Growing as
a leader in peptide
therapeutics
Company reg. no.
Zealand Pharma
Annual Report
2020
About Zealand Pharma
We intend to be a
leader in specialty
medicines focusing
on metabolic and
gastrointestinal diseases
and other rare disease
areas with significant
unmet medical needs
2Zealand Pharma ∞ Annual Report 2020
Overview 4
Zealand Pharma in short 5
Financial and sustainability highlights 6
Letter from the Chairman 7
Letter from the CEO 9
2020 Achievements 12
Consolidated key figures 13
2021 Outlook and objectives 14
Zealand Pharma’s first
independent launch 15
Established US Platform 17
Leveraging market presence 19
Five in 25 21
Zealand Pharma’s R&D platform
and pipeline 22
Peptide platform and pre-clinical
programs 23
Pre-Clinical Programs 25
Clinical Pipeline Overview 27
Three patient stories 28
Severe Hypoglycemia in diabetes 29
Congenital Hyperinsulinism 31
Type 1 Diabetes management 34
Other Hypoglycemic conditions 35
Obesity / Type 2 Diabetes 36
Short bowel syndrome 37
Corporate matters 40
Corporate governance 41
Corporate responsibility 44
Our People and culture 46
Risk management and internal control 48
Financial review 50
Shareholder information 53
Board of Directors 55
Corporate Management 58
Financial statements
Consolidated financial statements 60
Income statement 62
Statement of comprehensive income 62
Statement of financial position 63
Statement of cash flows 64
Statement of changes in equity 64
Business overview 65
Notes 66
Financial statements of
the parent company 100
Income statement 101
Statement of comprehensive income 101
Statement of financial position 102
Statement of cash flows 103
Statement of changes in equity 103
Notes 104
Alternative performance measures
for the group (non-audited) 117
Statement of the Board of Directors
and Executive Management 118
Independent auditor’s report 119
Other information 123
Sources 124
Addresses (company information) 124
Management review
Contents
CEO Letter
Read more on page
Patient stories
Read more on page
See our pipeline
Read more on page
3Zealand Pharma ∞ Annual Report 2020
Contents
Overview
Zealand Pharma in short 5
Financial and sustainability highlights 6
Letter from the Chairman 7
Letter from the CEO 9
2020 Achievements 12
Consolidated key figures 13
2021 Outlook and objectives 14
4Zealand Pharma ∞ Annual Report 2020
Overview
Zealand Pharma
in short
Every day we work to pursue our
mission of transforming patients’
lives through peptide innovations
and novel treatment solutions.
Our ambition is to be a leading provider of innovative peptide
therapeutics and novel treatment solutions to address the
unmet medical needs of patients. We have a unique peptide
research platform that we leverage to discover, develop and
commercialize innovative treatments focusing on metabolic
and gastrointestinal diseases, including rare disease areas. This
platform has enabled us to develop a broad pipeline of both
clinical and pre-clinical programs.
Headquartered in Copenhagen, we are a global company with
locations in Boston and Marlborough, MA, and New York, NY.
In , we established our commercial organization in the
U.S., where today we market the V-Go
®
insulin delivery device.
By , we plan to have five products on the market and are
working to make a number of our pipeline candidates available to
patients, beginning with the dasiglucagon auto-injector and pre-
filled syringe for severe hypoglycemia this year, pending regulato-
ry approval by the U.S. Food and Drug Administration (FDA).
Zealand Pharma at a glance
5x25
5 commercialized products by 2025
Fully integrated biotech with
U.S. commercial presence
329
Employees
Oces in Copenhagen, DK;
New York City, NY; Boston
and Marlborough, MA.
2020
Commercial
operation established
Commercial platform in
place to launch metabolic
and gastrointestinal
franchises
2
Strategic
partnerships
Boehringer Ingelheim and
Alexion Pharmaceuticals
4
Late stage assets
Three late-stage assets for
metabolic diseases, one for
GI diseases
Innovation
peptide research
platform and
robust pipeline
Find out more about Zealand at
zealandpharma.com/about-us
5Zealand Pharma ∞ Annual Report 2020
ZP in short
Restricted cashSecurities Cash and equivalents
Jan 2020 Dec 2020Jul 2020
150
200
250
300
440
642
664
1,160
1,380
1.257
Find out more at
zealandpharma.com/investor-relations
Financial and
sustainability
highlights
R&D investment, DKK
Revenue, DKK
Net operating expenses, DKK
ZEAL share price, DKK at Dec. ,
220.60
(-6% since Dec. 31, 2019)
Cash position, DKKm
353.3 m
(+756% v. 2019)
604.1 m
+8%
(v. 2019)
Employees (average)
297
53% in R&D
Administrative expenses, DKK
203.5 m
(+200% v. 2019)
1,092.1 m
(+74% v. 2019)
Share price, DKK
6Zealand Pharma ∞ Annual Report 2020
Financial and sustainability highlights
Letter from the Chairman
The start of
a new era
2020 marked Zealand Pharma’s
transformation from a small research
and development-focused company
to a fully integrated biopharmaceutical
company.
7Zealand Pharma ∞ Annual Report 2020
Letter from the chairman
When two visionary scientists founded the company
in 1998, it was only a dream that Zealand Pharma
would become an integrated biopharmaceutical
company. Today it is on the verge of its first poten-
tial independent product launch, has an established
commercial presence in the US, a broad and medi-
cally meaningful clinical pipeline, several promising
pre-clinical programs and a proven track record of
developing approved medicines. Thanks to a long-
term bold vision, exceptional global employees,
agility in an ever-evolving field and an unwavering
commitment to scientific discovery and patients,
Zealand Pharma is well positioned for success in a
new era.
Strength of our people
Zealand Pharma’s success is based on the collective
contributions from our talented employees, past and
present. Their creativity, teamwork, perseverance,
and ability to execute on our plans over the years
have contributed to our success. This really came
into focus in 2020, when we progressed against our
goals despite challenges presented by the COVID-19
pandemic. I am proud of and impressed by our grow-
ing team of talented professionals, who have chosen
to pursue their careers at Zealand Pharma.
Unique peptide platform
Our competitive and distinguishing advantage is our
unique peptide platform that allows us to design and
engineer highly innovative peptide or peptide-like
medicines. Since its inception, Zealand Pharma has
developed and commercialized two such medicines,
and in 2021, we expect to potentially achieve the
launch of dasiglucagon auto-injector and pre-filled
syringe for severe hypoglycemia by Zealand’s own
commercial subsidiary in the US. We are determined
to continue to build on our position of strength.
The courage to invest
Courage, boldness, and confidence are other influen-
tial elements that have transformed Zealand Pharma
into what it is today. In 2015, we made the bold de-
cision to rely less on partnerships so we could more
independently control our assets — and thereby our
future. We have demonstrated the courage to invest
significantly in our people and the R&D pipeline, as
well as our commercial capabilities in the US by ac-
quiring Valeritas.
The journey continues
While it has been a remarkable journey for Zealand
Pharma so far, our success is also built on a drive
for continual advancement. We feel an obligation to
always do more and create more value for patients,
shareholders, and society. We have significant poten-
tial, and we will continue to invest in developing new
medicines, expanding our research and development
eorts into new disease areas, and making our prod-
ucts available to as many patients as possible.
On behalf of the Board of Directors, I thank our
shareholders for your belief and support. I also thank
the CEO, Emmanuel Dulac, the Management team
and the rest of the organization for their fantastic
contributions and achievements in 2020. I look for-
ward to our continued collaboration to grow Zealand
Pharma even further.
Martin Nicklasson
Chairman of the Board of Directors
Our competitive and
distinguishing advantage is
our unique peptide platform
that allows us to design and
engineer highly innovative
peptide or peptide-like
medicines.
Martin Nicklasson
Chairman of the Board of Directors
8Zealand Pharma ∞ Annual Report 2020
Letter from the CEO
Ready to execute
on our potential
first independent
launch and pursue
our 2025 ambition
Zealand Pharma demonstrated the resilience,
energy, and innovative thinking that makes our
company unique as we faced the unprecedented
challenges presented by the global pandemic in
2020. Thanks to our employees’ dedication, we
kept our company, labs, and trials running, and also
started our transformation into a fully integrated
biopharmaceutical company with a commercial
presence in the US. We are now set up for our
potential first independent product launch in the
first half of 2021.
9Zealand Pharma ∞ Annual Report 2020
Letter from the CEO
It is with a great sense of pride that we at Zealand
Pharma reflect on 2020. Like so many other com-
panies across the globe, we encountered numerous
challenges due to the COVID-19 pandemic. Yet, we
worked to overcome them and pursue our strategic
objectives to transform into a fully integrated bio-
pharmaceutical company. Today we are in a strong
position as we approach the historical milestone of
independently launching our first product with the
anticipated launch of the dasiglucagon auto-injector
and pre-filled syringe for severe hypoglycemia in the
US in the first half of 2021 (pending approval).
This launch will also be an important step towards
achieving our 2025 vision. In the coming four years,
we aim to build on all of our earlier accomplishments
and leverage our platform and investments to expand
our leadership in peptides, conduct research and
development in new indications, and launch several
products as we build a high-performing commercial
organization.
Addressing COVID-19
The pandemic and the associated pressure on health
care systems, shutdowns, and restrictive health care
measures presented challenges to all facets of our
business. From the outset, our priority has been to
keep our employees, patients, business, and clinical
partners safe, while also supporting our communi-
ties’ eorts to reduce the transmission of COVID-19.
We quickly adapted to a much more virtual way of
working and managed to keep our company, labs,
and trials running.
We took measures to secure our discovery activities,
minimizing the impact of COVID-19 on our research
activities. Employees who could work from home
did so, while team members in laboratory facilities
worked in shifts to reduce the number of people
gathered at one time. We continued our clinical trials
while working with authorities, investigators, trial
sites, and contract research organizations to mini-
mize site visits and ensure optimal trial follow-ups.
We minimized business travel and relied on digital
technologies to meet virtually rather than in person.
Virtual meetings, trainings, and support also trans-
formed our engagement with health care providers
and patients, with whom we met less in person.
Progressing our clinical programs
Despite the circumstances of 2020, we accomplished
a lot, thanks to the resilience, energy, and innovative
thinking from our dedicated employees. For the first
time ever, we independently submitted a US Food
and Drug Administration (FDA) New Drug Applica-
tion (NDA) — for the dasiglucagon auto-injector and
pre-filled syringe for severe hypoglycemia — which
the FDA accepted in May. We are hopeful and excited
that, if approved, the dasiglucagon auto-injector and
pre-filled syringe for severe hypoglycemia can be-
come an important option for people with diabetes
and their caregivers to treat severe hypoglycemia.
Pending approval, the dasiglucagon auto-injector
and pre-filled syringe for severe hypoglycemia is
expected to become the first dasiglucagon–based
medicine made available to patients. We are also
developing dasiglucagon in Congenital Hyperinsu-
linism, a devastating ultra-rare disease, and we were
able to carry through the first Phase 3-trial in 2020,
with the next trial expected to read out this year. For
the bi-hormonal artificial pancreas pump, which also
uses dasiglucagon, we plan to initiate the pivotal
Phase 3-trial in 2021.
On behalf of the
Management team, and all
my other Zealand Pharma
colleagues, I extend my
thanks to our partners and
patients for trusting us. We
are committed to fulfilling
the significant potential
of Zealand Pharma and
realizing our mission to
transform patients’ lives
through peptide innovations
and novel treatment options.
Emmanuel Dulac
President and Chief Executive Ocer
Our partner, Boehringer Ingelheim (BI), progressed
the clinical development of BI-456909 with the initi-
ation of a Phase 2-trial in type 2 diabetes and obesity,
and plans to also pursue development in non-alco-
holic steatohepatitis (NASH).
We also made progress in the clinical development
of our gastrointestinal programs. Though the pan-
10Zealand Pharma ∞ Annual Report 2020
demic impacted patient recruitment for our Phase 3
trial with glepaglutide in Short Bowel Syndrome (SBS),
we kept the trial running. We also completed the first
Phase 1 trial with dapiglutide, a potential next gener-
ation of SBS treatment, and initiated another Phase 1
trial to move the program forward.
Expanding and advancing our early pipeline
In addition to our many clinical development pro-
grams, Zealand Pharma also has a broad pre-clinical
pipeline that gives us opportunities to grow our drug
portfolio candidates by expanding into new indica-
tions.
We made strong progress in our early pipeline dur-
ing 2020. We regained the worldwide rights to the
amylin-analog program from BI, and we expect to
start clinical development for this program in 2021.
In our GIP-program, which has potential for devel-
opment in multiple major diseases and compris-
es mono-, dual-, and triple-agonists, we selected
the lead molecule and progressed towards clinical
development. We also progressed our Alpha4Be-
ta7-program, which has the potential to provide our
first-ever oral peptide therapeutic. We are excited by
this prospect, as oral delivery could potentially ease
the use of peptide treatments for patients. It could
also make administering peptides easier and possibly
improve treatment and compliance.
Transforming to a fully integrated
biopharmaceutical company
While successfully driving our research and devel-
opment activities, we also managed to complete our
strategic objective of building our own commercial
platform in the US, thus transforming Zealand Phar-
ma into a fully integrated, global biopharmaceutical
company. We integrated sta and assets from Valer-
itas, growing our total number of employees world-
wide by approximately 50%, and gaining the V-Go
®
wearable insulin device. Through V-Go
®
, which is al-
ready on the market, Zealand has expanded its team
with a seasoned salesforce, laying the groundwork
for the potential launch of the dasiglucagon auto-in-
jector and pre-filled syringe for severe hypoglycemia.
Securing a strong financial position
With so many activities and achievements, we have
maintained a high level of investments across our
company. This is made possible by our strong financial
position, enhanced through a record-breaking capital
raise in Zealand’s history in June, raising DKK 658m.
This means we can continue to allocate adequate
resources, to ensure we achieve the highest value of
our assets.
Growing as a leader in peptide therapeutics
While 2020 was a successful year of transformation
for Zealand Pharma, we are focused and continue the
work needed to prepare to progress several products
as we build a high performing commercial organiza-
tion.
2021 will be a year of execution as we
set out to achieve our 2025 ambition
to expand our leadership in peptides,
conduct research and development in
new indications.
Five years ago, we were solely a Research &
Development- company with an early stage-pipeline.
Today, we have our own commercial presence in the
US, we have filed our first own marketing applica-
tion, are ready for our first ever independent product
launch and have a broad late-stage pipeline. This year
may be the end of the beginning for Zealand Pharma
as we enter yet another transformational year for the
company.
On behalf of the Management team, and all my other
Zealand Pharma colleagues, I extend my thanks to
our partners and patients for trusting us. We are
committed to fulfilling the significant potential of
Zealand Pharma and realizing our mission to trans-
form patients’ lives through peptide innovations and
novel treatment options.
Emmanuel Dulac
President and Chief Executive Ocer
11Zealand Pharma ∞ Annual Report 2020
2020
Achievements
In 2020, we took
a transformational
step by acquiring
and integrating our
US footprint, including
our commercialized
product V-Go.
Achievement
Built Zealand Pharma U.S. and
advanced launch readiness
• Established Boston-area oce for Zealand Pharma US operations
• Built US organization with key hires and through Valeritas acquisition
• Established launch readiness program for dasiglucagon auto-injector and pre-filled syringe
for severe hypoglycemia
Executed on the clinical
pipeline
• Dasiglucagon auto-injector and pre-filled syringe for severe hypoglycemia: Submitted NDA
to US FDA in Q1
• Dasiglucagon for congenital hyperinsulinism: First Phase 3 study completed, and second
Phase 3 study initiated
• Dasiglucagon for bi-hormonal artificial pancreas pump: End of Phase 2 meeting conducted
• Glepaglutide for short bowel syndrome: Patient enrolment in Phase 3 study advanced
• Dapiglutide for short bowel syndrome: Single Ascending Dose (SAD) executed, Multiple
Ascending Dose (MAD) trial initiated as part of Phase 1 program advancement
Advanced our early pipeline • Advanced four programs in pre-clinical development towards Phase 1 initiation (ZP8396
Amylin analog; complement C3 inhibitor
1
, ZP 10000 α4β7 integrin inhibitor; ZP6590 GIP; ZP
9830 Kv1.3 ion channel blocker)
Expanded our strong financial
and organizational position
• Completed the acquisition of Valeritas, with successful integration of US organization and
our commercialized product V-Go
• Boehringer-Ingelheim advanced our GLP-1/GLU to Phase II in type 2/Obesity and decided
to initiate a second program in non-alcoholic steatohepatitis (NASH) triggered a EUR 20
million milestone payment
• Secured a total of DKK 795 million in private placement over two rounds
¹ Partnered with Alexion Pharmaceuticals.
In addition, we advanced our pipeline programs,
most prominently submitting our first NDA for the
dasiglucagon auto-injector and pre-filled syringe for
severe hypoglycemia.
During the year we successfully kept our operations
running with a highly engaged work force through
the COVID-19 health crisis.
Find out more about Zealand at
zealandpharma.com/about-us
12Zealand Pharma ∞ Annual Report 2020
2020 Achievements
Consolidated key figures*
DKK ’
Income statement and
comprehensive income
Revenue , , , , ,
Gross margin , , , , ,
Research and development
expenses -, -, -, -, -,
Sales and Marketing expenses -,
Administrative expenses -, -, -, -, -,
Net operating expenses -,, -, -, -, -,
Operating result -, -, , -, -,
Net financial items -, , -, -, -,
Result before tax -, -, , -, -,
Income tax¹ -, , -, , ,
Net result for the period -, -, , -, -,
Comprehensive result
for the period -, -, , -, -,
Earnings/loss per share
– basic/diluted (DKK) -. -. . -. -.
Statement of financial position
Cash and cash equivalents , ,, , , ,
Marketable securities , , , ,
Cash, cash equivalents
and Marketable securities ,, ,, ,, , ,
Other assets , , , , ,
Total assets ,, ,, ,, , ,
Share capital (' shares) , , , , ,
Equity ,, ,, ,, , ,
Equity ratio² . . . . .
DKK ’
Cash flow
Cash outflow/inflow from
operating activities -, -, -, -, ,
Cash outflow/inflow from
investing activities -, -, , , -,
Cash outflow/inflow from
financing activities , , -, , ,
Purchase of property, plant
and equipment -, -, -, -, -,
Free cash flow³ -, -, -, -, ,
Other
Share price (DKK) . . . . .
Market capitalization (DKKm)⁴ , , , , ,
Equity per share (DKK)⁵ . . . . .
Average number of employees
Number of full time employees
at the end of the year
* The acquisition of the business from Valeritas is only reflected in key figures covering the period since April 2, 2020 being
the acquisition date.
¹ Zealand expects to be eligible to receive up to DKK 5.5 million in Danish corporate tax benefit related to R&D expenses
incurred for 2020, of which DKK 5.5 million has been recognized for the period ended December 31, 2020.
² Equity ratio is calculated as equity at the balance sheet date divided by total assets at the balance sheet date.
³ Free cash flow is calculated as the sum of cash flows from operating activities and purchase of property, plant and equip-
ment.
⁴ Market capitalization is calculated as outstanding shares at the balance sheet date times the share price at the balance sheet
date.
⁵ Equity per share is calculated as shareholders' equity divided by total number of shares less treasury shares.
13Zealand Pharma ∞ Annual Report 2020
Consolidated key figures
2021 Outlook
and Objectives
We expect 2021 to
be a year where we
continue to develop
as a fully integrated
biopharmaceutical
company, by launching
our first product and
thereby having two
marketed assets in the US
We will mobilize resources and galvanize our teams
to find ways to accelerate our late stage programs,
advance our early candidates and identify novel
treatment targets.
Financial guidance
In 2021, Zealand Pharma expects net product reve-
nue from the sales of its commercial products of DKK
220 million +/-10% compared to 2020 of DKK 161.3
million.
In 2021, Zealand Pharma expects revenue from exist-
ing license agreements. However, since such reve-
nue is uncertain in terms of size and timing, Zealand
Pharma does not intend to provide guidance on such
revenue.
Net operating expenses in 2021 are expected to be
DKK 1,250 million +/-10% compared to 2020 of DKK
1,092.1 million.
Objectives
Launch Dasiglucagon
auto-injector and pre-filled
syringe and
optimize commercialization
• Deliver on net revenue targets for V-Go and the dasiglucagon auto-injector and pre-filled
syringe for severe hypoglycemia (assuming FDA approval in March 2021)
Execute on the clinical pipeline • Dasiglucagon auto-injector and pre-filled syringe for severe hypoglycemia: Receive approv-
al from US FDA
• Dasiglucagon for congenital hyperinsulinism: Deliver second Phase 3 study and prepare
NDA/MAA for execution in 2022
• Dasiglucagon for bi-hormonal artificial pancreas pump: Initiate Phase 3 study
• Glepaglutide for short bowel syndrome: Finalize patient enrollment in Phase 3 study
• Dapiglutide for short bowel syndrome: Complete MAD Phase 1 program and decide on
Phase 2 study protocol
Enrich early pipeline and
develop our next generation
platform
• Advance pre-clinical drug candidates towards Phase 1
• Initiate new pre-clinical projects
• Develop our next generation peptide platform
Maintain a strong financial and
organizational position
• Ensure disciplined financial management and productive investments
• Focus company on operational performance and organizational health
14Zealand Pharma ∞ Annual Report 2020
2021 Outlook
Zealand Pharma’s
first independent
launch
Established US Platform 17
Leveraging market presence 19
Five in 25 21
"We are excited about the
prospect of launching
dasiglucagon auto-injector
and pre-filled syringe for
severe hypoglycemia as we
work tirelessly to deliver better
treatments to patients. With a
diversified pipeline and many
late-stage assets, we believe
‘Five in 25’ is possible."
Frank Sanders
President of Zealand Pharma U.S.
15Zealand Pharma ∞ Annual Report 2020
ZPs first independent launch - Indhold
Zealand Pharma’s
first independent
launch
With an established US platform
and commercial presence, we are
ready to introduce the dasiglucagon
auto-injector and pre-filled
syringe for severe hypoglycemia to
patients pending US FDA approval.
Dasiglucagon auto-injector
and pre-filled syringe for severe
hypoglycemia could potentially
become the first of five commercial
products to be launched by 2025.
16Zealand Pharma ∞ Annual Report 2020
Zealand Pharma’s first independent launch
Established US
Organization
In line with our strategy of
independently commercializing
our medicines, Zealand Pharma has
established its own fully-fledged
commercial operation in the US,
preparing us not only for the
dasiglucagon launch but for
the additional launches expected
by 2025.
In 2020, Zealand Pharma transformed from a primar-
ily R&D-focused company to a fully integrated bio-
tech company with an established footprint in the US
diabetes market. The establishment of our US com-
mercial platform is a pivotal element in our strategy,
and this transformation will allow us to independently
launch and market the medicines we develop on the
world’s biggest pharmaceutical market.
Accelerating commercial build-up
In April of 2020, we closed on a transaction with US-
based Valeritas Holdings, Inc., in which we acquired
all of the company’s assets including the marketed
V-Go
®
wearable insulin delivery device, providing us
with a commercial infrastructure and accelerating
our plans for build-up in the US. As part of the trans-
action, we gained an existing commercial organi-
zation and 110 employees, including approximately
75 sales representatives, all supporting systems,
processes, and the majority of established contracts,
US-based
in Marlborough,
Massachusetts
110 employees
including approximately
75 sales representatives
V-Go
®
One marketed product – a
wearable insulin delivery device
Acquired US activities in brief
as well as an operations site in Marlborough, Massa-
chusetts.
In parallel with the acquisition, we achieved an-
other historical milestone with the filing of our
first ever New Drug Application (NDA) with the US
Food and Drug Administration for the dasiglucagon
auto-injector and pre-filled syringe for severe hypo-
glycemia. Pending approval, the dasiglucagon au-
to-injector and pre-filled syringe for severe hypogly-
cemia will be the first product ever we launch on our
own, leveraging our US commercial platform.
By acquiring the already marketed V-Go
®
wearable
insulin delivery device, we immediately became a
commercially active company in the US, interacting
with key stakeholders in the diabetes space, including
patients, physicians and payors. Many of the these
stakeholders will also be essential for the successful
launch of the dasiglucagon auto-injector and pre-
17Zealand Pharma ∞ Annual Report 2020
Established US Platform
filled syringe. On top of its strategic value, V-Go
®
generates revenue that helps finance our significant
investments across commercial and Research & De-
velopment activities.
Successful integration
Due to the pandemic, the undertaking of integrating
our new colleagues and assets into Zealand Phar-
ma was done virtually with a very limited number of
physical meetings. We are proud to have risen to the
challenge and navigated this already complex task,
successfully completing the integration – increasing
the total number of employees by close to 50% –
according to plans and deadlines.
We also strengthened the US leadership team with
the appointment of Frank Sanders as President of
Zealand Pharma US. Having more than 25 years of
experience within commercial operations, Frank
joined from a position as general manager of the
US Commercial team at Sage Therapeutics and is a
member of Zealand Pharma’s global Corporate Man-
agement team.
We further expanded our operations in the US in July
of 2020 by opening a new oce in Boston, where
commercial operations are headquartered.
V-Go
®
wearable insulin delivery device
Designed to deliver insulin like the body does—gradually, during the day
and night—and replace both long-acting basal insulin and multiple meal-
time insulin injections, V-Go delivers a continuous basal insulin rate over
hours that mimics the body’s natural approach to all-day-and-night
blood sugar control. With a continuous, preset rate of fast-acting insulin
along with convenient, on-demand dosing at mealtimes (bolus dosing).
V-Go is designed to meet insulin needs throughout the day. Studies have
shown that V-Go provides better control of blood sugar levels than multi-
ple daily insulin injections.¹
¹ Lajara R, Nikkel C. Poster presented at: the International Society for Pharmacoeconomics and Outcomes Research nd Annual International Meeting; May ; Boston, MA.
18Zealand Pharma ∞ Annual Report 2020
For illustration onlyDasiglucagon
Leveraging market
presence for the
dasiglucagon
auto-injector and
pre-filled syringe
for severe
hypoglycemia
launch
With V-Go
®
marketed in the US, we
are well positioned with patients,
physicians and payors, to execute
an eective launch of dasiglucagon
auto-injector and pre-filled syringe
for severe hypoglycemia
pending approval.
Zealand Pharma is in a position of strength ahead
of the anticipated launch of the dasiglucagon
auto-injector and pre-filled syringe for severe
hypoglycemia, pending approval from the US Food
and Drug Administration. We plan to launch in late
June of 2021, following our PDUFA date of March 27,
2021.
With V-Go
®
already on the market, we will be able to
hit the ground running with the dasiglucagon launch.
Our sales representatives currently interact with
potential dasiglucagon prescribers including endo-
crinologists and diabetologists, covering the most
densely populated areas of the US.
Underdeveloped market
Dasiglucagon will address a US market where hy-
poglycemia is the most common cause for Emer-
gency Room (ER) visits for adults with diabetes, with
235,000 ER visits/year, of which 57,000 resulted in
hospitalizations
1
. Our highly experienced team of
sales, medical aairs, and market access profes-
sionals have a strong and active presence with US
medical opinion leaders, endocrinologists and diabe-
tologists, and major national and regional payors and
pharmacy benefit managers. Foundational marketing,
patient support, and commercial operations infra-
structure are being optimized ahead of the launch of
dasiglucagon.
~10%
annual market growth following new
entrant launches in 2019
New entrants have captured
approximately
~40%
volume market share
in 2020
Market volume
largely driven by Type 1 Diabetes
utilization (80% of TRx), with
additional penetration potential
across both Type 1 and Type 2
Diabetes patients at risk of severe
hypoglycemic events
$300M
total Gross Market Value (excluding
rebates & discounts)
Symphony Health, December TRx Quantity share and
Integrated WAC Sales
¹ Centers for Disease Control (CDC). Diabetes Statistics Report. .
19Zealand Pharma ∞ Annual Report 2020
Leveraging market presence for dasiglucagon m.v.
