lead compound bemcentinib.
BerGenBio’s EBIT in 2023 was a loss of NOK 192 million against a loss of NOK 306 million in 2022. The significant decrease in loss from 2022
to 2023 is a direct effect of the focused strategy including the rightsizing of the organization and is expected to further materialize in 2024.
Revenue were NOK 0.4 million (2022: NOK 0.4 million). Revenue in 2023 and 2022 resulted from a repayment of patent costs from our license
agreement with ADCT.
BERGENBIO
Annual Report & Accounts 2023
27
Governance/Remuneration report
›
IN ‘1,000 NOK COMMITTEE FEES
NAME POSITIONS 2023
BASE
BOARD FEE
AUDIT
COMMITTEE
REMUNERATION
COMMITTEE
CLINICAL
COMMITEE
2
OTHER
BENEFITS
3
TOTAL FEES
Anders Tullgren Chair of the board, Chair of Remuneration Committee and member of Audit Committee 650 30 45 123 858
Sveinung Hole
Non-executive member of the Board of Directors, member of Remuneration Committee
and member of Audit Committee
280 30 25 335
Debra Barker
Non-executive member of the Board of Directors, member of Remuneration Committee
and member of Clinical Committee
280 25 12 27 344
Sally Bennett
Non-executive member of the Board of Directors, Chair of the Audit Committee and
member of the Clinical Committee
280 55 12 11 358
Francois Thomas
1
Non-executive member of the Board of Directors, and Chair of Clinical Committee
117 23 140
Total remuneration 1,607 115 95 47 161 2,025
1
François Thomas was not re-elected as board member at the AGM in 2023 and resigned in May 2023.
2
Clinical Committee fee is according to AGM approval in 2022. The committee was discontinued in May 2023 and fee is paid to end of May 2023.
3
Other benefits include compensation for traveling hours related to board meetings and for taxes in connection with a one-off bonus received by the Chair of the Board in 2022, representing the after-tax value of 25,000 shares in BerGenBio.
The Nomination Committee, as defined in the
Corporate Governance section of BerGenBio’s
website, reviews Board fees at least annually. Fees
are evaluated relative to Nordic and UK companies
of comparable size and complexity to BerGenBio.
The work of the Board of Directors and committees
are covered in section 8 and 9 in the Corporate
Governance Report in the Annual Report.
The Nomination Committee prepares
recommendations for remuneration of the Board
of Directors. The recommendations are put before
shareholders for approval before they come into
effect. The Board of Directors’ remuneration is
approved by the shareholders as a separate item
on the agenda at the Annual General Meeting.
The Chairman and each member of the Board of
Directors receives a fixed annual fee. The Chairman
or Board members who participate in the Audit
Committee or Remuneration Committee receive
separate compensation for this.
As relevant, Board members not domiciled in
Norway are also entitled to compensation for
traveling time within business hours to and from
Board meetings.
Additional fees or benefits may be provided to
reflect, for example, accommodation, transport
and other business-related expenses incurred while
carrying out their role.
Board members are not eligible to participate in any
incentive arrangements operated by BerGenBio.
The remuneration of Board members is not linked
to the Company’s performance and does not
contain option elements.
4.1 REMUNERATION OF INDIVIDUAL MEMBERS OF THE BOARD OF DIRECTORS IN 2023
Table 4.1 Remuneration of individual members of the Board of Directors in 2023
4. Remuneration of the Board of Directors
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4.2 BOARD OF DIRECTORS SHAREHOLDINGS
The table illustrates shares purchased and sold by Board members in 2023.
Table 4.2 Board of Directors shareholdings
NAME SHARES AT 1 JANUARY 2023 ADDITIONS DURING THE YEAR SOLD DURING THE YEAR SHARES AT 31 DECEMBER 2023
Anders Tullgren 50,000 2,114,730 2,164,730
Sveinung Hole
1
107,394 3,000,000 107,394 3,000,000
Debra Barker 0 466,540 466,540
Sally Bennett 0 472,239 472,239
Total 157,394 6,053,509 107,394 6,103,509
1
Sveinung Hole holds his shares through Svev AS.
5. Remuneration of the Executive Management
Remuneration for the CEO is proposed by the Remuneration Committee and subsequently approved by the Board of Directors annually, in line
with the policy. Remuneration for other members of the Executive Management is proposed by the CEO to the Remuneration Committee for
their approval in line with the policy.
The remuneration arrangements for the BerGenBio Executive Management comprise the following elements:
REMUNERATION DESCRIPTION
Base salary
Enables BerGenBio to attract, engage and retain talent needed to drive long-term value creation. It is an annual market-consistent remuneration that is fixed based on skills,
performance, experience, scope of work and responsibility, taking into consideration the rate of pay rise for executives and other employees.
Short-term incentive (STI)
Enables BerGenBio to incentivize delivery of its short-term objectives and ensure a clear link with value creation. Performance measures and targets are normally set annually by
the Board of Directors. The Board sets the individual objectives of the CEO and the overall objectives for the executive team. The Committee, in discussion with the CEO, reviews
the level of performance achieved and the amount of STI earned by the members of the Executive Management.
The Board of Directors determines pay-outs based on performance against the targets and to ensure that the outcome is fair in the context of overall performance of BerGenBio
and the individual. Awards are normally paid out in cash. The target award for CEO is 50%, with a maximum award in any financial year up to 75% of base salary. For other
executives the target award is 30%, with a maximum award in any financial year up to 45% of base salary.
Long-term incentive (LTI) program
Enables BerGenBio to incentivize and reward long-term value creation and align with shareholders’ interest. Award of share options is not dependent on achieving specific
targets; however, their values are linked to BerGenBio’s share price and its development. Share options vest over three years from time of grant and expire eight years after grant.
Other benefits
Enables BerGenBio to provide market competitive and cost-effective benefits. Benefits may include, but are not limited to healthcare, life and accident insurance on customary terms,
house allowance. Specific benefit provision may be subject to minor change from time to time. Additional benefits may be provided on recruitment or to support relocation.
Pension
Encourages planning for retirement and long-term saving. BerGenBio ASA has a defined contribution pension plan according to the mandatory requirements in the Norwegian Law.
BerGenBio Limited has a defined contribution pension plan according to the requirements in the UK. Company-paid pension contributions are set considering the wider workforce
rate and market practice in the country in which the executive resides.
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TERMS AND CONDITIONS FOR INDEMNITY FOR THE
MEMBERS OF THE BOARD OF DIRECTORS
BerGenBio has a Directors and Officers’ liability insurance and indemnification
for the members of the Board of Directors. It is the policy of BerGenBio to
indemnify Directors and Officer’s against claims for damages. In 2023, no claims
were reported and BerGenBio did not indemnify its Directors and Officers against
claims for damages.
5.1 EXECUTIVE MANAGEMENT REMUNERATION BENCHMARK
Executive Management remuneration is evaluated annually against relevant
benchmarks of Nordic general industry companies and European biotech
companies, similar to BerGenBio in size, complexity, and market capitalization.
After the 2020 update, the BerGenBio Comparator Peer Group consists of
19 companies from the Nordic countries (13) and the UK (6) with number of
employees, revenue, R&D expense and market capitalization spanning from well
below to well above the relevant metrics for BerGenBio. The peer group is used
for a benchmarking of the Executive Management Team to assess the market
positioning of remuneration packages. A revised benchmark is expected to be
updated in 2024.
5.2 REMUNERATION OF INDIVIDUAL MEMBERS OF THE
EXECUTIVE MANAGEMENT IN 2023
Table 5.2.1 shows a decrease in the total remuneration to employed Executive
management by 12% and table 5.2.2 a reduction by 40% for executives engaged
as consultants, in total a reduction in remuneration to executive management by
19% from 2022 to 2023. This is caused by individual reduction in compensation
package and reduction of Executive Management members during 2023. The
full effect of this will materialize in 2024 and is expected to represent a 30-40%
reduction for the full year effect from 2022 in fixed currencies on total level.
Table 5.2.1 Remuneration of individual members of the Executive Management in 2023
This table is presented in nominated currency per individual Executive member.
IN ‘1,000 AND
NOMINATED CURRENCY
FIXED REMUNERATION VARIABLE REMUNERATION
NAME
Joined /
Departed
Currency Year
Base
salary
Pension
Severance
pay
Other
benefits
1
Total fixed
remuneration
% out of total
remuneration
Short-term
incentive
Total granted fair value
of share options
Total variable
remuneration
% out of total
remuneration
Total
Martin Olin
3
(CEO)
GBP
GBP
2023
2022
407
414
61
63
33
42
501
519
63%
56%
133
178
156
229
289
407
37%
44%
790
926
Rune Skeie (CEO)
NOK
NOK
2023
2022
1,960
1,876
205
192
27
19
2,192
2,086
61%
73%
375
472
1,025
286
1,400
758
39%
27%
3,592
2,844
Cristina Oliva (CMO)
Joined 25
April 2022
GBP
GBP
2023
2022
283
189
28
19
312
207
71%
69%
51
47
78
48
129
95
29%
31%
441
303
Other Executives
2
GBP
GBP
2023
2022
360
463
36
51
13
50
17 426
563
95%
74%
23
102
0
93
23
195
5%
26%
449
759
1
Other benefits include housing allowance, insurances, expenses to mobile, internet, newspapers, and other business-related expenses.
2
Other executives in 2023: Nigel McCracken (to 31 August 2023) and James Barnes (to 31 December 2023), in 2022: Nigel McCracken and James Barnes full year and Alison Messom (to 30 March 2022).
3
Base salary is reduced by 23 % effective from 1 October 2023. From 2024 base salary is nominated in DKK.
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Table 5.2.2 Remuneration of individual members of the
Executive Management engaged as contractors
IN ‘1,000 REMUNERATION
NAME Joined / Resigned Year Invoice fee
Gayle Mills
1
(CBO)
2023
2022
322 (USD)
346 (USD)
Gwyn Thomas
2
(Interim Head
of Clinical Development) Left 30 April 2022
2023
2022
0 (GBP)
99 (GBP)
Debbie Molyneux (CPO)
Left 30 June 2023 2023
2022
51 (GBP)
227 (GBP)
1
Gayle Mills is contracted through a consultancy agreement with a fixed monthly fee and is eligible
for an incentive fee on partnering and/or M&A deals.
2
Debbie Molyneux and Gwyn Thomas were contracted through individual consultancy agreements.
5.3 SHORT-TERM INCENTIVE OF THE EXECUTIVE
MANAGEMENT IN 2023
BerGenBio Executive Management participates in a short-term
incentive scheme in line with the Remuneration Policy. Target STI
level for CEO is 50% of base salary and 30% of base salary for all
other Executives, and maximum STI level is 75% of base salary for
CEO and 45% for other Executives. Individual STI is dependent on
performance and achievement of goals. Goals for 2023 consisted
of specific development goals relating to financials, bemcentinib
and organizational development. Overall achievement of corporate
goals for 2023 was 50%, with an average individual performance
achievement between 100%-130%. Short-term incentive for
Executive Management for 2023 amounted in total NOK 3.2 million.
CATEGORY MEASURES OVERALL ACHIEVEMENTS 2023
Financials • Secure additional capital to fund activities beyond 2023
Development of bemcentinib
• Patient enrollment in the Ph1b and initiation of Ph2a of the NSCLC STK11m clinical study
• Patient enrolment and interim analysis of the COVID-19 Ph2b clinical study (EUSolidAct)
• Establish clinical and regulatory plan to support development in other serious respiratory infections (SRI)
• Conduct formulation and manufacturing activities to support further development
Organization development
• Organization design to support strategy
• Financial strategy
• Pursue relevant partnership and licence opportunities
• Corporate compliance and inspection readiness
• Complete or close activities not part of the core strategy
Total 50%
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5.4 LONG-TERM INCENTIVE (LTI) PROGRAM
To promote and achieve long-term goals and strategies for
BerGenBio, as well as sustainability, and thereby contribute to
BerGenBio´s development and growth, incentive remuneration in the
form of share options are offered to the Executive Management and
the wider team.
Share options normally vest over three years by one third per
annum. The maximum award in respect of a financial year is 100%
of annual base salary for the CEO and 50% for all other executives
calculated according to the Black-Scholes model. Options are
awarded at an exercise price identical to the fair value of the shares
at the time of the grant, which is to be determined when the grant
is made. In addition to the exercise price, the participant shall pay
to the Company an amount that covers any payroll tax payable as
a result of exercising the options. Individual share option awards
are determined by considering the overall performance, potential,
competitiveness of the employment terms, position responsibility,
need for retention, and the overall long-term organization need.
Exercise is not subject to performance measures, but the value
of the options will be measured based on development in share
price. Vested share options can be exercised partly or fully at four
specified points per year in connection with the release of financial
results. In addition, the Board of Directors may allow exercise at
other suitable times during the year.
Annual Report & Accounts 2023
BERGENBIO
Annual Report & Accounts 2023
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Table 5.4 Long-term incentive (LTI) program
NAME Program Grant date Earliest vesting date Exercise price
No. of share options
Beginning of the year
No. of share
options granted
No. of share options
cancelled or reclassified
No. of share options
exercised
No. of share options
end of the year
Fair value of share options at
grant (1’000 NOK)
3
Martin Olin (CEO)
1
2023 08.12.2023 08.12.2024 0.2113 0 24,000,000 24,000,000 2,050
2022 23.11.2022 08.09.2022 7.59 950,000 950,000 2,714
Rune Skeie (CFO) 2023 08.12.2023 08.12.2024 0.2113 12,000,000 12,000,000 1,025
2022 23.11.2022 23.11.2023 7.59 100,000 100,000 286
2021 06.05.2021 06.05.2022 28.55 54,340 54,340 787
2020 08.04.2020 08.04.2021 15.00 146,667 146,667 1,100
2019 17.04.2019 17.04.2020 25.00 52,000 52,000 650
2018 31.10.2018 31.10.2019 28.50 20,000 20,000 285
2018 22.05.2018 22.05.2019 46.70 24,090 24,090 563
Cristina Oliva (CMO) 2023 08.12.2023 08.12.2024 0.2113 0 12,000,000 12,000,000 1,025
2022 23.11.2022 25.04.2023 7.59 200.000 200,000 571
Other executives
3
2022 21.11.2022 21.11.2023 7.59 385,000 (385,000) 0 1,100
2021 06.05.2021 06.05.2022 28.55 64,122 (21,374) 42,748 929
2020 08.04.2020 08.04.2021 15.00 178,000 178,000 1,335
2019 17.04.2019 17.04.2020 25.00 59,400 59,400 743
1
Fair value of total share options at grant date is based on Black Scholes fair value calculation (from 2021 program).
2
2022 grant includes initial grant from 2021.
3
Other executives are James Barnes and Nigel McCracken. For Nigel McCracken the number of options at end of 2023 are reclassified and not included as he resigned from the executive management in August 2023.
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5.5 EXECUTIVE MANAGEMENT SHAREHOLDINGS
Shares purchased and sold by Executive members in 2023.
Table 5.5 Executive Management shareholdingss
NAME SHARES AT 1 JANUARY 2023 ADDITIONS DURING THE YEAR RECLASSIFICATION SHARES AT 31 DECEMBER 2023
Martin Olin (CEO) 37,100 3,000,000 3,037,100
Rune Skeie (CFO) 0 388,785 388,785
James Barnes (COO to December 2023) 0 259,190 (259,190) 0
Nigel MacCracken (CSO to August 2023) 0 285,108 (285,108) 0
Total shares 37,100 3,933,083 (544,298) 3,425,885
6. Terms of termination and termination benefits
BerGenBio does not apply a standard notice policy. The normal notice period for the Executive Management Team is three months by the
executive or the Company. The CEO has a notice period of six months by the CEO or the Company. If the CEO’s employment is terminated
without cause by the Company, the CEO is entitled to receive a severance payment equal to 12 months remuneration excluding short term
incentive. If the CEO’s contract is terminated within 18 months of a change of control (or change of ownership), the CEO will be compensated
with 18 months’ remuneration.
Severance payments for executives will normally be made up of salary, benefits, pension contributions and short-term incentive (where eligible)
and would reflect the notice period of the contract. The Board of Directors reserves the right to make any other payments in connection with
a member of the Executive Management stepping down/ceasing employment where the payments are made in good faith in discharge of an
existing legal obligation (or by way of damages for breach of such an obligation) or by way of settlement of any claim arising in connection with
the individual stepping down/ceasing employment. Any termination payments, including payment during the notice period, may not exceed a
total value of the equivalent to 12 months’ remuneration. This maximum severance amount includes all components of remuneration, both fixed
and variable elements.
7. Comparison of remuneration and financial performance figures
BerGenBio will build up five years of comparative figures for the annual change in remuneration, Company performance, and average
remuneration based on full-time equivalents (“FTEs”) of employees other than Executive Management members. 2021 was the first year of
reporting and BerGenBio has chosen to only include relevant comparative figures from 2020 in table 7.1.
BERGENBIO
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TABLE 7.1 COMPARISON OF TOTAL REMUNERATION AND FINANCIAL PERFORMANCE FIGURES
Executive Management total remuneration includes base salary, pension, other remuneration, short-term incentive and total calculated fair
value of granted options. Table 7.1 is presented in NOK. Individual Executive Management members and Group employees have remuneration
nominated in GBP. The average exchange rates NOK/GBP used for conversion are: 2023: 13.13, 2022: 11.85, 2021: 11.83 and 2020: 12.05.
Caused by the weakness in NOK/GBP from 2022 to 2023, the NOK amount below for individual with base salary nominated in GBP is positive
affected by > 10%.
IN ‘1,000 NOK 2023
1
Change % 2022 Change % 2021 Change % 2020
Executive Management – remuneration
Martin Olin CEO, from September 2021
1
10,376 -5.4% 10,974 181.5% 3,898 0
Rune Skeie, CFO 3,592 26.3% 2,844 -13.0% 3,271 2.5% 3,190
Cristina Oliva CMO, from April 2022
1
5,787 61.5% 3,586 0 0
Other employed executives
1
5,902 -34.4% 8,990 -62.9% 24,204 -18.1% 29.546
Board of Directors – remuneration
Anders Tullgren, from January 2022 848 -23.9% 1,115 0 0
Sveinung Hole 335 -2.9% 345 -31.9 506 7.7% 470
Sally Bennet, from December 2020 358 -5.3% 378 20.2 315 1,201.6% 24
Debra Barker 344 -2.5% 353 10.3 320 26.4% 253
François Thomas, from Dec 2020 to May 2023 140 -59.9% 349 -4.7 366 1,251.5% 27
Stener Kvinnsland, to January 2022 24 -91.6 285 22.8% 232
1
Remuneration nominated in GBP. Converted to NOK by average annual currency rate. 2023 numbers in NOK are significantly (> 10%) effected by weakness in NOK.
The calculation of average fixed and variable remuneration is very sensitive to the relatively low number of FTEs involved and is further
impacted due to a significant reduction in FTEs during 2023 and 2022 as part of the announced focused strategy, compared to 2021 and 2020.
