EX-99.1(A) 3 tm1927472d5_ex99-1a.htm EXHIBIT 99.1(A)

Exhibit 99.1(a)

 

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Delivering on our commitment to patients Zealand Pharma Annual Revpport 2019 Company reg. no. 20045078

 

 

 

 

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2 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 2 On the cover Crosby was born with congenital hyperinsulinism. Read more page 18 In consideration of our impact on the environment, the Zealand Pharma Annual Report will transition to electronic copy only. A limited number of printed copies will be made of the Annual Report 2019, and it will be the last publication produced in print.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 3 Contents Management review Financial statements Changing lives About Zealand Pharma Shareholder Letter 2019 Achievements and financial highlights Consolidated Key Figures 2020 Outlook and objectives 4 5 6 Approaching commercialization 26 Consolidated financial statements Income statement Statement of comprehensive income Statement of financial position Statement of cash flows Statement of changes in equity Business overview Notes 50 50 51 52 52 53 54 Engaging partnerships 28 8 10 11 Corporate matters Corporate Governance Corporate Responsibility Our People Risk Management and Internal Control Financial Review Shareholder Information Board of Directors Corporate Management 31 32 35 36 38 40 43 45 47 Transforming peptides Pipeline overview Dasiglucagon: Severe hypoglycemia Dasiglucagon: Congenital hyperinsulinism Dasiglucagon: Automated diabetes management Dasiglucagon: Hypoglycemia following bariatric surgery Glepaglutide and ZP7570: Short bowel syndrome Pre-clinical projects 12 14 16 18 20 21 22 25 Financial statements of the parent company Income statement Statement of comprehensive income Statement of financial position Statement of cash flows Statement of changes in equity Notes 88 88 89 90 90 91 Alternative performance measures for the group (non-audited) 100 Statement of the Board of Directors and Executive Management Independent auditor’s report 101 102 Other information Sources Addresses (company information) 107 107

 

 

 

 

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4 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 4 Changing lives We work every day with patient communities and thought leaders to change the lives of people with severe medical conditions

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 5 About Zealand Pharma We are passionate about changing the lives of people with severe medical conditions through targeted development of next generation peptide therapeutics. Our ambition is to be a world leader in treating specialty gastrointestinal and metabolic diseases. We intend to deliver best-in-class treatment options that meet patient medical needs and ease the burden on the health care system. We utilize a business model with two approaches. First, we aim to retain full ownership and control of product candidates all the way to market in selected geographies. Second, we also engage in licensing partnerships that expand the opportunity and probability of success for selected products and/or indications. Our agile organization engages with partners across the value chain, such as leading Clinical Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs). Fully integrated biotech company Founded 1998 in Copenhagen, locations in Boston and New York Leading peptide platform A world leading peptide platform, with two medicines on the market Four potential launches in four years Accelerating late stage programs to launch new products into major markets beginning in 2021 Experienced team 179 employees of which 85% are in R&D Find out more about Zealand on zealandpharma.com/about-us

 

 

 

 

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6 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 6 Shareholder Letter Poised to on our to patients Over the past year, Zealand Pharma successfully operated an acceleration in strategy to become a fully integrated biotech company, maintaining highly productive research and development, while building our own commercial and medical operations. By maintaining control over our proprietary products, we will maximize value for our shareholders while simultaneously supporting access to our innovative treatments for patients in need.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 7 Building independent U.S. operations Establishing commercial and medical operations is the final step of our transformation. In the second half of 2019, we successfully onboarded key personnel, selected a site in the Boston-area to complement our New York office, and commenced the early build of our infrastructure. The momentum of these activities has carried into 2020, where we continue to execute a fast-paced plan to ensure our U.S. organization is fully operational by year end and ready to launch Zealand’s dasiglucagon HypoPal® rescue pen in 2021. Execution on our first new drug application In 2019, the clinical program for the dasiglucagon HypoPal® rescue pen was completed. The program includes four Phase 3 clinical studies that demonstrat-ed a consistent median time of 10 minutes to recovery from severe hypoglycemia for both adults and children when treated with dasiglucagon. These clinical results provide a solid foundation for our new drug application to the U.S. FDA, which we remain on-track to submit in the first quarter of 2020. been among the top three shareholders of Zealand Pharma since early 2018. The placement raised Van Herk’s percent of share capital to 19% and added DKK 559.6 million to Zealand’s existing cash resources. It is an honor to be recognized by an investor with a track record of success in biotech, and to receive substantial support from all shareholders who are keeping per-spective on our long term value creation. Transforming to deliver on our commitment The combination of dense news flow, clarification of our strategic intent, and acceleration on our road to commercialization have been positively recognized by the market and have supported an historical increase in valuation to our long time shareholders. In addition to the mentioned achievements, Zealand experienced other transformational changes during 2019. Transition of executives introduced Chief Financial Officer Matt Dallas and myself to the company. Also, we initiated a relocation in Denmark from the offices in which Zea-land has thrived for twenty years, to a new facility that can accommodate our success-driven growth. Our team continues to work hard, with the Zealand spirit that is distinct, collaborative, and determined. Progression of all pre-clinical and clinical programs Driven by an ambition to transform management of type 1 diabetes, we created dasiglucagon: a fast-acting glucagon analog that is stable in solution. This mole-cule allows us to envision multiple novel drug-device combinations: a rescue treatment for severe hypogly-cemia in a ready-to-use auto-injector or a prefilled sy-ringe, a multi-dose pen for mini dosing hypoglycemia, a chronic treatment with a continuous delivery pump for patients suffering from the rare disease congenital hyperinsulinism, and in an artificial pancreas in com-bination with insulin for type 1 diabetic patients (which received Breakthrough Device designation from the U.S. Food and Drug Administration in 2019). An acquisition to grow our strategic assets For the first time, Zealand brought an external asset into our peptide platform by acquiring Encycle Thera-peutics. The acquisition further strengthens our lead-ership in peptide therapeutics and novel treatments for gastrointestinal diseases, and reinforces our commit-ment to investing in both internal and external innova-tion to address significant unmet medical needs. Validation from partnering industry leaders We formed a new partnership with Alexion Pharma-ceuticals to collaborate in the discovery and devel-opment of peptide therapeutics for complement mediated diseases. This new partnership was followed by Boehringer Ingelheim’s decision to advance the GLP-1/glucagon dual agonist licensed from Zealand, BI 456906, into Phase 2 development for treatment of obesity and type 2 diabetes. We are thrilled these collaborations are expanding opportunities for our next generation peptide therapeutics to reach even more patients. On behalf of the Board of Directors, the Manage-ment team, and all Zealand colleagues: thanks to our shareholders, partners and patients for placing trust in our company. We are focused on achieving our ambitions, and delivering on the commitment that we make to patients: we will change lives by addressing severe medical needs with our next generation peptide therapeutics. We also progressed glepaglutide, a long-acting GLP-2 analog delivered in a ready-to-use auto-injector to help short bowel syndrome (SBS) patients improve absorption of nutrients and electrolytes. In our early pipeline, we advanced innovative dual pep-tides to improve patient outcomes, including a GLP-1/ GLP-2 agonist to also treat SBS, and a GLP-1/GLU agonist for type 2 diabetes/obesity. Additional support from institutional shareholders A private placement of shares was made with Van Herk Investments, a long-term investor in biotech who has Emmanuel Dulac President and Chief Executive Officer

 

 

 

 

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8 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 8 2019 Achievements In addition to advancing nearly every pipeline program, we realized two other significant accomplishments in 2019: a new license partnership with an industry leader, and Zealand's first acquisition. Accelerated our late-stage pipeline • Dasiglucagon HypoPal® rescue pen: Clinical program completed and NDA submission early 2020 • Dasiglucagon for dual-hormone pump: Phase 2 completed and Phase 3 planned for late 2020 • Dasiglucagon for congenital hyperinsulinism: Two pivotal Phase 3 trials initiated • Glepaglutide for short bowel syndrome: continued progress in Phase 3 Advanced our early pipeline • Once-weekly GLP-1/GLU for obesity/type 2 diabetes¹: Phase 1 completed and Phase 2 to be initiated early 2020 • Long-acting GLP-1/GLP-2 dual agonist (ZP7570) for SBS: Phase 1 initiated Expanded our strong financial and organizational position • Entered agreement with Alexion Pharmaceuticals to develop complement C3 inhibitor • Completed the company's first acquisition: Encycle Therapeutics, securing pre-clinical α4β7 integrin inhibitor and access to screening library of approximately 5,000 peptide-like macrocycles • Accelerated build-up of U.S. operations to prepare for first product launch anticipated in 2021 • Secured DKK 560 million in private placement with existing investor Van Herk Group ¹ BI456906, partnered with Boehringer Ingelheim

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 9 Financial highlights +28% 85% in R&D (+56% v. 2018) Find out more about Zealand at zealandpharma.com/investor Share price, DKK R&D investment, DKK 561.4 m (v. 2018) Employees (FTE) 179 Administrative expenses, DKK 67.9m Revenue, DKK 41.3 m (+9% v. 2018) ZEAL share price, DKK at Dec. 31, 2019 235.40 (+186% since Dec. 31, 2018) 300 250 200 150 100 Dec 2018 Jul 2019 Dec 2019 Cash position, DKKm299 299 319 75 21 2014 2015 2016 2017 2018 2019 SecuritiesRestricted cashCash and equivalents Net operating expenses, DKK 628.9m (+31% v. 2018) 419 538 323 6 589 861 1081

 

 

 

 

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10 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 10 Consolidated key figures Restated6 2018 Restated6 2017 Restated6 2016 Restated6 2015 DKK ’000 2019 DKK ’000 2019 2018 2017 2016 2015 Income statement and comprehensive income Cash flow Revenue Royalty expenses Research and development expenses Administrative expenses Other operating income Operating result Net financial items Result before tax Corporate tax Net result for the year Comprehensive income/loss Earnings/loss per share – basic (DKK) Earnings/loss per share – diluted (DKK) 41,333 -415 37,977 -3,356 136,322 -14,163 230,864 -30,931 182,573 -21,578 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 -409,455 -461,420 -278,746 40,904 -224,767 -51,666 882,925 221,351 -299,958 -1,594 -561,423 -67,881 444 -587,942 11,265 -576,677 5,136 -571,541 -571,541 -438,219 -43,543 1,099,526 652,385 -27,334 625,051 -43,773 581,278 581,278 -323,949 -47,343 607 -248,526 -31,387 -279,913 5,500 -274,413 -274,413 -261,387 -50,514 1,697 -110,271 -43,764 -154,035 5,500 -148,535 -148,535 -214,711 -38,793 12,828 -79,681 -38,505 -118,186 5,875 -112,311 -112,311 674,480 -155,449 337,930 157,146 96,413 -21,036 -430,491 -4,038 -463,418 -7,226 -285,972 -2,600 38,304 -4,040 -228,807 Other -16.91 18.94 -9.85 -6.11 -4.87 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 235.40 8,487 34.52 173 82.40 2,537 36.33 146 85.00 2,614 16.77 128 106.50 2,784 11.24 124 151.50 3,689 10.29 110 -16.91 18.94 -9.85 -6.11 -4.87 179 149 133 108 106 Statement of financial position ¹ Restricted cash serves as collateral for the royalty bond issued in 2014. No cash has been restricted since Zealand has redeemed the outstanding royalty bond in 2018. Equity ratio is calculated as equity at the balance sheet date divided by total assets at the balance sheet date. See page 100 regarding alternative performance measures. Market capitalization is calculated as outstanding shares at the balance sheet date times the share price at the balance sheet date. Equity per share is calculated as shareholders’ equity divided by total number of shares less treasury shares. Warrant expenses have been restated for the period 2015-2018. See note 1 to the consolidated financial statements. Cash and cash equivalents Restricted cash¹ Marketable securities Total assets Share capital (‘000 shares) Equity Equity ratio² Royalty bond 1,081,060 0 299,448 1,599,514 36,055 1,242,673 0.78 0 860,635 0 298,611 1,229,797 30,787 1,116,281 0.91 0 588,718 5,892 75,111 721,285 30,751 514,669 0.71 135,734 323,330 318,737 0 683,116 26,142 267,381 0.39 332,243 418,796 21,403 0 627,621 24,353 244,803 0.39 312,951 ² ³ ⁴ ⁵ ⁶

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 11 2020 Outlook and Objectives We expect to achieve several significant milestones in our dasiglucagon and glepaglutide programs in 2020, all advancing toward becoming a fully integrated biotech, so we can deliver on our commitment to changing patient lives and create additional value for shareholders. Financial guidance In 2020, Zealand expects revenue from existing license agreements. However, since such revenue is uncertain in terms of amount and timing, Zealand does not guide on such revenue. 2020 guidance 2019 2019 DKKm realized guidance¹ 1 As revised on August 15, 2019. 2 For definition of net operating expenses, refer to page 100. Net operating expenses in 2020 are expected to be within the DKK 790-810 million range. The increase compared to 2019 is due to a rise in administrative expenses as the Company prepares for the product launch and subsequent commercialization for the dasi-glucagon HypoPal Rescue Pen as well as the clinical development costs associated with glepaglutide and the dasiglucagon CHI and DHAP programs in Phase 3. Estimate guidance for 2019 was exceeded due to increased levels of support needed in internal staffing as well as from professional advisors and external service providers as the Company prepares for a product launch and subsequent commercialization. 2020 Objectives Advance our early pipeline and strategic alliances • • Complement C3 inhibitor¹: pre-clinical development towards Phase 1 initiation ZP 10000 α4β7 integrin inhibitor: pre-clinical development towards Phase 1 initiation Execute on the clinical pipeline • • Dasiglucagon HypoPal® rescue pen: submit new drug application to U.S. FDA Dasiglucagon for congenital hyperinsulinism: Phase 3 clinical results expected in 2020, on track for 2021 new drug application Dasiglucagon for dual-hormone artificial pancreas pump: Phase 3 study initiation Glepaglutide for short bowel syndrome: complete patient enrollment in Phase 3 study in 2020, with results and new drug application in 2021 ZP 7570 for short bowel syndrome: Phase 1 program advancement BI 456906 for obesity/type 2 diabetes²: Phase 2 initiation Amylin analog for obesity/type 2 diabetes2: Phase 1 initiation • • • • • Build Zealand Pharma U.S. and advance launch readiness • • Establish Boston-area office for Zealand Pharma U.S. operations Execute launch readiness program for dasiglucagon HypoPal rescue pen Maintain a strong financial and organizational position • Disciplined financial management with tight cost control ¹ Partnered with Alexion Pharmaceuticals. ² Partnered with Boehringer Ingelheim. Net operating expenses2 790-810 629580-600

 

 

 

 

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12 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 12 Zealand's pipeline has never been more robust than it is today, and we have an amazing team capable of expanding our leadership in the discovery and development of next generation peptide therapeutics.” Adam Steensberg Executive Vice President, Research & Development and Chief Medical Officer Transforming peptides

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 13 Transforming Peptides We leverage more than 20 years of experience discovering and developing peptide drugs to transform peptide projects into next generation therapeutics. Strategic expansion In 2019, Zealand Pharma completed its first acquisi-tion with the purchase of Encycle Therapeutics, Inc. The acquisition centered on a pre-clinical lead asset that is being developed to target integrin α4β7, which is involved in the pathogenesis of inflammatory bow-el disease (IBD). Notably, this macrocycle technology, derived from peptides, has enhanced potential for penetration of membranes, thus creating poten-tial for orally-delivered peptide drugs. Zealand also gained access to a screening library of approximately 5,000 unique macrocycles that could provide addi-tional targets for research using Zealand’s expertise in peptide development. Discovering and optimizing peptides to create new medicines Peptides represent a therapeutic modality with over 60 approved and marketed peptide drugs and many more in clinical development.¹ For more than twenty years, Zealand has been successfully optimizing native peptide hormones to confer the necessary properties to be a safe and effective drug. 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. To convert these native peptides into an effective peptide therapeutic 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. Working with external innovation In line with Zealand’s strategy to access cutting-edge technology, we have a range of research collabora-tions providing us with access to novel peptide librar-ies (e.g. Orbit Discovery UK, the Torrey Pines Institute for Molecular Studies U.S.A) or new technologies for peptide stabilization and delivery. All are focused on identifying peptides that act on disease-relevant targets. Zealand uses its unique in depth understanding of peptide chemistry and biology to focus the substitu-tion 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, and GLP-2. Enhancing their natural properties or combining their activities in single peptides has presented multiple therapeutic opportunities and led to lixizenatide, the first mar-keted peptide drug discovered by Zealand’s peptide platform. 20 years of experience Find out more about Zealand on zealandpharma.com/strategy ¹ J. Lau and M. Dunn, Therapeutic peptides: Historical perspectives, current development trends, and future directions. Bioorganic & Medicinal Chemistry, version 26, issue 10, 1 June 2018, p. 2700-2707.