2017 2019 2020 2021*2018
USDm
Gross sales (WAC level)
0
50
100
150
200
250
300
350
* Assuming % market growth.
Source: Symphony, as referenced for previous actuals.
Dasiglucagon auto-injector and pre-filled syringe
launches in growing market
Severe hypoglycemia is an underdeveloped market.
While approximately 675,000 glucagon prescriptions
were filled in 2020, there are more than 8.2 million
adults on insulin therapy in the US.
The significant growth potential is already starting
to materialize, supported by introductions of new
treatment solutions.
The launch of dasiglucagon in this growing market,
may increase awareness of the benefits of the new
treatment options for this acute, life-threatening
condition.
20Zealand Pharma ∞ Annual Report 2020
Five in 25
Zealand Pharma’s broad pipeline
provides the potential to build a
diversified product portfolio with five
marketed products by 2025.
NDA submission, established US commercial organization,
strengthened US leadership, opened Boston oce
Accelerating late stage
development
Robust pipeline including
three late stage programs
Approaching commercialization
Establishing operations in the US
Dasiglucagon
auto-injector and
pre-filled syringe
for severe hypo-
glycemia
NDA submission for
dasiglucagon auto-injector
and pre-filled syringe for
severe hypoglycemia
US leadership, commercial,
medical and corporate
infrastructure
Opened Boston facility
Dasiglucagon
for congenital
hyperinsulinism
Glepaglutide
for short bowel
syndrome
Dasiglucagon
bi-hormonel
artificial pancreas
Establishing our Peptide Platform
Founded
World-leading peptide platform with
two medicines brought to market
Licensed partnerships
-
potential product launches in years
The anticipated launch of dasiglucagon auto-injector
and pre-filled syringe for severe hypoglycemia in the
US is potentially just the first of a number of launches
of new medicines from Zealand Pharma in the coming
years. Our goal is to have five commercialized products
in the US by 2025.
Dasiglucagon for severe hypoglycemia is the first
product in our franchise built on the dasiglucagon
molecule. The next potential launch is a continuous
infusion for the treatment of Congenital Hyperinsulin-
ism (CHI), a rare disease with often devastating conse-
quences for patients and their families. We expect our
second Phase 3 trial to readout in 2021.
We are also planning to start a Phase 3 trial with
dasiglucagon used in a fully automated bi-hormonal
pump, in collaboration with Beta Bionics. This "bionic"
pancreas has been shown in Phase 2 studies to achieve
more stable levels of blood glucose levels, while
reducing hypoglycemia. If successful, this opportunity
constitutes another potential launch of dasiglucagon in
the coming years.
In the gastrointestinal field we have the potential to
launch a new treatment for patients with Short Bowel
Syndrome (SBS). Glepaglutide, a long-acting GLP-2
analog, is being developed in an auto-injector with
potential for convenient weekly administration. It is
currently in Phase 3 and has been granted orphan drug
designation by the US FDA.
We are excited about the our first independent launch
of dasiglucagon for severe hypoglycemia and the
prospect of having multiple additional potential new
product launches in the metabolic and gastrointestinal
disease areas over the next 5 years.
21Zealand Pharma ∞ Annual Report 2020
Five in 25
Zealand Pharma’s
R&D platform
and pipeline
Peptide platform and pre-clinical programs 23
Pre-Clinical Programs 25
Clinical Pipeline Overview 27
Three patient stories 28
Severe Hypoglycemia in diabetes 29
Congenital Hyperinsulinism 31
Type 1 Diabetes management 34
Other Hypoglycemic conditions 35
Obesity / Type 2 Diabetes 36
Short bowel syndrome 37
“Our R&D ambition is to establish the
next-generation peptide therapeutic
platform and a commitment to continue
building a high value pipeline.”
Adam Steensberg
CMO and Head of R&D.
22Zealand Pharma ∞ Annual Report 2020
Zealand Pharma’s R&D platform and pipeline
Find out more in our movie on
zealandpharma.com/peptide-platform-video
Protein
Peptide
Peptide
Amino acid
Peptide platform
Zealand Pharma’s peptide platform
allows us to engineer peptide
analogs with enhanced biological
activity, extended duration of action
and increased stability to provide
innovative and better treatments for
a range of dierent diseases.
Since our founding in 1998, Zealand Pharma’s sole
focus has been on the discovery and development
of peptide-based medicines to harness the power
of native peptides and enhancing their eects. We
have a unique peptide platform and design pro-
cess built around a deep understanding of peptide
chemistry, formulation know-how and intellectual
property rights combined with advanced computer
science. This allows us to engineer peptide analogs
with enhanced biological activity, extended duration
Validated peptide platform and design process
Peptides
What do we want?
• Agonist/Antagonist of biological
function
• Mono/Dual pharmacology
• Inhibition of protein:protein
interactions (PPI)
Peptide
Therapeutics
Chemistry &
Formulation
Peptide starting points
• Rational design
• Libraries of venoms
• Libraries with linear or
cyclic peptides
Designed properties
• Potency
• Short or long-acting
• Physical stability
• Chemical stability
• Solubility
• Pharmacokinetics
of action and increased stability to provide innovative
and better treatments for a range of diseases.
Our peptide platform is validated by the fact that
Zealand Pharma has now advanced more than ten
novel peptide-analogs into clinical development, two
of which are currently marketed. 2021 will hopefully
see the approval of a third Zealand Pharma mole-
cule; dasiglucagon as the active ingredient in the
dasiglucagon auto-injector and pre-filled syringe for
severe hypoglycemia.
ZP Peptide Properties Patient Benefits
High potency Small volume,
subcutaneous
High stability Ready-to-use
Extended half-life Reduced dosing
frequency
High specificity Reduced side
eects
23Zealand Pharma ∞ Annual Report 2020
Peptide platform and pre-clinical programs
Vital to human health
Peptides are produced by all living organisms and
humans have peptides in every cell and tissue. They
can function as biological messengers (hormones)
carrying information between cells or organs and
thereby perform a wide range of essential functions,
e.g., regulating appetite and blood glucose and
stimulating tissue growth. This makes peptides vital to
keeping us functioning and healthy.
Native peptides are composed of amino acids (fifty
or less) in a linear or cyclic form, have powerful
biological functions but are inherently unstable and
short-lived in the bloodstream. To convert these
native peptides into eective peptide therapeutics
requires the instability and thus duration of action
to be corrected while maintaining or enhancing the
biological activity. This requires modifications to the
amino acid sequence of the peptide, generally using
substitution with another amino acid.
Nature’s own inventions
Zealand Pharma uses its unique in-depth understand-
ing of peptide chemistry and biology to focus the
substitution process on key amino acids to remove
the weak points that result in poor solubility, stability
or activity, and thus create new drug candidates. We
have successfully applied this approach to glucagon,
amylin, GLP-1, GLP-2 and GIP. Enhancing their natural
properties or combining their activities in single pep-
tides present multiple therapeutic opportunities.
Our peptide platform in brief
10 novel peptide-
analogs
in clinical development
Dasiglucagon
is a Zealand Pharma molecule; the
active ingredient in the dasiglucagon
auto-injector and pre-filled syringe for
severe hypoglycemia
23 years of
experience
where Zealand Pharma’s sole focus
has been on the discovery and
development of peptide-based
medicines
We base our research and development on endog-
enous peptides found in humans and peptides from
venoms from various animals. We also manipulate
bacteria to produce peptide libraries. In other words,
we make broad use of nature’s own inventions to
improve human health and quality of life.
In line with Zealand’s strategy to access cutting-edge
technology, we have a range of research collabo-
rations providing us with access to novel peptide
libraries or new technologies for peptide stabilization
and delivery.
Because of their unique features – specificity, phys-
ical size and attractive risk profile – peptide-based
medicines may allow us to in the future treat diseases
that we can’t treat today. Furthermore, they may ena-
ble us to treat more patients, initiate treatment earlier
and ensure better treatment compliance, all of which
could improve health outcomes.
24Zealand Pharma ∞ Annual Report 2020
Find out more in our movie on
zealandpharma.com/peptide-platform-video
Pre-Clinical
Programs
New technologies and scientific
advancements within peptides
enable Zealand Pharma to
continuously optimize our
peptide platform. Our Research
and Development capabilities
and current pre-clinical programs
provide opportunities to grow our
scientific and medical presence by
expanding into new indications like
obesity and inflammatory diseases.
Our pre-clinical pipeline contains
programs focused on analogs of
endogenous peptide hormones, as
well as programs with innovative
peptide candidates acting on
components of the complement
cascade, ion channels and other
target classes.
Long-acting amylinanalog
Amylin is derived from B-cells in the pancreas
and is co-secreted with insulin. It both regu-
lates blood glucose by delaying gastric empty-
ing after meal ingestion and directly mod-
ulates satiety signals in the brain. Preclinical
studies also suggest that amylin, like glucagon,
can increase energy expenditure, contributing
to its weight loss eect.
Our lead molecule, ZP, is a long-acting
analog of amylin designed to allow for co-for-
mulation with other anti-obesity treatments.
It has demonstrated significant weight loss in
pre-clinical models of obesity.
We plan on Initiating Phase clinical testing
In .
Long-acting GIP analogs
Glucose-dependent insulinotropic peptide
(GIP) is synthesized by K cells, which are found
in the proximal intestine. GIP receptors are
expressed in many organs and tissues includ-
ing the central nervous system, enabling GIP
to influence regulation of appetite and satiety,
while showing antiemetic eects. Thus, GIP
can contribute to the ecacy of other an-
ti-obesity peptides by both a complementary
eect and by providing an improved thera-
peutic window of the other peptide.
Our lead molecule, ZP, has shown addi-
tive eects when co-administered with a GLP-
RA in pre-clinical obese models. We expect
to bring the analog to Phase in .
Kumanyika S et al., N Engl J Med () :-
Programs focusing
on obesity
The global prevalence of obesity has tripled
since the mid-1970s with 650 million adults and
124 million children and adolescents suering
from obesity. In the US alone, more than 40% of
the population are considered obese
1
. We hope
to address the obesety pandemic with peptide
molecules with built-in dual-acting pharmacology
or molecules with mono pharmacology that can
be combined or co-formulated with other anti-
obesity treatments
25Zealand Pharma ∞ Annual Report 2020
Pre-Clinical Programs
Integrin αβ inhibitor
ZP is being developed as an orally
delivered peptide drug to target integrin αβ,
which is involved in the pathogenesis of in-
flammatory bowel disease (IBD). Specific bind-
ing to surface αβ on the T cells prevents the
interaction with MAdCAM- on the endothelial
cells, which plays a critical role in immune cell
recruitment to the intestinal tissue. This mode
of action has been clinically validated in IBD
by vedolizumab, an approved injection-only
αβ integrin inhibitor antibody. ZP is a
peptide ligand that selectively binds to αβ,
and its ecacy has been demonstrated in vivo
in IBD models. ZP has binding proper-
ties on par with marketed antibodies as well
as oral bioavailability as demonstrated in vivo.
We are currently exploring the optimal oral
formulation for this compound while we pro-
gress the program towards clinical testing.
Kv. ion channel blockers
Kv. is a potassium conducting ion channel,
which is selectively upregulated on T eector
memory cells. T eector memory cells play
a key role in autoimmunity and chronic
inflammation by releasing pro-inflammatory
cytokines, which drives tissue damage. The
anti-inflammatory eects of blocking the
Kv. ion channel have been demonstrated in
multiple pre-clinical models of autoimmune
diseases. The specific and selective location
of the Kv. on the eector memory T cells
makes it an attractive pharmaceutical target,
as blocking preserves the protective eects
of the rest of the immune system. ZP
is a potent and selective Kv. blocker with
potential to treat a broad range of T cell
driven autoimmune diseases. Currently we are
progressing the molecule into IND enabling
toxicity studies and aim to target inflammatory
bowel diseases as a first indication, with the
expectation to initiate Phase in .
Complement C inhibitor
The complement system is a part of the innate
immune system and a central component of
the complement cascade is the C protein.
Altered activation of the complement cascade
is implicated in many immune-mediated
diseases and in particular rare diseases such
as paroxysmal nocturnal hemoglobinuria, cold
agglutinin disease, myasthenia gravis and C
glomerulopathy. There is currently only one
approved drug to treat complement mediated
diseases: an antibody that blocks the comple-
ment cascade C, the final step in comple-
ment activation. We have selected a candidate
molecule that acts on C, upstream of C
and thus oering potential dierentiation and
broader utility than the current therapy. The
candidate peptide is potent, selective, and
long-acting and has the potential to be best-
in-class, which we are currently progressing
into the next stage of development in collabo-
ration with Alexion.
Programs focusing
on chronic inflammatory diseases
Peptide medicines have proven their eectiveness in other therapeutic
areas such as type 2 diabetes and obesity and we believe that they
represent a great opportunity for new innovation in the chronic
inflammatory diseases area. The programs we are progressing represent
high-profile peptide targets that have shown to be dicult to address with
small molecules and antibodies or orally available peptides against disease
targets that have already been clinically proven with injectable antibodies.
26Zealand Pharma ∞ Annual Report 2020
Clinical Pipeline
overview
Zealand has a robust clinical pipeline
with programs across all stages of
development, including two ongoing
Phase 3 programs and another
expected to be initiated in 2021.
Product Candidate Phase Phase Phase Registration Marketed
Dasiglucagon auto-injector
and pre-filled syringe
Read more page 29
Dasiglucagon
S.C. Continuous Infusion
Read more page 31
Dasiglucagon Bi-Hormonal
Artificial Pancreas Pump
Read more page 34
Dasiglucagon
Adjustable Mini-Dose
Read more page 34
BI
GLP-/GLU Dial Agonist
Read more page 36
Glepaglutide GLP- Analog
Read more page 37
Dapiglutide
GLP-/GLP- Dual Agonist
Read more page 37
Type Diabetes management
Congenital hyperinsulinism
Severe hypoglycemia
MetabolicGI & Inflammatory
PBH/ TD exercise-
induced hypo
Short Bowel Syndrome (SBS)
SBS+
Obesity/TD/NASH
27Zealand Pharma ∞ Annual Report 2020
Clinical Pipeline Overview
Three patient
stories
Each story provides a backdrop for
how a disease can aect everyday
life for a patient, their family and
caregivers, and illustrates why we
are committed to delivering next
generation therapeutics to help
change lives.
Severe hypoglycemia
Robert lives with type diabetes. Despite wearing an insulin
delivery device, he has had multiple experiences with severe
hypoglycemia and he worries every day about the risk of yet
again being put in this situation by his disease. Robert tells
about what it feels like when you have a critical drop in blood
glucose levels.
Read more on page
Congenital Hyperinsulinism
Crosby was born with congenital hyperinsulinism. His parents
were warned that having a CHI baby was ”going to be a really
tough journey.” They tell about the challenges they have faced:
from receiving a rare prenatal diagnosis of the condition, trying
to manage his volatile blood glucose levels.
Read more on page
Short bowel syndrome
Dependent on parenteral support to survive, Mike must con-
nect to infusion equipment for eight hours a day, six days a
week. He tells about how reducing the complexity – and time
spent – for parenteral support enables him to make his disease
a smaller part of his life, and avoid that the disease defines him
in any way.
Read more on page
28Zealand Pharma ∞ Annual Report 2020
Three patient stories
Find out more about Zealand at
zealandpharma.com/dasiglucagon-rescue
Severe
Hypoglycemia in
diabetes
Severe hypoglycemia is an acute,
life-threatening condition resulting
from a critical drop in blood glucose
levels. Unpredictable and among the
most feared complications of diabetes
treatment, severe hypoglycemia
requires another person for rescue.
~8 million people
With diabetes are on insulin therapy in the US³
~235,000 Emergency
Room Visits
Occur annualy in the US due to severe hypoglycemia³
Dasiglucagon auto-injector and pre-filled syringe
The dasiglucagon auto-injector is a ready-to-use auto-injec-
tor containing . mg dasiglucagon, designed to oer people
with diabetes fast, eective and reliable treatment for severe
hypoglycemia.
Achievements
In March , Zealand Pharma submitted the New Drug
Application (NDA) for the dasiglucagon auto-injector and pre-
filled syringe for severe hypoglycemia to the US Food and Drug
Administration (FDA), which accepted the submission for review
in May .
The NDA is based on the clinical program which was conclud-
ed in . In the pivotal and confirmatory Phase trials, the
primary and all key secondary endpoints were successfully
achieved with a median time to blood glucose recovery of
minutes. Results from a pediatric Phase trial demonstrated
that the median time to blood glucose recovery was also
minutes in this patient population.
Next steps
Under the Prescription Drug User Fee Act (PDUFA), the FDA has
set a target action date of March , . Pending approval,
Zealand Pharma expects to launch dasiglucagon auto-injector
and pre-filled syringe for severe hypoglycemia later in .
This will be our first independent product launch.
2021
PDUFA date
March 27
phase 3-trials met
all primary and key
secondary endpoints
10 minutes
median time to recovery in all
three phase 3-trials
Preferred
mode of administration by
patients, care givers and HCPs⁴
Strandberg RB, et al. Diabetes Res Clin Pract. :-.
El-Menyar A, et al. J Emerg Trauma Shock. :-.
Centers for Disease Control (CDC). Diabetes Statistics Report. .
⁴ Zealand Pharma commissioned market research.
3
29Zealand Pharma ∞ Annual Report 2020
Severe Hypoglycemia in diabetes
Robert Floyd
Robert was diagnosed with type
diabetes about years ago. Every-
day he has to deal with the chal-
lenges of the disease. When Robert
was diagnosed and started taking
insulin, the company he worked for
had complaints about him checking
his blood sugar and doing insulin
shots. There are still things Robert
can’t do anymore because of his
diabetes, things he used to do all the
time.
As part of living with type diabe-
tes, Robert has also experienced
hypoglycemia multiple times. Mild
hypoglycemia is blood glucose less
than mg/dL, moderate hypogly-
cemia is blood glucose less than
mg/dL, and severe hypoglycemia is
defined as having low blood glucose
levels that requires assistance from
another person to treat.
Read more of Robert’s story at
zealandpharma.com/roberts-story
"It hit me like a ton of
bricks. No warnings,
one minute I was fine,
next minute I wasn’t."
Robert Floyd
Living with type 2 diabetes,
on the experience of severe
hypoglycemia
30Zealand Pharma ∞ Annual Report 2020
Congenital
Hyperinsulinism
Congenital hyperinsulinism (CHI)
is an ultra-rare and devastating
congenital disorder in newborns.
It is caused by a defect in
pancreatic beta cells, resulting
in insulin overproduction.
This leads to persistently and
dangerously low blood sugar
levels (hypoglycemia).
Orphanet. https://www.orpha.net/consor/cgi-bin/Disease_Search.php?lng=EN&data_id=&Disease_Disease_Search_diseaseGroup=Congenital-hyperinsulini%E%%A.
Accessed March ,
Congenital Hyperinsulinism International. https://congenitalhi.org/congenital-hyperinsulinism/. Accessed March , .
1/25,000-1/50,000
is the ratio of births in which CHI occurs in most
countries. It is the most frequent cause of severe,
persistent hypoglycemia in newborn babies and
children¹.
Next Steps
A second Phase trial with children with CHI from days up
to one year of age is ongoing, with topline results expected in
.
Achievements
The first Phase trial with children with CHI aged months
to years completed enrollment in August, with topline
results announced in December. The trial showed that dasi-
glucagon, on top of standard of care (SOC), did not significantly
reduce the rate of hypoglycemia compared to SOC alone
when assessed by intermittent self-measured plasma glucose
(primary endpoint). However, hypoglycemia was reduced by
–% with dasiglucagon as compared to SOC alone when
assessed by blinded continuous glucose monitoring (explora-
tory analysis).
Dasiglucagon treatment was assessed to be safe and well tol-
erated in the study, and out of patients chose to continue
into the long-term extension study.
Substantial burden of disease²
• High resistance to existing medical treatment
• High risk of seizures and permanent brain injury
• Most severe cases require pancreatic surgery
• Prolonged hospitalization and intolerable burden
to patients, families, caregivers, and healthcare
systems
Dasiglucagon Subcutaneous Continuous Infusion
Dasiglucagon is a potential first-in-class glucagon analog for the treatment of children with CHI.
The potential of chronic dasiglucagon infusion delivered via a pump to prevent hypoglycemia in children with CHI is being evaluated
in a Phase program. The aim is to reduce or eliminate the need for intensive hospital treatment, reduce the frequency of severe
hypo glycemia and need for constant feeding, and to potentially delay or eliminate the need for pancreatectomy. The US Food and
Drug Administration and the European Commission both granted orphan drug designation to dasiglucagon for the treatment of CHI.
31Zealand Pharma ∞ Annual Report 2020
Congenital Hyperinsulinism
Phase 3 program
spanning
newborns to
12-year-olds
Trial 17109
– Completed
Trial 17103
– Ongoing
Open-label
extension
study 17106
–Ongoing
32 patients, age 3 months-12 years.
Trial completed
Hypo-prone, maximum therapy,
incl. pancreatic surgery
8 weeks of treatment
(4 weeks follow-up)
25 days of treatment
(4 weeks follow-up)
Allows for long-term data
Newly diagnosed, dependent
on IV glucose
Patients from 17109 and 17103 with
ongoing positive benefit/risk
12 patients, age 7 days-12 months.
First patients enrolled; phase 3 trial
readout expected in 2021
Maximum 44 patients,
age 1 month onwards
32Zealand Pharma ∞ Annual Report 2020
Phase 3 program spanning newborns to 12-year-olds
Crosby
Julie and her husband, Leighton, al-
ready knew during pregnancy that their
first child, Crosby, would be born with
CHI. The disorder may cause Crosby to
have cognitive and physical disabilities
if not treated adequately.
“I can close my eyes and
easily remember sitting
on the couch in our one-
bedroom apartment,
bawling hysterically,
trying to tell my mother
what's going on, not able
to speak about it”
Julie,
mother of Crosby, who has CHI
Read more of Crossby’s story at
zealandpharma.com/crosbys-story
33Zealand Pharma ∞ Annual Report 2020
Type 1 diabetes
management
In spite of newer insulins and
better administration systems,
the vast majority of people with
Type 1 diabetes are unable to reach
glycemic goals as defined by the
American Diabetes Association.¹
Maintaining good control of blood glucose levels for
a person with type 1 diabetes requires continuous in-
tervention with insulin. The amount of insulin admin-
istered is subject to continuous adaptation dictated
by the individual’s blood glucose levels, food intake,
activities such as exercise, sickness, prior insulin
injections, etc.
When too much insulin is injected, dangerously low
blood glucose levels can develop and rapid intake of
sugar-rich food is needed to prevent development of
severe hypoglycemia. Conversely, injecting too little
insulin will lead to dangerously high blood glucose,
which is also associated with significant acute and
chronic complications.
Despite progress with faster acting modern insu-
lins and novel insulin pumps connected to glucose
sensors, current therapies require considerable eort
by people with diabetes and their caregivers. As such,
Type 1 diabetes remains one of the most burdensome
diseases to manage.
Achievements
Beta Bionics initiated the pivotal insulin-only iLet trial in people
with type diabetes. Late in the year we had the End-of-
Phase meeting with the FDA to agree on the scope of the
bi-homonal iLet.
Next Steps
Together with Beta Bionics we expect to initiate the pivotal
bi-hormonal phase -trial with dasiglucagon in .
Pettus et al., Diabetes Care () ():–.
Russell S et al. . Conference. DIABETES TECHNOLOGY & THERAPEUTICS. Page A-.
The iLet
®
bionic pancreas is an investigational device limited by law to
investigational use. Not available for sale.
iLet™
A pocket-sized, dual-
chamber, autonomous,
glycemic control system
(investigational device)
Dasiglucagon for bi-hormonal artificial pancreas pump systems
Zealand is developing a ml cartridge containing mg/ml dasiglucagon, intended for use in bi-hormonal artificial pancreas pumps.
We are collaborating with Beta Bionics, developer of the iLet™, a pocket-sized, dual-chamber, autonomous, glycemic control
system. The iLet mimics a biological pancreas by calculating and dosing insulin and/or glucagon (dasiglucagon) as needed, based
on data from the diabetic person’s continuous glucose monitor. The iLet is the world’s first autonomous bionic pancreas device — a
bi-hormonal system leveraging lifelong machine learning and artificial intelligence to deliver insulin and glucagon analogs for the
autonomous treatment of type diabetes.
Top-line results from a phase -trial in patients with type diabetes demonstrated that the bi-hormonal iLet using dasiglucagon
provided superior glycemic control over the insulin-only iLet. During the bi-hormonal period, % of participants had a mean CGM
glucose level of < mg/dL, corresponding to the glycemic target recommended by the ADA. The corresponding number for the
insulin-only system was %. Importantly these glycemic targets were achieved while time spent with blood glucose levels < mg/
dL was only .% in the bihormonal and .% in the insulin-only arm.²
34Zealand Pharma ∞ Annual Report 2020
Type 1 Diabetes management
Other
Hypoglycemic
conditions
People with Type 1 diabetes often
experience hypoglycemia after
exercise and people who have
undergone bariatric surgery as a
treatment for obesity, experience
reactive hypoglycemia after
eating a meal. Today there are
no approved treatment options
for these conditions.
Next Steps
Initiation of a Phase outpatient study in people with Type
diabetes and in people with post-bariatric hypoglycemia in
. The studies will utilize a durable mini-dose pen, being
developed by Zealand Pharma.
Achievements
We reported positive results in from a Phase trial in with
dasiglucagon in PBH in March . The results demonstrated
a single mini-dose injection of dasiglucagon in post bariatric
hypoglycemic patients significantly reduced meal-induced
hypoglycemia compared to placebo in individuals who have
undergone gastric bypass bariatric surgery.
We also initiated a Phase low-dose dasiglucagon trial for the
prevention of insulin-induced hypoglycemia in Type diabetes
in .
Dasiglucagon mini doses
Mini-dose dasiglucagon may provide an attractive treatment
solution for people who experience hypoglycemic events such
as Type diabetics or those who experience post bariatric
hypoglycemia.
¹ Salehi M et al. JCEM ; ():-.
² Riddel MC et al. Lancet Diabetes Endocrinol. ;():-.
Post-bariatric hypoglycemia
Post-bariatric hypoglycemia can be severe and disabling. The
prevalence is believed to be between -% of people who un-
dergo bariatric surgery¹. There are no approved treatments for
these people and as such there is a large unmet medical need.
Exercise-induced hypoglycemia
Many people with Type diabetes experience episodes of
hypoglycemia during or after physical activity. This can result in
improper diabetes management, with many people not getting
to their recommended long-term glycemic targets². We believe
their is a high unmet medical need for novel treatment oppor-
tunities in this setting.
35Zealand Pharma ∞ Annual Report 2020
Other Hypoglycemic conditions
Next Steps
Two additional Phase -trials — one in obesity, one in NASH —
are planned for initiation in . The first Phase trial in type
diabetes is expected to complete this year.
Achievements
A Phase trial in patients with type diabetes was initiated
in , based on the safety, tolerability, and favorable weight
loss potential in individuals with a BMI up to kg/m² observed
in Phase . This triggered a EUR million milestone payment
to Zealand Pharma.
Long-acting GLP-/GLU dual agonist (BI )
The GLP-/glucagon dual agonist activates two key hormone receptors simultaneously and may oer better blood sugar and
weight-loss control than current single-hormone receptor agonist treatments. The lead molecule, BI , is targeting treatment
of obesity, type diabetes and non-alcoholic steatohepatitis (NASH).
Clinical development is carried out by Boehringer Ingelheim with whom Zealand Pharma has a long and productive partnership.
Boehringer Ingelheim has a track record of excellence in research and development in cardiometabolic diseases which has resulted
in important breakthroughs in recent years, especially in thromboembolic diseases and type diabetes.
Under the terms of the agreement, Boehringer Ingelheim funds all research, development and commercialization activities. Zealand
Pharma is entitled to receive up to EUR million in outstanding milestone payments. The agreement also carries high-single digit
to low-double digit percentage royalties on global sales.