Increase of average fixed remuneration from 2022 to 2023 was 4% on Group level (from 2021 to 2022 4% on Group level).
BERGENBIO
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›
2023
1
Change % 2022 Change % 2021 Change % 2020
Financial performance figures: Employees – average remuneration based on FTE’s
Number of FTE’s (excl. Executive Management) – Group 20.7 -33.9% 31.3 -15.8% 37.2 47.1% 25.3
Average total remuneration for Group employees (1’000 NOK)
1 2
1,384 10.0% 1,258 -8.3% 1,371 25.9% 1,089
Average fixed remuneration for Group employees (1’000 NOK)
1 3
1,082 0.7% 1,074 10.5% 972 12.9% 861
Average variable remuneration for Group employees (1’000 NOK)
1 4
302 64.2% 184 -53.9% 399 75.2% 228
Number of FTE’s (excl. Executive Management) – Parent 9.0 -25.3% 12.0 -2.9% 12.4 15.9% 10.7
Average total remuneration for parent company employees (1’000 NOK)
2
1,277 16.7% 1,094 -4.2% 1,142 40.2% 815
Average fixed remuneration for parent company employees (1’000 NOK)
3
986 3.2% 956 23.5% 774 8.1% 716
Average variable remuneration for parent company employees (1’000 NOK)
4
290 110.0% 138 -62.4% 368 271.6% 99
Group financial results
Revenue of BerGenBio (´1.000 NOK) 354 -9.0% 389 -49.7% 774 28.8% 601
Research & Development (R&D) costs (´1.000 NOK) 141,800 -43.9% 252,600 -0.4% 253,700 22.6% 206,857
1
Remuneration nominated in GBP is converted to NOK by average annual currency rate. 2023. Numbers in NOK is significantly (> 10%) effected by weakness in NOK/GBP.
2
Average total remuneration for Group employees and Parent Company employees is calculated as total remuneration [salary, pension and short-term incentive for all employee (excluding Executive Management)
including fair value of granted options divided by total FTEs (excluding Executive Management)].
3
Average fixed remuneration for Group employees and Parent Company employees is calculated as fixed remuneration [salary and pension for all employees (excluding Executive Management) excluding short-term
incentive and fair value of granted options divided by total FTEs (excluding Executive Management)].
4
Variable remunerations include introduction of STI and LTI scheme for additional employees from 2021.
8. Compliance with the remuneration policy
The remuneration of members of the Board of Directors and Executive Management for 2023 is consistent with the scope of the Remuneration
Policy. There has been no deviation or derogation from the framework provided by the Remuneration Policy.
BERGENBIO
Annual Report & Accounts 2023
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›
The Board of Directors has today considered and approved the
Remuneration Report of BerGenBio for the financial year 1 January to
31 December 2023.
The Remuneration Report is presented in accordance with section
6–16a of the Norwegian Public Limited Companies Act.
In our opinion, the Remuneration Report is in accordance with
the Company’s Remuneration Policy, which has been adopted at
the Company’s Annual General Meeting, and is free of material
misstatement, whether due to fraud or error.
We recommend the Remuneration Report for advisory vote at the
Company’s Annual General Meeting.
Bergen, 30 April 2024
Board of Directors
9. Statement by the Board of Directors
Anders Tullgren
Chair of the Board of Directors
Sveinung Hole
Non-Executive Director
Dr. Sally Bennett
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
36
BERGENBIO
Annual Report & Accounts 2023
To the General Meeting of Bergenbio ASA
Opinion
We have performed an assurance engagement to obtain reasonable
assurance that Bergenbio ASA’s report on salary and other
remuneration to directors (the remuneration report) for the financial
year ended 31 December 2023 has been prepared in accordance with
section 6-16 b of the Norwegian Public Limited Liability Companies Act
and the accompanying regulation.
In our opinion, the remuneration report has been prepared, in all
material respects, in accordance with section 6-16 b of the Norwegian
Public Limited Liability Companies Act and the accompanying
regulation.
Board of directors’ responsibilities
The board of directors is responsible for the preparation of the
remuneration report and that it contains the information required in
section 6-16 b of the Norwegian Public Limited Liability Companies
Act and the accompanying regulation and for such internal control as
the board of directors determines is necessary for the preparation of a
remuneration report that is free from material misstatements, whether
due to fraud or error.
Our independence and quality control
We are independent of the company in accordance with the
requirements of the relevant laws and regulations in Norway and the
International Ethics Standards Board for Accountants’ International
Code of Ethics for Professional Accountants (including International
Independence Standards) (IESBA Code), and we have fulfilled our
other ethical responsibilities in accordance with these requirements.
The firm applies International Standard on Quality Management, which
requires the firm to design, implement and operate a system of quality
management including policies or procedures regarding compliance
with ethical requirements, professional standards and applicable legal
and regulatory requirements.
Auditor’s responsibilities
Our responsibility is to express an opinion on whether the
remuneration report contains the information required in section 6-16
b of the Norwegian Public Limited Liability Companies Act and the
accompanying regulation and that the information in the remuneration
report is free from material misstatements. We conducted our work in
accordance with the International Standard for Assurance Engagements
(ISAE) 3000 – “Assurance engagements other than audits or reviews of
historical financial information”.
We obtained an understanding of the remuneration policy approved
by the general meeting. Our procedures included obtaining an
understanding of the internal control relevant to the preparation of the
remuneration report in order to design procedures that are appropriate
in the circumstances, but not for the purpose of expressing an opinion
on the effectiveness of the company’s internal control. Further we
performed procedures to ensure completeness and accuracy of the
information provided in the remuneration report, including whether
it contains the information required by the law and accompanying
regulation. We believe that the evidence we have obtained is sufficient
and appropriate to provide a basis for our opinion.
Bergen, 30 April 2024
ERNST & YOUNG AS
Truls Nesslin
State Authorised Public Accountant (Norway)
37
Governance/Remuneration report
›
INDEPENDENT AUDITOR’S ASSURANCE REPORT ON REMUNERATION REPORT
37
Statsautoriserte revisorer
Ernst & Young AS
Thormøhlens gate 53 D, 5006 Bergen
Postboks 6163, 5892 Bergen
Foretaksregisteret: NO 976 389 387 MVA
Tlf: +47 24 00 24 00
www.ey.no
Medlemmer av Den norske Revisorforening
BERGENBIO
Annual Report & Accounts 2023
38
Corporate governance report
Governance/Corporate Governance report
›
BerGenBio considers good corporate governance to be a prerequisite
for value creation and trustworthiness, and for access to capital.
In order to secure strong and sustainable corporate governance,
it is important that BerGenBio ensures good and healthy business
practices, reliable financial reporting and an environment of
compliance with legislation and regulations.
BerGenBio is incorporated and registered in Norway and is subject
to Norwegian law. The Company’s shares are listed on Oslo Stock
Exchange (Oslo Børs) under the ticker BGBIO, and thus subject to
the requirement to prepare an annual statement of its principles
and practices for corporate governance. The Company endorses the
Norwegian Code of Practice for Corporate Governance, issued by the
Norwegian Corporate Governance Board (the “Code”). Compliance
with the Code is based on the “comply or explain” principle, which
means that the Company must either comply with the individual items
in the Code or explain why they have chosen an alternative solution.
IMPLEMENTATION AND REPORTING OF
CORPORATE GOVERNANCE
BerGenBio has governance documents setting out principles for how
business should be conducted. References to more specific policies
are included in this corporate governance report where relevant. The
BerGenBio governance regime is approved by the Board of Directors
in the Company.
BerGenBio believes good corporate governance involves
openness and trustful cooperation between the Company and all
its stakeholders. By practicing good corporate governance, the
Company’s Board of Directors and management will contribute to
achieving the Company’s objectives of openness, independence,
equal treatment, and control and management.
The following sections provide a discussion of the Company’s
corporate governance in relation to each section of the Code.
According to the Company’s own evaluation, the Company deviates
from the Code on the following points:
• Formulation of Company takeover policy (section 14)
• Formulation of guidelines for use of the auditor for services other
than auditing (section 15)
VALUES AND ETHICAL POLICIES
The Company’s main values and ethical principles form the basis
for the Code of Conduct. The Code of Conduct is distributed to all
employees, management and Board members, and published on the
Company’s website.
The Company’s Code of Conduct rules set forth the basic principles
for business practices and personal behavior for BerGenBio and
apply to all employees, as well as persons/entities related to the
Company, including hired consultants acting on behalf of the Group.
They comprise the Company’s main principles on issues such as
human and labor rights, health and safety, business ethics, legal
compliance, insider trading, whistleblowing and other relevant issues
related to the Company’s operations.
Material breaches of the ethical guidelines may result in termination
of employment/engagements.
1. Corporate Governance in BerGenBio
BERGENBIO
Annual Report & Accounts 2023
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›
2. Business
BerGenBio is a clinical-stage
biopharmaceutical Company focused
on developing novel medicines for
aggressive diseases. The Company’s lead
clinical asset, bemcentinib, targeting the
receptor tyrosine kinase AXL, is currently
in development in a Ph1b/2a study in 1L
STK 11 mutated NSCLC and preclinical
development for severe respiratory
infections.
The Company’s operations comply with
the business objective set forth in its
articles of associations section 3:
“The company’s objective is to
undertake research and development
in biotechnology with a focus on new
pharmaceutical therapeutics”.
The Company has developed clear goals
and strategies which are further described
in the Annual Report for 2023.
3. Equity and Dividends
CAPITAL ADEQUACY
BerGenBio’s total equity as of 31
December 2023 was NOK 127.5 million,
corresponding to an equity ratio of 73.1%.
The Company cash position as of 31
December 2023 was NOK 156.4 million.
In June 2023 the Company secured NOK
250 million in new funding from a Rights
Issue. As part of the Rights Issue the
Company issued 1,249,999,617 Warrants
to the subscribers in the Rights Issue.
The Warrants could be exercised in two
periods; the first in November 2023 where
5% of the total Warrants were exercised
with gross proceeds of NOK 8.9 million, and
the last period in April 2024 when 88.5%
of the Warrants were exercised with gross
proceeds of NOK 138.9 million. The cash
position in combination with the proceeds
from the Warrant exercise in April 2024 will
fund the planned activities into 2H 2025 on a
going concern basis. The Board of Directors
considers this to be an adequate level,
relative to the risk and scope of operations
based on the Company’s internal estimated
capital requirements.
DIVIDEND POLICY
BerGenBio has not developed a dividend
policy. The Company is focusing on the
development of novel pharmaceutical
products and does not anticipate paying
any cash dividend until sustainable
profitability is achieved. The Company has
not previously distributed any dividends to
its shareholders.
AUTHORIZATIONS TO THE
BOARD OF DIRECTORS
At the Company’s Annual General Meeting,
on 22 May 2023, the Board of Directors
was granted the following authorization:
• Authorization to increase the Company’s
share capital by up to NOK 12,909,000
in connection with its existing share
option scheme. The authorization is
effective until the earlier of the AGM in
2024 and 30 June 2024.
• Authorization to increase the Company
share capital by up to NOK 72,773,210
by subscription of new shares, which
constitute approximately 20% of
the Company´s outstanding shares
including all issued Warrants. The
purpose of the authorization is to permit
the issue of new shares to strengthen
the Company equity and to increase
the liquidity and/or to broaden the
Company’s shareholder base, in addition
to issue shares to Underwriters in the
Rights Issue which elect settlement
of the underwriting fee in shares. The
authorization is effective until the
earliest of the AGM in 2024 and 30
June 2024. By 31 December 2023 NOK
3,187,200 of this authorization has
been used to issue new shares to the
Underwriters in the Rights Issue.
For supplementary information on the
authorizations, reference is made to the
minutes of the Annual General Meeting
held on 22 May 2023, available from the
Company’s website.
BERGENBIO
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4. Equal Treatment
of Shareholders and
Transactions with Close
Associates
BerGenBio has only one class of shares.
Each share in the Company carries one vote,
and all shares carry equal rights, including
the right to participate in General Meetings.
All shareholders shall be treated on an equal
basis, unless there is just cause for treating
them differently.
SHARE ISSUES WITHOUT
PREFERENTIAL RIGHTS FOR
EXISTING SHAREHOLDERS
In the event of a share capital increase
through the issue of new shares, a decision
to waive the existing shareholders’
preferential rights to subscribe for shares
shall be justified. Where the Board of
Directors resolves to issue shares, and
waive the preferential rights of existing
shareholders pursuant to an authorization
granted to the Board of Directors by the
general meeting, the justification will be
publicly disclosed in a stock exchange
announcement issued in connection
with the shares issuance. There were no
such transactions in 2023. The Rights
Issue in June 2023 was conducted by
issuing subscription rights to all existing
shareholders and the Warrants issued
as part of the Rights Issue were issued
to all subscribers in the Rights Issue.
The Rights Issue was partly underwritten
and guaranteed by existing shareholders
and external underwriters. The fee to the
underwriters was set at market level for
similar transactions.
TRANSACTIONS IN
TREASURY SHARES
Any transactions in treasury shares shall be
carried out through Oslo Stock Exchange,
and in any case to prevailing stock
exchange prices. In the event that there is
limited liquidity in the Company’s shares,
the Company will consider other ways to
cater for equal treatment of shareholders.
There were no such transactions in 2023
APPROVAL OF AGREEMENTS
WITH SHAREHOLDERS AND
CLOSE ASSOCIATES
For transactions that are considered to
be not immaterial between the Company
and its closely related parties, the Board of
Directors will arrange for an independent
third-party valuation. Members of the Board
of Directors and executive personnel are
required to notify the Board of Directors
when such members have any significant,
direct or indirect, interest in a transaction
carried out by the Company. There were no
such transactions in 2023.
In October 2022 the Company secured a
shareholder loan facility agreement with
Meteva AS, holding 27% of the shares in
the Company. The contribution from the
Company were a comitment fee of 1.5%
on any undrawn amount and interest of
6% of any drawn amount. The maximum
contribution from the Company, consisting
of commitment fee and interest was
consider to be below the threshold in
the Norwegian Public Limited Liability
Companies Act section 3-10 which requires
approval by the General Meeting. The
Company also considers the terms in the
loan agreement to be favorable compared to
alternative similar financing solutions. The
facility was terminated by the approval of
the Rights Issue in May 2023 according to
the terms of the facility. As no amount was
drawn under the facility, the total fee under
the agreement was less than NOK 1 million.
5. Freely Negotiable Shares
The shares of the Company are freely
negotiable, and the Company’s articles of
association do not place any restrictions on
the negotiability of shares.
BERGENBIO
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6. General Meetings
The General Meeting is open to all
shareholders, and BerGenBio encourages
all shareholders to participate and exercise
their rights in connection with the Company’s
General Meetings. The right to participate
and vote at the general meeting can only
be exercised for shares registered in the
shareholders’ register by the fifth business
day prior to the day of the General Meeting.
Notice of a General Meeting and any
supporting documents, including the
recommendation by the Nomination
Committee and other information on the
resolutions to be considered, shall be made
available on the Company’s website no later
than 21 days prior to the date of the General
Meeting. In accordance with the Company’s
articles of association, documents that are
to be considered by the General Meeting are
not required to be sent to the shareholders
if they have been made available on the
Company’s website. The deadline for
registration of proxy or pre-votes will be set
as close to the meeting as possible, and all
the necessary registration information will
be described in the notice.
Shareholders unable to attend may vote by
proxy. Whenever possible, the Company will
prepare a proxy form that will allow separate
votes for the items that are to be considered
in the General Meeting.
The agenda for the Annual General Meeting
is stipulated by the articles of association,
and the main topics to be considered
include the approval of the annual accounts
and the Directors’ report, including
distribution of dividend, and remuneration
of leading personnel.
If the Board Chairman is the chair for the
General Meeting and there is disagreement
on individual items for which the Board
Chairman belongs to one of the factions,
or is not regarded as being impartial for
other reasons, another chairperson will be
appointed to ensure impartiality regarding
the items to be considered.
The Board Chairman and the CEO will be
present at General Meetings, together with
representatives of the Board. Representatives
of the Nomination Committee, the
Remuneration Committee and the Audit
Committee, as well as the auditor, should be
present at General Meetings where matters
of relevance for such committees/persons
are on the agenda.
Minutes from the General Meetings will
be published in accordance with the stock
exchange regulations and made available on
the Company’s website.
In 2023, BerGenBio held its Annual General
Meeting on 22 May 2023.
7. Nomination Committee
The Nomination Committee of BerGenBio
consists of three members, elected
pursuant to section 9 of the Company’s
Articles of Association.
The Nomination Committee is responsible for
recommending candidates for the election
of members and Chairman of the Board
of Directors, candidates for the election of
members and Chairman of the Nomination
Committee, and remuneration of the Board
of Directors, Board subcommittees and the
Nomination Committee.
The objectives, responsibilities and functions
of the Committee are further described in the
“Instructions for the Nomination Committee”,
which were adopted by the General Meeting
at the AGM in 2017. The instructions are
available from the Company’s website.
The current Nomination Committee
consists of:
• Hans Peter Bøhn (Chair) – elected at the
Annual General Meeting 22 March 2017
• Ann-Tove Kongsnes – elected at the
Annual General Meeting 19 June 2014
• Shantrez Miller Gillebo – elected at
the Extraordinary General Meeting 9
December 2020
All members are elected with a term until
the Annual General Meeting in 2025. All
members are considered independent of
the Company’s Board of Directors and
Executive Management.
All shareholders are entitled to nominate
candidates to the Board and contact
information for proposing candidates can
be found on the Company’s website.
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Pursuant to the articles of association
section 5, the Company’s Board of Directors
shall consist of three to seven members.
As of 31 December 2023, the Board of
Directors consisted of four members, of
which two are women:
• Anders Tullgren (Chair) – elected at the
Extraordinary General Meeting (EGM)
6 January 2022 and re-elected at the
AGM in 2022 up to the AGM in 2024
• Sveinung Hole – elected at the Annual
General Meeting (AGM) in 2010 and
re-elected annually, last time at the AGM
on 28 April 2022 up to the AGM in 2024
• Debra Barker – elected at the Annual
General Meeting on 13 March 2019 and
re-elected up to the Annual General
Meeting in 2025
• Sally Bennett – elected at the
Extraordinary General Meeting on
9 December 2020 and re-elected up to
the Annual General Meeting in 2025
The composition of the Board of Directors
is in compliance with the independence
requirements of the Norwegian Code of
Practice for Corporate Governance, (the
“Corporate Governance Code”), meaning
that (i) the majority of the shareholder-
elected Board Members are independent of
the Company’s Executive Management and
material business contacts, (ii) at least two
of the shareholder-elected Board Members
are independent of the Company’s main
shareholders (shareholders holding more
than 10% of the shares in the Company),
and (iii) no members of the Company’s
Management serve on the Board of
Directors. Furthermore, pursuant to the
Norwegian Public Limited Companies Act,
if the Board of Directors of a Norwegian
Public Limited Liability Company consists of
four to five members, then each gender shall
be represented by at least two members.
All board members are independent of the
Company’s significant business relations
and large shareholders (shareholders
holding more than 10% of the shares in the
Company) and of the Management.