 

 

 

 

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14 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 14 Pipeline Overview Zealand has a robust pipeline, including one registration-ready program, two Phase 3 programs with one more entering Phase 3 this year, and several promising early development projects. Find out more about Zealand’s pipeline at zealandpharma.com/product-pipeline Product Candidate Indication Pre-clinical Phase 1 Phase 2 Phase 3 Regi-stration Development Programs Dasiglucagon HypoPal® Rescue PenSevere hypoglycomia Read more page 16 Dasiglucagon S.C. Continuous infusion Congenital hyperinsulinism Read more page 18 Dasiglucagon Dual-hormone Pump Diabetes management Read more page 20 Glepaglutide GLP-2 Analog Short bowel syndrome Read more page 23 ZP7570 GLP-1/GLP-2 Dual Agonist Short bowel syndrome Read more page 23 BI 456909 GLP-1/GLU Dual Agonist Obesity/Type 2 diabetes1 Read more page 24 Amylin Analog Obesity/Type 2 diabetes2 Read more page 24 Pre-Clinical Programs Complement C3 InhibitorsUndisclosed³ Read more page 25 ZP10000 α4β7 integrin inhibitor Inflammatory bowel disease⁴ Read more page 25 Ion Channel Blockers Undisclosed Read more page 25 GIP/GLP-1/Glucagon Mono/Dual/Triple Undisclosed Read more page 25

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 15 Three patient stories We are honored to present three profiles of people living with severe unmet medical needs. Each story provides a backdrop for how a disease can affect every day life for a patient, their family and caregivers, and illustrates why we are committed to delivering next generation therapeutics to help change their lives. Severe hypoglycemia Anders lives with Type 1 diabetes. When his blood glucose levels crashed unexpectedly, he experienced severe hypoglycemia. Onset of severe hypoglycemia was unpredictable despite diligent management of Anders' blood glucose levels. Read more page 16 Congenital Hyperinsulinism Crosby was born with congenital hyper-insulinism. His parents were warned that having a CHI baby was "going to be a really tough journey." They tell about the chal-lenges they have faced: from receiving a rare prenatal diagnosis of the condition, to trying to manage his volatile blood gluclose levels. Read more page 18 Short bowel syndrome Will was diagnosed with short bowel syn-drome at age 13. He began receiving total parenteral support, a lifesaving therapy for patients with intestinal failure that provides all the elements of nutrition and hydration needed to live via intravenous infusion. Read more page 22

 

 

 

 

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16 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 16 Severe hypoglycemia Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels. Among the most feared complications of diabetes treatment1, severe hypoglycemia requires another person for rescue.² 6 million people With diabetes are on insulin therapy in the U.S.3 ~300,000 hospitalizations Occur annually in the U.S. due to severe hypoglycemia4 Dasiglucagon HypoPal® Rescue Pen The Dasiglucagon HypoPal® Rescue Pen is a ready-to-use auto-injector containing 0.6 mg dasiglucagon, and is designed to offer diabetes patients fast and effective treatment for severe hypoglycemia. 2019 Achievements The clinical program was concluded in 2019. In the pivotal and confirmatory Phase 3 trials, the primary and all key secondary endpoints were successfully achieved with a median time to blood glucose recovery of 10 minutes. Results from a pediatric Phase 3 study demonstrate that the median time to blood glucose recovery was 10 minutes for dasiglucagon also in children. Next steps The submission of the New Drug Application with the U.S. FDA is on track for early 2020. Build-up of U.S. commercial operations is on track to support the anticipated launch in 2021. Read more of Anders’ story at zealandpharma.com/anders-story

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 17 “Diabetes affects me all the time, and I have to think about it no matter what I do.” Anders lives with type 1 diabetes. He constantly mon-itors his blood glucose levels to maintain glycemic control and good health. Despite wearing an insulin pump to improve management of insulin injections, he has experienced severe hypoglycemia multiple times and it remains on the most feared challenges of living with his type 1 diabetes. Anders Dasiglucagon HypoPal® rescue pen for potential fast treatment of severe hypoglycemia; on track for early 2020 NDA submission. For illustration only Pivotal Phase 35 40 min Confirmatory Phase 36 Pediatric Phase 37 35 min 30 min 12 min 12 min 10 min 10 min 10 min Dasiglucagon Placebo 0.6 mg GlucaGen® 1.0 mg Dasiglucagon 0.6 mg Placebo Dasiglucagon Placebo 0.6 mg GlucaGen® 1.0 mg Median time to blood glucose recovery

 

 

 

 

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18 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 18 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). 300 newborns Are diagnosed every year with genetically determined CHI in the U.S. and EU1,2 Substantial burden of disease High resistance to existing medical treatment3 High risk of seizures and permanent brain injury4 Most severe cases require pancreatic surgery5 Prolonged hospitalization and intolerable burden to patients, families, caregivers, and healthcare systems2,6 Dasiglucagon Subcutaneous Continuous Infusion Dasiglucagon is a potential first-in-class glucagon analog for the treatment of children with congenital hyperinsulinism. The potential of chronic dasiglucagon infusion delivered via a pump to prevent hypoglycemia in children with CHI is being evaluated in a Phase 3 program. The aim is to reduce or eliminate the need for intensive hospital treatment, reduce the frequen-cy of dangerous low blood glucose and need for constant feeding, and to potentially delay or elimi-nate the need for pancreatectomy. The U.S. FDA and the European Commission both granted orphan drug designation to dasiglucagon for the treatment of CHI. Read more of Crosby’s story at zealandpharma.com/crosbys-story

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 19 2019 Achievements The first Phase 3 trial with 32 CHI children aged 3 months to 12 years is ongoing and, the second Phase 3 trial with 12 CHI children from 7 days up to one year of age was initiated in December 2019. Next Steps Based on strong progress in patient enrollment, results from the Phase 3 studies are expected in 2020. “Even though he appears to be such a normal kid, any moment his blood sugar can drop to a really dangerous level. Crosby needs to have a nurse with him at school because his blood sugar, even on medication, is extremely volatile.” Julie, Crosby’s mother

 

 

 

 

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20 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 20 Automated diabetes management A person with type 1 diabetes depends on multiple daily insulin injections to maintain plasma glucose in the normal ranges.1,2 Dasiglucagon for dual hormone artificial pancreas pump systems Zealand is developing a 1 ml cartridge contain-ing 4 mg/ml dasiglucagon, intended for use in dual-hormone artificial pancreas pumps. Currently, maintaining blood glucose levels requires continuous intervention with insulin. The amount of insulin administered is subject to continuous adapta-tion dictated by the individual’s blood glucose levels, food intake, activities such as exercise, sickness, prior insulin injections, etc. We are collaborating with Beta Bionics, develop-er 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. Zealand has invest-ed USD 5 million in Beta Bionics. 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 effort by the people with diabetes and their caregivers. As such, type 1 diabetes remains one of the most bur-densome diseases to manage. 2019 Achievements Top-line results from a Phase 2 trial in patients with Type 1 diabetes demonstrated that the bihormonal iLet using dasiglucagon provided superior glycemic control over the insulin-only iLet. During the bihormonal period, 90% of participants had a mean CGM glucose level of < 154 mg/dL, whereas only 50% of participants on the insulin-only iLet achieved this. Importantly these glycemic targets were achieved while time spent with low blood glucose levels < 54 mg/dL was only 0.3% in the bihormonal and 0.6% in the insulin-only arm. When a person with type 1 diabetes experiences dangerously low blood glucose, they produce an insufficient amount of the counteracting hormone glucagon, and depend on frequent ingestion of excessive food to re-establish normal glucose levels. Moreover, most people with type 1 diabetes keep blood glucose levels in the higher ranges; only 17% of children and 21% of adults diagnosed with diabetes in the U.S. achieved the glycemic targets recommended by American Diabetes Association.3 Next Steps Zealand and Beta Bionics are in dialogue with the FDA and expect to initiate the pivotal Phase 3 trial in late 2020.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 21 Hypoglycemia following bariatric surgery A number of patients who have undergone bariatric surgery as a treatment for obesity, experience reactive hypoglycemia after eating a meal. Thus, ingesting additional food or drink to increase plasma glucose is not an option. There is no approved treatment option for the estimated 6,000 patients in the U.S. who suffer from this serious condition. Dasiglucagon mini dose Dasiglucagon mini dose may provide an attractive treatment solution for people with type 1 diabe-tes who experience hypoglycemic events, and for whom eating or drinking carbohydrates is not an option, similar to the post-bariatric patients. 2019 Achievements In October, a new clinical program was initiated for dasiglucagon to evaluate its potential as a novel treatment for patients with post bariatric surgery hypoglycemia. Next Steps Results from the Phase 2 clinical proof of concept dose-finding trial expected in 2020.

 

 

 

 

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22 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 22 Short bowel syndrome Patients with SBS have undergone massive intestinal surgery resulting in significantly reduced or complete loss of intestinal function. Underlying causes for SBS include inflammatory bow-el syndrome, intestinal infarction, radiation damage or trauma, and recurrent intestinal obstruction or con-genital disorders.1,2,3 SBS affects an estimated 20,000-40,000 people in the U.S. and Europe.4 SBS patients cannot absorb adequate fluids and nu-trition taken orally, and those most severely affected become dependent on home parenteral support to sur-vive. Home parenteral support is delivered through daily infusion of intravenous fluids and nutrition via a central venous catheter.1,2 Long-term use of parenteral support carries a risk of catheter-related blood stream infec-tions, 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 significant 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 been demonstrated to increase the absorptive capacity of the remaining intestines, and thus enables the patient to realize their full potential for intestinal rehabilitation following surgery. Despite the clear benefits of reducing the dependency on parenteral support, people treated with the only currently available short-acting GLP-2 therapy have shown high levels of treatment discontinuation,1,2 which Zealand views as an opportunity for more ef-fective, less complex and better tolerated treatments tailored to the needs of SBS patients. Read more of Will’s story at zealandpharma.com/wills-story

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 23 Will has had short bowel syndrome since he was 13 years old. When first diagnosed, he was receiving infusions of total parenteral nutrition (TPN) for 12 hours, every night of the week. “As a thirteen year old, the hardest part for me was that I wasn’t able to participate in sports. At the time, that was my biggest concern. I realized later… it was a lot bigger than just that.” Being connected to the TPN infusion limited his ability to leave the house and attend school. He has worked hard to regain his freedom and quality of life by optimizing his TPN and being connected fewer hours and days per week. His goal is to be completely free from receiving TPN. Will Glepaglutide Glepaglutide is a long-acting GLP-2 analog being developed in an auto-injector with potential for convenient weekly administration. GLP-2 molecules stimulate the growth of intestinal tissue, increase nu-trient and fluid absorption, increase intestinal blood flow, and reduce gastric secretion and emptying. ZP7570 ZP7570 is a potential first-in-class and long-acting GLP-1R/GLP-2R dual agonist. ZP7570 is designed to improve management of SBS beyond what is achievable with mono GLP-2 treatments, and may represent a next level of innovation for helping SBS patients to further realize full potential for intestinal rehabilitation. 2019 Achievements The clinical program was started in June 2019 with a Phase 1a single-ascending dose, safety and tolerability trial. 2019 Achievements Phase 3 pivotal trial progress and ramp up in patient enrollment. Next steps Patient enrollment is expected to be completed in 2020, and results are expected in the first half of 2021. Next Steps Following good progress in the Phase 1a trial, we expect to initiate a Phase 1b multiple-ascending dose, safety and tolerability trial in 2020.

 

 

 

 

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24 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 24 Obesity / Type 2 Diabetes Excessive weight and obesity are amongst 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 insufficient therapeutic options available, resulting in a high unmet medical need for safe and effective treatments that achieve significant weight loss. Long-acting GLP-1/GLU dual agonist with Boehringer Ingelheim The GLP-1/glucagon dual agonist activates two key gut hormone receptors simultaneously and may offer better blood sugar and weight-loss control than current single-hormone receptor agonist treatments. The lead molecule BI 456906 is targeting treatment of diabetes and obesity. Long-acting amylin analog with Boehringer Ingelheim Amylin is a pancreatic peptide hormone that plays an important role in decreasing food intake and in the regulation of postprandial plasma glucose levels. The compound is a long-acting analog of amylin and has demonstrated significant weight loss in pre-clinical models of obesity.² A Phase 2 trial will be initiated in early 2020, based on the safety, tolerability, and favorable weight loss potential in individuals with a BMI up to 40 kg/m² observed in Phase 1.¹ In pre-clinical studies, Zealand and Boehringer In-gelheim observed that the novel, long-acting amylin analog may prevent the development of obesity in pre-clinical models, suggesting its potential use in treating obesity and obesity-related comorbidities. The Phase 2 trial is a randomized, parallel group, dose-finding study of subcutaneously administered BI 456906, compared with placebo and open-la-bel semaglutide in 410 patients with Type 2 dia-betes mellitus. The main objective of the trial is to demonstrate a dose-relationship of BI 456906 on HbA1c from baseline to 16 weeks relative to placebo. Secondary objectives are to assess the effect of BI 456906 on change in body weight. An open-label comparator (semaglutide) will allow for comparison of the effects against a pure GLP-1R agonist. Find out more about our research at zealandpharma.com/our-approach

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 25 Pre-Clinical Projects We continually look for opportunities to enhance native peptides, expand current Zealand drugs into new indications, or discover novel peptide therapeutics to address unmet needs in specialty gastrointestinal and metabolic diseases. We have in-depth knowledge of the role of GLP-2 in physiology and disease through our work on glep-aglutide, and we see exciting opportunities beyond short bowel syndrome. We have recently optimized a single peptide, ZP7570, which has activity at both the GLP-1 and GLP-2 receptors, with the potential to treat specialty gastrointestinal and liver diseases. This program will enter clinical development in the first half of 2019. We further utilize our understanding to discover peptides that act as agonists and antagonists of other endogenous hormones and their receptors. Our pre-clinical pipeline includes programs focused on analogs of endogenous peptide hormones, as well as exploration of peptides as therapeutics acting on components of the complement cascade, ion chan-nels and other target classes. Complement C3 inhibitors Altered activation of the com-plement cascade is implicated in many immune mediated diseases and in particular rare diseases such as paroxysmal nocturnal hemoglobinuria, cold agglutinin disease, myas-thenia gravis and C3 glomeru-lopathy. There is currently only one approved drug to treat complement mediated diseas-es: an antibody that blocks the complement cascade at C5, the final step in complement activation. Integrin α4β7 Inhibitor ZP10000 (formerly ET3764) is being developed as an orally-delivered peptide drug to target integrin α4β7, which is involved in the pathogenesis of inflammatory bowel disease (IBD). The target’s mode of action has been clinically validated in IBD by vedolizum-ab, an approved, infusion-only α4β7 integrin inhibitor. Ion Channel Blockers Ion channels are transmem-brane proteins that control ion flow across cell membranes in almost all living cells. Their dysregulation is implicated in many diseases includ-ing inflammatory diseases, metabolic disorders and rare channelopathies, and modify-ing their function is likely to be therapeutically relevant. GIP analogs Expanding on our GLP-1 ex-perience, we have discovered potent selective analogs of gastric inhibitory peptide (GIP) and extended this to single peptides that have dual activity at both GIP and GLP-1 as well as single peptides with triple activity (GIP/GLP-1/glucagon). These peptides have therapeu-tic potential to treat meta-bolic diseases such as type 2 diabetes and obesity with early clinical validation of GIP/ GLP-1 dual agonist provided by a Phase 2 study reported in 2018 (Frias et al, The Lancet 392:2180-2193). We have identified novel peptides that are potent and selective blockers of ion chan-nels that may play roles in in-flammation. Further optimiza-tion is required and we expect these programs to contribute to the clinical pipeline in the future. We have identified novel pep-tides that are potent, selective, long-acting inhibitors of the complement cascade acting at factor C3, upstream of C5 and thus offering potential differentiation and broader utility than current therapy. A candidate will be selected for pre-clinical toxicology in 2020 and progression to clinical de-velopment is expected in 2021. Find out more about our research at zealandpharma.com/our-approach

 

 

 

 

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26 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 26 Through new partnerships with industry leaders and strategic investments in innovation, we are creating opportunities to help more patients with our novel therapeutics while maximizing shareholder value." Marino Garcia, Senior Vice President, Business Development, International Commercial & New Product Planning Approaching commercialization

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 27 Approaching commercialization We are building a fully integrated commercial biotech company with U.S. operations to market our own therapies for rare diseases. Establishing our presence in the U.S. Zealand is on a journey to transform into a fully integrated biotech company including commercial operations. productive period built the robust pipeline that we have today, with four late-stage programs followed by high potential early-and pre-clinical candidates. As we are approaching commercialization, Zealand entered into the final stage of transformation in 2019. We are on the verge of four potential exciting prod-uct launches in four years. With the decision made last year to independently launch the dasiglucagon HypoPal® rescue pen in the United States in 2021, we quickly took action to begin building U.S. opera-tions and infrastructure which will be launch-ready in 2021. From our humble beginning in 1998, we have worked to establish and strengthen our peptide platform. Our skilled experience in transforming peptides into novel therapeutics is proven by two products that have been brought to market, and the licensed partner-ships in which we have engaged during the past 20 years. A strategic shift in 2015 was made to enable Zealand to retain a greater portion of the value creation, by commercializing fully-owned products. The period immediately following saw our emphasis on late stage clinical development, while maintaining our strength in discovery and research. This incredibly Delivering to patients globally Our team is further dedicated to making Zealand products available in markets outside the U.S., and currently assessing the optimal way to best deliver these much-needed therapeutics to patients. Our strategy has consistently been to transform into a fully integrated biotech company with commercial operations in the U.S. for short bowel Licensed partnerships 4 potential product launches in 4 years 2020 Accelerating late stage development Robust pipeline including three late stage programs Establishing our Peptide Platform Founded 1998 World-leading peptide platform with two medicines brought to market Approaching commercialization Establishing operations in the U.S. NDA submission for dasiglucagon HypoPal® rescue pen planned U.S. leadership, commercial, medical and corporate infrastructure Glepaglutide syndrome Dasiglucagon Dasiglucagon Dasiglucagon HypoPal® Rescuefor congenitaldual hormone Pen for severehyperinsulinismartificial pancreas hypoglycemia Boston facility to open 1998 2019 2021 2022 2023+

 

 

 

 

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28 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 28 "We leverage agility, collaboration and boldness to create and foster strong partnerships across our value chain." Ivan Møller Senior Vice President, Technical Development and Operations Engaging Partnerships

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 29 Engaging Partnerships We engage with development and commercial partners to enhance innovation and expand opportunities across markets and therapeutics areas. Boehringer Ingelheim Zealand has a long-term and productive partnership with Boehringer Ingelheim, to develop an amylin analog and GLP-1/GLU product candidates for obesity and/or type 2 diabetes. Alexion Pharmaceuticals In March 2019, Zealand entered into a license, research and development agreement with Alexion Pharmaceuticals to develop novel therapies to treat complement mediated diseases. Zealand has licensed two product candidates to Boehringer Ingelheim, both with potential for once-weekly administration. Under the terms of the two agreements, Boehringer Ingelheim funds all research, development and commercialization activ-ities. For the GLP-1/glucagon dual agonist, Zealand is entitled to receive up to EUR 365 million in outstand-ing milestone payments. The agreement also carries high-single digit to low-double digit percentage royal-ties on global sales. The other collaboration compound is a long-acting amylin analog for which Zealand is entitled to receive up to EUR 283 million in outstanding milestone payments, and mid-single digit to low-dou-ble digit percentage royalties on global sales. Peptides offer a number of advantages, including be-ing highly selective and potent, allowing low dosage volumes for ease of administration, and having the potential to treat a broad range of complement-me-diated diseases. Under the Alexion license, research and develop-ment agreement, we received an immediate upfront non-refundable payment of USD 25 million for the C3 program and a concurrent USD 15 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 115 million, as well as up to USD 495 million in sales-re-lated milestones and high single-to low double-digit royalty payments. Additional programs will provide further non-refundable upfront payments, develop-ment and sales milestone and royalties. Boehringer Ingelheim’s track record of excellence in research and development in cardiometabolic diseas-es is evidence of its innovation which has resulted in important breakthroughs in recent years, especially in thromboembolic diseases and type 2 diabetes. Find out more about our research at zealandpharma.com/our-approach

 

 

 

 

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30 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 30 Beta Bionics Beta Bionics and Zealand have a non-exclusive development partnership with the primary goal of obtaining regulatory approval to use dasiglucagon in the bihormonal configuration of the iLet1. The iLet, developed by Beta Bionics, is the world’s first autonomous bionic pancreas device. This bihor-monal system leverages lifelong machine learning and artificial intelligence to deliver insulin and gluca-gon analogs for automated management of Type 1 diabetes. In addition to dosing insulin, the iLet doses dasiglucagon — Zealand's glucagon analog with a unique stability profile in a ready-to-use aqueous solution. 1 Caution: the iLet is an investigational device, limited by federal law to investigational use.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 31 "Conscientious cost management and operational efficiency will enable us to deliver on our current programs, and complete our transformation in a revenue-generating provider of treatments." Matt Dallas Senior Vice President and Chief Financial Officer Corporate matters

 

 

 

 