Obesity /
Type 2 diabetes
Excessive weight and obesity are
among the leading risk factors for
heart disease, ischemic stroke, liver
diseases and type 2 diabetes as well
as for a number of cancers.
There are insucient therapeutic options available,
resulting in a high unmet medical need for safe and
eective treatments that achieve significant weight loss.
Include reference next to “Excessive weight and obesity…” (subtitle): Hruby A et al. Am J Public Health. ; (): –.
36Zealand Pharma ∞ Annual Report 2020
Obesity / type 2 diabetes
Short bowel
syndrome
Patients with Short bowel
syndrome (SBS) have undergone
massive intestinal surgery
resulting in significantly reduced
or complete loss of intestinal
function.
Underlying causes for SBS include inflammatory
bowel syndrome, intestinal infarction, radiation dam-
age or trauma, and recurrent intestinal obstruction
or congenital disorders.¹
,
²
,
³ SBS aects an estimated
20,000-40,000 people in the US and Europe.⁴
SBS patients cannot absorb adequate fluids and nutri-
tion taken orally, and those most severely aected
become dependent on home parenteral support to
survive. Home parenteral support is delivered through
daily infusion of intravenous fluids and nutrition via a
central venous catheter.¹
,
² Long-term use of paren-
teral support carries a risk of catheter-related blood
stream infections, blood clots, and organ impairment
including liver and kidney damage.² Patients are
required to connect to the infusion lines and pumps
for up to 16 hours every day, which can pose signifi-
cant restrictions on ability to engage in normal daily
activities.⁵
Limitations of current treatments
Management of SBS is a complex multidisciplinary
task with a focus on optimizing the patient’s hydra-
tion and nutritional status. It includes striking the right
balance between parenteral support and oral intake
of fluids and nutrition. Treatment with GLP-2 analogs
has demonstrated an increase in the absorptive ca-
pacity of the remaining intestine, thereby making the
patients less dependent on parenteral support with
some gaining full enteral autonomy.
Despite the clear benefits of reducing the depend-
ency on parenteral support, people treated with the
only currently available short-acting GLP-2 therapy
have shown high levels of treatment discontinua-
tion,¹
,
² emphasizing the need for more eective, less
complex and better tolerated treatments tailored to
the needs of SBS patients.
Achievements
Worked diligently to support the patients and investigators
in the Pivotal Phase trial to accommodate the constraints
Imposed by Covid-. While recruitment into the trial was
impaired in we have started to see patient enrolment
increasing towards pre-Covid levels after the Introduction of
vaccinations.
Next Steps
We continue to work closely with investigators on recruiting
participants and progressing the Phase trial.
Pending a continued positive development in enrolment we
expect the results of the trial in .
Pironi L et al. Clin Nutr ;:–
Jeppesen P. Expert Opinion Orphan Drugs ;:–
Bielawska B. Nutrients ;:–
Transparency Market Research; Short Bowel Syndrome Market,
Torres C. Current Paediatr ;:–; Bielawska B. Nutrients ;:–; Pironi L et al. Clin Nutr ;:–; Hofstetter S et al. Curr Med Res Opin
;:–
Glepaglutide
Glepaglutide is a long-acting GLP- analog being developed in an auto-injector with potential for convenient weekly administration.
GLP- molecules stimulate the growth of intestinal tissue, increase nutrient and fluid absorption, increase intestinal blood flow, and
reduce gastric secretion and emptying.
37Zealand Pharma ∞ Annual Report 2020
Short bowel syndrome
Achievements
We completed the first Phase a single-ascending dose, safety
and tolerability trial in healthy volunteers in Q . Dapiglu-
tide was found to have a good safety and tolerability profile,
and we observed a plasma half-life, of approximately
hours, allowing for once weekly dosing. We initiated and dosed
the first subjects in the Phase b multiple-ascending dose safe-
ty and tolerability trial in November.
Next Steps
We expect to complete the Phase b-trial in with the aim
of initiating Phase -development in .
Dapiglutide
Dapiglutide is a potential first-in-class and long-acting GLP-R/
GLP-R dual agonist. It’s designed to improve management of
SBS beyond what is achievable with regular GLP- treatments
and may represent a next level of innovation for helping SBS
patients to further realize the full potential for enteral autono-
my.
The gastrointestinal tract – in a healthy person and in a SBS patient
Normal person
Length of gastrointestinal tract
~8.5 m / ~25 ft
SBS patient
Length of gastrointestinal tract
<2 m / ~6.5 ft
38Zealand Pharma ∞ Annual Report 2020
Short bowel - case
Mike
Mike was born with an abnormal
cluster of veins in his small bow-
el. When that cluster had ruptured,
Mike progressed through a series of
surgeries that resulted in removing
approximately seven meters of his
intestine. Mike had now become a
patient with short bowel syndrome.
The remaining eight centimeters of his
intestine were not capable of absorbing
the nutrition and fluids Mike needed to
live, so he also became dependent on
parenteral support to survive. Reducing
the complexity – and time spent – for
parenteral support enables this driven
college football coach to get back in
the game.
“I want it (SBS) to be a
small part of my life. I
don’t want it to define
me in any way.”
Mike,
Living with short bowel syndrome
Read more of Mike's story at
zealandpharma.com/mikes-story
39Zealand Pharma ∞ Annual Report 2020
Corporate
matters
Corporate governance 41
Corporate responsibility 44
Our People and culture 46
Risk management and internal control 48
Financial review 50
Shareholder information 53
Board of Directors 55
Corporate Management 58
“2020 has been a year of
unparalleled growth and
transformation for Zealand and
we will continue to be financially
strong by eciently managing
the investments we make in our
research and development and
commercial organizations.”
Matt Dallas
Senior Vice President and
Chief Financial Ocer
40Zealand Pharma ∞ Annual Report 2020
Corporate matters
Corporate
Governance
Zealand’s approach to corporate
governance is founded on ethics and
integrity, and forms the basis of our
eorts to ensure strong confidence
from our shareholders, partners,
employees and other stakeholders.
Annual General Meeting
Board of Directors
Nomination
Committee¹
Corporate Management
Organization
¹ The full board acts as its own nomination committee.
Remuneration
Committee
Audit
Committee
41Zealand Pharma ∞ Annual Report 2020
Corporate Governance
Overview of meetings in 2020
Attended Absent
Audit Remuneration Nomination
Board Committee Committee Committee
Martin Nicklasson
Kirsten A. Drejer - -
Jerey Berkowitz -
Bernadette Connaughton -
Alain Munoz -
Leonard Kruimer -
Michael J Owen -
Jens Peter Stenvang - -
Hanne Heidenheim Bak
- - -
Frederik Barfoed Beck
- - -
Gertrud Koefoed Rasmussen
- - -
Iben Louise Gjelstrup
- - -
retired as board member afterr AGM
started as board member after AGM
42Zealand Pharma ∞ Annual Report 2020
CM - COVER
The charter of the Audit Committee is available at:
zealandpharma.com/audit-committee/
The charter of the Remuneration Committee, the re-
muneration report, the remuneration policy and the
guidelines for incentive pay are available at:
zealandpharma.com/remuneration-committee
The rules of procedure of the Nomination-Commit-
tee are available at:
zealandpharma.com/nomination-committee/
Evaluation of the Board of Directors
In an independent vendor, PWC, evaluat-
ed the Board of Directors.
The process included electronic ques-
tionnaires and one on one interviews with
members of the Board and members of the
Corporate Management. There were also one
on one meetings between the chairman and
each board member.
In general, there was a good level of satis-
faction reported with the operation of the
Board and its interaction with members of the
Corporate Management. The evaluation, in
general, revealed a good performance by the
Board of Directors as well as good collabora-
tion between the Board of Directors and the
Corporate Management.
Compliance with the Corporate
Governance Recommendations
Zealand complies with the Recommenda-
tions on Corporate Governance issued by the
Danish Committee on Corporate Governance,
November , , with one exception:
. Board committees (Recommendation,
section ..): The Remuneration and Com-
pensation Committee will be using the same
external advisers as the Executive Manage-
ment. The Board considers that the external
advisers will provide professional and unbiased
advice in both capacities: as advisers to the
Executive Management and to the Remunera-
tion Committee.
43Zealand Pharma ∞ Annual Report 2020
CM - Corporate Governance
Corporate
Responsibility
As we work toward realizing our
ambition of becoming a fully
integrated biopharmaceutical
company, to improve care for
patients and deliver value for our
shareholders, we further recognize
the importance of protecting the
world around us. We believe in
operating as a responsible company
that serves broader economic,
societal, and environmental interests.
Diversity
44Zealand Pharma ∞ Annual Report 2020
Corporate Responsibility
2020
2019
Men
Women
%
64 (67)
36 (33)
Quality in everything we do
Zealand Pharma
Board of Directors as of
December 31, 2020:
4 women and
7men
giving a female
representation of 36%
(2019: 33%).
Zealand Board of Directors
45Zealand Pharma ∞ Annual Report 2020
42 (42)
58 (58)
2020
2019
Men
Women
%
Our People
and culture
Our team's well-being, competency
development, and engagement
are key to realizing our ambitious
business goals. We strive to cultivate
a diverse, unique, energizing,
and respectful environment for
all employees, regardless of their
background.
Engagement
We are proud that close to 100% of employees across
all geographies and functional areas believe in the
future of Zealand, according to our 2020 engage-
ment survey results. Our people are as dedicated and
ambitious as ever, helping to achieve major organiza-
tional goals despite the global COVID-19 pandemic.
We aspire to maintain this level of engagement as we
continue our journey.
Talent
Zealand strives to be among the very best employers
in our industry as we continue our strategic focus
on building a world-class, fully integrated biophar-
maceutical organization. While building on Zealand’s
unique strengths and culture, Zealand is increasing-
ly diversifying our workforce to meet tomorrow's
demands and keep our innovation power to attract
"Everyday, our team approaches
discovery and research projects with
a unique combination of curiosity,
determination and enthusiasm. This is
the core of Zealand's success."
Rie Schultz Hansen
Vice President,
Discovery and Innovation
Zealand total
46Zealand Pharma ∞ Annual Report 2020
Our People and culture
and retain global talent, we refreshed our company
DNA in 2020 and values to reflect a global organ-
ization and the values we represent. Through the
co-business ownership of our employees, we can
continue to grow a company with highly specialized
employees committed to changing lives by evolving
our business and our pipeline
In 2020, the executive management team and
board of directors engaged in talent and succession
planning discussions to ensure business continuity
and health. Through the co-business ownership of
our employees, we can continue to grow a com-
pany with highly specialized employees committed
to evolving our business and our pipeline, who also
share our dedication to changing lives.
Safe work environment
Zealand works systematically to maintain a safe and
healthy work environment. We maintain numerous
procedures to support our work environment, and
train all Zealand employees in standard safety proto-
cols to enable self-management of their own occu-
pational safety.
47Zealand Pharma ∞ Annual Report 2020
Risk management
and internal
control
We constantly monitor and assess
the overall risk of doing business in
the pharmaceutical/biotech industry
and the particular risks associated
with our current activities and
corporate profile.
This section contains a summary of Zealand’s key risk
areas and how we attempt to address and mitigate
such risks. Environmental and ethical risks are cov-
ered in our corporate social responsibility reporting,
and risks related to financial reporting are covered in
our corporate governance reporting.
Doing business in the pharmaceutical/biotech indus-
try involves major financial risks. The development of
novel medicines takes several years, costs are high,
and the probability of reaching the market is relatively
low due to developmental and regulatory hurdles.
Zealand’s Management is responsible for imple-
menting adequate systems and policies in relation
to risk management and internal control, and for
assessing the overall and specific risks associated
with Zealand’s business and operations. Furthermore,
Zealand’s Management seeks to ensure that such
risks are managed optimally and in a responsible and
ecient manner.
Risks of particular importance to Zealand are scientif-
ic and development risks, commercial risks, intellec-
tual property risks, clinical trial risks, regulatory risks,
partner interest risks, and financial risks. Risk and
mitigation plans are monitored by Management, and
the continuous risk assessment is an integral part of
the yearly reporting to the Board of Directors.
Zealand risk and mitigation
Commercial activities
– products in research
and development
Research and
development
Risk
Risks relating to the sales
of V-Go
®
, market size,
competition, develop-
ment time and costs,
partner interest and
pricing of products in
development.
Research and develop-
ment of new pharma-
ceutical medicines is
inherently a high-risk
activity. The probabil-
ity of discovering and
developing an ecient
and safe new medicine
with strong IP protection
is very low.
Mitigation
Zealand maintains a
reporting system for
V-Go
®
to monitor the
product and will establish
a similar system for future
launches. From early in
the research phase and
throughout development,
commercial potential
and risks are assessed to
ensure that final products
have the potential to be
commercially viable. In
order to cope with the
restrictions imposed by
COVID- Zealand has
adapted its marketing ac-
titives to protect its sta
and patients.
Throughout the research
and development pro-
cess, Zealand regularly
assesses these risks by
means of a quarterly risk
assessment of all the
Company’s research and
development projects,
conducted by Manage-
ment together with the
department heads and
project managers. This
assessment, which is
presented to the Board of
Directors, describes each
project and measures its
progress based on mile-
stones. It analyzes the
individual risks of each
project and prioritizes the
project portfolio.
48Zealand Pharma ∞ Annual Report 2020
Risk management and internal control
Zealand risk and mitigation – continued
Clinical trials Intellectual property Regulatory Future partnerships Financial IT
Risk
Our product candidates will
need to undergo time-con-
suming and expensive trials to
document ecacy and safety,
the outcome of which is
unpredictable, and for which
there is a high risk of failure.
If clinical trials of our product
candidates fail to satisfactorily
demonstrate safety and e-
cacy to the FDA, the EMA and
other comparable regulatory
authorities, Zealand may incur
additional costs or experi-
ence delays in completing,
or ultimately not be able to
complete, the development
of these product candidates.
If Zealand or its partners were
to face infringement claims
or challenges by third parties,
an adverse outcome could
subject Zealand or its part-
ners to significant liabilities to
such third parties. This could
lead Zealand or its partners to
curtail or cease the develop-
ment of some or all of their
candidate drugs, or cause
Zealand’s partners to seek
legal or contractual remedies
against Zealand, potentially
involving a reduction in the
royalties due to Zealand.
The regulatory approval
processes of the FDA, the
EMA and other comparable
regulatory authorities are
lengthy, time consuming and
inherently unpredictable, and
if Zealand or its collaboration
partners are ultimately unable
to obtain regulatory approval
for their internal or outli-
censed product candidates,
Zealand’s business could be
substantially harmed.
Entering into collaborations
with partners can bring
significant benefits as well
as involve risks. In addition,
full control of the product is
often given to the partner.
Financial risks relate to cash
and treasury management,
liquidity forecasts and financ-
ing opportunities.
The company’s information
technology systems are key
to its operations and need
protection from intrusion
from unauthorized entry.
Mitigation
Zealand’s clinical project
teams work closely with
external expert clinicians and
product development experts
within the industry to design,
set up and conduct the
clinical programs. Zealand’s
employees have been select-
ed due to their extensive ex-
perience within their field of
expertise, receive training and
are continuously developed
to fulfill requirements. Zea-
land also engages in meetings
with regulatory authorities to
ensure that there is alignment
on the regulatory strategy and
trial requirements.
Zealand’s patent department
works closely with external
patent counsels and partners’
patent counsels to minimize
the risk of patent infringe-
ment claims as well as to
prepare any patent defense
should this be necessary.
Zealand’s employees receive
training and updates on
policies regarding the correct
and lawful management of
external intellectual property.
Zealand’s regulatory de-
partment works closely with
external consultants and
regulatory agents to develop
regulatory strategies and
frequently interacts with
regulatory agencies.
Zealand has taken a decision
to increase its focus on pro-
prietary programs in order to
decrease its dependence on
partners in the development
process and capture more of
the value of its projects.
Partnerships may still be
relevant in the future and, to
maximize the value of such
partnerships, Zealand strives
to foster a close and open
dialogue with its partners,
thereby building strong part-
nerships that work eectively.
Financial risks are managed in
accordance with the Finance
Policy, regularly assessed by
the Company’s Management
and reported to the Audit
Committee and the Board of
Directors. During and
Zealand has worked to
design and implement an In-
ternal Control Framework to
respond to the requirements
of the Sarbanes- Oxley Act as
a result of the US listing.See
also p. , note - Financial
risks.
The company employs
qualified IT professionals
who use external assistance
from qualified vendors to
provide advice on cyber-
security and systems security
were relevant. All members
of sta are trained in IT
security and its IT systems
use authentication systems
to reduce the risk of
unauthorized entry into its
systems. It has appropriate
protection from viruses and
malware. Its most sensitive
data is encrypted and subject
to restricted internal use.
49Zealand Pharma ∞ Annual Report 2020
CM - Corporate responsibility
Financial review
Financial review for the period
January 1 – December 31, 2020.
Comparative figures for the corresponding period in
2019 are shown in brackets except for the financial
position, which expresses the comparative figures as
of December 31, 2019.
Financial results
Revenue, cost of goods sold, and gross margin re-
ported for V-Go are as of the closing of the Valeritas
Asset Purchase on April 2, 2020 and do not include
figures from the first quarter of 2020.
Revenue
∆ in
DKK million ∆ percent
Sale of goods . . %
License and
milestone revenue . . . %
Total revenue . . . %
Revenue was driven by net sales of the V-Go wear-
able insulin delivery device, the phase 2 milestone
payment triggered in June 2020 from our partnership
agreement with Boehringer Ingelheim and revenue
recognition related to our collaboration with Alexion.
Gross margin
∆ in
DKK million ∆ percent
Gross margin . . . %
The increase in gross margin is due to V-Go sales
in 2020 and the revenue incurred as a result of the
Boehringer Ingelheim phase 2 milestone.
Research and development expenses
∆ in
DKK million ∆ percent
Research and
development expenses . . . %
The increase in research and development expenses
mainly relates to the regulatory eorts to support the
NDA filing for the dasiglucagon auto-injector and
pre-filled syringe for severe hypoglycemia, the on-
going clinical development of the dasiglucagon and
glepaglutide programs, as well as pre-clinical and re-
search activities for the Zealand early stage pipeline.
The R&D share of the personnel expenses for the
year ended December 31, 2020 was DKK 204.2
million (178.1). The increase is mainly related to an
increase in the number of employees in the clinical
development organization.
Sales and marketing expenses
∆ in
DKK million ∆ percent
Sales and marketing
expenses . . %
Zealand’s commercial activities commenced in 2020
with the acquisition of the Valeritas business in April
2020.
50Zealand Pharma ∞ Annual Report 2020
Financial review
Administrative expenses
∆ in
DKK million ∆ percent
Administrative
expenses . . . %
The primary increase in administrative expenses is a
result of the expansion of the company through the
Valeritas acquisition including consulting and legal
costs related to the transaction, new compensation
expenses for employees brought on board as part
of the acquisition, and administrative support for the
V-Go program.
Operating result
∆ in
DKK million ∆ percent
Operating result -. -. -. -%
The operating result reflects gross margin, research
and development expenses, sales and marketing and
administrative expenses, as discussed above and oth-
er operating expenses explained in note 7.
Financial income and financial expenses
∆ in
DKK million ∆ percent
Net financial items -. . -. -%
Financial income and financial expenses, which we
refer to collectively as net financial items, consist
of interest income and expense, dividend, banking
fees and impact from adjustments from changes in
currencies. The decrease is primarily driven by un-
favorable changes in currencies by DKK 39.5 million
and unfavorable impact from fair value adjustment by
DKK 2.1 million.
Result before tax
∆ in
DKK million ∆ percent
Result before tax -. -. -. -%
Result before tax reflects the operating result and net
financial items, as discussed above.
Income tax
∆ in
DKK million ∆ percent
Income tax -. . -. -%
The net income tax benefit is mainly impacted by
DKK 5.5 million related to the Danish tax credit
scheme (Skattekreditordningen) under which compa-
nies may annually obtain payment of the tax base of
losses originating from R&D expenses of up to DKK
25.0 million (tax value of DKK 5.5 million) and oset
by income tax expenses in USA.
No deferred tax asset regarding the Danish parent
company has been recognized in the statement of
financial position due to uncertainty as to whether
tax losses carried forward can be utilized within the
near term.
Net result
∆ in
DKK million ∆ percent
Net result -. -. -. -%
The increase is primarily a result of the increases in
Research and development and sales and marketing
expenses.
51Zealand Pharma ∞ Annual Report 2020
Liquidity and capital resources
Equity
Dec. Dec. ∆ in
DKK million , , ∆ percent
Equity ,. ,. -. -%
Equity ratio % % N/A N/A
Equity ratio is calculated as equity at the balance
sheet date divided by total assets at the balance sheet
date. The decrease in equity is driven by the loss for
the period oset by the costs from the direct issue
and private placement in June of DKK 657.7 million,
the private placement in March of DKK 137.2 million,
and issue of shares related to exercise of warrants of
DKK 31.8 million oset by the loss for the period and
costs incurred in connection with the capital increas-
es.
Cash, cash equivalents and
Marketable securities
Dec. Dec. ∆ in
DKK million , , ∆ percent
Cash, cash
equivalents and
Marketable securities ,. ,. . -%
The year over year decrease in cash and cash equiv-
alents is partially due by the increase in cash used for
operations as well as the USD 24.5 million payment
for the Valeritas asset purchase agreement oset by
capital increases resulting from a private placement
in March, a financing completed in June as well as
the EUR 20.0 million Boehringer Ingelheim milestone
triggered in June.
Cash flow
∆ in
DKK million ∆ percent
Cash used in
operating activities -. -. -. %
Cash used in
investing activities -. -. -. %
Cash flow from
financing activities . . . %
Net cash flow -. -. -. %
The increase in cash used in operating activities from
the same period in 2019 is mainly related to our
research and development and sales and market-
ing expenses increasing as a result of the regulatory
and pre-commercial activities for the dasigluca-
gon auto-injector and pre-filled syringe for severe
hypoglycemia as well as the commercial activities
and support for the V-Go wearable insulin delivery
device. Cash used in operating activities was positive-
ly impacted by the upfront payment from the Alexion
license agreement received in 2019.
Cash used in investing activities in 2020 related
mainly to the acquisition of Valeritas business of
DKK 167.7 million. Cash flow from investing activities
for 2019 was primarily related to the Beta Bionics
investment and the payment from Royalty Pharma for
royalty expenses related to the sale of future royalty
and milestones (remainder balance from the 2018
transaction).
Cash from financing activities increased primarily as
a result of the March private placement and June
financing in an aggregate amount of DKK 794.9
million. Cash from financing activities for 2019 was
mainly related to a capital increase as part of the
agreement with Alexion and a private placement
completed in 2019.
52Zealand Pharma ∞ Annual Report 2020
20 (43)
31 (22)
38 (2)
5 (11)
1 (7)
0 (6)
5 (9)
%
Denmark
United Kingdom
Sweden
France
Rest of Europe
Rest of World
United States
2020
2019
Shareholder
information
Zealand is dual listed on Nasdaq
Copenhagen and Nasdaq Global
Select Market, New York, under the
ticker symbol ZEAL.
At December 31, 2020, the nominal value of
Zealand’s share capital was DKK 39,799,706, divided
into 39,799,706 shares with a nominal value of DKK 1
each. Zealand Pharma completed a capital increase
in January 2021, following the registration of the new
shares, Zealand's nominal share capital amounts to
DKK 43,400,547 divided into 43,400,547 shares with a
nominal value of DKK 1 each.
In 2020 the share capital increased by a nominal
value of DKK 3.7 million through two directed issues
and private placements (DKK 3.4 million in total) and
exercise of employee warrants (DKK 0.3 million). All
Zealand shares are ordinary shares and belong to one
class. Each share listed by name in Zealand’s share-
holder register represents one vote at the annual
general meeting and other shareholders’ meetings.
Change in number of shareholders during 2020
The number of registered shareholders in Zealand
Pharma increased to 17,677 at December 31, 2020,
from 14,567 at December 31, 2019. In addition,
1,742,842 shares were represented by ADSs traded on
Nasdaq Global Select Market, New York.
At March 8, 2021, Zealand had 19,248 registered
shareholders, representing a total of 39,546,329
shares.
Institutional shares by geography
Ownership
The following shareholders are registered in
Zealand Pharma’s register of shareholders as being
the owners of a minimum of 5% of the voting rights
or a minimum of 5% of the share capital (one share
equals one vote) at March 2, 2021:
• Van Herk Investments, Netherlands (16.8% of
votes/16.8% of capital).
'See note for information on ownership per December ,
53Zealand Pharma ∞ Annual Report 2020
Shareholder information
Index
January February March April May June July August September October November December
60
70
80
90
100
110
120
130
140
Zealand Pharma OMX Copenhagen Mid Cap NASDAQ Biotech
Share price performance
The price of Zealand’s shares decreased by 6% during
2020 with a share price at year-end of DKK 220.6,
compared to DKK 235.4 at year-end 2019.
As of January 4, 2021, Zealand Pharma moved to the
Large Cap from the Mid Cap segment at Nasdaq
Copenhagen. The Large Cap segment includes com-
panies with a market value of EUR 1 billion or more.
Nasdaq charting 2020 of Zealand's share price
Annual General Meeting
The annual general meeting is scheduled to be
held on Thursday, April 15, 2021 at 3:00 PM CET, at
Zealand Pharma, Sydmarken 11, DK-2860 Søborg.
Additional information will become available at www.
zealandpharma.com/annual-general-meeting no lat-
er than 3 weeks before the annual general meeting.
Financial calendar
Date Event
April Annual General Meeting
May Interim report for Q
August Interim report for H
November Interim report for Q
All dates are subject to NASDAQ deadlines and reporting re-
quirements and are subject to change.
Find out more about our investor relations at
zealandpharma.com/investor-relations
Analyst coverage
Zealand is followed by the financial institutions and analysts
listed below:
Institution Analyst’s name
US
Guggenheim Etzer Darout
Morgan Stanley David N. Lebowitz
Needham Joseph Stringer
United Kingdom
Goldman, Sachs & Co. Graig C. Suvannavejh
Jeeries Peter Welford
France
Bryan, Garnier & Co Eric Le Berrigaud
Netherlands
Kempen Suzanne van Voorthuizen
Denmark
Carnegie Jesper Ilsøe
Danske Bank Thomas Bowers
Nordea Michael Novod
Core share data
Denmark U.S.
Number of shares ,, ,,
and ADSs at
Dec. ,
Listing Nasdaq Nasdaq Global Select
Copenhagen Market, New York
Ticker symbol ZEAL ZEAL
Index memberships Nasdaq STOXX Europe
Copenhagen TMI Pharm
Large Cap
54Zealand Pharma ∞ Annual Report 2020
CM - Financial review
Board of
Directors and
Corporate
Management
Martin Nicklasson Kirsten A. Drejer Jerey Berkowitz
Position Chairman Vice Chairman Board member
Year of birth 1955 1956 1966
Nationality Swedish Danish American
Gender Male Female Male
First elected 2015 2018 2019
Committee AuC, RemCo chair and
NomCo chair
NomCoo AuC, NomCo
Independent Yes Yes Yes
Special
competencies
Extensive general management
and research and development
experience from AstraZeneca Plc
and Swedish Orphan Biovitrum
AB.
More than years of interna-
tional experience in the phar-
maceutical and biotech industry.
Before co-founding Symphogen
A/S in , held several scientific
and managerial positions at Novo
Nordisk A/S.
Global executive with extensive
branded and generic pharmaceu-
tical, retail pharmacy, wholesale
drug distribution, specialty, payor
and healthcare services leadership
experience in P&L accountable
roles.
Current positions Chairman of the board of Kymab
Ltd. Board member of Basilea
Pharmaceutica Ltd.
Chairman of the board of Bioneer
A/S, Antag Therapeutics ApS, and
ResoTher Pharma ApS. Board
member of Bioporto A/S, Lyhne
& Co, and Alligator Bioscience.