Board members are not part of the share option program in the Company but are encouraged to own shares in BerGenBio. The following
shares are held by the Board as of 31 December 2023:
NAME POSITION CONSIDERED INDEPENDENT SERVED SINCE TERM EXPIRES BOARD MEETING ATTENDANCE 2023 SHARES
Anders Tullgren Chair Yes 06.01.2022 AGM 2024 16 2,164,730
Sveinung Hole Board member Yes 01.09.2010 AGM 2024 16 3,000,000
1
Debra Barker Board member Yes 13.03.2019 AGM 2025 15 466,540
Sally Bennett Board member Yes 09.12.2020 AGM 2025 16 472,239
1
Sveinung Hole holds 3,000,000 shares in the Company through Svev AS, a wholly-owned company of Sveinung Hole.
8. Board of Directors; Composition and Independence
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9. The Work of the Board of Directors
The Board of Directors is responsible for
the management of the Company, including
the appointment of the Chief Executive
Officer (CEO), convening and preparing
for General Meetings and supervising the
daily management and the activities of the
Company in general.
The Board of Directors has implemented
instructions for the Board and the Executive
Management, with focus on allocation of
internal responsibilities and duties. The
objectives, responsibilities and functions
of the Board of Directors and the CEO are
in compliance with rules and standards
applicable to the Company and are
described in the Company’s “Instructions for
the Board of Directors” and “Instructions for
the CEO”.
The Board of Directors will produce
an annual schedule for its work, with
particular focus on objectives, strategy and
implementation. The CEO is responsible for
keeping the Board of Directors informed
and provides regular reports to the Board
of Directors about the Company’s activities,
position and financial and operational
developments. During 2023, the Board of
Directors held 16 meetings.
The Board of Directors’ consideration of
material matters in which the Chairman
of the Board is, or has been, personally
involved, shall be chaired by another
member of the Board.
The Board of Directors shall annually
evaluate its performance and expertise in
the previous year. The evaluation is made
available to the Nomination Committee.
AUDIT COMMITTEE
The Board of Directors established an Audit
Committee on 28 February 2017, which is a
subcommittee of the Board of Directors. Its
main duties are to assess the Company’s
financial reporting and internal control,
monitor statutory audit and report outcome
of the audit to the Board of Directors. The
Audit Committee also supports the Board
in the administration and exercise of its
responsibility for supervision in accordance
with applicable rules and legislations. From
2021 pre-approval of non-audit services
delivered by the independent auditor is
required from the Audit Committee. The
Company’s Audit Committee is governed
by the Norwegian Public Limited Liability
Companies Act and a separate instruction
adopted by the Board of Directors. The
Audit Committee has held five meetings
in 2023, and met with the Auditor,
EY, separately without the Executive
Management present.
The members of the Audit Committee are
elected by and amongst the members of
the Board of Directors for a term of up to
two years. The current members of the
Audit Committee are:
• Sally Bennett (Chair)
• Sveinung Hole
• Anders Tullgren
CLINICAL COMMITTEE
The Board of Directors had established
a Clinical Committee in December 2020
as a preparatory and advisory committee
for the Board of Directors, to address
questions relating to clinical development
and trials. Due to the size of the board
and the Company’s focused strategy, the
committee was terminated at the Annual
General Meeting in May 2023.
BERGENBIO
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10. Risk Management and Internal Control
The Board of Directors of BerGenBio are responsible for ensuring
that the Company has sound and appropriate risk management and
internal control systems in accordance with the regulations that
apply to its business activities.
The Company has implemented a comprehensive set of relevant
corporate manuals and procedures, which provide detailed descriptions
of procedures covering all aspects of managing its operations,
including the development of clinical data and financial performance.
The procedures and manuals are continuously revised to reflect best
practice derived from experience or adopted through regulations.
The Board of Directors receives reports from the management on
developments and results related to strategy, finance, KPIs, risk
management, clinical studies, challenges and plans for the coming
periods. In addition, quarterly and annual reports are prepared in
accordance with the listing requirements and recommendations of
Oslo Børs, and they are reviewed by the Audit Committee prior to the
Board’s approval and subsequent publication.
BerGenBio prepares its financial accounts in accordance with the
international accounting standard IFRS, which aims to provide a true
and fair overview of the Company’s assets, financial obligations,
financial position and operating profit. For information on the
Company’s financial risk and risk management, reference is made to
the Board of Directors’ report and Note 20 in the 2023 annual report.
11. Remuneration of the Board of Directors
The remuneration of the Board of Directors is determined by the
shareholders at the Annual General Meeting of the Company based
on the proposal from the Nomination Committee. Guidelines are
set out in the Remuneration policy approved by the AGM 19 March
2021. The level of the remuneration is based on remuneration of
Board members for comparable companies and reflects the Board of
Directors’ responsibility, expertise, the complexity of the Company,
as well as time spent and the level of activity in both the Board of
Directors and any Board Committees.
The remuneration of Board members is not linked to the Company’s
performance and does not contain option elements. Board members
who participate in the Audit Committee or Remuneration Committee
receive separate compensation for this.
Detailed information on the remuneration of the Board of Directors
can be found in the Remuneration Report for 2023.
Members of the Board of Directors, or companies with which they
are associated, should not engage in specific assignments for the
Company in addition to their appointment as members of the Board,
but if they do, this shall be fully disclosed to the Board of Directors.
The remuneration for such additional duties will be approved by the
Board of Directors and specifically identified in the annual report.
12. Remuneration of Executive
Management Team
The Remuneration Policy sets out the main principles for remuneration
of BerGenBio’s Executive Management Team, and was approved by the
AGM on 19 March 2021.
The overall objectives of the Remuneration Policy are to:
• Support the purpose and sustainability of the Company
• Align the remuneration components with the interests of
shareholders and other stakeholders relevant to the above
• Support delivery of BerGenBio’s strategic priorities
• Attract, motivate, and retain members of the Board of Directors
and the Executive Management Team of the appropriate caliber
given the size and complexity of the business; and
• Reward members of the Executive Management Team in line with
corporate and individual performance
Detailed information on the remuneration of the Executive Management
Team can be found in the Remuneration Report for 2023.
BERGENBIO
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13. Information and Communications
BerGenBio complies with Oslo Børs’ Code of Practice for IR. The
Board of Directors has adopted an investor relations (IR) policy, to
clarify roles and responsibilities related to financial reporting, regulate
contact with shareholders and the investor market and ensure that
the principles of openness and equal treatment of market participants
are followed. The IR policy is available from the Company’s website.
In addition, the Board has adopted separate instructions for financial
reporting and the handling of inside information in line with the EU’s
Market Abuse Regulation and the Norwegian Securities Trading Act.
The Company will each year publish a financial calendar, providing
an overview of the dates for major events such as its Annual General
Meeting and publication of interim financial reports and annual report.
Interim reports are published on a quarterly basis, in line with Oslo
Børs’ recommendations. The Company will give open presentations in
connection with its interim financial reporting.
All financial and other IR information is provided in English. All
information is distributed to the Company’s shareholders by postings
on the Company’s website at the same time as it is sent to Oslo Børs
through its information system www.newsweb.no.
14. Take-Overs
There are no defense mechanisms against take-over bids in the
Company’s articles of association, nor have other measures
been implemented to specifically hinder acquisitions of shares in
the Company.
In the event of a take-over process, the Board of Directors and the
Executive Management will ensure that the Company’s shareholders
are treated equally and that the Company’s activities are not
unnecessarily interrupted. The Board of Directors has a special
responsibility in ensuring that the shareholders have sufficient
information and time to assess the offer. In addition to complying
with relevant legislation and regulations, the Board of Directors will
seek to comply with the recommendations in the Code, including a
valuation from an independent third party. On this basis,
the Board of Directors will make a recommendation as to whether
the shareholders should accept the bid.
The Board of Directors has not established any other written
guidelines for procedures to be followed in the event of a take-over
bid, as such situations normally are characterized by specific and
one-off situations which makes guidelines challenging to prepare.
15. Auditor
The Company’s auditor is EY and is regarded as independent in relation
to BerGenBio ASA. The Audit Committee and Board of Directors
receives an annual confirmation from the auditor that the requirements
regarding in-dependence and objectivity have been satisfied.
The auditor prepares an annual plan for carrying out the auditing
work, which is made known to the Audit Committee.
The Audit Committee have annual meetings with the auditor to
discuss the annual accounts, accounting principles, assessment
of any important accounting estimates and matters of importance
on which there has been dis-agreement between the auditor and
the Company’s Executive Management. At least once per year, the
auditor will present to the Audit Committee a review of the Company’s
internal control procedures, including identification of weaknesses
and proposals for improvement. These meetings will also be held with
an opportunity for a review with the auditor, without the Company’s
day-to-day management being present. No separate guidelines have
been prepared for use of the auditor for services other than auditing,
but from 2021 pre-approval is required from the Audit Committee for
non-audit services.
The Board of Directors will disclose the remuneration paid to the
auditor, to the shareholders, at the Annual General Meeting, including
a break-down of the fee paid for audit work and fees paid for other
specific assignments, if any. The Audit Committee has reviewed the
work of the auditor and recommend to the General Meeting to retain
EY as the Company’s auditor. The auditor will participate at the
Annual General Meeting.
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Board of Directors report
Governance/Board of Directors report
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BerGenBio ASA (“the Company”) and its
subsidiaries (together “the Group”) is a
biopharmaceutical Company developing
novel medicines for patients with severe
unmet medical needs, with a focus on
cancer and severe respiratory infections.
The Company is a world-leader in
understanding the potential applications
of AXL inhibition in mediating aggressive
diseases.
The Company’s lead clinical asset,
bemcentinib, targeting the receptor tyrosine
kinase AXL, is currently in development
in a Ph1b/2a study in 1L STK 11 mutated
NSCLC and preclinical development for
severe respiratory infections.
In NSCLC, the Company is investigating
bemcentinib as a potential combination
treatment for STK11 mutated advanced/
metastatic NSCLC and received FDA Fast
Track designation in November 2021.
In early 2023, the Company announced
positive topline Ph2 data (BGBC008)
studying bemcentinib in combination
with the immune checkpoint inhibitor
pembrolizumab in 2L NSCLC. Further
encouraging data from the Investigator
Led Ph1b study (BGBIL005) of bemcentinib
in combination with the chemotherapy
docetaxel was also reported. The Company
believes both datasets provide encouraging
clinical and scientific rationale which
substantiate our near-term strategy of
conduct of 1L STK11m NSCLC Ph1b/2a
(BGB016) study of bemcentinib in
combination with immune checkpoint
inhibition and doublet chemotherapy.
In severe respiratory infections, our initial
focus was the study of bemcentinib
in hospitalized, COVID-19 patients.
Bemcentinib was studied in combination
with standard of care in two completed
hospitalized COVID-19 studies
demonstrating clinical response and
biomarker improvement consistent with
reduced inflammatory response. Based
on these data, in 2022 bemcentinib was
accepted into the EU funded EU-SolidAct
Ph2b trial in hospitalized COVID-19 patients.
In 2023, The EU-SolidAct and BerGenBio
mutually decided to discontinue the study
due to the changing nature of the COVID-19
pandemic resulting in fewer patients
developing severe respiratory symptoms.
While further study in COVID-19 has been
discontinued, the need continues for an
effective new treatment for hospitalized
patients who develop Acute Respiratory
Distress Syndrome (ARDS) from infections
including influenza and RSV. The Company
is currently working with prestigious
academic collaborators to further develop
preclinical data supporting the expansion
into treatment of ARDS.
The Company has also announced that
as a part of its focused strategy, it will be
seeking a partner to advance development
of tilvestamab (formerly BGB149), a first-in-
class anti-AXL antibody.
BerGenBio’s focused near-term strategy
includes the following
key initiatives:
• Aggressively pursue the NSCLC
opportunity for patients harboring
STK11 mutations in a global,
open label Ph1b/2a trial
• Pursue the potential within severe
respiratory infections in preclinical studies
• Explore the potential to out-license
tilvestamab
Strategy
BERGENBIO
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Operational review
During 2023 the Company maintained its
clinical research focus with its lead drug
candidate bemcentinib, a novel, once-a-
day, orally-administered, highly-selective
inhibitor of AXL. Data generated through
clinical trials so far have been encouraging
and the Company is committed to
continuing the progression of bemcentinib,
alone or in partnership, into late-stage
clinical trials and through to regulatory
approval where data warrants.
The FDA has granted Fast Track
Designations for bemcentinib for the
treatment of bemcentinib in STK11m
NSCLC patients and in 2L NSCLC patients.
Clinical Trial Progress: NSCLC Post-
year close in March 2024, the Company
announced it had initiated the Ph2a portion
of its BGBC016 study of bemcentinib in
combination with standard of care therapy
in 1L STK11m NSCLC patients.
Progress:
Tilvestamab (BGB149)
Tilvestamab (BGB149) is the first functional
blocking anti-AXL monoclonal antibody
to enter clinical development and is
BerGenBio’s second clinical stage drug
development program targeting AXL. The
mechanism of action of tilvestamab differs
from that of bemcentinib by blocking the
binding AXL’s ligand Gas6, preventing
receptor activation and resulting in receptor
internalization. Based on preclinical
data generated by the Company and by
academic groups, the Company believes
tilvestamab has potential to treat fibrotic
diseases and certain gynecological
cancers. As a result of BerGenBio’s focused
development strategy, the Company has
initiated out-licensing activities for this
product candidate.
Progress: Companion
Diagnostics Program
The availability of a predictive biomarker
test significantly enhances the chance
of regulatory success and later
reimbursement, in general, and particularly
for high-value oncology drugs.
The development of a Companion Diagnostics
test is a strategic priority for the Company.
In certain indications, such as STK11m
NSCLC, the availability of a clinically validated
Companion Diagnostic assay will be critical
to market adoption. Extensive activities
have been conducted to evaluate the most
predictive biomarkers for bemcentinib
development with encouraging results.
Other progress
The Company sponsored trial (BGBC003)
of bemcentinib in AML and MDS has been
completed in 2022 and data was released
in 2023. While the data were encouraging,
the Company has chosen to focus its near-
term resources on the advancement of
bemcentinib in 1L NSCLC STK11m patients.
The Company supports its own clinical
development program with a broad
portfolio of investigator sponsored clinical
trials of high scientific value, commercial
interest and KOL endorsement. This is
considered a cost-effective strategy to
explore opportunities for potential future
label extension for bemcentinib.
Similarly, pre-clinical academic
collaborations exploring AXL’s role in
driving serious diseases continue to be an
important part of BerGenBio’s strategy to
expand the understanding of AXL biology
and potential clinical ap-plications of our
selective AXL inhibitors.
Organization development
The Company has focused its strategy over
the previous two years and the organization
has been resized to fit the business needs.
The Company has maintained all required
functions as either full time employees or
as part-time consultants. This resizing has
also affected the Executive Management
and the Board of Directors. The Company
expects significant cost savings from this
which partly materialized in 2023 but will
materialize with full effect in 2024.
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Risks and uncertainties
The Group operates in a highly competitive
industry sector with many large players and
may be subject to rapid and substantial
technological change.
Our experience from the COVID-19
pandemic over the last years makes us
confident we can adjust our operations to
react to significant industry changes, such
as limitations on clinical trial recruitment.
A future event such as this may impact the
operations differently but the Company and
the industry now have valuable experience
in adjusting to rapidly evolving conditions.
BerGenBio is currently in a development
phase involving activities that entail
exposure to various risks. BerGenBio’s lead
product candidate bemcentinib is currently
in Ph2 clinical trials. This is regarded as an
early stage of development and the clinical
studies may not prove to be successful.
Timelines for completion of clinical studies
are to some extent dependent on external
factors outside the control of the Group,
including resource capacity at clinical trial
sites, competition for patients, etc.
The financial success of BerGenBio and/or
its commercial partners requires obtaining
marketing authorization and achieving
an acceptable reimbursement price for
its drugs. There can be no guarantee that
the drugs will obtain the selling prices or
reimbursement rates foreseen.
BerGenBio has a liability insurance which
covers Directors and Officers in the
Company and subsidiaries.
Financial risks
INTEREST RATE RISK
The Group holds cash and cash equivalents
and does not have any borrowings. The
Group’s interest rate risk is; therefore, in
the rate of return of its cash on hand. Bank
deposits and money market funds are
exposed to market fluctuations in interest
rates, which affect the financial income and
the return on cash.
EXCHANGE RATE RISK
The value of non-Norwegian currency
denominated costs will be affected by
changes in currency exchange rates or
exchange control regulations. The Group
undertakes various transactions in foreign
currencies and is consequently exposed
to fluctuations in exchange rates. The
exposure arises largely from the clinical
trials and research expenses and operations
in subsidiaries. The Group is mainly exposed
to fluctuations in pounds sterling (GBP),
euro (EUR), and US dollar (USD). The Group
are holding part of the bank deposit in GBP,
EUR and USD depending on the need for
such foreign exchange.
The foreign currency exposure is also mostly
linked to trade payables with short payment
terms. The Group might consider changing
its current risk management of foreign
exchange rate if it deems it appropriate.
CREDIT RISK
Credit risk is the risk of a counterparty’s
default in a financial asset, liability or
customer contract, giving a financial loss.
The Group’s receivables are generally
limited to receivables from public
authorities by way of government grants.
The credit risk generated from financial
assets in the Group is limited since it is
cash deposits. The Group places its cash
in bank deposits in recognized financial
institutions to limit its credit risk exposure.
The Group has not suffered any loss on
receivables during 2023 and the Group
considers its credit risk as low.
BERGENBIO
Annual Report & Accounts 2023
49
Governance/Board of Directors report
›
FUNDING AND LIQUIDITY RISK
Liquidity is monitored by Group management.
The Group works continuously to ensure
financial flexibility in the short and
long term to achieve its strategic and
operational objectives.
Funding of ongoing operations is and will
be for some time dependent on external
sources, mainly equity contributions.
Significant changes to financial market
conditions, may affect the climate for
investor investments and consequently
the Company ability to secure adequate
funding to pursue its strategy.
In June 2023 the Company completed an
equity funding of total NOK 250 million. In
addition, the Company issued 1.2 billion
Warrants that could be exercised during
specific periods in November 2023 or
April 2024. On the 15 April 2024 expiry of
the Warrant exercise period, total gross
proceeds of NOK 147.8 million were
received from exercise of the Warrants,
where NOK 8.9 million were received in the
November 2023 exercise and NOK 138.9
million in the April 2024 exercise.
The cash position in combination with the
proceeds from the exercise of the Warrants
in April 2024 will fund the planned activities
into 2H 2025 on a going concern basis.
Non-financial risks
TECHNOLOGY RISK
The Group’s lead product candidate,
bemcentinib (BGB324), is currently in a
Ph1b/2a clinical trial. This is regarded as an
early stage of development and the Group’s
clinical studies may not prove to
be successful.
COMPETITIVE TECHNOLOGY
The Group operates in a highly competitive
industry sector with many large players
and is subject to rapid and substantial
technological change.