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32 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 32 Corporate Governance Zealand’s approach to corporate governance is founded on ethics and integrity, and forms the basis of our efforts to ensure strong confidence from our shareholders, partners, employees and other stakeholders. Corporate governance structure As a company incorporated under the laws of Den-mark, and with its shares admitted to trading and offi-cial listing on Nasdaq Copenhagen, as well as having American Depositary Shares representing Zealand shares trading on Nasdaq Global Select Market in New York, Zealand is subject to various applicable legis-lations, standards and other regulations for publicly traded companies. These include Danish and U.S. securities law and the recommendations on corpo-rate governance issued by the Danish Committee on Corporate Governance (in the below ‘‘the Recom-mendations’’). Annual General Meeting Board of mmittee¹ Management structure Zealand has a two-tier management structure com-posed of the Board of Directors (“the Board”) and the Corporate Management. The Board is responsible for the overall visions, strategies and objectives, the financial and managerial supervision of Zealand as well as for regular evaluation of the work of the Corporate Management. In addition, the Board provides general oversight of Zealand's activities and ensures that it is managed in a manner and in accordance with applica-ble law and Zealand's articles of association. Committee emuneration and Compensation Committee The Board approves the policies and procedures, and Corporate Management is responsible for the day-to-day management of Zealand in compliance with the guidelines and directions set by the Board of Directors. The allocation of responsibilities between the Board and the Corporate Management is stipulated in the Rules of Procedure. Corporate Management Organization Board of Directors The Board of Directors plays an active role in setting Zealand's strategies and goals and in monitoring the operations and results. The Board of Directors func-Read the full report on corporate governance at zealandpharma.com/corporate-governance ¹ Shareholder elected board members act as Nomination committee. Directors No mination Co Audit R

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 33 Evaluation of the Board of Directors In the first two months of 2020 the annual evaluation of the Board of Directors was car-ried out by an independent vendor, PwC. The process included electronic questionnaires 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. tions according to its rules of procedure. Board duties include establishing Zealand’s strategy, policies and activities to achieve Zealand's objectives in accordance with the Articles of Association. Committee. The full board acts as its own Nomination Committee. Audit Committee The Audit Committee assists the Board of Directors with oversight of financial reporting, internal control and risk management related to finance, and other activities delegated by the Board of Directors. In line with the Recommendations, the Board of Directors annually reviews and determines the qual-ifications and experience needed on the Board. The chairman supervises the Board of Director's annual self-evaluation of its performance. 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. Specific topics discussed in 2019 included accounting treatment of agreement with Alexion Pharmaceuticals and acquisition of Encycle Therapeutics, auditor’s re-ports, accounting policies, internal controls, including SOX (Sarbanes-Oxley Act) compliance, risk manage-ment, insurance policy, year-end topics and external financing. The Board of Directors met thirteen times in 2019, of which seven meetings were physical meetings. Board Committees The Board has established committees to support the Board in its duties: Audit Committee, Remunera-tion and Compensation Committee, and Nomination The Audit Committee met nine times in 2019, of which four meetings were physical meetings. Overview of meetings in 2019 Attended Absent Remuneration and Compensation Committee Audit Committee Nomination Committee Board Martin Nicklasson Kirsten A. Drejer Jeffrey Berkowitz1 Bernadette Connaughton1 Alain Munoz Leonard Kruimer Michael J Owen Hanne Heidenheim Bak Jens Peter Stenvang Rosemary Crane2 Catherine Moukheibir2 - - - - - - - - - - - - 1 Elected at the Annual General Meeting on April 4, 2019 2 Stepped down at the Annual General Meeting held on April 4, 2019

 

 

 

 

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34 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 34 Compliance with the Corporate Governance Recommendations Zealand complies with the Recommenda-tions on Corporate Governance issued by the Danish Committee on Corporate Governance, November 23, 2017, with one exception: Remuneration and Compensation Committee The Remuneration and Compensation Committee proposes the remuneration policy and general guide-lines for incentive pay for the Board of Directors and the CEO of Zealand as well as targets for compa-ny-operated performance-related incentive programs. These policies and guidelines set out the various com-ponents of the remuneration, including fixed and vari-able remuneration such as pension schemes, benefits, retention bonuses, severance and incentive schemes as well as the related bonus and evaluation criteria. 3.4 Board committees (Recommendation, section 3.4.8): 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 and Compensation Committee. Specific topics discussed in 2019 included warrant programs, long-term incentive programs in general, company goals, employee salary levels, employee pensions, and CEO and Board compensation. The Remuneration and Compensation Committee met physically three times in 2019. Nomination committee The Nomination Committee consists of all of the sev-en shareholder-elected board members. The charter of the Audit Committee is available at: www.zealandpharma.com/audit-committee The Nomination Committee make recommendations for decisions to the Board of Directors regarding board and CEO positions and identifies and recommend candidates for the Board of Directors. The charter of the Remuneration and Compensation Committee, the remuneration report, the remuneration policy and the guidelines for incentive pay are available at: www.zealandpharma.com/remuneration-and-compensation-committee Specific topics discussed in 2019 included the re-placement of CEO, as Britt Meelby Jensen resigned in November 2018, and candidates for the Board of Directors. The rules of procedure of the Nomination Committee are available at: www.zealandpharma.com/nomination-committee The Nomination Committee met physically two times in 2019.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 35 Corporate responsibility As we work toward improving care for patients and delivering 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. Addressing global challenges Zealand is focused on supporting six of the UN Sustainable Development Goals that are relevant to our business. Zealand’s guiding principles for operating responsibly include: • Enabling health, well-being, and competency de-velopment of our employees, while ensuring a safe workplace, • Focusing collaboration with advocacy groups to consolidate relations and obtain better treatment options for patients, • Conducting business according to the highest ethical standards, • Working actively and systematically to minimize our impact on the environment and climate, and • Communicating our corporate responsibility ac-tions openly and honestly to external collaboration partners, including our suppliers. SDG 3: Ensure healthy lives and promote well-being for all at all ages SDG 5: Achieve gender equality and empower all women and girls SDG 10: Reduce inequality within and among countries Commitment to Sustainable Development Goals Zealand is committed to addressing global challeng-es through support of the Sustainable Development Goals established by the United Nations. Six goals that are relevant to our business were placed into fo-cus last year, and we continue to identify and imple-ment initiatives and metrics to evaluate our progress in these areas. Additional goals may be considered as our company continues to grow and evolve. SDG 12: Ensure sustainable consumption and production patterns SDG 16: Promote peaceful and inclusive societies for sustainable development, provide access to justice for all and build effective, accountable and inclusive institutions at all levels Reporting framework Our corporate responsibility efforts are based on the requirements of the Danish Financial Statements Act, and we comply with relevant laws, standards and guidelines for reporting on corporate social responsi-bility (CSR) activities. We have incorporated selected UN Sustainable Development Goals that are aligned to our business to further connect Zealand’s efforts with those of other companies to address global challenges. SDG 17: Strengthen the means of implementation and revitalize the global partnership for sustainable development Read the full report at zealandpharma.com/csr

 

 

 

 

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36 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 36 Our People Highly qualified and motivated employees are a prerequisite for achieving the ambitious Zealand business goals. We aspire to attract, develop and retain the best people and to be a company where employees thrive, regardless of their background or nationality. Diversity Engagement Highly qualified and motivated employees are a pre-requisite for achieving the ambitious Zealand busi-ness goals. Zealand’s annual employee engagement survey helps leaders and employees to continuously improve the working environment, and results from the 2019 survey show that Zealand employees are both dedicated and motivated. Zealand total % 42 Men Women 2019 Competency development Ensuring every employee has opportunity to both improve upon their existing strengths while develop-ing skills is critical to attracting and retaining qualified and engaged employees. An analysis of all compe-tency development plans made in 2019 showed that the quantity and quality of competency development plans has increased compared to previous years. 58 Zealand Board of Directors % 33 Men Women 2019 Health and well-being We work to ensure our employees’ well-being and have a number of policies in place to promote phys-ical and psychosocial health as well as the safety of Zealand’s working environment. Zealand has tak-en Danish Labor Law as a starting point for related policies and, in many cases, has gone beyond what is required of public companies in order to be more considerate of and responsive to the needs of its workforce. 67 Other key employee numbers 46.1 Average age of work force 17% Non-Danish employees 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. 3 Ph.D. students Read about Zealand as a workplace at zealandpharma.com/zealand-as-a-work-place 1 Other trainees

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 37 "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

 

 

 

 

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38 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 38 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. Zealand risk and mitigation 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. Commercial activities – products in research and development Research and development 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. Risks relating to mar-ket size, competition, development 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 efficient and safe new medicine with strong IP protection is very low. 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 efficient manner. From early in the research phase and throughout development, commer-cial potential and risks are assessed to ensure that final products have the potential to be commer-cially viable. Any major changes in the commer-cial potential of a drug candidate can lead to reduced value prospects and, ultimately, discontin-ued development. 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. 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. Mitigation Risk

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 39 Zealand risk and mitigation – continued Clinical trials Intellectual property Regulatory Future partnerships Financial Our product candidates will need to undergo time-consuming and expensive trials to document efficacy 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 efficacy to the FDA, the EMA and other comparable regulatory authorities, Zealand may incur additional costs or experience delays in complet-ing, or ultimately not be able to complete, the development of these product candidates. If Zealand or its partners were to face infringement claims or chal-lenges by third parties, an adverse outcome could subject Zealand or its partners to significant liabilities to such third parties. This could lead Zealand or its partners to curtail or cease the development of some or all of their candidate drugs, or cause Zealand’s partners to seek legal or contractual rem-edies against Zealand, potentially involving a reduction in the royal-ties due to Zealand. The regulatory approval processes of the FDA, the EMA and other comparable regulatory authori-ties 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 outlicensed 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 prod-uct is often given to the partner. Financial risks relate to cash and treasury management, liquidity forecasts and financing opportu-nities. Zealand’s clinical project teams work closely with external expert clinicians and product develop-ment experts within the industry to design, set up and conduct the clinical programs. Zealand’s employees have been selected due to their extensive experience within their field of expertise, receive training and are continuously de-veloped to fulfill requirements. Zealand’s patent department works closely with external patent counsels and partners’ patent counsels to minimize the risk of patent infringement claims as well as to prepare any patent defense should this be necessary. Zealand’s regulatory department works closely with external con-sultants and regulatory agents to develop regulatory strategies and frequently interacts with regulato-ry agencies. Zealand has taken a decision to increase its focus on proprietary programs in order to decrease its dependence on partners in the development process and capture more of the value of its projects. Financial risks are managed in ac-cordance with the Finance Policy, regularly assessed by the Com-pany’s Management and reported to the Audit Committee and the Board of Directors. Zealand is continuously working to design and implement an Internal Control Framework responding to current business risks and the require-ments of the Sarbanes-Oxley Act. See also p. 84, note 26 - Financial risks. However, partnerships may still be relevant in the future and, in order to maximize the value of such partnerships, Zealand strives to foster a close and open dialogue with its partners, thereby building strong partnerships that work effectively. Zealand’s employees receive training and updates on policies regarding the correct and lawful management of external intellec-tual property. Mitigation Risk

 

 

 

 

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40 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 40 Financial review Financial review for the period January 1 – December 31, 2019 Since there is no significant difference in the devel-opment of the Group and the Parent Company, the financial review is based on the Group’s consolidated financial information for the year ended December 31, 2019, with comparative figures for 2018 in brack-ets. a payment of DKK 9.8 million from an undisclosed counterpart in connection with a Material Transfer Agreement and a payment of DKK 3.3 million from a license agreement with Protagonist Therapeutics Inc. No royalty revenue were received in 2019 (24.9). The royalty revenues in 2018 were earned before the sale of future Sanofi royalties and milestones from sales of Lyxumia®/Adlyxin® and Soliqua® 100/33 that con-tributed with DKK 1,098.9 million in Other Operating Income in 2018. Income statement The net result for the financial year 2019 was DKK -571.5 million (581.3). Further developing the late stage clinical programs and expansion of the early pipeline together with the commercialization efforts are driving the cost base of Zealand. These factors have increased R&D by DKK 123.2 million and in-creased administrative expenses by DKK 24.3 million in G&A compared to the year before. Royalty Expenses Royalty expenses for the year amounted to DKK 0.4 million (3.4) paid to third parties relating to the license agreement with Sanofi. Research and development expenses Research and development (R&D) expenses amount-ed to DKK 561.4 million (438.2). The increase in R&D expenses for the year ended December 31, 2019, was primarily related to external costs of DKK 71.6 million from the planned development activities across the Zealand programs. The amount comprises costs for the three dasiglucagon programs, with main part on the Phase 3 trials and launch preparations relating to the rescue pen for severe hypoglycemia. It also includes costs for the Phase 3 trial with glepaglutide and clinical cost for the GLP-1/GLP-2 Dual agonist as well as costs relating to pre-clinical activities. The 2018 result was mainly a consequence of an increase in Other operating income from the sale of future milestones and royalties relating to the Sanofi license having a net gain of DKK 1,098.9 million. Revenue Revenue in 2019 amounted to DKK 41.3 million (38.0). Revenue from research and development activities amounted to DKK 41.3 million (0.0) that comprised DKK 38.0 million Alexion Pharmaceuticals and DKK 3.3 million from an undisclosed counterpart in con-nection with a Material Transfer Agreement. Revenue related to the Alexion agreement is recognized over the duration of the project based on the percentage of completion. The R&D share of the personnel expenses for the year ended December 31, 2019, was DKK 178.1 million (153.6). The increase is mainly related to an increase in the number of employees in the clinical development organization. No milestone payments were received in 2019 (13.1). The milestone payments in 2018 comprised

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 41 Operating result The operating result for the year was DKK -587.9 million (652.4). During Q1 2019, it was determined that warrants comprised by the 2010 and 2015 employee incentive programs granted in the period 2014 until Q4 2018 should be recognized over the vesting period (typ-ically 3 years) and not when granted, and therefore expenses have been overstated in this period. Such misstatements have been corrected with retrospec-tive impact and thus comparable periods as of and for the years ended December 31, 2018 and 2017 have been restated as presented in note 1 to the con-solidated financial statements. R&D and administrative expenses DKKm 700 600 500 400 300 200 100 0 Net financial items Net financial items amounted to DKK 11.3 million (-27.3). The increase in financial income is mainly due to the fair value adjustment of the investment in Beta Bionics as well as an increase in interest and favora-ble currency exchange rates. The majority of the de-crease in financial expense is due to the redemption of the royalty bond in 2018, which also saw interest expense and amortized costs related to that bond in the period totaling DKK 33.4 million. In 2019, inter-est expenses were mainly comprised of the negative return on cash balances in DKK and EUR. 2013 2014 2015 2016 2017 2018 2019 R&D expenses Administrative expenses Administrative expenses Administrative expenses amounted to DKK 67.9 million (43.5). As the company becomes a fully inte-grated biotech with commercial and medial opera-tions, there are increased levels of support needed in internal staffing as well as from professional advisors and external service providers. There is an increase in administrative expenses as a result and as the Com-pany prepares for a product launch and subsequent commercialization. to uncertainty as to when and whether tax losses carried forward will be utilized. Result before tax Result before tax was DKK -576.7 million (625.1). Net result and comprehensive result The net result and comprehensive result both amounted to DKK -571.5 million (581.3), in both cases due to the factors described above. Corporate tax With a net loss, no tax expense has been recorded for the period. However, under Danish tax legisla-tion, Zealand is eligible to receive DKK 5.5 million in cash relating to the tax loss that originates from R&D expenses for 2019. Corporate tax benefit amount to DKK 5.1 million (-43.8) including a minor tax expense in Zealand US. Allocation of result No dividend has been proposed, and the net result for the year of DKK -571.5 million (581.3) has been transferred to retained losses. Other operating income Other operating income amounted to DKK 0.4 million (1,099.5) and mainly consists of government grants. 2018 was heavily impacted by the net gain from the agreement to sell future royalty streams and USD 85 million of potential commercial milestones for Soliqua® 100/33/ Suliqua® and Lyxumia®/Adlyxin® to Royalty Pharma. No deferred tax asset has similar to prior years been recognized in the statement of financial position due

 

 

 

 

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42 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 42 Cash outflow/inflow from investing activities Cash flow from investing activities amounted to DKK -51.7 million (882.9), mainly comprising purchase of other investment and property, plant and equip-ment. 2018 was driven by the cash net gain from the agreement to sell future royalty streams and USD 85 million of potential commercial milestones for Soliqua® 100/33/ Suliqua® and Lyxumia®/Adlyxin of DKK 1,105.5 million. Statement of financial position Cash and cash equivalents, restricted cash and securities Marketable securities, cash and cash equivalents At December 31, 2019, marketable securities, cash and cash equivalents amounted to DKK 1,380.5 mil-lion (1,159.2). The increase in cash and cash equiv-alents is mainly due to the net proceeds from the issue of shares in the year of DKK 683.2 million, and the upfront cash and equity investment the company received, USD 40 million, from the initiation of the partnership program with Alexion Pharmaceuticals. DKKm 1,500 1,200 900 600 300 Cash flows related to other investments for the peri-od amounted to DKK 22.8 million (0.0). Investment is related to Beta Bionics, Inc. committed in 2018, but not paid until early 2019. 0 2013 2014 2015 2016 2017 2018 2019 Securities Restricted cash Cash and equivalents Equity Equity amounted to DKK 1,242.7 million (1,116.3) at December 31, 2019, corresponding to an equity ratio of 78% (91%). The increase in equity is a result of the capital increase including share premium of DKK 683.2 million in total (2.8) partly set off by the net re-sult for the year of DKK -571.5 million (581.3) and the recognition of warrants of DKK 14.8 million (17.5). Investments in plant and equipment for the period amounted to DKK -21.0 million (-4.0), mainly related to improvement of the new leased headquarter in Denmark paid in cash. No additional investments in marketable securities has been made in 2019 (225.6). Zealand’s marketable securities portfolio comprises listed short term bonds in Danish Kroner to reduce interest expenses, while still having the cash readily available for R&D activities and other business opportunities. Cash flow Cash outflow/inflow from operating activities Cash flow from operating activities amounted to DKK -409.5 million (-461.4), mainly due to the loss for the year adjusted for the upfront cash and equity invest-ment from the Alexion agreement. Cash outflow/inflow from financing activities Cash flow from financing activities amounted to DKK 674.5 million (-155.4), mainly related to capital contri-bution from Van Herk Investments, Alexion Pharma-ceuticals and proceeds from employees exercising warrants. 2018 mainly related to the repayment of the royalty bond. The cash outflow from operating activities for 2018 was adjusted by the cash net gain from the agree-ment to sell future royalty streams and USD 85 mil-lion of potential commercial milestones for Soliqua® 100/33/ Suliqua® and Lyxumia®/Adlyxin® and for other non-cash items. The total cash flow for full-year 2019 amounted to DKK 213.4 million (266.1).