Advisory board member of The
Faculty of Pharmaceutical Scienc-
es, Univ. of Copenhagen, and
DTU Bioengineering. Expert panel
member for InnoBooster grants.
Member of the Board of Directors
of H. Lundbeck A/S, Esperion
Theraptics, Inc. and Uniphar PLC.
Zealand shares at
December 31, 2020
2,570 800 200
Zealand warrants at
December 31, 2020
0 0 0
Change in owner-
ship in 2020
+1,570 +300 +200
Zealand Board of Directors at March 11, 2021
Find out more about the Board of Directors at
zealandpharma.com/
board-of-directors-and-nomination-committee
55Zealand Pharma ∞ Annual Report 2020
Board of Directors and Corporate Management
Bernadette Connaughton Leonard Kruimer Alain Munoz Michael John Owen
Position Board member Board member Board member Board member
Year of birth 1958 1958 1949 1951
Nationality American Dutch French British
Gender Female Male Male Male
First elected 2019 2019 2005¹ 2012
Committee AuC, NomCo AuC Chair, NomCo RemCo, NomCo RemCo, NomCo
Independent Yes Yes No Yes
Special
competencies
More than years of global strategic,
commercial and leadership expertise,
and a broad perspective on the strategy,
capabilities and governance required for
successful execution in U.S. and interna-
tional markets.
More than years of experience in
corporate finance, planning and strategy,
including years in senior executive
positions in private and publicly listed
biotechnology companies.
Physician qualified cardiology and
intensive care. Experience in the pharma-
ceutical industry at senior management
level. Served as SVP for international
development in the Sanofi Group and in
the pharmaceutical division of Fournier
Laboratories.
Research experience focusing on the
immune system and more than publi-
cations. Has held several leading positions
at GlaxoSmithKline, most recently as SVP
and head of biopharmaceuticals research.
Current positions Board member of Halozyme Therapeu-
tics, Inc. and Syneos Health, Inc.
Chairman of the Board of BioInvent
International AB and independent board
member of Oncolytics. Member of the
investment advisory council of Karmijn
Kapitaal. Director AI Global Investments
(Netherlands) PCC Ltd.
Independent board member of Amryt
Pharma, Auris Medical and Oxthera.
Member of the Scientific advisory board
of Valneva SE.
Chairman of the board of Ossianix Inc.
Member of the board of Avacta Group
plc, ReNeuron Group plc, Sareum
Holdings plc, Iksuda Therapeutics and
GammaDelta Therapeutics. Adviser to the
CRT Pioneer Fund.
Zealand shares at
December 31, 2020
500 4,000 5,250 300
Zealand warrants at
December 31, 2020
0 0 0 0
Change in owner-
ship in 2020
0 0 0 0
¹ Resigned in 2006 and re-elected in 2007.
² Employee-elected board members are elected for a period of four years.
Zealand Board of Directors at March 11, 2021, continued
56Zealand Pharma ∞ Annual Report 2020
Frederik Barfoed Beck
Gertrud Koefoed Rasmussen Iben Louise Gjelstrup Jens Peter Stenvang
Position Employee-elected board member¹ Employee-elected board member¹ Employee-elected board member¹ Employee-elected board member ¹
Year of birth 1967 1972 1977
Nationality Danish Danish Danish Danish
Gender Male Female Female Male
First elected 2020 2020 2020
Committee
Independent No No No No
Special
competencies
Current positions Senior Outsourcing Manager Director, Clinical Operations, GI and
Translational Development
Principal Laboratory Technologist Senior Application Specialist
Zealand shares at
December 31, 2020
4,798 0 840 ,
Zealand warrants at
December 31, 2020
9,700 10,750 2,750 ,
Change in owner-
ship in 2020
+2,000 0 +100 +,
¹ Employee-elected board members are elected for a period of four years..
Zealand Board of Directors at March 11, 2021, continued
57Zealand Pharma ∞ Annual Report 2020
Emmanuel Dulac Matthew Dallas Adam Steensberg Ivan Møller
Position Executive Management
President and
Chief Executive Ocer
Executive Management
Senior Vice President and
Chief Financial Ocer
Executive Management
Executive Vice President,
Research and Development, and Chief
Medical Ocer
Senior Vice President,
Technical Development and Operations
Year of birth 1969 1975 1974 1972
Nationality French American Danish American/Danish
Gender Male Male Male Male
Joined Zealand 2019 2019 2010 2018
Experience Prior to joining Zealand Pharma, Emmanuel
was Chief Commercial Ocer for Alny-
lam Pharmaceuticals, a biopharmaceutical
company based in Boston, where he was
responsible for establishing country opera-
tions and building commercial capabilities
to successfully launch their first commercial
drug.
Emmanuel is a board member of Proteosta-
sis Therapeutics, Inc.
Prior to joining Zealand Pharma, Matt served
as chief financial ocer at Aveo Pharmaceu-
ticals, leading finance for the publicly traded
biotechnology company and was addi-
tionally responsible for investor relations,
facilities and information technology. He was
previously CFO at CoLucid Pharmaceuticals,
which was acquired by Eli Lilly. His earlier
career included positions at Genzyme, NEN
Life Science Products, and Kimberly Clark.
Prior to joining Zealand, Adam led clini-
cal research teams as medical director at
Novo Nordisk and worked as a clinician at
Rigshospitalet, University of Copenhagen.
Adam was a medical and scientific advisor
in the areas of endocrinology, cardiology,
gastroenterology and rheumatology, and has
significant experience of leading regulatory
strategies.
Adam is a board observer at Beta Bionics, Inc.
and a board member of Cessatech ApS.
Prior to joining Zealand, Ivan worked for
Novartis in both generics and pharmaceu-
tical manufacturing, as well as in strategy,
quality assurance, contract manufacturing
and supply chain leadership in Germany, the
US and Switzerland.
Earlier, Ivan was project leader at Boston
Consulting Group in the pharmaceutical
R&D and manufacturing areas.
Zealand shares at
December 31, 2020
0 0 0 0
Zealand warrants at
December 31, 2020
113,848 51,275 208,286 81,420
Zealand PSUs at
December 31, 2020
8,835 0 5,065 2,803
RSUs at December
31, 2020
6,657 4,019 3,990 3,018
Change in ownership
in 2020
0 0 -17,011 0
Zealand Corporate Management at March 11, 2021
58Zealand Pharma ∞ Annual Report 2020
Corporate management
Marino Garcia Frank Sanders
Position Senior Vice President,
Business Development,
International Commercial and New Product
Planning
Senior Vice President,
President Zealand Pharma US, Inc.
Year of birth 1966 1969
Nationality Canadian/Spanish American
Gender Male Male
Joined Zealand 2018 2020
Experience Marino has almost years of global pharma
and biotech experience in senior com-
mercial, corporate strategy, and business
development roles. He has held various US.
and international leadership positions of
increasing responsibility at pharmaceutical
companies, including Synergy Pharma, Apta-
lis Pharma, Vifor Pharma, Aspreva Pharma-
ceuticals, Pfizer and Eli Lilly & Co.
Frank has an accomplished career with over years of experience
in the pharmaceutical industry. Prior to Zealand, Frank was Senior
Vice President, US Commercial for Sage Therapeutics, a biopharma-
ceutical company based in Cambridge, Massachusetts. At Sage, he
had direct General Manager responsibility for Sales, Account Man-
agement, Marketing, Patient Services and Commercial Operations
and was responsible for the design, build, and overall performance
of the US commercial function. Prior to joining Sage, Frank served
as Vice President, Market Access Strategic Account Management
at Janssen Pharmaceutical Companies of Johnson & Johnson and
held a wide range of leadership roles for GlaxoSmithKline including
Vice President, Customer Strategy and Vice President, Field Sales.
Zealand shares at
December 31, 2020
0 0
Zealand warrants at
December 31, 2020
80,711 43,217
Zealand PSUs at
December 31, 2020
3,062 0
RSUs at December
31, 2020
3,918 5,864
Change in ownership
in 2020
0 0
59Zealand Pharma ∞ Annual Report 2020
Financial
statements
60Zealand Pharma ∞ Annual Report 2020
Financial statements
Notes
1 Significant accounting policies, and significant
accounting estimates and assessments 66
2 Revenue 71
3 Royalty expenses 75
4 Research, development and administrative expenses 76
5 Fees to auditors appointed at the Annual
General Meeting 76
6 Information on sta and remuneration 76
7 Other operating, net 81
8 Financial income 82
9 Financial expenses 82
10 Income tax 83
11 Basic and diluted earnings per share 84
12 Impairment 85
13 Intangible assets 86
14 Property, plant and equipment 87
15 Right-of-use assets and lease liabilities 89
16 Inventory 90
17 Other investments 91
18 Trade receivables 91
19 Prepaid expenses 91
20 Other receivables 92
21 Marketable securities 92
22 Cash and cash equivalents 92
23 Share capital 92
24 Deferred revenue 93
25 Provision 93
26 Other liabilities 94
27 Contingent assets, liabilities and
other contractual obligations 94
28 Financial risks 94
29 Business combinations 97
30 Related parties 99
31 Adjustments for non-cash items 99
32 Change in working capital 99
33 Significant events after the balance sheet date 99
34 Approval of the annual report 99
Contents –
consolidated
financial
statements
Consolidated financial statements
Income statement 62
Statement of comprehensive income 62
Statement of financial position 63
Statement of cash flows 64
Statement of changes in equity 64
Business overview 65
61Zealand Pharma ∞ Annual Report 2020
Con Fin – Content
Consolidated statements of comprehensive income for the years ended
December , , and
DKK thousand Note
Net result for the year -846,729 -571,541 581,278
Other comprehensive income
Items that will be reclassified to income statement
when certain conditions are met:
Exchange dierences on translation of foreign operations 8,977 0 0
Comprehensive result for the year -837,752 -571,541 581,278
Total comprehenvise income attributable to
shareholders of Zealand Pharma A/S -837,752 -571,541 581,278
The Business overview on page and the accompanying notes on pages to form an
integral part of these financial statements.
Consolidated income statement for the years ended
December , , and
DKK thousand Note
Revenue 353,314 41,333 37,977
Cost of goods sold -90,565 0 0
Royalty expenses 0 -415 -3,356
Gross margin 262,749 40,918 34,621
Research and development expenses , -604,081 -561,423 -438,219
Sales and marketing expenses ,, -285,256 0 0
Administrative expenses , -202,770 -67,881 -43,543
Operating expenses -1,092,107 -629,304 -481,762
Other operating items, net 36,997 444 1,099,526
Operating result -792,361 -587,942 652,385
Financial income 2,022 14,655 9,988
Financial expenses -49,314 -3,390 -37,322
Result before tax -839,653 -576,677 625,051
Income tax (expense) benefit -7,076 5,136 -43,773
Net result for the period -846,729 -571,541 581,278
Earnings/(loss) per share – basic (DKK) -22.07 -16.91 18.94
Earnings/(loss) per share - diluted (DKK) -22.07 -16.91 18.94
Net result attributable to shareholders
of Zealand Pharma A/S -846,729 -571,541 581,278
Consolidated financial statements
62Zealand Pharma ∞ Annual Report 2020
Con Fin – Income Statement
Consolidated statements of financial position
as of December , and
DKK thousand Note
Assets
Non-current assets
Intangible assets , 57,485 2,480
Property, plant and equipment 85,040 39,708
Right-of-use assets 127,998 85,632
Deposits 16,650 9,012
Corporate tax receivable 1,268 0
Prepaid expenses 13,117 0
Deferred tax assets 8,370 0
Other investments 32,333 35,632
Total non-current assets 342,261 172,464
Current assets
Inventories 65,040 0
Trade receivables 46,484 751
Prepaid expenses 35,156 30,755
Corporate tax receivable 5,500 7,101
Other receivables 9,942 7,935
Marketable securities 297,345 299,448
Cash and cash equivalents 960,221 1,081,060
Total current assets 1,419,688 1,427,050
Total assets 1,761,949 1,599,514
DKK thousand Note
Liabilities and equity
Share capital 39,800 36,055
Share premium 3,470,787 2,650,142
Currency translation reserve 8,977 0
Accumulated loss -2,290,253 -1,443,524
Shareholders' equity 1,229,311 1,242,673
Deferred revenue 44,587 83,639
Other liabilities 16,744 0
Lease liabilities 116,047 78,068
Non-current liabilities 177,378 161,707
Trade payables 70,384 57,533
Corporate tax payables 30,394 614
Lease liabilities 14,072 7,692
Deferred revenue 53,182 56,251
Discount and rebate provision 36,673 0
Other liabilities 150,555 73,044
Current liabilities 355,260 195,134
Total liabilities 532,638 356,841
Total shareholder' equity and liabilities 1,761,949 1,599,514
Consolidated financial statements
63Zealand Pharma ∞ Annual Report 2020
Con Fin – Financial position
Consolidated statements of cash flows for the years
ended December , , and
DKK thousand Note
Net result for the year -846,729 -571,541 581,278
Bargain purchase -36,395 0 0
Adjustments for other non-cash items 143,138 9,207 101,930
Change in working capital 97,818 10,873 12,785
Interest received 895 5,413 4,263
Interest paid -4,562 -3,390 -16,705
Deferred revenue -42,881 139,890 0
Sale of future royalties and milestones 0 0 -1,105,471
Income tax paid/received 0 93 -39,500
Cash flow from operating activities -688,716 -409,455 -461,420
Acquisition of Valeritas business, net of cash acquired -167,791 0 0
Transfer from restricted cash related to royalty bond 0 0 6,124
Sale of future royalties and milestones 0 0 1,275,802
Royalty expenses regarding sale of
future royalty and milestones 0 0 -170,331
Change in deposits -3,972 -6,250 -33
Purchase of other investments and marked securities 0 -22,803 -225,719
Purchase of property, plant and equipment -25,044 -21,036 -4,038
Purchase of intangible assets 0 -2,480 0
Sale of property, plant and equipment 0 25 0
Dividends on securities 0 878 1,020
Cash flow from investing activities -196,807 -51,666 882,925
Proceeds from issuance of shares related to
exercise of share based compensation 41,363 52,468 2,884
Proceeds from issuance of shares 791,503 645,145 0
Costs related to issuance of shares -42,706 -14,444 -22
Lease installments -29,219 -8,689 -158,311
Cash flow from financing activities 760,941 674,480 -155,449
Decrease/increase in cash and cash equivalents -124,582 213,359 266,056
Cash and cash equivalents at beginning of period 1,081,060 860,635 588,718
Exchange rate adjustments 3,743 7,066 5,861
Cash and cash equivalents at end of period 960,221 1,081,060 860,635
Consolidated statements of changes in shareholders' equity
at December , , and
Share Share Translation Retained
DKK thousand capital premium reserve losses Total
Equity at January , 36,055 2,650,142 0 -1,443,524 1,242,673
Other comprehensive income 0 0 8,977 0 8,977
Net result for the year 0 0 0 -846,729 -846,729
Share based compensation 0 30,485 0 0 30,485
Capital increases 3,745 832,866 0 0 836,611
Cost related to capital increases 0 -42,706 0 0 -42,706
Equity at December , 39,800 3,470,787 8,977 -2,290,253 1,229,311
Equity at January , 30,787 1,957,477 0 -871,983 1,116,281
Other comprehensive income 0 0 0 0 0
Net result for the year 0 0 0 -571,541 -571,541
Share based compensation 0 14,764 0 0 14,764
Capital increases 5,268 692,345 0 0 697,613
Cost related to capital increases -14,444 0 0 -14,444
Equity at December , 36,055 2,650,142 0 -1,443,524 1,242,673
Equity at January , 30,751 1,937,179 0 -1,453,261 514,669
Other comprehensive income 0 0 0 0 0
Net result for the year 0 0 0 581,278 581,278
Share based compensation 0 17,472 0 0 17,472
Capital increases 36 2,826 0 0 2,862
Equity at December , 30,787 1,957,477 0 -871,983 1,116,281
Consolidated financial statements
64Zealand Pharma ∞ Annual Report 2020
Con Fin – Cash Flow Con Fin – Equity
Consolidated financial statements
Business overview
Zealand (the “Company”, the “Group”, “Zealand” and “we”) was founded in and is a bio-
technology company focused on the discovery and development of innovative peptide-based
medicines. More than drug candidates invented by Zealand have advanced into clinical de-
velopment, of which two have reached the market. Zealand’s current pipeline of internal prod-
uct candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio
also includes two clinical license collaborations with Boehringer Ingelheim and one discover
and develop collaboration with Alexion Pharmaceuticals.
In September we entered into an agreement with Royalty Pharma to transfer all the royal-
ties that we were due to earn from our agreement with Sanofi in exchange for an upfront
one-time payment of USD million. Excluded from this agreement was a potential milestone
payment from Sanofi of up to USD million.
In April , we acquired substantially all of the medical technology business from Valeritas
Holdings, Inc. Refer to note .
Please refer to page for an overview of our Pipeline.
Owner- Voting
Company summary Domicile ship rights
Zealand Pharma A/S subsidiaries
ZP Holding SPV K/S Denmark % %
ZP General Partner ApS Denmark % %
Zealand Pharma US Inc. United States % %
Zealand Pharma California US, LLC. United States % %
Encycle Therapeutics Inc. Canada % %
ZP SPV K/S Denmark % %
ZP General Partner ApS Denmark % %
ZP Holding SPV K/S subsidiaries
ZP SPV K/S Denmark % %
ZP General Partner ApS Denmark % %
65Zealand Pharma ∞ Annual Report 2020
Con Fin – Business overview
Notes
Note – Significant accounting policies, and significant accounting estimates and assessments
Significant accounting policies
Basis of preparation
The consolidated financial statements of Zealand have been prepared in accordance with
International Financial Reporting Standards (IFRS) as issued by the International Accounting
Standards Board (IASB) and as adopted by the EU and additional requirements under the Danish
Financial Statements Act (class D).
The Board of Directors considered and approved the Annual Report of Zealand on March
, . The Annual Report will be submitted to the shareholders of Zealand for approval at
the Annual General Meeting on April , .
The consolidated financial statements are presented on a historical cost basis, except for cer-
tain financial assets and liabilities measured at fair value.
Historical cost is generally based on the fair value of the consideration given in exchange for
goods and services.
Fair value is the price that would be received to sell an asset or paid to transfer a liability in
an orderly transaction between market participants at the measurement date, regardless of
whether that price is directly observable or estimated using another valuation technique.
For financial reporting purposes, fair value measurements are categorized into Level , or
based on the degree to which the inputs to the fair value measurements are observable and
on the significance of the inputs to the fair value measurement as a whole. The inputs are
described as follows:
• Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities
that the entity can access at the measurement date
• Level 2 inputs are inputs, other than quoted prices included within Level 1 that are observable
for the asset or liability, either directly or indirectly
• Level 3 inputs are fair value measures derived from valuation techniques that include inputs
for the asset or liability that are not based on observable market data (unobservable inputs).
The consolidated financial statements are presented in Danish kroner (DKK), which is the func-
tional currency of the Parent Company.
In the narrative sections of the financial statements, comparative figures for and are
shown in brackets if not indicated otherwise.
Implementation of new and revised standards and interpretations
A few amendments apply for the first time in , but do not have an impact on the consoli-
dated financial statements of the Group.
Amendments to IFRS : Definition of a Business
The amendment to IFRS clarifies that to be considered a business, an integrated set of activ-
ities and assets must include, at a minimum, an input and a substantive process that together
significantly contribute to the ability to create output. Furthermore, it clarified that a business
can exist without including all of the inputs and processes needed to create outputs.
Amendments to IFRS , IFRS and IAS : Interest Rate Benchmark Reform
The amendments to IFRS , IFRS and IAS Financial Instruments: Recognition and Meas-
urement provide a number of reliefs, which apply to all hedging relationships that are directly
aected by interest rate benchmark reform. A hedging relationship is aected if the reform
gives rise to uncertainties about the timing and or amount of benchmark-based cash flows of
the hedged item or the hedging instrument.
Amendments to IAS and IAS : Definition of Material
The amendments provide a new definition of material that states “information is material if
omitting, misstating or obscuring it could reasonably be expected to influence decisions that
the primary users of general purpose financial statements make on the basis of those financial
statements, which provide financial information about a specific reporting entity.”
The amendments clarify that materiality will depend on the nature or magnitude of informa-
tion, either individually or in combination with other information, in the context of the financial
statements. A misstatement of information is material if it could reasonably be expected to
influence decisions made by the primary users.
66Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 1
Notes
Note – Significant accounting policies, and significant accounting estimates and assessments (continued)
Standards and interpretations issued, but not yet applied
IASB has issued a number of new and amended standards which are not yet eective. None of
these new standards or amendments are expected to impact the Group.
Accounting policies
The Group has applied new accounting policies to the following areas as a consequence of the
acquisition of the Valeritas business as disclosed in note .
• Revenue (extended)
• Cost of goods sold
• Sales and marketing expenses (extended)
• Impairment testing (Extended)
• Inventories
• Trade receivables write-down (extended)
• Discount and rebate provision
• Business combinations
The accounting policies are apart from the line items above unchanged from last year. The
accounting policies for specific line items and transactions are included in the respective notes
to the financial statements except for basis and principles of consolidation, foreign currency
translation, classification of income statement, segment reporting, classification of financial
assets and the cash flow statement, which are included below.
Basis of consolidation
The consolidated financial statements incorporate the financial statements of the Company
and entities (including structured entities) controlled by the Company and its subsidiaries. Con-
trol is achieved when the Company:
• has power over the investee;
• is exposed, or has rights, to variable returns from its involvement with the investee; and
• has the ability to use its power to aect its returns.
The Company reassesses whether it controls an investee if facts and circumstances indicate
that there are changes to one or more of the three elements of control listed above.
Principles of consolidation
The consolidated financial statements are prepared on the basis of the financial statements of
the parent company and the individual subsidiaries, which are based on uniform accounting
policies and accounting periods in all Group entities. Consolidation of Group entities is per-
formed after elimination of all intra-Group transactions, balances, income and expenses.
Functional currency
A functional currency is determined for each Group entity. The functional currency is the cur-
rency used in the primary financial environment in which the individual Group entity operates.
Foreign currency translation
Transactions denominated in currencies other than the transacting entity's functional currency
are translated at the exchange rates on the transaction dates.
Exchange dierences arising between the rate on the transaction date and the rate on the pay-
ment day are recognized in the income statement as financial income or financial expenses.
Receivables, payables and other monetary items denominated in foreign currencies that have
not been settled at the statement of financial position date are translated by applying the ex-
change rates at the statement of financial position date. Dierences arising between the rate at
the statement of financial position date and the rate at the date on which the receivable or pay-
able arose are recognized in the income statement as financial income and financial expenses.
Recognition in the consolidated financial statements
On preparation of the consolidated financial statements, the income statements of entities with
a functional currency dierent from DKK are translated at the average exchange rate for the pe-
riod, and balance sheet items are translated at the exchange rate ruling at the reporting date.
Foreign exchange dierences arising on translation of the equity of foreign entities and on
translation of receivables considered part of net investment are recognised directly in other
comprehensive income.
Foreign exchange dierences arising on the translation of income statements from the average
exchange rate for the period to the exchange rate ruling at the reporting date are also recog-
nised in other comprehensive income. Adjustments are presented under a separate translation
reserve in equity.
Materiality in financial reporting
In preparing the Annual Report, Management seeks to improve the information value of the
consolidated financial statements, the notes to the statements and other measures disclosed by
presenting the information in a way that supports the understanding of the Group’s perfor-
mance in the reporting period.
This objective is achieved by presenting fair transactional aggregation levels on line items and
other financial information, emphasising information that is considered of material importance
to the user and making relevant rather than generic descriptions throughout the Annual Report.
67Zealand Pharma ∞ Annual Report 2020
Notes
Note – Significant accounting policies, and significant accounting estimates and assessments (continued)
All disclosures are made in compliance with the International Financial Reporting Standards, the
Danish Financial Statements Act and other relevant regulations, ensuring a true and fair view
throughout the Annual Report.
Consolidated financial statements
Income statement
The expenses recognized in the income statement is presented as an analysis using a classifica-
tion based on their function.
Cost of goods sold
Cost of goods sold includes raw materials, labor costs, manufacturing overhead expenses and
reserves for anticipated scrap and inventory obsolescence.
Segment reporting
The Group is managed by a Corporate Management team reporting to the Chief Executive
Ocer. The Corporate Management team, including the Chief Executive Ocer, represents the
chief operating decision maker (CODM). No separate business areas or separate business units
have been identified in connection with line of business, product candidates or geographical
markets. Consequently, there is no segment reporting concerning business areas or geograph-
ical areas.
Statement of financial position
Financial assets
Financial assets include receivables, marketable securities and cash. Financial assets are divided
into categories of which the following are relevant for the Group:
. Financial assets at amortized cost comprising of receivables with contractual cash flows
solely comprising of payment of principal and interest and which are held for the purpose of
collecting the contractual cash flow.
. Financial assets at fair value through the income statement, which are marketable securities
categorized as equity instruments are held for trading and classified at fair value through
profit and loss.
. Equity investments. These investments are measured at fair value through the profit and loss.
Financial assets are assigned to the dierent categories by Management on initial recognition,
depending on the cash flow characteristics and purpose for which the assets were acquired.
All financial assets are recognized on their settlement date. All financial assets other than those
classified at fair value through the income statement are initially recognized at fair value, plus
transaction costs.
Statement of cash flows
The cash flow statement is prepared in accordance with the indirect method on the basis of the
operating result for the year. The statement shows the cash flows broken down into operating,
investing and financing activities, cash and cash equivalents at the beginning and end of the
year, and the impact of the calculated cash flows on cash and cash equivalents. The cash flow
statement cannot be derived directly from the balance sheet and income statement.
Cash flows in foreign currencies are translated into Danish kroner at the exchange rate on the
transaction date.
Cash flow from operating activities
Cash flow from operating activities is presented indirectly and is calculated as the net operating
result adjusted for depreciation and amortization, sale of royalties, non-cash operating items,
changes in net working capital, financial items paid, and income tax benefits received and paid.
Cash flow from investing activities
Cash flow from investing activities includes cash flows from the sale of future royalties and
milestone relating to the Sanofi license, purchase and sale of property, plant and equipment, in-
vestments and deposits, net cashflow from acquisition of Valertias activities, as well as transfers
to and from restricted cash related to the royalty bond.
Cash flow from financing activities
Cash flow from financing activities includes proceeds from issuance of new ordinary shares,
proceeds from issuance of shares related to exercise of sharebased compensation. and related
costs, finance lease installments and loan financing.
Cash and cash equivalents
Cash and cash equivalents comprise cash and bank balances. Cash and cash equivalents are
instruments with original maturities of days or less. The Company does not have any cash
equivalents for the years ended December , and .
Information on COVID-
Our business, operations and clinical studies were, of course, impacted by the eects of
COVID-. Although our clinical studies continued without interruption during , there
were delays and increased total costs arising from the implications of COVID-.
However, we have not recognized any write-os, impairments of assets, or losses to onerous
contracts due to COVID-. The impairment of V-Go IP as explained in note was due to
68Zealand Pharma ∞ Annual Report 2020
Notes
Note – Significant accounting policies, and significant accounting estimates and assessments (continued)
Managements decision to allocate resources to support future product launches while limiting
the investment in the V-Go product.
The COVID- pandemic is also having an eect on other aspects of our business, including:
our third-party manufacturers, and other third parties; albeit with no material eect or impact.
The COVID- pandemic may, in the long-term, aect the productivity of our sta; our ability
to attract, integrate, manage and retain qualified personnel or key employees; our global supply
chains and relationships with vendors and other parties; significant disruption of global financial
markets; and reduced ability to secure additional funding. We continuously monitor the
COVID- pandemic and its potential impact on our business and financials.