The Group is currently in a development
phase involving activities that entail
exposure to various risks. The Group’s
lead product candidate bemcentinib is
currently in a Ph1b/2a clinical trial. This is
regarded as an early stage of development
and the clinical studies may not prove to
be successful. Timelines for completion
of clinical studies are to some extent
dependent on external factors outside the
control of the Group, including resource
capacity at clinical trial sites, competition
for patients, etc.
PATENT AND INTELLECTUAL
PROPERTY IP RISKS
The success of the Company will highly
depend on the Company’s ability to obtain
and maintain patent protection for its
products, methods, processes and other
technologies, to preserve trade secrets,
to prevent third parties from infringing
proprietary rights of the Company and to
operate without infringing the proprietary
rights of third parties. To date, the
Company holds certain exclusive patent
rights in major markets. The patent rights
are limited in time. The Company cannot
predict the range of protection any patents
will afford against competitors and
competing technologies, including whether
third parties will find ways to invalidate the
patents, obtain patents claiming aspects
similar to those covered by the Company’s
patents and patent applications, and
whether the Company may be subject to
litigation proceedings.
BERGENBIO
Annual Report & Accounts 2023
50
Governance/Board of Directors report
›
REGULATORY AND
COMMERCIAL RISKS
The financial success of the Group requires
obtaining marketing authorization and
achieving an acceptable reimbursement
price for its drugs. There can be no
guarantee that the Group’s drugs will obtain
the selling prices or reimbursement rates
foreseen by the Group.
The Group will need approvals from the FDA
to market its products in the US, and from
the European Medicines Agency (EMA) to
market its products in Europe, as well as
equivalent regulatory authorities in other
worldwide jurisdictions to commercialize
in those regions. The Group’s future
earnings are likely to be largely dependent
on the timely marketing authorization of
bemcentinib for various indications.
Financial review
(Figures in brackets = same period 2022
unless stated otherwise).
ACCOUNTING POLICIES
The financial statements of BerGenBio Group
have been prepared in accordance with
International Financial Reporting Standards
(IFRS) as adopted by the EU on 31 December
2023. Figures are for the Group and for the
Parent Company BerGenBio ASA labelled
ASA on the next page.
FINANCIAL RESULTS
OPERATING REVENUES
Revenue for the full year 2023 amounted
to NOK 0.4 million (NOK 0.4 million) for
the Group and NOK 1.0 million (NOK 1.0
million) for ASA. Revenue in the Group in
2023 and 2022 are refund of patent costs
from an out-licensed agreement with ADCT.
OPERATING EXPENSES
Total operating expenses for 2023 for the
Group amounted to NOK 192.2 million
(NOK 306.0 million), and NOK 192.9 million
(NOK 306.2 million) for ASA.
Employee expenses were NOK 55.6 million
(NOK 68.7 million) for the Group and NOK
19.3 million (NOK 22.4 million) for ASA.
Payroll expenses decreased for the full
year compared to 2022. As part of the
focused strategy FTE's has been reduced
from 28 FTE's end of 2022 to 16 FTE's
end of 2023. For the full-year 2023, other
operating costs for the Group amounted to
NOK 136.3 million (NOK 236.4 million), and
NOK 173.3 million (NOK 282.9 million) for
ASA. Operating expenses are mainly driven
by activities in the development program
and reflecting the effects of the focused
strategy previously announced where
the Company currently is focusing on 1L
NSCLC STK11m compared to 2022 where
additional clinical studies were active and
open.
The Group has recognized government
grants amounting to NOK 9.6 million
(NOK 10.4 million) for the full-year 2023.
Government grants are recognized as cost
reduction in the profit and loss. Payroll
expenses have been reduced by NOK
5.0 million (NOK 5.1 million) and other
operating expenses by NOK 4.6 million
(NOK 5.3 million) as a result of these
government grants. ASA has recognized
government grants for a total of NOK 5.1
million (NOK 6.6 million) for the full year
2023. Payroll expenses have been reduced
by NOK 0.6 million (NOK 1.3 million) and
other operating expenses by NOK 4.6
million (NOK 5.3 million) as a result of
these government grants.
The operating loss for the Group in 2023
was NOK 191.8 million (NOK 305.6 million)
and NOK 191.8 million (NOK 305.2 million)
for ASA, reflecting the operations during the
period and the focused strategy including
decrease in activity and decrease in the
headcount after restructuring.
Net financial gain for the Group was NOK
1.4 million (gain NOK 3.5 million) and NOK
1.2 million (NOK 3.9 million) for ASA for the
full-year 2023.
Losses after tax for the Group were NOK
190.4 million (NOK 302.1 million) and NOK
190.6 million (NOK 301.4 million) for ASA
for the full year 2023.
BERGENBIO
Annual Report & Accounts 2023
51
Governance/Board of Directors report
›
FINANCIAL POSITION
Total assets as of 31 December 2023 for
the Group increased to NOK 174.3 million
(NOK 166.7 million at year-end 2022) for the
Group and to NOK 168.0 million (NOK 156.2
million at year-end 2022) for ASA, mainly
due to the funding secured in 2023 reduced
by the operational loss in the period.
Total liabilities were NOK 46.9 million (NOK
78.2 million at year-end 2022) for the Group
and NOK 41.2 million (NOK 67.0 million at
year-end 2022) for ASA.
Total equity as of 31 December 2023 was
NOK 127.5 million (NOK 88.5 million at
year-end 2022) for the Group and NOK 126.8
million (NOK 89.2 million at year-end 2022)
for ASA, corresponding to an equity ratio
of 73.1% (53.1%) for the Group and 75.5%
(57.1%) for ASA.
CASH FLOW
Net cash flow from operating activities was
negative by NOK 225.1 million (NOK 288.2
million) for the Group and negative by NOK
218.2 million (NOK 292.0 million) for ASA
for the full-year 2023, mainly driven by the
level of activity and changes in working
capital.
Net cash flow received from investing
activities during the full-year 2023 was NOK
3 million (NOK 3.2 million) for the Group
and NOK 2.8 million (NOK 3.2 million) for
ASA.
Net cash flow from financing activities
was NOK 224.9 million (NOK 2.9 million)
for the Group and NOK 224.9 million (NOK
2.9 million) for ASA for the full-year 2023,
representing the proceeds from the funding
secured in the year.
Cash and cash equivalents increased to
NOK 156.4 million (NOK 150.8 million) for
the Group and NOK 148.6 million (NOK
138.3 million) for ASA.
Research and
development
While the research and development
strategy is designed in-house in BerGenBio,
the Group leverages its network of external
contract research organizations (CROs) in
order to execute its development strategy.
BerGenBio also collaborates with academic
institutions to extend the research in areas
of interest of the Group.
The Group has employed experienced
personnel that are capable of directing
work that is performed by the CROs. This
approach to product development allows
the Group to quickly change research
directions and efforts when needed and
to quickly bring in new technologies and
expertise when necessary.
Uncertainties related to the regulatory
approval process and results from ongoing
clinical trials generally indicate that the
criteria for capitalization of R&D costs
are not met until market authorization
is obtained from relevant regulatory
authorities. The Group has currently no
development expenditure that qualifies for
recognition as an asset under IAS 38.
Going concern
The Board stated that the annual accounts
represent a true and fair view of the Group’s
financial position at the turn of the year.
According to the Norwegian Accounting
Act section 3-3 (a), the Board of Directors
confirmed that the financial statements
have been prepared under the assumption
of going concern.
BERGENBIO
Annual Report & Accounts 2023
52
Governance/Board of Directors report
›
Environmental, social and
governance (ESG)
In order to have a real impact we have
identified ESG topics in BerGenBio’s
value chain that are material for us and
our stakeholders. Our key stakeholders
include our patients and their families, our
employees, investors, regulators, suppliers
and other business partners, such as
research organizations and academic
institutions. The have mapped our value
chain and review of industry standards,
other organizations and peers. The topics
which are of most strategic importance
to us are; innovation, clinical trial conduct,
business ethics, economic performance
and patient health and safety.
In connection with the materiality analysis,
we also analyzed the United Nation’s
Sustainability Development Goals (SDGs)
to identify those we have the largest
impact upon. We directly contribute to SDG
3 – health and wellbeing. In addition, we
also contribute to SDG 8 – decent work
and economic growth for our employees
and society, SDG 9 – industry, innovation
and infrastructure – through our research
and development and finally, SDG 17
– partnerships for the goals – through
our extensive cooperation with research
organizations and academic institutions.
Given the current stage of development
of BerGenBio, we do not have significant
negative impact on the goals, but this may
change when we move into production and
will be reassessed.
All topics are addressed in the ESG
section of this annual report and we refer
to the World Economic Forum disclosure
reference index in the appendix, for
ease of location, along with an overview
of performance data. The reporting
in this section addresses BerGenBio’s
requirements under section 3-3 a and c of
the Norwegian Accounting Act.
The ESG analysis provided a basis for
determining BerGenBio’s ambitions and
KPIs and alignment with our strategy.
We also determined metrics to monitor
our performance for our material ESG
topics. Moreover, we strengthened our
management structures by revising our
Corporate Social Responsibility policy and
augmenting it to our new Code of Conduct
in addition to strengthening our responsible
supply chain management.
Since 2021 we have reported in line
with the current ESG mapping. The new
sustainability standards CRSD will not be
mandatory for BerGenBio before 2026.
BerGenBio does not expect to voluntarily
adopt the standards before it will be
mandatory; however, the ESG reporting
will be improved and aligned over the next
years as the relevant standards will develop
before fully implemented.
Share information
As of 31 December 2023, there were
2,688,689,214 ordinary shares outstanding,
up from 88,660,532 shares at year end
2022. The increase in number of shares
is mainly caused by the Rights Issue
completed in June 2023. In addition, there
were 1,181,842,935 issued Warrants which
expired 15 April 2024.
The Company has one class of shares, and
all shares carry equal voting rights.
The Company had more than 14,000
shareholders as of 31 December 2023.
The results for BerGenBio ASA for 2023
show a loss of tNOK 190,597. At year end
2023 more than 50% of the share capital
were lost. The board has addressed the
issue and supports the focused strategy with
a significantly lower cash use. The Board
proposes that the loss in 2023 is carried
forward and will propose to the Annual
General Meeting to approve a decrease of
the share capital to cover the loss.
BERGENBIO
Annual Report & Accounts 2023
53
Governance/Board of Directors report
›
Outlook
BerGenBio’s clinical development program with bemcentinib and
financial position together, provide a strong foundation to create and
deliver significant value for its shareholders.
The Board considers that the results emerging from on-going
development programs provide support for AXL inhibition as an
attractive approach for cancer therapy and respiratory diseases.
Further clinical data will be reported at future medical congresses
and as appropriate by the Company.
We continue to develop our organization with skilled and
experienced personel to support our strategies.
The cash position in combination with the proceeds from the
Warrant exercise in April 2024 will fund the planned activities into 2H
2025 on a going concern basis.
In retaining global rights to bemcentinib, BerGenBio maintains
complete strategic flexibility for its future development and
commercialization. It is anticipated that the high novelty of
bemcentinib plus its promising therapeutic profile, particularly in
combination with existing therapies, could make it an attractive
target for partnering. A go-to market strategy may also be
considered in selected indications in discrete territories, where
potentially greater value for shareholders could be created.
The Board believes the potential of bemcentinib is relevant to several
aggressive diseases and therapeutic indications. However, the recent
and ongoing geopolitical situation and associated impacts on financial
market conditions requires a highly focused development strategy.
Anders Tullgren
Chair of the Board of Directors
Sveinung Hole
Non-Executive Director
Dr. Sally Bennett
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
Martin Olin
CEO
Bergen, 30 April 2024
The Board of Directors, BerGenBio ASA
BERGENBIO
Annual Report & Accounts 2023
54
Governance/Confirmation from the Board of Directors and CEO
›
Confirmation from the Board of Directors and CEO
We confirm that, to the best of our knowledge, the financial statements for the period from 1 January to 31 December 2023 have been prepared
in accordance with IFRS as adopted by EU and the Norwegian Accounting Act and give a true and fair view of the Group and the Company’s
consolidated assets, liabilities, financial position and results of operations, and that the Report of the Board of Directors provides a true and fair
view of the development and performance of the business and the position of the Group and the Company together with a description of the key
risks and uncertainty factors that the Company is facing.
Anders Tullgren
Chair of the Board of Directors
Sveinung Hole
Non-Executive Director
Dr. Sally Bennett
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
Martin Olin
CEO
Bergen, 30 April 2024
The Board of Directors, BerGenBio ASA
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Financial Report
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55
Financial Report
1 JANUARY - 31 DECEMBER |
NOK 1000
Income Statement and other Comprehensive Income
PARENT 2022 PARENT 2023 NOTE GROUP 2023 GROUP 2022
980 1,036
Revenue
4 354 389
19,895 16,135
Payroll and other related employee cost
5, 7, 10 52,428 66,143
2,546 3,177
Employee share option cost
5, 6 3,177 2,546
883 223
Depreciation
8 223 883
282,887 173,323
Other operating expenses
7, 9 ,13, 22 136,345 236,451
306,211 192,857
Total operating expenses
(305,231) (191,821)
Operating profit (loss)
(191,819 ) (305,635 )
14,926 13,169
Finance income
11 13,409 15,027
11,071 11,945
Finance expense
9, 11 11,991 11,514
3,856 1,224
Financial items, net
(301,375) (190,597)
Profit (loss) before tax
(190,401 ) (302,122 )
0 0
Income tax expense
12 0 0
(301,375) (190,597)
Profit (loss) after tax
(190,401 ) (302,122 )
Other comprehensive income (loss)
Items which may be reclassified over profit and loss
0 0
Exchange differences on translation of foreign operations
(301,375) (190,597)
Total comprehensive income for the year
(189,234 ) (302,606 )
Earnings per share:
(3.40) (0.13)
Basic and diluted per share
14 (0.13 ) (3.41 )
BERGENBIO
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56
31 DECEMBER |
NOK 1000
Statement of Financial Position
PARENT 2022 PARENT 2023 NOTE GROUP 2023 GROUP 2022
ASSETS
Non-current assets
43 431 Property, plant and equipment and right-of-use assets 8 431 43
43 431 Total non-current assets 431 43
Current assets
17,905 18,948 Other current assets 7, 15, 22 17,482 15,860
138,288 148,637 Cash and cash equivalents 16, 20 156,421 150,803
156,192 167,585 Total current assets 173,904 166,663
156,235 168,016 TOTAL ASSETS 174,335 166,706
EQUITY AND LIABILITIES
Equity
Paid in capital
8,866 268,869 Share capital 17 268,869 8,866
36,495 1,569 Share premium 17 854 35,780
43,852 46,987 Other paid in capital 6, 17 46,987 43,852
89,213 317,424 Total paid in capital 316,710 88,498
0 (190,597) Retained earnings 17 (189,234 ) 0
89,213 126,827 Total equity 127,476 88,498
Non-current liabilities
275 0 Long term debt 9, 20, 24 0 275
275 0 Total non-current liabilities 0 275
Current liabilities
27,156 17,745 Accounts payable 18,605 29,634
39,591 23,401 Other current liabilities 9, 18, 22 28,212 48,299
0 42 Provisions 19 42 0
66,747 41,188 Total current liabilities 46,859 77,933
67,022 41,188 Total liabilities 46,859 78,208
156,235 168,016 TOTAL EQUITY AND LIABILITIES 174,335 166,706
BERGENBIO
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57
NOK 1000
Statement of Changes in Equity
GROUP 2023 NOTE SHARE CAPITAL SHARE PREMIUM OTHER PAID IN CAPITAL RETAINED EARNINGS TOTAL EQUITY
Balance at 1 January 2023 8,866 35,780 43,852 0 88,498
Profit (loss) after tax0 0 0 (190,401 ) (190,401 )
Other comprehensive income (loss) for the year, net of income tax0 0 0 1,167 1,167
Total comprehensive income (loss) for the year 0 0 0 (189,234 ) (189,234 )
Recognition of share-based payments 5,60 0 3,135 0 3,135
Issue of ordinary shares 17 260,003 2,045 0 0 262,048
Share issue costs 170 (36,971 )0 0 (36,971 )
Transactions with owners 260,003 (34,926 ) 3,135 0 228,211
Balance at 31 December 2023 268,869 854 46,987 (189,234 ) 127,476
GROUP 2022 NOTE SHARE CAPITAL SHARE PREMIUM OTHER PAID IN CAPITAL RETAINED EARNINGS TOTAL EQUITY
Balance at 1 January 2022 8,846 335,195 40,386 0 384,426
Profit (loss) after tax0 (302,122 )0 0 (302,122 )
Other comprehensive income (loss) for the year, net of income tax0 (484 )0 0 (484 )
Total comprehensive income (loss) for the year 0 (302,606 ) 0 0 (302,606 )
Recognition of share-based payments 5, 60 0 3,466 0 3,466
Issue of ordinary shares 17 21 3,198 0 0 3,218
Share issue costs 170 (7 )0 0 (7 )
Transactions with owners 21 3,191 3,466 0 6,678
Balance at 31 December 2022 8,866 35,780 43,852 0 88,498
BERGENBIO
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Strategic Report | Financial Report
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58
NOK 1000
Statement of Changes in Equity
PARENT 2023 NOTE SHARE CAPITAL SHARE PREMIUM OTHER PAID IN CAPITAL RETAINED EARNINGS TOTAL EQUITY
Balance at 1 January 2023 8,866 36,495 43,852 0 89,213
Profit (loss) for the year000 (190,597) (190,597)
Other comprehensive income (loss) for the year, net of income tax0000 0
Total comprehensive income (loss) for the year 0 0 0 (190,597) (190,597)
Recognition of share-based payments 5, 600 3,135 0 3,135
Issue of ordinary shares 17 260,003 2,045 00 262,048
Share issue costs 170 (36,971)00 (36,971)
Transactions with owners 260,003 (34,926) 3,135 0 228,211
Balance at 31 December 2023 268,869 1,569 46,987 (190,597) 126,827
PARENT 2022 NOTE SHARE CAPITAL SHARE PREMIUM OTHER PAID IN CAPITAL RETAINED EARNINGS TOTAL EQUITY
Balance at 1 January 2022 8,846 334,679 40,386 0 383,910
Profit (loss) for the year0 (301,375)00 (301,375)
Other comprehensive income (loss) for the year, net of income tax0 0 00 0
Total comprehensive income (loss) for the year 0 (301,375) 0 0 (301,375)
Recognition of share-based payments 5, 600 3,466 0 3,466
Issue of ordinary shares 17 21 3,198 00 3,218
Share issue costs 170 (7)00 (7)
Transactions with owners 21 3,191 3,466 0 6,678
Balance at 31 December 2022 8,866 36,495 43,852 0 89,213
BERGENBIO
Annual Report & Accounts 2023
Strategic Report | Financial Report
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59
1 JANUARY - 31 DECEMBER |
NOK 1000
Statement of Cash Flows
PARENT 2022 PARENT 2023 NOTE GROUP 2023 GROUP 2022
Cash flow from operating activities
(301,375) (190,597) Profit (loss) before tax (190,401 ) (302,122 )
Adjustments for:
883 223 Depreciation of property, plant and equipment 8 223 883
3,466 3,135 Share-based payment expense 5 3,135 3,466
(969) 42 Movement in provisions 10, 19 42 (969 )
3,835 (863) Currency -gains/+loss not related to operating activities (1,613 ) 3,280
(2,857) (2,838) Net interest received (3,055 ) (2,949 )
Working capital adjustments:
(6,194) (1,043) Decrease in trade and other receivables and prepayments (1,622 ) (3,462 )
11,180 (26,294) Increase in trade and other payables (31,809 ) 13,641
(292,029) (218,236) Net cash flow from operating activities (225,101 ) (288,231 )
Cash flows from investing activities
2,857 2,838 Interest received 3,055 2,949
299 0 Sale/(purchase) of property, plant and equipment 80 299
3,155 2,838 Net cash flow used in investing activities 3,055 3,248
Cash flows from financing activities
3,218 262,048 Proceeds from issue of share capital 17 262,048 3,218
(7) (36,971) Share issue cost (36,971 ) (7 )
(307) (193) Cash payments for the principal portion of the lease liability 9 (193 ) (307 )
2,904 224,884 NET CASH FLOW FROM FINANCING ACTIVITIES 224,884 2,904
(3,835) 863 Effects of exchange rate changes on cash and cash equivalents 2,780 (3,764 )
(285,970) 9,486 Net increase/(decrease) in cash and cash equivalents 2,838 (282,080 )
428,093 138,288 Cash and cash equivalents at beginning of period 16 150,803 436,646
138,288 148,637 Cash and cash equivalents at end of period 16 156,421 150,803
BERGENBIO
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60
NOTE 1 Corporate information
as the Parent Company and its subsidiaries
(together “the Group”) is a clinical-stage
BerGenBio’s lead product, bemcentinib
(BGB324), is a selective, potent, oral small
molecule AXL inhibitor and is currently being
developed in STK11 mutated NSCLC and
severe respiratory infections. The Company
believes it is the most advanced selective AXL
inhibitor currently in clinical development.
company incorporated and domiciled in
is Møllendalsbakken 9, 5009 Bergen, Norway .