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 43 Shareholder information Zealand is dual listed on Nasdaq Copenhagen and Nasdaq Global Select Market, New York, under the ticker symbol ZEAL. Total shareholder composition At December 31, 2019, the nominal value of Zea-land’s share capital was DKK 36,054,661, divided into 36,054,661 shares with a nominal value of DKK 1 each. The share capital has remained unchanged as of March 12, 2020. % <1 5 15 43 Institutional Strategic Investor Domestic retail Non-Institutional Company related Miscellaneous 2019 The share capital has increased by a nominal value of DKK 5.3 million in 2019 mainly as a result of the subscription of shares by Van Herk Investments and Alexion Pharmaceuticals (DKK 4.8 million in total) and exercise of employee warrants (DKK 0.5 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. 18 19 Institutional shares by investment style % 31 27 Change in number of shareholders during 2019 The number of registered Zealand shareholders decreased from 16,227 registered shareholders at December 31, 2018, the number decreased to 14,567 at December 31, 2019. In addition, 2,726,647 shares were represented by ADSs traded on Nasdaq Global Select Market, New York. Value Growth GARP Hedge fund Index Other 2019 5 8 20 9 At March 6, 2020, Zealand had 15,179 registered shareholders, representing a total of 34,754,967 shares. Institutional shares by geography % 2 9 Ownership The following shareholders are registered in Zea-land’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 9, 2020: 43 6 United States Denmark United Kingdom Sweden France Rest of Europe Rest of World 7 2019 11 Find out more about our investor relations at zealandpharma.com/investor 22 • Van Herk Investments, Netherlands (19.3% of votes/19.3% of capital).

 

 

 

 

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44 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 44 • Wellington Management Group LLP, U.S. (9.8% of votes/9.8% of capital). Analyst coverage Zealand is followed by the financial institutions and analysts listed below: Core share data Denmark U.S. Number of shares and ADSs at Dec. 31, 2019 36,054,661 2,726,647 • Sunstone LSV Management A/S, Denmark (6.0% of votes/6.0% of capital). Institution Analyst’s name Listing Nasdaq Copenhagen Nasdaq Global Select Market, New York Share price performance The price of Zealand’s shares increased by 186% during the year, which was above relevant indices, such as the OMX Copenhagen Mid Cap index and the NASDAQ Biotechnology index. The share price at year-end 2019 was DKK 235.40, compared to DKK 82.40 at year-end 2018. U.S. Guggenheim Morgan Stanley Needham Etzer Darout David N. Lebowitz Alan Carr Ticker symbol ZEAL ZEAL Index membership OMXC Copenhagen Midcap STOXX Europe TMI Pharm United Kingdom Goldman, Sachs & Co. Jefferies Graig C. Suvannavejh Peter Welford France Bryan, Garnier & Co Oddo Securities Annual General Meeting The annual general meeting is scheduled to be held on Thursday, April 2, 2020 at 3:00 PM CET, at Zealand Pharma, Sydmarken 11, DK-2860 Søborg. Additional information will become available at www.zealand-pharma.com/annual-general-meeting no later than 3 weeks before the annual general meeting. Financial calendar 2020 Eric Le Berrigaud Oussama Denguir Date Event April 2 May 14 August 13 November 12 Annual General Meeting Interim report for Q1 2020 Interim report for H1 2020 Interim report for Q3 2020 Netherlands Kempen Suzanne van Voorthuizen Denmark Carnegie Danske Bank Handelsbanken Nordea Jesper Ilsøe Thomas Bowers Peter Sehested Michael Novod All dates are subject to NASDAQ deadlines and reporting re-quirements and are subject to change. Nasdaq charting 2019 of Zealand's share price Index 300 275 250 225 200 175 150 125 100 January February March April May June July August September October November December Zealand Pharma OMX Copenhagen Mid Cap NASDAQ Biotech

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 45 Board of Directors and Corporate Management Zealand Board of Directors at March 12, 2020 Martin Nicklasson Kirsten A. Drejer Jeffrey 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 AuC Independent Yes Yes Yes Special competencies Extensive general management and research and development experience from AstraZeneca Plc and Swedish Orphan Biovitrum AB More than 30 years of interna-tional experience in the phar-maceutical and biotech industry. Before co-founding Symphogen A/S in 2000, 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 Orexo AB and Kymab Ltd. Board mem-ber 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 Infinity Phar-maceuticals, Inc. Zealand shares at December 31, 2019 1,000 500 0 Find out more about the Board of Directors at zealandpharma.com/ board-of-directors-and-nomination-committee Zealand warrants at December 31, 2019 0 0 0 Change in owner-ship in 2019 0 0 0

 

 

 

 

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46 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 46 Zealand Board of Directors at March 12, 2020, continued Bernadette Connaughton Hanne Heidenheim Bak Leonard Kruimer Alain Munoz Michael John Owen Jens Peter Stenvang Position Board member Board member Board member Board member Employee-elected board member¹ Employee-elected board member¹ Year of birth 1958 1958 1949 1951 1953 1954 Nationality American Dutch French British Danish Danish Gender Female Male Male Male Female Male First elected 2019 2019 2005² 2012 2012³ 2014⁴ Committee AuC Chair RemCo RemCo Independent Yes Yes No Yes No No Special competencies More than 30 years of global strategic, com-mercial and leadership expertise, and a broad per-spective on the strategy, capabilities and govern-ance required for success-ful execution in U.S. and international markets. More than 30 years of experience in corporate finance, planning and strategy, including 15 years in senior executive positions in private and publicly listed biotechnol-ogy companies. Physician qualified cardi-ology and intensive care. Experience in the phar-maceutical industry at senior management level. Served as SVP for interna-tional development in the Sanofi Group and in the pharmaceutical division of Fournier Laboratories. Research experience focusing on the immune system and more than 150 publications. Has held several leading positions at GlaxoSmithKline, most recently as SVP and head of biopharmaceuticals research. Project management ex-perience in drug develop-ment from lead to launch, focusing on CNS disease and orphan drugs. Experi-ence in disease awareness and customer relationship management. Current positions Board member of Halozyme Therapeutics, Inc. and Syneos Health, Inc. Board member of Boys and Girls Club of Mercer County. Chairman of the Board of BioInvent International AB and independent board member of Oncolytics. Member of the investment advisory council of Karmijn Kapitaal. 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., and is a 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. Senior Director, Medical Affairs Operations. Laboratory Technician (Biology). Zealand shares at December 31, 2019 500 4,000 5,250 300 9,684 2,800 Zealand warrants at December 31, 2019 0 0 0 0 14,000 4,000 ¹ Employee-elected board members are elected for a period of four years. ² Resigned in 2006 and re-elected in 2007. ³ Elected term ended in 2014; re-elected in 2016 for a period of four years. ⁴ Elected term ended in 2018; re-elected in 2018 for a period of two years. Change in owner-ship in 2019 +500 +1,500 0 +300 -15,000 -700

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 47 Zealand Corporate Management at March 12, 2020 Emmanuel Dulac Matthew Dallas Adam Steensberg Ivan Møller Marino Garcia Position Executive Management President and Chief Executive Officer (from April 22, 2019) Executive Management Senior Vice President and Chief Financial Officer (from October 7, 2019) Executive Management Executive Vice President, Research and Development, and Chief Medical Officer Senior Vice President, Technical Development and Operations Senior Vice President, Business Development, International Commercial and New Product Planning Year of birth 1969 1975 1974 1972 1966 Nationality French American Danish American/Danish Canadian/Spanish Gender Male Male Male Male Male Joined Zealand 2019 2019 2010 2018 2018 Experience Prior to joining Zealand, Em-manuel was Chief Commercial Officer for Alnylam Pharmaceu-ticals, a biopharmaceutical com-pany based in Boston, where he was responsible for establishing country operations and building commercial capabilities to successfully launch their first commercial drug. Prior to joining Zealand, Matt served as chief financial officer at Aveo Pharmaceuticals, leading finance for the publicly traded biotechnology company and was additionally responsible for investor relations, facilities and information technology. He was previously CFO at CoLucid Phar-maceuticals, 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 clinical research teams as medical director at Novo Nor-disk 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. Prior to joining Zealand, Ivan worked for Novartis in both generics and pharmaceutical manufacturing, as well as in strategy, quality assurance, con-tract manufacturing and supply chain leadership in Germany, the U.S. and Switzerland. Marino has almost 25 years of global pharma and biotech ex-perience in senior commercial, corporate strategy, and business development roles. He has held various U.S. and international leadership positions of increas-ing responsibility at pharma-ceutical companies, including Synergy Pharma, Aptalis Pharma, Vifor Pharma, Aspreva Pharma-ceuticals, Pfizer and Eli Lilly & Co. Ivan was project leader at The Boston Consulting Group in the pharmaceutical R&D and manu-facturing areas. Emmanuel is a board member of Proteostasis Therapeutics, Inc. Adam is a board member of Beta Bionics, Inc. Zealand shares at December 31, 2019 0 0 17,011 0 0 Zealand warrants at December 31, 2019 74,933 27,277 269,961 63,778 65,976 Zealand PSUs at December 31, 2019 8,835 0 5,065 2,803 3,062 Change in ownership in 2019 0 0 -5,789 0 0

 

 

 

 

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48 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 48 Financial statements

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 49 Contents – consolidated financial statements Consolidated financial statements Income statement Statement of comprehensive income Statement of financial position Statement of cash flows Statement of changes in equity Business overview 50 50 51 52 52 53 Notes 1 Significant accounting policies, and significant accounting estimates and assessments Revenue Royalty expenses Research, development and administrative expenses Fees to auditors appointed at the Annual General Meeting Information on staff and remuneration Other operating income Financial income Financial expenses Income tax benefit Basic and diluted earnings per share Licenses, rights and patents Property, plant and equipment Right-of-use assets Other investments 16 17 18 19 20 21 22 23 24 25 Trade receivables Prepaid expenses Other receivables Marketable securities Cash and cash equivalents Share capital Royalty bond Deferred revenue Other liabilities Contingent assets, liabilities and other contractual obligations Financial risks Related parties Adjustments for non-cash items Change in working capital Significant events after the balance sheet date Approval of the annual report 80 80 80 80 81 81 82 83 83 54 61 64 64 2 3 4 5 65 65 73 74 74 75 76 77 78 79 80 6 7 8 9 10 11 12 13 14 15 83 84 86 86 86 86 86 26 27 28 29 30 31

 

 

 

 

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50 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 50 Consolidated financial statements Consolidated income statement for the years ended December 31, 2019, 2018 and 2017 Consolidated statements of comprehensive income for the years ended December 31, 2019, 2018 and 2017 Restated1 2018 Restated1 2017 Restated1 Restated1 DKK thousand Note 2019 DKK thousand Note 2019 2018 2017 1 See note 1 to the consolidated financial statements. The Business overview on page 53 and the accompanying notes on pages 54 to 86 form an integral part of these financial statements. 1 See note 1 to the consolidated financial statements. Revenue2 Royalty expenses3 Research and development expenses4,6 Administrative expenses4,5,6 Other operating income7 41,333 -415 -561,423 -67,881 444 37,977136,322 -3,356-14,163 -438,219-323,949 -43,543-47,343 1,099,526607 Operating result Financial income8 Financial expenses9 -587,942 14,655 -3,390 652,385 -248,526 9,9882,122 -37,322-33,509 Result before tax Income tax10 -576,677 5,136 625,051 -279,913 -43,7735,500 Net result for the year -571,541 581,278 -274,413 Earnings/loss per share – DKK Basic earnings/loss per share11 Diluted earnings/loss per share11 -16.91 -16.91 18.94-9.85 18.94-9.85 Net result for the year Other comprehensive income (loss) -571,541 0 581,278 -274,413 00 Comprehensive result for the year -571,541 581,278 -274,413

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 51 Consolidated financial statements Consolidated statements of financial position as of December 31, 2019, 2018 and 2017 Restated1 2018 Restated1 2017 Restated1 2018 Restated1 2017 DKK thousand Note 2019 DKK thousand Note 2019 1 See note 1 to the consolidated financial statements 1 See note 1 to the consolidated financial statements Significant accounting policies, and significant accounting estimates and assessments Fees to auditors appointed at the Annual General Meeting Information on staff and remuneration Contingent assets, liabilities and other contractual commitments Financial risks Related parties Significant events after the balance sheet date 1 5 6 25 26 27 30 Liabilities and equity Share capital21 Share premium Retained losses 36,055 2,650,142 -1,443,524 30,78730,751 1,957,477 1,937,179 -871,983 -1,453,261 Equity 1,242,673 1,116,281 514,669 Royalty bond22 Deferred revenue23,26 Lease liabilities26 0 83,639 78,068 0132,986 00 00 Non-current liabilities 161,707 0 132,986 Trade payables Corporate tax payables Royalty bond22 Lease liabilities26 Deferred revenue23 Other liabilities24 57,533 614 0 7,692 56,251 73,044 32,65229,428 00 02,748 00 00 80,86441,454 Current liabilities 195,134 113,516 73,630 Total liabilities 356,841 113,516 206,616 Total equity and liabilities 1,599,514 1,229,797 721,285 Assets Non-current assets Licenses, rights and patents12 Plant and machinery13 Other fixtures and fittings, tools and equipment13 Leasehold improvements13 Fixed assets under construction13 Right-of-use assets14 Deposits Restricted cash Other investments15 2,480 13,457 8,337 3,913 14,001 85,632 9,012 0 35,632 00 13,65014,855 1,794953 186304 00 00 2,7622,729 05,892 32,5829,312 Total non-current assets 172,464 50,974 34,045 Current assets Trade receivables16 Prepaid expenses17 Corporate tax receivable Other receivables18 Marketable securities19 Cash and cash equivalents20 751 30,755 7,101 7,935 299,448 1,081,060 3,2745,679 11,7407,253 1,1955,500 3,3684,979 298,61175,111 860,635588,718 Total current assets 1,427,050 1,178,823 687,240 Total assets 1,599,514 1,229,797 721,285

 

 

 

 

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52 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 52 Consolidated financial statements Consolidated statements of cash flows for the years ended December 31, 2019, 2018 and 2017 Consolidated statements of changes in equity at December 31, 2019, 2018 and 2017 Restated1 2018 Restated1 2017 Share capital Share premium Retained losses DKK thousand Note 2019 DKK thousand Total Equity at January 1, 2019 as originally presented Correction of error (net of tax)1 30,787 0 1,979,493 -22,016 -893,999 22,016 1,116,281 0 Restated equity at January 1, 2019 30,787 1,957,477 -871,983 1,116,281 Comprehensive result for the year Net result for the year Warrant compensation expenses Capital increases Cost related to capital increases 0 0 5,268 0 0 14,764 692,345 -14,444 -571,541 0 0 0 -571,541 14,764 697,613 -14,444 Equity at December 31, 2019 36,055 2,650,142 -1,443,524 1,242,673 Equity at January 1, 2018 as originally presented Correction of error (net of tax)1 30,751 0 1,959,199 -1,475,281 514,669 0 -22,020 22,020 Restated equity at January 1, 2018 Comprehensive result for the year Net profit for the year (restated)¹ Warrant compensation expenses Capital increases Restated equity at December 31, 2018 30,751 1,937,179 -1,453,261 514,669 0 0 36 30,787 0 17,472 2,826 1,957,477 581,278 0 0 -871,983 581,278 17,472 2,862 1,116,281 Equity at January 1, 2017 as originally presented Correction of error (net of tax)1 26,142 0 1,441,263 -1,200,023 267,382 0 -21,175 21,175 Restated equity at January 1, 2017 26,142 1,420,088 -1,178,848 267,382 Comprehensive loss for the year Net loss for the year Warrant compensation expenses Capital increases Cost related to capital increases 0 0 4,609 0 0 19,311 569,041 -71,261 -274,413 0 0 0 -274,413 19,311 573,650 -71,261 Equity at December 31, 2017 30,751 1,937,179 -1,453,261 514,669 1 See note 1 to the consolidated financial statements. 1 See note 1 to the consolidated financial statements Net result for the year Adjustments for non-cash items28 Change in working capital29 Deferred revenue23 Financial income received8 Financial expenses paid9 Sale of future royalties and milestones7 Income tax receipt Income tax paid -571,541 9,207 10,873 139,890 5,413 -3,390 0 93 0 581,278-274,413 101,93024,534 12,785-11,304 00 4,2632,048 -16,705-25,111 -1,105,4710 5,5005,500 -45,0000 Cash (outflow)/inflow from operating activities -409,455 -461,420 -278,746 Transfer to restricted cash related to royalty bond Transfer from restricted cash related to royalty bond Transfer from restricted cash for royalty bond, interest Sale of future royalties and milestones7 Royalty expenses related to sale of future royalties and milestones7 Change in deposit Purchase of other investments24 Purchase of marketable securities Sale of securities Purchase of property, plant and equipment13 Purchase of intangible assets12 Sale of fixed assets Dividends on securities8 0 0 0 0 0 -6,250 -22,803 0 0 -21,036 -2,480 25 878 0-60,675 6,124365,795 07,725 1,275,8020 -170,3310 -33-39 0-9,312 -299,849-75,037 74,2300 -4,038-7,226 00 0120 1,0200 Cash (outflow)/inflow from investing activities -51,666 882,925 221,351 Proceeds from issuance of shares related to exercise of warrants Proceeds from issuance of shares (2017: IPO) Costs related to issuance of shares (2017: IPO) Leasing installments Repayment of royalty bond 22 52,468 645,145 -14,444 -8,689 0 2,8846,790 0567,076 -22-59,576 00 -158,311-176,360 Cash (outflow)/inflow from financing activities 674,480 -155,449 337,930 Increase/(Decrease) in cash and cash equivalents Cash and cash equivalents at January 1 Exchange rate adjustments 213,359 860,635 7,066 266,056280,535 588,718323,330 5,861-15,147 Cash and cash equivalents at December 31 1,081,060 860,635 588,718

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 53 Consolidated financial statements Business overview Zealand (the “Company”, the “Group”, “Zealand” and “we”) was founded in 1998 and is a bio-technology company focused on the discovery and development of innovative peptide-based medicines. More than 10 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. 4 Dasiglucagon for Congenital hyperinsulinism Congenital hyperinsulinism, or CHI, is an ultra-rare but devastating disease caused by inap-propriately elevated insulin secretion irrespective of glucose levels. This leads to frequent and often severe hypoglycemia and long-term irreversible damage to health. In January 2018, the FDA issued a safe-to-proceed letter. Two pivotal Phase 3 trials were initiated in 2019. In addition to the late stage clinical programs we also have a pipeline of pre-clinical programs with the potential to enter into the clinic in 2020 and the years to come. In September 2018 we entered into an agreement with Royalty Pharma to transfer all the royal-ties that we were due to earn from our 2003 agreement with Sanofi in exchange for an upfront one-time payment of USD 205 million. Excluded from this agreement was a potential milestone payment from Sanofi of up to USD 15 million. Please refer to note 7. Other significant events during 2019 are the agreement with Alexion Pharmaceuticals to collab-orate on developing a complement C3 Inhibitor and the acquisition of Encycle Therapeutics securing pre-clinical 4 7 integrin inhibitor and access to screening library of approximately 5,000 peptide-like macrocycles. Both being part of the pre-clinical expansion of the pipeline. We have four fully owned programs in late clinical development: Owner-ship Voting rights Company summary Domicile 1 Glepaglutide, a long-acting GLP-2 analog in development for the treatment of short bowel syndrome (SBS). The pivotal Phase 3 trial in 129 patients has continued in 2019 with expected full enrolment in 2020. On track for 2021 results and new drug application. Zealand Pharma A/S subsidiaries ZP Holding SPV K/S ZP General Partner 1 ApS Zealand Pharma US Inc. Encycle Therapeutics Inc. ZP SPV 3 K/S ZP General Partner 3 ApS Denmark Denmark United States Canada Denmark Denmark 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% Dasiglucagon, a Zealand-invented proprietary glucagon analog currently in development for three different indications: 2 Dasiglucagon HypoPal® Rescue Pen for severe hypoglycemia Ready-to-use dasiglucagon may offer diabetes patients and their families a fast treatment solution for severe hypoglycemia that is easier to use than currently marketed glucagon kits. The pivotal Phase 3 clinical program with dasiglucagon for the treatment of severe hypogly-cemia was completed and New Drug Application submission is planned for first part of 2020. ZP Holding SPV K/S subsidiaries ZP SPV 1 K/S ZP General Partner 2 ApS Denmark Denmark 100% 100% 100% 100% 3 Dasiglucagon in Dual-hormone pump therapy for diabetes treatment Zealand has already reported positive results from two Phase 2a trials in 2017. In 2019 Phase 2 trial was completed and Phase 3 is planned for late 2020.

