Annual Report
& Accounts
2021
Developing
breakthrough
AXL therapeutics
to improve
patients’ lives
Highlights 2021
OUR VISION: BerGenBio
(OSE:BGBIO) is a clinical stage
biopharmaceutical company
developing innovative drugs
for aggressive diseases
including cancer and severe
respiratory infections
Initiated new lung
cancer STK11
program
Focused
bemcentinib
strategy
established
Maturing AML
data
Treated >600
patients to date with
bemcentinib
Fast track
designations
received
Initiated Phase IB
tilvestamab trial
Clinical ecacy
seen in COVID-19
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Annual Report & Accounts 2021
OVERVIEW
01–03
Dear Shareholders
It is my great pleasure to deliver my rst annual update to
shareholders as Chairman of BerGenBio. I’m very excited
and pleased to have joined the Company at such a pivotal time
in our development. I would like to take this opportunity to
extend my gratitude to my predecessor Sveinung Hole for
his service as Chairman since 2019. I look forward to working
alongside Sveinung as he continues his role on the Board.
My own background comprises over 35 years of senior roles in
the life-sciences industry, spanning from large pharmaceutical
and small/mid-size biotech companies where I was responsible
“I have been impressed with the
depth of knowledge and expertise
at all levels of the Company.”
Chair’s Statement
for global development and commercialization of several
different products mainly within speciality care. During my
career, I have been fortunate to have worked with several
virology and oncology products and to have led the successful
launch of the Bristol Myers Squibbs immuno-oncology portfolio
in several countries around the world.
This experience, gained over a long career, led me to recognize
the great potential and opportunity offered by BerGenBio’s
strategy of utilizing selective inhibitors of the tyrosine kinase
target AXL as a potential therapies in oncology and
infectious diseases.
The biology of AXL itself is intriguing, with a growing body of
published research demonstrating the important role it can play
in several diseases: promoting immune evasion, drug resistance
and the spread of cancer cells, and in immune cells where it
suppresses tumor recognition and cell-killing.
Crucially, AXL does not mutate, and selectively blocking its
activity represents a novel and credible approach to interfere
with the survival mechanisms utilized by cancer and infectious
diseases, thus holding the promise to improve the efcacy of
chemotherapy, targeted therapies and immuno-oncology drugs.
BerGenBio pioneered the research and development of AXL
as a potential target, and during my brief time here I have been
impressed with the depth of knowledge and expertise at all
levels of the Company. In addition to extensive research
conducted in-house and with academic partners, we have
gained clinical experience in over 600 patients dosed with our
lead candidate bemcentinib, which has been shown to be safe
and well tolerated across a broad patient population in several
indications. The acquired understanding provides a strong
basis for optimizing our ongoing and future clinical trial
programs and to help us to forge a long-term vision for
the Company.
Under the leadership of CEO Martin Olin, I believe we now
have a clear strategy in place to achieve our vision and to
maximize the potential of bemcentinib by focusing our efforts
on highly specic patient populations underserved by current
treatments within oncology and respiratory infections.
Areas of focus within oncology include Non-Small Cell Lung
Cancer (NSCLC) patients harboring STK11 mutations and
potentially patients with relapsed Adult Myeloid Leukemia
(AML). Within respiratory infections, we are encouraged by
bemcentinib’s potential as an antiviral agent, particularly in
severe respiratory infections, as evidenced by encouraging
data from recent phase II trials undertaken in COVID-19.
Further details on the specic steps we will be undertaking to
progress bemcentinib’s development in these areas is outlined
elsewhere in this report. I have full condence in the ability of
our senior management and staff to execute this strategy and
deliver on the potential of our pipeline.
I am optimistic about the future prospects of our company and
our ability to continue building BerGenBio, creating value for
our shareholders while conducting our business in line with our
responsibilities as a good corporate citizen. On behalf of the
Board, I would like to extend my appreciation to all of our staff,
shareholders and partners for their continued support as we
continue to work to realize our vision to help patients suffering
from aggressive diseases.
Anders Tullgren
Chair of the Board of Directors
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Dear Shareholders
BerGenBio’s focus throughout 2021 has been the continued
development of our lead candidate, bemcentinib, a potentially
rst-in-class selective AXL inhibitor currently undergoing Phase
II clinical trials in NSCLC, AML and COVID-19. Since taking up
my role as CEO of the Company in September, I have been
working with the board and senior management team to rene
our strategic priorities to optimize the development pathway
for this promising candidate.
By the end of 2021 we have treated more than 600 patients
and accumulated a valuable understanding of the indications
and patient subgroups which appear most likely to benet from
bemcentinib treatment. Accordingly, we will prioritize the
clinical development of bemcentinib within NSCLC and severe
respiratory infections.
Firstly, in NSCLC, the largest oncology indication, mutations
in STK11 (up to 20% of NSCLC) has been shown to confer to
poor prognosis and limited response to treatment with anti-
PD1/PD-L1 therapies. Currently there are no effective therapies
specically directed toward this large, identiable sub-group
of NSCLC patients.
Encouragingly, preclinical data suggest that bemcentinib restores
sensitivity to anti-PD1/L1 immune checkpoint therapies in the
presence of STK11 mutations and STK11 mutated patients in
our BGBC008 trial showed encouraging clinical benet from
the combination of bemcentinib/anti-PD1 treatment.
Chief Executive’s Statement
The importance of this sub-population is being increasingly
acknowledged, and in November we were pleased to receive
FDA Fast Track designation for bemcentinib in combination
with an anti-PD-(L)1 agent as a treatment for patients with
STK11 altered advanced/metastatic NSCLC without
actionable mutations.
In the pursuit of this signicant opportunity, we look to
aggressively advance our research and clinical activities while
also evaluating partnering opportunities to further expand our
work in this promising area.
Secondly, we are investigating bemcentinib as a potential
therapy for the treatment of severe respiratory infections,
initially within COVID-19. To this end, at the beginning of
2022 we were pleased to announce our participation in the
EUSolidAct trial, part of the pan-European COVID-19 research
project EU-RESPONSE. As part of this Phase II adaptive,
multicenter trial, bemcentinib will be studied in up to 500
hospitalized COVID-19 patients. This provides a unique
opportunity to validate the ndings of previous studies,
at a substantially reduced cost to the company.
As with regards to AML, despite recent approvals of additional
1st line AML treatments, we continue to see a clear unmet
medical need for 2 line AML patients who are unable to
tolerate intensive chemotherapy. Bemcentinib has shown
promising early clinical data in relapsed AML patients in our
Phase II (BGBC003) AML trial and data from this trial continues
to mature. When a mature dataset and regulatory feedback are
available, we will determine next steps in this indication.
I would like to give my thanks to the Shareholders, our Board,
our partners and academic collaborators, for their ongoing
support. We have strengthened our Board, and with the
appointment of Anders Tullgren we have a Chairman with
extensive experience in overseeing the development of
innovate drug pipelines, which will no doubt prove hugely
valuable to us as we progress. I would like to thank Sveinung
Hole for his strategic advice and expertise – particularly during
my rst few months at the Company, and who will remain a
vital member of the Board.
The Board and management team share the vision of
translating the expertise and understanding gained by
BerGenBio around AXL inhibition into clear next steps for our
company. With a solid cash position, we will continue to work
hard to deliver on this vision in the coming year and beyond.
While our strategy and plans are anchored in a strong scientic
rationale supported by preclinical and clinical data the
successful execution of it is only possible with the right talent
and experience – represented by all our employees. I would
like to use this opportunity to thank all employees for their
valuable contribution and commitment to make a difference for
patients in need of better treatment options.
Martin Olin
Chief Executive Ofcer
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Strategic Report
Contents
05 BerGenBio’s Unique Position and
Approach in the Biotechnology Field
06 AXL – a Promising Target to Treat
Life-Threatening Diseases
07 Two AXL Targeting Drug Candidates
in Clinical Development
08 Our Development Focus
09 Pipeline Overview
10 Industry Context
14 NSCLC: Unique Opportunity to Establish
a New Biomarker Driven Market
15 Severe Respiratory Infections:
COVID-19 and Beyond, Opportunities
16 AML: An Aggressive Disease With Limited
Treatment Options
17 Environmental, Social and Governance
04
Annual Report & Accounts 2021
Our business model
BerGenBio is the only company solely focused on exploiting the potential of
AXL inhibition for therapeutic purposes, providing it with a unique
competitive position in the biopharmaceutical industry.
BerGenBio has built the world’s-leading understanding of
the tyrosine kinase target AXL. First identied as a promising
cancer target, BerGenBio has also explored and validated the
signicant role that AXL plays as a driver of hematological and
solid cancers, and severe respiratory infections. BerGenBio is
uniquely positioned to explore potential clinical applications
of its selective AXL inhibitors bemcentinib and tilvestamab as
potential treatments for several life-threatening conditions.
BerGenBio is currently developing two potentially rst-in-class
selective AXL inhibitors: bemcentinib, a small molecule AXL
inhibitor currently in several Phase II trials and tilvestamab, a
selective monoclonal antibody directed at the AXL receptor,
currently in a Phase Ib trial.
BerGenBio has established a network of prestigious collaborators and
uses advanced technologies to enable the exploration of multiple potential
applications of its AXL inhibitors.
BerGenBio has studied its product candidates across a number
of 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
Sponsored Trials (ISTs).
BerGenBio intends to continue to develop its drug candidates
itself and through strategic partnerships and retains all strategic
options for the future commercialization of its products.
BERGENBIO’S UNIQUE POSITION AND APPROACH IN THE BIOTECHNOLOGY FIELD
WORLD-LEADING EXPERTISE ON AXL INHIBITORS AND THEIR THERAPEUTIC APPLICATIONS
We have successfully translated our
world-leading research on AXL’s
biological role into two proprietary
first-in-class clinical development
candidates: the highly selective,
oral small molecule AXL inhibitor
bemcentinib, and the novel, anti-AXL
therapeutic antibody tilvestamab.
We believe our clinical development
candidates are well-positioned to
become potential treatment
modalities for aggressive diseases.
Our unique position
Current partnerships with industry-leading institutions and
companies are listed below:
Corporate Partnerships
ADC Therapeutics Merck & Co. (MSD)
Collaborations with Leading Academic Institution
German Cancer Research Center
(DKFZ)
University of Bergen
Harvard Medical School University Hospital Leipzig
Haukeland University Hospital University of Iowa
Massachusetts Institute of
Technology
University of Manchester
MD Anderson Cancer Center University Medical Center,
Mannheim
Oslo Hospital / EUSolidAct University of Texas Southwestern
Medical Center
Southampton University
As a core part of its business model, BerGenBio will continue
to advance its research into identifying which patients may
benet most from treatment with our product candidates.
The availability of biomarkers has been shown to be an
important success factor in the clinical development of
oncology agents, providing insights into patient selection
and conrmation of mechanism(s) of action. The availability
of prognostic biomarkers may also facilitate registration and
reimbursement of our novel drugs. BerGenBio is employing
a development strategy that includes extensive biomarker
discovery activities and potential development of a companion
diagnostic in parallel.
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A promising target
The tyrosine kinase target AXL is known to play
an important role in both the innate and adaptive
immune systems.
Overexpression of AXL is known to be a
predictor of poor outcome in many diseases.
Respiratory
• Viral entry cofactor
• Immune suppression
• ECM production
• Migration
• Basal cell proliferation
• Reduced cytokine signalling
Cancer
• Invasion/Migration
• Drug resistance
• Proliferation
• Survival
• Immune suppression
Tilvestamab (BGB149)
• Anti-AXL fully humanised
monoclonal antibody
• Highly selective to human AXL
• Stable formulation, scalable
manufacturing process
Bemcentinib (BGB324)
• Orally bioavailable small
molecule TKI
• Highly selective for AXL
• Potent
• Once-a-day administration
• Favourable safety prole
• Combines with other
cancer drugs
Intracellular
Extracellular
AXL signaling
blocked
CANCER CELL
Kinase
domain
BGB’s AXL Inhibitors
Key Roles of AXL
AXL – A PROMISING TARGET TO TREAT
LIFE-THREATENING DISEASES
THE TYROSINE KINASE TARGET AXL IS KNOWN
TO PLAY AN IMPORTANT ROLE IN BOTH THE INNATE
AND ADAPTIVE IMMUNE SYSTEMS
AXL is a tyrosine kinase target that mediates aggressive
disease. Under normal healthy physiological conditions,
there is very low expression of AXL. However, in
aggressive diseases, such as cancer and severe
respiratory infections, AXL signaling is upregulated in
response to hypoxia, inammation, cellular stress and
drug treatment.
The activation of AXL occurs when it binds to
the ligand GAS6, resulting in overexpression and
intracellular signaling. The graphic to the right
illustrates the two mechanisms of action by which
BerGenBio’s proprietary compounds – bemcentinib
and tilvestamab – selectively inhibit AXL, along with
the resulting manifestations of AXL activation in cancer
and severe respiratory infections.
BerGenBio is focusing on the potential to reverse the
damaging effects of AXL activation in a broad range of
life-threatening illnesses through its potent, selective
AXL inhibitors, bemcentinib and tilvestamab.
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Bemcentinb was licensed from Rigel, Inc. and we hold exclusive
rights to develop and commercialize the product world-wide.
Tilvestamab – AXL Selective Monoclonal Antibody in Phase 1B
Tilvestamab Profile at a Glance (BGB149)
• Anti-AXL fully humanized monoclonal antibody
• Highly selective to human AXL
• Activity seen in pre-clinical models of cancer and brosis
• Well tolerated in Phase I study; Phase Ib on-going
Tilvestamab, a therapeutic anti-AXL antibody discovered and
developed by BerGenBio, is being studied in a Phase Ib clinical
study designed to substantiate its immune-activation properties
and to potentially aid in biomarker identication.
Out-Licensed Product Candidate
In addition to our two proprietary programs, an AXL
antibody developed by BerGenBio has been licensed to
ADC Therapeutics and it is being used in an antibody-drug-
conjugate (ADC) format. ADC Therapeutics is expected to
advance its program called ADCT-601 into a Phase Ib clinical
trial during 2022.
1) To date bemcentinib has been studied in combination with the immune checkpoint inhibitor pembrolizumab, with
platin-containing chemotherapy, with the AML chemotherapy LDAC, and with standard-of-care COVID-19 treatments
for hospitalized patients
Bemcentinib – Oral Selective AXL Inhibitor in
Multiple Phase II Trials
Bemcentinib Profile at a Glance (BGB324)
• Oral, small molecule tyrosine kinase inhibitor
• First-in-class, highly selective, potent AXL inhibitor
• Once-a-day administration
• Favorable safety prole alone and in combination
1)
• Studied in >600 patients in 8 oncology indications
and COVID-19
Our lead molecule, bemcentinib, is in Phase II clinical testing
in patients with NSCLC, AML and COVID-19.
As of the end of 2021, bemcentinib had been studied in over
600 patients, demonstrating its safety as a monotherapy and
in combination with chemotherapy and immune checkpoint
inhibition. This large safety database positions us well to
advance the development of bemcentinib towards the market.
Clinical data generated with bemcentinib in multiple Phase I
and Phase II trials to date conrm its potential utility as a
therapy in cancer and for the treatment of COVID-19. Based on
preclinical and early clinical data, we also believe bemcentinib
may have the ability to enhance outcomes when combined
with immunotherapy in NSCLC. Taken together, our initial data
form the basis of BerGenBio’s preparations for the late-stage
clinical strategy for bemcentinib.
Our product candidates
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In late 2021, our Chief Executive Ocer
Martin Olin led the BerGenBio management
team in an extensive strategic analysis of
the potential near-term applications of
our lead molecule, bemcentinib. This
indication-focused process included analysis
of the scientific rationale underlying the
indication, the clinical data obtained to date
and the market opportunity.
The results of this intensive process identied two major
focus areas for the near-term development of our lead
compound bemcentinib, along with key considerations
for their prioritization:
• NSCLC patients with STK11 mutations (STK11m)
– Unique proprietary position in currently underserved,
large biomarker population
– Strong preclinical data supports activity in STK11m
patients and initial clinical signs of efcacy
• Hospitalized COVID-19 patients
– AXL upregulation known to be associated with
severe respiratory infections
– Indications of efcacy in two prior Phase II trials
– Opportunity to participate in established platform
study across the EU
Although the analysis identied additional indications with
signicant promise, BerGenBio will apply this focused strategy
to accelerate the advancement of bemcentinib with NSCLC
and COVID-19 patients.
Strategic Analysis Criteria Potential Bemcentinib Indications
• Clinical results to date
• Clinical trial
recruitment feasibility
• Potential for
accelerated approval
• Competitive intensity
• Unmet needs
• Potential market size
• Reimbursement/pricing
Our development focus
BerGenBio has now
established a focused
development path for its
lead compound bemcentinib
most likely to benefit
• AXL role in disease
• Strength of
pre-clinical validation
Clinical
Feasibility
Scientific
Rationale
Market
Opportunity
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BerGenBio has built a
significant dataset within
oncology and severe
respiratory infections (COVID)
Pipeline Overview
BerGenBio Clinical Pipeline
Candidate Targeted Indication Preclinical Phase I Phase II Registrational
oncology
Bemcentinib AML & MDS
Bemcentinib 2L NSCLC
Tilvestamab
Ovarian Cancer
Phase Ib
Mipasetamab uzoptirine Solid Tumors
Fully out-licensed mAb
viral
Bemcentinib COVID-19
Additionally, bemcentinib is being studied in Investigator Led Trials in glioblastoma, 2L lung cancer, melanoma,
pancreatic cancer and mesothelioma.
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Industry Context
BerGenBio is focused on some
of the world’s most pressing
life-threatening diseases: NSCLC
and severe respiratory
infections (COVID-19)
Oncology Market Dynamics
Oncology – an innovative growing market
Cancer is the second leading cause of death globally and one
of the largest burdens on healthcare systems. GLOBOCAN
2020 estimated 19.3 million new cancer cases and almost
10.0 million cancer deaths occurred in 2020. The top 3 causes
of deaths being lung cancer, colorectal cancer and liver cancer.
The global cancer burden is expected to grow to 28.4 million
cases in 2040, a 47% rise from 2020.
IQVIA estimates that global sales of oncology therapeutics
were $184 billion in 2021 and will grow to $269 billion by the
year 2025. Growth is being driven by the approval of innovative
drugs, notably immuno-oncology therapeutics and the growing
use of cancer therapies in developing countries.
1) American Cancer Society – Cancer Facts & Figures 2021 (also cited as Siegel R. L. et al., Cancer Statistics, CA Cancer J
Clin. 2021, 71, 7–33. https://doi.org/10.3322/caac.21654)
The company is developing compounds for two highly attractive segments of the world-wide pharmaceutical
market: oncology and COVID-19/severe respiratory infections. The below graph of the world’s largest selling
pharmaceutical products in 2020 (latest full year data available) demonstrates the importance of the pharmaceutical
segments in which BerGenBio is developing its product candidates. In addition to the signicant sales of COVID-19
vaccines, sales of Veklury(R) remdesivir, the only anti-viral with full regulatory approval in hospitalized COVID-19
patients, totaled $5.6B in 2020, demonstrating the high need for treatments of severe respiratory illnesses,
such as COVID-19.
COVID-19 vaccine (Pzer/BioNTech)
Humira (AbbVie)
Keytruda (Merck & Co)
COVID-19 vaccine (Moderna)
Eliquis (BMS/Pzer)
Revlimid (BMS)
Stelara (J&J)
Biktarvy (Gilead)
Opdivo (BMS)
Dupixent (Sano/Regeneron) 7.4
0 5 10 15 20 25 30 35
9
9.8
10.15
11.25
11.85
19.55
19.55
20.35
29.05
Drug name (company name)
Projected sales in billion U.S. dollars
Source: Statistica 2022
COVID-19 Oncology
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Industry Context continued
The pace of innovation in the treatment of cancers has been
a signicant driver of improved patient benet. The oncology
treatment landscape has evolved signicantly over the past
decade with the advent of new targeted therapeutics and
immunotherapy. Historic standard of care for cancer included
surgery, chemotherapy and radiotherapy. However, a paradigm
shift in the understanding of cancer has ushered in a new age
of precision medicines that provides benets to both patients
and healthcare systems. In addition, the market launch of cell
therapies, such as CAR-T therapy where a patient’s T-cells are
engineered to attack cancers has begun to transform the
treatment of hematological cancers. However, to date, these
approaches have shown limited activity in solid cancers.