Significant accounting estimates and judgments
The preparation of the consolidated financial statements requires Management to make judg-
ments and estimates that aect the reported amounts of revenues, expenses, assets and liabil-
ities, and the accompanying disclosures. In applying our accounting policies, Management is
required to make judgements and estimates about the carrying amounts of assets and liabilities
that are not readily apparent from other sources. The estimates and associated assumptions are
based on historical experience and other factors that are considered to be relevant. Actual re-
sults may dier from these estimates. The estimates and underlying assumptions are reviewed
on an ongoing basis. Revisions to accounting estimates are recognized in the period in which
the estimate is revised if the revision aects only that period, or in the period of the revision and
future periods if the revision aects both current and future periods.
The estimates used are based on assumptions assessed to be reasonable by Management.
However, estimates are inherently uncertain and unpredictable. The assumptions may be
incomplete or inaccurate, and unexpected events or circumstances may occur. Furthermore,
we are subject to risks and uncertainties that may result in deviations in actual results compared
with estimates.
Please refer to the table below to see in which note the accounting estimates and judgements
are presented.
Notes including management’s estimates and judgements
Estimates Judgements
– Revenue X X
– Employee incentive programs X
– Encycle Therapeutics, Inc. acquisition X
– Discount and rebate provision X X
– Business Combinations X X
Additional description of Management estimates and judgements made are described below
Revenue recognition (management estimate and judgement)
Revenue comprises license payments, milestone payments, product revenue and royalty in-
come. License payments which provide the buyer with the right to use the license as it exists at
the date of transfer are recognized upon transfer of the associated licensing rights at the point
at which the buyer obtains the right to use the license. Upon entering into agreements with
multiple components, Management determines whether individual components are distinct,
which is the case if the buyer can obtain benefits from the goods or service and the promise is
distinct within the context of the contract. If no individual components are distinct, the contract
is treated as a single performance obligation. When entering into licensing and development
agreements, a critical judgment relates to whether the customer could continue development
of the Intellectual Property (IP) to the stage promised by Zealand under the promise to provide
R&D services. If this is not the case, the IP and the R&D services are considered a single perfor-
mance obligation.
Milestone payments are related to the collaborative research agreements with commercial
partners and are recognized when it is highly probable that Zealand Pharma will become enti-
tled to the milestone which is generally when the milestone is achieved. Royalty income from
licenses is based on third-party sales of licensed products and is recognized in accordance with
contract terms in the period in which the sales occur.
Revenue from transactions involving the rendering of services which are consumed by the cus-
tomer simultaneously with delivery is recognized along with delivery of the services.
Employee incentive programs (management estimates)
In accordance with IFRS , Share-based Payment, the fair value of the warrants classified
as equity settled is measured at the grant date and recognized as an expense in the income
statement over the vesting period. The fair value of each warrant granted during the year is
69Zealand Pharma ∞ Annual Report 2020
Notes
Note – Significant accounting policies, and significant accounting estimates and assessments (continued)
estimated using the Black– Scholes option pricing model. This requires the input of subjective
assumptions such as:
• The expected stock price volatility, which is based on the historical volatility of Zealand’s
share price
• The selection of the risk-free interest rate, which is determined as the interest rate on Danish
government bonds with a maturity equal to the expected term
• The duration of the warrants, which is assumed to be until the middle of the exercise period
The total fair value of the warrants is recognized in the income statement over the vesting
period. An adjustment is made to reflect an expected attrition rate during the vesting period.
The attrition rate is re-estimated at year-end based on the historical attrition rate resulting
in recognition of an expense equal to grant date fair value of the number of warrants which
actually vest.
Discount and rebate (management estimate and judgement)
Provisions regarding sales rebates and discounts granted to government agencies, wholesal-
ers, retail pharmacies, managed care and other customers are recorded at the time the related
revenues are recorded or when the incentives are oered.
For both managed care rebates and the medicare part D rebates, the key assumptions relate
to the rebate percentages by each pharmacy as determined in each pharmacy's contract with
the Company and forecasted number of prescriptions that will be filled by each pharmacy (re-
ferred to as payor mix). For co-pay card redemptions, the key assumptions relate to expected
settlement rate for sales units remaining in the channel that have yet to be presented under
co-pay terms. These assumptions are made based on historical actuals, which are used to es-
timate forecasted trends, including payor mix and settlement rates, which are used to estimate
the expected settlement of managed care rebates and medicare part D rebates, and co-pay
card redemption, and the specific terms in the individual agreements. Unsettled rebates are
recognized as provisions when the timing or amount is uncertain. Where absolute amounts are
known, the rebates are recognized as provisions.Please refer to note for further information
on sales rebates and provisions.
Encycle Therapeutics, Inc. acquisition (management judgement)
As of October , Zealand acquired all outstanding shares in Encycle Therapeutics, Inc. and
all its intellectual property, including all rights to develop and commercialize the lead asset.
Zealand did not acquire any infrastructure or personnel costs with this transaction. The total
future consideration for the acquisition could potentially reach USD million in one-time
contingent value rights (“earn-outs”), of which USD million in earn-outs could be payable up
to the successful completion of a Phase study. All earn-outs are payable in cash and/or Zea-
land equity at Zealand’s discretion, are linked to the lead asset only, and contingent on certain
future successful development, regulatory, and commercial-related milestones. There is also a
potential mid-single digit royalty on global net sales from the lead asset.
The acquistion has been measured based on the overall cost of the transaction less the fair
value of the cash balance and trade payables also acquired. The fair value of the contingent
considerations related to Encycle Therapeutics was assessed to be zero as per the acquisition
date based on the significant uncertainty of the outcome of the development to be performed
by Zealand.
Business Combinations (management estimates and judgements)
In applying the acquisition method of accounting, estimates are an integral part of assessing fair
values of several identifiable assets acquired and liabilities assumed, as observable market prices
are typically not available.
Valuation techniques where estimates are applied typically relate to determining the present
value of future uncertain cash flows or assessing other events in which the outcome is uncer-
tain at the date of acquisition.
More significant estimates are typically applied in accounting for Intellectual properties, cus-
tomer relationships, trade receivables, deferred tax and debt.
The calculation of the fair value of intangible assets is most sensitive to the revenue and gross
margin growths. Please refer to note for further information on Business Combinations.
As a result of the uncertainties inherent in fair value estimation, measurement period adjust-
ments may be applied.
70Zealand Pharma ∞ Annual Report 2020
Notes
Note – Revenue
Accounting policies
Revenue comprises license payments, milestone payments, royalty income and sale of goods.
License payments which provide the buyer with the right to use the license as it exists at the date
of transfer are recognized upon transfer of the associated licensing rights at the point at which
the buyer obtains the right to use the license. Milestone payments related to the collaborative
research agreements with commercial partners are recognized when it is highly probable that
Zealand Pharma will become entitled to the milestone which is generally when the milestone is
achieved. Royalty income from licenses is based on third-party sales of licensed products and is
recognized in accordance with contract terms in the period in which the sales occur.
Revenue from transactions involving the rendering of services which are consumed by the
customer simultaneously with delivery is recognized along with delivery of the services.
Upon entering into agreements with multiple components, Management determines whether
individual components are distinct, which is the case if the buyer can obtain benefits from the
goods or service and the promise is distinct within the context of the contract. If no individual
components are distinct, the contract is treated as having a single performance obligation.
Revenue is recognized based on the percentage of completion of the R&D services, which is
estimated based on the expenses incurred during that period. Zealand applies the output based
method (budget cost) when determining the timing of satisfaction of performance obliga-
tions as the development services are performed by an indeterminate number of acts over the
development timeline and accordingly, time elapsed and budget costs as an output measure is
considered to be the unit which most appropriately depicts the transfer of control of services to
Alexion In total.
Trade receivables are recognised as services delivered are invoiced to the customer and are not
adjusted for any financing components as credit terms are short – typically between to
days – and the financing component therefore insignificant. Where services delivered have yet
to be invoiced and invoices on services received from vendors have still to be received, con-
tract assets and accrued cost of services are recognised at the reporting date.
Revenue from sale of goods
Revenue from sale of goods is recognized at a point in time when control of the goods are
transferred to the customer and recorded net of adjustments for managed care rebates, whole-
sale distributions fees, cash discounts, prompt pay discounts, and co-pay card redemptions, all
of which are established at the time of sale.
In order to prepare the consolidated financial statements, the company is required to make es-
timates regarding the amounts earned or to be claimed on the related product sales, including
the following:
• Managed care and Medicare rebates, which are based on the estimated end user pay or mix
and related contractual rebates;
• distribution fees, prompt pay discounts and other discounts, which are recorded based on
specified payment terms, and which vary by customer and other incentive programs; and
• Co-pay card redemption charges which are based on the net transaction costs of prescrip-
tions filled via a company-subsidized card program and other incentive programs.
Zealand believes rebates and co-pay card redemptions related to sales in the U.S. are complex
in nature and establishing appropriate provisions requires assessment of multiple factors as well
as significant judgement and estimation by management as not all conditions are known at the
time of sale.
The Group has concluded that it is the principal in this revenue arrangements since it controls
the goods before transferring them to the customer.
Return Reserve
We record allowances for product returns as a reduction of revenue at the time product sales
are recorded. Several factors are considered in determining whether an allowance for product
returns is required, including the customers’ return rights and our historical experience with
returns and the amount of product sales in the distribution channel not consumed by patients
and subject to return. Management replies on historical return rates to estimate returns. In the
future, as any of these factors and/or the history of product returns change, adjustments to the
allowance for product returns will be reflected
Revenue from Alexion
In , we recognized DKK . million (: . million) as income from the license,
research and development agreement signed in March reflecting the progress on the
lead project. Under the agreement DKK . million is accounted for as deferred revenue at
December , .
In , DKK . million of other revenue is recognized related to other projects with Alexion.
No revenue was recognized in .
Revenue from Sanofi
No revenue was recognized in or . In , we recognized DKK . million as roy-
alty income, reflecting milestones related to sales of Lyxumia® of EUR . million and sales of
Soliqua
®
/ of EUR . million. No milestone revenue was received.
71Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 2
Notes
Note – Revenue (continued)
Revenue from Boehringer Ingelheim (BI)
In , we recognized DKK . million as income from milestone payments from BI related
to the initiation of the Phase trial for the long-acting GLP-/glucagon.
No revenue was recognized from BI in or , as no milestone event was achieved.
Revenue from sale of goods
In , we recognized DKK . million as net sales from goods sold generated from our
V-Go product. The rights to the V-Go product was acquired on April , as part of the busi-
ness combination described in note . Thus Revenue from sale of the V-Go product recog-
nized in solely relates to the period April - December .
Revenue from other agreements
In , we recognized zero revenue from other agreements.
In and , we recognized DKK . million and DKK . million, respectively, in revenues
from a milestone payment and license option payments, respectively, from undisclosed coun-
terparties relating to two Material Transfer Agreements.
In , we recognized DKK . million in revenue from milestone payments from Protagonist
Therapeutics in connection with the start of Phase with the novel hepcidin mimetic PTG-.
Zealand is managed and operated as one business unit, which is reflected in the organizational
structure and internal reporting. No separate lines of business or separate business entities have
been identified with respect to any of the product candidates or geographical markets and no
segment information is currently disclosed in the internal reporting.
Information about Geographical Areas
Net revenue in Germany comprise DKK . million in milestone revenue whereas net sales in
US comprise DKK . million including license revenues and sale of goods. No other country
accounts for more than % of the net total sales. In we had significant customers with
revenue from sale of goods. Customer A, amounted to DKK . million (: DKK million),
Customer B amounted to DKK . million (: DKK million) and Customer C DKK . mil-
lion (: DKK million).
Of the Company’s non-current assets, which comprise intangible assets, property, plant and
equipment, right-of-use assets and prepayments, DKK . million is located in Denmark and
DKK . million in US.
Recognized revenue can be specified as follows for all agreements:
DKK thousand
Boehringer Ingelheim International GmbH ,
Alexion Pharmaceuticals Inc. , ,
Undisclosed counterpart , ,
Protagonist Therapeutics, Inc. ,
Total license and milestone revenue , , ,
Sanofi-Aventis Deutschland GmbH ,
Total royalty revenue ,
V-Go gross sales ,
Reductions* -,
Total revenue from sale of goods ,
Total revenue , , ,
Royalty revenue can be specified as follows:
Soliqua
®
,
Lyxumia
®
,
Total royalty revenue ,
Total revenue recognized over time , ,
Total revenue recognized at a point in time , , ,
* Discounts and rebates are specified below and discussed further in note ..
Sales gross-to-net reconciliation
DKK thousand
V-Go gross sales ,
Customer and Contractual price reductions -,
Returns and sales reductions -,
Net sales ,
72Zealand Pharma ∞ Annual Report 2020
Notes
Note – Revenue (continued)
Accounting for the Alexion Pharmaceuticals, Inc. Agreement
In March , Zealand entered into a license, research and development agreement with
Alexion Pharmaceuticals, Inc. (Alexion) to develop novel therapies to treat complement medi-
ated diseases. This agreement provided Zealand an immediate cash injection as well as further
external validation of Zealand’s peptide platform.
The collaboration with Alexion is not limited to C but oers the potential to work on identifi-
cation of peptide inhibitors to up to three additional components of the complement cascade.
Zealand will have responsibility for the C project and other targets up to IND and Alexion will
then progress the peptides into clinical development.
Under the Alexion license, research and development agreement, Zealand has received an
upfront non-refundable payment of USD million for the C program and a concurrent USD
million equity investment in Zealand at a premium to the market price. The agreement also
provides the potential for development-related milestones of up to USD million, as well as
up to USD million in sales-related milestones and high single- to low double-digit royalty
payments. The additional programs will provide further non-refundable upfront payments
(USD million each), development and sales milestone and royalties.
Accounting treatment
The non-refundable up-front fee was allocated to the combined license, research and devel-
opment services, and is being recognized as revenue along with provision of the research and
development services under the lead program. Expenses to provide the services is being recog-
nized when incurred. Further, the premium over the market share price on the Zealand shares
subscribed by Alexion, DKK . million, is attributed to the Agreement as further consideration
and consequently also recognized over the period over which the R&D services are provided. ,
Alexion has paid USD million, corresponding to DKK . million that as of December ,
has aected equity by DKK . million, deferred revenue by DKK . million, and reve-
nue by DKK . million in . Hence the cash flow from operating activities was DKK .
million and the cash flow from financing activities was DKK . million.
In revenue of DKK . million was recognized.
Milestone payments, if any, will be recognized as revenue when the relevant milestones are
achieved as they relate to performance obligations already satisfied at this stage. Royalty pay-
ments, if any, will be recognized along with the underlying sales.
Significant judgement applied (performance obligations and revenue recognition)
Determination of whether the license transferred and the research and development services
constitute separate performance obligations, or form part a single performance obligation
comprising a combined output has a significant impact on the accounting treatment. Zealand
has applied significant judgment to determine whether the promised services are distinct and
concluded that Alexion cannot benefit from the license alone. It is Zealand assessment that the
R&D services under this agreement requires specific Zealand know-how and expertise which
cannot be easily identified or sourced externally. Therefore, Alexion would not in the absence
of the contractual provisions have had the practical ability to engage a third-party R&D service
provider to provide the agreed R&D services.
Judgments and estimates in respect of output is made when entering the agreement and is
based on research and development budgets and plans. The planned service periods (output)
and budget costs for the respective research and development projects are assessed on an
ongoing basis. If the expected service period is changed significantly, this will require a reas-
sessment.
All Zealand’s revenue-generating transactions have been subject to such evaluation by man-
agement.
As the nature of the collaboration with Alexion may aect the accounting treatment of the
agreement, Zealand has considered whether the agreement takes the form of a collaborative
partnership with Alexion rather than a customer-vendor agreement. After consideration of all
facts and circumstances, Zealand has assessed that the agreement takes the form of a custom-
er-vendor relationship. Accordingly, the agreement is treated under the guidelines of IFRS
Revenue from Contracts with Customers.
As any additional programs are optional and paid for separately, they are not considered part
of the initial agreement. It has been considered whether the options for additional compo-
nents represent a material right and, thus, a separate performance obligation under the initial
agreement to which a portion of the initial upfront payment should be allocated. Zealand has
determined that the probability of exercising the option is low and in combination with the fact
that the development is significantly less advanced than the lead target, we have determined
that the options do not represent a material right.
Accounting for the Sanofi License Agreement
In , Zealand entered into a license agreement with Sanofi (the Sanofi License Agreement),
pursuant to which Zealand granted Sanofi exclusive rights to its patents, know-how and other
intellectual property relating to lixisenatide, for all fields. Pursuant to the Sanofi License Agree-
73Zealand Pharma ∞ Annual Report 2020
Notes
Note – Revenue (continued)
ment, which has been amended over the years, Sanofi assumed responsibility for the further
development, manufacturing and marketing of lixisenatide, and we cannot research or develop
lixisenatide while the Sanofi License Agreement remains in eect.
Under the Sanofi License Agreement, Zealand were eligible to receive remaining milestone
payments relating to commercialized products of up to USD million, contingent on the
achievement of certain sales levels, as well as royalties on global sales of such products. Royal-
ties correspond to tiered, low-double-digit percentages of Sanofi’s global net sales of lixisenati-
de (branded as AdlyxinR in the U.S. and as LyxumiaR in the EU and in other countries) plus a
% royalty on global net sales of a combination of lixisenatide and insulin glargine units/ml
(LantusR) marketed under the brand name SoliquaR / in the U.S. and as SuliquaR in the EU.
In , Sanofi challenged the validity of certain patents owned by a competitor, AstraZeneca
(and its aliates), in both administrative and court proceedings in the U.S. and in certain other
countries, and AstraZeneca brought counterclaims in the U.S. proceedings asserting that prod-
ucts containing lixisenatide infringe its patents. Sanofi and AstraZeneca subsequently agreed to
settle all claims and counterclaims between them in various proceedings relating to lixisenatide.
Our financial obligations related to this now-resolved intellectual property dispute could reduce
our net revenue from the original commercial milestone payments from Sanofi relating to Soli-
qua R //SuliquaR. The amount and timing of any such reductions of future revenue are
not currently known, but they will not exceed USD million in total.
Zealand pays Alkermes plc % of all payments received on lixisenatide while lixisenatide is sub-
ject to a commercialization agreement such as the Sanofi License Agreement. Zealand also pay
one of the inventors of the Structure Induced Probe (SIP) technology employed in lixisensatide
a .% royalty on amounts received in connection with drug candidates that, like lixisenatide,
are produced using the SIP technology.
Milestone payments have been recognized as revenue when the relevant milestones are
achieved.
All future royalties and all but up to USD million of future milestone payments relating to the
Sanofi License Agreement were sold to Royalty Pharma in September . Refer to note .
Accounting for the Boehringer Ingelheim License Agreements
In , Zealand entered into a license, research and development collaboration agreement
with Boehringer Ingelheim International GmbH (BI) to advance novel GLP-/glucagon dual-
acting peptide receptor agonists (GGDAs) for the treatment of patients with type diabetes and
obesity. Under the terms of the BI License Agreement, BI paid a fixed amount per full-time
employee and other costs related to all research, development and commercialization in re-
spect of the compounds covered by the agreement.
Zealand is eligible to receive license and milestone payments of up to EUR million, of
which EUR million was outstanding at December , , related to the achievement of
pre-specified development, regulatory and commercial milestones for the lead product. We are
also eligible to receive tiered royalties ranging from high single-digit to low double-digit per-
centages on BI’s sales of all products stemming from this collaboration. In addition, we retain
copromotion rights in Scandinavia.
In , Zealand entered into a second global license, research and development collaboration
agreement with BI (the BI License Agreement). This agreement pertained to a collabo-
ration on a specific therapeutic peptide project from our portfolio of preclinical programs for
a period of up to four and a half years, with the aim of developing novel drugs to improve the
treatment of patients with cardiometabolic diseases. In , BI selected a novel peptide thera-
peutic to be advanced into preclinical development under this agreement.
No product candidates out licensed to BI are currently marketed, and accordingly we have not
received any royalty payments to date under our licensing agreements with BI.
Milestone payments are recognized as revenue when the relevant milestones are achieved.
Accounting for other license agreements
In , Zealand recognized revenue related to a Material Transfer Agreement with an undis-
closed counterpart. The revenue related to a license option has been recognized in the period
in which the services were rendered.
In , Zealand entered into a material transfer agreement with an undisclosed counterpart.
A milestone payment was recognized as revenue, when the relevant milestone was achieved.
Such Material Transfer agreement related to the delivery of an existing material to the undis-
closed third party. No remaining performance obligations exist related to such agreement.
Milestone payments are recognized as revenue when the relevant milestones are achieved.
74Zealand Pharma ∞ Annual Report 2020
Notes
Note – Research, development, sales, marketing and administrative expenses
Accounting policies
Research expenses comprise salaries, share-based compensation, contributions to pension
schemes and other expenses, including patent expenses, as well as depreciation and amortiza-
tion directly attributable to the Group’s research activities. Research expenses are recognized in
the income statement as incurred.
Development expenses comprise salaries, share-based compensation, contributions to pension
schemes and other expenses, including depreciation and amortization, directly attributable to
the Group’s development activities. Development expenses are recognized in the income state-
ment as incurred, except where the capitalization criteria is met.
No indirect costs that are not directly attributable to research and development activities are
included in the disclosure of research and development expenses recognized in the income
statement. Overhead expenses have been allocated to research and development or adminis-
trative expenses based on the number of employees in each department, determined accord-
ing to the respective employees’ associated undertakings.
Judgment applied related to research and development expenses
A development project involves a single product candidate undergoing a large number of tests
to demonstrate its safety profile and its eect on human beings, prior to obtaining the nec-
essary final approval for the product from the appropriate authorities. The future economic
benefits associated with the individual development projects are dependent on obtaining such
approval. Considering the significant risk and duration of the development period for biological
products, Management has concluded that whether the intangible asset will generate probable
future economic benefits cannot be estimated with sucient certainty until the project has
been finalized and the necessary final regulatory approval of the product has been obtained.
Accordingly, Zealand has not recognized such assets at this time, and all research and develop-
ment expenses are therefore recognized in the income statement when incurred.
Capitalization of development costs assumes that, in the Group’s opinion, the development
of the technology or the product has been completed, all necessary public registrations and
marketing approvals have been received, and expenses can be reliably measured. Furthermore,
it must be established that the technology or the product can be commercialized and that the
future income from the product can cover not only the production, selling and administra-
tive expenses but also development expenses. Zealand has not capitalized any development
expenses in , or .
Note – Royalty expenses
Accounting policies
Royalty expenses comprise contractual amounts payable to third parties that are derived from
the milestone payments and royalty income earned from the corresponding collaboration
agreements.
We have agreed to pay some of our revenue in deferred payments or royalties to third parties.
At the time of the dissolution of a former joint venture with Elan Corporation, plc (Elan) and
certain of its subsidiaries that were party to the joint venture agreement with us, we agreed to
pay royalties to Elan – now Alkermes plc, as successor in interest to a termination agreement
between us and the Elan entities – including % of future payments we receive in respect of
lixisenatide under the Sanofi License Agreement.
In addition, we have agreed to pay a royalty of .% of the total amounts we receive in connec-
tion with our SIP-modified peptides, including lixisenatide, to one of the inventors of our SIP
technology, who is one of our employees. The royalty to be paid to this inventor is calculated
on the basis of all the amounts we receive, including license payments, milestone payments
and sales. In , the royalty expenses relate to mentioned inventor.
In , the royalty expenses related to royalties from sales of Lyxumia
®
and Soliqua
®
/
and milestone payments received from Sanofi. The arrangement was settled in as part of
transferring the right to future royalty and milestone payments under the Sanofi agreement.
75Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 3-4
Notes
Note – Fees to auditors appointed at the Annual General Meeting
DKK thousand
Audit , , ,
Audit-related services and other assurance engagements , ,
Tax advice
Other
Total fees , , ,
The fee for audit-related services and other assurance engagements and other services provid-
ed to the Group by EY godkendt Revisionspartnerselskab in consisted of Audit of Annual
Report, Audit of -F SEC filing, including SOX b attestation procedures, quarterly reviews,
other auditor’s reports on various statements for public authorities, and other accounting advi-
sory services. (Deloitte Statsautoriseret Revisionspartnerselskab in and )
Note – Information on sta and remuneration
DKK thousand
Total sta costs can be specified as follows:
Wages and salaries , , ,
Sharebased payment costs , , ,
Pension schemes (defined contribution plans) , , ,
Other payroll and sta-related costs , , ,
Total , , ,
The amount is charged as:
Research and development expenses , , ,
Sale and marketing expenses ,
Administrative expenses , , ,
Cost of goods sold ,
Inventory ,
Total , , ,
Average number of employees
Note – Research, development, sales, marketing and administrative expenses
(continued)
DKK thousand
Sta costs (note ) -, -, -,
Depreciation and impairment losses, property,
plant and equipment and right-of-use assets (note ,) -, -, -,
Other external research and development costs -, -, -,
Total research and development costs -, -, -,
Sale and Marketing expenses
Sales and marketing expenses include expenses for sales personnel and expenses related to
company premises in the US used for sales activities. Other significant expenses include prod-
uct demonstration samples, trade show expenses, professional fees for our contracted cus-
tomer support center and other consultants, insurance, facilities and information technology
expenses. Overhead expenses have been allocated to sales and marketing expenses according
to the number of employees in each department, based on the respective employees’ associat-
ed undertakings.
Administrative expenses
Administrative expenses include expenses for administrative personnel, expenses related to
company premises, depreciation on tangible assets and right-of-use assets, investor relations,
etc. Overhead expenses have been allocated to research and development or administrative
expenses according to the number of employees in each department, based on the respective
employees’ associated undertakings.
76Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 5-6
Notes
Note – Information on sta and remuneration (continued)
Base Committee Total Base Committee Total Base Committee Total
DKK thousand board fee fees fees board fee fees fees board fee fees fees
Remuneration to the Board of Directors
Martin Nicklasson
Kirsten Drejer¹
Alain Munoz
Michael Owen
Bernadette Mary Connaughton
Jerey Berkowitz
Leonard Kruimer
Jens Peter Stenvang²
Gertrud Koefoed Rasmussen²
Frederik Barfoed Beck²
Iben Louise Gjelstrup²
Hanne Heidenheim Bak⁵
Rosemary Crane⁴
Catherine Moukheibir⁴
Helle Haxgart²
,
³
Total , , , , , ,
Kirsten Drejer was appointed vice chairman at the General Meeting on April in .
Employee-elected board members; the table only includes remuneration for board work.
This board member resigned from the Board in .
These board members resigned from the Board in .
These board members resigned from the Board in .
The disclosed remuneration for board members excludes minor mandatory social security costs paid by the company.
It also excludes reimbursed expenses incurred in connection with board meetings, such as travel and accomodation.
77Zealand Pharma ∞ Annual Report 2020
Notes
Note – Information on sta and remuneration (continued)
Other Sharebased
Pension short term compensation
DKK thousand Base salary Bonus contribution benefits expenses Total
Remuneration to the Executive Management
Emmanuel Dulac¹ , , , ,
Adam Sinding Steensberg² , , , ,
Matthew Donald Dallas³ , , , ,
Total , , , , ,
Total Other Coporate Management⁵ , , , ,
Total , , , , , ,
Remuneration to the Executive Management
Emmanuel Dulac¹ , , ,
Adam Sinding Steensberg² , , , ,
Matthew Donald Dallas³ ,
Britt Meelby Jensen⁴ , ,
Mats Blom⁴ , ,
Total , , , , , ,
Total other Corporate Management⁵ , , , ,
Total , , , , , ,
Remuneration to the Executive Management
Britt Meelby Jensen , , ,
Mats Blom , , , ,
Total , , , ,
Total Other Coporate Management⁵ , , , , ,
Total , , , , , ,
¹ Emmanuel Dulac was appointed as CEO at April , .
² Former Interim CEO Adam Sinding Steensberg was appointed EVP, R&D and CMO at April , .
³ Matthew Donald Dallas was appointed CFO at October , .
⁴ Former CEO Britt Meelby Jensen and former CFO Mats Blom resigned from Zealand at February , and March , , respectively.