 

 

 

 

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54 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 54 Notes Note 1 – Significant accounting policies, and significant accounting estimates and assessments Significant accounting policies Implementation of new and revised standards and interpretations The Group has adopted the following new and amended standards as described below. Other amendments effective for 2019 have no impact on the financial statements for Zealand. 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. IFRS 16 Leases IFRS 16 replaces IAS 17 and requires all leases to be recognized as a right-of-use asset and lease liability, measured at the present value of future lease payments. The right-of-use asset is subsequently depreciated in a similar way to other depreciable assets over the lease term and interest calculated on the lease liability in a similar way to how it is calculated on finance leases under IAS 17. Consequently, the change impacts the presentation in the income statement and the statement of cash flows. The Board of Directors considered and approved the 2019 Annual Report of Zealand on March 12, 2020. The Annual Report will be submitted to the shareholders of Zealand for approval at the Annual General Meeting on April 2, 2020. The consolidated financial statements are presented on a historical cost basis, except for cer-tain financial assets and liabilities measured at fair value. The Group leases properties, equipment and cars. The Group recognizes leases as a right-of-use asset and a corresponding liability at the date at which the leased asset is available for use. We refer to note 14 regarding the right-of-use assets and liabilities. Historical cost is generally based on the fair value of the consideration given in exchange for goods and services. On adoption of IFRS 16, the Group recognized lease liabilities in relation to leases, which had previously been classified as “operating leases” under the principles of IAS 17, Leases. These li-abilities were measured at the present value of the remaining lease payments, discounted using the Lessee’s incremental borrowing rate as of January 1, 2019. 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. The associated right-of-use assets were at the transition date measured at the amount equal to the lease liability, adjusted by the amount of any prepaid or accrued lease payments relating to the leases recognized in the statement of financial position as at December 31, 2018. For financial reporting purposes, fair value measurements are categorized into Level 1, 2 or 3 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: In the income statement, application of IFRS 16 results in recognition of a depreciation of the right-of-use asset and an interest expense rather than an operating lease expense. • Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date • Implementation method • The Group has adopted IFRS 16, Leases from January 1, 2019, using the modified retro-spective approach whereby comparative figures are not restated. • 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 IFRIC 23, Uncertainty over income tax treatments IFRIC 23 provides guidance in respect of recognition and measurement of income tax balanc-es if uncertainty over the tax treatment exist. Implementation of the interpretation has had no impact on the income tax balances recognized in the financial statements. • 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. Annual improvements 2015-2017 Comprises minor changes to IFRS 3, IFRS 11, IAS 12 and IAS 23. The amendments have no impact on the accounting policies applied. In the narrative sections of the financial statements, comparative figures for 2018 and 2017 are shown in brackets.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 55 Notes Note 1 – Significant accounting policies, and significant accounting estimates and assessments (continued) Standards and interpretations not yet applied IASB has issued a number of new and amended standards which are not yet effective. None of these new standards or amendments are expected to impact the Group’s accounting policies. 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. Non-monetary assets purchased in foreign currencies are measured at the exchange rate on the transaction date. Accounting policies The accounting policies are apart from the application of IFRS 16, Leases, unchanged from last year. The accounting policies for specific line items and transactions are included in the respec-tive 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. 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. 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: Segment reporting The Group is managed by a Corporate Management team reporting to the Chief Executive Officer. The Corporate Management team, including the Chief Executive Officer, represents the chief operating decision maker (CODM). No separate business areas or separate business units have been identified in connection with product candidates or geographical markets. Conse-quently, there is no segment reporting concerning business areas or geographical areas. • has power over the investee; • is exposed, or has rights, to variable returns from its involvement with the investee; and Statement of financial position • has the ability to use its power to affect its returns. 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: 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. 1. 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. 2. Financial assets at fair value through the income statement, which are marketable securities held in a business model whose purpose is to regularly sell marketable securities within the portfolio. Foreign currency translation Transactions denominated in foreign currencies are translated at the exchange rates on the transaction dates. 3. Equity investments. These investments are measured at fair value through the income state-ment. Exchange differences 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. Financial assets are assigned to the different 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. 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. Differences arising between the rate at

 

 

 

 

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56 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 56 Notes Note 1 – Significant accounting policies, and significant accounting estimates and assessments (continued) Statement of cash flows The cash flow statement is prepared in accordance with the indirect method on the basis of the net loss for the year. The statement shows the cash flows broken down into operating, invest-ing 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. affects only that period, or in the period of the revision and future periods if the revision affects 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. 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 result ad-justed for sale of royalties, non-cash operating items, changes in net working capital, financial items paid, and income tax benefits received and paid. No significant changes have been made to accounting estimates and assessments in 2019. The following are the most significant accounting judgements and estimates applied by Man-agement in these financial statements: 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, investments and deposits, as well as transfers to and from restricted cash related to the royalty bond. Revenue recognition (management judgement) Revenue comprises license payments, milestone payments and royalty income. 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 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 performance obligation. Cash flow from financing activities Cash flow from financing activities includes proceeds from issuance of new shares and related costs, finance lease installments and loan financing. Cash and cash equivalents Cash and cash equivalents comprise cash and bank balances. Significant accounting estimates and judgments In applying our accounting policies, Management is required to make judgments based on the specific facts and circumstances relevant to the assessment. 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. In preparing the financial statements, Management makes a number of accounting estimates that form the basis for the recognition and measurement of our assets and liabilities. 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. In applying our accounting policies, Management is required to make judgements and esti-mates about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates including assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates. The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to ac-counting estimates are recognized in the period in which the estimate is revised if the revision Employee incentive programs (management estimates) In accordance with IFRS 2, 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

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 57 Notes Note 1 – 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: (cliff vesting). The vesting period is typically 3 years resulting in straight-line recognition of the cost over 3 years rather than up front. • The expected stock price volatility, which is based on the historical volatility of Zealand’s share price The restatement affects reported profit/loss for the year ended December 31, 2018 and prior years. While the impact on interim periods is significant, the full year impact is insignificant as the impact between the quarterly interim periods primarily nets out the full year impact. • 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 Due to the fact that the warrants are equity settled, the counter-entry to the restated expense is equity. Consequently, the restatement has no impact on reported total equity in any periods. The value of warrants recognized in equity is presented as part of share premium. Consequent-ly, the restatement results in a reduction of the share premium and a corresponding decrease in accumulated loss equal to the cumulative effect on reported profit/loss in prior years for warrants not fully vested as at January 1, 2018. • 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. The impact of the restatements of warrants on the statement of cash flow is solely a reclassi-fication between “Net profit/loss for the period” and “Change in working capital”. Hence, there is no impact on the cash flow from operating activities. Therefore, the Company deemed it irrelevant to present restated statements of cash flow. Encycle Therapeutics, Inc. acquisition (management judgement) As of October 2019, 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 will not be acquiring any infrastructure or personnel costs with this transaction. The total future consideration for the acquisition could potentially reach USD 80 million in one-time contingent value rights (“earn-outs”), of which USD 10 million in earn-outs could be payable up to the successful completion of a Phase 2 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. Management has assessed that this acquisition is an asset acquisition, and thus will be accounted for in accord-ance with IAS 38, Intangible Assets and is not considered a business combination under IFRS 3, Business Combinations. The nature and impact of each restatement in 2017 and 2018 per line item in the consolidated income statement and consolidated statement of financial position for Zealand is presented on page 58 and 59. Income statement: Research and development expenses and Administrative expenses Warrant expenses recognized in staff expenses classified as Research and development expens-es and Administrative expenses, respectively, have been restated as described above. The restatement has an opposing tax impact of 22% in 2018 because of the positive taxable income, whereas there is no recognized tax impact in 2017 due to the negative taxable income. Restatement (management judgement) During Q1 2019 a restatement related to warrants was identified by Management. The Com-pany grants, on a regular basis, equity settled warrants to Corporate Management and other employees. Historically, the warrants were deemed vested at grant date. Consequently, the full fair value at grant date has been recognized as an expense as of this date. Management has reconsidered the allocation of expenses of warrants. Management has concluded, the warrants vest at a future date as they become exercisable only upon continued employment during the time period from grant date up until the specified future date (i.e. the date upon which the warrants become exercisable). All warrants granted at one point in time vest on the same date Statement of financial position: Share premium/Retained Losses (Equity) The counter-entry to the warrant expenses recognized in the income statement (debit) is Share Premium (credit) in Equity. The impact on the income statement is recognized in Retained losses (debit) in Equity, thus results in no net impact on Equity. The restatement of Share premium and Retained losses impact shows the cumulative impact.

 

 

 

 

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58 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 58 Notes Note 1 – Significant accounting policies, and significant accounting estimates and assessments (continued) Consolidated income statement for the twelve month period ended December 31, 2018 Consolidated income statement for the twelve month period ended December 31, 2017 As most recently reported, December 31, 2018 Amount as adjusted, December 31, 2018 As most recently reported, December 31, 2017 Amount as adjusted, December 31, 2017 Restate-ment Restate-ment DKK thousand DKK thousand Revenue Royalty expenses Research and development expenses Administrative expenses Other operating income 136,322 -14,163 0 0 136,322 -14,163 Revenue Royalty expenses Research and development expenses Administrative expenses Other operating income 37,977 -3,356 0 0 37,977 -3,356 -324,667 -47,470 607 718 127 0 -323,949 -47,343 607 -438,215 -43,542 1,099,526 -4 -1 0 -438,219 -43,543 1,099,526 Operating result -249,371 845 -248,526 Operating result 652,390 -5 652,385 Financial income Financial expenses 2,122 -33,509 0 0 2,122 -33,509 Financial income Financial expenses 9,988 -37,322 0 0 9,988 -37,322 Result before tax -280,758 845 -279,913 Result before tax 625,056 -5 625,051 Income tax 5,500 0 5,500 Income tax -43,774 1 -43,773 Net result for the year -275,258 845 -274,413 Net result for the year 581,282 -4 581,278 Loss per share - basic (DKK) Loss per share - diluted (DKK) -9.88 -9.88 -0.03 -0.03 -9.85 -9.85 Earnings per share - basic (DKK) Earnings per share - diluted (DKK) 18.94 18.94 0.00 0.00 18.94 18.94 Consolidated statements of comprehensive income for the year ended December 31, 2017 Consolidated statements of comprehensive income for the year ended December 31, 2018 As most recently reported, December 31, 2017 Amount as adjusted, December 31, 2017 As most recently reported, December 31, 2018 Amount as adjusted, December 31, 2018 Restate-ment Restate-ment DKK thousand DKK thousand Net result for the year Other comprehensive income (loss) -275,258 845 -274,413 Net result for the year Other comprehensive income (loss) 581,282 -4 581,278 0 0 0 0 0 0 Net result for the year -275,258 845 -274,413 Net result for the year 581,282 -4 581,278

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 59 Notes Note 1 – Significant accounting policies, and significant accounting estimates and assessments (continued) Consolidated statement of financial position as of December 31, 2018 Consolidated statement of financial position as of December 31, 2017 As most recently reported, December 31, 2018 Amount as adjusted, December 31, 2018 As most recently reported, December 31, 2017 Amount as adjusted, December 31, 2017 Restate-ment Restate-ment DKK thousand DKK thousand Equity and liabilities Equity and liabilities Share capital Share premium Retained losses 30,787 1,979,493 -893,999 0 -22,016 22,016 30,787 1,957,477 -871,983 Share capital Share premium Retained losses 30,751 1,959,199 -1,475,281 0 -22,020 22,020 30,751 1,937,179 -1,453,261 Equity 1,116,281 0 1,116,281 Equity 514,669 0 514,669 Royalty bond Deferred revenue Lease liabilities 0 0 0 0 0 0 0 0 0 Royalty bond Deferred revenue Lease liabilities 132,986 0 0 0 0 0 132,986 0 0 Non-current liabilities 0 0 0 Non-current liabilities 132,986 0 132,986 Trade payables Corporate tax payables Royalty bond Lease liabilities Deferred revenue Other liabilities 32,652 0 0 0 0 80,864 0 0 0 0 0 0 32,652 0 0 0 0 80,864 Trade payables Corporate tax payables Royalty bond Lease liabilities Deferred revenue Other liabilities 29,428 0 2,748 0 0 41,454 0 0 0 0 0 0 29,428 0 2,748 0 0 41,454 Current liabilities 113,516 0 113,516 Current liabilities 73,630 0 73,630 Total liabilities 113,516 0 113,516 Total liabilities 206,616 0 206,616 Total equity and liabilities 1,229,797 0 1,229,797 Total equity and liabilities 721,285 0 721,285

 

 

 

 

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60 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 60 Notes Note 1 – Change in accounting policies (continued) Change in accounting policies Below is explained the impact of the adoption of IFRS 16, Leases on the Group’s financial state-ments. The Group has also elected not to reassess whether a contract is, or contains a lease at the date of initial application. Instead, for contracts entered into before the transition date the Group relied on its assessment made applying IAS 17 and IFRIC 4, Determining Whether an Arrangement Contains a Lease. As indicated above, the Group has adopted IFRS 16, Leases retrospectively from January 1, 2019, but has not changed comparatives for the 2018 reporting period, as permitted under the specific transition provisions in the standard. The changes arise from the new leasing standard are therefore recognized in the opening statement of financial position on January 1, 2019. The new accounting policies are disclosed in note 14. Measurement of lease liabilities DKK thousand Jan 1, 2019 On adoption of IFRS 16, the Group recognized lease liabilities in relation to leases which had previously been classified as ‘operating leases’ under the principles of IAS 17, Leases. These lia-bilities were measured at the present value of the remaining lease payments, discounted using the lessee’s incremental borrowing rate as of January 1, 2019. The weighted average lessee’s incremental borrowing rate applied to the lease liabilities was 2.1%. No leases were previously classified as finance leases under the principles of IAS 17. Practical expedients applied In applying IFRS 16 for the first time, the Group has used the following practical expedients permitted by the standard: • applying a single discount rate to a portfolio of leases with reasonably similar characteristics • relying on previous assessments on whether leases are onerous as an alternative to perform-ing an impairment review – there were no onerous contracts as at January 1, 2019, and • using hindsight in determining the lease term where the contract contains options to extend or terminate the lease. Reconciliation Operating lease obligations disclosed at December 31, 2018 Discounted using the lessee’s incremental borrowing rate of at the date of initial application Initial recognition of lease liabilities during 2019 Adjustments as a result of recognition of non-lease components Adjustments as a result of a different treatment of extension and termination options Adjustments as a result of lease liabilities to be recognized in subsequent years 67,507 -11,723 -32,198 1,241 4,529 -19,308 Lease liabilities recognized at January 1, 2019 10,048 Of which are: – Current lease liabilities – Non-current lease liabilities 7,118 2,930 10,048

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 61 Notes Note 2 – Revenue being recognized when incurred. Further, the premium over the market share price on the Zea-land shares subscribed by Alexion, DKK 12.7 million, is attributed to the Agreement as further consideration and consequently also recognized over the period over which the R&D servic-es are provided. 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. In total, Alexion has paid USD 40 million, corresponding to DKK 262.9 million that as of December 31, 2019 has affected equity by DKK 85.6 million, deferred revenue by DKK 139.9 million, and revenue by DKK 37.4 million in 2019. Hence the cash flow from operating activities is DKK 177.3 million and the cash flow from financing activities is DKK 85.6 million. Accounting policies Revenue comprises license payments, milestone payments and royalty income. 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. 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. 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. 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. Significant judgment applied 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. Accounting for the Alexion Pharmaceuticals, Inc. Agreement In March 2019, 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 C3 but offers 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 C3 project and other targets up to IND and Alexion will then progress the peptides into clinical development. As the nature of the collaboration with Alexion may affect 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 15 Revenue from Contracts with Customers. Under the Alexion license, research and development agreement, Zealand has received an upfront non-refundable payment of USD 25 million for the C3 program and a concurrent USD 15 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 115 million, as well as up to USD 495 million in sales-related milestones and high single-to low double-digit royalty payments. The 3 additional programs will provide further non-refundable upfront payments (USD 15 million each), development and sales milestone and royalties. 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 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 incurred to provide the services is

 

 

 

 

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62 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 62 Notes Note 2 – Revenue (continued) Accounting for the Sanofi License Agreement In 2003, 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-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 effect. and obesity. Under the terms of the 2011 BI License Agreement, BI paid a fixed amount per full-time employee and other costs related to all research, development and commercialization in respect of the compounds covered by the agreement. Zealand is eligible to receive license and milestone payments of up to EUR 386 million, of which EUR 365 million was outstanding at December 31, 2019, 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. Under the Sanofi License Agreement, Zealand were eligible to receive remaining milestone payments relating to commercialized products of up to USD 100 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 10% royalty on global net sales of a combination of lixisenatide and insulin glargine 100 units/ml (LantusR) marketed under the brand name SoliquaR 100/33 in the U.S. and as SuliquaR in the EU. In 2016, Sanofi challenged the validity of certain patents owned by a competitor, AstraZeneca (and its affiliates), 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. In 2014, Zealand entered into a second global license, research and development collaboration agreement with BI (the 2014 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 2015, BI selected a novel peptide thera-peutic to be advanced into preclinical development under this agreement. Pursuant to this agreement, we have worked with BI to advance the therapeutic peptides stemming from this research collaboration into preclinical development. BI is responsible for conducting preclinical and clinical development as well as for the commercialization of products stemming from the agreement and funding all activities under the agreement. We are eligible to receive license and milestone payments of up to EUR 295 million for the first compound to be developed and marketed under the collaboration, of which EUR 283 million was outstanding at December 31, 2019. We are also eligible to receive tiered royalties ranging from high single-digit to low-double-digit percentages on global sales of products arising from this collaboration. We retain copromotion rights in Scandinavia and are not eligible for royalty payments in those countries if we exercise such rights. 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 100/33/SuliquaR. The amount and timing of any such reductions of future revenue are not currently known, but they will not exceed USD 15 million in total. Refer to note 25. Zealand pay Alkermes plc 13% 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 0.5% royalty on amounts received in connection with drug candidates that, like lixisenatide, are produced using the SIP technology. 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. In September 2019, Boehringer Ingelheim and Zealand announced that Boehringer Ingelheim plans to initiate Phase 2 development of the GLP-1/glucagon dual agonist BI 456906. The Phase 2 trial for BI 456906 is expected to be initiated in first part of 2020 and will trigger a EUR 20 million milestone payment to Zealand at which time the revenue will be recognized. Milestone payments have been recognized as revenue when the relevant milestones are achieved. All future royalties and all but up to USD 15 million of future milestone payments relating to the Sanofi License Agreement were sold to Royalty Pharma in September 2018. Refer to note 7. Milestone payments are recognized as revenue when the relevant milestones are achieved. Accounting for the Boehringer Ingelheim License Agreements In 2011, Zealand entered into a license, research and development collaboration agreement with Boehringer Ingelheim International GmbH (BI) to advance novel GLP-1/glucagon du-al-acting peptide receptor agonists (GGDAs) for the treatment of patients with type 2 diabetes