A key driver of improved patient outcomes has been the
advent of immunotherapies such as anti-PD1/PDL1 antibody
treatments. Combining immunotherapies with chemotherapy is
increasingly becoming the best approach to treat the complex
and constantly mutating disease that is cancer. Preclinical and
clinical data indicate that bemcentinib holds the promise of
further improving patient response to currently marketed
immunotherapies alone or in combination with chemotherapy.
Over the past 5 years, 62 innovative oncology therapies have
been launched in the US, the largest single pharmaceutical
market. Collectively these therapies have been approved for
over 130 indications across 24 different tumor types. Although
improvements in the outlook for patients have been signicant,
complete cures are still a goal that is not reached for many
patients due to acquired treatment resistance resulting in
inevitable disease progression.
The regulatory approval of new cancer therapies has
increasingly occurred through expedited reviews or
breakthrough designations – two FDA regulatory procedures
that can shorten the regulatory path to market approval in the
US. Accelerated approvals or EU conditional approvals which
provide market approval based on Phase I or Phase II trials
have also increased, particularly for compounds which employ
rst-in-class mechanisms. Outside of the US, China has rapidly
expanded its approvals of innovative oncology therapies,
launching 37 new products over the past 5 years, up from 6 in
the prior 5 years. Launches in the major EU and UK markets
total 53 in the past 5 years.
Source: IQVIA Oncology Review 2021
The rapid adoption of new
precision medicines and
immunotherapies has
created new opportunities
for BerGenBio
2021–2025 Key Facts
+64% total
spending growth
(9–12% CAGR)
+$105Bn
~+100 new
oncology drugs
0 0%
2011 2016 20212012 2017 20222013 2018 20232014 2019 20242015 2020 2025
300 20%
18%
14%
10%
6%
250
16%
200
12%
150
Spending constant US$Bn
% Spending growth constant US$
8%
100
4%
50
2%
Forecast
Global Oncology Spending and Growth
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Following the advent of precision medicines, the prices of
innovative cancer drugs have steadily risen over the past
decade, starting with novel targeted therapies and now
immunotherapies. The median annual price of new cancer
drugs launched in the US in 2019 was almost $150,000,
compared to less than $80,000 in 2013. Personalized medicine
strategies that use predictive biomarker tests to identify the
patients most likely to respond to treatment can command
broader reimbursement and higher pricing due to improved
treatment efcacy. The chart to the right illustrates the growth
in spending on oncology therapeutics by tumor type driven
primarily by increased use of innovative therapeutics, including
immunotherapies and targeted small molecule products.
Immunotherapy – now the standard of care in many cancers
It is increasingly recognized that cancer is a disease of the
immune system. The ability of cancers to evade or escape the
immune response is recognized to be one of the most important
hallmarks of cancer. The pharmaceutical industry has focused
extensive research efforts over the last decade to identify
immunotherapies that activate and enhance the body’s immune
system to target and kill cancer cells. These therapies have
yielded exceptional results, inducing durable responses in some
previously intractable cancers. Checkpoint inhibitors, in particular
those targeting the PD-1/PD-L1 pathway, have been the most
successful immuno-oncology therapies to date and are expected
to continue to be the backbone of immunotherapy treatment in
the foreseeable future. Therapeutic antibodies inhibiting the
PD-1/PD-L1 pathway have seen broad uptake and are now
approved in more than 20 different cancer indications.
Following the approval of the rst checkpoint inhibitors,
there have been multiple approvals for combinations of
checkpoint inhibitors with targeted therapies and
chemotherapies. Despite their success, there remains a
signicant demand for new innovative treatments and
combinations thereof to address the persisting unmet
medical needs and further advance the current standard of
care to improve patient life span and quality of life. Synergistic
combinations of checkpoint inhibitors with new immuno-
oncology agents or targeted therapies to improve response
and to address acquired treatment resistance represent a
signicant commercial opportunity.
The rapid adoption of new
precision medicines and
immunotherapies has
created new opportunities
for BerGenBio
Industry Context continued
Source: IQVIA
All other 11%
CAGR
-1%
21%
32%
23%
4%
5%
11%
20%
27%
12%
NHL
Kidney cancer
NSCLC
CML
Prostate cancer
CLL
Breast cancer
Melanoma
Multiple myeloma
CRC
2017 2018 2019 2020
$81bn
$93bn
$108bn
$11bn
16%
16%
16%
15%
14%
10%
7%
6%
14%
10%
7%
7%
12%
9%
9%
7%
10%
9%
8%
8%
Oncology Spending by Tumor in US, EU4+UK and Japan 2017–2020
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COVID-19/severe respiratory infections
In late 2021, the COVID-19 pandemic continued to disrupt
lives and cause signicant morbidity and mortality. As of
mid-December 2021, the COVID-19 pandemic had killed over
5.3 million people worldwide. The virus had spread to 199
countries/territories, with more than 274 million conrmed
cases. The highest ofcial case counts as of December 2021
occurred in the US, India, Brazil, UK, Russia, Turkey, France,
Germany, Iran, and Spain. The US alone accounted for
more than 50 million conrmed COVID-19 cases and over
806,000 deaths.
Although highly efcacious vaccines are available, there is
signicant room for improvement in treatments for COVID-19.
The standard of care today for hospitalized patients consists of
corticosteroids, antibody treatments and the anti-viral remdesivir.
In spite of the availability of treatments, deaths continue to occur
particularly in hospitalized patients who are unvaccinated, are
immuno-compromised or have other pre-existing conditions.
At the end of 2021, the emergence of the omicron variant of
COVID-19 rapidly spread throughout the world. In spite of the
seemingly relatively milder nature of the variant, hospitalizations
increased particularly for unvaccinated patients. In addition,
the number of break-through infections in the fully vaccinated
population has increased with the advent of the omicron variant.
Data also suggest that some currently used antibody treatments in
hospitalized patients may not be fully effective against the omicron
variant. Effective COVID-19 treatments for hospitalized patients
that are agnostic to variants remain a high unmet medical need.
In late 2021, two anti-viral oral therapies were conditionally
approved in the US for at-home use for recently diagnosed
COVID-19. These therapies have shown the ability to
signicantly reduce the need for hospitalization and to reduce
deaths. The company believes; however, that the limited
availability of these drugs, coupled with the need for the
availability of rapid testing, and the need to initiate therapy
within ve days of symptom onset will not eliminate the need
for new COVID-19 treatments for hospitalized patients.
Importantly, BerGenBio believes that its product candidate
bemcentinib, due to its mechanism of action, could have
activity against all current and future variants of COVID-19. In
addition, preclinical data and analysis of efcacy in COVID-19
patients leads us to believe there is the opportunity to study
bemcentinib in other severe respiratory infections including,
but not limited to acute lung injury secondary to infection.
Source: University of Oxford January 26, 2022
Source: BerGenBio
1) Available under Emergency Use Authorizations
Industry Context continued
Dynamics Point to Continued Need for New Therapies
Vaccines At-home Treatments Hospital Treatments
Approved
Products
mRNA vaccines
Traditional vaccines
Paxlovid
Molnupiravir
Corticosteroids
Antibody therapy
1)
Remdesivir
Baricitinib
1)
Current
Situation
As of early 2022, only 60.8% of adults
W/W have had ≤1 vaccine dose
Vaccine resistance continues
Shown to reduce hospitalizations
by 50–90%
1)
Death rate still ~10%
Current therapies have modest
activity, variant coverage
Impact on
Hospitalization Rate
Breakthrough infections, vaccine
adversity continue to drive
hospitalizations
Limited: only for vulnerable pts, need to
dose w/in 5 days; requires rapid testing
Signicant # of hospitalizations
expected to continue; level dependent
on variant, seasonality
COVID-19 will continue to be a
key threat to health for the
foreseeable future
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The Opportunity
Lung cancer is the 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 approximately 85% of patients.
NSCLC generally presents late and patients are frequently
diagnosed with 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). The activation of
AXL is a recognized negative prognostic factor and has been
shown to be an important resistance mechanism in NSCLC.
Over the last decade the NSCLC treatment paradigm has
evolved signicantly with the approval of targeted therapies and
immunotherapies. It is now routine to screen NSCLC patients
presenting with advanced disease for the presence of driver
mutations to determine the optimal treatment approach.
Mutations that can be specically addressed with targeted
therapies today include EGFR and ALK mutations.
These targeted therapies, including the products Tagrisso
®
(Astra Zeneca) and Xalkori
®
(Pzer) achieved estimated sales
of more than 5billion USD in 2021.
A driver mutation of the STK11 gene has been identied as being
associated with NSCLC patients with poor treatment outcome;
however, to date there are no targeted therapies available for this
large patient population. STK11 mutations (STK11m) occur in up
to 20% of NSCLC patients. Data suggest that use of standard of
care immune checkpoint inhibitors such as anti-PD1/PDL1 and
anti-CTLA-4 therapies, are signicantly less effective in treating
STK11m patients. BerGenBio is focusing on improving the
therapeutic outcome for this underserved biomarker population.
In late 2022, BerGenBio received a US FDA Fast Track designation
for bemcentinib in NSCLCpatients harboring a STK11 mutation.
Common NSCLC Mutations
The chart above illustrates the high frequency of STK11
mutations in NSCLC.
In late 2021 at the Society for Immunotherapy of Cancer
(SITC) annual meeting, BerGenBio and its collaborators at
the University of Southwest Texas Medical Center reported
preclinical data illustrating the mechanism of action of poor
response to checkpoint inhibition in STK11 mutated patients.
20% STK11
18% KRAS
Other
11% KRAS
G12C
19% EGFR
3% HER2
3% MET
5% BRAF
3% ALK
18% Other
Source: World J Clin Oncol. 2021 Apr 24; 12(4): 217–237
BGB’s Clinical Strategy in NSCLC
BerGenBio plans to initiate a Phase 1B study in 2022 to study
the safety of bemcentinib in combination with an anti-PD1
antibody and chemotherapy. This study is expected to be
the rst step in developing bemcentinib for the treatment of
STK11m patients in 1L lung cancer. 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 recognised and targeted by the
immune system, while reducing its immunosuppressive effects.
The potentiating effects of bemcentinib to enhance efcacy
and address PD-1 treatment resistance are supported by
encouraging data from the ongoing Phase II study (BGB008)
of bemcentinib in combination with Keytruda. In late 2021,
the US FDA awarded a Fast Track designation for the use of
bemcentinib in STK11m NSCLC patients.
The company has previously studied the safety of bemcentinib
with an anti-PD1 antibody (Keytruda
®
). The planned Phase Ib
study will be the rst time bemcentinib has been studied in
combination with both an anti-PD1 and chemotherapy.
Following the completion of this study, BerGenBio expects
to move into larger controlled, randomized studies in this
patient population.
The BerGenBio study of bemcentinib in 2L NSCLC (BGB008)
has been fully recruited and the study is on-going. We continue
to evaluate our data to determine if treatment of a broad
population of 2L NSCLC patients or 2L NSCLC patients with
STK11 mutations warrant additional study.
Indication Highlight – NSCLC
Unique opportunity to
establish a new biomarker
driven NSCLC market
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Severe respiratory infections:
COVID-19 and beyond
The Opportunity
2021 saw the rapid evolution of the COVID-19 pandemic
and efforts to control its spread and associated morbidity
and mortality. In spite of the availability of effective vaccines,
much of the world remains unvaccinated and the need for
new treatments for hospitalized patients persists. Much like
the u (inuenza virus), COVID-19 could become endemic
with seasonal spikes in infection rates requiring long-term
intervention strategies.
In the near-to-mid term there is likely to be signicant
demand for multiple effective treatment options for COVID-19.
The standard of care is being constantly revised as our
understanding of the SARS-CoV-2 virus and the COVID-19
disease increases. Building an arsenal of multiple treatments
that work through different mechanisms of action is important
as COVID-19 is a multifaceted illness that affects individuals in
different ways. There remains an urgent need for treatments
across the entire treatment spectrum.
Bemcentinib has been shown to have a unique dual mechanism
of action to combat severe respiratory infections. In SARS-
CoV-2 viral infections, preclinical studies indicate that AXL
plays a key role via two mechanisms. AXL is used by the virus
to gain entry into cells, facilitating viral replication and spread.
It is also involved in suppressing Type 1 Interferon, a key anti-
viral defense mechanism of the immune system. Bemcentinib
has been shown to suppress both of these AXL mechanisms,
potentially reducing the severity of disease.
Clinical Strategy in COVID/Severe Respiratory Infections
The Company believes that the most rapid route to
investigating the role of bemcentinib in severe respiratory
infections is through collaboration with government sponsored
trials to identify new COVID therapies. In January 2022, the
Company announced a collaboration with the Oslo University
Hospital under which bemcentinib will be studied in the EU-
funded EU-SolidAct trial in hospitalized COVID-19 patients.
The EU-SolidAct trial – European DisCoVeRy for Solidarity:
An Adaptive Pandemic and Emerging Infection Platform Trial
– is part of EU-RESPONSE, a pan-European research project
involved with the rapid and coordinated investigation of
medications to treat COVID-19. Under the trial, bemcentinib
will be studied in up to 500 hospitalized COVID-19 patients.
In support of the trial, BerGenBio will provide bemcentinib
drug material and incremental funding of costs related to
the bemcentinib sub-protocol.
The Company expects that patient treatment with bemcentinib
under the EU-SolidAct protocol will start in the rst half of 2022.
Bemcentinib was selected for inclusion in the EU-SolidAct
protocol following the completion of two Phase II trials
exploring bemcentinib efcacy in combination with current
standard of care treatments in hospitalized patients. The trials
were part of the UK’s ACCORD-2 study that was funded
primarily by the Department of Health and Social Care (DHSC),
and a company sponsored study in South Africa and India.
Based on the role AXL plays in other severe respiratory
infections, BerGenBio believes that bemcentinib may hold
promise as a treatment for other severe respiratory conditions
such as acute lung injury secondary to infection. We will
continue to evaluate these potential applications
in preclinical models in collaboration with academics
specializing in these areas.
Indication Highlight – Covid-19
The evolving COVID-19
pandemic provides a unique
opportunity to evaluate
bemcentinib as a treatment
for severe respiratory
infections
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The Opportunity
AML is the most common type of acute leukemia in adults. It is
characterized by a rapid proliferation of immature white cells in
the bone marrow. This results in accumulation of leukemic cells
and subsequent interference with normal blood cell production,
leading to complications including anemia, infections and
bleeding. AML is diagnosed in over 20,000 patients in the
US annually and is rapidly lethal if left untreated. Successful
treatment typically requires intensive chemotherapy with or
without bone marrow transplantation; however, relapse and
resistance are common. Consequently, there is an urgent need
for effective therapies in patients who are relapsed/refractory
after initial therapy, particularly those who are ineligible for
intensive therapy or bone marrow transplant due to age or
co-morbidities.
The median age of AML diagnosis is 65 and ~70% of patients
are deemed unable to tolerate intensive chemotherapy.
In 2019, AbbVie/Roche’s BCL-2 inhibitor Venclexta
®
was
approved in combination with hypomethylating agents (HMA)
or low dose cytarabine (LDAC) in newly diagnosed patients
who cannot tolerate intensive chemotherapy. Venclexta has
now become the standard of care for these frail patients.
Unfortunately almost all of these patients will relapse following
even a successful response to this rst line therapy providing
an increasingly large pool of second line unt AML patients.
Relapsed AML patients have limited treatment options today.
There is no standard of care for relapsed patients resulting in
many patients preferring to enter into a clinical trial given the
poor outcome provided by currently available treatments. Thus,
an effective therapy for relapsed AML patients ineligible for
intensive therapy has the potential to capture a signicant share
of patient use. AXL overexpression has been widely established
as a negative prognostic factor in AML and early clinical data of
AXL inhibition with bemcentinib has shown promising anti-
leukemic activity and immune activation.
BGB’s Clinical Strategy in AML
BerGenBio is exploring the utility of its AXL inhibitor
bemcentinib as a monotherapy and in combination with
chemotherapy in AML in the multicohort Phase II study
BGBC003. The combination of bemcentinib with LDAC has
shown promising results in relapsed AML patients, that if
conrmed could lead to a shift in the treatment paradigm.
In recognition of the unmet needs for this patient population,
the US FDA has granted bemcentinib Orphan Drug
Designation as well as Fast Track designation in AML.
Following full availability of the dataset in relapsed AML
patients from our Phase II study and regulatory interactions,
BerGenBio will determine its clinical strategy in this
patient population.
Indication Highlight – AML
AML: An Aggressive
Disease With a Poor
Clinical Outcome
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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.
Introduction
For us to reach our ESG-related ambitions, we consider good
governance to be of the utmost importance. While we took
signicant steps in 2020, we raised ESG even higher on our
agenda in 2021. We use the term ESG to describe our
commitments as a responsible corporate citizen, and we fully
support the United Nations’ Sustainable Development Goals
(SDGs) and Agenda 2030.
While we have gathered the central ESG-related information
in this section of the report, we also refer to other parts of the
report where the issues in question are explained and
presented in more detail. Governance related topics are
presented rst 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.
ESG at BerGenBio
We started the journey to strengthen our sustainability
management in 2020, and through 2021 these efforts have
been continued and broadened, as we show in this report.
Our prioritization of ESG is also reected in our strategy and
our values.
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.
In the rst phase of developing BerGenBio’s sustainability
strategy, we identied a set of ESG topics related to our activities
and our value chain that are material for us and our stakeholders.
In the next phase we have proceeded to develop our ESG
ambitions and KPIs and we have aligned these with our strategy.
Going forward we will further integrate the material ESG topics
into our strategy and governance, including setting strategic
ESG targets and incorporating additional metrics. We have now
established a foundation which will grow with us to ensure our
sustainable value-creation as our Company further develops.
Progress and status on actions and initiatives mentioned in our
2020 report:
• Implementation of our updated Code of Conduct has been
delayed. We aim to have the updated Code of Conduct
implemented in 2022.
• In 2021 we completed implementation of a supplier self-
assessment questionnaire based on the pharmaceutical
sector standard (Pharmaceutical Supply Chain Initiative, PSCI)
in our supplier management system. This questionnaire will
be used as part of the selection process for new vendors as
well as mapping of existing vendors.
A whistleblower policy with independent third party reporting
channel will be implemented in 1H 2022 This provides a
condential and transparent way for staff to communicate any
behavior that may involve wrongdoing, give rise to illegal
activity or contravene BerGenBio’s governance standards,
and cases can more easily be escalated to the right attention
level within BerGenBio.
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 goal for BerGenBio is consequently
to innovate (SDG 9) to enable SDG 3 – healthy lives and
promote wellbeing for all at all ages. While this is our end
goal, we are working systematically at contributing to this goal
by 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 manage to be a role model for responsible
production (SDG 12) – an actor working in partnerships with
others (SDG 12 and SDG 17) in order to promote innovation
(SDG 9), economic growth and decent work (SDG 8).
Environmental, Social and Governance
Key goals for BerGenBio
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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-specic 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 pharmaceutical 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 also
ensure that our drugs will be available for all, and we adhere
to international agreements.
The safety and wellbeing 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 the production
and commercialization phase of our Company development.
We embed drug-safety considerations throughout the drug
development lifecycle. Our research from the 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 efcacy, 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 proles 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. It is
also of paramount importance to us to ensure the personal
information of our patients and no claims of any data breaches
were received in 2021.
SDG 8, 12 and 17
While BerGenBio is a clinical trial stage company with only
marginal production 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
dialogue and contracts with our partners and suppliers. You
can read more about our efforts related to responsible sourcing
under the Responsible Sourcing heading of this ESG report,
and we are also initiating actions to be ready for the Norwegian
Transparency Act that comes into effect in 2022. 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.
Environmental, Social and Governance continued
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 sound 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 nancial statements.
BerGenBio intends to develop its drug candidates itself and
through strategic partnerships in multiple indications, and
retains all strategic options for the future commercialization
of its products. While the research and development strategy
is designed in-house, the Company leverages its network
of external contract research organizations (CROs) to execute
its 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.
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Material topics
To ensure that our commitment towards sustainability results
in activities that positively impact our key sustainability targets,
we have performed a materiality analysis. 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, our employees, investors, regulators,
suppliers, and other business partners such as research
organizations and academic institutions.
This resulted in a mapping of the ESG topics that are deemed
as important for our long-term sustained value creation.
The matrix to the right provides an overview of these topics,
arranged according to the signicance of their ESG impacts,
and the topics’ inuence 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 83 for ease of location.