BerGenBio retains strategic flexibility for the
further development and commercialization
of its product candidates: it is anticipated that
the novelty of bemcentinib and its promising
therapeutic profile could make it (and later
other pipeline candidates) attractive targets
for strategic partnering. A “go-to market”
strategy will also be considered in select
indications in discrete territories.
The consolidated financial statements and the
financial statement for the Company cover
the year ending 31 December 2023 and were
approved for issue by the Board of Directors
on 30 April 2024.
NOTE 2 Basis for preparation and
significant accounting policies
The principal accounting policies applied
in the preparation of these financial
statements are set out below. These policies
have been consistently applied in all periods
presented. Amounts are in Norwegian kroner
(NOK) and all values are presented in 1,000
NOK, except when otherwise indicated. The
presenting currency of the Group and the
Company is NOK.
Basis for preparation
The consolidated financial statements for the
Group and the Company have been prepared
in accordance with IFRS ® Accounting
Standards as adopted by the EU. The
consolidated financial statements and the
Company financial statements have been
prepared on a historical cost basis, except for
the money market fund which is recognized at
fair value through profit and loss.
Basis for consolidation
The consolidated financial statements are
comprised of the financial statements of
the Company and its subsidiaries as of
31 December 2023. The subsidiaries are
BerGenBio Limited, located in Oxford in
the United Kingdom and BerGenBio ApS in
Denmark, both 100% owned and controlled
by the Parent Company BerGenBio ASA.
BerGenBio Limited was incorporated in 2017
with a share capital of NOK 1,044. BerGenBio
ApS was incorporated in 2023 with an share
capital of DKK 40,000.
Going concern
The Group works continuously to ensure
financial flexibility in the short and long
term to achieve its strategic and operational
objectives. Capital markets are used as a
source of liquidity when appropriate and when
conditions in these markets are acceptable. In
June 2023 the Group secured NOK 250 million
in a Rights Issue equity funding. In addition,
the Company issued 1.2 billion Warrants that
could be exercised during specific periods in
November 2023 or April 2024. At expiry of the
Warrant exercise period 15 April 2024 total
gross proceeds of NOK 138.9 million were
received from exercise of the Warrants in the
April 2024 exercise.
The Board of Directors has reasonable
expectation that the Group will maintain
adequate resources to continue in operational
existence for the foreseeable future.
The cash position in combination with the
proceeds from the Warrant exercise in April
2024 will fund the planned activities into 2H
Notes to the Financial Statements
BERGENBIO
Annual Report & Accounts 2023
2025 on a going concern basis. The financial
statements are prepared under the going
concern assumption.
Summary of significant accounting policies
The new and amended standards and
interpretations from IFRS that were adopted
by the EU with effect from 2023 did not have
a significant impact on the reporting for 2022
and 2023. The Group has not early adopted
any standard, interpretation or amendment
that has been issued but is not yet effective.
Revenue recognition
Revenue from contracts with customers is
recognized when control of the goods or
services are transferred to the customer at
an amount that reflects the consideration to
which the Group and the Company expects
to be entitled in exchange for those goods or
services. The Group and the Company have
generally concluded that it is the principal in
its revenue arrangements, because it typically
controls the goods or services before
transferring them to the customer.
The Group’s and the Company’s products
are still in the research and development
phase, and have limited revenue from sales
of products yet.
The Group (the Company) has entered
into an out-license agreement where
development, regulatory and sales-based
milestones trigger revenue payment to the
Group (the Company). Revenue from out-
license agreements are recognized in the
period the milestone events occurred.
Government grants
Government grants are recognized when
there is reasonable assurance that the
grant will be received and all attached
conditions will be complied with. The grant
is recognized in the income statement in
the same period as the related costs, and
presented net. Government grants are
recognized at the value of the contribution
at the transaction date.
Government grants are normally related to
either reimbursements of employee costs
and classified as a reduction of payroll
and related expenses, or related to other
operating activities and thus classified as a
reduction of other operating expenses.
Research and development costs
Research costs are expensed as incurred.
Internal development costs related to
the Group’s development of products are
recognized in the income statement in the
year incurred unless it meets the asset
recognition criteria of IAS 38 “Intangible
Assets”. An internally generated asset arising
from the development phase of an R&D
project is recognized as an intangible asset
if the Group can demonstrate:
• It
s ability to use or sell the intangible assets
• The technical feasibility of completing
the intangible asset so that the asset
will be available for use or sale
• Its intention to complete and its ability
and intention to use or sell the asset
• How the asset will generate future
economic benefits
• The availability of adequate technical,
financial and other resources to
complete the development and use or
sale of the asset
• The ability to measure reliably the
expenditure during development
Uncertainties related to the regulatory
approval process and results from on-
going clinical trials, generally indicate that
the criteria are not met until the time when
marketing authorization is obtained from
relevant regulatory authorities. The Group
has currently no development expenditure
qualifying for recognition under IAS 38.
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Property, plant and equipment
Property, plant and equipment are stated
at cost, net of accumulated depreciation
and accumulated impairment losses, if any.
Acquisition cost includes expenditures that
are directly attributable to the acquisition
of the individual item. Property, plant and
equipment are depreciated on a straight-
line basis over the expected useful life of
the asset. If significant individual parts of
the assets have different useful lives, they
are recognized and depreciated separately.
Depreciation commences when the assets
are ready for their intended use.
An item of property, plant and equipment
and any significant part initially recognized
is derecognized upon disposal or when no
future economic benefits are expected from
its use or disposal. Any gain or loss arising
on derecognition of the asset (calculated
as the difference between the net disposal
proceeds and the carrying amount of the
asset) is included in the income statement
when the asset is derecognized.
The residual values, useful lives and
methods of depreciation of the property,
plant and equipment are reviewed at each
financial year and adjusted prospectively, if
appropriate.
Investment in subsidiaries
Subsidiaries are consolidated in the
Group Financial Statement. In the Company
Financial Statement subsidiaries are
measured at cost.
Lease
Identifying a lease
At the inception of a contract, the Group
assesses whether the contract is, or
contains, a lease. A contract is, or contains
a lease, if the contract conveys the right
to control the use of an identified asset
for a period of time in exchange for
consideration.
The Group (the Company) as a lessee
Separating components in the lease contract
For contracts that constitute, or contain a
lease, the Group (the Company) separates
lease components if it benefits from the use
of each underlying asset either on its own
or together with other resources that are
readily available, and the underlying asset
is neither highly dependent on, nor highly
interrelated with, the other underlying assets
in the contract. The Group (the Company)
then accounts for each lease component
within the contract as a lease separately
from non-lease components of the contract.
Recognition of lease and exemptions
At the lease commencement date, the Group
(the Company) recognizes a lease liability
and corresponding right-of-use asset for all
lease agreements in which it is the lessee,
except for the following exemptions applied:
• Short-term leases
(defined as 12 months or less)
• Low value assets
For these leases, the Group (the Company)
recognizes the lease payments as other
operating expenses in the statement of
profit or loss when they incurred.
Lease liabilities
The lease liability is recognized at the
commencement date of the lease. The
Group (the Company) measures the lease
liability at the present value of the lease
payments for the right to use the underlying
asset during the lease term that are not
paid at the commencement date.
The lease term represents the non-
cancellable period of the lease, together
with periods covered by an option either to
extend or to terminate the lease when the
Group (the Company) is reasonably certain
to exercise this option.
The lease payments included in the
measurement are comprised of fixed
lease payments (including in-substance
fixed payments), less any lease incentives
receivable.
The lease liability is subsequently
measured by increasing the carrying
amount to reflect interest on the lease
liability, reducing the carrying amount
to reflect the lease payments made and
remeasuring the carrying amount to reflect
any reassessment or lease modifications.
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The Group (the Company) does not include
variable lease payments in the lease
liability. Instead, the Group (the Company)
recognizes these variable lease expenses in
profit or loss when they occur.
Right-of-use assets
The Group measures the right-of use asset
at cost, less any accumulated depreciation
and impairment losses, adjusted for any
remeasurement of lease liabilities. The cost
of the right-of-use asset comprise:
• The amount of the initial measurement
of the lease liability recognized
• Any lease payments made at or before
the commencement date, less any
incentives received
• Any initial direct costs incurred by
the Group.
The Group (the Company) applies
the depreciation requirements in IAS
16 Property, Plant and Equipment in
depreciating the right-of-use asset, except
that the right-of-use asset is depreciated
from the commencement date to the earlier
of the lease term and the remaining useful
life of the right-of-use asset.
The Group (the Company) applies IAS 36
Impairment of Assets to determine whether
the right-of-use asset is impaired and to
account for any impairment loss identified.
Financial assets
Initial recognition and measurement
Financial assets are classified, at initial
recognition, as subsequently measured at
amortized cost, fair value through other
comprehensive income (OCI), and fair value
through profit or loss.
Financial assets are recognized initially
at fair value plus, in the case of financial
assets not recorded at fair value through
profit or loss, transaction costs that are
attributable to the acquisition of the
financial asset.
Financial assets are derecognized when the
rights to receive cash flows from the assets
have expired or the Group has transferred
its rights to receive cash flows from the
assets.
Financial assets at amortized cost
This category is the most relevant to the
Group. The Group 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 (EIR) method and are subject
to impairment. Gains and losses are
recognized in profit or loss when the asset
is derecognized, modified or impaired
Financial assets at fair value through profit
or loss
Financial assets at fair value through
profit or loss are carried in the statement
of financial position at fair value with net
changes in fair value recognized in the
statement of profit or loss.
The Group financial assets at fair value
through profit or loss include money
markets fund.
Financial liabilities
Initial recognition and measurement
Financial liabilities are classified, at initial
recognition, as financial liabilities at fair
value through profit or loss.
All financial liabilities are recognized
initially at fair value.
The Group’s financial liabilities include
trade and other payables, and loans and
borrowings.
The Group does not have financial liabilities
at fair value through profit and loss.
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Subsequent measurement
For purposes of subsequent measurement,
financial liabilities are classified in two
categories:
• Financial liabilities at fair value through
profit or loss
• Financial liabilities at amortized cost
(loans and borrowings).
Derecognition
A financial liability is derecognized
when the obligation under the liability is
discharged, cancelled or expires.
Share-based payments
The Group operates an equity-settled, share-
based compensation plan, under which the
Group receives services from employees
as consideration for share-based payments
(options).
The cost of equity-settled transactions
is determined by the fair value at the
date when the grant is made using an
appropriate valuation model.
That cost is recognized, together with a
corresponding increase in other paid in
capital in equity, over the period in which
the performance and/or service conditions
are fulfilled in employee benefits expense.
The cumulative expense recognized
for equity-settled transactions at each
reporting date until the vesting date reflects
the extent to which the vesting period has
expired and the Group’s best estimate of
the number of equity instruments that will
ultimately vest. The statement of profit
or loss expense or credit for a period
represents the movement in cumulative
expense recognized at the beginning and
end of that period and is recognized in
employee benefits expense.
The fair value of the options granted is
measured using the Black-Scholes model.
Measurement inputs include share price
on the measurement date, exercise price
of the instrument, expected volatility,
weighted average expected life of the
instruments, expected dividends and the
risk-free interest rate.
When the options are exercised, the Group
will issue new shares. The proceeds received
net of any directly attributable transaction
costs are recognized as share capital
(nominal value) and share premium reserve.
Taxes
Current income tax
Current income tax assets and liabilities
are measured at the amount expected to
be recovered from or paid to the taxation
authorities. The tax rates and tax laws used
to compute the amount are those that are
enacted or substantively enacted, at the
reporting date in the country where the Group
operates and generates taxable income.
Deferred tax
Deferred tax is provided using the liability
method on temporary differences between
the tax bases of assets and liabilities and
their carrying amounts for financial reporting
purposes at the reporting date.
Deferred tax liabilities are recognized for
all taxable temporary differences, except
when the deferred tax liability arises from
the initial recognition of goodwill or an
asset or liability in a transaction that is not a
business combination and, at the time of the
transaction, affects neither the accounting
profit nor taxable profit or loss.
Deferred tax assets are recognized for all
deductible temporary differences, the carry
forward of unused tax credits and any
unused tax losses. Deferred tax assets are
recognized to the extent that it is probable
that taxable profit will be available against
which the deductible temporary differences,
and the carry forward of unused tax credits
and unused tax losses can be utilized.
The carrying amount of deferred tax assets is
reviewed at each reporting date and reduced
to the extent that it is no longer probable that
sufficient taxable profit will be available to
allow all or part of the deferred tax asset to be
utilized. Unrecognized deferred tax assets are
re-assessed at each reporting date and are
recognized to the extent that it has become
probable that future taxable profits will allow
the deferred tax asset to be recovered.
Deferred tax assets and liabilities are
measured at the tax rates that are expected
to apply in the year when the asset is realized
or the liability is settled, based on tax rates
(and tax laws) that have been enacted or
substantively enacted at the reporting date.
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Deferred tax relating to items recognized
outside profit or loss is recognized outside
profit or loss. Deferred tax items are
recognized in correlation to the underlying
transaction either in OCI or directly in equity.
Foreign currencies
The Group’s financial statements are
presented in NOK, which is also the parent’s
functional currency.
For each entity within the Group, the Group
has determined the functional currency based
on the primary economic environment of
which the entity operates. Items included
in the financial statements are measured
using that functional currency based on the
primary economic environment of which the
entity operates. Items included in the financial
statements are measured using that functional
currency. The functional currency for the
Group’s entities are NOK, GBP and DKK.
On consolidation, the assets and liabilities
of foreign operations are translated into
Norwegian Kroner at the rate of exchange
prevailing at the reporting date and their
statements of profit or loss are translated
at exchange rates prevailing at the dates of
the transactions. The exchange differences
arising on translation for consolidation are
recognized in OCI.
For consolidation purposes the following
exchange rates have been used:
| 31.12.2023 | 31.12.2022 | |
| NOK / GBP | 12,93 | 11,85 |
| NOK / DKK | 1,53 |
Profit and loss from BerGenBioLimited and
BerGenBio ApS has been converted to NOK on
a transaction by transaction exchange rate.
Transactions and balances
Transactions in foreign currencies are
recorded at their respective functional
currency spot rates at the date the
transaction first qualifies for recognition.
Monetary assets and liabilities denominated
in foreign currencies are translated at the
functional currency spot rates of exchange at
the reporting date.
Differences arising on settlement or
translation of monetary items are recognized
in profit or loss as financial items.
Cash and short-term deposits
Cash and short-term deposits in the
statement of financial position comprise
cash at banks and on hand, short-term
deposits with a maturity of three months
or less and money market funds, which are
subject to an insignificant risk of changes
in value, as this are held for the purpose of
meeting short-term cash commitments.
See note 3.
For the purpose of the statement of cash
flows, cash and cash equivalents consist of
cash, short-term deposits and money market
fund as defined above. The indirect method is
used to prepare the statement of cash flow.
Provisions
Provisions are recognized when the
Group has a present obligation (legal or
constructive) as a result of a past event,
it is probable that an outflow of resources
embodying economic benefits will be
required to settle the obligation and a reliable
estimate can be made of the amount of
the obligation. The expense relating to
a provision is presented in the Income
Statement and other Comprehensive Income
net of any reimbursement.
If the effect of the time value of money is
material, provisions are discounted using
a current pre-tax rate that reflects, when
appropriate, the risks specific to the liability.
When discounting is used, the increase in
the provision due to the passage of time is
recognized as a finance cost.
Pensions and other post-employment benefits
The Group has a defined contribution pension
scheme for all employees. Under the defined
contribution scheme, the Group does not
commit itself to paying specific future pension
benefits, but makes annual contributions to the
employees’ pension savings.
The Group’s payment to the defined
contribution scheme amounts to 7% of salary
up to 12G and 18.1% of salary between 7.1G
and 12G for Norwegian employees and 7-10%
for UK employees (G is Norwegian National
Insurance basic amount).
Further details about pensions, and the closing
of the defined benefit scheme, are given in
Note 10.
New and amended standards and
interpretations
The standards and interpretations that are
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issued, but not yet effective, up to the date of
issuance of the Group’s financial statements
are disclosed in the following section. Note
that only the ones that are expected to have
material impact on the Group’s financial
position, performance, and/ or disclosures are
discussed. The Group intends to adopt these
standards, if applicable, when they become
effective.
Changes in accounting policies and
disclosures
The a ccounting policies adopted are
consistent with those of the previous financial
year, except for the amendments to IFRS
which have been implemented by the Group
during the current financial year. No additional
new standard have been applicable for the
Group’s 2023 financial statements.
Other standards
Other standards, interpretations and
amendments that are issued, but not yet
effective are either not applicable for the Group
or is not expected to have a material impact of
the financial statements.
NOTE 3 Significant accounting
judgments, estimates and
assumptions
The preparation of the Group’s financial
statements requires management to make
judgments, estimates and assumptions that
affect the reported amounts of revenues,
expenses, assets and liabilities, and the
disclosure of contingent liabilities. Uncertainty
about these assumptions and estimates could
result in outcomes that require a material
adjustment to the carrying amount of assets
or liabilities affected in future periods.