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 63 Notes Note 2 – Revenue (continued) Accounting for other license agreements In 2019, 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. 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. In 2018, 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. All Zealand revenue can be attributed to countries other than Denmark. Revenue from Alexion In 2019, we recognized DKK 37.4 million as income from the license, research and develop-ment agreement signed in March 2019 reflecting the progress on the lead project. Under the agreement DKK 139.9 million is accounted for as deferred revenue at December 31, 2019. Milestone payments are recognized as revenue when the relevant milestones are achieved. Recognized revenue can be specified as follows for all agreements: DKK 0.6 million of other revenue is recognized related to other projects with Alexion. DKK thousand 2019 2018 2017 Revenue from Sanofi In 2018, we recognized DKK 24.9 million as royalty income, reflecting sales of Lyxumia® of EUR 9.5 million and sales of Soliqua® 100/33 of EUR 23.8 million. No milestone revenue was received. In 2017, we recognized DKK 69.6 million in revenue from milestone payments from Sanofi under the Sanofi License Agreement in connection with the approval of Suliqua® in the EU in January 2017. In addition, in 2017 we recognized DKK 35.3 million as royalty income, reflecting sales of Lyxumia® of EUR 22.4 million and sales of Soliqua® 100/33 of EUR 25.1 million. Revenue from Boehringer Ingelheim No revenue was recognized from BI in 2019 or 2018, as no milestone event was achieved. In 2017, we recognized DKK 29.8 million in revenue from milestone payments from BI related to the initiation of the Phase 1 trial for the long-acting amylin analog. Revenue from other agreements In 2018 and 2019, we recognized DKK 9.8 million and DKK 3.3 million, respectively, in revenues from a milestone payment and license option payments, respectively, from undisclosed coun-terparts relating to two Material Transfer Agreements. In 2017 and 2018, we recognized DKK 1.7 million and DKK 3.3 million, respectively, in revenue from milestone payments from Protagonist Therapeutics in connection with the start of Phase 1 and 2, respectively, with the novel hepcidin mimetic PTG-300. On September 6, 2018, Zealand entered into an agreement under which all rights to sales based royalties and milestone payments under the Sanofi agreement were transferred to Royalty Pharma for a fixed consideration. The gain net of transaction costs and settlement of the liabili-ty to Alkermes plc and another investor is included in other operating income. Refer to note 7. Alexion Pharmaceuticals Inc. Undisclosed counterpart Protagonist Therapeutics, Inc. Sanofi-Aventis Deutschland GmbH Boehringer Ingelheim International GmbH 38,021 3,312 - - - - - 9,845-3,2741,662 - 69,603 - 29,750 Total license and milestone revenue 41,333 13,119 101,015 Sanofi-Aventis Deutschland GmbH - 24,85835,307 Total royalty revenue 0 24,858 35,307 Total revenue 41,333 37,977 136,322 Royalty revenue can be specified as follows: Soliqua® Lyxumia® - - 17,78618,655 7,07216,652 Total royalty revenue 0 24,858 35,307

 

 

 

 

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64 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 64 Notes Note 3 – Royalty expenses Note 4 – Research, development and administrative 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. Accounting policies Research expenses comprise salaries, contributions to pension schemes and other expenses, including patent expenses, as well as depreciation and amortization directly attributable to the Group’s research activities. Research expenses are recognized in the income statement as incurred. 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 13% of future payments we receive in respect of lixisenatide under the Sanofi License Agreement. Development expenses comprise salaries, contributions to pension schemes and other expens-es, including depreciation and amortization, directly attributable to the Group’s development activities. Development expenses are recognized in the income statement 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. In addition, we have agreed to pay a royalty of 0.5% 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 2019, the royalty expenses relate to mentioned inventor. 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 effect 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 sufficient 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. In 2018 and 2017, the royalty expenses related to royalties from sales of Lyxumia® and Soliqua® 100/33 and milestone payments received from Sanofi. As further discussed in note 7, the arrangement was settled in 2018 as part of transferring the right to future royalty and milestone payments under the Sanofi agreement.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 65 Notes Note 4 – Research, development and administrative expenses (continued) Note 5 – Fees to auditors appointed at the Annual General Meeting 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 2019, 2018 or 2017. DKK thousand 2019 2018 2017 Administrative expenses Administrative expenses include expenses for administrative personnel, expenses related to company premises, depreciation on right-of-use assets, investor relations, etc. Overhead ex-penses have been allocated to research and development or administrative expenses according to the number of employees in each department, based on the respective employees’ associat-ed undertakings. The fee for audit-related services and other assurance engagements and other services provid-ed to the Group by Deloitte Statsautoriseret Revisionspartnerselskab in 2019 consisted of assis-tance work in relation to existing internal control processes, other auditor’s reports on various statements for public authorities, and other accounting advisory services. Note 6 – Information on staff and remuneration Restated 2018 Restated 2017 DKK thousand 2019 Total staff costs can be specified as follows: Wages and salaries Share-based payment costs Pension schemes (defined contribution plans) Other payroll and staff-related costs 175,104 14,764 13,430 14,932 141,661112,614 17,47419,311 11,0659,135 9,78310,135 Total 218,230 179,983 151,195 The amount is charged as: Research and development expenses Administrative expenses 178,089 40,141 153,601118,573 26,38232,622 Total 218,230 179,983 151,195 Average number of employees 173 146 128 Audit Audit-related services and other assurance engagements Tax advice Other 1,847 1,731 0 12 1,6611,199 7182,418 106114 0196 Total fees 3,590 2,485 3,927

 

 

 

 

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66 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 66 Notes Note 6 – Information on staff and remuneration (continued) 2019 2018 2017 1 2 3 4 5 Kirsten Drejer was appointed vice chairman at the General Meeting on April 4 in 2019. Employee-elected board members; the table only includes remuneration for board work. This board member resigned from the Board in 2017. This board member resigned from the Board in 2018. These board members resigned from the Board in 2019. 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. DKK thousand BaseCommitteeTotal board fee Fees fees BaseCommitteeTotal BaseCommitteeTotal board fee Fees feesboard fee Feesfees Remuneration to the Board of Directors Martin Nicklasson Kirsten Drejer¹ Alain Munoz Michael Owen Bernadette Mary Connaughton Jeffrey Berkowitz Leonard Kruimer Jens Peter Stenvang² Hanne Heidenheim Bak² Rosemary Crane⁵ Catherine Moukheibir⁵ Helle Haxgart², ⁴ Rasmus Just², ³ 750100850 4670467 40050450 40050450 2670267 26733300 267100367 4000400 4000400 13317150 13350183 000 000 650100750550100650 2000200000 3005035025033283 3005035025050300 000000 000000 000000 30003002500250 30003001980198 3335038335050400 300150450250150400 100010021021 0002290229 Total 3,884 400 4,284 2,783 400 3,183 2,348 383 2,731

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 67 Notes Note 6 – Information on staff and remuneration (continued) Other Warrant Pension contribution short term compensation DKK thousand Base salary Bonus benefits expenses Total 2019 Remuneration to the Executive Management Emmanuel Dulac¹ Adam Sinding Steensberg² Matthew Donald Dallas³ Britt Meelby Jensen⁴ Mats Blom⁴ 3,100 2,807 588 1,745 655 9,072 1,032 534 419 248 620 505 0 175 66 855 269 5 60 61 832 2,304 82 0 1,677 14,479 6,917 1,209 2,399 2,707 Total 8,895 11,305 1,366 1,250 4,895 27,711 Other Corporate Management⁵ 6,559 2,580 389 46 1,972 11,546 Total 6,559 2,580 389 46 1,972 11,546 Total 15,454 13,885 1,755 1,296 6,867 39,257 2018 Remuneration to the Executive Management Britt Meelby Jensen Mats Blom Restated 0 1,888 Restated 7,441 6,075 4,189 2,621 2,513 1,031 419 262 320 273 Total 6,810 3,544 681 593 1,888 13,516 Other Corporate Management⁵ 6,689 2,653 604 1,035 4,471 15,452 Total 6,689 2,653 604 1,035 4,471 15,452 Total 13,499 6,197 1,285 1,628 6,359 28,968 2017 Remuneration to the Executive Management Britt Meelby Jensen Mats Blom Restated 4,554 1,747 Restated 11,574 5,763 3,915 2,496 2,482 999 392 250 231 271 Total 6,411 3,481 642 502 6,301 17,337 Other Corporate Management⁵ 4,416 1,787 442 388 3,125 10,158 Total 4,416 1,787 442 388 3,125 10,158 Total 10,827 5,268 1,084 890 9,426 27,495 ¹ Emmanuel Dulac was appointed as CEO at April 25, 2019. ² Former Interim CEO Adam Sinding Steensberg was appointed EVP, R&D and CMO at April 25, 2019. ³ Matthew Donald Dallas was appointed CFO at October 10, 2019. ⁴ Former CEO Britt Meelby Jensen and former CFO Mats Blom resigned from Zealand at February 28, 2019 and March 28, 2019, respectively. ⁵ Other Corporate Management in 2019 comprised three members (2018: Four and 2017: Two).

 

 

 

 

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68 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 68 Notes Note 6 – Information on staff and remuneration (continued) Accounting policies The value of services received as consideration for granted warrants is measured at the fair value of the warrant. The fair value 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 offsetting entry to this is recognized under equity. An estimate is made of the number of warrants expected to vest. Subsequently, an adjustment 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. The 2010 employee incentive program Program of 2010 10/Feb/12 Program of 2010 19/Nov/12 Program of 2010 08/Feb/13 Program of 2010 01/Apr/14 Program of 2010 25/Mar/15 Program of 2010 05/May/15 Total Number of warrants Outstanding at January 1, 2019 Forfeited during the year Exercised during the year Expired during the year 0 0 0 0 0 0 0 0 0 0 0 0 72,000 0 -72,000 0 100,000 0 -68,000 0 46,359 0 -36,000 0 218,359 0 -176,000 0 Outstanding at December 31, 2019 0 0 0 0 32,000 10,359 42,359 Specified as follows: Executive Management Other employees 0 42,359 0 0 0 0 0 0 0 0 0 32,000 0 10,359 Total 0 0 0 0 32,000 10,359 42,359 Number of warrants Outstanding at January 1, 2018 Forfeited during the year Exercised during the year Expired during the year 0 0 0 0 0 0 0 0 183,425 0 0 -183,425 100,000 0 -28,000 0 100,000 0 0 0 46,359 0 0 0 429,784 0 -28,000 -183,425 Outstanding at December 31, 2018 0 0 0 72,000 100,000 46,359 218,359 Specified as follows: Executive Management Other employees 0 0 0 0 0 0 0 72,000 0 100,000 0 46,359 0 218,359 Total 0 0 0 72,000 100,000 46,359 218,359

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 69 Notes Note 6 – Information on staff and remuneration (continued) The 2010 employee incentive program (continued) Program of 2010 10/Feb/12 Program of 2010 19/Nov/12 Program of 2010 08/Feb/13 Program of 2010 01/Apr/14 Program of 2010 25/Mar/15 Program of 2010 05/May/15 Total Number of warrants Outstanding at January 1, 2017 Forfeited during the year Exercised during the year Expired during the year 6,250 0 0 -6,250 214,883 0 0 -214,883 261,137 0 -77,712 0 100,000 0 0 0 100,000 0 0 0 46,359 0 0 0 728,629 0 -77,712 -221,133 Outstanding at December 31, 2017 0 0 183,425 100,000 100,000 46,359 429,784 Specified as follows: Executive Management Other employees 0 429,784 0 0 0 0 0 183,425 0 100,000 0 100,000 0 46,359 Total 0 0 183,425 100,000 100,000 46,359 429,784 Exercise period From Until 10/Feb/15 10/Feb/17 19/Nov/15 19/Nov/17 10/Feb/16 10/Feb/18 01/Apr/17 01/Apr/19 25/Mar/18 25/Mar/20 05/May/18 05/May/20 Black–Scholes parameters Term (months) Share price Exercise price (DKK) Volatility* Risk-free interest rate Cost price Dividend 60 70.0 77.0 44.0% 0.37% 24.74 not expected 60 86.0 113.3 56.0% 0.86% 23.76 not expected 60 79.05 87.45 39.3% 0.66% 25.38 not expected 60 69.0 75.9 37.5% 0.71% 21.05 not expected 60 115.5 127.05 41.9% -0.21% 37.78 not expected 60 92.0 101.2 43.7% -0.10% 31.63 not expected * The volatility rate used is based on the actual volatility of the Zealand share price.

 

 

 

 

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70 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 70 Notes Note 6 – Information on staff and remuneration (continued) The 2015 employee incentive program Program Program Program Program of 2015 of 2015 of 2015 of 2015 05/May/15 05/May/15 05/Apr/16 05/Apr/16 Program of 2015 Program Program Program Program Program Program Program Program Program Program Program of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 Program of 2015 5/Dec/19 Program of 2015 5/Dec/19 Program of 2015 5/Dec/19 15/Jul/16 06/Apr/17 06/Apr/17 25/Aug/17 25/Aug/17 22/May/18 15/Oct/18 10/Apr/19 13/Jun/19 13/Jun/19 13/Jun/19 13/Jun/19 Total Number of warrants Outstanding at January 1, 2019 Granted during the year Forfeited during the year Exercised during the year Expired during the year 0 0 0 0 0 342,250 0 -9,050 -242,550 0 321,750 0 -40,250 -71,425 0 0 0 0 0 0 40,000 0 -40,000 0 0 381,000 0 -88,750 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 510,000 0 -92,000 0 0 40,000 0 0 0 0 0 397,750 -17,500 0 0 0 168,388 -26,716 0 0 0 8,659 0 0 0 0 8,659 0 0 0 0 8,658 0 0 0 0 16,304 0 0 0 0 16,304 0 0 0 0 1,635,000 16,307 0 0 0 641,029 -314,266 -313,975 0 Outstanding at December 31, 2019 0 90,650 210,075 0 0 292,250 0 0 0 418,000 40,000 380,250 141,672 8,659 8,659 8,658 16,304 16,304 16,307 1,647,788 Specified as follows: Executive Management Other employees 0 0 45,000 45,650 60,000 150,075 0 0 0 0 57,000 235,250 0 0 0 0 0 0 65,000 353,000 0 40,000 0 380,250 117,894 23,778 0 8,659 0 8,659 0 8,658 9,093 7,211 9,092 7,212 9,092 372,171 7,215 1,275,617 Total 0 90,650 210,075 0 0 292,250 0 0 0 418,000 40,000 380,250 141,672 8,659 8,659 8,658 16,304 16,304 16,307 1,647,788 Number of warrants Outstanding at January 1, 2018 Granted during the year Forfeited during the year Exercised during the year Expired during the year 100,000 0 -100,000 0 0 349,750 0 0 -7,500 0 328,750 0 -7,000 0 0 85,434 0 -85,434 0 0 40,000 0 0 0 0 405,500 0 -24,500 0 0 93,392 0 -93,392 0 0 14,566 0 -14,566 0 0 6,608 0 -6,608 0 0 0 615,500 -105,500 0 0 0 40,000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1,424,000 0 0 0 0 655,500 -437,000 -7,500 0 Outstanding at December 31, 2018 0 342,250 321,750 0 40,000 381,000 0 0 0 510,000 40,000 0 0 0 0 0 0 0 0 1,635,000 Specified as follows: Executive Management Other employees 0 217,000 0 1,418,000 0 0 75,000 267,250 25,000 296,750 0 0 0 40,000 57,000 324,000 0 0 0 0 0 0 60,000 450,000 0 40,000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Total 0 342,250 321,750 0 40,000 381,000 0 0 0 510,000 40,000 0 0 0 0 0 0 0 0 1,635,000

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 71 Notes Note 6 – Information on staff and remuneration (continued) The 2015 employee incentive program Program Program Program Program of 2015 of 2015 of 2015 of 2015 05/May/15 05/May/15 05/Apr/16 05/Apr/16 Program Program Program Program Program Program Program Program Program Program Program Program of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 of 2015 15/Jul/16 06/Apr/17 06/Apr/17 25/Aug/17 25/Aug/17 22/May/18 15/Oct/18 10/Apr/19 13/Jun/19 13/Jun/19 13/Jun/19 13/Jun/19 Program of 2015 5/Dec/19 Program of 2015 5/Dec/19 Program of 2015 5/Dec/19 Total Number of warrants Outstanding at January 1, 2017 Granted during the year Forfeited during the year Exercised during the year Expired during the year 100,000 0 0 0 0 357,250 0 -7,500 0 0 345,000 0 -16,250 0 0 100,000 0 -14,566 0 0 40,000 0 0 0 0 0 424,000 -18,500 0 0 0 93,392 0 0 0 0 14,566 0 0 0 0 6,608 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 942,250 538,566 -56,816 0 0 Outstanding at December 31, 2017 100,000 349,750 328,750 85,434 40,000 405,500 93,392 14,566 6,608 0 0 0 0 0 0 0 0 0 0 1,424,000 Specified as follows: Executive Management Other employees 100,000 0 75,000 274,750 25,000 303,750 85,434 0 0 40,000 57,000 348,500 93,392 0 14,566 0 6,608 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 457,000 0 967,000 Total 100,000 349,750 328,750 85,434 40,000 405,500 93,392 14,566 6,608 0 0 0 0 0 0 0 0 0 0 1,424,000 Exercise period From Until 05/May/16 05/May/18 05/May/20 05/May/20 05/Apr/19 05/Apr/21 05/Apr/17 05/Apr/21 15/Jul/19 15/Jul/21 06/Apr/20 06/Apr/22 06/Apr/18 25/Aug/17 06/Apr/22 25/Aug/22 06/Apr/18 22/May/21 15/Oct/21 06/Apr/22 22/May/23 15/Oct/23 10/Apr/22 13/Jun/22 13/Jun/20 13/Jun/21 13/Jun/22 05/Dec/20 05/Dec/21 05/Dec/22 10/Apr/24 13/Jun/24 13/Jun/24 13/Jun/24 13/Jun/24 05/Dec/24 05/Dec/24 05/Dec/24 Black–Scholes parameters Term (months) Share price (DKK) Exercise price (DKK) Volatility* Risk-free interest rate Cost price (DKK) Dividend 60 92.0 101.2 43.7% -0.10% 31.63 not expected 60 92.0 101.2 43.7% -0.10% 31.63 not expected 60 129.5 142.45 43.5% -0.04% 44.42 not expected 60 129.5 142.45 43.5% -0.04% 44.42 not expected 60 126.0 138.6 45.0% -0.33% 44.23 not expected 60 123.0 135.3 43.6% -0.24% 41.92 not expected 60 123.0 135.3 43.6% -0.24% 41.92 not expected 60 118.5 142.45 43.0% -0.16% 36.74 not expected 60 118.5 135.3 43.0% -0.16% 38.58 not expected 60 100.8 100.8 42.6% 0.05% 36.98 not expected 60 90.0 90.0 42.5% -0.03% 32.83 not expected 48 127.0 127.0 43.5% -0.45% 41.94 not expected 48 138.6 138.6 43.0% -0.59% 45.04 not expected 48 138.6 138.6 43.0% -0.59% 45.04 not expected 48 138.6 138.6 43.0% -0.59% 45.04 not expected 48 138.6 138.6 43.0% -0.59% 45.04 not expected 48 220.0 220.0 41.9% -0.63% 69.52 not expected 48 220.0 220.0 41.9% -0.63% 69.52 not expected 48 220.0 220.0 41.9% -0.63% 69.52 not expected * The average traded share price on the exercise date(s) of the 2010 warrant program was 124.6 and the average traded share price on the exercise date(s) of the 2015 warrant program was 151.7.