Communicate decisions
and monitor development
Monitor and communicate
Protection of human
and labor rights
Inuence on stakeholder assessments & decisions
Signicance of environmental, social & governance impacts
Legend
Environment Social Governance
Clinical trial
conduct
Patient health
and safety
Economic
Innovation
Business ethics
performance
Occupational health and safety
Climate and Environmental
management
Wellbeing of employees
Board governance
Talent attraction and retention
Responsible sourcing
Strategic, active communication,
clear governance and follow-up
Active governance and communication
Environmental, Social and Governance continued
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Governance
Business ethics
To ensure that patients, research and development partners,
employees, shareholders and other stakeholders feel condent
about our commitment to operate in accordance with responsible,
ethical and sound corporate and business principles, BerGenBio
has established a set of ethical guidelines that are presented in
its policy for corporate social responsibility (CSR policy). These
guidelines provide a framework for what BerGenBio considers
responsible conduct, and denes the individual responsibilities
of all employees and Board members through a combination of
broad principles and specic requirements. The CSR policy is
available on BerGenBio’s website.
Our CSR policy will be strengthened to include additional
topics such as conicts of interest, marketing practices and
fair competition, data privacy and integrity, supplier conduct
and a patient rst approach. The policy will also augmented
to become our Code of Conduct to reect our commitment
to sustainability. Our aim is to have the Code of Conduct
approved by management and the Board of Directors and
implemented in 2022. The Code of Conduct will then be
distributed to all employees, managers and Board members
and shall also be referred to in all employment contracts.
BerGenBio takes a zero-tolerance stance towards corruption,
money laundering and insider trading. All employees are
encouraged to report any breaches of BerGenBio regulations.
No incidents were reported in 2021.
Board governance
For BerGenBio it is important that the Board reects the
diversity of their company’s stakeholders to be more 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 ve
non-executive members of which two are women. Four of the
members are independent. The members of the Board reect
different nationalities and a breadth of competencies, including
health, medicine, pharmacy, research, nance and ESG.
Further information is provided in Section 8: Board of Directors
and Independence, which can be found in 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 2021, we had no critical
inspection ndings from any of our 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 and other registries in
accordance with international legislation. We also support
academia by sharing clinical data upon request pursuant to
relevant regulations and protocols.
Patient health and safety
As discussed in relation to SDG 3, the safety and wellbeing 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 the production and commercialization phase of our
Company development. We embed drug-safety considerations
throughout the drug development lifecycle. Our research from
the pre-clinical studies are 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 proles 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. It is also of paramount importance to us to ensure the
personal information of our patients, and no claims of any
breaches were received in 2021.
Environmental, Social and Governance continued
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Responsible sourcing
We rely on third parties for clinical studies (Contract Research
Organizations), supply of raw materials, ofce supplies and
housekeeping services. We currently have 10 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.
Following the ESG analysis, we strengthened our responsible
supply-chain management. This involved development of a
supplier self-assessment questionnaire. The questionnaire
is based on a recognized pharmaceutical sector standard
(Pharmaceutical Supply Chain Initiative, PSCI) and has been
implemented into our existing supplier management system.
In 2022 we will establish routines for meeting the new
Transparency Act, which entails routines for due diligence with
a focus on risks of human rights violations in our value chain.
This is also discussed in the next section.
Our Chief Operating Ofcer is responsible for procurement
and supply chain management-linked activities and oversees
effective implementation of management systems. Our vendor
selection and management process evaluate vendors on ESG
criteria. Under the process we conduct an analysis to determine
our critical suppliers based on risks and opportunities linked
with each vendor. Going forward, we will administer the self-
assessment questionnaire to existing prioritized vendors and to
potential new vendors, as part of the vendor selection process.
The vendor self-assessment process will enable us to appraise
our partners based on their adherence to regulatory norms as
well as social and environmental standards. It will also provide
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 will guide us in engaging with them to
strengthen their performance on identied 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 new Code of Conduct that will be implemented in 2022.
Whilst 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 2021.
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 scientic 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.
BerGenBio have made substantial research & development
(R&D) investments to strengthen our pipeline and identify
new therapeutic opportunities. While our research laboratories
provide us with the requisite tools and infrastructure, our
greatest R&D assets are our scientists and collaborators,
and the scientic know-how they represent. We have 4 peer-
reviewed publications and 15 presentations that stand as
testament to our organizational knowledge-base.
Over the years, we have strategically expanded our capabilities
and our sphere of impact by engaging in partnerships with
industry leaders. This has made it possible for us to accelerate
our innovation-linked pursuits. We have partnered with leading
academic institutions, pharmaceutical companies and clinical
research organizations for advancement of our R&D efforts.
You can see a list of our key partnerships under the Our unique
position heading of the Strategic Report.
Environmental, Social and Governance continued
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Social
Our approach to social sustainability is reected 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 creates value
for patients, society, and shareholders. Therefore, sustainability
is a foundation of our activities and 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. Following
the results of our materiality analysis, we especially focus on
activities that affects the topics: diversity and inclusion, pay
equality and wage level, talent attraction and retention, skills
for the future, wellbeing 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 46 people, of which 63% are women. Three out
of eight executives in the management team are women whilst
two out of the six members of our Board of Directors are
women. Our team represents 11 nationalities, and their
different backgrounds enhance our ability to innovate and
strengthen our work environment. Our team of highly-educated
employee, includes 19 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.
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 (ref. 2021 report) 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. To comply with new requirements
effective from 1 October 2021, our Remuneration Policy is
presented as a separate document, following this link.
The policy is not materially changed but updated to reect
the upcoming formal requirements as they materialize.
Environmental, Social and Governance continued
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Talent araction and retention
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 skillsets, among other considerations.
In 2021 we welcomed 16 new colleagues to our team, of which
59% were women. In addition, we have two PhD students
employed. All employees receive regular performance and
development evaluation.
Skills for the future
Growing our employees and ensuring they are developing
themselves, and providing the right skills to support BerGenBio
is an important part of the annual development process for
employees. During the year our employees have attended
conferences which have mainly been online as COVID-19
restrictions prevented these from taking place in person.
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.
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).
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
reect on their progress and set professional goals. The
appraisal process also helps in aligning 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.
Wellbeing of employees
Employee wellbeing is important to boost workplace
satisfaction and productivity levels. To ensure the wellbeing
of our employees, we consider it important to focus on job
satisfaction, nancial security, a healthy work environment and
overall engagement in organizational activities. The global
pandemic during 2021 required continued changes in working
arrangements with working from home and sustained focus
on wellbeing of employees. The global pandemic meant that
most staff transitioned to working from home. We supported
our employees with sessions focusing on wellbeing during
lockdown and providing skills development to enable effective
working from virtual ofces. We continued the series of regular
monthly virtual social sessions, which commenced in 2020
which included quizzes, team coffee mornings and a very
popular photography competition. 2021 also saw us mark
Mental Health Awareness Month with a series of activities as
well as marking Blood Cancer Awareness Month with a team
awareness session and charity fundraising.
We periodically capture our workforce’s sentiment and
feedback through employee engagement surveys. In the
employee engagement survey conducted in 2021, we had
a 75% response rate with an engagement score of 80%. The
feedback that we receive from our employees helps us update
our policies and design interventions to enhance employee
engagement and satisfaction. We provide competitive
compensation for all our employees which is commensurate
with their level of experience, qualication and expertise.
We had a sick-leave of 1.4% in 2021 compared to 2.0% in 2020.
All employees can take advantage of our exible 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 wellbeing of our employees
and provide them assistance to cope with identied ailments.
2020 saw the introduction of two dedicated mental health
rst-aiders to support wellbeing and all staff have access to
private medical care. In response to the global pandemic we
continually assessed risks to ensure a safe return to work and
continued our workstation assessments to ensure our
employees have safe work spaces and the right equipment
to work virtually.
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. Our laboratory safety
management systems conform to the requirements of ISO
15190:2003 and OSHA 3404 laboratory safety guidelines.
A systematic protocol is in place to record and investigate any
untoward incidents. In 2021, no occupational safety-linked
incident occurred at any of our facilities.
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Environment
BerGenBio has a relatively low environmental impact at the
current stage of the Company. Nevertheless, we take our
impact seriously and have taken measures to start measuring
our impact in order to properly manage environmental risks
as we grow.
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 large-scale
manufacturing activities, our environmental footprint stems
primarily from the resources consumed in our laboratories and
ofce spaces. In addition, we also account for the footprint
arising out of our indirect business activities such as employee
travel and supply-chain operations. We are conscious of the
impact of waste that we generate, specically bio-hazardous
waste. We are also cognizant of the impact of pharmaceuticals
in 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.
In 2021 we started mapping our GHG-emissions to develop
baselines for setting emission targets. We consider this a rst
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
Protcol’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 2021 were 17,54 tonnes CO
2
e. The
results of our initial mapping of direct and indirect emissions
conrm that business travel is where we have our largest
impact, representing 66% of our total emissions. Travel
activities have been heavily reduced the past two years due to
the COVID-19 pandemic. In order to secure the development
of our projects, some level of travel between our Norway and
UK ofces is necessary. We will, in general continue to conduct
digital meetings when possible, to limit travel.
Source tCO
2
e
Share of
emissions
Scope 2
Total electricity and heat 5,89 34%
Scope 3
Total ights 11,65 66%
Total 17,54 100%
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 ofces and laboratories in Norway and the
UK, use of electricity and district heating represent 34% of our
total emissions.
Environmental, Social and Governance continued
We acknowledge that a large part of the emissions within our
business are found in Scope 3. In 2022, we will initiate actions
for identifying the most relevant sources to further develop
our carbon account. A rst step in this work will be to initiate
conversations with our suppliers in order to collect data on
our indirect emissions generated by our impact on activities
represented by our partners’ operations.
ESG actions for 2022
In 2022, we will take further steps to strengthen our work on
ESG. We have initiated a strategy process in which we will fully
integrate sustainability into our business strategy and will
develop a sustainability roadmap and action plan. We will also
establish a waste minimization plan to identify opportunities to
reduce waste from our operations that will take into account
where in our value chain we generate waste, types of waste
and how waste is handled. In addition, we will start a project to
align our business with the Norwegian Transparency Act that
will enter into force in June 2022 as well as initiate alignment
with the recommendations of the Task Force on Climate-related
Financial Disclosures (TCFD).
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STRATEGIC REPORT
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Governance
Report
Contents
26 Board of Directors
27 Management Team
29 Remuneration Report
42 Corporate Governance Report
49 Board of Directors’ Report
25
Annual Report & Accounts 2021
BerGenBio Board of Directors
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 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).
SVEINUNG HOLE
Non-Executive Director
Sveinung Hole is the CEO of Trond
Mohn Foundation and Stiftelsen
Kristian Gerhard Jebsen. Hole
holds a number of Board positions
amongst others at Tromsø Research
Foundation, Sarsia investment funds,
SKGJ PE Invest, ICON Capital VII, PE
Helse AS and Prophylix Pharma AS.
He also headed the Health & Care21
Strategy Council appointed by the
Norwegian Minister of Health
(2019–2021). Formerly he was the
CEO of Sarsia Seed AS, Board
Member of Norwegian Venture
Capital Association and Bergen
Hospital Trust (Helse Bergen). Hole
has also held various top management
positions in the Nordic and US. Hole
holds a Master of International
Management from BI Norwegian
Business School.
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
served until recently as the Chief
Medical and Development Ofcer at
Polyphor Ltd. 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. She is a UK-Swiss citizen.
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 nancial
sector within the life science and
biopharmaceutical space. She has
spent the last 15 years at Healthcor,
a US based global healthcare and life
science investment manager, where
she is currently a senior member of
the private investment team. Prior
to Healthcor she spent a decade in
senior analyst roles at ING Financial
Markets and latterly Piper Jaffray. She
is a member of the Advisory Board of
the P4 Precision Medicine Accelerator
Programme in the UK and has served
on the Council of Governors at UCLH,
an NHS Foundation Trust Hospital.
She is a member of the Institute of
Directors (IoD) and has been awarded
the CertIoD qualication. Dr Bennett
received a BSc in Anatomical Sciences
and a Medical Degree, awarded with
Honours, both from the University of
Manchester. She is a UK citizen.
DR FRANÇOIS THOMAS
Independent Non-Executive Director
François Thomas has more than 25
years of experience in the life sciences
sector and is currently a Venture
Partner at Somac, responsible for
management of the Inserm Transfert
Initiative portfolio. Prior to this he was
the CEO of Cytheris, a private biotech
company, and has held management
positions at Ipsen (VP Clinical
Development), Genset (VP Licensing
and Pharmacogenomics), led the
healthcare corporate nance at Bryan
Garnier and was a Venture Partner at
Atlas Ventures. He has been on the
Board of Directors of more than 20
biotech companies in the EU and
North America, and has been involved
in the development of multiple
HemOnc drugs during his professional
career. Dr Thomas is a French-certied
medical oncologist, a former
assistant professor at the Gustave
Roussy Institute, and received an
MSc in cancer biology and an MBA
in management from Paris University
and MIT (Boston), respectively. He is
a French citizen.
Mr Tullgren joined the Board of
Directors on 6 January 2022 as
Chairman. He is a Swedish citizen
and resides in Portugal.
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
aended 17 Board meetings in 2021.
Dr Barker joined the Board
of Directors on 13 March 2019.
She is a UK citizen and resides
in Switzerland. She aended
18 Board meetings in 2021.
Dr Benne joined the Board of
Directors on 9 December 2020.
She is a UK citizen and resides
in the UK. She aended 18 Board
meetings in 2021.
Mr Thomas joined the Board of
Directors on 9 December 2020.
He is a French citizen and resides
in France. He aended 17 Board
meetings in 2021.
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Management Team
MARTIN OLIN
Chief Executive Ocer
Martin Olin joined BerGenBio as Chief
Executive Ofcer in September 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.
NIGEL MCCRACKEN MSC, PHD
Chief Scientific Ocer
Dr Nigel McCracken joined
BerGenBio as Chief Scientic Ofcer
in 2021. He has more than 25 years
of experience across Pharma, Biotech
and CRO companies, most recently
as the Chief Operating Ofcer,
concurrently holding the position
as Senior VP Discovery and Early
Development, at NuCana plc.
Prior to this he was an Executive
Board Member and Vice President of
Translational Medicine at Debiopharm
International. Dr McCracken has
worked in senior roles in the US and
Europe, covering both preclinical
and clinical development within a
number of therapeutic areas such
as cardiovascular, respiratory, rare
disease, oncology, anti-infectives,
metabolic disease, neuroscience,
haematology and GI with both small
and large molecules. He has broad
experience recognizing and
evaluating high-quality science
and also has a deep business and
regulatory understanding and has
spent the last eight years working
primarily in oncology with a focus on
developing drug candidates in the
area of targeted therapy and targeted
delivery. Dr McCracken has a BSc in
Biochemistry and Pharmacology
as well as a PhD in Biochemical
Toxicology and an MSc in
Clinical Pharmacology.
RUNE SKEIE
Chief Financial Ocer
Rune Skeie joined BerGenBio as Chief
Financial Ofcer in 2018. He has over
20 years of nancial 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
Authorised Public Accountant.
JAMES BARNES PHD
Chief Operating Ocer
Dr James Barnes joined BerGenBio in
March 2019 as Director of Regulatory
Affairs and Programme Management.
He has more than 15 years’
experience in the elds of regulatory
strategy, regulatory policy and project
management across a wide range of
therapeutic areas, including oncology.
His early and late-stage development
experience, recently focused on
innovative breakthrough products for
rare diseases, has been gained from
both pharmaceutical and consultancy
roles. He has a Cellular & Molecular
Biology PhD from the University of
Bristol in the eld of colorectal cancer
and held a Postdoctoral Research
position in Human Embryonic Stem
Cells at the University of Shefeld.
GAYLE MILLS
Chief Business Ocer
Gayle Mills joined BerGenBio as Chief
Business Ofcer in November 2021.
Ms Mills has held a variety of positions
at senior levels in both major
pharmaceutical and biotechnology
rms. Her most recent position was as
Chief Business Ofcer 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 signicant
partnerships with several major
pharmaceutical rms, she has been
actively involved in the negotiation
and execution of the acquisitions of
Symphogen A/S, ROXRO Pharma and
Abgenix, Inc.
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Management Team continued
GWYN THOMAS MD, BCH
Interim Head of Clinical Development
Dr E. Gwyn Thomas joined BerGenBio
in June 2021 as Interim Head of
Clinical Development. Dr Thomas is
a physician specializing in medical
oncology and clinical pharmacology
and has over 25 years of experience
in pharmaceutical medicine, drug
development and medical affairs.
Having trained at the Royal Marsden
Hospital, London and the Christie
Hospital, Manchester, Dr Thomas has
held senior leadership roles at Wyeth
Research, Genzyme Europe, Ibsen,
Blue Earth Diagnostics and
Mundipharma Research. During his
career, Dr Thomas has successfully
managed a number of New Drug
Applications in the US, Japan and
Singapore, as well as Marketing
Authorisation Applications for new
drug candidates in Europe.
DEBBIE MOLYNEUX
Chief People Ocer
Debbie Molyneux joined the
Company in 2019 as Consultant for
Human Resources. She has 20 years
experience of HR in multi-national
organizations and SMEs in a variety of
industry sectors, including medical
devices. Debbie has experience of
leading multi-national HR teams
with strategic leadership and her
consultancy has seen her support
businesses undergoing change,
advising management teams and
providing a wide range of HR services
including organization design and
learning and development. Debbie
is a graduate of the University of
Birmingham, a member of the Russell
Group of Universities, holds a post-
graduate qualication in Human
Resource Management from Oxford
Brookes University, and is a Chartered
Member of the CIPD (Chartered
Institute of Personnel and
Development).
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Remuneration Report
Our remuneration policy has
not materially changed but is
updated and reflecting the
formal requirements, like the
Shareholder Rights Directive
(SRD II), as they materialize.
1. Chairman’s leer
We are pleased to share the 2021 BerGenBio Remuneration
Report. With this report, we are providing greater insight and
transparency into the remuneration outcomes for 2021 and our
Executive remuneration practices. In 2021, the Remuneration
Committee engaged external assistance to ensure our policies
are compliant and that the application serves our business
needs. Our remuneration policy has not materially changed but
is updated and reecting the formal requirements, like the
Shareholder Rights Directive (SRD II), as they materialize.
I joined as Chair of the Board of Directors and Remuneration
Committee in January 2022 replacing Sveinung Hole who
remains as Board member, member of the Remuneration
Committee and the Audit Committee.
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 scientic rationale,
pre-clinical and clinical data confers to a clear rationale
for advancing our two highly selective AXL inhibitors,
bemcentinib and tilvestamab, towards potential treatment
modalities addressing unmet medical needs. The COVID-19
pandemic has affected BerGenBio along with many other
companies across this sector. However, for BerGenBio the
pandemic also presented a unique business opportunity
related to bemcentinib’s potential role in treating hospitalized
COVID-19 patients.
In August 2021 BerGenBio announced the change of our CEO.
Our former CEO Richard Godfrey stepped down with
immediate effect to pursue other business interests. In
September 2021 Martin Olin joined as our new CEO. Martin
brings more than 20 years of executive experience in the
pharmaceutical and biotechnology industry to BerGenBio.
We are condent that BerGenBio under Martin’s leadership is
well-positioned to bring our two drug candidates to patients
in great need for more effective treatment modalities.
After careful consideration, the Board of Directors has applied
its remuneration practices cautiously, but be able 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.
Anders Tullgren
Chairman of the Remuneration Committee
7 April 2022
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Annual Report & Accounts 2021
29
2. Introduction
2.1 Remuneration policy and objectives
The remuneration principles for the Board and Executive
Management are governed by our Remuneration Policy, which
has been 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; and
• 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”), inclusive of remuneration
received from the subsidiary BerGenBio Limited, and of the
Executive Management of BerGenBio in 2021.
The disclosures are primarily derived from the audited nancial
statements, which are available at www.bergenbio.com. 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 and Remuneration Commiees
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.
The Nomination Committee of BerGenBio ASA consist of three
members: Hans Peter Bøhn (Chairman), Ann-Tove Kongsnes
and Shantrez Miller Gillebo. The Nomination Committee shall
recommend candidates for the election of member and
Chairman to the Board of Directors; and remuneration for the
Board of Directors. 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.
In 2021, the Remuneration Committee held seven meetings
and consisted of three members: Sveinung Hole (Chairman),
Debra Barker and Sally Bennett. As of 6 January 2022 the
composition is: Anders Tullgren (Chairman), Sveinung Hole and
Debra Barker. The objective 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 benets strategy, review the
performance and prepare matters relating to other material
employment issues in respect of the Executive Management.