⁵ Other Corporate Management in comprised three members (: three and : four.)
Accounting policies
The value of services received as consider-
ation for granted warrants is measured at
the fair value of the warrant. The fair value
of equity settled share based compensa-
tion is determined at the grant date and
is recognized in the income statement as
employee benefit expense over the period
in which the warrants vest. The osetting
entry to this is recognized under equity. An
estimate is made of the number of warrants
expected to vest. Subsequently, an adjust-
ment is made for changes in the estimate of
the number of warrants, which will vest, so
the total expense is equal to fair value of the
actual number of warrants which vest. The
fair value of warrants granted is estimated
using the Black–Scholes pricing model and
Monte Carlo model in programs with value
caps whereas the average share price prior
to grant is used for RSU and PSUs
78Zealand Pharma ∞ Annual Report 2020
Notes
Note – Information on sta and remuneration (continued)
The employee
incentive programs of
Warrant programs existing during the period
Maximum years of options granted years years years
Method of settlement equity-
settled
Outstanding at the beginning of the period ,, ,
Granted during the period , ,
Forfeited during the period -,
Exercised during the period -, -,
Expired during the period -,
Outstanding at the end of the period , ,,
Exercisable at the end of the period ,
Warrants outstanding at the end of the period
Range of exercise prices . .- .-
. .
Weighted-average remaining contractual life . .
Number held by Executive Management ,
Outstanding at the beginning of the period ,, ,
Granted during the period ,
Forfeited during the period -,
Exercised during the period -, -,
Expired during the period
Outstanding at the end of the period ,, ,
Exercisable at the end of the period , ,
Warrants outstanding at the end of the period
Range of exercise prices .- .-
. .
Weighted-average remaining contractual life . .
Number held by Executive Management ,
Warrants exercised during the period
Weighted-average share price at the date of exercise . .
Weighted-average exercise price for expired during the period .
Weighted-average exercise price for forfeited during the period . .
Weighted-average exercise price for outstanding at period end . .
Determination of fair value of the warrants granted during the period
The exercise price is determined by the closing price of Zealand’s shares on Nasdaq Copenha-
gen on the day prior to the grant date. For warrants granted before April , , the exercise
price is determined by the closing price of Zealand’s shares on Nasdaq Copenhagen on the day
prior to the grant date plus %.
Warrants granted prior to April , expire automatically after five years. Warrants vest
either after years of service, with / each month from the grant date, or with / after
one year, / after two years and / after three years. The service cost is recognized over the
respective vesting periods. Warrants granted from April , and going forward expires
automatically after years.
Warrants may be exercised four times a year during a four-week period starting from the date
of the publication of Zealand’s Annual Report or interim reports. Dividend is not expected.
For warrants granted before January , , the volatility rate used is based on the -year
historical volatility of the Zealand share price. For warrants granted after January , , the
volatility rate used is based on a historical volatility of the Zealand share price calculated as the
vesting period of years plus % of the exercise period (: years, : years).
79Zealand Pharma ∞ Annual Report 2020
Notes
Note – Information on sta and remuneration (continued)
The fair value of the warrants compensation granted in was determined using the Black-
Scholes and Monte Carlo model using the following inputs as at day of grant and using average
fair market value for RSUs and PSUs:
Grant year
Type RSUs Warrants PSU Warrants Warrants
Term months Up to months Up to Up to
months months months
Weighted average . . . . .
share price (DKK) to . to . to . to .
Exercise price (DKK) . . .
to . to .
Volatility (%) N/A . N/A . .
to . to . to .
Risk-free interest rate (%) N/A -. N/A -. -.
to -. to -. to .
Exercise period to-from N/A Apr' N/A Jun' May
to Apr' to Dec' to Oct'
No granted , , , , ,
Cost price (DKK) . . . . .
to . to . to . to .
Expense arising from share-based payment transactions
Research and development expenses , , ,
Sale and Marketing expenses ,
Administrative expenses , , ,
Total , , ,
Eect on income statement
In , the fair value of Warrants, RSU and PSUs recognized in the income statement amounts
to DKK . million in total of which DKK . million relate to PSUs and DKK . million relate to
RSUs (: DKK . million and : DKK . million). DKK . million relate to the Execu-
tive Management (: DKK . million and : DKK . million) is recognized in the income
statement..
Fair value RSUs
The number of restricted share units granted in totals ,, of which , is granted
on April , and , granted on September , . For the , granted on April ,
, the value is determined based on the simple average of the closing price of the Compa-
ny's share on Nasdaq Copenhagen A/S for a period of five trading days following the publica-
tion of the annual report of the Company for . For the , granted on September ,
, the value is determined based on the simple average of the closing price of the Compa-
ny's share on Nasdaq Copenhagen A/S for a period of five trading days prior to the grant date.
The programs granted in are initially valued at DKK . million.
Fair value PSUs
The number of performance share units granted is , determined based on the average
share price of the shares of the Company for the three-day trading period following the latest
open trading window preceding the allotment.
The program is initially valued at DKK . million.
Employee warrant programs
In order to motivate and retain key employees and encourage the achievement of common
goals for employees, Management and shareholders, the Group has established an incentive
plan based on warrant programs. Incentive programs have been oered in , and in
the - period.
The warrants are granted in accordance with the authorizations given to the Board of Directors
by the shareholders. The Board of Directors has fixed the terms of and size of the grants, taking
into account authorizations from the shareholders, the Group’s guidelines for incentive pay,
an assessment of expectations of the recipient’s work eorts and contribution to the Group’s
growth, as well as the need to motivate and retain the recipient. Grant takes place on the
date of establishment of the program. Exercise of warrants is by default subject to continuing
employment with the Group. The warrants granted are subject to the provisions of the Danish
Public Companies Act regarding termination of employees prior to their exercise of warrants in
the case of recipients covered by the Act.
employee incentive program
This program was established in for Zealand’s Board of Directors, Executive Management,
employees and consultants.
80Zealand Pharma ∞ Annual Report 2020
Notes
The Board of Directors was authorized to issue up to ,, warrants in the period until No-
vember , . The program has expired and a total of ,, warrants have been granted.
As of December , , ,, warrants have been exercised, The total proceeds amount
to DKK . million (: DKK . million and : DKK . million). As of December
, , zero warrants can still be exercised.
employee incentive program
This program was established in for Zealand’s Executive Management and employees.
The Board of Directors was authorized to issue up to ,, warrants in the period un-
til April, . As of December , , ,, warrants have been granted, ,,
warrants have been exercised, , have expired and , warrants have forfeited. The
program has expired and no further warrants can be granted. The total proceeds amount to
DKK . million (: DKK . million and : DKK . million). As of December , ,
,, warrants can still be exercised.
employee incentive program
This program was established in for Zealand’s Executive Management and employees.
The Board of Directors was authorized to issue up to , warrants in the period until April,
. As of December , , , warrants have been granted, This means that the re-
maining number of warrants that can be granted is ,. The total proceeds amount to DKK
. million (: DKK . million and : DKK . million). As of December , , zero
warrants can be exercised.
long-term incentive program (LTIP) for Corporate Management
This program was established in for Zealand’s Corporate Management.
Under the LTIP, the Executive Management and Other Corporate Management are eligible to
receive a number of performance share units (“PSUs”) at no cost, as determined by the Board of
Directors. Thereafter, PSUs are expected to be granted annually (together with any share-based
long-term incentive program, up to a maximum of % of Zealand’s share capital). The targets
for the first PSUs granted on June , under the LTIP are related to Zealand's filing of a
submission for a New Drug Approval ("NDA") to the Food and Drug Administration ("FDA") in the
United States and Zealand's receipt of an approval letter from the FDA for this NDA application.
The PSUs will vest over a three-year period. The PSUs that have not vested will lapse without
any compensation. Each vested PSU entitles the holder to receive one share in Zealand at no
cost provided that the targets are met.
Note – Information on sta and remuneration (continued)
No of PSUs
Number of shares
At January ,
Granted during the year ,
Vested during the year
Forfeited during the year -,
At December , ,
No of RSUs
Number of shares
At January
Granted during the year ,
Vested during the year
Forfeited during the year
At December ,
Note – Other operating items, net
Accounting policies
Other operating items comprises gains from sale of intangible assets, research funding from
business partners and government grants. A gain from disposal of intangible assets is recog-
nized when control over the asset is transferred to the buyer. The gain is determined as the
disposal proceeds less the carrying amount, if any, and disposal costs.
Research funding is recognized in the period when the research activities have been performed
and government grants are recognized periodically when the work supported by the grant has
been reported.
Bargain purchase are recognized when the purchase price allocation is finalized.Government
grants are recognized when a final and firm right to the grant has been obtained. Government
grants are included in Other operating income, as the grants are considered to be cost refunds.
81Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 7
Notes
Note – Other operating items, net (continued)
DKK thousand
Government grants
Gain from Bargain Purchase, cf, note ,
Gross proceeds from sale of future
royalties and milestones ,,
Royalty expenses regarding the above sale of
future royalties and milestones -,
Fee, advisors regarding the above sale of
future royalties and milestones -,
Total other operating income , ,,
Zealand entered in September into an agreement to sell future royalties and USD . mil-
lion of potential commercial milestones for Soliqua
®
// Suliqua
®
and Lyxumia
®
/ Adlyxin
®
to Royalty Pharma. Under the agreement, all rights and obligations under the Sanofi Licensing
agreement apart from potential payments from Sanofi of up to USD . million, expected in
and have been transferred to the buyer. Zealand had in received USD .
million (DKK ,. million) upon closing of the transaction on September , . In ,
royalty expenses to third parties amounted to .% or DKK . million and fees to advisors
amounted to DKK . million. The Sanofi license agreement was classified as an intangible as-
set upon adoption of IFRS , and the agreement with Royalty Pharma was treated as a sale of
this license. The payment to the third parties was considered additional cost price for a license
forming part of the rights under the Sanofi agreement and therefore forming part of the gain.
As part of the license agreements with Boehringer Ingelheim ('BI'), BI is responsible for con-
ducting preclinical and clinical development, as well as for commercializing the products
stemming from the agreement and funding all activities under the agreement.
In addition, Zealand received government grants in , and .
A gain from the Bargain purchase of DKK million is recognized as part of the acquistion
explained in note .
Note – Financial income
Accounting policies
Financial income includes interest from trade receivables, as well as realized and unrealized ex-
change rate adjustments, fair value adjustments of other investments and marketable securities
and dividends from marketable securities.
Interest income is recognized in the income statement in accordance with the eective interest
rate method.
DKK thousand
Interest income from financial assets measured
at amortized costs , ,
Fair value adjustments of other investments
and marketable securities, cf. note ,
Exchange rate adjustments , ,
Dividend, Marketable securities ,
Total financial income , , ,
Note – Financial expenses
Accounting policies
Financial expenses include interest expenses, as well as realized and unrealized exchange rate
adjustments, interest on lease obligations and fair value adjustments of securities. In addition,
expenses related to the royalty bond until settlement in September were amortized over
the expected duration of the bond and recognized as financial expenses until it was settled in
September .
Interest expense is recognized in the income statement in accordance with the eective inter-
est rate method.
DKK thousand
Interest expenses from liabilities at amortized costs , , ,
Amortization of financing costs ,
Fair value adjustments of marketable securities, cf. note , ,
Loss on sale of marketable securities, cf. note
Other financial expenses , ,
Exchange rate adjustments ,
Total financial expenses , , ,
82Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 8-9
Notes
Note – Income tax
Accounting policies
Income tax on results for the year, which comprises current tax and changes in deferred tax,
is recognized in the income statement, whereas the portion attributable to entries in equity is
recognized directly in equity.
Current tax liabilities and current tax receivables are recognized in the statement of financial
position as tax calculated on the taxable income for the year adjusted for tax on previous years’
taxable income and taxes paid on account/prepaid.
Deferred tax is measured according to the statement of financial position liability method in
respect of temporary dierences between the carrying amount and the tax base of assets and
liabilities.
Deferred tax liabilities are generally recognized for all taxable temporary dierences, and de-
ferred tax assets are recognized to the extent that it is probable that taxable profits will be avail-
able against which deductible temporary dierences can be utilized. Such deferred tax assets
and liabilities are not recognized if the temporary dierence arises from the initial recognition
(other than in a business combination) of other assets and liabilities in a transaction that aects
neither the taxable profit nor the accounting profit. In addition, deferred tax liabilities are not
recognized if the temporary dierence arises from the initial recognition of goodwill.
Deferred tax liabilities are recognized for taxable temporary dierences arising on investments
in subsidiaries except where the Group is able to control the reversal of the temporary dier-
ence and it is probable that the temporary dierence will not be reversed in the foreseeable
future. Deferred tax assets arising from deductible temporary dierences associated with such
investments and interest are only recognized to the extent that it is probable that there will be
sucient taxable profits against which to utilize the benefits of the temporary dierences and
they are expected to be reversed in the foreseeable future.
The carrying amount of deferred tax assets is reviewed at each statement of financial position
date and reduced to the extent that it is no longer probable that sucient taxable profits will
be available to allow all or part of the asset to be recovered. In case of ongoing tax disputes a
provisions for are included as part of deferred tax assets, tax receivables and tax payables.
This judgment is made on an ongoing basis and is based on recent historical losses carrying
more weight than factors such as budgets and business plans for the coming years, including
planned commercial initiatives. The creation and development of therapeutic products within
the biotechnology and pharmaceutical industry is subject to considerable risks and uncertain-
ties. Zealand has so far reported significant losses and, consequently, has unused tax losses.
Management has concluded that deferred tax assets should not be recognized at December
, . (None recognized in .)
Deferred tax assets and liabilities are oset when there is a legally enforceable right to set o
current tax assets against current tax liabilities, they relate to income taxes levied by the same
taxation authority and the Group intends to settle its current tax assets and liabilities on a net
basis.
Deferred tax is calculated at the tax rates that are expected to apply in the period when the
liability is settled or the asset is realized, based on tax laws and rates that have been enacted
or substantively enacted at the statement of financial position date.Deferred tax from business
combinations is initially recognized at fair value.
Income tax receivables are recognized in accordance with the Danish tax credit scheme (Skat-
tekreditordningen). Companies covered by the tax credit scheme may obtain payment of the
tax base of losses originating from research and development expenses of up to DKK million
(tax value of DKK . million).
Under Danish tax legislation, Zealand is eligible to receive DKK . million in (DKK .
million in and DKK . million ) in cash relating to the surrendered tax loss of DKK
million (DKK million in and DKK million for ) based on qualifying research
and development expenses. These tax receipts comprise the entire current tax benefit in
and , respectively.
The income from sale of future royalties and milestones in resulted in a positive net re-
sult, meaning that Zealand was not in eligible for similar tax income based on qualifying
research and development expenses, but was able to utilize a portion of the unrecognized
deferred tax asset
When considering tax and duties disputes, Management applies significant estimates of the
likely outcome based on the knowledge available of the actual substance of the disputes,
including opinions and estimates by external tax experts and case law, if available. The
resolution of disputes may take several years, and the outcome is subject to considerable
uncertainty.
83Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 10
Notes
Note – Income tax (continued)
DKK thousand
Net result for the year before tax -, -, ,
Corporate tax rate in Denmark .% .% .%
Expected tax benefit/(expenses) , , -,
Adjustment for foreign tax rates -
Adjustment for non-deductible expenses , - -
Adjustment for non-taxable income -,
Adjustment for exercised warrants , -, -,
Adjustment for R&D extra deduction -, , ,
Tax eect on exercise of warrants -, ,
Tax eect on expired warrants -
Warrant - share price development -, ,
Adjustment to prior year
Change in tax assets (not recognized) -, -, ,
Total income tax expense/benefit -, , -,
DKK thousand
Specification of deferred tax assets:
Tax losses carried forward (available indefinitely) ,, , ,
Research and development expenses , , ,
Intangible assets , , ,
Non-current assets , , ,
Liabilities , ,
Other , , ,
Total temporary dierences ,, ,, ,
Calculated potential deferred tax asset at local tax rate , , ,
Deferred tax asset not expected to be utilized -, -, -,
Recognized deferred tax asset ,
Note – Basic and diluted earnings per share
Accounting policies
Basic result per share
Basic result per share is calculated as the net result for the period that is allocated to the parent
company’s ordinary shares, divided by the weighted average number of ordinary shares out-
standing. This includes the treasury shares held by the company.
Diluted result per share
Diluted result per share is calculated as the net result for the period that is allocated to the
parent company’s ordinary shares, divided by the weighted average number of ordinary shares
outstanding and adjusted by the dilutive eect of potential ordinary shares.
The result and weighted average number of ordinary shares used in the calculation of basic and
diluted result per share are as follows:
DKK thousand
Net result for the year -, -, ,
Net result used in the calculation of basic and
diluted earnings/losses per share -, -, ,
Weighted average number of ordinary shares ,, ,, ,,
Weighted average number of treasury shares -, -, -,
Weighted average number of ordinary shares used
in the calculation of basic earnings per share ,, ,, ,,
Weighted average number of ordinary shares used
in the calculation of diluted earnings per share ,, ,, ,,
Basic earnings/loss per share (DKK) -. -. .
Diluted earnings/loss per share (DKK) -. -. .
84Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 11
Notes
Note – Basic and diluted earnings per share (continued)
The following potential ordinary shares are anti-dilutive at December , (anti-dilutive
at December , and dilutive December , ) and are therefore not included in the
weighted average number of ordinary shares for the purpose of diluted earnings per share:
DKK thousand
Outstanding warrants under the employee
incentive program , ,
Outstanding warrants under the employee
incentive program ,, ,, ,,
Outstanding Restricted Share Units (RSUs) under
the LTIP program ,
Outstanding Performance Share Units (PSUs) under
the LTIP program , ,
Outstanding warrants under the employee
incentive program ,
Total outstanding warrants ,, ,, ,,
- out of which these are dilutive ,
- out of which these are anti-dilutive ,, ,, ,,
Note – Impairment
Accounting policies
Assets with indefitie usefull time are annually assesed for impairment whereas assets with defi-
nite usefull lifetime are assessed for impairment indicators.
Each year, the assets are reviewed in order to assess whether there are indications of impair-
ment. If such indications exist, the recoverable amount, determined as the higher amount of
the fair value of the asset adjusted for expected costs to sell and the value in use of the asset, is
calculated. The value in use is calculated based on the estimated future cash flows, discounted
by using a pre-tax discount rate that reflects current market assessments of the time value of
money and the risks specific to the asset.
If the recoverable amount of an asset or its cash-generating unit is lower than the carrying
amount, an impairment charge is recognized in respect of the asset. The impairment loss is
recognized in the income statement. In addition, for goodwill and other intangible assets with
indefinite useful lives, impairment tests are performed at each balance sheet date, regardless
of whether there are any indications of impairment. For acquisitions, the first impairment test is
performed before the end of the year of acquisition.
Key assumptions in the impairment test
The impairment assessment for identified a need for impairment on the V-Go related
Intellectual property of DKK . million. The impairment loss was primarily related to Man-
agement’s decision to allocate resources to support future product launches while limiting the
investment in the V-Go product.
No impairment indicators were identified in .
Through the assessment of impairment indicators regarding the V-Go intellectual property,
Management identified impairment indicators and an impairment test was performed by calcu-
lating recoverable amount of the V-Go intellectual property.
The recoverable amount was determined based on a value in use calculation using cash flow
and projections for subsequent years up to and including , equivalent to the expected
useful life of the intangible asset. The expected future net cash flows are determined based on
budgets and business plans approved by Management Board. From onwards, a perpetual
cash flow decreasing by the terminal growth rate of -% is used. The pre-tax discount rate
applied to the cash flow projections was %. The analysis showed a need of an impairment of
DKK . million regarding the V-Go Intellectual property. The amount is recognized as sales
and marketing expenses in the income statement.
Due to the full impairment of the V-Go related intellectual property, no additional sensitivity
analysis is performed.
85Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 12
Notes
Note – Intangible assets
Accounting policies
Separately acquired licenses, rights and patents are initially measured at cost. Licenses, rights
and patents acquired in connection with the purchase of a legal entity where substantially all
of the fair value of the gross assets acquired is concentrated in a single asset are considered an
asset acquisition and initially recognized at cost at the acquisition date. The cost accumulation
model has been applied for accounting for contingent considerations, whereby all further con-
sideration is added when incurred, to the cost of the asset initially recorded.
The acquired intangibles have a finite useful life and are subsequently carried at cost less
accumulated amortizations using the straight-line method over the estimated useful life and
impairment losses. The amortization periods are as follows:
• License, rights and patents: Based on lifetime of patent etc.
• Intellectual property: 10 years
• Physician relationsship: 8 years
Amortizations will recognized in the income statement as R&D expenses when the intangibles
are available for use based on the determined useful life. Useful lifetime is assessed continuous-
ly for all new acquried assets.
If circumstances or changes in Zealand's operations indicate that the carrying amount of the
intangibles may not be recoverable, Management will review the intangibles for impairment.
Refer to note .
At December , , licenses, rights and patents comprise a right that will be included in a
future development project originating from the acquisition of Encycle Therapeutics in October
and the intangible assets arising from the acquisition of Valertias activities.
The right has been measured based on the overall cost of the transaction less the fair value of
the cash balance and trade payables also acquired. The fair value of the contingent consider-
ations related to Encycle Therapeutics was assessed to be zero as per the acquisition date due
to Zealand applying the cost accumulation model for accounting for contingent considera-
tions, whereby all further consideration is added when incurred, to the cost of the asset initially
recorded.
Physician relationships and IP rights acquired through business combinations are measured
at fair value at the acquisition date and amortized on a systematic basis over their useful life
and years respectively (unless the asset has an indefinite useful life, in which case it is not
amortized).
Licenses
rights Intellectual Physician
DKK thousand and patents property relationship
Cost at January , ,
Additions due to business combinations, cf. note , ,
Additions
Currency translation -,
Cost at December , , , ,
Amortization at January ,
Amortization for the year ,
Impairment, cf. note ,
Currency translation -
Amortization at December , , ,
Carrying amount at December , , ,
Amortization and impairment for the financial year
has been charged as:
Research and development expenses
Administrative expenses
Sale and marketing expenses , ,
Total , ,
Cost at January ,
Additions ,
Cost at December , ,
Amortization at January ,
Amortization at December ,
Carrying amount at December , ,
Amortization for the financial year has been charged as:
Research and development expenses
Sale and marketing expenses
Administrative expenses
Total
86Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 13
Notes
Note – Property, plant and equipment
Accounting policies
Plant and machinery, other fixtures and fittings, tools and equipment and leasehold improve-
ments are measured at cost less accumulated depreciation.
Cost comprises acquisition price and costs directly related to acquisition until the time when
the Group starts using the asset.
Tangible assets under construction are recorded as work in progress until construction has
been completed and use of asset commenced.
The basis for depreciation is cost less estimated residual value at the end of the useful life. As-
sets are depreciated using the straight-line method over the expected useful lives of the assets.
The depreciation periods are as follows:
• Buildings 5-13 years
• Plant and machinery 5-10 years
• Other fixtures and fittings, tools and equipment 3-5 years
Gains and losses arising from disposal of plant and equipment are stated as the dierence
between the selling price less the costs of disposal and the carrying amount of the asset at the
time of the disposal. Gains and losses are recognized in the income statement under Research
and development expenses, Sale and marketing expenses and Administrative expenses.
At the end of each reporting period, the Group reviews the carrying amount of property, plant
and equipment as well as non-current asset investments to determine whether there is an
indication that those assets have suered an impairment loss. If any such indication exists, the
recoverable amount of the asset is estimated to determine the extent of the impairment loss (if
any). If it is not possible to estimate the recoverable amount of an individual asset, the Group
estimates the recoverable amount of the cash-generating unit to which the asset belongs. If
a reasonable and consistent basis of allocation can be identified, assets are also allocated to
cash-generating units, or allocated to the smallest group of cash-generating units for which a
reasonable and consistent allocation basis can be identified.
The recoverable amount is the higher of fair value less costs of disposal and value in use. The
estimated future cash flows are discounted to their present value using a pre-tax discount rate
that reflects the current market assessments of the time value of money and the risks specific
to the asset for which the estimates of future cash flows have not been adjusted.
No impairments to property. plant and equipment have been recognized for , and
.
87Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 14
Notes
Plant and Other fixtures Building Assets under
DKK thousand machinery and fittings improvements construction
Cost at January , , , ,
Transfer -
Additions , , , ,
Retirements -, - -
Cost at December , , , , ,
Accumulated depreciation
at January , , , ,
Transfer -
Depreciation for the year , ,
Retirements -, - -
Accumulated depreciation
at December , , , ,
Carrying amount
at December , , , , ,
Depreciation for the
financial year has been
charged as:
Research and
development expenses ,
Administrative expenses
Sale and marketing expenses
Total , ,
Note – Property, plant and equipment (continued)
Plant and Other fixtures Building Assets under
DKK thousand machinery and fittings improvements construction
Cost at January , , , , ,
Transfer , -,
Addition from
business combinations , , , ,
Additions , , ,
Retirements -, - -,
Currency translation -, - - -
Cost at December , , , , ,
Accumulated depreciation
at January , , , ,
Transfer
Depreciation for the year , , ,
Retirements -, - -,
Currency translation - , -
Accumulated depreciation
at December , , , ,
Carrying amount
at December , , , , ,
Depreciation for the
financial year has been
charged as:
Research and
development expenses -, -, -,
Administrative expenses - - -
Sale and marketing expenses -
Total -, -, -,
88Zealand Pharma ∞ Annual Report 2020
Notes
Note – Right-of-use assets and lease liabilities
Accounting policies
The Group leases an oce buildings, equipment and vehicles. The rental contract for the HQ
oce building has been made for a minimum period of years (terminable by the landlord
after years). Management has assessed the lease period to be years. The rental contract
for the US oce site has been made for a minimum period of years. Equipment and vehicles
are leased over a period of - years with no extension option.
Contracts may contain both lease and non-lease components. The group allocates the con-
sideration in the contract to the lease and non-lease components according to the specific
pricing of the services in the agreements.
Lease terms are negotiated on an individual basis and contain a wide range of dierent terms
and conditions. The lease agreements do not impose any covenants other than the security
interests in the leased assets that are held by the lessor.
Until the financial year, all leases were classified as operating leases, but are from January
, recognized as a right-and-use asset and corresponding liability at the date at which the
asset is available for use by Zealand. IFRS determines whether a contract contains a lease on
the basis of whether the customer has the right to control the use of an identified asset for a pe-
riod of time in exchange for consideration. Zealand applies the definition of a lease and related
guidance set out in IFRS to all contracts entered into or changed on or after January , .
Assets and liabilities arising from a lease are initially measured on a present value basis. Lease
liabilities include the net present value of the following lease payments:
• fixed payments less any lease incentives receivable
• variable lease payment that are based on an index or a rate, initially measured using the index
or rate as at the commencement date
Lease payments to be made under reasonably certain extension options are also included in
the measurement of the liability.
Short-term and low value leases are also recognized as right-of-use assets.
The lease payments are discounted using the interest rate implicit in the lease. If that rate
cannot be readily determined, which is generally the case for leases in the Group, the Group’s
incremental borrowing rate is used, being the rate that the group would have to pay to borrow
the funds necessary to obtain an asset of similar value to the right-of-use asset in a similar
economic environment with similar terms, security and conditions.
The Group is exposed to potential future increases in variable lease payments based on an in-
dex or rate, which are not included in the lease liability until they take eect. When adjustments
to lease payments based on an index or rate take eect, the lease liability is reassessed and
adjusted against the right-of-use asset.
Lease payments are allocated between principal and finance cost. The finance cost is charged
to the income statement over the lease period to ensure a constant periodic rate of interest on
the remaining balance of the liability for each period.
Right-of-use assets are measured at cost comprising the following:
• the amount of the initial measurement of lease liability
• any lease payments made at or before the commencement date less any lease incentives
received
• any initial direct costs and restoration costs.