 

 

 

 

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72 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 72 Notes Note 6 – Information on staff and remuneration (continued) 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 offered in 2005, 2007 and in the 2009-2019 period. 2010 employee incentive program This program was established in 2010 for Zealand’s Board of Directors, Executive Management, employees and consultants. The Board of Directors was authorized to issue up to 2,750,000 warrants in the period until No-vember 2, 2015. The program has expired and a total of 2,355,495 warrants have been granted. As of December 31, 2019, 1,755,809 warrants have been exercised, 422,327 warrants have ex-pired without being exercised, and 135,000 warrants have forfeited. The total proceeds amount to DKK 145.1 million (2018: DKK 127.4 million and 2017: DKK 125.3 million). As of December 31, 2019, 42,359 warrants can still be exercised. 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 efforts 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. 2015 employee incentive program This program was established in 2015 for Zealand’s Executive Management and employees. The Board of Directors was authorized to issue up to 2,750,000 warrants in the period until April, 2020. As of December 31, 2019, 2,788,595 warrants have been granted, 321,475 warrants have been exercised, and 819,332 warrants have forfeited. This means that the remaining num-ber of warrants that can be granted is 780,737. The total proceeds amount to DKK 35.5 million (2018: DKK 0.8 million and 2017: DKK 0.0 million). As of December 31, 2019, 1,647,788 warrants can still be exercised. 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 19, 2018, 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 10%. Warrants expire automatically after five years. Warrants vest either after 3 years of service, with 1/36 each month from the grant date, or with 1/3 after one year, 1/3 after two years and 1/3 after three years. The service cost is recognized over the respective vesting periods. 2019 long-term incentive program (LTIP) for Corporate Management This program was established in 2019 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 10% of Zealand’s share capital). 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. For warrants granted in 2015 and earlier, the volatility rate used is based on the actual volatility of the Zealand share price. For warrants granted after January 1, 2016, the volatility rate used is based on the 5-year historical volatility of the Zealand share price. For warrants granted after January 1, 2019, the volatility rate used is based on the 4-year historical volatility of the Zealand share price calculated as the vesting period of 3 years plus 50% of the exercise period (two years). The change in the accounting estimate is based on more information on the average length of time for which similar warrants in the past have remained outstanding. The change does only impact warrant expenses recognized in staff expenses in the current or future finan-cial period related to warrants granted since January 1, 2019. The targets for the first PSUs granted on June 13, 2019 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.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 73 Notes Note 6 – Information on staff and remuneration (continued) Note 7 – Other operating income The number of performance share units granted is 22,915 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. Accounting policies Other operating income 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. The program is initially valued at DKK 3.2 million. DKK thousand 2019 2018 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. 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. DKK thousand 2019 2018 2017 Effect on income statement In 2019, the fair value of warrants and PSUs recognized in the income statement amounts to DKK 14.8 million in total of which DKK 0.5 million relate to PSUs (2018: DKK 17.5 million and 2017: DKK 19.3 million), of which DKK 3.2 million relate to the Executive Management (2018: DKK 1.9 million and 2017: DKK 6.3 million). Restated 2018 Restated 2017 DKK thousand 2019 Zealand entered in September 2018 into an agreement to sell future royalties and USD 85.0 mil-lion of potential commercial milestones for Soliqua® 100/33/ 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 15.0 million, expected in 2020 and 2022 (refer to note 25) have been transferred to the buyer. Zealand had in 2018 The amount is charged as: Research and development expenses Administrative expenses 12,191 2,573 13,91911,291 3,5558,020 Total 14,764 17,474 19,311 Government grants 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 Research funding 444 0 0 0 0 630567 1,310,2370 -176,8820 -34,4590 040 Total other operating income 444 1,099,526 607 Number of shares At January 1 Granted during the year Vested during the year Forfeited during the year 0 22,915 0 -3,150 0 0 0 0 At December 31 19,765 0

 

 

 

 

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74 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 74 Notes Note 7 – Other operating income (continued) Note 9 – Financial expenses received USD 205.0 million (DKK 1,310.2 million) upon closing of the transaction on September 17, 2018. In 2018, royalty expenses to third parties amounted to 13.5% or DKK 176.9 million and fees to advisors amounted to DKK 34.5 million. The Sanofi license agreement was classified as an intangible asset upon adoption of IFRS 15, 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. Accounting policies Financial expenses include interest expenses, as well as realized and unrealized exchange rate adjustments and fair value adjustments of securities. In addition, expenses related to the royalty bond until settlement in September 2018 were amortized over the expected duration of the bond and recognized as financial expenses until it was settled in September 2018. The royalty bond is described further in note 22. Interest expense is recognized in the income statement in accordance with the effective inter-est rate method. 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 stem-ming from the agreement and funding all activities under the agreement. In addition, Zealand received government grants in 2019, 2018 and 2017. DKK thousand 2019 2018 2017 Note 8 – Financial income Accounting policies Financial income includes interest from trade receivables, as well as realized and unrealized exchange rate adjustments, fair value adjustments of marketable securities and dividends from marketable securities. Interest income is recognized in the income statement in accordance with the effective interest rate method. DKK thousand 2019 2018 2017 Interest income from financial assets measured at amortized costs Fair value adjustments of Other investments and Marketable securities Exchange rate adjustments Dividend, Marketable securities 5,413 2,846 5,518 878 4,2632,048 074 4,7050 1,0200 Total financial income 14,655 9,988 2,122 Interest expenses from financial liabilities measured at amortized costs Amortization of financing costs Fair value adjustments of Marketable securities Loss on sale of Marketable securities Other financial expenses Exchange rate adjustments 3,205 0 0 0 185 0 15,08018,913 18,3475,748 1,3890 8810 1,625949 07,899 Total financial expenses 3,390 37,322 33,509

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 75 Notes Note 10 – Income tax benefit 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. 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 31, 2019. 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 assets and liabilities are offset when there is a legally enforceable right to set off 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 measured according to the statement of financial position liability method in respect of temporary differences between the carrying amount and the tax base of assets and liabilities. Deferred tax liabilities are generally recognized for all taxable temporary differences, 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 differences can be utilized. Such deferred tax assets and liabilities are not recognized if the temporary difference arises from the initial recognition (other than in a business combination) of other assets and liabilities in a transaction that affects neither the taxable profit nor the accounting profit. In addition, deferred tax liabilities are not recognized if the temporary difference arises from the initial recognition of goodwill. 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. 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 25 million (tax value of DKK 5.5 million). Deferred tax liabilities are recognized for taxable temporary differences arising on investments in subsidiaries except where the Group is able to control the reversal of the temporary differ-ence and it is probable that the temporary difference will not be reversed in the foreseeable future. Deferred tax assets arising from deductible temporary differences associated with such investments and interest are only recognized to the extent that it is probable that there will be sufficient taxable profits against which to utilize the benefits of the temporary differences and they are expected to be reversed in the foreseeable future. Under Danish tax legislation, Zealand is eligible to receive DKK 5.5 million (DKK 0.0 million in 2018 and DKK 5.5 million 2017) in cash relating to the surrendered tax loss of DKK 108 million (none in 2018 and DKK 156.5 million for 2017) based on qualifying research and development expenses. These tax receipts comprise the entire current tax benefit in 2019 and 2017, respec-tively. The income from sale of future royalties and milestones in 2018 resulted in a positive net result, meaning that Zealand was not 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. 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 sufficient taxable profits will be available to allow all or part of the asset to be recovered.

 

 

 

 

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76 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 76 Notes Note 10 – Income tax benefit (continued) Note 11 – Basic and diluted earnings per share Restated 2018 Restated 2017 Accounting policies DKK thousand 2019 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. 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 effect 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: Restated 2018 Restated 2017 DKK thousand 2019 Restated 2018 Restated 2017 DKK thousand 2019 136,755 210,148 50,308 67,590 79,986 104,377 Breakdown of unrecognized deferred tax assets: Tax losses carried forward (available indefinitely) Research and development expenses Rights Non-current assets Liabilities Other 681,531 460,007 35,849 51,677 139,890 70,306 580,937872,670 35,84943,019 00 Total temporary differences 1,439,260 883,835 1,297,804 Corporate tax rate in Denmark Calculated potential deferred tax asset at local tax rate Write-down of deferred tax asset 22.0% 316,637 -316,637 22.0%22.0% 194,444285,517 -194,444-285,517 Recognized deferred tax asset 0 0 0 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 -571,541 -571,541 33,866,709 -64,223 581,278-274,413 581,278-274,413 30,754,948 27,918,271 -64,223-64,223 Weighted average number of ordinary shares used in the calculation of basic earnings per share 33,802,486 30,690,725 27,854,048 Weighted average number of ordinary shares used in the calculation of diluted earnings per share 33,802,486 30,696,404 27,854,048 Basic earnings/loss per share (DKK) -16.91 18.94 -9.85 Diluted earnings/loss per share (DKK) -16.91 18.94 -9.85 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 super deduction Tax effect on exercise of warrants Tax effect on expired warrants Warrant - share price development Change in tax assets (not recognized) -576,677 22.0% 126,869 -947 964 -1,653 1,676 6,092 175 4,050 -132,090 625,051-279,913 22.0%22.0% -137,51161,581 -65-62 00 -2,228-1,732 1,4270 8688 151-4,407 00 94,445-50,568 Total income tax expense/benefit 5,136 -43,773 5,500

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 77 Notes Note 11 – Basic and diluted earnings per share (continued) Note 12 – Licenses, rights and patents The following potential ordinary shares are anti-dilutive at December 31, 2019 (dilutive at December 31, 2018 and anti-dilutive December 31, 2017) and are therefore not included in the weighted average number of ordinary shares for the purpose of diluted earnings per share: 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 will include the fair value on the date of acquisition of any contingent considerations. Any subsequent changes to the fair value will be recorded against the asset's cost. Potential ordinary shares are excluded at December 31, 2019 due to anti-dilutive effect (included at December 31, 2018, but excluded at December 31, 2017) related to: DKK thousand 2019 2018 2017 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. Amortizations will recognized in the income statement as R&D expenses when the intangibles are available for use based on the determined useful life. 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. At December 31, 2019 licenses, rights and patents comprises a right that will be included in a future development project originating from the acquisition of Encycle Therapeutics in October 2019. 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 considera-tions 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. Licenses, rights and patents DKK thousand Cost at January 1, 2019 Additions - 2,480 Cost at December 31, 2019 2,480 Amortization at January 1, 2019 - Amortization at December 31, 2019 - Carrying amount at December 31, 2019 2,480 Outstanding warrants under the 2010 employee incentive program Outstanding warrants under the 2015 employee incentive program Outstanding Performance Share Units (PSUs) under the LTIP 2019 program 42,359 1,647,788 19,765 218,359429,784 1,635,000 1,424,000 00 Total outstanding warrants 1,709,912 1,853,359 1,853,784 - out of which these warrants and PSUs are dilutive - out of which these warrants and PSUs are anti-dilutive 0 1,709,912 72,0000 1,781,359 1,853,784

 

 

 

 

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78 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 78 Notes Note 13 – 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. Plant and Other fixtures Building improvements Assets under construction DKK thousand machinery and fittings Cost at January 1, 2019 Transfer Additions Retirements 55,545 0 3,419 -1,811 5,130 27 7,630 -286 10,800 -27 3,918 -918 0 0 14,001 0 Cost comprises acquisition price and costs directly related to acquisition until the time when the Group starts using the asset. Cost at December 31, 2019 57,153 12,501 13,773 14,001 Tangible assets under construction are recorded as work in progress until construction has been completed and use of asset commenced. Accumulated depreciation at January 1, 2019 Transfer Depreciation for the year Retirements 41,895 0 3,483 -1,682 3,336 27 1,085 -284 10,614 -27 157 -884 0 0 0 0 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: Accumulated depreciation at December 31, 2019 43,696 4,164 9,860 0 • • • Buildings 5-13 years Plant and machinery 5-10 years Other fixtures and fittings, tools and equipment 3-5 years Carrying amount at December 31, 2019 13,457 8,337 3,913 14,001 Depreciation for the financial year has been charged as: Research and development expenses Administrative expenses Gains and losses arising from disposal of plant and equipment are stated as the difference 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 and Administrative expenses. 3,483 0 926 159 134 23 0 0 Total 3,483 1,085 157 0 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 suffered 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. Cost at January 1, 2018 Adjustment to prior year Retirements 53,629 2,748 -832 4,382 1,290 -542 10,800 - - 0 0 0 Cost at December 31, 2018 55,545 5,130 10,800 0 Accumulated depreciation at January 1, 2018 Depreciation for the year Retirements 38,774 3,941 -820 3,429 449 -542 10,496 118 - 0 0 0 Accumulated depreciation at December 31, 2018 41,895 3,336 10,614 0 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. Carrying amount at December 31, 2018 13,650 1,794 186 0 Depreciation for the financial year has been charged as: Research and development expenses Administrative expenses No impairments have been recognized for 2019, 2018 and 2017. 3,941 - 382 67 100 18 0 0 Total 3,941 449 118 0

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 79 Notes Note 14 – Right-of-use assets Accounting policies The Group leases an office building, equipment and vehicles. The rental contract for the office building has been made for a minimum period of 13 years (terminable by the landlord after 15 years). Management has assessed the lease period to be 13 years. Equipment and vehicles are leased over a period of 3-4 years with no extension option. 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. 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 different 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. 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 leases: Dec 31, Until the 2018 financial year, all leases were classified as operating leases, but are from January 1, 2019 recognized as a right-and-use asset and corresponding liability at the date at which the asset is available for use by Zealand. IFRS 16 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 16 to all contracts entered into or changed on or after January 1, 2019. Jan 1, 2019 DKK thousand 2019 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. DKK thousand 2019 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 effect. When adjustments to lease payments based on an index or rate take effect, the lease liability is reassessed and adjusted against the right-of-use asset. The total cash outflow for leases in 2019 was DKK 9.3 million. Depreciation charge of right-of-use-assets Land and buildings Other fixtures and fittings 7,724 1,094 8,818 Interest expense (included in finance expenses) 621 Right-of-use assets Buildings Other fixtures and fittings 84,1487,750 1,4842,298 85,632 10,048 Lease liabilities Current Non-current 7,6927,118 78,0682,930 85,760 10,048

 

 

 

 

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80 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 80 Notes Note 15 – Other investments Note 17 – Prepaid expenses 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. 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. The Group’s other investments consist of a USD 5.3 million (2018: USD 5.0 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 1.6% (2018: 2.0%) ownership of Beta Bionics, Inc., and is recorded at a fair value of DKK 35.6 million as of December 31, 2019 (DKK 32.6 million as of December 31, 2018). Prepayments are measured at cost and are tested for impairment at the statement of financial position date. 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 offering in June 2019 and the share price at that point was used as the basis for determining fair value. Management has determined that there has been no significant changes to fair value since then accordingly the fair value as at December 31, 2019 has been measured on a consistent basis. Measurement is considered a level 3 measurement. The increase by DKK 19.0 million from 2018 (DKK 11.7 million) to 2019 (DKK 30.8 million) is primarily related to an increase in prepaid insurance, taken as a result of higher insurance costs because of the increased liability risk from the late stage pipeline and ongoing clinical trials. Note 18 – Other receivables A fair value adjustment of DKK 2.2 million and currency conversion impact of DKK 0.8 million, respectively, have been recognized in financial income in 2019 (2018: DKK 0.0 million). Accounting policies Other receivables are measured on initial recognition at fair value and subsequently at amor-tized cost, usually equal to the nominal value. Note 16 – Trade receivables DKK thousand 2019 2018 Accounting policies Trade receivables are recognized and derecognized on a settlement date basis. They are measured at nominal value less expected credit losses based on historical experience. Zealand applies the simplified approach for determining expected credit losses. Trade receivables are mainly related to milestone and royalty payments from our collaboration agreements and are due in 30-60 days. Note 19 – Marketable securities There are no overdue receivables and the write-down for expected credit losses is not material. At December 31, 2019, Zealand had no trade receivables related to milestone payments. Accounting policies The Group’s Marketable securities portfolio comprises a bond portfolio. The investment strate-gy allows for regular sales and Management has determined that the “hold to collect” or “hold to collect and sell” criteria are not met. Consequently, the securities are classified at fair value through profit or loss. Refer to note 26, Financial risks. At December 31, 2018, Zealand had trade receivables related to the milestone from Protagonist Therapeutics, Inc. VAT Other 5,437 2,498 2,980 388 Total other receivables 7,935 3,368

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 81 Notes Note 20 – Cash and cash equivalents Note 21 – Share capital (continued) Accounting policies Cash is measured on initial recognition at fair value and subsequently at amortized cost, usually equal to the nominal value. Share capital Share capital at January 1, 2017 Capital increase on March 23, 2017 Capital increase on April 13, 2017 Capital increase on May 30, 2017 Capital increase on June 15, 2017 Capital increase on August 14, 2017 Capital increase on August 18, 2017 Capital increase on September 1, 2017 Capital increase on September 22, 2017 26,142,365 9,500 22,000 5,000 8,537 4,375,000 156,250 1,500 28,675 DKK thousand 2019 2018 Capital increase on November 20, 2017 2,500 Share capital at December 31, 2017 30,751,327 Note 21 – Share capital Share capital at January 1, 2016 Capital increase on March 30, 2016 Capital increase on April 14, 2016 Capital increase on May 26, 2016 Capital increase on June 16, 2016 Capital increase on September 6, 2016 Capital increase on September 23, 2016 Capital increase on September 29, 2016 Capital increase on November 17, 2016 Capital increase on November 25, 2016 Capital increase on December 8, 2016 24,352,769 46,613 50,453 43,071 41,269 7,400 45,457 1,475,221 8,200 57,913 13,999 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. Share capital Share capital at January 1, 2019 Capital increase on March 15, 2019 Capital increase on March 20, 2019 Capital increase on April 5, 2019 Capital increase on May 28, 2019 Capital increase on June 14, 2019 Capital increase on August 23, 2019 Capital increase on September 5, 2019 Capital increase on September 13, 2019 Capital increase on November 22, 2019 Capital increase on December 13, 2019 30,786,827 72,000 802,859 18,250 45,539 89,315 16,500 3,975,000 59,171 158,225 30,975 Share capital at December 31, 2016 26,142,365 Share capital at January 1, 2015 Capital increase on March 21, 2015 Capital increase on April 11, 2015 Capital increase on June 2, 2015 Capital increase on June 20, 2015 Capital increase on September 8, 2015 Capital increase on September 26, 2015 Capital increase on November 4, 2015 Capital increase on November 13, 2015 Capital increase on December 4, 2015 23,193,047 120,833 106,220 51,487 46,521 383,190 150,702 60,843 176,456 63,470 Share capital at December 31, 2019 36,054,661 Share capital at January 1, 2018 Capital increase on September 14, 2018 30,751,327 7,500 Share capital at December 31, 2015 24,352,769 Capital increase on December 14, 2018 28,000 Share capital at December 31, 2018 30,786,827 DKK USD EUR 732,405 306,748 41,907 343,585 96,526 420,524 Total cash and cash equivalents 1,081,060 860,635