The Remuneration Committee reviews the approach to
remuneration based on the following principles:
Principle 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 nancial and non-nancial 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 exible 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 eld,
BerGenBio’s strategy hinges upon actionable strategic priorities. Each of these strategic priorities consists of several themes where
BerGenBio has dened specic nancial and non-nancial goals and related actions to execute over time.
Remuneration Report continued
Annual Report & Accounts 2021
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3. Overall Company financial performance in 2021
In 2021 BerGenBio continued with its clinical trials of
bemcentinib in immune evasive and therapy resistant cancers;
NSCLC and AML, and as a potential treatment for severe
respiratory infections, initially for hospitalized COVID-19 patients.
BerGenBio’s EBIT reached a loss of NOK 314 million in 2021
against a loss of NOK 261 million in 2020. Revenue stood at
NOK 0.8 million (2020: NOK 0.6 million). Revenue in 2021
and 2020 is refund of patent-cost from a license agreement
with ADCT.
4. Remuneration of the Board of Directors
The Nomination Committee, as dened 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 xed annual fee. The Chairman or Board members
who participate in the Audit Committee, Remuneration
Committee or Clinical Committee receive separate
compensation for this. Individual Board members may be
required to take on specic ad hoc tasks outside their normal
duties assigned by the Board of Directors. In each such case, the
Board of Directors shall determine a xed fee (e.g. per diem) for
the work carried out related to those tasks. The xed and total
fees will be disclosed in the annual Remuneration Report.
As relevant, Board members not domiciled in Norway are also entitled to compensation for travelling time to and from
Board meetings.
Additional fees or benets may be provided to reect, for example, accommodation, ofce, 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 2021
Table 4.1 Remuneration of individual members of the Board of Directors in 2021
in ‘1,000 NOK
Committee fees
Name Position 2021
Base Board
fee
Audit
Committee
Remuneration
Committee
Clinical
Committee
Other
benets
5)
Total fees
Sveinung Hole
1)
Chairman of the Board, Chair of Remuneration Committee
and member of Audit Committee
442 22 43 506
Stener
Kvinnsland
2)
Non-executive member of the Board of Directors and
member of the Clinical Committee
250 35 285
Debra Barker Non-executive member of the Board of Directors, member
of Remuneration Committee and member of Clinical
Committee
250 22 35 14 320
Sally Bennett
3)
Non-executive member of the Board of Directors, Chair of
the Audit Committee and member of the Remuneration
Committee
250 43 22 315
François Thomas
4)
Non-executive member of the Board of Directors, Chair of
Clinical committee and member of the Audit Committee
250 22 75 20 366
Total remuneration 1,441 86 86 145 33 1,792
1) Sveinung Hole has as of 6 January 2022 changed his position to non-executive member of the Board of Directors, member of the Remuneration Committee and member of Audit Committee
2) Stener Kvinnsland has as of 6 January 2022 resigned his position as member of the Board of Directors and member of the Clinical Committee
3) Sally Bennett has as of 6 January 2022 resigned as a member of the Remuneration Committee
4) François Thomas has as of 6 January 2022 resigned as a member of the Audit Committee
5) Other benets include compensation for traveling hours related to Board meetings
Remuneration Report continued
OVERVIEW
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56–85
Annual Report & Accounts 2021
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STRATEGIC REPORT
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4.2 Board of Directors shareholdings
The table illustrates shares purchased and sold by Board
members in 2021.
Table 4.2 Board of Directors shareholdings
Name
Shares at
1 January
2021
Additions
during the
year
Sold during
the year
Shares at
31 December
2021
Sveinung Hole 107, 394 107, 394
Stener Kvinnsland 104,444 104,444
Debra Barker
Sally Bennett
François Thomas
Total 211,838 211,838
Anders Tullgren was elected as Chairman of the Board of
Directors as of 6 January 2022. At time of election, he held
25,000 shares in BerGenBio and an additional 25,000 shares
will be purchased in 2022 as part of his one-time bonus on his
appointment as Chairman of the Board.
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 xed 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 nancial year up to 75% of base salary. For other executives the target
award is 30%, with a maximum award in any nancial 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 specic 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 benets Enables BerGenBio to provide market competitive and cost-effective benets. Benets may include, but are not limited to
healthcare, life and accident insurance on customary terms. Specic benet provision may be subject to minor change from
time to time. Additional benets may be provided on recruitment or to support relocation.
Pension Encourages planning for retirement and long-term saving. BerGenBio ASA has a dened contribution pension plan
according to the mandatory requirements in the Norwegian Law. BerGenBio Limited has a dened 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.
Terms and conditions for indemnity for the members of the Board of Directors
BerGenBio has a Directors and Ofcers’ liability insurance and indemnication for the members of the Board of Directors. It is the
policy of BerGenBio to indemnify Directors and Ofcer’s against claims for damages of up to NOK 100 million. In 2021, no claims
were reported and BerGenBio did not indemnify its Directors and Ofcers 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 the remuneration packages.
Remuneration Report continued
OVERVIEW
01–03
FINANCIAL STATEMENTS
56–85
Annual Report & Accounts 2021
32
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STRATEGIC REPORT
04–24
5.2 Remuneration of individual members of the Executive Management in 2021
Table 5.2.1 Remuneration of individual members of the Executive Management in 2021
in ‘1,000 NOK
Fixed remuneration Variable remuneration
Name
Joined/
Departed Year Base salary Pension Severance pay
4)
Other benets
6)
Total xed
remuneration
% out of total
remuneration
Short-term
bonus One-off bonus
2)
Total granted
fair value of
share options
Total variable
remuneration
% out of total
remuneration Total
Martin Olin
1)
(CEO)
Joined
8 Sep 2021
2021 1,461 232 1,693 43% 705 1,500 2,205 57% 3,898
2020 0
Richard Godfrey
3)
(Previous CEO)
Departed
22 Aug 2021
2021 2,227 118 5,145 408 7,898 66% 933 3,150 4,083 34% 11,981
2020 3,100 197 12 3,309 41% 1,621 3,100 4,721 59% 8,030
Rune Skeie
5)
(CFO)
2021 1,896 180 14 2,090 64% 394 787 1,181 36% 3,271
2020 1,450 193 12 1,655 52% 435 1,100 1,535 48% 3,190
Nigel McCracken
(CSO)
Joined
1 Mar 2021
2021 2,168 217 2,385 86% 390 390 14% 2,775
2020 0
James B Lorens
(Previous CSO)
Departed
31 Dec 2020
2021 0
2020 2,678 201 8 2,887 58% 763 1,339 2,102 42% 4,989
James Barnes
(Chief Operating Ofcer)
2021 2,104 210 2,314 63% 410 929 1,339 37% 3,653
2020 1,919 192 2,111 52% 625 1,335 1,960 48% 4,071
Remuneration Report continued
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Annual Report & Accounts 2021
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STRATEGIC REPORT
04–24
Table 5.2.1 Remuneration of individual members of the Executive Management in 2021 (continued)
in ‘1,000 NOK
Fixed remuneration Variable remuneration
Name
Joined/
Departed Year
Base
salary Pension
Severance
pay
4)
Other
benets
6)
Total xed
remuneration
% out of total
remuneration
Short-term
bonus
One-off
bonus
2)
Total granted
fair value of
share options
Total variable
remuneration
% out of total
remuneration Total
Hani Gabra
(Previous CMO)
Departed
17 July 2021
7)
2021 1,672 1,672 100% 0% 1,672
2020 3,118 180 3,298 58% 815 1,560 2,375 42% 5,673
Other executives
8)
2021 3,340 413 26 3,780 62% 546 1,798 2,344 38% 6,123
2020 3,538 418 26 3,982 59% 1,026 1,775 2,801 41% 6,783
1) Martin Olin has been remunerated as CEO from 8 September 2021
2) Martin Olin has received a sign-on bonus of NOK 1.500k.
3) Richard Godfrey stepped down as CEO as of 22 August 2021
4) Richard Godfrey’s last date of employment was 22 August 2021. The total severance payment of NOK 5.145k equal to 12 months base salary, bonus and other benets. 50% of the severance payment was paid in August 2021 and the remaining 50% in January 2022.
5) Rune Skeie has been interim CEO in the period 22 August to 8 September 2021. Compensation included in base salary.
6) Other benets include housing allowance, insurances, expenses to mobile, internet, newspapers, and other business-related expenses
7) Stepped down from Executive Management during 2021 but remains employed as of 31 December 2021.
8) Other Executives are Alison Mession, Gro Gausdal and endre Kjærland. Gro Gausdal and Endre Kjærland stepped down from Executive Management from 30 November 2021 but remain employee in BerGenBio.
Table 5.2.2 Remuneration of individual members of the Executive Management engaged as contractors
in ‘1,000 NOK
Remuneration
Name
Joined/
Resigned Year Invoiced fee
Gayle Mills
1)
(Chief Business Ofcer)
Joined
8 Oct 2021 2021 544
2020 0
Gwyn Thomas
2)
(Interim Head of Clinical Development)
Joined
28 Jun 2021 2021 1,317
2020 0
Debbie Molyneux
2)
(Chief People Ofcer) 2021 2,405
2020 2,304
1) Gayle Mills has joined the Executive Management from 8 October 2021. Gayle Mills is employed through a consultancy agreement with a xed monthly fee and eligible for an incentive fee on partnering deals.
2) Gwyn Thomas and Debbie Molyneux are employed through individual consultancy agreements.
Remuneration Report continued
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56–85
Annual Report & Accounts 2021
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STRATEGIC REPORT
04–24
5.3 Short-term incentive of the Executive Management in 2021
BerGenBio Executive Management participate in a short-term incentive scheme in line with the Remuneration Policy. Target bonus level for CEO is 50% of base salary and 30% of base salary for all other
Executives. Individual bonus is dependent on performance and achievement of goals. Goals for 2021 consisted of specic development goals of bemcentinib, development goals of tilvestamab and
organization development. Overall achievement of corporate goals for 2021 ended on 50% with an individual achievement range of 50% to 75%.
Short-term bonus for Executive Management for 2021 amounted in total NOK 3.4 million.
Category Measures Overall achievements 2021
Development of bemcentinib • Advance the clinical development of bemcentinib related to AML, NSCLC and COVID-19 to position
bemcentinib for conrmatory trials
• Conduct formulation and manufacturing activities to support further development
50%
Development of tilvestamab • Establish proof of concept (pre-clinical) and conduct MAD and PK/PD trials
• Conduct formulation and manufacturing activities to support clinical development
50%
Organization development • Development of management and quality systems
• Financial strategy
• Pursue where relevant partnership and licence opportunities
50%
Remuneration Report continued
OVERVIEW
01–03
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56–85
Annual Report & Accounts 2021
35
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STRATEGIC REPORT
04–24
5.4 Long-term incentive (LTI) programme
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 option schemes is 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 nancial 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 initial grant, which is to be determined when the initial
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 specied
points per year in connection with the release of nancial results. In addition, the Board of Directors may allow exercise at other suitable times during the year.
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
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)
Richard Godfrey (Previous CEO)
2)
2021 06.05.2021 06.05.2022 28.55 217, 361 (217, 361) 3,150
2020 08.04.2020 08.04.2021 15.00 413,333 (275,555) (70,000) 67,778 3,100
2019 17.04.2019 17.04.2020 25.00 236,800 (78,933) 157, 8 67 2,960
2018 31.10.2018 31.10.2019 28.50 50,000 (16,667) 33,333 713
2018 22.05.2018 22.05.2019 46.70 122,484 122,484 2,860
2016 19.12.2016 19.12.2017 24.00 100,000 100,000 1,200
2015 22.05.2015 22.05.2016 16.01 275,000 (137,50 0) 137, 5 0 0 2,201
2014 11.06.2014 11.06.2015 11.15 120,000 (120,000) 669
2013 03.09.2013 03.09.2014 10.62 150,000 (150,000) 797
2013 13.06.2013 13.06.2014 10.62 75,000 (75,000) 398
Rune Skeie (CFO) 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
1) Martin Olin will join the LTI program in 2022
2) Richard Godfrey is entitled to keep the vested outstanding share options for six months after he stepped down as CEO as of 22 August 2021
3) Fair value of total share options at grant date is based on Black Scholes fair value calculation from 2021
Remuneration Report continued
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56–85
Annual Report & Accounts 2021
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STRATEGIC REPORT
04–24
Table 5.4 Long-term incentive (LTI) program (continued)
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
No. of share
options exercised Reclassication
No. of share
options end of the
year
Fair value of share
options at grant
(1’000 NOK)
3)
James B Lorens (Previous CSO) 2019 17.04.2019 17.04.2020 25.00 6,933 (6,933) 260
2018 31.10.2018 31.10.2019 28.50 4,666 (4,666) 100
2018 22.05.2018 22.05.2019 46.70 7,138 ( 7,138) 250
2016 19.12.2016 19.12.2017 24.00 50,000 (50,000) 600
2015 22.05.2015 22.05.2016 16.01 275,000 (275,000) 2,201
2014 11.06.2014 11.06.2015 11.15 70,000 (70,000) 390
2013 03.09.2013 03.09.2014 10.62 55,000 (55,000) 292
2013 13.06.2013 13.06.2014 10.62 100,000 (100,000) 531
James Barnes
(Chief Operating Ofcer) 2021 06.05.2021 06.05.2022 28.55 64,122 64,122 929
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
Hani Gabra (CMO) 2020 08.04.2020 08.04.2021 15.00 208,000 208,000 1,560
Other Executives
4)
2021 06.05.2021 06.05.2022 28.55 124,103 (63,035) 61,068 1,798
2020 08.04.2020 08.04.2021 15.00 236,667 (128,667) 108,000 1,775
2019 17.04.2019 17.04.2020 25.00 20,180 (20,180) 252
2018 31.10.2018 31.10.2019 28.50 19,829 (19,829) 372
2018 22.05.2018 22.05.2019 46.70 50,225 (50,225) 776
2016 19.12.2016 19.12.2017 24.00 35,000 (35,000) 340
2015 22.05.2015 22.05.2016 16.01 20,000 (20,000) 160
3) Fair value of total share options at grant date is based on Black Scholes fair value calculation from 2021.
4) Other Executives are Alison Messom, Gro Gaudal (stepped down from Executive Management 30 November 2021) and Endre Kjærland (stepped down from Executive Management 30 November 2021). Gro Gausdal and Endre Kjærland holds the share options after stepping down as Executive Management members and as such the share options have been reclassied.
Remuneration Report continued
OVERVIEW
01–03
FINANCIAL STATEMENTS
56–85
Annual Report & Accounts 2021
37
CORPORATE GOVERNANCE
25–55
STRATEGIC REPORT
04–24
5.5 Executive Management Shareholdings
Shares purchased and sold by Executive members in 2021.
Table 5.5 Executive Management shareholdings
Name
Shares at
1 January 2021
Additions during
the year
Sold during
the year Reclassication
Shares at
31 December 2021
Martin Olin (CEO)
3)
Richard Godfrey
(Previous CEO)
1)
21,005 (21,005)
Endre Kjærland
2)
3,262 (3,262)
Total shares 24,267 (24,267)
1) Richard Godfrey holds the shares after he stepped down as CEO and as such the shares have been reclassied.
2) Endre Kjærland holds the shares after his resignation as Executive Management member and as such the shares has been reclassied.
3) In 2022, Martin Olin purchased in total 37,100 shares.
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 3 months by the executive or the Company. The CEO has a notice period
of 6 months by the CEO and 6 months by 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 bonus. 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, benets, pension
contributions and bonus (where eligible) and would reect 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 xed and variable elements.
Remuneration Report continued
OVERVIEW
01–03
FINANCIAL STATEMENTS
56–85
Annual Report & Accounts 2021
38
CORPORATE GOVERNANCE
25–55
STRATEGIC REPORT
04–24
Remuneration Report continued
In ‘1,000 NOK 2021 Change, % 2020
Executive Management – remuneration
Martin Olin
1)
3,898 0
Richard Godfrey
2)
11,981 49.2% 8,030
Rune Skeie 3,271 2.5% 3,190
Nigel McCracken
3)
2,775 0
James B. Lorens
4)
0 -100% 4,989
James Barnes 3,653 -10.3% 4,071
Hani Gabra
5)
1,672 -70.5% 5,673
Other employed executives 6,124 -9.7% 6,783
Board of Directors – remuneration
Anders Tullgren, from 6 January 2022 0 0.0% 0
Sveinung Hole 506 7.7% 470
Stener Kvinnsland 285 22.8% 232
Debra Barker 320 26.4% 253
Sally Bennett
6)
315 1,201.6% 24
François Thomas
7)
366 1,251.5% 27
1) Martin Olin joined as CEO from 8 September 2021
2) Richard Godfrey stepped down as CEO as of 22 August 2021. The total remuneration includes a total severance payment of NOK 5,145k. When annualising the total remuneration
excluding the severance payment a total increase of 5% has been realised compared to 2020.
3) Nigel McCracken joined as CSO from 1 March 2021
4) James B Lorens departed as member of Executive Management as of 30 December 2020
5) Hani Gabra has stepped down as previous CMO on 17 July 2021
6) Sally Bennett joined as member of Board of Directors from 9 December 2020
7) François Thomas joined as member of Board of Directors from 9 December 2020
The calculation of average xed and variable remuneration is very sensitive to the relatively low
number of FTEs involved and is further impacted due to increasing FTEs during 2021 compared
to 2020.
2021 Change, % 2020
Financial performance gures
Employees – average remuneration based on FTE:
Number of FTEs (excl. Executive Management) – Group 37. 2 47.1% 25.3
Average total remuneration for Group employees
(1,000 NOK)
10) 12)
1,371 25.9% 1,089
Average xed remuneration for Group employees
(1,000 NOK)
11)
972 12.9% 861
Average variable remuneration for Group
employees (1,000 NOK)
12)
399 75.2% 228
Number of FTEs (excl. Executive Management) – Parent 12.4 15.9% 10.7
Average total remuneration for Company employees
(1,000 NOK)
10) 12)
1,142 40.2% 815
Average xed remuneration for Company
employees (1,000 NOK)
11)
774 8.1% 716
Average variable remuneration for Company
employees (1,000 NOK)
12)
368 271.6% 99
Group nancial results:
Revenue of BerGenBio (1,000 NOK) 774 28.8% 601
Research & Development (R&D) costs (1,000 NOK) 259,900 25.6% 206,857
10) Average total remuneration for Group employees and Company employees is calculated as total remuneration (salary, pension and short-term bonus for all employees (excluding
Executive Management) including fair value of granted options divided by total FTEs (excluding Executive Management)
11) Average xed remuneration for Group employees and Company employees is calculated as xed remuneration (salary, pension and short-term bonus for all employees (excluding
Executive Management) excluding fair value of granted options divided by total FTEs (excluding Executive Management)
12) Variable remuneration include introduction of STI and LTI scheme for additional employees in 2021.
7. Comparison of remuneration and financial performance figures
This is the rst year of reporting and BerGenBio has chosen to include relevant comparative gures for 2020. Prospectively and year-on-year, BerGenBio will build up ve years of comparative gures
for the annual change in remuneration, in Company performance, and in average remuneration based on full-time equivalents (“FTEs”) of employees other than Executive Management members.
Table 7.1 Comparison of remuneration and financial performance figures
Executive Management remuneration include base salary, pension, other remuneration, short-term bonus and total calculated fair value of granted options.
OVERVIEW
01–03
FINANCIAL STATEMENTS
56–85
Annual Report & Accounts 2021
39
CORPORATE GOVERNANCE
25–55
STRATEGIC REPORT
04–24
Remuneration Report continued
8. Compliance with the remuneration policy
The remuneration of members of the Board of Directors and Executive Management for 2021 is
consistent with the scope of the Remuneration Policy. There has been no deviation or derogation
from the framework provided by the Remuneration Policy.
9. Statement by the Board of Directors
The Board of Directors has today considered and approved the Remuneration Report of
BerGenBio for the nancial year 1 January to 31 December 2021.
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, 7 April 2022
Board of Directors
Anders Tullgren
Chairman
Debra Barker
Non-Executive Director
Sveinung Hole
Non-Executive Director
Sally Bennett
Non-Executive Director
François Thomas
Non-Executive Director
FINANCIAL STATEMENTS
56-87
OVERVIEW
01-03
Annual Report & Accounts 2021
40
CORPORATE GOVERNANCE
25–55
STRATEGIC REPORT
04–24
Remuneration Report continued
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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 2021 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. Our firm
applies International Standard on Quality Control 1 (ISQC 1) and accordingly maintains a comprehensive
system of quality control including documented policies and 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.