Right-of-use assets are generally depreciated over the shorter of the asset's useful life and the
lease term on a straight-line basis. If the Group is reasonably certain to exercise a purchase
option, the right-of-use asset is depreciated over the underlying asset’s useful life.
Amounts recognized in the statement of financial position
The statement of financial position shows the following amounts relating to right-of-use assets:
Other
Oce fixtures and
DKK thousand Buildings fittings
As at January , , ,
Additions due to business combination, cf. note ,
Additions ,
Retirements -, -
Reversal of depreciations ,
Depreciation expense -, -
Currency translation -,
As at December , , ,
As at January , , ,
Additions ,
Depreciation expense -, -,
As at December , , ,
Set out below are the carrying amounts of lease liabilities and the movements
during the period.
89Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 15
Notes
Note – Right-of-use assets and lease liabilities (continued)
As at January , ,
Additions due to business combinations, cf. note ,
Additions , ,
Accretion of interest ,
Payments -, -,
Currency translation -,
As at December , ,
Current , ,
Non-current , ,
The following are the amounts recognised in income statement:
Depreciation expense of right-of-use assets -, -,
Interest expense on lease liabilities -,
Total amount recognised in profit and loss -, -,
Cashflow -, -,
Total cash outflow for leases -, -,
Depreciation for the financial year has been charged as:
Research and development expenses -, -,
Administrative expenses -, -,
Sale and marketing expenses
Total -, -,
Note – Inventories
Accounting policies
Raw materials, work in progress and finished goods are stated at the lower of cost and net
realizable value. Cost is determined on a first in, first out basis and comprises direct materials,
direct labor and an appropriate proportion of variable and fixed overhead expenditure, the latter
being allocated on the basis of normal operating capacity. Costs of purchased inventory are
determined after deducting rebates and discounts. Net realizable value is the estimated selling
price in the ordinary course of business less the estimated costs of completion and the estimat-
ed costs necessary to make the sale.
Inventory manufactured prior to regulatory approval (prelaunch inventory) is capitalised but
immediately provided for, until there is a high probability of regulatory approval for the product.
A write-down is made against inventory, and the cost is recognised in the income statement as
research and development costs. Once there is a high probability of regulatory approval being
obtained, the write-down is reversed, up to no more than the original cost.
We review our inventory for excess or obsolescence and write down inventory that has no
alternative uses to its net realizable. Economic conditions, customer demand and changes in
purchasing and distribution can aect the carrying value of inventory. As circumstances war-
rant, we record provisions for potentially obsolete or slow moving inventory and lower of cost
or net realizable value inventory adjustments. In some instances, these adjustments can have
a material eect on the financial results of an annual or interim period. In order to determine
such adjustments, we evaluate the age, inventory turns, future sales forecasts and the estimated
fair value of inventory.
Inventories comprise:
DKK thousand
Raw materials ,
Work in process ,
Finished goods ,
Total ,
Direct costs ,
Indirect production costs ,
90Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 16
Notes
Note – Trade receivables
Accounting policies
On initial recognition, receivables are measured at fair value. The Group holds the trade receiv-
ables with the objective to collect the contractual cash flows and therefore measures them
subsequently at amortized cost.
Trade receivables are written down for expected credit losses. The Group applies the simplified
approach in IFRS to measuring expected credit losses which uses a lifetime expected loss
allowance for trade receivables and contract assets. A write-down is recognized in sales and
marketing expenses.
There are no material overdue receivables and the write-down for expected credit losses is not
material.
At December , and , Zealand had no trade receivables related to milestone pay-
ments.
Note – Prepaid expenses
Accounting policies
Prepaid expenses comprise amounts paid in respect of goods or services to be received in
subsequent financial periods. Clinical trials, which are outsourced to Clinical Research Organ-
izations (“CROs”), take several years to complete. As such, Management is required to make
estimates based on the progress and costs incurred to-date for the ongoing trials. Judgements
are made in determining the amount of costs to be expensed during the period, or recognized
as prepayments or accruals on the statement of financial position.
Other receivables are measured at amortized cost less impairment. Prepayments include ex-
penditures related to future financial periods and are measured at nominal value
The increase by DKK . million from (DKK . million) to (DKK . million) is
primarily related to an increase in prepaid insurance, taken as a result of higher insurance costs
because of the increased premiums required for Director & Ocer insurance.
Note – Inventories (continued)
Write downs recognized on inventories were reflected in the cost of goods sold. They were
comprised as follows:
DKK thousand
Accumulated write downs, January
Addition from business combination, cf. note -,
Write downs in the reporting period
Reversals or utilization of write downs ,
Exchange dierences
Accumulated write downs, December -,
DKK . million is recognized as cost of goods sold during .
Note – Other investments
Accounting policies
Other investments are measured on initial recognition at cost, and subsequently at fair value.
Changes in fair value are recognized in the income statement under financial items.
The Group’s other investments consist of a USD . million (: USD . million) investment
in Beta Bionics, Inc., the developer of iLet™, a fully integrated dual-hormone pump (bionic
pancreas) for autonomous diabetes care. The investment in Beta Bionics, Inc. is recorded at fair
value through profit and loss. This investment represents .% (:.%) ownership of Beta
Bionics, Inc., and is recorded at a fair value of DKK . million as of December , (DKK
. million as of December , ).
In determining fair value, Zealand considered the impact of any recent share capital issuances
by Beta Bionics as an indicator of the fair value of the shares. In particular, Beta Bionics under-
took a capital oering in June and subsequent infliction points was used as the basis for
determining fair value. Measurement is considered a level measurement.
A fair value adjustment of DKK . million and currency conversion impact of DKK -. million,
respectively, have been recognized in financial income in (: DKK . million and DKK
. million respectively).
91Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 17-19
Notes
Note – Other receivables
Accounting policies
Other receivables are measured on initial recognition at cost and subsequently at amortized
cost.
DKK thousand
VAT , ,
Other , ,
Total other receivables , ,
Note – Marketable securities
Accounting policies
The Group’s Marketable securities portfolio comprises a investmetn in a bond portfolio. The
investment is categorized as equity instruments held for trading. Consequently, the securities
are classified at fair value through profit or loss. Refer to note , Financial risks.
A net fair value adjustment of DKK -. million from marketable securities have been recog-
nized in financial expenses, respectively, in (: DKK . million in financial income.
Note – Cash and cash equivalents
Accounting policies
Cash is measured on initial recognition at cost.
DKK thousand
DKK , ,
USD , ,
EUR , ,
Total cash and cash equivalents , ,,
Note – Share capital
Accounting policies
Consideration paid and proceeds from selling treasury shares recognized directly in equity
within retained losses. Capital reductions through cancellation of treasury shares reduce the
share capital by an amount equal to the original cost price of the shares. Dividend payments are
recognized as a deduction of equity and a corresponding liability when declared.
No, of shares (thousand)
January , ,
Increase due to issue of new shares , ,
December , ,
The share capital solely consists of one class of ordinary shares all issued of DKK each and all
shares rank equally. The shares are negotiable instruments with no restrictions on their trans-
ferability. All shares have been fully paid. At the annual general meeting on April , Zealand
was authorized to increase the nominal share capital by nominally DKK ,, during the
period until April , . At December , nominally DKK ,, of the authorization
remains. Further please refer to note for the capital increase made in January .
On June , a total of ,, new shares have been subscribed through a private and
direct shares issue with a net proceeds pf DKK . million. On March , a total of ,
new shares have been subscribed through a private share issue to US based investors with a net
proceeds of DKK . million. The cost of share issues amounts to DKK . million.
On March , , a total of , new shares have been subscribed through a direct share
issue to Alexion Pharmaceuticals, Inc. in connection with entering into the license agreement
with Zealand Pharma A/S with net proceeds of DKK . million, including costs of DKK
million. On September , , a total of ,, new shares have been subscribed through
a private placement and directed share issue to existing shareholder Van Herk Investments
B.V. with net proceeds of DKK . million, including costs of DKK . million. Other capital
increases in and related to exercise of warrant programs.
Expenses directly related to capital increases are deducted from equity.
At December , , there were , treasury shares (: ,), equivalent to .%
(: .%) of the share capital and corresponding to a market value of DKK . million (:
DKK . million). , treasury shares have been allocated to performance shares units (PSUs)
as part of Zealand Pharma’s long-term incentive program (LTIP) granted June , . Of these
a total of , PSU’s remain. See note for a further description of the LTIP program.
Rules on changing the Articles of Association
All resolutions put to the vote of shareholders at general meetings are subject to adoption by
a simple majority of votes, unless the Danish Companies Act (Selskabsloven) or our Articles of
Association prescribe other requirements.
92Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 20-23
Notes
Note – Deferred revenue
The Group has recognized the following liabilities related to contracts with customers.
DKK thousand
Deferred revenues at January ,
Customer payment received, cf. note . ,
Revenue recognized during the year -, -,
Total deferred revenue , ,
Non-current deferred revenue , ,
Current deferred revenue , ,
, ,
Deferred revenue occurred in connection with the agreement with Alexion Pharmaceuticals,
Inc. as disclosed in Note . An up-front payment of DKK . million was received of which
DKK . million has been recognized during and DKK . million in .
Management expects that approx. DKK million of the up-front payment received will be rec-
ognized as revenue during . The remaining payment is expected to be recognized during
and according to the progress of the development project.
Note – Provision
Provision Provision
for sales for product
DKK thousand rebates returns total total
Provision at the beginning of the year
Addition due to acquisition cf note , , ,
Adjustments for the year , ,
Utilization during the period -, -, -,
Reversal of provisions from
previous years -, -,
Currency translation adjustments -, - -,
Provision at year-end , ,
Provisions comprise current sales rebates and discounts granted to government agencies,
wholesalers, retail pharmacies, Managed Care and other customers, which are recorded at the
time the related revenues are recorded or when the incentives are oered.
Provisions are calculated based on historical experience and the specific terms in the individ-
ual agreements. Unsettled rebates are recognised as provisions when the timing or amount is
uncertain. Where absolute amounts are known, the rebates are recognised as other liabilities.
Please refer to note and note for further information on sales rebates and provisions and
managements estimates and judgements.
Zealand Pharma issues credit notes for expired goods as a part of normal business. Where there
is historical experience or a reasonably accurate estimate of expected future returns can other-
wise be made, a provision for estimated product returns is recorded. The provision is measured
at gross sales value.
Accounting policies
Provisions are recognized when the Company has an existing legal or constructive obligation as
a result of events occurring prior to or on the balance sheet date, and it is probable that the uti-
lization of economic resources will be required to settle the obligation. Provisions are measured
at management’s best estimate of the expenses required to settle the obligation.
93Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 24-25
Notes
Note – Financial risks
The objective of Zealand’s financial management policy is to reduce the Group’s sensitivity
to fluctuations in exchange rates, interest rates, credit rating and liquidity. Zealand’s financial
management policy has been endorsed by Zealand’s Audit Committee and ultimately approved
by Zealand’s Board of Directors.
Zealand is exposed to various financial risks, including foreign exchange rate risk, interest rate
risk, credit risk and liquidity risk.
Capital structure
Zealand aims to have an adequate capital structure in relation to the underlying operating
results and research and development projects, so that it is always possible to provide sucient
capital to support operations and long-term growth targets.
The Board of Directors finds that the current capital and share structure is appropriate for the
shareholders and the Group.
Exchange rate risk
Most of Zealand’s financial transactions are in DKK, USD and EUR.
Due to Denmark’s long-standing fixed exchange rate policy vis-à-vis the EUR, Zealand has
evaluated that there is no material transaction exposure or exchange rate risk regarding trans-
actions in EUR.
Zealand’s milestone payments have been agreed in foreign currencies, namely USD and EUR.
However, as milestone payments are unpredictable in terms of timing, the payments are not
included in the basic exchange rate risk evaluation.
Currency exposure regarding our US activities are managed by having revenue and expenses in
the same currency.
As Zealand conducts clinical trials and toxicology studies around the world, Zealand will be
exposed to exchange rate risks associated with the denominated currency, which is primarily
USD based on volume and fluctuations against DKK. To date, Zealand’s policy has been to man-
age the transaction and translation risk associated with the USD passively, placing the revenue
received from milestone payments in USD in a USD account for future payment of Zealand’s
expenses denominated in USD, covering payments for the next - months and thus match-
ing Zealand’s assets with its liabilities.
As of December , , Zealand holds DKK . million (: DKK . million) of its cash
in USD.
Note – Other liabilities
Accounting policies
Financial liabilities are recognized initially at cost less transaction costs. In subsequent periods,
financial liabilities are measured at amortized cost corresponding to the capitalized value using
the eective interest method.
DKK thousand
Employee benefits , ,
Royalty payable to third party , ,
Development project costs , ,
Other payables , ,
Total other liabilities , ,
Current , ,
Non-current ,
Note – Contingent assets, liabilities and other contractual obligations
Contingent assets include potential future milestone payments. Contingent liabilities and other
contractual obligations include contractual obligations related to agreements with contract
research organizations (CROs), milestone payments and lease commitments.
Accounting policies
Contingent assets and liabilities are disclosed, unless the possibility of an inflow or outflow of
resources embodying economic benefits is virtually certain.
Contingent Assets
At December , , Zealand is still eligible for a payment from Sanofi of up to USD . mil-
lion, of which DKK . million is expected in and DKK . million in . However, it is
Management’s opinion that the amount of any payment cannot be determined on a suciently
reliable basis, and therefore have not recognized an asset in the statement of financial position
of the Group.
Contingent liabilities and Contractual obligations
At December , , total contractual obligations related to agreements with CROs amount-
ed to DKK . million (DKK . million for and DKK . million for the years up
to and including ).
Zealand may be required to pay future development, regulatory and commercial milestones
related to the acquisition of Encycle Therapeutics. Refer to note .
94Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 26-28
Notes
Interest rate risk
Zealand has a policy of avoiding financial instruments that expose the Group to any unwanted
financial risks. As of December , , Zealand only has Lesae liabilities as interest bearing
debt amounting to DKK . million. Up until the redemption in September , Zealand had
a fixed rate royalty bond.
During , all cash has been held in current bank accounts in USD, EUR and DKK. Interest
rates on bank deposits in DKK and EUR have been negative since , while USD accounts
have generated a low level of interest income.
During and , Zealand has invested in low risk marketable securities. The Group’s mar-
ketable securities portfolio comprises bonds in Danish kroner. The average weighted duration
of the bond portfolio on the statement of financial position date was years in both years.
Credit risk
Zealand is exposed to credit risk in respect of receivables, bank balances and bonds. The max-
imum credit risk corresponds to the carrying amount. Management believes that credit risk is
limited, as the counterparties to the trade receivables are large global pharmaceutical compa-
nies and wholesalers.
Cash and bonds are not deemed to be subject to credit risk, as the counterparties are banks
with investment-grade ratings (i.e. BBB- or higher from Standard & Poor’s).
Liquidity risk
The purpose of Zealand’s cash management is to ensure that the Group has sucient and
flexible financial resources at its disposal at all times.
Zealand’s short-term liquidity is managed and monitored by means of the Company’s quarter-
ly budget revisions to balance the demand for liquidity and maximize the Company’s interest
income by matching its free cash in fixed-rate, fixed-term bank deposits and bonds with its
expected future cash burn.
Sensitivity analysis
The table shows the eect on profit/loss and equity of reasonably likely changes in the financial
variables in the statement of financial position.
DKK thousand Fluctuation Eect Fluctuation Eect
USD +/-% , +/-% ,
Note – Financial risks (continued)
Contractual maturity (liquidity risk)
A breakdown of the Group’s aggregate liquidity risk on financial assets and liabilities is given
below.
The following table details the Group’s remaining contractual maturity for its financial liabilities
with agreed repayment periods. The table has been prepared using the undiscounted cash
flows for financial liabilities, based on the earliest date on which the Group can be required to
pay. The table includes both interest and principal cash flows. To the extent that the specific
timing of interest or principal flows is dependent on future events, the table has been prepared
based on Management’s best estimate of such timing at the end of the reporting period. The
contractual maturity is based on the earliest date on which the Group may be required to pay.
With the exception of leasing, there are no interest cash-flows to be included in the table below
for the existing financial liabilities as they are not interest-bearing financial liabilities.
<
DKK thousand months - Years > Years Total
Trade payables , ,
Leasing , , , ,
Other liabilities , , ,
Total financial liabilities
at December , , , , ,
Trade payables , ,
Leasing , , , ,
Other liabilities , ,
Total financial liabilities
at December , , , , ,
All cash flows are non-discounted and include all liabilities under contracts.
95Zealand Pharma ∞ Annual Report 2020
Notes
DKK thousand
Categories of financial instruments
Deposits , ,
Trade receivables ,
Other receivables , ,
Cash and cash equivalents , ,,
Financial assets at amortized costs ,, ,,
Marketable securities , ,
Other investments , ,
Financial assets measured at fair value through profit or loss , ,
Lease liabilities , ,
Trade payables , ,
Other liabilities , ,
Financial liabilities measured at amortized cost , ,
The fair value of marketable securities is based on Level in the fair value hierarchy.
The fair value of other investments is based on level in the fair value hierarchy. Refer to note .
There were no transfer between levels , and for recurring fair value measurement during
the period ended December , or .
The carrying amount of financial assets and financial liabilities approximated the fair value.
Note – Financial risks (continued)
Capital Management
Zealand’s goal is to maintain a strong capital base to maintain investor, creditor and market
confidence, and a continuous advancement of Zealand’s product pipeline and business in
general. Zealand is primarily financed through capital increases and partnership collaboration
income and had, as of December , , a cash position of DKK . million (: ,.
million). The cash position supports the advancement of our product pipeline and operations.
The adequacy of our available funds will depend on many factors, including progress in our
research and development programs, the magnitude of those programs, our commitments
to existing and new clinical collaborators, our ability to establish commercial and licensing
arrangements, our capital expenditures, market developments, and any future acquisitions. Ac-
cordingly, we may require additional funds and may attempt to raise additional funds through
equity or debt financings, collaborative agreements with partners, or from other sources.
The Board of Directors monitors the share and capital structure to ensure that Zealand’s capital
resources support the strategic goals. There was no change in the group’s approach to capital
management procedures in .
Neither Zealand Pharma A/S nor any of its subsidiaries are subject to externally imposed capital
requirements.
96Zealand Pharma ∞ Annual Report 2020
Notes
Note – Business combinations
Accounting policy
Business combinations are accounted for using the acquisition method of accounting. At the
date of the acquisition, the Company initially recognizes the fair value of the identifiable assets
acquired, the liabilities assumed and any non-controlling interest in the acquired business.
The consideration transferred is measured at fair value at the date of acquisition and the excess
of the consideration transferred over the fair value of net identifiable assets of the business
acquired is recorded as goodwill. In circumstances where the consideration transferred is less
than the fair value of net identifiable assets of the business acquired, the dierence is recog-
nized directly in the consolidated statement of profit or loss as a bargain purchase.
Where the settlement of any part of cash consideration is deferred, the amounts payable in the
future are discounted to their present value. Contingent consideration is classified either as eq-
uity or a financial liability and is recognized at fair value on the acquisition date. Amounts clas-
sified as a financial liability are subsequently remeasured to fair value in accordance with IFRS
(Financial Instruments), with changes in fair value recognized in the consolidated statement of
comprehensive loss as an administrative expense.
Business combinations require management making an assessment of the fair value of the
net assets acquired as well as an assessment regarding whether control exists. Management
judgement is particularly involved in the recognition and measurement of the following items at
fair value:
• intellectual property: this may include patents, licenses, trademarks and similar rights for
currently marketed products, and also the rights and scientific knowledge associated with
projects that are currently in research or development phases, and requires the projection
of estimated future cash inflows and outflows and relevant risks, the terminal value of these
assets, discount rates and weighted average costs of capital,
• working capital items such as trade receivables, inventory (raw materials, work in process,
parts and finished goods), prepaid expenses, trade payables, and fixed assets
• Guarantees, warranties, indemnities, rights, claims, counterclaims etc. set o against third
parties relating to the acquired assets or assumed liabilities, including rights under vendors’
and manufacturers’ warranties, indemnities, guaranties and avoidance claims and causes of
action under any applicable Law, employee liabilities and other contingencies
In all cases, management makes an assessment based on the underlying economic substance
of the items concerned, and not only on the contractual terms, in order to fairly present these
items. In making these assessments, management relies to a significant extent on the work of
valuation experts. However, the assessments are highly subjective and sensitive to the assump-
tions used.
In accordance with IFRS , if a business combination indicates a bargain gain all applied as-
sumptions will be reassessed by Management before recognition.
Directly attributable acquisition-related costs are expensed as incurred within the consolidated
statement of comprehensive loss.
Customer relationships and IP rights acquired through business combinations are measured
at fair value at the acquisition date and amortized on a systematic basis over their useful life
and years respectively (unless the asset has an indefinite useful life, in which case it is not
amortized).
Acquisition of medical technology business from Valeritas, Inc.
On April , (or “the acquisition date”) Zealand acquired substantially all of the medical
technology business from Valeritas Holdings, Inc. (or “Valeritas”) pursuant to the terms of the
stalking horse asset purchase agreement previously entered into with Valeritas and following
approval by the U.S. Bankruptcy Court for the District of Delaware on March , .
Valeritas was a U.S. based commercial-stage company whose activities comprised develop-
ment, production and sale of wearable disposable insulin pumps and has therefore been ac-
quired to accelerate Zealand’s plans for establishing U.S. operations to support the anticipated
launch of the auto-injector and pre-filled syringe for severe hypoglycemia.
The acquisition comprises all medical technology business related tangible and intangible
assets that pursuant to the Bankruptcy Code was transferred to Zealand free and clear of all
claims, liabilities and encumbrances including the Valeritas workforce. Additionally, the acquisi-
tion includes most of the working capital assets and selected liabilities.
Under IFRS , Business Combinations, the acquisition has been accounted for as a business
combination using the acquisition method. The consolidated financial statements include the
results of Valeritas for the from the acquisition date.
The consideration transferred was DKK . million (USD . million), and the fair values of
the identifiable assets and liabilities of Valeritas as at the date of acquisition were:
97Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 29
DKK thousand Fair value recognized on acquisition
Assets
Physician Relationship ,
V-Go IP ,
Property, plant and equipment ,
Right-of-use assets ,
Inventories ,
Trade receivables ,
Other assets ,
Cash and cash equivalents
Liabilities
Deferred tax liability -,
Trade payables -,
Lease liabilities -,
Other liabilities -,
Total identifiable net assets at fair value ,
Bargain purchase recognized -,
Purchase consideration transferred ,
Analysis of cash flows on acquisition:
Net cash acquired
(included in cash flows from investing activities)
Cash paid -,
Net cash flow on acquisition -,
The fair value attributable to intangible assets (DKK . million as of the acquisition date)
consists of the value arising from the existing Valeritas physician network and relationships,
valued at DKK . million which is based on the estimated cost it would require to establish
similar network and relationships, or a so-called with/without valuation method, and intel-
lectual property related to the V-Go technology, valued at DKK . million using an excess
earnings model. (Subsequently impaired. Refer to note ) The valuations is calculated using
cash flow projections from financial budget approved by Corporate Management covering a
year period. The discount rate applied to the cash flow projections is %. The growth rate
used to extrapolate the cash flows of the unit beyond the year period is -% which reflects
Note – Business combinations (continued)
our estimate of the expected lifetime of the product of years with a significant decrease in
revenues afterwards.
The calculation of the fair value of intangible assets is most sensitive to the revenue and gross
margin growths.Revenue and gross margin: Revenue and gross margin are based on historical
trends. The revenue growth applied in the calculation is between -% in the -year budget
period with the first years having the highest revenue growth in percentage.Operating costs:
Operating costs are based on historical trends and industry knowledge. Operating costs over
the -year budget period has been adjusted to incorporate the allocation related to shared
eorts of future product launches.
Trade receivables have been measured at the contractual amount expected to be received
which approximates the fair value of DKK . million. The amounts have not been discounted,
as maturity on receivables is generally very short and the discounted eect therefore immate-
rial.
The acquisition resulted in a bargain purchase gain of DKK . million which was recognized
within other operating income in the consolidated income statement. The gain arose as the
fair value of the net assets acquired (DKK . million) exceeded the fair value of the purchase
consideration (DKK . million). The gain is primarily attributable to the Company purchasing
the medical technology business of Valeritas out of bankruptcy. Valeritas encountered opera-
tional and financial diculties in late and filed for Bankruptcy in February .Specifically,
the fair value of the tangible and financial assets acquired (DKK . million), such as invento-
ries, trade receivables, and property, plant and equipment, represents a significant component
of the purchase price prior to consideration of the fair value of the identified intangible assets.
Acquisition-related costs of DKK . million have been expensed and are included in adminis-
trative expenses in profit or loss and are part of operating cash flows in the statement of cash
flows have all been incurred in the three months period ended March , .Adjustments
may be applied to the various net asset categories when full alignment to Zealand accounting
policies is finalized. Consequently, adjustments may be applied for a period of up to twelve
months from the acquisition date in accordance with IFRS .
The Valeritas business acquisition has contributed with net revenues of approximately DKK
. million in net revenue and profit and loss of approximately DKK -. million to the
Group for the period ending December , since the acquisition on April , .
If the acquisition had occurred on January , the consolidated pro forma revenue and
operating result of Zealand Pharma Group for the period ended December would have
been approximately DKK . million and DKK -. million, respectively.
98Zealand Pharma ∞ Annual Report 2020
Notes
Note – Change in working capital
DKK thousand
(Increase)/decrease in receivables -, -, -
(Increase)/decrease in Inventory -,
Increase/(decrease) in payables and other liabilities , , ,
Adjustment for non-cash investing activities -,
Cash outflow for investment in Beta Bionics ,
Change in working capital , , ,
Note – Significant events after the balance sheet date
On January , a total of ,, new shares have been subscribed through a private
share issue with gross proceeds of DKK million.
No other significant events have occurred after the end of the reporting period.
Note – Approval of the annual report
The Annual Report has been approved by the Board of Directors and Executive Management
and authorized for issue on March , .
Note – Related parties
Zealand has no related parties with controlling interest.
Zealand’s other related parties comprise the Company’s Board of Directors and Corporate
Management.
Remuneration to the Board of Directors and Corporate Management is disclosed in note .
No further transactions with related parties were conducted during the year.
Ownership
The following shareholder is registered in Zealand’s register of shareholders as owning min-
imum % of the voting rights or minimum % of the share capital ( share equals vote) at
December , :
• Van Herk Investments, Rotterdam, Netherlands
Note – Adjustments for non-cash items
DKK thousand
Depreciation, amortization and impairment , , ,
Sharebased compensation expenses , , ,
Income tax income -, -,
Income tax expense , ,
Financial income -, -,
Financial expenses , , ,
Non paid royalty expenses regarding sale of
future royalties and milestones ,
Exchange rate adjustments , -, ,
Total adjustments , , ,
99Zealand Pharma ∞ Annual Report 2020
Con Fin – Note 30-34
Notes
1 Significant accounting policies, and significant
accounting estimates and assessments 104
2 Revenue 104
3 Fees to auditors appointed at the Annual
General Meeting 105
4 Information on sta and remuneration 105
5 Financial income 108
6 Financial expenses 108
7 Other operating items 108
8 Income tax 108
9 Basic and diluted earnings per share 109
10 Intangible assets 109
11 Property, plant and equipment 110
12 Right-of-use assets and lease liabilities 111
13 Inventories 112
14 Investments in subsidiaries 113
15 Other investments 113
16 Prepaid expenses 114
17 Other receivables 114
18 Cash and cash equivalents 114
19 Share capital 114
20 Other liabilities 114
21 Contingent assets, liabilities and other
contractual obligations 114
22 Financial risks 115
23 Transactions with related parties 116
24 Adjustments for non-cash items 116
25 Change in working capital 116
26 Allocation of result 116
27 Significant events after the balance sheet date 116
28 Approval of the annual report 116
Contents –
Parent company
Financial statements of the parent company
Income statement 101
Statement of comprehensive income 101
Statement of financial position 102
Statement of cash flows 103
Statement of changes in equity 103
100Zealand Pharma ∞ Annual Report 2020
Par Fin – Contents
Income statement
DKK thousand Note
Revenue , ,
Cost of goods sold -,
Gross margin , ,
Research and development expenses -, -,
Sale and marketing expenses -,
Administrative expenses , -, -,
Other operating items ,
Operating result -, -,
Income from subsidiaries
Financial income , ,
Financial expenses -, -,
Result before tax -, -,
Corporate tax , ,
Net result for the year -, -,
Earnings per share – DKK
Basic earnings/loss per share -. -.