Estimates and assumptions
Preparation of the accounts in accordance
with IFRS requires the use of judgment,
estimates and assumptions that have
consequences for recognition in the balance
sheet of assets and liabilities and recorded
revenues and expenses. The use of estimates
and assumptions is based on the best
discretionary judgement of the Group’s
management.
Share-based payments
The Group initially measures the cost of
equity-settled transactions with employees
using the Black-Scholes model to determine
the fair value of the liability incurred.
Estimating fair value for share-based payment
transactions requires determination of the
most appropriate valuation model, which
is dependent on the terms and conditions
of the grant. This estimate also requires
determination of the most appropriate inputs
to the valuation model including the expected
life of the share option, volatility and dividend
yield and making assumptions about them.
The assumptions and models used for
estimating fair value for share-based payment
transactions are disclosed in Note 6.
Money market fund
Money market fund is classified as cash and
cash equivalent. The criteria for classifying
this as cash equivalent are that these funds
are short term, highly liquid, readily convertible
into known amounts of cash and subject
to insignificant risk of change in value. The
evaluation of these criteria require use of
judgment. The purpose of the fund is to meet
short term commitments, and hence the
Company has access to use the funds with
only a few days notice. The funds invested
in is well-known and have invested in shares
exchanged in an active marked, and hence
the funds are considered highly liquid. Even
though it is not possible to know the exact
amount of cash the funds can be converted
to, the funds in which the money is invested
are low risk and low profit, and hence it is
possible to predict the most likely outcomes.
There are expected to be insignificant
changes in value of these funds.
NOTE 4 Segments and revenue
For management purposes the Group is
organized as one business unit and the
internal reporting is structured in accordance
with this.
The Group has entered into an out-license
agreement where development, regulatory
and sales-based milestones are due upon
the occurrence of certain specific events. In
2023 or 2022 there has not been any clinical
milestone payment from this out-licence
agreement and the revenue represents refund
of patent costs.
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NOTE 5 Payroll and related expenses
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 15,115 | 12,068 | Salaries | 39,720 | 49,768 |
| 2,706 | 2,120 | Social security tax | 6,947 | 7,864 |
| 1,322 | 1,095 | Pension expense | 3,256 | 4,095 |
| 1,728 | 1,264 | Bonus | 4,900 | 8,748 |
| 374 | 163 | Other remnueration | 2,655 | 790 |
| (1,349) | (575) | Government grants | (5,050) | (5,122) |
| 19,895 | 16,135 | Total payroll and other employee related cost | 52,428 | 66,143 |
| 3,466 | 3,135 | Share option expense employees | 3,135 | 3,466 |
| (920) | 42 | Accrued social security tax on share options | 42 | (920) |
| 2,546 | 3,177 | Total employee share option cost | 3,177 | 2,546 |
| 22,441 | 19,312 | Total employee benefit cost | 55,605 | 68,689 |
| 13 | 10 | Average number of full time equivalent employees | 25 | 36 |
For remueration to Executive Management and Board of Directors, please see Remuneration Report in the Governance section of the Annual report.
Key Executive Management personel and Board of Directors compensation (in 1,000 NOK):
| GROUP 2023 | GROUP 2022 | |
| Short-term employee benefits | 21,554 | 21,936 |
| Post-employment benefit | 1,847 | 1,757 |
| Other long-term benefits | 0 | 0 |
| Termination benefits | 171 | 588 |
| Share-base payment (period cost) | 2,224 | 815 |
| Total | 25,796 | 25,096 |
Most of the Executive remuneration is nominated in GBP and converted to NOK in the table above acording to the average exchange rates.
Weakness of NOK/GBP has in 2023 been above 10% impacting the NOK amount above.
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NOTE 6 Employee share option program
The Group has a share option scheme for employees. Each option gives the right to acquire one share in BerGenBio on exercise.
The Group has a share option program to ensure focus and align the Group’s long term performance with shareholder values and interest.
Most of the employees in the Group take part in the option program. The program also serves to retain and attract senior management.
The exercise price for options granted is set at the market price of the shares at the time of grant of the options. In general, for options granted
after 2012 the options expire eight years after the date of grant.
Options normally vest annually in equal tranches over a three-year period following the date of grant.
| TOTAL OPTIONS | 2023 | 2022 | ||
| NUMBER OF OPTIONS | WEIGHTED AVERAGE EXERCISE PRICE | NUMBER OF OPTIONS | WEIGHTED AVERAGE EXERCISE PRICE | |
| Balance at 1 January | 4,219,845 | 15.13 | 3,560,897 | 22.96 |
| Granted during the period 2 | 112,000,000 | 0.21 | 2,114,230 | 7.59 |
| Exercised during the period 1 | 0 | 0.0 | (205,277) | 15.68 |
| Forfeited and cancelled | (570,725) | 14.30 | (1,250,005) | 24.61 |
| Balance at 31 December | 115,649,120 | 0.68 | 4,219,845 | 15.13 |
1
Average share price at date of exercise was NOK 17.71 in 2022. There was no option exercise in 2023.
2
112,000,000 options were granted in the twelve months period ended 31 December 2023 and 2,114,230 options were granted in the twelve months period ended 31 December 2022.
In the Annual General Meeting on the 22 March 2017 it was resolved a split of the shares so that 1 share with a nominal value of NOK 10 was
split into 100 shares with a nominal value of NOK 0.10. The overview above takes into account the share split.
The average weighted expected remaining lifetime of options is 3 years at year end. The exercise price is calculated as the weighted average
exercise price of the forfeited, cancelled and exercised options.
| VESTED OPTIONS | 2023 | 2022 |
| Options vested at 1 January | 1,615,066 | 1,541,168 |
| Exercised and forfeited in the period | (166,508) | (1,003,946) |
| Vested in the period | 1,124,057 | 1,077,844 |
| Options vested at 31 December | 2,572,615 | 1,615,066 |
| Total outstanding number of options | 115,649,120 | 4,219,845 |
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The options are valued using the Black-
Scholes model.
The risk-free interest rates are based on
rates from Norges Bank and Oslo Stock
Exchange on the grant date (bonds and
certificates) equal to the expected term
of the option being valued. Where there is
no exact match between the term of the
interest rates and the term of the options,
interpolation is used to estimate
a comparable term.
The vesting period is the period during which
the conditions to obtain the right to exercise
must be satisfied. The Group has estimated
an expected vesting date and this date is used
as basis for the expected lifetime. The Group
expects the options to be exercised earlier
than the expiry date. For options granted
earlier than 2014, the mean of the expected
vesting date and expiry date has been used
to calculate expected lifetime due to the
lack of exercise pattern history for the Group
and experience from other companies in
combination with the relatively long lifetime of
these options (up to eight years).
For valuation purposes 62,69% expected
future volatility has been applied. To find the
expected volatility, we use the Company’s
annualized standard deviation of the
continuously compounded rates of return on
the historic share price for the term equal to
the life of the option
For 2023 the value of the share options
expensed through the profit or loss amounts
to NOK 3.1 million (for the same period in
2022: NOK 3.5 million). In addition, a change
in provision for social security contributions
on share options of NOK 0.04 million (for
the same period in 2022: NOK -0.9 million).
The provision for social security contribution
is calculated on the difference between the
share price and exercise price on exercisable
option as at the end of the period.
Outstanding Instruments Overview
| NUMBER OF | WEIGHTED AVERAGE REMAINING | WEIGHTED AVERAGE | VESTED INSTRUMENTS | WEIGHTED AVERAGE | |
| STRIKE | INSTRUMENTS | CONTRACTUAL LIFE | STRIKE PRICE | 31.12.2023 | STRIKE PRICE |
| PRICE | |||||
| OUTSTANDING INSTRUMENTS | VESTED INSTRUMENTS | ||||
| 0.21 | 112 000 000 | 7.94 | 0.21 | 0 | 0.00 |
| 7.59 | 1 822 266 | 6.15 | 7.59 | 880 981 | 7.59 |
| 15.00 | 815 061 | 2.85 | 15.00 | 815 061 | 15.00 |
| 24.00 | 60 000 | 0.15 | 24.00 | 60 000 | 24.00 |
| 25.00 | 216 225 | 2.16 | 25.00 | 216 225 | 25.00 |
| 28.50 | 89 000 | 2.54 | 28.50 | 89 000 | 28.50 |
| 28.55 | 571 650 | 4.07 | 28.55 | 436 430 | 28.55 |
| 46.70 | 74 918 | 2.00 | 46.70 | 74 918 | 46.70 |
| 115 649 120 | 2 572 615 | ||||
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Annual Report & Accounts 2023
NOTE 7 Government grants
Government grants have been recognized in the profit or loss as a reduction of related expense with the following amounts:
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 1,349 | 575 | Payroll and related expenses | 5,050 | 5,122 |
| 5,298 | 4,570 | Other operating expenses | 4,570 | 5,298 |
| 6,648 | 5,145 | Total | 9,620 | 10,420 |
Grants receivable at 31 December are detailed as follows:
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 172 | 0 | Grants from Research Council, BIA | 0 | 172 |
| 496 | 227 | Grants from Research Council, PhD | 227 | 496 |
| 4,750 | 4,750 | Grants from SkatteFunn | 4,750 | 4,750 |
| 0 | 0 | Grants R&D UK | 4,410 | 7,958 |
| 5,418 | 4,977 | Total | 9,387 | 13,375 |
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BIA grants from the Research Counsil:
The Company has one grant from the
Research Council, programs for user-
managed innovation arena (BIA) which
ended in 2022. The BIA grant (“AXL as a
therapeutic target in fibrosis; biology and
biomarkers”) has been awarded from 2019
at an amount up to NOK 10.7 million. The
Group has recognized NOK 0.0 million in
2023 (2022: NOK 0.3 million) classified
partly as reduction of payroll and related
expenses and partly as a cost reduction of
other operating expenses.
PhD grants from the Research Council:
BerGenBio has been awarded two grants
supporting industrial PhD’s in 2020-
2023. The fellowship covers 50% of the
established current rates for doctoral
research fellowships and an operating
grant to cover up to 50% of additional
costs related to costly laboratory testing
connected with the research fellow’s
doctoral work.
The Group has recognized NOK 0.4 million
in 2023 (2022: NOK 1.6 million) classified
partly as reduction of payroll and related
expenses and partly as a cost reduction of
other operating expenses.
BERGENBIO
Annual Report & Accounts 2023
SkatteFunn
R&D projects have currently been approved for SkatteFunn (a Norwegian
government R&D tax incentive program designed to stimulate R&D in
Norwegian trade and industry) for the period from 2021 until the end of
2024. The Group has recognized NOK 4.8 million in 2023 (2022: NOK
4.8 million) classified partly as reduction of payroll and related expenses
and partly as a cost reduction of other operating expenses.
Innovation Norway
BerGenBio has been awarded a NOK 24 million (USD 2.85m) grant from
Innovation Norway to support the clinical development of bemcentinib in
combination with Merck & Co.’s KEYTRUDA® (pembrolizumab) in patients
with advanced lung cancer.
The grant from Innovation Norway is an Industrial Development Award
(IFU). The IFU program is directed to Norwegian companies developing
new products or services in collaboration with foreign companies.
BerGenBio has by end of 2020 recognized and received the total
grant of NOK 24 million. The grant may be withdrawn under certain
circumstances.
R&D tax grants UK
BerGenBio Limited, a 100% subsidiary of BerGenBio ASA, has been granted
R&D tax grants in UK from 2017. R&D grants are approved retrospectly by
application. The Group has in 2023 recognized NOK 4.2 (2022: NOK
3.7 million) classified as reduction of payroll and related expenses.
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NOTE 8 Property, plant & equipment
| YEAR ENDED 31 DECEMBER 2023 PARENT/GROUP | FURNITURES | EQUIPMENT / FITTINGS | RIGHT TO USE PROPERTY | TOTAL |
| Cost at 1 January 2023 | 137 | 1,590 | 3,143 | 4,870 |
| Additions in the year | 0 | 0 | 611 | 611 |
| Disposals in the year | 0 | 0 | 0 | 0 |
| Cost at 31 December 2023 | 137 | 1,590 | 3,754 | 5,481 |
| Accumulated depreciation at 1 January 2023 | (94) | (1,590) | (3,143) | (4,827) |
| Depreciation in the year | (19) | 0 | (204) | (223) |
| Accumulated depreciation at 31 December 2023 | (113) | (1,590) | (3,347) | (5,050) |
| Net carrying amount at 31 December 2023 | 24 | 0 | 408 | 431 |
| Estimated useful life | 5 years | 5 years | 2 / 5 years | |
| Depreciation method | Straight-line | Straight-line | Over right of use time |
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| YEAR ENDED 31 DECEMBER 2022 PARENT/GROUP | FURNITURES | EQUIPMENT / FITTINGS | RIGHT TO USE PROPERTY | TOTAL |
| Cost at 1 January 2022 | 137 | 1,632 | 3,366 | 5,135 |
| Additions in the year | 0 | 0 | 0 | 0 |
| Disposals in the year | 0 | (42) | (223) | (265) |
| Cost at 31 December 2022 | 137 | 1,590 | 3,143 | 4,870 |
| Accumulated depreciation at 1 January 2022 | (66) | (1,537) | (2,340) | (3,944) |
| Depreciation in the year | (27) | (53) | (803) | (883) |
| Accumulated depreciation at 31 December 2022 | (94) | (1,590) | (3,143) | (4,827) |
| Net carrying amount at 31 December 2022 | 43 | 0 | 0 | 43 |
| Estimated useful life | 5 years | 5 years | 2 / 5 years | |
| Depreciation method | Straight-line | Straight-line | Over right of use time |
Research & Development
Expenses for research and development
for the financial year 2023 for the Group
were gross NOK 151.4 million (net NOK
141.8 million reduced of grants NOK 9.6
million)of which gross NOK 115.3 million
(net NOK 110.7 million) was classified as
other operating expenses and gross NOK
36.1 million (net NOK 31.0 million) was
classified as payroll.
Expenses for research and development
for the financial year 2022 for the Group
were gross NOK 263.0 million (net NOK
252.6 million reduced of grants NOK 10.4
million) of which gross NOK 212.5 million
(net NOK 207.2 million) was classified as
other operating expenses and gross NOK
50.5 million (net NOK 45.4 million) was
classified as payroll.
NOTE 9 Leases
The Group (the Company) as a leesee
The Group rents office premises in UK. The
UK rental agreement can be terminated by
either party with a one month notice period.
The rental agreement in UK is considered
a short term lease recognized directly in
profit or loss.
Right-of-use assets
The Group (the Company) lease premises
in Bergen, Norway, for office purposes.
This lease agreement was in 2023
extended to end of December 2024. The
Group’s (the Company’s) right-of-use assets
are categorized and presented in Note 8.
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Lease liabilities
| PARENT 2022 | PARENT 2023 | SUMMARY OF THE LEASE LIABILITIES | GROUP 2023 | GROUP 2022 |
| 1,623 | 0 | Total lease liabilities at 1 January | 0 | 1,623 |
| -1,169 | 611 | New lease liabilities recognised in the year | 611 | (1,169) |
| -454 | -193 | Cash payments for the principal portion of the lease liability | (193) | (454) |
| -66 | -17 | Cash payments for the interest portion of the lease liability | (17) | (66) |
| 66 | 17 | Interest expense on lease liabilities | 17 | 66 |
| 0 | 0 | Currency exchange differences | 0 | 0 |
| 0 | 418 | Total lease liabilities at 31 December | 418 | 0 |
| 0 | 418 | Current lease liabilities (note 18) | 418 | 0 |
| 0 | 0 | Non-current lease liabilities | 0 | 0 |
| 454 | 210 | Total cash outflows for leases | 210 | 454 |
The leases do not contain any restrictions on the Group’s dividend policy or financing. The Group does not have significant residual value
guarantees related to its leases to disclose.
| PARENT 2022 | PARENT 2023 | UNDISCOUNTED LEASE LIABILITIES AND MATURITY OF CASH OUTFLOWS | 2023 | 2022 |
| 87 | 436 | Less than 1 year | 487 | 325 |
| 0 | 0 | 1-5 years | 0 | 0 |
| 87 | 436 | Total undiscounted lease liabilities at 31 December | 487 | 325 |
| PARENT 2022 | PARENT 2023 | SUMMARY OF OTHER LEASE EXPENSES RECOGNISED IN PROFIT OR LOSS | 2023 | 2022 |
| 0 | 0 | Variable lease payments expensed in the period | 0 | 0 |
| 0 | 210 | Operating expenses in the period related to short-term leases | 2,069 | 2,550 |
| 85 | 34 | Operating expenses in the period related to low value assets | 34 | 85 |
| 85 | 244 | Total lease expenses included in other operating expenses | 2,103 | 2,635 |
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Practical expedients applied
The Group currently has one lease agreement
for offices in Oxford. The lease agreement
is short term and is renewed on a monthly
basis. The Group has currently one lease
agreement for offices in Norway which expires
31 December 2024. The Group also leases
printers with contract terms of five years.
The Group has elected to apply the practical
expedient of low value assets for some of
these leases and does not recognize lease
liabilities or right-of-use assets. The leases are
instead expensed when they incur. The Group
has also applied the practical expedient to
not recognize lease liabilities and right-of-use
assets for short-term leases, presented in the
table above.
Extension options
The Group has no extension options for lease
arrangements as of 31 December 2023.
NOTE 10 Pensions
BerGenBio ASA is required to have an
occupational pension scheme in accordance
with the Norwegian law on required
occupational pension (“lov om obligatorisk
tjenestepensjon”). The Company has a
contribution pension scheme which complies
with the Act on Mandatory company pensions.
The Group and the Company has contribution
pension schemes.
The Group’s payment to the defined
contribution scheme amounts to 7% of salary
up to 12G and 18.1% of salary between 7.1G
and 12G for Norwegian employees and 7-10%
for UK employees (G is Norwegian National
Insurance basic amount).