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
A member firm of Ernst & Young Global Limited
INDEPENDENT AUDITOR’S ASSURANCE REPORT ON REMUNERATION REPORT
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 2021 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. Our firm
applies International Standard on Quality Control 1 (ISQC 1) and accordingly maintains a comprehensive
system of quality control including documented policies and 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.
2
Independent auditor’s assurance report on remuneration report - BerGenBio ASA 2021
A member firm of Ernst & Young Global Limited
Bergen, 7 April 2022
ERNST & YOUNG AS
Truls Nesslin
State Authorised Public Accountant (Norway)
Annual Report & Accounts 2021
41
FINANCIAL STATEMENTS
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Corporate Governance Report
1. Corporate Governance in BerGenBio
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 nancial 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, most recently revised on 17 October 2018
(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
specic 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 practising 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 Company’s corporate social responsibility (CRS)
policy. The CSR policy is distributed to all employees,
management and Board members, and published on the
Company’s website.
The Company’s ethical and CRS rules set forth the basic
principles for business practices and personal behaviour 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.
2. Business
BerGenBio is a clinical-stage biopharmaceutical company
focused on developing novel medicines for aggressive
diseases, including advanced, treatment-resistant cancers.
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 2021.
3. Equity and Dividends
Capital adequacy
BerGenBio’s total equity at 31 December 2021 was NOK 384
million, corresponding to an equity ratio of 85%. 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.
The Company’s capital situation is continuously monitored, and
the Board of Directors will take adequate steps to capitalise the
Company if deemed necessary.
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Corporate Governance Report continued
Dividend policy
BerGenBio has not developed any dividend policy.
The Company is focusing on the development of novel
pharmaceutical products and does not anticipate paying
any cash dividend until sustainable protability 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 19 March 2021,
the Board of Directors was granted the following authorization:
• Authorization to increase the Company’s share capital by
up to NOK 872,599.80 in connection with its existing share
option scheme. The authorization is effective until the earlier
of the AGM in 2022 and 30 June 2022.
• Authorization to increase the Company share capital by
up to NOK 1,745,199.50 by subscription of new shares,
which constitute approximately 20% of the Company´s
outstanding shares. 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.
For supplementary information on the authorizations, reference
is made to the minutes of the Annual General Meeting held on
19 March 2021, available from the Company’s website.
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 justied.
Where the Board of Directors resolves to issue shares, and
waive the preferential rights of existing shareholders pursuant
to an authorisation granted to the Board of Directors by the
general meeting, the justication will be publicly disclosed in
a stock exchange announcement issued in connection with the
shares issuance. There were no such transactions in 2021.
Transactions in treasury shares
Any transactions in treasury shares shall be carried out through
Oslo Børs, 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 2021.
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 signicant, direct or indirect, interest
in a transaction carried out by the Company. There were no
such transactions in 2021.
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.
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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 fth 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 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 2021, BerGenBio held its Annual General Meeting on
19 March.
7. Nomination Commiee
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 13 March 2019
• Ann-Tove Kongsnes – elected at the Annual General
Meeting 13 March 2019
• 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 2023. 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.
Corporate Governance Report continued
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8. Board of Directors; Composition and Independence
Pursuant to the articles of association section 5, the Company’s
Board of Directors shall consist of three to seven members.
At 31 December 2021, the Board of Directors consisted of
ve members, of which two are women:
• Sveinung Hole (Chair) – elected at the Annual General
Meeting (AGM) in 2010 and re-elected annually, last time at
the AGM on 16 March 2020, from 6 January 2022 continue
as Board member up to the AGM in 2022.
• Stener Kvinnsland – elected at the AGM in 2015 and
re-elected annually, last time at the AGM on 16 March 2020.
Resigned from the Board 6 January 2022.
• Debra Barker – elected at the Annual General Meeting on
13 March 2019 and re-elected up to the Annual General
Meeting in 2023
• Sally Bennett – elected at the Extraordinary General Meeting
on 9 December 2020 and re-elected up to the Annual
General Meeting in 2023
• François Thomas – elected at the Extraordinary General
Meeting on 9 December 2020 and re-elected up to the
Annual General Meeting in 2023
In an Extraordinary General Meeting 6 January 2022, Anders
Tullgren was elected as Chairman of the board, Sveinung Hole
was reconrmed as Board member and Stener Kvinnsland
resigned from the Board. He will continue in an observer/
advisory position.
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 ve members, then each gender shall be
represented by at least two members.
Except for Sveinung Hole and Stener Kvinnsland, all Board
Members are independent of the Company’s signicant
business relations and large shareholders (shareholders
holding more than 10% of the shares in the Company)
and of the Management.
Board members are encouraged to own shares in BerGenBio. The following shares are held by the Board as of 31 December 2021:
Name Position
Considered
independent Served since Term expires
Board meeting
attendance 2021 Shares Share options
Sveinung Hole Chair/Board member No 01.09.2010 AGM 2022 17 107, 394
14
0
Stener Kvinnsland Board member No 22.02.2015 6 Jan 2022 17 104,444 0
Debra Barker Board member Yes 13.03.2019 AGM 2023 18 0 0
Sally Bennett Board member Yes 09.12.2020 AGM 2023 18 0 0
François Thomas Board member Yes 09.12.2020 AGM 2023 17 0 0
14) Sveinung Hole holds 104,444 shares in the Company through Svev AS, a wholly-owned company of Sveinung Hole, and 2,950 shares directly
Corporate Governance Report continued
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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
Ofcer (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 nancial and operational developments. During 2021,
the Board of Directors held 18 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 Commiee
The Board of Directors established an Audit Committee on
28 February 2017, which is a sub committee of the Board of
Directors. Its main duties are to assess the Company’s nancial
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 ve
meetings in 2021, 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, from 6 January 2022
François Thomas served as Audit Committee member up to 6
January 2022.
Clinical Commiee
The Board of Directors 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.
The members of the Clinical Committee are elected by and
amongst the members of the Board of Directors. The current
members of the Clinical Committee are;
• François Thomas (Chair)
• Debra Barker
• Sally Bennett (from 6 January 2022)
Stener Kvinnsland served as Clinical Committee member up to
6 January 2022.
Corporate Governance Report continued
Remuneration Commiee
The Board of Directors has established a Remuneration
Committee as a preparatory and advisory committee for
the Board of Directors, to address questions relating to
remuneration of the Company’s Executive Management.
The duties are described in the Company’s “Instructions for the
Remuneration Committee”. The main duties include the
responsibility to review the remuneration and benets strategy
of the members of the Executive Management; review the
performance of the Executive Management vs. the adopted
objectives and recruitment policies, career planning and
management development plans; and prepare matters related
to other material employment issues in respect of the Executive
Management. The Remuneration Committee meets as often as
deemed necessary, but normally four to six times a year.
The members of the Remuneration Committee are elected by
and amongst the members of the Board of Directors for a term
of up to two years and shall be independent of the Company’s
Executive Management. The current members of the
Remuneration Committee are:
• Anders Tullgren (Chair), from 6 January 2022
• Sveinung Hole, Chair up to 6 January 2022
• Debra Barker
Sally Bennett served as Remuneration Committee member up
to 6 January 2022.
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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 nancial performance. The procedures and manuals
are continuously revised to reect 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, nance, 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 nancial accounts in accordance with
the international accounting standard IFRS, which aims to
provide a true and fair overview of the Company’s assets,
nancial obligations, nancial position and operating prot.
For information on the Company’s nancial risk and risk
management, reference is made to the Board of Directors’
report and Note 20 in the 2021 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 reects 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, Remuneration Committee or Clinical Committee
receive separate compensation for this.
Detailed information on the remuneration of the Board of
Directors can be found in the Remuneration Report for 2021.
Members of the Board of Directors, or companies with which
they are associated, should not engage in specic 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 specically
identied in the annual report.
Corporate Governance Report continued
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 2021.
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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 nancial
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 nancial 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 nancial calendar,
providing an overview of the dates for major events such as its
ordinary general meeting and publication of interim nancial
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 nancial reporting.
All nancial 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.
Corporate Governance Report continued
14. Take-Overs
There are no defence mechanisms against take-over bids in the
Company’s articles of association, nor have other measures
been implemented to specically 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 sufcient 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
specic 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 conrmation from the auditor that
the requirements regarding independence and objectivity have
been satised.
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 disagreement 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 identication 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 specic 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
Strategy
BerGenBio ASA (“the Company”) and its subsidiary (together
“the Group”) is a biopharmaceutical company developing
novel medicines for patients with severe unmet medical needs,
with a focus on advanced, immune-evasive and treatment-
resistant cancers and respiratory diseases. The Company has
two key clinical assets targeting the receptor tyrosine kinase
AXL. The Company’s lead asset bemcentinib is currently in
Phase II development in 2nd line (2L) NSCLC, 2nd line (2L) AML
and as a treatment for severe respiratory infections, initially in
hospitalized COVID-19 patients. The Company is a world-
leader in understanding the potential applications of AXL
inhibition in mediating aggressive diseases.
The Company’s lead drug candidate, bemcentinib, is a highly
selective, potent, oral, rst-in-class small-molecule AXL
inhibitor, currently being evaluated in a Phase II clinical
program in AML and NSCLC and in COVID-19.
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 2L AML, bemcentinib has shown promising early clinical data
in relapsed patients unt for intensive chemotherapy. Following
full availability of the dataset from this Phase II study and
regulatory interaction, BerGenBio will determine its clinical
strategy in this patient population.
In respiratory disease, COVID-19 has been an initial focus.
Encouraging survival benet data from two Phase II bemcentinib
COVID-19 studies were shared at the European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) in July
2021. In early 2022 BerGenBio announced its participation in
the EU-SolidAct trial, part of EU-RESPONSE, a pan-European
research project and will share updates as they emerge.
In addition, a broad set of investigator-initiated trials are
exploring the wider potential of bemcentinib in disease
indications with strong scientic rationale, Key Opinion Leaders
(KOL) support, and high unmet medical need with a view to
developing future pipeline opportunities.
BerGenBio’s second clinical asset is tilvestamab (formerly
BGB149), a rst-in-class anti-AXL antibody which is currently in
an international Phase Ib rst-in-patient trial to evaluate safety,
tolerability and determine a recommended Phase II dose.
BerGenBio’s focused near-term strategy includes the following
key initiatives:
• Aggressively pursue the NSCLC opportunity for patients
harboring STK11 mutations through additional pre-clinical
work and conducting clinical trials
• Pursue the potential within acute respiratory disease initially
through the EU-SolidAct sponsored platform to conduct a
conrmatory randomized placebo-controlled trial to position
bemcentinib as a treatment modality in hospitalized
COVID-19 patients
• Following full availability of the dataset from the 2L AML
Phase 2 study and regulatory interaction, BerGenBio will
determine its clinical strategy in this patient population.
• Progress the clinical development of tilvestamab
• Secure additional pipeline opportunities for the Company’s
AXL inhibitors in oncology and respiratory diseases.
Operational review
During 2021 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 into late-stage clinical trials and through to
regulatory approval where data warrants.
The FDA has granted Fast Track Designation for bemcentinib
for the treatment of AML as well as for bemcentinib in
combination with an anti-PD-(L)1 agent as a treatment for
patients with STK11 mutated advanced/metastatic NSCLC.
The Company’s focus going forward is on the clinical
development of bemcentinib within NSCLC, AML and acute
respiratory diseases, representing three distinct shots on goal.
Clinical Trial Progress: NSCLC
In 2021, BerGenBio progressed its Phase II clinical trial
(BGBC008) assessing bemcentinib in combination with
pembrolizumab in 2L patients with NSCLC.
Updated data from this study was presented at the Society for
Immunotherapy of Cancer (SITC) Annual Meeting in November
2021. In pre-clinical NSCLC mouse models harboring STK11
mutations, sensitivity to PD-1 blockade was evaluated in the
absence and presence of bemcentinib. Systemic inhibition of
AXL with bemcentinib resulted in the expansion of tumor-
associated T cells and restored therapeutic response to anti-
PD-1 checkpoint inhibition. Data from the Phase II bemcentinib
and pembrolizumab (Keytruda®) combination study (BGBC008)
in advanced NSCLC showed that 3 of 3 evaluable patients with
identied STK11 mutations demonstrated objective clinical
response/clinical benet to the combination of bemcentinib
and pembrolizumab.
In November 2021, the Company was granted FDA Fast Track
Designation for the STK11 mutated population and the
Company also signed an exclusive license to intellectual
property covering the treatment of STK11 mutated patients.
The Company intends to pursue the STK11 opportunity
through initiation of clinical trials during 2022.
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Clinical Trial Progress: COVID-19
In response to the global pandemic that emerged in early
2020, BerGenBio began to explore bemcentinib as a potential
COVID-19 treatment, based on the Company’s understanding
of its reported potent anti-viral activity in preclinical models
against several enveloped viruses, including Ebola and Zika.
Two COVID-19 bemcentinib studies were undertaken:
• A Phase II study which was part of the UK Research and
Innovation (UKRI) funded COVID-19 ACCORD platform trial
• A BerGenBio-sponsored Phase II study of 120 hospitalized
COVID-19 patients in South Africa and India (BGBC020)
In April 2021 the Company provided an update on data from
BGBC020 and ACCORD2 which showed bemcentinib was well
tolerated by patients with no signicant safety concerns. Both
studies demonstrated a numerically lower number of deaths in
the bemcentinib arm vs. standard of care (1 vs. 5 and 2 vs. 3
respectively). A post-hoc analysis identied a sub-group of
patients with more severe disease where there was evidence of
a benet from bemcentinib treatment. This sub-group
represented more than 60% of the patients across the two
studies. The data reported increased survival, a signicantly
reduced likelihood of progression to ventilation and a
signicantly increased likelihood of shorter time to recovery or
discharge. The data generated from these studies has been
thoroughly evaluated to inform the design and endpoints of
future studies.
In January 2022, BerGenBio announced that bemcentinib will
be included in the sponsored EU-SolidAct Phase II adaptive,
multi-center trial. Bemcentinib will be studied in up to 500
hospitalized COVID-19 patients.
Clinical Trial Progress: AML
BerGenBio is assessing bemcentinib as a treatment for AML
and Myelodysplastic Syndromes (MDS). The US FDA has
granted bemcentinib Fast Track Designation and Orphan Drug
status for the treatment of AML in patients unt for intensive
chemotherapy.
BGBC003 is a Phase II trial of bemcentinib in combination with
low-dose cytarabine (LDAC) chemotherapy in AML patients
who cannot tolerate intensive chemotherapy. Encouraging
updated preliminary data from the study was presented at the
European Hematology Association (EHA) conference in June.
The data, although not yet mature, suggest there is a
meaningful clinical benet to patients, supporting bemcentinib
as a therapeutic modality in AML.
Following full availability of the dataset in relapsed patients
from our Phase II study and regulatory interactions, BerGenBio
will determine its clinical strategy in this patient population.
Progress: tilvestamab (BGB149)
Tilvestamab (BGB149) is the rst functional blocking anti-AXL
monoclonal antibody to enter clinical development and is
BerGenBio’s second clinical stage drug development program
targeting AXL.
In June 2021 data from a preclinical study conducted to
characterize AXL as a target in chronic kidney disease (CKD)
and to investigate the anti-brotic efcacy of tilvestamab using
an ex-vivo model of human Precision Cut Kidney Slices (PCKSs)
was presented at the European Renal Association –
European Dialysis and Transplant Association (ERA-EDTA)
Virtual Congress.
The study results showed that AXL expression was induced in
key cell populations during the development of kidney brosis
in the unilateral ureteric-outow obstruction (UUO) model of
kidney brosis in mice. These data support AXL as a novel
target in CKD and highlight the potential of tilvestamab as a
promising candidate for pharmacologic intervention in kidney
brosis, with potential synergies with current reno-protective
therapies warranting further exploration.
An international Phase Ib rst-in-patient trial investigating
tilvestamab (BGB149) is currently ongoing to study safety,
tolerability and determine a recommended Phase II dose
(RP2D) for use in subsequent clinical trials.
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Progress: Companion Diagnostics Program
The availability of a predictive biomarker test signicantly
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.
Other progress
The company supports its own clinical development program
with a broad portfolio of investigator sponsored clinical
trials of high scientic 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 applications of our selective
AXL inhibitors.
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.
The long-term impact of the COVID-19 pandemic remains
unclear. Our ability to conduct clinical trials at the expected
pace is a risk factor in the evolving pandemic.
BerGenBio is currently in a development phase involving
activities that entail exposure to various risks. BerGenBio’s lead
product candidate bemcentinib is currently in Phase II 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 nancial 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
Ofcers in the Company and subsidiaries. The insurance is
limited to NOK 100,000,000 per claim and in total during the
insurance period.
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 are exposed to
market uctuations in interest rates, which affect the nancial
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
uctuations in exchange rates. The exposure arises largely from
the clinical trials and research expenses. The Group is mainly
exposed to uctuations 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 nancial
asset, liability or customer contract, giving a nancial loss. The
Group’s receivables are generally limited to receivables from
public authorities by way of government grants. The credit risk
generated from nancial assets in the Group is limited since it is
cash deposits. The Group places its cash in bank deposits in
recognized nancial institutions to limit its credit risk exposure.
The Group has not suffered any loss on receivables during 2021
and the Group considers its credit risk as low.
Funding and liquidity risk
Liquidity is monitored on a continued basis by Group
management.
The Group works continuously to ensure nancial exibility
in the short and long term to achieve its strategic and
operational objectives.
Funding of ongoing operations is and will be for some time
depending on external sources, mainly equity contributions.
Signicant changes to nancial market conditions, may affect
the climate for investor investments.
Management considers the Group’s liquidity situation to
be satisfactory.
Board of Directors’ Report continued
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Non-financial risks
Technology risk
The Group’s lead product candidate, bemcentinib (BGB324),
is currently in Phase II clinical trials. 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 long-term impact of the COVID-19
crisis remains unclear although no greater for BerGenBio than
any other business in the sector.
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 Phase II 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.
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 nd 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.
Regulatory and commercial risks
The nancial 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 2020 unless stated otherwise)
Accounting policies
The nancial statements of BerGenBio Group have been
prepared in accordance with International Financial Reporting
Standards (IFRS) as adopted by the EU on 31 December 2021.
Figures are for the Group and for the Parent Company
BerGenBio ASA labelled ASA below.
Financial results
Operating revenues
Revenue for the full year 2021 amounted to NOK 0.8 million
(NOK 0.6 million) for the Group and NOK 1.2 million (NOK 0.7
million) for ASA. Revenue in 2021 and 2020 is refund of patent
costs from an out-licensed agreement with ADCT.
Board of Directors’ Report continued
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Operating expenses
Total operating expenses for 2021 for the Group amounted to
NOK 315.2 million (NOK 261.7 million), and NOK 317.4 million
(NOK 263.3 million) for ASA.
Employee expenses were NOK 74.0 million (NOK 60.2 million)
for the Group and NOK 32.3 million (NOK 35.9 million) for
ASA. Payroll expenses increased in 2021 compared to 2020
due to increased headcount as part of organizational
development in preparation for the next phase of clinical trials,
including transfer of contractors to employees. In addition,
employee expenses increase is attributed to the change of
CEO, including severance payment to the departing CEO.
Employee share option costs decreased compared to 2020
caused by negative development of the share price in the year
and the decrease of non-cash accruals for social security tax.
For the full-year 2021, other operating costs for the Group
amounted to NOK 239.9 million (NOK 200.8 million), and NOK
283.8 million (NOK 226,6 million) for ASA. The increased costs
year-on-year are related to increased clinical trial activities with
a signicant number of patients recruited in 1H 2021. Some of
these trials have completed recruitment during 2021.
The Group has recognized government grants amounting to
NOK 13.3 million (NOK 21.4 million) for the full-year 2021.
Government grants are recognized as cost reduction in the
prot and loss. Payroll expenses have been reduced by NOK
6.4 million (NOK 4.8 million) and operating expenses by NOK
6.9 million (NOK 16.6 million) as a result of these government
grants. ASA has recognized government grants for a total of
NOK 8.6 million (NOK 18.6 million) for the full year 2021.
Payroll expenses have been reduced by NOK 1.7 million
(NOK 2.0 million) and operating expenses by NOK 6.9 million
(NOK 16.6 million) as a result of these government grants.