Diluted earnings/loss per share -. -.
Statement of comprehensive income
DKK thousand Note
Net result for the year -, -,
Other comprehensive income (loss)
Comprehensive result for the year -, -,
Financial statements of the parent company
101Zealand Pharma ∞ Annual Report 2020
Par Fin – Income Statement
DKK thousand Note
Liabilities and equity
Share capital , ,
Share premium ,, ,,
Retained loss -,, -,,
Shareholders' equity ,, ,,
Deferred revenue , ,
Other liabilities ,
Lease liabilities , ,
Non-current liabilities , ,
Trade payables , ,
Payables to subsidiaries ,
Lease liabilities , ,
Deferred revenue , ,
Other liabilities , ,
Current liabilities , ,
Total liabilities , ,
Total shareholders' equity and liabilities ,, ,,
Financial statements of the parent company
Statement of financial position at December
DKK thousand Note
Assets
Non-current assets
Intangibles (Intellectual property) ,
Property, plant and equipment , ,
Right of use asset/lease liabilities , ,
Investment in subsidiaries , ,
Intercompany ,
Corporate tax receivable ,
Deposits , ,
Prepaid expenses ,
Other investments , ,
Total non-current assets , ,
Current assets
Trade receivables
Inventory ,
Receivables from subsidiaries ,
Prepaid expenses , ,
Corporate tax receivable , ,
Other receivables , ,
Marketable securities , ,
Cash and cash equivalents , ,,
Total current assets ,, ,,
Total assets ,, ,,
102Zealand Pharma ∞ Annual Report 2020
Par Fin – Financial position
Statement of cash flows
DKK thousand Note
Net result for the year -, -,
Adjustments for non-cash items , ,
Change in working capital , ,
Financial income received ,
Financial expenses paid -, -,
Deferred revenue -, ,
Income tax receipt
Cash inflow/outflow from operating activities -, -,
Change in deposit -,
Investment in subsidiaries -, -,
Purchase of other investments -,
Purchase of intangible assets -,
Dividends on marketable securities
Purchase of property, plant and equipment -, -,
Sale of fixed assets
Cash outflow from investing activities -, -,
Proceeds from issuance of shares related to exercise of warrants , ,
Proceeds from issuance of shares , ,
Costs related to issuance of shares -, -,
Leasing installments -, -,
Cash inflow from financing activities , ,
Decrease/increase in cash and cash equivalents -, ,
Cash and cash equivalents at January ,, ,
Exchange rate adjustments , ,
Cash and cash equivalents at December , ,,
Statement of changes in equity
Share Share Retained
DKK thousand capital premium loss Total
Equity at January , , ,, -,, ,,
Comprehensive income for the year
Net result for the year -, -,
Warrant compensation expenses , ,
Capital increases , , ,
Costs related to capital increases -, -,
Equity at December , , ,, -,, ,,
Equity at January , , ,, -, ,,
Comprehensive income for the year
Net result for the year -, -,
Warrant compensation expenses , ,
Capital increases , , ,
Costs related to capital increases -, -,
Equity at December , , ,, -,, ,,
Financial statements of the parent company
103Zealand Pharma ∞ Annual Report 2020
Par Fin – Cash flow Par Fin – Equity
Notes
Note – Significant accounting policies, and significant accounting
estimates and assessments
Significant accounting policies
Basis of preparation
The financial statements of the parent company have been prepared in accordance with Inter-
national Financial Reporting Standards (IFRS) as adopted by the EU and additional requirements
under the Danish Financial Statements Act (Class D).
The accounting policies for the financial statements of the parent company are unchanged
from the previous financial year. A number of new or amended standards became applicable
for the current reporting period. The parent company did not change its accounting policies
as a result of the adoption of these standards. The accounting policies are the same as for the
consolidated financial statements with the supplementary accounting policies for the parent
described below. For a description of the accounting policies of the group, please refer to the
consolidated financial statements.
Note disclosures have only been included in the Parent Financial Statement where amounts
dier from the Consolidation financial statement.
In the narrative sections of the financial statements, comparative figures for are shown in
brackets.
Supplementary accounting policies for the Parent Company
Other operating income
Capital contributions to subsidiaries is recognized at fair value. Any gain or loss based on the
dierence from the carrying amount of the assets will be recognized as other operating items
provided the increase does not result in the impairment of the investment, or an expense
(based on the carrying amount of the asset given away)
Investments in subsidiaries
Please refer to note Investments in subsidiaries.
Note – Revenue
Recognized revenue can be specified as follows for all agreements:
DKK thousand
Boehringer Ingelheim International GmbH ,
Alexion Phamaceuticals Inc. , ,
Undisclosed counterpart ,
ZP SPV K/S ,
Total license and milestone revenue , ,
Intercompany sales ,
Total revenue from good sold ,
Total revenue , ,
Total revenue recognised over time , ,
Total revenue recognised at a point in time , ,
Please refer to note in the consolidated financial statements for additional information
regarding revenue.
104Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 1-2
Notes
Note – Fees to auditors appointed at the Annual General Meeting
DKK thousand
Audit , ,
Audit-related services and other assurance engagements , ,
Tax advice
Other
Total fees , ,
The fee for audit-related services and other assurance engagements and other services provid-
ed to the Parent Company by EY godkendt Revisionspartnerselskab in consisted of Audit
of Annual Report, Audit of -F SEC filing, including SOX b attestation procedures, quarterly
reviews, other auditor’s reports on various statements for public authorities, and other account-
ing advisory services. (Deloitte Statsautoriseret Revisionspartnerselskab in )
Note – Information on sta and remuneration
DKK thousand
Total sta salaries can be specified as follows:
Wages and salaries , ,
Share based payment costs , ,
Pension schemes (defined contribution plans) , ,
Other payroll and sta-related costs , ,
Total , ,
The amount is charged as:
Research and development expenses , ,
Administrative expenses , ,
Total , ,
Average number of employees
For remuneration to the Board of Directors please refer to note to the consolidated financial
statements and for additional information regarding sta costs.
105Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 3-4
Notes
Note – Information on sta and remuneration (continued)
Other Warrant
Pension short term compensation
DKK thousand Base salary Bonus contribution benefits expenses Total
Remuneration to the Executive Management
Emmanuel Dulac¹ , , , ,
Adam Sinding Steensberg² , , , ,
Matthew Donald Dallas
4
Total , , , , ,
Total Other Corporate Management
, , , ,
Total , , , , , ,
Remuneration to the Executive Management
Emmanuel Dulac¹ , , ,
Adam Sinding Steensberg² , , , ,
Britt Meelby Jensen³ , ,
Mats Blom³ , ,
Total , , , , , ,
Total Other Coporate Management
5
, , , ,
Total , , , , , ,
¹ Emmanuel Dulac was appointed as CEO at April , .
² Former Interim CEO Adam Sinding Steensberg was appointed EVP, R&D and CMO at April , .
3 Former CEO Britt Meelby Jensen and former CFO Mats Blom resigned from Zealand at February , and March , , respectively.
4 Matthew Dallas has tax obligations in Denmark, so a part of his salary is paid out in Denmark.
5 Other Corporate Management in comprised one member (: Three).
106Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 4
Notes
Note – Information on sta and remuneration (continued)
The employee
incentive programs of
Warrant programs existing during the period
Maximum term of options granted N/A
Method of settlement
equity-settled
Outstanding at the beginning of the period ,, ,
Granted during the period ,
Forfeited during the period -,
Exercised during the period -, -,
Expired during the period -,
Outstanding at the end of the period; and ,,
Exercisable at the end of the period ,
Warrants outstanding at the end of the period
Range of exercise prices .- .-
. .
Weighted-average remaining contractual life .
Number held by Executive Management ,
Outstanding at the beginning of the period ,, ,
Granted during the period ,
Forfeited during the period -,
Exercised during the period -, -,
Expired during the period
Outstanding at the end of the period; and ,, ,
Exercisable at the end of the period , ,
Warrants outstanding at the end of the period
Range of exercise prices .- .-
. .
Weighted-average remaining contractual life . .
Number held by Executive Management ,
Warrants exercised during the period
Weighted-average share price at the date of exercise . .
Expense arising from share-based payment transactions
Research and development expenses , ,
Sale and marketing expenses
Administrative expenses , ,
Total , ,
Eect of fair value of PSUs recognised in the income statement is DKK . (: DKK .
million.
Eect of fair value of RSUs recognised in the income statement is DKK . (: DKK .
million.
The long-term incentive program (LTIP) for Corporate Management
No of PSUs
Number of shares
At January ,
Granted during the year ,
Vested during the year
Forfeited during the year -,
At December , ,
No of RSUs
Number of shares
At January
Granted during the year ,
Vested during the year
Forfeited during the year
At December ,
107Zealand Pharma ∞ Annual Report 2020
Notes
Note – Financial income
DKK thousand
Interest income from financial assets measured at amortized costs ,
Interest income ,
Fair value adjustments of Other investments and marketable securities ,
Dividend, marketable securities
Exchange rate adjustments ,
Total financial income , ,
Please refer to note in the consolidated financial statements for additional information
regarding financial income.
Note – Financial expenses
DKK thousand
Other financial expenses , ,
Fair value adjustments of Marketable securities ,
Interest on financial assets ,
Exchange rate adjustments ,
Total financial expenses , ,
Please refer to note in the consolidated financial statements for additional information
regarding finacial expenses.
Note - Other operating items
DKK thousand
Government grants
Contributed IP rights to Zealand Pharma SPV K/S ,
Other
Total other operating items ,
Please refer to note in the consolidated financial statements for additional information
regarding other operating items.
Note – Income tax
DKK thousand
Net result for the year before tax -, -,
Corporate tax rate in Denmark .% .%
Expected tax benefit/(expenses) , ,
Adjustment for non-deductible expenses , -
Adjustment for non-taxable income -,
Adjustment for exercised warrants , -,
Adjustment for R&D extra deduction -, ,
Tax eect on exercise of warrants -, ,
Tax eect on expired warrants -
Warrant - share price development -, ,
Adjustment to prior years -,
Change in tax assets (not recognized) -, -,
Total income tax expense/benefit , ,
DKK thousand
Specification of unrecognized deferred tax assets:
Tax losses carried forward (available indefinitely) ,, ,
Research and development expenses , ,
Licenses, rights and patents , ,
Non-current assets , ,
Liabilities , ,
Other , ,
Total temporary dierences ,, ,,
Calculated potential deferred tax asset at local tax rate , ,
Deferred tax asset not expected to be utilized -, -,
Recognized deferred tax asset
Please refer to note in the consolidated financial statements for additional information
regarding income tax.
108Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 5-8
Notes
Note – Intangible assets
Licenses,
rights
DKK thousand and patents
Cost at January ,
Additions ,
Retirements
Cost at December , ,
Depreciation at January ,
Depreciation for the year
Impairment ,
Depreciation at December , ,
Carrying amount at December , ,
Depreciation for the financial year has been charged as:
Research and development expenses
Sale and marketing expenses ,
Administrative expenses
Total ,
Cost at January ,
Additions
Cost at December ,
Amortization at January ,
Amortization at December ,
Carrying amount at December ,
Depreciation for the financial year has been charged as:
Research and development expenses
Administrative expenses
Total
Please refer to note in the consolidated financial statements for additional information
regarding intangible assets.
Note – Basic and diluted earnings per share
The result and weighted average number of ordinary shares used in the calculation of basic and
diluted result per share are as follows:
DKK thousand
Net result for the year -, -,
Net result used in the calculation of basic and diluted
earnings/losses per share -, -,
Weighted average number of ordinary shares ,, ,,
Weighted average number of treasury shares -, -,
Weighted average number of ordinary shares used in the
calculation of basic earnings/losses per share ,, ,,
Weighted average number of ordinary shares used in the
calculation of basic and diluted earnings/losses per share ,, ,,
Basic earning/loss per share (DKK) -. -.
Diluted earning/loss per share (DKK) -. -.
Regarding a specification of potential ordinary shares, which are dilutive or antidilutive, please refer to note to the consoli-
dated financial statements.
109Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 9-10
Notes
Note – Property, plant and equipment
Plant and Other fixtures Building Assets under
DKK thousand machinery and fittings improvements construction
Cost at January , , , , ,
Transfer , -,
Additions , , , ,
Retirements -, - -,
Cost at December , , , , ,
Accumulated depreciation
at January , , , ,
Depreciation for the year , , ,
Retirements -, - -,5
Accumulated depreciation
at December , , , ,
Carrying amount
at December , , , , ,
Depreciation for the
financial year has been
charged as:
Research and
development expenses , , ,
Sale and marketing expenses
Administrative expenses
Total , , ,
Note – Property, plant and equipment (continued)
Plant and Other fixtures Building Assets under
DKK thousand machinery and fittings improvements construction
Cost at January , , , ,
Transfer -
Additions , , , ,
Retirements -, - -
Cost at December , , , , ,
Accumulated depreciation
at January , , , ,
Transfer -
Depreciation for the year , ,
Retirements -, - -
Accumulated depreciation
at December , , , ,
Carrying amount
at December , , , , ,
Depreciation for the
financial year has been
charged as:
Research and
development expenses ,
Administrative expenses
Total , ,
Please refer to note in the consolidated financial statements for additional information regarding
property, plant and equipment.
110Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 11
Notes
Note – Right-of-use assets and lease liabilities
Amounts recognized in the statement of financial position
The statement of financial position shows the following amounts relating to leases:
Other
fixtures and
DKK thousand Buildings fittings
As at January , , ,
Additions ,
Retirements -, -
Reversal of depreciations ,
Depreciation expense -, -
As at December , , ,
As at January , , ,
Additions ,
Depreciation expense -, -,
As at December , , ,
Note – Right-of-use assets and lease liabilities (continued)
Set out below are the carrying amounts of lease liabilities and the movements
during the period.
As at January , ,
Additions , ,
Accretion of interest ,
Payments -, -,
As at December , ,
Current , ,
Non-current , ,
The following are the amounts recognised in profit and loss:
Depreciation expense of right-of-use assets -, -,
Interest expense on lease liabilities ,
Expense relating to short-term leases (included in cost of sales)
Expense relating to leases of low-value assets
(included in administrative expenses)
Variable lease payments (included in cost of sales)
Total amount recognised in profit and loss -, -,
Cashflow -, -,
Total cash outflow for leases -, -,
Please refer to note in the consolidated financial statements for additional information re-
garding right-of-use assets and lease liabilities.
111Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 12
Note – Inventories
Inventories were comprised as follows:
DKK thousand
Raw materials ,
Work in process ,
Finished goods ,
Total ,
Direct costs ,
Indirect production costs ,
Write downs recognized on inventories were reflected in the cost of goods sold. They were
comprised as follows:
DKK thousand
Accumulated write downs, January
Additions -,
Write downs in the reporting period -
Reversals or utilization of write downs
Exchange dierences
Accumulated write downs, December -,
Please refer to note in the consolidated financial statements for additional information
regarding inventory.
Par Fin – Note 13
112Zealand Pharma ∞ Annual Report 2020
Notes
Note – Investments in subsidiaries
Accounting policies
Investments in subsidiaries are measured at cost in the parent company’s financial statements.
Where the recoverable amount of the investment is lower than cost, the investments are writ-
ten down to this lower value.
DKK thousand
Cost at January , ,
Additions ,
Cost at December , ,
Value adjustments at January ,
Value adjustments for the year
Value adjustments at December , .
Carrying amount at December , ,
Cost at January ,
Additions ,
Cost at December , ,
Value adjustments at January ,
Value adjustments for the year
Value adjustments at December ,
Carrying amount at December , ,
Voting
Company summary Domicile Ownership rights
Zealand Pharma A/S subsidiaries:
ZP Holding SPV K/S Denmark % %
ZP General Partner ApS Denmark % %
Zealand Pharma US, Inc. United States % %
Zealand Pharma California US, LLC. United States % %
Encycle Therapeutics, Inc. Canada % %
ZP SPV K/S Denmark % %
ZP General Partner ApS Denmark % %
ZP Holding SPV K/S subsidiaries:
ZP SPV K/S Denmark % %
ZP General Partner ApS Denmark % %
Pursuant to section () of the Danish Financial Statements Act, Management has chosen to
submit an exemption declaration ('Undtagelseserklæring' in Danish) and has not issued annual
reports for ZP SPV K/S, ZP Holding SPV K/S and ZP SPV K/S.
The financial statements of the two companies are fully consolidated in the consolidated finan-
cial statements of Zealand Pharma A/S.
No income has been received from subsidiaries during the or .
Note – Other investments
Please refer to note to the consolidated financial statements.
113Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 14-15
Notes
Note – Prepaid expenses
The increase in Prepaid expenses of DKK . million from to is primarily related to
higher insurance coverage for Management and Board members due to increase liability risk.
Please refer to note in the consolidated financial statements for additional information
regarding prepaid expenses.
Note – Other receivables
DKK thousand
VAT , ,
Other , ,
Total other receivables , ,
Please refer to note in the consolidated financial statements for additional information
regarding other receivables.
Note – Cash and cash equivalents
DKK thousand
DKK , ,
USD , ,
EUR , ,
Total cash and cash equivalents , ,,
Please refer to note in the consolidated financial statements for additional information re-
garding cash and cash equivalents.
Note – Share capital
Please refer to note to the consolidated financial statements.
Note – Other liabilities
DKK thousand
Employee benefits , ,
Development project costs , ,
Other payables , ,
Total other liabilities , ,
Current: , ,
Non-currenct ,
Please refer to note in the consolidated financial statements for additional information
regarding other liabilities.
Note – Contingent assets, liabilities and other contractual obligations
Zealand Pharma A/S is part of a Danish joint taxation. Consequently, referring to the Danish
Corporation Tax Act regulations, Zealand Pharma A/S is liable for any income taxes, etc. for the
jointly taxed companies and Zealand Pharma A/S is likewise liable for any obligations to with-
hold tax at source on interest, royalties and returns for the jointly taxed companies.
Please refer to note to the consolidated financial statements for information on contractual
obligations.
114Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 16-21
Notes
Note – Financial risks
Please refer to note to the consolidated financial statements.
Contractual maturity (liquidity risk)
A breakdown of the Company’s aggregate liquidity risk on financial assets and liabilities is given
below.
The following table details the Company’s remaining contractual maturity for its financial liabil-
ities with agreed repayment periods. The table has been prepared using the undiscounted cash
flows for financial liabilities, based on the earliest date on which the Company can be required
to pay. The table includes both interest and principal cash flows. To the extent that the specific
timing of interest or principal flows is dependent on future events, the table has been prepared
based on Management’s best estimate of such timing at the end of the reporting period. The
contractual maturity is based on the earliest date on which the Company may be required to
pay.
There are no interest cash-flows to be included in the table below for the existing financial
liabilities as they are not interest-bearing financial liabilities.
<
DKK thousand months - Years > years Total
Trade payables , ,
Leasing , , , ,
Other liabilities , ,
Total financial liabilities
at December , , , , ,
Trade payables , ,
Leasing , , , ,
Other liabilities , ,
Total financial liabilities
at December , , , , ,
All cash flows are undiscounted and include all liabilities under contracts.
DKK thousand
Categories of financial instruments
Deposits , ,
Trade receivables
Receivables from subsidiaries , ,
Other receivables , ,
Cash and cash equivalents , ,,
Financial assets measured at amortized cost ,, ,,
Marketable securities , ,
Other investments , ,
Financial assets measured at fair value through profit or loss , ,
Trade payables , ,
Payables to subsidiaries ,
Lease liabilities , ,
Other liabilities , ,
Financial liabilities measured at amortized cost , ,
The fair value of marketable securities is based on Level in the fair value hierarchy.
The fair value of other investments is based on level in the fair value hierarchy.
At December , and , the carrying amount of other financial assets and financial
liabilities approximated the fair value.
115Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 22
Notes
Note – Transactions with related parties
‘Zealand Pharma A/S' related parties are the board of directors, executive management, and
close members of the family of these persons. Refer to note in the consolidated financial
statements for remuneration of Board of Directors. Refer to note in these parent company
financial statements for remuneration of the executive management team.
The parent company had the following transactions with subsidiaries:
Revenue: DKK million (DKK million)
Other income: DKK . million (DKK million)
Sale and marketing costs: DKK . million (DKK million)
Receivables: DKK . million (DKK , million)
Payables: DKK . million (DKK , million)
Note – Adjustments for non-cash items
DKK thousand
Depreciation , ,
Warrant compensation expenses , ,
Income tax receipt -,
Income tax expense
Financial income -,
Financial expenses , ,
Exchange rate adjustments , -,
Total adjustments , ,
Note – Change in working capital
DKK thousand
Increase/decrease in receivables -, -,
Increase/decrease in inventory -,
Increase/decrease in payables , ,
Increase/decrease in other liabilities ,
Adjustment for non-cash investing activities -,
Adjustment for cash outflow for investment in Beta Bionics ,
Change in working capital , ,
Note – Allocation of result
The Board of Directors proposes that the parent company’s net result of DKK -.
million (: net result of DKK -. million) be carried forward to next year by transfer to
retained loss.
Note – Significant events after the balance sheet date
Please refer to note in the consolidated financial statements.
Note – Approval of the annual report
Please refer to note in the consolidated financial statements.
116Zealand Pharma ∞ Annual Report 2020
Par Fin – Note 23-28
Free cash flow
Free cash flow is calculated as the sum of cash flows from operating activities less purchase of
property, plant and equipment. A positive free cash flow shows that the Group is able to finance
its activities and that external financing or capital raises is thus not necessary for the Group’s
operating activities. Therefore, Executive Management believes that this non-IFRS liquidity
measure provides useful information to investors in addition to the most directly comparable
IFRS financial measure “Net cash flow from operating activities.” The table below shows a rec-
onciliation of free cash flow for , and :
DKK thousand
Cash (outflow)/inflow from operating activities -, -, -,
Less purchase of property, plant and equipment -, -, -,
Free cash flow -, -, -,
Alternative performance measures for the Group (non-audited)
117Zealand Pharma ∞ Annual Report 2020
Par Fin – Alternative performance measures
Statement of the
Board of Directors
and Executive
Management
Executive Management
Emmanuel Dulac
President and
Chief Executive Ocer
Matthew Douglas Dallas
Senior Vice President and
Chief Financial Ocer
Board of Directors
Alf Gunnar Martin Nicklasson
Chairman
Kirsten Aarup Drejer
Vice Chairman
Bernadette Connaughton
Board member
Leonard Kruimer
Board member
Alain Munoz
Board member
Jens Peter Stenvang
Board member
Employee elected
Iben Louise Gjelstrup
Board member
Employee elected
Jerey Berkowitz
Board member
Adam Sinding Steensberg
Executive Vice President,
Research & Development, and
Chief Medical Ocer
Michael John Owen
Board member
Frederik Barfoed Beck
Board member
Employee elected
Gertrud Koefoed Rasmussen
Board member
Employee elected
118Zealand Pharma ∞ Annual Report 2020
Statement – Management
Independent
auditor’s report
Report on the audit of the Consolidated Financial
Statements and Parent Company Financial
Statements
119Zealand Pharma ∞ Annual Report 2020
Statement – Independent auditor
120Zealand Pharma ∞ Annual Report 2020
121Zealand Pharma ∞ Annual Report 2020
122Zealand Pharma ∞ Annual Report 2020
Copenhagen, March 11, 2021
EY Godkendt Revisionspartnerselskab
Christian Schwenn Johansen Rasmus Bloch Jespersen
State Authorised State Authorised
Public Accountant Public Accountant
mne33234 mne35503
123Zealand Pharma ∞ Annual Report 2020
Other
information
124Zealand Pharma ∞ Annual Report 2020
Other – COVER
Sources Company
information
Zealand Pharma A/S
Sydmarken
Søborg
Denmark
CVR no.:
Tel: +
Fax: +
Zealand Pharma U.S., Inc.
Farnsworth Street
th Floor
Boston, MA
info@zealandpharma.com
www.zealandpharma.com
Established
April ,
Registered oce
Gladsaxe
Auditors
EY Godkendt Revisionspartnerselskab
CVR no.:
Transforming Peptides
J. Lau and M. Dunn, Therapeutic peptides: Historical perspectives, current devel-
opment trends, and future directions. Bioorganic & Medicinal Chemistry, version ,
issue , June , p. -
Pipeline Overview
Partnered with Boehringer Ingelheim. Zealand eligible for EUR m in outstand-
ing milestones
Partnered with Boehringer Ingelheim. Zealand eligible for EUR m in outstand-
ing milestones
Partnered with Aexion Pharmaceuticals. Zealand eligible for USD m in out-
standing milestones
Acquired with Encycle Therapeutics
Severe hypoglycemia
¹ Kalra 2013, UK Hypoglycemia Study Group
2
American Diabetes Association, diabetes.org
3
cdc.gov and diabetes.org and www.diabetesselfmanagement.com/diabetes-
resources/tools-tech/insulin-pumps
4
National Diabetes Statistics Report. CDC. 2014
5
Company announcement No. 23/2018, Zealand Pharma achieves primary and
key secondary endpoints in pivotal Phase 3 trial with dasiglucagon for severe
hypoglycemia
6
Company announcement No. 15/2019, Zealand Pharma achieves primary and key
secondary endpoints in second pivotal Phase 3 trial with dasiglucagon for severe
hypoglycemia
7
Company announcement No. 35/2019, Zealand Pharma achieves primary and
key secondary endpoints in pediatric Phase 3 trial with dasiglucagon for severe
hypoglycemia
Congenital hyperinsulinism
1
https://www.orpha.net/consor/cgi-bin/ (not including transient cases due to
perinatal stress or diabetic mother)
2
Congenital Hyperinsulinism International. Available at: http://congenitalhi.org
3
Thornton PS et al., J Pediatr. 2015;167(2):238-45
4
Meissner T et al., Long-term follow-up of 114 patients with congenital hyper-
insulinism. Eur J Endocrinol 2003;149:43-510
5
Yorifuji et al. Pediatrics International 2014;56:467
6
Eljamel et al. Orphanet Journal of Rare Diseases 2018;13:123
Automated diabetes management
¹ ADA Section : pA
2
ADA Section : pC; pA
3
Nicole C. Foster, et al, and for the TD Exchange Clinic Network. Diabetes
Technology & Therapeutics. Feb .
Short bowel syndrome
¹ Pironi L et al. Clin Nutr ;:–
2
Jeppesen P. Expert Opinion Orphan Drugs ;:–
3
Bielawska B. Nutrients ;:–
4
Transparency Market Research; Short Bowel Syndrome Market,
5
Torres C. Current Paediatr ;:–; Bielawska B. Nutrients ;:–;
Pironi L et al. Clin Nutr ;:–; Hofstetter S et al. Curr Med Res Opin
;:–
Obesity/Type 2 diabetes
¹ Company announcement No. /, September ,
2
Skarbaliene, J., Pagler, T., Eickelmann, P., and Just, R. Anti-obesity eects of the
novel long-acting amylin analogue ZP in high-fat diet fed rats. Poster, the
American Diabetes Association’s (ADA) th Scientific Sessions, New Orleans,
125Zealand Pharma ∞ Annual Report 2020
Other – Sources - Company info
Design and production: Noted
Zealand Pharma A/S
Sydmarken 11
DK-2860 Søborg
Denmark
Tel: +45 88 77 36 00
Fax: +45 88 77 38 98
CVR no.: 20 04 50 78
zealandpharma.com