NOTE 11 Financial income & expenses
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| Financial income | ||||
| 10 | 69 | Interest income on tax repaid | 69 | 10 |
| 2,847 | 2,769 | Interest income on bank deposits | 2,986 | 2,939 |
| 12,070 | 10,331 | Other finance income | 10,354 | 12,078 |
| 14,926 | 13,169 | Total financial income | 13,409 | 15,027 |
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| Financial expense | ||||
| 309 | 592 | Other interest expense | 578 | 321 |
| 10,762 | 11,354 | Other finance expense | 11,413 | 11,193 |
| 11,071 | 11,945 | Total financial expense | 11,991 | 11,514 |
| 3,856 | 1,224 | Net financial income | 1,418 | 3,513 |
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NOTE 12 Income tax
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| (301,375) | (190,597) | Profit before tax | (190,401) | (302,122) |
| (66,302) | (41,931) | Income taxes calculated at 22% | (41,888) | (66,467) |
| (16) | 0 | Adjustment in respect of current income tax of previous years | 0 | (16) |
| 765 | 705 | Non deductible expenses | 705 | 765 |
| (1,045) | (1,045) | Non-taxable income | (1,045) | (1,045) |
| 66,598 | 42,272 | Change in deferred tax asset not recognized | 42,229 | 66,763 |
| 0 | 0 | Tax expense | 0 | 0 |
| 0 | 0 | Income tax expense reported in income statement | 0 | 0 |
Deferred tax and deferred tax assets
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| Deferred tax assets (22% of temporary differences) | ||||
| (399,430) | (442,357) | Tax losses carried forward | (442,357) | (399,495) |
| (14) | (11) | Property, plant and equipment | (11) | (58) |
| 0 | (9) | Other | (9) | 0 |
| 399,444 | 442,377 | Deferred tax asset not recognized | 442,377 | 399,553 |
| 0 | 0 | Deferred tax assets - gross | 0 | 0 |
The Company has a tax loss of NOK 192.6 million in 2023, and in total a tax loss carried forward as of 31 December 2023 on NOK 2,010.7
million.There are no timing restrictions on carrying forward the tax loss, and it can be carried forward indefinitely.
The deferred tax asset has not been recognized in the statement of financial position, as the Company does not consider that taxable income in
the short-term will sufficiently support the use of a deferred tax asset.
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NOTE 13 Other operating expenses
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 189,508 | 98,153 | Program expenses, clinical trials and research | 99,282 | 194,063 |
| 685 | 309 | Office rent and expenses | 3,727 | 3,331 |
| 71,666 | 55,225 | Consultants R&D projects | 8,504 | 8,340 |
| 8,101 | 18,203 | Patent and licence expenses | 6,002 | 8,101 |
| 18,225 | 6,002 | Other operating expenses | 23,400 | 27,915 |
| (5,298) | (4,570) | Government grants | (4,570) | (5,298) |
| 282,887 | 173,323 | Total | 136,345 | 236,451 |
Specification auditor’s fee
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 313 | 228 | Statutory audit | 291 | 313 |
| 173 | 264 | Other assurance services | 264 | 173 |
| 0 | 0 | Other non-assurance services | 0 | 0 |
| 20 | 22 | Tax consultant services | 22 | 20 |
| 506 | 513 | Total | 577 | 506 |
Amounts are excluding VAT.
NOTE 14 Earnings per share
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| (301,375) | (190,597) | Profit after tax | (190,401) | (302,122) |
| 88,636,493 | 1,431,301,497 | Weighted average number of outstanding shares during the year | 1,431,301,497 | 88,636,493 |
| (3.40) | (0.13) | Earnings (loss) per share - basic and diluted (NOK) | ( |
( |
Share options issued and warrants have a potential dilutive effect on earnings per share. No dilutive effect has been recognized as potential
ordinary shares only shall be treated as dilutive if their conversion to ordinary shares would decrease earnings per share or increase loss per
share from continuing operations. As the Group is currently loss-making, an increase in the average number of shares would have anti-dilutive
effects.
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NOTE 15 Other current assets
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 5,418 | 4,977 | Government grants | 9,387 | 13,375 |
| 290 | 355 | Refundable VAT | 355 | 290 |
| 1,183 | 7,008 | Prepaid expenses | 7,390 | 1,804 |
| 389 | 410 | Other receivables | 349 | 390 |
| 10,625 | 6,199 | Receivables intercompany | ||
| 17,905 | 18,948 | Total | 17,482 | 15,860 |
NOTE 16 Cash and cash equivalents
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 733 | 452 | Employee withholding tax | 452 | 733 |
| 80,188 | 85,608 | Short-term bank deposits | 93,392 | 92,704 |
| 57,367 | 62,577 | Money market fonds | 62,577 | 57,367 |
| 138,288 | 148,637 | Total | 156,421 | 150,803 |
Of the total balance in cash and cash equivalents, NOK 0.5 million
(2022: NOK 0.7 million) relates to restricted funds for employee
withholding taxes.
The Group’s short-term bank deposits are on variable rate terms.
Money market funds are classified as Cash and cash equivalents as
this is short term placement held for the purpose of meeting short-
term cash commitments. Risk is low and the fund is highly liquid.
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NOTE 17 Share capital and shareholder information
The Group has one class of shares and all shares carry equal voting rights.
| AS OF 31 DECEMBER | NUMBER OF AUTHORIZED SHARES | NOMINAL VALUE (NOK) | BOOK VALUE (NOK) |
| Ordinary shares 2023 | 2,688,689,214 | 0.10 | 268,868,921.40 |
| Ordinary shares 2022 | 88,660,532 | 0.10 | 8,866,053.20 |
Changes in the outstanding number of shares
| 2023 | 2022 | |
| Ordinary shares at 1 January | 88,660,532 | 88,455,255 |
| Issue of ordinary shares | 2,600,028,682 | 205,277 |
| Ordinary shares at 31 December | 2,688,689,214 | 88,660,532 |
The Annual General Meeting held 22 May
2023 approved issuance of up to 2.5
billion new shares in a Rights Issue, and an
additional up to 1.25 billion Warrants. The
Rights Issue was successfully completed
13 June 2023 and fully subscribed. 2.5
billion shares were issued and 1.25 billion
Warrants. The Warrants represent a right
to receive one share at a predefined issue
price in specific windows. In November
2023, 68,156,682 Warrants were exercised
at NOK 0.13 per share. As of 31 December
2023 the total number of Warrants
outstanding was 1,181,842,935, of which
1,106,565,434 Warants were exercised in
April 2024. At end of April 2024 there are no
outstanding Warrants from the Rights Issue
in 2023.
The Board of Directors has been granted a
mandate from the general meeting held on
22 May 2023 to increase the share capital
with up to NOK 12,909,000 by subscription
of new shares. The power of attorney was
granted for the purpose of issuance of new
shares in accordance with the Company’s
share incentive program and is valid until
the earlier of the Annual General Meeting
in 2024 and 30 June 2024. See note 4 for
more information about the share incentive
program and number of options granted.
The Board of Directors has been granted a
mandate from the general meeting held on
22 May 2023 to increase the share capital
with up to NOK 72,773,210 by subscription
of new shares. The proxy is valid until the
earlier of the annual general meeting in
2024 and 30 June 2024. In June 2023,
the share capital was increased by NOK
3,187,200 by use of this board proxy.
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Ownership structure as of 31.12.2023
| SHAREHOLDER | NUMBER OF SHARES | PERCENTAGE SHARE OF TOTAL SHARES | |
| Meteva AS | 704,815,981 | 26.2 % | |
| Investinor Direkte AS | 182,337,576 | 6.8 % | |
| Bera AS | 55,768,426 | 2.1 % | |
| Nordnet Livsforsikring AS | 47,483,089 | 1.8 % | |
| Sarsia Development AS | 33,675,000 | 1.3 % | |
| Zaim, Kevin | 28,000,000 | 1.0 % | |
| Nordnet Bank AB | NOMINEE | 27,610,715 | 1.0 % |
| Marstia Invest AS | 26,833,824 | 1.0 % | |
| Jakob Hatteland Holding AS | 25,200,000 | 0.9 % | |
| The Bank Of New York Mellon SA/NV, RE 259567 | NOMINEE | 25,025,058 | 0.9 % |
| Mohn, Marit | 24,817,824 | 0.9 % | |
| Høse AS | 21,006,588 | 0.8 % | |
| Skandinaviska Enskilda Banken Ab | 14,651,278 | 0.5 % | |
| Danske Bank A/S | NOMINEE | 14,545,506 | 0.5 % |
| The Bank Of New York Mellon SA/NV, RE 585665 | NOMINEE | 10,905,250 | 0.4 % |
| J.P. Morgan Securities PLC | 10,817,020 | 0.4 % | |
| Holm, Jørgen | 10,474,332 | 0.4 % | |
| Holø, Johan | 10,100,000 | 0.4 % | |
| Jahatt AS | 10,075,000 | 0.4 % | |
| Silberg, Johnny | 10,000,000 | 0.4 % | |
| Top 20 Shareholders | 1,294,142,467 | 48.1 % | |
| Total Other Shareholders | 1,394,546,747 | 51.9 % | |
| Total Number Of Shares | 2,688,689,214 | 100.0 % |
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Ownership structure as of 31.12.2022
| SHAREHOLDER | NUMBER OF SHARES | PERCENTAGE SHARE OF TOTAL SHARES | |
| Meteva AS | 24,139,650 | 27.2 % | |
| Investinor Direkte AS | 7,270,780 | 8.2 % | |
| Fjarde Ap-Fonden | 4,487,493 | 5.1 % | |
| Sarsia Seed AS | 2,117,900 | 2.4 % | |
| J.P. Morgan SE | NOMINEE I | 1,726,731 | 1.9 % |
| Bera AS | 1,712,426 | 1.9 % | |
| Verdipapirfondet Nordea Avkastning | 1,510,174 | 1.7 % | |
| Sarsia Development AS | 1,175,000 | 1.3 % | |
| Verdipapirfondet Nordea Norge Plus | 901,260 | 1.0 % | |
| Verdipapirfondet Nordea Kapital | 881,920 | 1.0 % | |
| Verdipapirfondet Nordea Norge Verdi | 864,688 | 1.0 % | |
| Marit Mohn | 850,000 | 1.0 % | |
| Marstia Invest AS | 850,000 | 1.0 % | |
| Verdipapirfondet KLP Aksjenorge In | 574,309 | 0.6 % | |
| Norda ASA | 519,614 | 0.6 % | |
| Louise Mohn | 509,676 | 0.6 % | |
| J.P. Morgan SE | NOMINEE II | 422,541 | 0.5 % |
| Høse AS | 383,111 | 0.4 % | |
| MP Pensjon PK | 372,783 | 0.4 % | |
| Nordnet Livsforsikring AS | 371,168 | 0.4 % | |
| Top 20 Shareholders | 51,641,224 | 58.2 % | |
| Total Other Shareholders | 37,019,308 | 41.8 % | |
| Total Number Of Shares | 88,660,532 | 100.0 % |
For shares in the Company held by the Executive management and Board of Directors, please see Remuneration Report in the Governance
section of the Annual report.
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NOTE 18 Other current liabilities
| PARENT 2022 | PARENT 2023 | GROUP 2023 | GROUP 2022 | |
| 1,281 | 848 | Unpaid duties and charges | 1,499 | 1,623 |
| 1,215 | 1,121 | Unpaid vacation pay | 1,121 | 1,215 |
| 0 | 418 | Current lease liabilities | 418 | 0 |
| 37,096 | 21,014 | Other accrued costs | 25,173 | 45,461 |
| 39,591 | 23,401 | Total | 28,212 | 48,299 |
NOTE 19 Provisions
| PARENT 2022 | PARENT 2023 | SOCIAL SECURITY CONTRIBUTIONS ON SHARE OPTIONS | GROUP 2023 | GROUP 2022 |
| 969 | 0 | Balance at 1 January | 0 | 969 |
| −969 | 42 | Additional provisions recognised | 42 | (969) |
| 0 | 42 | Balance at 31 December | 42 | 0 |
| 0 | 42 | Current | 42 | 0 |
| 0 | 0 | Non-current | 0 | 0 |
The provision for social security contributions on share options is calculated based on the number of options outstanding at the reporting
date that are expected to be exercised. The provision is based on the difference between market price and strike price. The market price of the
shares at the reporting date is the best estimate of market price at the date of exercise.
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NOTE 20 Financial instruments and
risk management objectives & policies
The Group’s activities are exposed to
certain financial risks including foreign
exchange risk, credit risk and liquidity risk.
The risk is however of such character that
the Group has chosen not to put in place
any measures to mitigate the potential
unpredictability of the financial markets.
The Group had NOK 156.4 million in cash
and cash equivalents at year end 2023.
The main purpose of this is to finance
the Group’s activities and ongoing clinical
trials. The Group has various assets and
liabilities such as receivables and trade
payables, which originate directly from
its operations. All financial assets and
liabilities are carried at amortized cost
except for the money market fund which
is at fair value. All financial assets and
liabilities are short-term in nature and
their carrying value approximates fair
value. The cash and cash equivalent and
account payable is in financial instruments
measured at amortized cost.
The Group does currently not use financial
derivatives.
Foreign currency risk
The value of non-Norwegian currency
denominated revenues and costs will be
affected by changes in currency exchange
rates or exchange control regulations. The
Group undertakes various transactions
in foreign currencies and is consequently
exposed to fluctuations in exchange rates.
The exposure arises largely from research
expenses. The Group is mainly exposed to
fluctuations in euro (EUR), pounds sterling
(GBP) and US dollar (USD).
The Group has chosen not to hedge its
operational performance as the Group’s
cash flow is denominated in several
currencies that change depending on where
clinical trials are run. The foreign currency
exposure is also mostly linked to trade
payables with short payment terms. The
Group may consider changing its current
risk management of foreign exchange rate
if it deems it necessary.
Interest rate risk
The Group holds NOK 156.4 million in
cash and cash equivalents at end of 2023.
The Group’s interest rate risk is therefore
in the rate of return of its cash on hand.
Bank deposits are exposed to market
fluctuations in interest rates, which affects
the financial income and the return on
cash. The Group had 3.0 million in interest
income in 2023 (NOK 2.9 million 2022).
The shareholder loan facility secured from
Meteva AS in October 2022 had a facility
fee of 1.5% of any un-drawn amount.
Facility fee for 2023 is expensed with NOK
0.5 million in 2023 (2022: NOK 0.3 million).
Credit risk
Credit risk is the risk of a counterparty’s
default in a financial asset, liability or
customer contract, giving a financial loss.
The Group’s receivables are generally
limited to receivables from public
authorities by way of government grants.
The credit risk generated from financial
assets in the Group is limited since it is
cash deposits. The Company only places
its cash in bank deposits and a limited risk
money market fund in recognized financial
institutions to limit its credit risk exposure.
The Group has not suffered any loss on
receivables during 2023 and the Group
considers its credit risk as low.
Liquidity risk
Liquidity is monitored by Group manage-
ment. Management considers the Group’s
liquidity situation to be satisfactory. The
Group raised total NOK 250 million in a
Rights Issue equity funding in June 2023.
In addition the Group issued Warrants to
subscribers in the Rights Issue providing a
total potential funding of NOK 154 million
if fully exercised. The cash position of the
Group at year end 2023 was NOK 156.4 mil-
lion, compared to NOK150.8 million at year
end 2022. The cash position in combination
with the proceeds from exercise of War-
rants in April 2024 of NOK 138.9 million will
fund the planned activities into 2H 2025 on
a going concern basis.
Capital management
The Board of Directors’ goal is to maintain
a strong capital base in order to preserve
the confidence of investors, creditors and
to develop business activities.
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Change in liabilities arising from financing activities
| CURRENT LEASE LIABILITIES (NOTE 9) | NON-CURRENT LEASE LIABILITIES (NOTE 9) | |
| 1 january 2023 | 0 | 0 |
| Cash flows | (193) | 0 |
| New leases | 611 | 0 |
| Other | 0 | 0 |
| 31 December 2023 | 418 | 0 |
| 1 january 2022 | 681 | 942 |
| Cash flows | (454) | 0 |
| New leases | (1,169) | 0 |
| Other | 942 | (942) |
| 31 December 2022 | 0 | 0 |
Other includes the effect of reclassification of non-current lease liabilities to current.
The Group classifies interest paid as cash flow from operation activities.
NOTE 21 Subsidiaries
The Group’s subsidiary at 31 December 2023 are set out below. The share capital consist solely of ordinary shares that are held directly by the
Group, and the proportion of ownership interests held equals the voting rights held by the Group.
| Name of entity | BerGenBio Limited | BerGenBio ApS |
| Place of business | Oxford, U.K. | Köge, DK |
| Ownership interest held by the Group | 100% | 100% |
| Principal activities | Clinical management sevices | CMC and management services |
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NOTE 22 Intercompany
BerGenBio ASA have entered into two intercompany management agreements with BerGenBio Limited. R&D services are delivered from
BerGenBio Limited to BerGenBio ASA and management services are delivered from BerGenBio ASA to BerGenBio Limited.
| PARENT 2023 | PARENT 2022 | |
| Purchase from BerGenBio Limited (included in other operation expenses) | 50,284 | 65,618 |
| Receivables BerGenBio Limited (included in other current assets) | 4,640 | 10,625 |
NOTE 23 Subsequent events
In April 2024, in the last exercise period of the Warrants issued as part of the Rights Issue in June 2023, the Company received gross proceeds
of NOK 138.9 million from exercise of 1,106,565,434 Warrants. This represented 93.6% of the remaining Warrants.
NOTE 24 Shareholder loan
The Company secured a shareholder loan facility 24 October 2022 of up to NOK 100 million from Meteva AS, a major shareholder in the
Company. The facility was not drawn and was terminated in May 2023 at the approval of the Rights issue, according to the facility terms. As of
31 December 2023 there are no shareholder loan facility.
Anders Tullgren
Chair of the Board of Directors
Sveinung Hole
Non-Executive Director
Dr. Sally Bennett
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
Martin Olin
CEO
Bergen, 30 April 2024
The Board of Directors, BerGenBio ASA
BERGENBIO
Annual Report & Accounts 2023
INDEPENDENT AUDITOR’S REPORT
To the Annual Shareholders’ Meeting of BerGenBio ASA
Report on the audit of the financial statements
Opinion
We have audited the financial statements of BerGenBio ASA (the
Company), which comprise the financial statements of the Company
and the consolidated financial statements of the Company and its
subsidiaries (the Group). The financial statements of the Company
and the Group comprise the statement of financial position as at 31
December 2023 and the income statement and other comprehensive
income for the year then ended, and notes to the financial statements,
including material accounting policy information.
In our opinion, the financial statements comply with applicable legal
requirements and give a true and fair view of the financial position of the
Company and the Group as at 31 December 2023 and their financial
performance and cash flows for the year then ended in accordance with
IFRS Accounting Standards as adopted by the EU.
Our opinion is consistent with our additional report to the audit
committee.
Basis for opinion
“We conducted our audit in accordance with International Standards on
Auditing (ISAs). Our responsibilities under those standards are further
described in the Auditor’s responsibilities for the audit of the financial
statements section of our report. We are independent of the Company
and the Group in accordance with the requirements of the relevant
laws and regulations in Norway and the International Ethics Standards
Board for Accountants’ International Code of Ethics for Professional
Accountants (including International Independence Standards) (IESBA
Code), and we have fulfilled our other ethical responsibilities in
accordance with these requirements. We believe that the audit evidence
we have obtained is sufficient and appropriate to provide a basis for our
opinion”
To the best of our knowledge and belief, no prohibited non-audit
services referred to in the Audit Regulation (537/2014) Article 5.1 have
been provided.
We have been the auditor of the Company for 16 years from the
election by the general meeting of the shareholders on 21 December
2007 for the accounting year 2008.
Key audit matters
Key audit matters are those matters that, in our professional judgment,
were of most significance in our audit of the financial statements for
2023. We have determined that there are no key audit matters to
communicate in our report.