The operating loss for the Group in 2021 was NOK 314.5
million (NOK 261.1 million) and NOK 316.2 million (NOK 262.6
million) for ASA, reecting the increased level of activity related
to the clinical trials and organizational develoment.
Net nancial gain for the Group was NOK 5.1 million (gain
NOK 4.1 million) and NOK 5.5 million (NOK 4.1 million) for
ASA for the full-year 2021.
Losses after tax for the Group were NOK 309.4 million (NOK
257.0 million) and NOK 310.7 million (NOK 258.6 million) for
ASA for the full year 2021.
Financial position
Total assets as of 31 December 2021 for the Group decreased
to NOK 450.2 million (NOK 738.2 million at year-end 2020) for
the Group and to NOK 441.0 million (NOK 733.5 million at
year-end 2020) for ASA, mainly due to the operational loss in
the period.
Total liabilities were NOK 65.8 million (NOK 68.0 million at
year-end 2020) for the Group and NOK 57.1 million (NOK 62.6
million at year-end 2020) for ASA.
Total equity as of 31 December 2021 was NOK 384.4 million
(NOK 670.2 million at year-end 2020) for the Group and NOK
383.9 million (NOK 670.9 million at year-end 2020) for ASA,
corresponding to an equity ratio of 85.4% (90.8%) for the
Group and 87.1% (91.5%) for ASA.
Cash flow
Net cash ow from operating activities was negative by NOK
303.3 million (NOK 234.3 million) for the Group and negative
by NOK 311.4 million (NOK 234.3 million) for ASA for the
full-year 2021, mainly driven by the level of activity related to
the clinical trials the Group is conducting, as well as milestone
payments related to progress made.
Net cash ow received from investing activities during the
full-year 2021 was NOK 3.1 million (NOK 3.5 million) for the
Group and NOK 3.1 million (NOK 3.5 million) for ASA.
Net cash ow from nancing activities was NOK 16.0 million
(NOK 699.5 million) for the Group and NOK 16.0 million (NOK
699.5 million) for ASA for the full-year 2021, representing the
proceeds from the private placements in 2020 on total gross
NOK 740 million.
Cash and cash equivalents decreased to NOK 436.6 million
(NOK 721.6 million) for the Group and NOK 428.1 million
(NOK 721.2 million) for ASA.
Board of Directors’ Report continued
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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
qualies 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 nancial position at the turn of the year.
According to the Norwegian Accounting Act section 3-3 (a), the
Board of Directors conrmed that the nancial statements have
been prepared under the assumption of going concern.
Environmental, social and governance (ESG)
In order to have a real impact, we worked to strengthen our
sustainability management. The aim was to identify 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 work involved mapping of our value chain and a 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
nally, 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 signicant 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.
Share information
As of 31 December 2021, there were 88,455,255 ordinary
shares outstanding, up from 87,259,983 shares at year
end 2020.
The Company has one class of shares and all shares carry equal
voting rights.
The Company had more than 12,000 shareholders at
31 December 2021.
The results for BerGenBio ASA for 2021 show a loss of tNOK
310,657. The Board proposes that the loss should be covered
by share premium.
Board of Directors’ Report continued
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Outlook
BerGenBio’s broad clinical development program with
bemcentinib, pipeline of AXL inhibitors and nancial position
together, provide a strong foundation to create and deliver
signicant 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 personal to support our strategies.
In retaining global rights to bemcentinib, BerGenBio maintains
complete strategic exibility for its future development and
commercialization. It is anticipated that the high novelty of
bemcentinib plus its promising therapeutic prole, particularly
in combination with existing therapies, could make it and future
pipeline candidates attractive targets for partnering. A go-to
market strategy may also be considered in selected indications
in discrete territories, where greater value for shareholders
could be created.
The Board believes the potential of our two rst-in-class
AXL inhibitors are relevant therapeutic modalities in several
aggressive diseases. However the recent and ongoing
geopolitical situation and associated impacts on nancial
market conditions requires a highly focused development
strategy.
The Board of Directors, BerGenBio ASA
Bergen, 7 April 2022
Confirmation from the Board of Directors and CEO
We conrm that, to the best of our knowledge, the nancial
statements for the period from 1 January to 31 December 2021
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, nancial 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.
The Board of Directors, BerGenBio ASA
Bergen, 7 April 2022
Anders Tullgren
Chairman
Anders Tullgren
Chairman
Dr. Sally Bennett
Non-Executive Director
Dr. Sally Bennett
Non-Executive Director
Sveinung Hole
Non-Executive Director
Sveinung Hole
Non-Executive Director
Dr. François Thomas
Non-Executive Director
Dr. François Thomas
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
Martin Olin
CEO
Martin Olin
CEO
Board of Directors’ Report continued
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Income Statement and Other Comprehensive Income
1 January – 31 December
(NOK 1000)
Parent 2020 Parent 2021 Note Group 2021 Group 2020
651 1,232 Revenue 4 774 601
24,573 35,320 Payroll and other related employee cost 5, 7, 10 69,929 48,832
11,346 (2,997) Employee share option cost 5, 6 4,116 11,346
726 1,312 Depreciation 8 1,312 726
226,648 283,786 Other operating expenses 7, 9, 13, 22 239,880 200,788
263,293 317,421 Total operating expenses 315,237 261,692
(262,642) (316,189) Operating prot (loss) (314,464 ) (261,091 )
18,812 14,934 Finance income 11 15,993 19,499
14,733 9,403 Finance expense 9, 11 10,894 15,437
4,079 5,531 Financial items, net 5,100 4,062
(258,563) (310,657) Prot (loss) before tax (309,364 ) (257,029 )
0 0 Income tax expense 12 0 0
(258,563) (310,657) Prot (loss) after tax (309,364 ) (257,029 )
Other comprehensive income (loss)
Items which may be reclassied over prot and loss net of tax
0 0 Translation effects (112 ) 0
(258,563) (310,657) Total comprehensive income for the year (309,476 ) (257,029 )
Earnings per share:
(3.45) (3.53) – Basic and diluted per share 14 (3.52 ) (3.43 )
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Statement of Financial Position
31 December
(NOK 1000)
Parent 2020 Parent 2021 Note Group 2021 Group 2020
ASSETS
Non-current assets
2,332 1,191 Property, plant and equipment and right-of-use assets 8 1,191 2,332
2,332 1,191 Total non-current assets 1,191 2,332
Current assets
9,985 11,711 Other current assets 7, 15, 22 12,398 14,228
721,161 428,093 Cash and cash equivalents 16, 20 436,646 721,641
731,146 439,804 Total current assets 449,045 735,869
733,478 440,995 TOTAL ASSETS 450,236 738,200
EQUITY AND LIABILITIES
Equity
Paid in capital
8,726 8,846 Share capital 17 8,846 8,726
628,896 334,679 Share premium 17 335,195 628,231
33,272 40,386 Other paid in capital 6, 17 40,386 33,272
670,894 383,910 Total paid in capital 384,426 670,229
670,894 383,910 Total equity 384,426 670,229
Non-current liabilities
1,367 942 Long term debt 9 942 1,367
1,367 942 Total non-current liabilities 942 1,367
Current liabilities
20,132 25,455 Accounts payable 26,726 22,550
35,078 29,719 Other current liabilities 9, 18, 22 37,172 38,046
6,008 969 Provisions 19 969 6,008
61,217 56,143 Total current liabilities 64,868 66,604
62,584 57,085 Total liabilities 65,810 67,971
733,478 440,995 TOTAL EQUITY AND LIABILITIES 450,236 738,200
The Board of Directors, BerGenBio ASA
Bergen, 7 April 2022
Anders Tullgren
Chairman
Dr. Sally Bennett
Non-Executive Director
Sveinung Hole
Non-Executive Director
Dr. François Thomas
Non-Executive Director
Dr. Debra Barker
Non-Executive Director
Martin Olin
CEO
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Group 2021 Note Share capital Share premium Other paid in capital Total equity
Balance at 1 January 2021 8,726 628,231 33,272 670,229
Prot (loss) after tax (309,364 ) (309,364 )
Exchange differences on translation of foreign operations (112 ) (112 )
Total comprehensive income (loss) for the year 0 (309,476 ) 0 (309,476 )
Recognition of share-based payments 5, 6 7,113 7,113
Issue of ordinary shares 17 120 16,510 16,629
Share issue costs 17 (70 ) (70 )
Transactions with owners 120 16,440 7,113 23,673
Balance at 31 December 2021 8,846 335,195 40,386 384,426
Group 2020 Note Share capital Share premium Other paid in capital Total equity
Balance at 1 January 2020 6,108 187,786 25,860 219,754
Prot (loss) after tax (257,029 ) (257,029 )
Exchange differences on translation of foreign operations 0
Total comprehensive income (loss) for the year 0 (257,029 ) 0 (257,029 )
Recognition of share-based payments 5, 6 7,412 7,412
Issue of ordinary shares 17 2,618 738,234 740,852
Share issue costs 17 (40,760 ) (40,760 )
Transactions with owners 2,618 697,474 7,412 707,504
Balance at 31 December 2020 8,726 628,231 33,272 670,229
Statement of Changes in Equity
(NOK 1000)
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Parent 2021 Note Share capital Share premium Other paid in capital Total equity
Balance at 1 January 2021 8,726 628,896 33,273 670,894
Prot (loss) for the year (310,657) (310,657)
Other comprehensive income (loss) for the year, net of income tax 0
Total comprehensive income (loss) for the year (310,657) (310,657)
Recognition of share-based payments 5, 6 7,113 7,113
Issue of ordinary shares 17 120 16,510 16,629
Share issue costs 17 (70) (70)
Transactions with owners 120 16,440 7,113 23,673
Balance at 31 December 2021 8,846 334,679 40,386 383,910
Parent 2020 Note Share capital Share premium Other paid in capital Total equity
Balance at 1 January 2020 6,108 189,985 25,861 221,953
Prot (loss) for the year (258,563) (258,563)
Other comprehensive income (loss) for the year, net of income tax 0
Total comprehensive income (loss) for the year (258,563) (258,563)
Recognition of share-based payments 5, 6 7,412 7,412
Issue of ordinary shares 17 2,618 738,234 740,852
Share issue costs 17 (40,760) (40,760)
Transactions with owners 2,618 697,474 7,412 707,504
Balance at 31 December 2020 8,726 628,896 33,273 670,894
Statement of Changes in Equity continued
(NOK 1000)
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Statement of Cash Flows
1 January – 31 December (NOK 1000)
Parent 2020 Parent 2021 Note Group 2021 Group 2020
Cash ow from operating activities
(258,563) (310,657) Prot (loss) before tax (309,364 ) (257,029 )
Adjustments for:
726 1,312 Depreciation of property, plant and equipment 8 1,312 726
7,412 7,113 Share-based payment expense 5 7,113 7,412
3,934 (5,039) Movement in provisions 10, 19 (5,039 ) 3,934
270 779 Currency -gains/+loss not related to operating activities 667 710
(3,614) (3,130) Interest received (3,130 ) (3,614 )
Working capital adjustments:
6,938 (1,726) Decrease in trade and other receivables and prepayments 1,830 1,590
8,622 (67) Increase in trade and other payables 3,270 11,982
(234,276) (311,415) Net cash ow from operating activities (303,340 ) (234,290 )
Cash ows from investing activities
3,614 3,130 Interest received 3,130 3,614
(67) Purchase of property, plant and equipment 8 (67 )
3,548 3,130 Net cash ow used in investing activities 3,130 3,548
Cash ows from nancing activities
740,852 16,629 Proceeds from issue of share capital 17 16,629 740,852
(40,760) (70) Share issue cost (70 ) (40,760 )
(585) (565) Cash payments for the principal portion of the lease liability 9 (565 ) (585 )
699,507 15,995 Net cash ow from nancing activities 15,995 699,507
(270) (779) Effects of exchange rate changes on cash and cash equivalents (779 ) (710 )
468,779 (292,290) Net increase/(decrease) in cash and cash equivalents (284,216 ) 468,765
252,653 721,161 Cash and cash equivalents at beginning of period 16 721,641 253,586
721,161 428,093 Cash and cash equivalents at end of period 16 436,646 721,641
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Note 1 – Corporate information
and its subsidiary (together “the Group”) is a clinical-stage
BerGenBio’s lead product, bemcentinib (BGB324), is a
selective, potent and orally bio-available small molecule
AXL inhibitor in Phase II clinical trials in major cancer
indications and COVID-19. It is the most advanced selective
AXL inhibitor in clinical development.
incorporated and domiciled in Norway . The address of the
registered ofce is Jonas Lies vei 91, 5009 Bergen, Norway .
BerGenBio retains strategic exibility for the further
development and commercialization of its product
candidates: it is anticipated that the high novelty of
bemcentinib plus its promising therapeutic prole could
make it (and later other pipeline candidates) attractive
targets for strategic partnering; a “Go-to market”
strategy will also be considered in selected indications
in discrete territories.
The consolidated nancial statements and the nancial
statement for the Company cover the year ending
31 December 2021 and were approved for issue by
the Board of Directors on 7 April 2022.
Note 2 – Basis for preparation and
significant accounting policies
The principal accounting policies applied in the preparation
of these nancial statements are set out below. These
policies have consistently been 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 nancial statements for the Group and
the Company have been prepared in accordance with IFRS
as adopted by the EU. The consolidated nancial
statements and the Company nancial statements have
been prepared on a historical cost basis, except money
market fund which is recognised at fair value through prot
and loss.
Basis for consolidation
The consolidated nancial statements comprise the nancial
statements of the Company and its subsidiary as at
31 December 2021. The subsidiary is BerGenBio Limited,
located in Oxford in the United Kingdom and is 100%
owned and controlled by the Parent Company BerGenBio
ASA. BerGenBio Limited was incorporated 10 January 2017
with a share capital of NOK 1,044.
Going concern
The Group works continuously to ensure nancial exibility
in the short and long term to achieve its strategic and
operational objectives. Capital markets are used as a source
of liquidity when this is appropriate and when conditions in
these markets are acceptable. In 2020, funding of total
NOK 740 million was raised, and thus the Board of Directors
has reasonable expectation that the Group will maintain
adequate resources to continue in operational existence
for the foreseeable future. The nancial 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 2021 did
not have any signicant impact on the reporting for 2020
and 2021. 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 recognised when
control of the goods or services are transferred to the
customer at an amount that reects 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 has 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 no revenue
from sales of products yet.
The Group (the Company) has entered into an Out-licence
agreement where development, regulatory and sales-
based milestones trigger revenue payment to the Group
(the Company). Revenue from out-licence agreements
are recognised in the period when 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
recognised in the income statement in the same period as
the related costs, and presented net. Government grants
are recognised at the value of the contribution at the
transaction date.
Government grants are normally related to either
reimbursements of employee costs and classied as a
reduction of payroll and related expenses, or related to
other operating activities and thus classied as a reduction
of other operating expenses.
Notes to the Financial Statements
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Notes to the Financial Statements continued
Note 2 – Basis for preparation and
significant accounting policies continued
Research and development costs
Research costs are expensed as incurred. Internal
development costs related to the Group’s development of
products are recognised 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 recognised as an intangible asset if the Group
can demonstrate:
• Its 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 benets
• The availability of adequate technical, nancial and other
resources to complete the development and use or sell
the asset
• The ability to measure reliably the expenditure
during development.
Uncertainties related to the regulatory approval process and
results from ongoing 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 that qualies for recognition under IAS 38.
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 signicant individual parts of the assets have different
useful lives, they are recognised and depreciated separately.
Depreciation commences when the assets are ready for
their intended use.
An item of property, plant and equipment and any
signicant part initially recognised is derecognized upon
disposal or when no future economic benets 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 nancial 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.
Significant accounting policies
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 identied 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 benets
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 leases and exemptions
At the lease commencement date, the Group (the
Company) recognises 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 (dened as 12 months or less)
• Low value assets.
For these leases, the Group (the Company) recognises the
lease payments as other operating expenses in the
statement of prot or loss when they incurred.
Lease liabilities
The lease liability is recognised 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 comprise
of xed lease payments (including in-substance xed
payments), less any lease incentives receivable.
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Note 2 – Basis for preparation and
significant accounting policies continued
The lease liability is subsequently measured by increasing
the carrying amount to reect interest on the lease liability,
reducing the carrying amount to reect the lease payments
made and remeasuring the carrying amount to reect any
reassessment or lease modications.
The Group (the Company) does not include variable
lease payments in the lease liability. Instead, the Group
(the Company) recognises these variable lease expenses
in prot 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 comprises:
• The amount of the initial measurement of the lease
liability recognised
• 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 identied.
Financial assets
Initial recognition and measurement
Financial assets are classied, at initial recognition,
as subsequently measured at amortized cost, fair value
through other comprehensive income (OCI), and fair
value through prot or loss.
Financial assets are recognised initially at fair value plus,
in the case of nancial assets not recorded at fair value
through prot or loss, transaction costs that are attributable
to the acquisition of the nancial asset.
Financial assets at amortized cost
The Group measures nancial assets at amortized cost if
both of the following conditions are met:
• The nancial asset is held within a business model with
the objective to hold nancial assets in order to collect
contractual cash ows; and
• The contractual terms of the nancial asset give rise
on specied dates to cash ows 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
prot or loss when the asset is derecognized, modied
or impaired.
Financial assets at fair value through profit or loss
Financial assets at fair value through prot or loss are
carried in the statement of nancial position at fair value
with net changes in fair value recognised in the statement of
prot or loss.
The Group nancial assets at fair value through prot or loss
include money markets fund.
Impairment of financial assets
The Group assesses, at each reporting date, whether there
is objective evidence that a nancial asset or a group of
nancial assets is impaired. An impairment exists if one or
more events that has occurred since the initial recognition
of the asset (an incurred ‘loss event’), has an impact on the
estimated future cash ows of the nancial asset or the
group of nancial assets that can be reliably estimated.
Evidence of impairment may include indications that the
debtors or a group of debtors is experiencing signicant
nancial difculty, default or delinquency in interest or
principal payments, the probability that they will enter
bankruptcy or other nancial reorganization and observable
data indicating that there is a measurable decrease in the
estimated future cash ows, such as changes in arrears or
economic conditions that correlate with defaults.
The amount of any impairment loss identied is measured
as the difference between the asset’s carrying amount
and the present value of estimated future cash ows
(excluding future expected credit losses that have not
yet been incurred).
Financial liabilities
Initial recognition and measurement
Financial liabilities are classied, at initial recognition,
as nancial liabilities at fair value through prot or loss.
All nancial liabilities are recognized initially at fair value.
The Group’s nancial liabilities include trade and other
payables, and loans and borrowings.
The Group does not have nancial liabilities at fair value
through prot and loss.
Notes to the Financial Statements continued
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Note 2 – Basis for preparation and
significant accounting policies continued
Derecognition
A nancial liability is derecognized when the obligation
under the liability is discharged or cancelled or expires.
Share-based payments
The Group operates an equity-settled, share-based
compensation plan, under which the Group receives
services from employees and members of the Board 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
fullled in employee benets expense. The cumulative
expense recognized for equity-settled transactions at each
reporting date until the vesting date reects 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 prot 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 benets 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 nancial 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 prot nor taxable prot 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
recognised to the extent that it is probable that taxable
prot 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 sufcient taxable prot will be
available to allow all or part of the deferred tax asset to be
utilized. Unrecognized deferred tax assets are reassessed at
each reporting date and are recognized to the extent that it
has become probable that future taxable prots 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.
Deferred tax relating to items recognized outside prot or
loss is recognized outside prot 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 nancial 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 where the entity operates. Items included in
the nancial statements are measured using that functional
currency based on the primary economic environment
where the entity operates. The functional currency for the
Group’s entities are GBP and NOK.
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 prot or loss are translated at exchange rates
prevailing at the dates of the transactions. The exchange
differences arising on translation for consolidation are
recognised in OCI.
Notes to the Financial Statements continued
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Notes to the Financial Statements continued
Note 2 – Basis for preparation and
significant accounting policies continued
For consolidation purpose the following exchange rates
have been used:
31.12.2021 31.12.2020
NOK/GBP 11.89 11.64
Prot and loss from BerGenBio Limited has been converted
to NOK on a transaction by transaction exchange rate basis.
Transactions and balances
Transactions in foreign currencies are recorded at their
respective functional currency spot rates at the date the
transaction rst qualies 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 recognised in prot or loss as nancial items.
Cash and short-term deposits
Cash and short-term deposits in the statement of nancial
position comprise cash at banks and on hand and short-
term deposits with a maturity of three months or less, which
are subject to an insignicant risk of changes in value.
For the purpose of the statement of cash ows, cash and
cash equivalents consist of cash and short-term deposits, as
dened above. The indirect method is used to prepare the
statement of cash ow.
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 outow of resources embodying
economic benets 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
reects, when appropriate, the risks specic to the liability.
When discounting is used, the increase in the provision due
to the passage of time is recognised as a nance cost.
Pensions and other post-employment benefits
The Group have a dened contribution pension scheme for
all employees. Under the dened contribution scheme, the
Group does not commit itself to paying specic future
pension benets, but makes annual contributions to the
employee’s pension savings.
The Group’s payment to the dened 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
dened benet scheme, are given in Note 10.
New and amended standards and interpretations
The standards and interpretations that are issued, but not
yet effective, up to the date of issuance of the Group’s
nancial statements are disclosed in the following.
Note that only the ones that are expected to have material
impact on the Group’s nancial position, performance, and/
or disclosures are discussed. The Group intends to adopt
these standards, if applicable, when they become effective.
The following amendments became effective as at
1 January 2021:
• Interest Rate Benchmark Reform – Phase 2 – Amendments
to IFRS 9, IAS 39, IFRS 7, IFRS 4 and IFRS 16.
• Covid-19-Related Rent Concessions beyond 30 June
2021 Amendment to IFRS 16.
The amendments listed above did not have any impact on
the amounts recognised in prior periods and are not
expected to signicantly affect the current or future periods.
Changes in accounting policies and disclosures
The accounting policies adopted are consistent with those
of the previous nancial year, except for the amendments to
IFRS which have been implemented by the Group during
the current nancial year. No additional new standards have
been applicable for the Group’s 2021 nancial statements.
Other standards
Other standards, interpretations and amendments that are
issued, but not yet effective are either not applicable for the
Group or are not expected to have a material impact of the
nancial statements.
Note 3 – Significant accounting
judgements, estimates and assumptions
The preparation of the Group’s nancial statements requires
management to make judgements, 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 judgement, 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.
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Notes to the Financial Statements continued
Note 3 – Significant accounting
judgements, estimates and assumptions
continued
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 classied 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
insignicant risk of change in value. The evaluation of these
criteria require use of judgement. The purpose of the fund
is to meet short term commitments.
Note 4 – Segments and revenue
For management purposes the Group is organised as one
business unit and the internal reporting is structured in
accordance with this.
The Group has entered into an out-licence agreement
where development, regulatory and sales-based milestones
are due upon the occurrence of certain specic events. In
2021 or 2020 there has not been any clinical milestone
payment from this out-licence agreement and the revenue
represents refund of patent costs.
Note 5 – Payroll and related expenses
Parent 2020 Parent 2021 Group 2021 Group 2020
17,451 23,407 Salaries 58,910 37, 3 6 4
3,209 3,423 Social security tax 7,728 5,840
1,523 1,496 Pension expense 4,343 3,075
3,500 1,118 Bonus 4,466 6,062
904 421 Other remuneration 855 1,291
(2,014) (1,657) Government grants (6,373) (4,800)
24,573 28,206 Total payroll and other employee related cost 69,929 48,832
7,412 7,113 Share option expense employees 7,113 7,412
3,934 (2,997) Accrued social security tax on share options (2,997) 3,934
11,346 4,116 Total employee share option cost 4,116 11,346
35,919 32,323 Total employee benet cost 74,045 60,177
16 16 Average number of full time equivalent employees 44 34
For individual remuneration to Executive Management and Board of Directors, please see Remuneration Report in the Governance section of the Annual Report.
Total compensation to Executive Management and Board of Directors compensation in 2021:
2021
Short-term employee benets 21,985
Post-employment benet 1,371
Other long-term benets 0
Termination benets 5,145
Share-base payment (period cost) 2,288
Total 30,789
OVERVIEW
01–03
STRATEGIC REPORT
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56–85
66
Annual Report & Accounts 2021
Notes to the Financial Statements continued
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 attract and retain 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 vest annually in equal tranches over a three-year period following the date of grant.
For the twelve months ended 31 December
2021 2020
Total options
Number of
options
Weighted average
exercise price
Number of
options
Weighted average
exercise price
Balance at 1 January 4,209,232 18.45 2,569,547 21.07
Granted during the period 1,379,871 28.55 2,026,663 15.00
Exercised during the period
1)
(1,195,272) 13.91 (102,500) 11.15
Forfeited and cancelled (832,934) 22.43 (284,478) 20.14
Balance at 31 December 3,560,897 22.96 4,209,232 18.45
1) Average share price at date of exercise was NOK 26.55 for 2021 (NOK 37.50 for 2020).
1.379.871 options were granted in the 12 month period ended 31 December 2021 and 2.026.663 options were granted in the 12 month period ended 31 December 2020.
In the Annual General Meeting on 22 March 2017 it was resolved a split of the shares so that one 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 three years at year-end.
The exercise price is calculated as the weighted average exercise price of the forfeited, cancelled and exercised options.
Vested options 2021 2020
Options vested at 1 January 1, 8 87, 201 1,701,981
Exercised and forfeited in the period (1,195,272) (163,552)
Vested in the period 849, 239 348,772
Options vested at 31 December 1,541,168 1,887,201
Total outstanding number of options 3,560,897 4,209,232
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 certicates) 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.
OVERVIEW
01–03
STRATEGIC REPORT
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56–85
67
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 6 – Employee share option program continued
The vesting period is the period during which the conditions to obtain the right to exercise must be satised. 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 66.54% expected future volatility has been applied . To nd the expected volatility, we use the Company’s annualised 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 2021 the value of the share options expensed through the prot or loss amounts to NOK 7.1 million (for the same period in 2020: NOK 7.4 million). In addition, a change in provision
for social security contributions on share options of NOK -3.0 million (for the same period in 2020: NOK 3.9 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
Outstanding Instruments Vested Instruments
Strike price
Number of
instruments
Weighted
Average remaining
contractual life
Weighted
Average
Strike Price
Vested
instruments
31.12.2021
Weighted
Average
Strike Price
15.00 1,370,768 6.27 15.00 490,754 15.00
16.01 217, 50 0 1.16 16.01 217, 50 0 16.01
24.00 160,000 2.00 24.00 160,000 24.00
25.00 430,319 5.30 25.00 341,442 25.00
28.50 130,000 4.83 28.50 130,000 28.50
28.55 1,050,838 7.35 28.55 0 0.00
46.70 201,472 4.40 46.70 201,472 46.70
3,560,897 1,541,168
Note 7 – Government grants
Government grants have been recognized in the prot or loss as a reduction of related expense with the following amounts
Parent 2020 Parent 2021 Group 2021 Group 2020
2,014 1,657 Payroll and related expenses 6,373 4,800
16,616 6,914 Other operating expenses 6,914 16,616
18,630 8,571 Total 13,287 21,417
OVERVIEW
01–03
STRATEGIC REPORT
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56–85
68
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 7 – Government grants continued
Grants receivable as at 31 December are detailed as follows:
Parent 2020 Parent 2021 Group 2021 Group 2020
2,551 755 Grants from Research Council, BIA 755 2,551
591 519 Grants from Research Council, PhD 519 591
4,750 4,750 Grants from SkatteFunn 4,750 4,750
0 0 Grants R&D UK 4,224 4,243
7,892 6,024 Total 10,248 12 ,135
BIA grants from the Research Council:
The Company currently has one grant from the Research Council, program for user-managed innovation arena (BIA) in 2021. One additional grant ended in December 2020.
The BIA grant (“Investigator-Initiated Trials for AXL driven cancers with high unmet clinical need”) totals to NOK 15.1 million and covers the period from February 2017 to January 2021.
The Group has recognised NOK 0.0 million in 2021 (2020: NOK 3.2 million) classied partly as reduction of payroll and related expenses and partly as a cost reduction of other
operating expenses.
The BIA grant (“AXL as a therapeutic target in brosis; biology and biomarkers”) has been awarded from 2019 and amount in total up to NOK 10.7 million. The Group has recognized
NOK 2.3 million in 2021 (2020: NOK 4.5 million) classied partly a 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. 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 fellows’ doctoral work.
The Group has recognised NOK 1.6 million in 2021 (2020: NOK 1.2 million) classied partly as a reduction of payroll and related expenses and partly as a cost reduction of other
operating expenses.
SkaeFunn:
R&D projects have 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
2018 until the end of 2020. The Company has applied for SkatteFunn from 2021 to 2024 and the application was approved in 2021. The Group has recognized NOK 4.8 million in 2021
(2020: NOK 4.8 million) classied partly as a reduction of payroll and related expenses and partly as a cost reduction of other operating expenses.
Innovasjon Norge:
BerGenBio has been awarded a NOK 24 million (USD 2.85m) grant from Innovation Norway to support the clinical development of BGB324 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 the end of 2020 recognized and received the total grant of NOK 24 million. The grant may be withdrawn under certain circumstances.
OVERVIEW
01–03
STRATEGIC REPORT
04–24
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25–55
FINANCIAL STATEMENTS
56–85
69
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 7 – Government grants continued
R&D tax grants UK:
BerGenBio Limited, a 100% subsidiary of BerGenBio ASA, has been granted R&D tax grants in the UK from 2017. R&D grants are approved retrospectively by application. The Group
has in 2021 recognized NOK 4.2 (2020: NOK 2.9 mill) classied as reduction of payroll and related expenses for the year 2021.
Note 8 – Property, plant and equipment
Year ended 31 December 2021 Parent/Group Furnitures
Equipment/
ttings
Right to
use property Total
Cost at 1 January 2021 137 1,632 3,195 4,964
Additions in the year 0 0 171 171
Disposals in the year 0 0 0 0
Cost at 31 December 2021 137 1,632 3,366 5,135
Accumulated depreciation at 1 January 2021 (39) (1,414) (1,178) (2,632)
Depreciation in the year (27) (123) (1,162) (1,312)
Accumulated depreciation at 31 December 2021 (66) (1,537) (2,340) (3,944)
Net carrying amount at 31 December 2021 70 96 1,026 1,191
Estimated useful life 5 years 5 years 2–5 years
Depreciation method Straight-line Straight-line
Over right
of use time
Year ended 31 December 2020 Parent/Group Furnitures
Equipment/
ttings
Right to
use property Total
Cost at 1 January 2020 70 1,632 1,178 2,880
Additions in the year 67 0 2,016 2,083
Disposals in the year 0 0 0 0
Cost at 31 December 2020 137 1,632 3,195 4,964
Accumulated depreciation at 1 January 2020 (22) (1,264) (620) (1,906)
Depreciation in the year (17) (151) (558) (726)
Accumulated depreciation at 31 December 2020 (39) (1,414) (1,178) (2,632)
Net carrying amount at 31 December 2020 97 218 2,016 2,332
Estimated useful life 5 years 5 years 2–5 years
Depreciation method Straight-line Straight-line
Over right
of use time
OVERVIEW
01–03
STRATEGIC REPORT
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25–55
FINANCIAL STATEMENTS
56–85
70
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 8 – Property, plant and equipment continued
Research & Development
Expenses for research and development for the nancial year 2021 for Parent/Group was gross NOK 268.5 million (net NOK 259.9 million reduced of grants NOK 8.6 million) of which
gross NOK 260.7 million (net NOK 258.7 million) was classied as other operating expenses and gross NOK 7.8 million (net NOK 6.1 million) was classied as payroll.
For 2020 gross NOK 225.5 million (net NOK 206.9 million reduced of grants NOK 18.6) was expensed for research and development, of which gross NOK 218.4 million (net NOK
201.8 million) was classied as other operating expenses and gross NOK 7 million (net NOK 5.0 million) was classied as payroll.
The gures are net of government grants that have been recognized in the prot or loss as a reduction of related expense.
Note 9 – Leases
The Group (the Company) as a leasee
The Company rent premises in Bergen, Norway, for ofce and laboratory purposes under two rental agreements. The rental agreements expired on 1 December 2020, and were
extended for an additional ve years. The rental agreements can be terminated by either party with a 6 months notice period. In addition, the Group rents ofce premises in UK. The
rental agreement can be terminated by either party with a one month notice period. The two rental agreements in Bergen are recognized on the statement of nancial position, while
the rental agreement in UK is considered a short term lease recognized directly in prot or loss.
Right-of-use assets
The Group (the Company) leases ofces. The Group’s (the Company’s) right-of-use assets are categorized and presented in Note 8.
OVERVIEW
01–03
STRATEGIC REPORT
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FINANCIAL STATEMENTS
56–85
71
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 9 – Leases continued
Lease liabilities
Summary of the lease liabilities Total
Total lease liabilities at 1 January 2020 585
New lease liabilities recognized in the year 2,016
Cash payments for the principal portion of the lease liability (585)
Cash payments for the interest portion of the lease liability (19)
Interest expense on lease liabilities 19
Currency exchange differences 0
Total lease liabilities at 31 December 2020 2,016
Total lease liabilities at 1 January 2021 2,016
New lease liabilities recognized in the year 171
Cash payments for the principal portion of the lease liability (564)
Cash payments for the interest portion of the lease liability (116)
Interest expense on lease liabilities 116
Currency exchange differences 0
Total lease liabilities at 31 December 2021 1,623
Current lease liabilities (Note 18) 681
Non-current lease liabilities 942
Total cash outows for leases 564
The leases do not contain any restrictions on the Group’s dividend policy or nancing. The Group does not have signicant residual value guarantees related to its leases to disclose.
Cash ow for lease recognized as operational expenses is NOK 1,799 (NOK 1,582 in 2020).
Undiscounted lease liabilities and maturity of cash outows 2020 2021
Less than 1 year
1–5 years
681
1,381
328
1,054
Total undiscounted lease liabilities at 31 December 2,062 1,382
Summary of other lease expenses recognised in prot or loss 2020 2021
Variable lease payments expensed in the period 0 0
Operating expenses in the period related to short-term leases (including short-term low value assets) 1,582 1,799
Operating expenses in the period related to low value assets (excluding short-term leases included above) 26 26
Total lease expenses included in other operating expenses 1,608 1,825
OVERVIEW
01–03
STRATEGIC REPORT
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25–55
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56–85
72
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 9 – Leases continued
Practical expedients applied
The Group has a lease agreement for ofces in Oxford. The lease agreement is short term and is renewed on a months basis. The Group also leases printers with contract terms of ve
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 recognise lease liabilities and right-of-use assets for short-term leases, presented in the
table above.
Extension options
The Group’s lease of buildings expire in 2022 and 2025. The 2025 lease agreement includes the option to extend for ve years from 2025. The Group (the Company) has not recognized
lease liability corresponding to the option period, as the Group (the Company) do not consider it reasonably certain that extension rights will be executed. The Group’s potential future
lease payments not included in the lease liabilities related to extension options is MNOK 2.6 (gross) at 31 December 2021.
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 a contribution pension scheme.
The Group’s payment to the dened 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 the Norwegian National Insurance basic amount).
Note 11 – Financial income and expense
Parent 2020 Parent 2021 Group 2021 Group 2020
Financial income
55 0 Interest income on tax repaid 0 55
4,367 3,130 Interest income on bank deposits 3,130 4,367
14,390 11,804 Other nance income 12,864 15,077
18,812 14,934 Total nancial income 15,993 19,499
Parent 2020 Parent 2021 Group 2021 Group 2020
Financial expense
26 7 Other interest expense 53 32
14,707 9,396 Other nance expense 10,841 15,405
14,733 9,403 Total nancial expense 10,894 15,437
4,079 5,531 Net nancial income 5,100 4,062
OVERVIEW
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25–55
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56–85
73
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 12 – Income tax
Parent 2020 Parent 2021 Group 2021 Group 2020
(258,563) (310,657) Prot before tax (309,364) (257,029)
(56,884) (68,345) Income taxes calculated at 22% (68,060) (56,546)
Adjustment in respect of current income tax of previous years
Changes in unrecognized deferred tax asset
1,631 1,565 Non-deductible expenses 1,565 1,631
(1,054) (1,054) Non-taxable income (1,951) (1,054)
Change in temporary differences
56,307 67, 8 3 4 Change in deferred tax asset not recognized 68,445 55,970
0 0 Tax expense 0 0
Income tax expense reported in income statement
Parent 2020 Parent 2021 Group 2021 Group 2020
Deferred tax assets (22% of temporary differences)
Pensions
(263,898) (332,706) Tax losses carried forward (332,706) (263,560)
(49) (58) Property, plant and equipment (58) (49)
Inventory
(1,322) (213) Other (213) (1,322)
265,268 332,976 Deferred tax asset not recognized 332,976 264,931
Deferred tax asset not recognized in other comprehensive income (OCI)
0 0 Deferred tax assets – gross 0 0
The Company has a tax loss of NOK 312.7 million in 2021, and in total a tax loss carried forward as of 31 December 2021 of NOK 1 512.2 million. There are no timing restrictions on
carrying forward the tax loss, and it can be carried forward indenitely.
The deferred tax asset has not been recognised in the statement of nancial position, as the Company does not consider that taxable income in the short-term will sufciently support
the use of a deferred tax asset.
OVERVIEW
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56–85
74
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 13 – Other operating expenses
Parent 2020 Parent 2021 Group 2021 Group 2020
163,442 191,316 Program expenses, clinical trials and research 193,076 163,442
752 649 Ofce rent and expenses 2,447 2,364
31,150 68,387 Consultants, R&D projects 12,744 21,792
6,041 7, 491 Patent and license expenses 7,491 6,041
41,880 22,857 Other operating expenses 31,035 23,766
(16,616) (6,914) Government grants (6,914) (16,616)
226,648 283,786 Total 239,880 200,788
Specification auditor’s fee
Parent 2020 Parent 2021 Group 2021 Group 2020
233 238 Statutory audit 400 336
248 20 Other assurance services 20 248
0 0 Other non-assurance services 71 68
12 12 Tax consultant services 71 69
493 270 Total 563 721
Amounts are excluding VAT.
The fees to Wellers, the statutory auditors of BerGenBio Limited, UK, amounted to NOK 109 for statutory audit, NOK 71 other non-assurance services, and NOK 59 for tax consultancy
services out of a total audit fee for the Group of NOK 563.
Note 14 – Earnings per share
Parent 2020 Parent 2021 Group 2021 Group 2020
(258,563) (310,657) Prot after tax (309,364) (257, 0 2 9)
74,919,830 87,956,563 Weighted average number of outstanding shares during the year 87,956,563 74,919,830
(3.45) (3.53) Earnings (loss) per share – basic and diluted (NOK) (3.52) (3.43)
Share options issued 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 increased 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.
OVERVIEW
01–03
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04–24
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25–55
FINANCIAL STATEMENTS
56–85
75
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 15 – Other current assets
Parent 2020 Parent 2021 Group 2021 Group 2020
7, 892 6,024 Government grants 10,248 12,135
772 676 Refundable VAT 676 772
726 637 Prepaid expenses 701 726
595 4,374 Other receivables 774 595
9,985 11,711 Total 12,398 14,228
Note 16 – Cash and cash equivalents
Parent 2020 Parent 2021 Group 2021 Group 2020
1,016 756 Employee withholding tax 756 1,016
217, 515 121,243 Short-term bank deposits 129,796 217,9 94
502,631 306,094 Money market funds 306,094 502,631
721,161 428,093 Total 436,646 721,641
Of the total balance in cash and cash equivalents, NOK 0.8 million (2020: NOK 1.0 million) relates to restricted funds for employees withholding taxes.
The Group’s short-term bank deposits are on variable rate terms.
Money market funds are classied 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.