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Statsautoriserte revisorer
Ernst & Young AS
Thormøhlens gate 53 D, 5006 Bergen
Postboks 6163, 5892 Bergen
Foretaksregisteret: NO 976 389 387 MVA
Tlf: +47 24 00 24 00
www.ey.no
Medlemmer av Den norske Revisorforening
BERGENBIO
Annual Report & Accounts 2023
Other information
Other information consists of the information included in the annual report
other than the financial statements and our auditor’s report thereon.
Management (the board of directors and the chief executive officer)
is responsible for the other information. Our opinion on the financial
statements does not cover the other information, and we do not express
any form of assurance conclusion thereon.
In connection with our audit of the financial statements, our responsibility
is to read the other information, and, in doing so, consider whether the
board of directors’ report, the statement on corporate governance and
the statement on corporate social responsibility contain the information
required by applicable legal requirements and whether the other
information is materially inconsistent with the financial statements or our
knowledge obtained in the audit, or otherwise appears to be materially
misstated. If, based on the work we have performed, we conclude that
there is a material misstatement of this other information or that the
information required by applicable legal requirements is not included, we
are required to report that fact.
We have nothing to report in this regard, and in our opinion, the board
of directors’ report, the statement on corporate governance and the
statement on corporate social responsibility are consistent with the
financial statements and contain the information required by applicable
legal requirements.
Responsibilities of management for the financial statements
Management is responsible for the preparation and fair presentation of
the financial statements in accordance with IFRS Accounting Standards
as adopted by the EU, and for such internal control as management
determines is necessary to enable the preparation of financial statements
that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, management is responsible for
assessing the Company’s and the Group’s ability to continue as a going
concern, disclosing, as applicable, matters related to going concern and
using the going concern basis of accounting unless management either
intends to liquidate the Company or the Group, or to cease operations, or
has no realistic alternative but to do so.
Auditor’s responsibilities for the audit of the financial
statements
Our objectives are to obtain reasonable assurance about whether the
financial statements as a whole are free from material misstatement,
whether due to fraud or error, and to issue an auditor’s report that
includes our opinion. Reasonable assurance is a high level of assurance,
but is not a guarantee that an audit conducted in accordance with ISAs
will always detect a material misstatement when it exists.
Misstatements can arise from fraud or error and are considered material
if, individually or in the aggregate, they could reasonably be expected to
influence the economic decisions of users taken on the basis of these
financial statements.
As part of an audit in accordance with ISAs, we exercise professional
judgment and maintain professional scepticism throughout the audit. We
also:
• Identify and assess the risks of material misstatement of the financial
statements, whether due to fraud or error, design and perform audit
procedures responsive to those risks, and obtain audit evidence that
is sufficient and appropriate to provide a basis for our opinion. The
risk of not detecting a material misstatement resulting from fraud is
higher than for one resulting from error, as fraud may involve collusion,
forgery, intentional omissions, misrepresentations, or the override of
internal control.
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87
• 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 Company’s and the Group’s internal control.
• Evaluate the appropriateness of accounting policies used and the
reasonableness of accounting estimates and related disclosures made
by management.
• Conclude on the appropriateness of management’s use of the going
concern basis of accounting and, based on the audit evidence
obtained, whether a material uncertainty exists related to events or
conditions that may cast significant doubt on the Company’s and the
Group’s ability to continue as a going concern. If we conclude that a
material uncertainty exists, we are required to draw attention in our
auditor’s report to the related disclosures in the financial statements
or, if such disclosures are inadequate, to modify our opinion. Our
conclusions are based on the audit evidence obtained up to the date
of our auditor’s report. However, future events or conditions may
cause the Company and the Group to cease to continue as a going
concern.
• Evaluate the overall presentation, structure and content of the financial
statements, including the disclosures, and whether the financial
statements represent the underlying transactions and events in a
manner that achieves fair presentation.
• Obtain sufficient appropriate audit evidence regarding the financial
information of the entities or business activities within the Group to
express an opinion on the consolidated financial statements. We are
responsible for the direction, supervision and performance of the
group audit. We remain solely responsible for our audit opinion.
We communicate with the board of directors regarding, among other
matters, the planned scope and timing of the audit and significant audit
findings, including any significant deficiencies in internal control that we
identify during our audit.
We also provide the audit committee with a statement that we have
complied with relevant ethical requirements regarding independence, and
to communicate with them all relationships and other matters that may
reasonably be thought to bear on our independence, and where applica-
ble, related safeguards.
From the matters communicated with the board of directors, we determine
those matters that were of most significance in the audit of the financial
statements of the current period and are therefore the key audit matters.
We describe these matters in our auditor’s report unless law or regulation
precludes public disclosure about the matter or when, in extremely rare
circumstances, we determine that a matter should not be communicat-
ed in our report because the adverse consequences of doing so would
reasonably be expected to outweigh the public interest benefits of such
communication.
Report on other legal and regulatory requirement
Report on compliance with regulation on European Single
Electronic Format (ESEF)
Opinion
As part of the audit of the financial statements of BerGenBio ASA we have
performed an assurance engagement to obtain reasonable assurance
about whether the financial statements included in the annual report,
with the file name 213800TYYFXKYF3V2A23-2023-12-31-en, have been
prepared, in all material respects, in compliance with the requirements of
the Commission Delegated Regulation (EU) 2019/815 on the European
Single Electronic Format (ESEF Regulation) and regulation pursuant
BERGENBIO
Annual Report & Accounts 2023
to Section 5-5 of the Norwegian Securities Trading Act, which includes
requirements related to the preparation of the annual report in XHTML
format and iXBRL tagging of the consolidated financial statements.
In our opinion, the financial statements, included in the annual report,
have been prepared, in all material respects, in compliance with the ESEF
Regulation.
Management’s responsibilities
Management is responsible for the preparation of the annual report in
compliance with the ESEF Regulation. This responsibility comprises an
adequate process and such internal control as management determines
is necessary.
Auditor’s responsibilities
Our responsibility, based on audit evidence obtained, is to express an
opinion on whether, in all material respects, the financial statements
included in the annual report have been prepared in accordance with the
ESEF Regulation. We conduct our work in accordance with the Interna-
tional Standard for Assurance Engagements (ISAE) 3000 – “Assurance
engagements other than audits or reviews of historical financial informa-
tion”. The standard requires us to plan and perform procedures to obtain
reasonable assurance about whether the financial statements included
in the annual report have been prepared in accordance with the ESEF
Regulation.
As part of our work, we perform procedures to obtain an understanding
of the company’s processes for preparing the financial statements in
accordance with the ESEF Regulation. We test whether the financial
statements are presented in XHTML-format. We evaluate the complete-
ness and accuracy of the iXBRL tagging of the consolidated financial
statements and assess management’s use of judgement. Our procedures
include reconciliation of the iXBRL tagged data with the audited financial
statements in human-readable format. We believe that the evidence we
have obtained is sufficient and appropriate to provide a basis for our
opinion.
Bergen, 30 April 2024
ERNST & YOUNG AS
Truls Nesslin
State Authorised Public Accountant (Norway)
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WEF index & data summary
| THEME | DISCLOSURE REFERENCE | METRIC | 2023 | 2022 | 2021 | 2020 | REPORT |
| REFERENCE | |||||||
| WEF Metric: Governance | |||||||
| Governing Purpose | The British Academy and Colin | Setting purpose | Qualitative | Qualitative | Qualitative | Qualitative | |
| Mayer, GRI (102-26), EPIC and other | |||||||
| Total number of board members (#) | 4 | 5 | 5 | 5 | Page 18, 22 | ||
| Board diversity (men/women) (%) | 50/50 | 60/40 | 60/40 | 60/40 | Page 18, 22 | ||
| Quality of Governing Body | GRI (102-22), GRI (405-1a), IR (4B) | ||||||
| Number of non-executive board members (#) | 4 | 5 | 5 | 5 | Page 18, 22 | ||
| Number of independent board members (#) | 4 | 5 | 3 | 3 | Page 22 | ||
| Stakeholder Engagement | GRI (102-21), GRI (102-43), GRI (102-47) | Impact of material issues on stakeholders | Qualitative | Qualitative | Qualitative | Qualitative | |
| Percentage of employees receiving Code of Conduct training (%) | 100 | 0 | 0 | 0 | Page 16 | ||
| GRI(205-2), GRI(205-3) | |||||||
| Ethical Behavior | Confirmed incidents of corruption (#) | 0 | 0 | 0 | 0 | Page 16 | |
| GRI (102-17) | Protected ethics advice and reporting mechanism | Qualitative | Qualitative | Qualitative | Qualitative | ||
| EPIC, GRI (102-15), World Economic | |||||||
| Risk & Opportunity Oversight | Forum Integrated Corporate | Integrating risk and opportunity into business processes | Qualitative | Qualitative | Qualitative | Qualitative | |
| Governance, IR (4D) | |||||||
| Responsible Sourcing | Own indicator, adapted from | Number of material suppliers who undertook supplier | 4 | 0 | 0 | 0 | Page 17 |
| GRI (408-1.b), GRI (409-1) | ESG self-assessment (#) | ||||||
| WEF Metric: Planet | |||||||
| GHG emissions Scope 2 (tCO2e) | 2.03 | 5.63 | 5.89 | Page 21 | |||
| Climate Change | GRI 205: 1-3; TCFD; GHG Protocol | ||||||
| GHG emissions Scope 3 (tCO2e) | 74.88 | 49 | 11.65 | Page 21 | |||
| Natural Capital Protocol (2016); | |||||||
| ISO 14008: Monetary valuation of | |||||||
| Solid Waste | environmental impacts and related | Impact of solid waste disposal | Qualitative | Qualitative | Qualitative | Qualitative | |
| environmental aspects (2019); | |||||||
| Value Balaning Alliance |
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Annual Report & Accounts 2023
| THEME | DISCLOSURE REFERENCE | METRIC | 2023 | 2022 | 2021 | 2020 | REPORT |
| REFERENCE | |||||||
| WEF Metric: People | |||||||
| GRI (102-8) | Total number of employees (#) | 16 | 29 | 46 | 42 | Page 18 | |
| GRI (405-1.b) | Employee diversity (Men/Women) (%) | 44/56 | 38/62 | 37/63 | 41/59 | Page 18 | |
| BerGenBio indicator | Number of interns/postgraduate students/ | 2 | 3 | 2 | 2 | Page 19 | |
| PhD students employed (#) | |||||||
| Adapted, to include other indicators | Employees regularly receiving | ||||||
| Dignity and Equality | performance and development evaluation | 100 | 100 | 100 | 100 | Page 19 | |
| of diversity, from GRI 401-1 (a & b) | (%) | ||||||
| BerGenBio indicator | Personnel with PhDs (#) | 6 | 14 | 19 | 16 | Page 18 | |
| Confirmed incidents of discrimination (#) | 0 | 0 | 0 | 0 | Page 17 | ||
| GRI (408-1.b), GRI (409-1) | Risk of incidents of child, forced or | ||||||
| compulsory labour | Qualititive | Qualititive | Qualititive | Qualititive | |||
| Number of Injuries (#) | 0 | 0 | 0 | 0 | Page 20 | ||
| GRI (403-9.a & .b) | |||||||
| Injury rate (%) | 0 | 0 | 0 | 0 | Page 20 | ||
| Norwegian Accounting Act | Sick-leave ($) | 3.6 | 2.3 | 1.4 | 2 | Page 20 | |
| Health & Well-being | |||||||
| Survey | |||||||
| BerGenBio indicator | Employee survey response rate (%) and | Surevey | administered | 75% response, | 85% response, | Page | |
| engagement score (%) | delayed | biennially (next | 80% engagement | 84% engagement | |||
| one due 2023) | |||||||
| Total number of substantiated complaints | |||||||
| received with regard to patient personal | 0 | 0 | 0 | 0 | Page 17 | ||
| Patient safety | GRI (418-1) | data breach (#) | |||||
| Output of patient/clinical trial participant | 1 | 1 | 1 | 1 | Page 17 | ||
| assistance program (#) |
WEF index & data summary | Continued
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| THEME | DISCLOSURE REFERENCE | METRIC | 2023 | 2022 | 2021 | 2020 | REPORT |
| REFERENCE | |||||||
| WEF Metric: Prosperity | |||||||
| New hires (#) | 2 | 6 | 16 | 14 | Page 19 | ||
| Adapted, to include other indicators of | New hires diversity (men/women) (%) | 0/100 | 16.5/83.5 | 41/59 | 21.5/78.5 | Page 19 | |
| diversity, from GRI 401-1 and 201-4 | |||||||
| Turnover rate (%) | 52 | 59 | 23 | 10 | Page 19 | ||
| Revenues (NOK million) | 0.4 | 0.4 | 0.8 | 0.6 | Page 55 | ||
| Operating Cost (NOK million) | 192.2 | 306.0 | 315.2 | 261,7 | Page 55 | ||
| Employment & Wealth Creation | Employee wages and benefits (NOK million) | 55.6 | 68.7 | 74.0 | 60.18 | Page 55, 67 | |
| GRI (201-1), GRI (201-4) | |||||||
| Payments to government (other than taxes) | 0 | 0 | 0 | 0 | |||
| (NOK million) | |||||||
| Financial assistance from the government | 9.6 | 10.4 | 13.3 | 21.4 | Page 70 | ||
| As referenced in IAS 7 and US | Share buyback plus dividend payments | 0 | 0 | 0 | 0 | Page 39 | |
| GAAP ASC 230 | (NOK million) | ||||||
| Community & Social Vitality | Adapted from GRI 201-1 | Total taxes paid (NOK million) | 6.9 | 7.9 | 7.7 | 5.8 | Page 67 |
| US GAAP ASC 730 | R&D spend (NOK million) | 151.4 | 263.0 | 268.5 | 225.5 | Page 72 | |
| Pharma Indicator, Industry best practice | Number of patents granted (#) | 6 | 8 | 21 | 10 | Page 49 | |
| Innovation of Better Products | |||||||
| & Services | Pharma Indicator, Industry best practice | Number of peer-reviewed publications | 4 | 1 | 4 | 2 | Page 18 |
| BGB has contributed to (#) | |||||||
| Pharma Indicator, Industry best practice | Number of international presentations (#) | 12 | 12 | 15 | 9 | Page 18 | |
| SASB (HC-BP-210a.1.) | Number of clinical trials registered and | 0 | 2 | 1 | 1 | Page 16 | |
| initiated during the year (#) | |||||||
| Adapted from SASB (HC-BP-210a.1.) | Total number of discontinued clinical trials | 0 | 0 | 0 | 0 | Page 9, 47 | |
| due to non-compliance (#) | |||||||
| Clinical trial conduct | |||||||
| Adapted from SASB (HC-BP-210a.2.) | Critical inspection findings (#) | 0 | 0 | 0 | 0 | Page 16 | |
| Total amount of monetary losses as a | |||||||
| Adapted from SASB (HC-BP-210a.3.) | result of legal proceedings associated | 0 | 0 | 0 | 0 | Page 16 | |
| with clinical trials (NOK million) |
WEF index & data summary | Continued
›
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Glossary
1L First line cancer treatment
2L Second line cancer treatment
ADCT ADC Therapeutics SA
ADCT-601 Product candidate under development by ADCT
ALK Anaplastic lymphoma kinase
AML Acute Myeloid Leukemia
ARDS Acute Respiratory Distress Syndrome
AXL AXL tyrosine kinase receptor
BGB BerGenBio
BGBIO BerGenBio ticker symbol on Oslo Stock Exchange
BRAF B-Raf proto-oncogene, serine/threonine kinase
CEO Chief Executive Officer
COVID-19 Infectious disease caused by SARS-CoV-2 virus
CROs Contract research organizations
CSR Corporate social responsibility
DCs Dendritic cells
DNA Deoxyribonucleid acid
EGFR Epidermal growth factor receptor
EMT Endothelial-mesenchymal transition
ERBB2
v-erb-b2 avian erythroblastic leukemia viral
oncogene homolog 2 (also known as HER2)
ESG Environmental, Social and Governance
EU European Union
EU5 UK, France, Germany, Italy & Spain
EU-SolidAct
An EU sponsored Ph2b study of hospitalized
COVID-19 patients
EY Ernst and Young AS
FDA US Food and Drug Administration
FTEs Full time equivalents
GAS6 Growth arrest-specific 6 (AXL ligand)
GBP British pound sterling
GCP Good Clinical Practice
GHG Greenhouse gas
GMP Good Manufacturing Practice
IFN1 Type-1 interferons
IFU Industrial Development Award (Norwegian)
IRS International Financial Reporting Standards
ISO International Organization for Standardization
ILT Investigator Led Trials
IP Intellectual property
KPI Key Performance Indicator
KRAS Kristen Rat Sarcoma Viral oncogene homolog
KRASG12C A specific mutation of KRAS
LTI Long-term incentives
MET MET proto-oncogene, receptor tyrosine kinase
MDS Myelodyplastic syndrome
M1 M1 macrophages
M2 M2 macrophages
MHC-1 Major histocompatibility complex class I
MOA Mechanism of action
mOS Median overall survival
NOK Norwegian Kroner
NSCLC Non-Small Cell Lung Cancer
OCI Other Comprehensive Income
OSE Oslo Stock Exchange
PD-1 Programmed death 1
PD-L1 Programmed death-ligand 1
PFS Progression free survival
Ph1(b) Phase 1 or Phase 1b clinical trial
Ph2 Phase 2 clinical trial
PhD Doctor of philosophy
PSCI Pharmaceutical Supply Chain Initiative
R&D Research & development
ROS Reactive oxygen stress
ROS1 ROS proto-oncogene 1, receptor tyrosine kinase
RSV Respiratory syncytial virus
SDG Sustainable Development Goals
SEER
National Cancer Institute's Surveillance,
Epidemiology, and End Results Program
SRI Severe respiratory infections
STI Short-term incentives
STK11 Serine/threonine kinase gene
STK11m Mutation(s) in the STK11 gene
TKI Tyrosine Kinase Inhibitor
TME Tumor microenvironment
UK United Kingdom
US United States
USD United States dollars
BERGENBIO
Annual Report & Accounts 2023
BERGENBIO
Annual Report & Accounts 2023
Contact Us
BerGenBio ASA Analyst Coverage
H.C. Wainwright & Co
JOSEPH PANTGINIS
Telephone
+1 646 975 6968
E-mail
Carnegie
ARVID NECANDER
Telephone
+46 8 5886 8846
E-mail
ULRIK TRATTNER
Telephone
+46 8 5886 8589
E-mail
DNB Markets
GEIR HILLER HOLOM
Telephone
+47 977 66 583
E-mail
PATRIK LING
Telephone
+46 8 473 48 43
E-mail
Address
Møllendalsbakken 9, 5009 Bergen, Norway
P.O. Box 2324
Møllendal, 5867 Bergen, Norway
Telephone
+47 55 96 11 59
E-mail
Investor Relations Contact
MARTIN OLIN | CEO
RUNE SKEIE | CFO
E-mail
Media Relations
JAN LILLEBY | Lilleby Frisch AS
E-mail
93