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 2021 88,455,255 0.10 8,845,525.50
Ordinary shares 2020 87, 259,983 0.10 8,725,998.30
Changes in the outstanding number of shares
2021 2020
Ordinary shares at 1 January 87, 259,983 61,076,590
Issue of ordinary shares 1,195,272 26,183,393
Ordinary shares at 31 December 88,455,255 87,259,983
OVERVIEW
01–03
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56–85
76
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 17 – Share capital and shareholder information continued
Ownership structure as of 31.12.2021
Shareholder Number of shares
Percentage share
of total shares
METEVA AS 23,798,564 26.9%
INVESTINOR DIREKTE AS 7, 270,78 0 8.2%
FJARDE AP-FONDEN 4,487,493 5.1%
SARSIA SEED AS 2,117,90 0 2.4%
BERA AS 1,712,426 1.9%
VERDIPAPIRFONDET NORDEA AVKASTNING 1,510,174 1.7%
VERDIPAPIRFONDET NORDEA KAPITAL 1,504,740 1.7%
VERDIPAPIRFONDET KLP AKSJENORGE 1,440,000 1.6%
SARSIA DEVELOPMENT AS 1,175,000 1.3%
J.P. MORGAN BANK LUXEMBOURG S.A. NOM 1,088,228 1.2%
VERDIPAPIRFONDET NORDEA NORGE PLUS 909,260 1.0%
VERDIPAPIRFONDET NORDEA NORGE VERD 864,688 1.0%
MARIT MOHN 850,000 1.0%
MARSTIA INVEST AS 850,000 1.0%
NORDNET LIVSFORSIKRING AS 660,469 0.7%
LOUISE MOHN 509,676 0.6%
J.P. MORGAN BANK LUXEMBOURG S.A. NOM 430,541 0.5%
KEVIN ZAIM 374,000 0.4%
NORDNET BANK AB NOM 359,581 0.4%
RO INVEST AS 350,000 0.4%
Top 20 shareholders 52,263,520 59.1%
Total other shareholders 36,191,735 40.9%
Total number of shares 88,455,255 100.0%
The Board of Directors has been granted a mandate from the Annual General Meeting held on 19 March 2021 to increase the share capital with up to NOK 872,599.80 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 2022 and 30 June 2022. From 19 March 2021 to end of December 2021 there has been issued 633,673 new shares under this proxy at a nominal value of
NOK 63,367.30. See Note 4 for more information about the share incentive program and numbers of option granted.
The Board of Directors has been granted a mandate from the Annual General Meeting held on 19 March 2021 to increase the share capital with up to NOK 1,745,199.50 by subscription
of new shares. The proxy is valid until the earlier of the Annual General Meeting in 2022 and 30 June 2022.
OVERVIEW
01–03
STRATEGIC REPORT
04–24
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25–55
FINANCIAL STATEMENTS
56–85
77
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 17 – Share capital and shareholder information continued
Ownership structure as of 31.12.2020
Shareholder Number of shares
Percentage share of
total shares
METEVA AS 23,041,253 26.0%
INVESTINOR AS 7, 270,78 0 8.2%
FJARDE AP-FONDEN 3,623,698 4.1%
SARSIA SEED AS 2,117,90 0 2.4%
VERDIPAPIRFONDET ALFRED BERG GAMBA 1,918,329 2.2%
BERA AS 1,712,426 1.9%
MP PENSJON PK 1,572,983 1.8%
VERDIPAPIRFONDET KLP AKSJENORGE 1,540,000 1.7%
VERDIPAPIRFONDET NORDEA KAPITAL 1,524,740 1.7%
VERDIPAPIRFONDET NORDEA AVKASTNING 1,510,174 1.7%
VERDIPAPIRFONDET NORDEA NORGE VERD 1,212,488 1.4%
SARSIA DEVELOPMENT AS 1,175,000 1.3%
VERDIPAPIRFONDET ALFRED BERG NORGE 1,106,606 1.3%
VERDIPAPIRFONDET NORDEA NORGE PLUS 854,160 1.0%
MARIT MOHN 850,000 1.0%
MARSTIA INVEST AS 850,000 1.0%
VERDIPAPIRFONDET ALFRED BERG AKTIV 768,198 0.9%
J.P MORGAN BANK LUXEMBOURG S.A. NOM 740,428 0.8%
LOUISE MOHN 509,676 0.6%
VERDIPAPIRFONDET KLP AKSJENORGE IN 497,69 9 0.6%
Top 20 shareholders 54,396,538 61.5%
Total other shareholders 32,863,445 37.7%
Total number of shares 87, 259,98 3 99.2%
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.
OVERVIEW
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56–85
78
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 18 – Other current liabilities
Parent 2020 Parent 2021 Group 2021 Group 2020
1,784 1,351 Unpaid duties and charges 1,643 1,753
1,736 1,556 Unpaid vacation pay 1,556 1,736
650 681 Current lease liabilities 681 650
30,908 26,131 Other accrued costs 33,292 33,908
35,078 29,719 Total 37,172 38,046
Note 19 – Provisions
Social security
contributions on share
options Total
Balance at 1 January 2021 6,008 6,008
Additional provisions recognised (5,039) (5,039)
Balance at 31 December 2021 (969) 969
Current (969) (969)
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.
Note 20 – Financial instruments and risk management objectives and policies
The Group’s activities are exposed to certain nancial 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 nancial markets. The Group has NOK 436.6 million in cash and cash equivalents at year-end. The main
purpose of this is to nance 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 nancial assets and liabilities are carried at amortized cost except for money market fund which is at fair value. All nancial 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 nancial instruments measured at amortized cost.
The Group does currently not use nancial 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 uctuations in exchange rates. The exposure arises largely from research expenses. The Group is mainly
exposed to uctuations 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 ow is denominated in several currencies depending on where clinical trials are run. 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 necessary.
OVERVIEW
01–03
STRATEGIC REPORT
04–24
CORPORATE GOVERNANCE
25–55
FINANCIAL STATEMENTS
56–85
79
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 20 – Financial instruments and risk management objectives and policies continued
Interest rate risk
The Group holds NOK 436.6 million in 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 are exposed to market uctuations in interest rates, which affects the nancial income and the return on cash. The Group had NOK 3.1 million in interest income in 2021
(NOK 4.4 million 2020).
Credit risk
Credit risk is the risk of a counterparty’s default in a nancial asset, liability or customer contract, giving a nancial loss. The Group’s receivables are generally limited to receivables
from public authorities by way of government grants. The credit risk generated from nancial assets in the Group is limited since it is cash deposits. The Company only places its cash
in bank deposits and limited risk money market fund in recognized nancial institutions to limit its credit risk exposure. The Group had NOK 3.6 million in interest income in 2021
(NOK 4.4 million in 2020).
The Group has not suffered any loss on receivables during 2021 and the Group considers its credit risk as low.
Change in liabilities arising from nancing activities
Current lease
liabilities (Note 9)
Non-current lease
liabilities (Note 9)
1 January 2021 650 1,366
Cash ows (564) 0
New leases 171 0
Other 424 (424)
31 December 2021 681 942
1 January 2020 585 0
Cash ows (585) 0
New leases 650 1,366
Other 0 0
31 December 2020 650 1,366
Other includes the effect of reclassication of non-current lease liabilities to current. The Group classies interest paid as cash ow from operation activities.
Liquidity risk
Liquidity is monitored on a continual basis by Group management. Management considers the Group’s liquidity situation to be satisfactory. The Group raised total NOK 740 million in
equity funding during 2020. The cash position of the Group at year-end 2021 was NOK 436.6 million, compared to NOK 721.6 million at year-end 2020.
Capital management
The Board of Directors’ goal is to maintain a strong capital base in order to preserve the condence of investors, creditors and to develop business activities.
OVERVIEW
01–03
STRATEGIC REPORT
04–24
CORPORATE GOVERNANCE
25–55
FINANCIAL STATEMENTS
56–85
80
Annual Report & Accounts 2021
Notes to the Financial Statements continued
Note 21 – Subsidiaries
The Group’s subsidiaries at 31 December 2021 are set out below. The share capital consists 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
Place of business Oxford, U.K.
Ownership interest held by the Group 100%
Principal activities Management of clinical studies
Note 22 – Intercompany
BerGenBio ASA have entered into an intercompany management agreement with BerGenBio Limited. Services are delivered from BerGenBio Limited to BerGenBio ASA.
Parent 2021 Parent 2020
Purchase from BerGenBio Limited (included in other operation expenses) 63,612 48,077
Receivables BerGenBio Limited (included in other current assets, in 2020 included in current liabilities) 3,601 (1,075)
Note 23 – Subsequent events
The funding of ongoing operations is and will likely for a foreseeable time be depending on external sources, mainly through equity contributions. The geopolitical situation arising
during February 2022 has signicantly impacted the general nancial market conditions. Signicant long-term changes to nancial market conditions, may affect the climate for
investor investments.
Note 24 – Other information, COVID-19
The Company has been able to keep its operation ongoing in the COVID-19 pandemic without signicant impacts.
OVERVIEW
01–03
STRATEGIC REPORT
04–24
CORPORATE GOVERNANCE
25–55
FINANCIAL STATEMENTS
56–85
81
Annual Report & Accounts 2021
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
A member firm of Ernst & Young Global Limited
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 2021 and the income statement and other comprehensive income
for the year then ended, and notes to the financial statements, including a summary of significant
accounting policies.
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 2021 and their financial
performance and cash flows for the year then ended in accordance with International Financial Reporting
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 14 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 2021. We have determined that there are no key audit matters to
communicate in our report.
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 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
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
A member firm of Ernst & Young Global Limited
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 2021 and the income statement and other comprehensive income
for the year then ended, and notes to the financial statements, including a summary of significant
accounting policies.
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 2021 and their financial
performance and cash flows for the year then ended in accordance with International Financial Reporting
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 14 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 2021. We have determined that there are no key audit matters to
communicate in our report.
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 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
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
A member firm of Ernst & Young Global Limited
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 2021 and the income statement and other comprehensive income
for the year then ended, and notes to the financial statements, including a summary of significant
accounting policies.
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 2021 and their financial
performance and cash flows for the year then ended in accordance with International Financial Reporting
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 14 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 2021. We have determined that there are no key audit matters to
communicate in our report.
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 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
2
Independent auditor's report - BerGenBio ASA 2021
A member firm of Ernst & Young Global Limited
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 International Financial Reporting 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.
• 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
OVERVIEW
01–03
STRATEGIC REPORT
04–24
CORPORATE GOVERNANCE
25–55
FINANCIAL STATEMENTS
56–85
82
Annual Report & Accounts 2021
2
Independent auditor's report - BerGenBio ASA 2021
A member firm of Ernst & Young Global Limited
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 International Financial Reporting 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.
• 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
3
Independent auditor's report - BerGenBio ASA 2021
A member firm of Ernst & Young Global Limited
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 applicable, 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 communicated 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 our audit of the financial statements of BerGenBio ASA we have performed an assurance
engagement to obtain reasonable assurance whether the financial statements included in the annual
report, with the file name bergenbioasa-2021-12-31-en has 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 given with legal basis in 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 an annual report and iXBRL tagging of the consolidated
financial statements that complies with the ESEF Regulation. This responsibility comprises an adequate
process and such internal control as management determines is necessary to enable the preparation of
an annual report and iXBRL tagging of the consolidated financial statements that is compliant with the
ESEF Regulation.
Auditor’s responsibilities
Our responsibility 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 based on the
evidence we have obtained. We conducted our engagement in accordance with the International
Standard for Assurance Engagements (ISAE) 3000 – “Assurance engagements other than audits or
3
Independent auditor's report - BerGenBio ASA 2021
A member firm of Ernst & Young Global Limited
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 applicable, 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 communicated 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 our audit of the financial statements of BerGenBio ASA we have performed an assurance
engagement to obtain reasonable assurance whether the financial statements included in the annual
report, with the file name bergenbioasa-2021-12-31-en has 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 given with legal basis in 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 an annual report and iXBRL tagging of the consolidated
financial statements that complies with the ESEF Regulation. This responsibility comprises an adequate
process and such internal control as management determines is necessary to enable the preparation of
an annual report and iXBRL tagging of the consolidated financial statements that is compliant with the
ESEF Regulation.
Auditor’s responsibilities
Our responsibility 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 based on the
evidence we have obtained. We conducted our engagement in accordance with the International
Standard for Assurance Engagements (ISAE) 3000 – “Assurance engagements other than audits or
4
Independent auditor's report - BerGenBio ASA 2021
A member firm of Ernst & Young Global Limited
reviews of historical financial information”. The standard requires us to plan and perform procedures to
obtain reasonable assurance that the financial statements included in the annual report have been
prepared in accordance with the ESEF Regulation.
As part of our work, we performed procedures to obtain an understanding of the company’s processes for
preparing its annual report in XHTML format. We evaluated the completeness and accuracy of the iXBRL
tagging and assessed management’s use of judgement. Our work comprised 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, 7 April 2022
ERNST & YOUNG AS
___________________
Truls Nesslin
State Authorised Public Accountant (Norway)
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
A member firm of Ernst & Young Global Limited
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 2021 and the income statement and other comprehensive income
for the year then ended, and notes to the financial statements, including a summary of significant
accounting policies.
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 2021 and their financial
performance and cash flows for the year then ended in accordance with International Financial Reporting
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 14 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 2021. We have determined that there are no key audit matters to
communicate in our report.
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 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
OVERVIEW
01–03
STRATEGIC REPORT
04–24
CORPORATE GOVERNANCE
25–55
FINANCIAL STATEMENTS
56–85
83
Annual Report & Accounts 2021
WEF Metric: GovernanceWEF Metric: PlanetWEF Metric: People
WEF index and data summary
Theme Disclosure reference Metric 2020 2021 Report reference
Governing Purpose The British Academy and Colin Mayer, GRI
(102-26), EPIC and others
Setting purpose Qualitative Qualitative
Quality of Governing
Body
GRI (102-22), GRI (405-1a), IR (4B) Total number of Board members (#) 5 5 Page 45
Board diversity (men/women) (%) 60/40 60/40 Page 45
Number of non-executive Board members (#) 5 5 Page 45
Number of independent Board members (#) 3 3 Page 45
Stakeholder Engagement GRI (102-21), GRI (102-43), GRI (102-47) Impact of material issues on stakeholders Qualitative Qualitative
Ethical Behaviour GRI (205-2), GRI (205-3) Percentage of employees receiving Code of conduct training (%) 0 0 Pages 17, 20, 21
and 54
Conrmed incidents of corruption (#) 0 0 Page 20
GRI (102-17) Protected ethics advice and reporting mechanism Qualitative Qualitative
Risk and Opportunity
Oversight
EPIC, GRI (102-15), World Economic Forum
Integrated Corporate Governance, IR (4D)
Integrating risk and opportunity into business processes Qualitative Qualitative
Responsible sourcing Own indicator, adapted from GRI (408-1.b),
GRI (409-1)
Number of material suppliers who undertook supplier ESG self-
assessment (#)
0 0 Page 21
Climate Change GRI 305:1-3; TCFD; GHG Protocol Scope 2 total (tCO
2
e) – 5.89 Page 24
Scope 3 total (tCO
2
e) – 11.65 Page 24
Solid Waste Natural Capital Protocol (2016); ISO 14008:
Monetary valuation of environmental impacts and
related environmental aspects (2019); Value
Balancing Alliance
Impact of solid waste disposal Qualitative Qualitative
Dignity and Equality GRI (102-8) Total number of employees (#) 42 46 Page 22
GRI (405-1.b) Employee diversity (Men/women) (%) 41/59 37/63 Page 22
BerGenBio indicator Number of interns/postgraduate students/ PhD students employed (#) 2 2 Page 23
Adapted, to include other indicators of diversity,
from GRI 401-1 (a & b)
Employees regularly receiving performance and development
evaluation (%)
100 100 Page 23
BerGenBio indicator Personnel with PhD (#) 16 19 Page 22
GRI (408-1.b), GRI (409-1) Conrmed incidents of discrimination (#) 0 0 Page 21 and 22
Risk of incidents of child, forced or compulsory labour Qualitative Qualitative
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WEF Metric: PeopleWEF Metric: Prosperity
WEF index and data summary continued
Theme Disclosure reference Metric 2020 2021 Report reference
Health and Well-being GRI (403-9.a & .b) Number of injuries 0 0 Page 23
Injury rate 0 0 Page 23
Norwegian Accounting Act Sick-leave (%) 2 1,4% Page 23
BerGenBio indicator Employee survey response rate (%) and engagement score (%) 84 / 84 75/80 Page 23
Patient Safety GRI (418-1) Total number of substantiated complaints received with regard to
patient personal data breach
0 0 Page 20
Employment and Wealth
creation
Adapted, to include other indicators of diversity,
from GRI 401-1 (a & b)
New hires (#) 14 16 Page 23
New hires diversity (men/women) (%) 21.5/78.5 41/59 Page 23
Turnover rate (%) 10 23 Page 23
GRI 201-1 and 201-4 Revenues (NOK Million) 0.6 0.8 Page 52
Operating costs (NOK Million) 261.7 315.2 Page 53
Employee wages and benets (NOK Million) 60.18 74 Page 33–39
Payments to governments (other than tax) (NOK Million) 0 0
Financial assistance from governments (NOK Million) 21.4 13.3 Page 69
As referenced in IAS 7 and US GAAP ASC 230 Share buybacks plus divided payments (NOK Million) 0 0
Community and Social
Vitality
Adapted from GRI 201-1 Total taxes paid (NOK Million) 5.8 7.7 Page 74
Innovation of Better
Products and Services
US GAAP ASC 730 Total R&D spend (#) 225.5 268.5 Page 71
Pharma Indicator, Industry best practice Number of patents granted (#) 10 18 Page 52
Pharma Indicator, Industry best practice Number of peer-reviewed publications BerGenBio has contributed
to (#)
2 4 Page 21
Pharma Indicator, Industry best practice Number of international presentations (#) 9 15 Page 21
Clinical Trial Conduct SASB (HC-BP-210a.1.)
Adapted from SASB (HC-BP-210a.1.)
Number of clinical trials registered and initiated during the year (#) 1 1 Page 20
Total number of discontinued clinical trials due to non-compliance (#) 0 0 Page 20
Adapted from SASB (HC-BP-210a.2.) Critical inspection ndings (#) 0 0 Page 20
Adapted from SASB (HC-BP-210a.3.) Total amount of monetary losses as a result of legal proceedings
associated with clinical trials (NOK million)
0 0 Page 20
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ACCORD Accelerating COVID-19 Research
& Development
ADC Antibody-drug conjugate
ADCT ADC Therapeutics SA
ALK Anaplastic lymphoma kinase
AML Acute Myeloid Leukaemia
AXL AXL tyrosine kinase receptor
BCL-2 B-Cell Lymphoma 2 gene
BGB BerGenBio
BGBIO BerGenBio ticker symbol on Oslo
Stock Exchange
CAR-T Chimeric Antigen Receptor T Cells
CSR Corporate social responsibility
EGFR Epidermal growth factor receptor
ECM Extracellular matrix
EndMT Endothelial-mesenchymal transition
ESG Environmental, Social and Governance
EU European Union
EY Ernst and Young AS
FDA Food and Drug Administration
GAS6 Growth arrest-specic 6 (AXL ligand)
GCP Good Clinical Practice
GHG Greenhouse Gas
GLOBOCAN Online Cancer Statistics Database
GMP Good Manufacturing Practice
HMA Hypomethylating agents (for AML)
IFU Industrial Development Award (Norwegian)
IFRS International Financial Reporting Standards
ISO International Organization for Standardization
IST Investigator Sponsored Trials
KPI Key Performance Indicator
LDAC Low-dose AraC
mAb Monoclonal antibody
MSD Merck & Co., Inc., d.b.a. Merck Sharp &
Dohme outside the United States and Canada
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
PhD Doctor of philosophy
PSCI Pharmaceutical Supply Chain Initiative
R&D Research & development
SARS-CoV-2 Severe acute respiratory syndrome
coronavirus 2
SDG Sustainable Development Goals
SEER US National Cancer Institute Cancer Program
SITC Society for Immunotherapy of Cancer
STK11 Serine/threonine kinase gene
STK11m Mutation(s) in the STK11 gene
TKI Tyrosine Kinase Inhibitor
UK United Kingdom
US United States
Glossary
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BerGenBio ASA
Jonas Lies vei 91, 5009 Bergen, Norway
Telephone: +47 55 96 11 59
E-mail: [email protected]
Investor Relations Contact
E-mail: [email protected]
Martin Olin
CEO
Rune Skeie
CFO
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
Telephone: +44 20 3709 5700
E-mail: [email protected]
Analyst Coverage
H.C. Wainwright & Co
Joseph Pantginis
Telephone: +1 646 975 6968
E-mail: jpantginis@hcwresearch.com
Arctic Securities
Lars Mørland Knudsen
Telephone: +47 41 70 72 80
E-mail: [email protected]
Carnegie
Ulrik Traner
Telephone: +46 8 5886 8589
E-mail: [email protected]
DNB Markets
Patrik Ling
Telephone: +46 8 473 48 43
E-mail: [email protected]
Edison Group
Sean Conroy
Telephone: +44 203 077 5700
E-mail: sconroy@edisongroup.com
Contact Us
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