 

 

 

 

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82 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 82 Notes Note 21 – Share capital (continued) Note 22 – Royalty bond The share capital solely consists of one class of ordinary shares all issued of DKK 1 each and all shares rank equally. The shares are negotiable instruments with no restrictions on their transfer-ability. All shares have been fully paid. Accounting policies The royalty bond was initially measured at the time of borrowing at fair value less any transac-tion costs and subsequently measured at amortized cost corresponding to the capitalized value using the effective interest method. Consequently, the difference between the proceeds of the loan and the amount to be repaid is recognized as a financial expense in the income statement over the term of the loan. On March 20, 2019, a total of 802,859 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 85.6 million, including costs of DKK 0 million. On September 5, 2019, a total of 3,975,000 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 545.6 million, including costs of DKK 14.0 million. Other capital increases in 2019 and 2018 related to exercise of warrant programs. On September 6, 2018 Zealand entered into an agreement to sell future royalties and USD 85 million of potential commercial milestones for Soliqua® 100/33/ Suliqua® and Lyxumia®/Adlyx-in® to Royalty Pharma. Zealand received USD 205.0 million (DKK 1,310.2 million) upon closing of the transaction on September 17, 2018. Zealand also redeemed the outstanding royalty bond of USD 24.7 million (DKK 157.6 million). Expenses directly related to capital increases are deducted from equity. In 2019 expenses of DKK 0.4 million (2018: DKK 0.1 million) related to the exercise of warrant programs. Zealand will remain eligible for a payment from Sanofi up to USD 15.0 million in 2020 and 2022. Refer to note 25. At December 31, 2019, there were 64,223 treasury shares (2018: 64,223), equivalent to 0.2% (2018: 0.2%) of the share capital and corresponding to a market value of DKK 15.1 million (2018: DKK 5.3 million). 22,915 treasury shares have been allocated to performance shares units (PSUs) as part of Zealand Pharma’s long-term incentive program (LTIP) granted June 13, 2019. Of these a total of 19,765 PSU’s remain. See note 6 for a further description of the LTIP program. The table below details changes in the Group’s liabilities arising from financing activities re-garding the royalty bond, including both cash and non-cash changes. Liabilities arising from financing activities are those for which cash flows were, or future cash flows will be, classified in the Group’s consolidated statements of cash flows as cash flows from financing activities. 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. DKK thousand 2019 2018 January 1 Financing cash flows (repayment) Amortization of financing costs Exchange rate adjustments 0 0 0 0 135,734 -158,311 18,347 4,230 December 31 0 0

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 83 Notes Note 23 – Deferred revenue Note 24 – Other liabilities (continued) The Group has recognized the following liabilities related to contracts with customers. DKK thousand 2019 2018 DKK thousand 2019 2018 Note 25 – 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. Deferred revenue occurred in connection with the agreement with Alexion Pharmaceuticals, Inc. as disclosed in Note 2. An up-front payment of USD 25 million (DKK 177.3 million) was received of which DKK 37.4 million has been recognized during 2019. Accounting policies Contingent assets and liabilities are disclosed, unless the possibility of an inflow or outflow of resources embodying economic benefits is virtually certain. Management expects that approx. DKK 56 million of the up-front payment received will be rec-ognized as revenue during 2020. The remaining payment is expected to be recognized during 2021 and 2022 according to the progress of the development project. At December 31, 2019, Zealand is still eligible for a payment from Sanofi of up to USD 15.0 million in 2020 and 2022. However, it is Management’s opinion that the amount of any payment cannot be determined on a sufficiently reliable basis, and therefore have not recognized an asset in the statement of financial position of the Group. Note 24 – Other liabilities At December 31, 2019, total contractual obligations related to agreements with CROs amount-ed to DKK 318.9 million (DKK 230.2 million for 2020 and DKK 88.8 million for the years 2021 up to and including 2023). Accounting policies Financial liabilities are recognized initially at fair value less transaction costs. In subsequent pe-riods, financial liabilities are measured at amortized cost corresponding to the capitalized value using the effective interest method. Zealand may be required to pay future development, regulatory and commercial milestones related to the acquisition of Encycle Therapeutics. Refer to note 12. Provisions are measured as the best estimate of the costs needed at the statement of financial position date to settle obligations. Provisions also include accruals, and contingent payments on the conclusion of agreements, contracts, etc. Accounting policies Up until 2018, Lease agreements were classified as either finance or operating leases based on the criteria in IAS 17 Leases. Lease payments under operating leases and other rental agree-ments were recognized in the income statement over the term of the agreements. In 2018, none of the Group’s leases were classified as finance leases. Refer to note 1 for accounting policy for leases effective since January 1, 2019. Deferred revenues at January 1 Customer payment received Revenue recognized during the year 0 177,315 -37,425 0 0 0 Total deferred revenue 139,890 0 Non-current deferred revenue Current deferred revenue 83,639 56,251 0 0 139,890 0 Severance payment Employee benefits Royalty payable to third party Investment in Beta Bionics Other payables 170 36,082 6,843 0 29,949 925 34,971 6,682 22,803 15,483 Total other liabilities 73,044 80,864

 

 

 

 

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84 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 84 Notes Note 26 – 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. Interest rate risk Zealand has a policy of avoiding financial instruments that expose the Group to any unwanted financial risks. As of December 31, 2019, Zealand is free of interest bearing debt. Up until the redemption in September 2018 Zealand had a fixed rate royalty bond. During 2019, 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 2018, while USD accounts have generated a low level of interest income. 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 sufficient capital to support operations and long-term growth targets. During 2019 and 2018, 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 3 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. 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 transaction exposure or exchange rate risk regarding transactions in EUR. 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 sufficient and flexible financial resources at its disposal at all times. 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. 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. 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 12-24 months and thus match-ing Zealand’s assets with its liabilities. Sensitivity analysis The table shows the effect on profit/loss and equity of reasonably likely changes in the financial variables in the statement of financial position. Up until September 2018, a USD denominated royalty bond was outstanding which up until this point in time established a significant exchange rate risk vs. USD. After redemption of the remaining outstanding amount, USD 24.7 million, Zealand is debt free. 2019 Fluctuation Effect 2018 Fluctuation DKK thousand Effect As of December 31, 2019, Zealand holds DKK 306.7 million (DKK 96.5 million) of its cash in USD. USD +/-10% 30,657 +/-10%9,627

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 85 Notes Note 26 – Financial risks (continued) Contractual maturity (liquidity risk) A breakdown of the Group’s aggregate liquidity risk on financial assets and liabilities is given below. DKK thousand 2019 2018 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. < 12 months DKK thousand 1-5 Years > 5 Years Total Trade payables Leasing Other liabilities 57,533 7,692 73,044 0 23,359 0 0 54,709 0 57,533 85,760 73,044 The fair value of securities is based on Level 1 in the fair value hierarchy. Total financial liabilities at December 31, 2019 138,269 23,359 54,709 216,337 The fair value of other investments is based on level 3 in the fair value hierarchy. Refer to note 15. Trade payables Other liabilities 32,652 80,864 0 0 0 0 32,652 80,864 The carrying amount of financial assets and financial liabilities approximated the fair value. Total financial liabilities at December 31, 2018 113,516 0 0 113,516 All cash flows are non-discounted and include all liabilities under contracts. Interest payments on the royalty bond redeemed in September 2018 were calculated using the fixed interest rate (9.375%) and the expected payback time as of each statement of financial position date. Categories of financial instruments Deposits Trade receivables Other receivables Cash and cash equivalents 9,012 751 7,935 1,081,060 2,762 3,274 3,368 860,635 Financial assets at amortized cost 1,098,758 870,039 Marketable securities Other investments 299,448 35,632 298,611 32,582 Financial assets measured at fair value through profit or loss 335,080 331,193 Lease liabilities Trade payables Other liabilities 85,760 57,533 73,044 0 32,652 80,864 Financial liabilities measured at amortized cost 216,337 113,516

 

 

 

 

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86 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 86 Notes Note 27 – Related parties Note 29 – Change in working capital Zealand has no related parties with controlling interest. DKK thousand 2019 2018 2017 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 6. No further transactions with related parties were conducted during the year. Ownership The following shareholders are registered in Zealand’s register of shareholders as owning minimum 5% of the voting rights or minimum 5% of the share capital (1 share equals 1 vote) at March 12, 2020: Note 30 – Significant events after the balance sheet date • Van Herk Investments, Rotterdam, Netherlands On February 10, 2020, Zealand announced a bid to acquire substantially all assets of Valeritas Holdings, Inc. for a total cash consideration of USD 23 million. On February 9, 2020, Valeritas Holdings, Inc. and its subsidiaries filed voluntary petitions under Chapter 11 of the US Bankrupt-cy Code in the US Bankruptcy Court. If Zealand's bid is selected, the sale will be subject to ap-proval by the Bankruptcy Court and certain other closing conditions. There can be no certainty that the transaction will be concluded. • Sunstone Capital A/S, Copenhagen, Denmark • Wellington Management Company LLP, Boston, U.S. No other significant events have occurred after the end of the reporting period. Note 28 – Adjustments for non-cash items Restated 2018 Restated 2017 DKK thousand 2019 Note 31 – 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 12, 2020. Depreciation Warrant 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 13,682 14,763 -5,999 614 -9,306 3,390 0 -7,937 4,5084,757 17,47419,311 0-5,500 43,7730 0-2,048 19,73625,610 6,5750 9,864-17,596 Total adjustments 9,207 101,930 24,534 (Increase)/decrease in receivables Increase/(decrease) in payables Adjustment for non-cash investing activities Cash outflow for investment in Beta Bionics -21,059 17,061 -7,932 22,803 -4711,306 13,256-12,610 00 00 Change in working capital 10,873 12,785 -11,304

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 87 Contents – Financial statements of the parent company Income statement Statement of comprehensive income Statement of financial position Statement of cash flows Statement of changes in equity 88 88 89 90 90 Parent company Notes 1 Significant accounting policies, and significant accounting estimates and assessments Revenue Fees to auditors appointed at the Annual General Meeting Information on staff and remuneration Financial income Financial expenses Basic and diluted earnings per share Investments in subsidiaries Other investments Prepaid expenses Other receivables Cash and cash equivalents Share capital 14 15 Other liabilities Contingent assets, liabilities and other contractual obligations Financial risks Transactions with related parties Adjustments for non-cash items Change in working capital Allocation of result Significant events after the balance sheet date Approval of the annual report 97 91 91 2 3 97 98 99 99 99 99 99 99 16 17 18 19 20 21 22 91 92 95 95 95 96 96 97 97 97 97 4 5 6 7 8 9 10 11 12 13

 

 

 

 

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88 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 88 Financial statements of the parent company Income statement Statement of comprehensive income Restated1 2018 Restated1 2018 DKK thousand Note 2019 DKK thousand Note 2019 Revenue Research and development expenses Administrative expenses Other operating income 2 4 3,4 41,333 -553,085 -75,977 444 13,119 -437,955 -42,953 630 Net result for the year Other comprehensive income (loss) -570,167 0 498,512 0 Comprehensive result for the year -570,167 498,512 ¹ See note 1 to the consolidated financial statements. Operating result -587,285 -467,159 Income from subsidiaries Financial income Financial expenses 0 14,755 -3,137 1,000,000 12,904 -3,512 5 6 Result before tax -575,667 542,233 Corporate tax 5,500 -43,721 Net result for the year -570,167 498,512 Earnings per share – DKK Basic earnings/loss per share Diluted earnings/loss per share 7 7 -16.87 -16.87 16.24 16.24 ¹ See note 1 to the consolidated financial statements.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 89 Financial statements of the parent company Statement of financial position at December 31 Restated1 2018 Restated1 2017 Restated1 2018 Restated1 2017 DKK thousand Note 2019 DKK thousand Note 2019 Assets Non-current assets Plant and machinery Other fixtures and fittings, tools and equipment Buildings Right-of-use asset Fixed assets under construction Investment in subsidiaries Deposits Other investments Liabilities and equity Share capital Share premium Retained loss 13 36,055 2,646,418 -1,488,763 30,787 1,954,721 -918,596 30,751 1,934,494 -1,417,107 13,457 8,337 3,913 85,632 14,001 2,601 8,968 35,557 13,650 1,794 186 0 0 380 2,762 32,582 14,855 953 304 0 0 380 2,729 9,312 Equity 1,193,710 1,066,912 548,138 Deferred revenue Lease liabilities 83,639 78,068 0 0 0 0 8 Non-current liabilities 161,707 0 0 9 Total non-current assets 172,466 51,354 28,533 Trade payables Payables to subsidiaries Lease liabilities Deferred revenue Other liabilities 57,082 0 7,692 56,251 64,399 32,409 546 0 0 73,754 29,424 0 0 0 37,487 Current assets Trade receivables Receivables from subsidiaries Prepaid expenses Corporate tax receivable Other receivables Marketable securities Cash and cash equivalents 733 3,271 30,494 6,682 7,936 299,448 1,019,811 3,274 0 11,698 1,278 3,103 298,611 804,303 0 127 7,253 5,500 4,950 75,111 493,575 14 10 Current liabilities 185,424 106,709 66,911 11 Total liabilities 347,131 106,709 66,911 Total equity and liabilities 1,540,841 1,173,621 615,049 12 ¹ See Note 1 to the consolidated financial statements. Total current assets 1,368,375 1,122,267 586,516 Significant accounting policies, and significant accounting estimates and assessments Contingent assets, liabilities and other contractual obligations Financial risks Transactions with related parties Allocation of result Significant events after the balance sheet date Approval of the annual report 1 Total assets 1,540,841 1,173,621 615,049 ¹ See Note 1 to the consolidated financial statements. 15 16 17 20 21 22

 

 

 

 

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90 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 90 Financial statements of the parent company Statement of cash flows Statement of changes in equity Restated1 2018 Share capital Share premium Retained loss DKK thousand Note 2019 DKK thousand Total 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 Income tax paid -570,167 7,975 5,284 5,387 -3,137 139,890 93 0 498,512 58,505 11,250 3,269 -1,242 0 5,500 -45,000 Equity at January 1, 2019 as originally presented Correction of error (net of tax)¹ 30,787 0 1,976,736 -22,016 -940,611 22,016 1,066,912 0 18 19 Restated equity at January 1, 2019 30,787 1,954,720 -918,595 1,066,912 Comprehensive income for the year Net result for the year 0 0 -570,167 -570,167 Warrant compensation expenses Capital increases Costs related to capital increases 0 5,268 0 13,796 692,345 -14,444 0 13,796 697,613 -14,444 Cash inflow/outflow from operating activities -414,675 530,794 0 Change in deposit Investment in subsidiaries Purchase of other investments Purchase of marketable securities Sale of marketable securities Dividends on marketable securities Purchase of property, plant and equipment Sale of fixed assets -6,206 -2,221 -22,803 0 0 878 -21,036 25 -33 0 0 -299,849 74,230 1,020 -4,038 0 Equity at December 31, 2019 36,055 2,646,417 -1,488,762 1,193,710 8 9 Equity at January 1, 2018 as originally presented Correction of error (net of tax)¹ 30,751 1,956,514 -1,439,127 548,138 0 -22,020 22,020 Restated equity at January 1, 2018 30,751 1,934,494 -1,417,107 548,138 Comprehensive income for the year Net profit for the year (restated)¹ Cash outflow from investing activities -51,363 -228,670 0 0 498,512 498,511 Proceeds from issuance of shares related to exercise of warrants Proceeds from issuance of shares Costs related to issuance of shares Leasing installments 52,468 645,145 -14,444 -8,689 2,884 0 -22 0 Warrant compensation expenses Capital increases 0 36 17,400 2,826 0 0 17,401 2,862 Restated equity at December 31, 2018 30,787 1,954,720 -918,595 1,066,912 1 See note 1 to the consolidated financial statements. Cash inflow from financing activities 674,480 2,862 Decrease/increase in cash and cash equivalents Cash and cash equivalents at January 1 Exchange rate adjustments 208,442 804,303 7,066 304,986 493,575 5,742 Cash and cash equivalents at December 31 1,019,811 804,303

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 91 Notes Note 1 – Significant accounting policies, and significant accounting estimates and assessments Note 2 – Revenue Recognized revenue can be specified as follows: Significant accounting policies DKK thousand 2019 2018 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. Alexion Pharmaceuticals, Inc. Undisclosed counterpart Protagonist Therapeutics, Inc. 38,021 3,312 - - 9,845 3,274 Total license and milestone revenue 41,333 13,119 The accounting policies for the financial statements of the parent company are unchanged from the previous financial year except for a change of accounting policy for leases as de-scribed in note 1 to the consolidated financial statements. The accounting policies are the same as for the consolidated financial statements with the adjustments described below. For a description of the accounting policies of the group, please refer to the consolidated financial statements. Please refer to note 2 to the consolidated financial statements. Note 3 – Fees to auditors appointed at the Annual General Meeting Note disclosures have only been included in the consolidated financial statements where the amounts recognized in the separate financial statements for the parent company are identical. DKK thousand 2019 2018 Audit Audit-related services and other assurance engagements Tax advice Other 1,783 1,731 0 12 1,661 718 106 0 In the narrative sections of the financial statements, comparative figures for 2018 are shown in brackets. Investments in subsidiaries Please refer to note 8 Investments in subsidiaries. Total fees 3,526 2,485 Restatement (management judgement) Management has reconsidered the allocation of expenses of warrants. The fee for audit-related services and other assurance engagements and other services provid-ed to the Parent Company by Deloitte Statsautoriseret Revisionspartnerselskab in 2019 consist-ed of assistance work in relation to existing internal control processes, other auditor’s reports on various statements for public authorities, and other accounting advisory services. For more details on the restatements and the description of the impact on the separate fi-nancial statements of the parent company for 2018, please refer to note 1 in the consolidated financial statements as the impact is identical to the consolidated financial statements.

 

 

 

 

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92 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 92 Notes Note 4 – Information on staff and remuneration Restated1 2018 DKK thousand 2019 Total staff salaries can be specified as follows: Wages and salaries Share based incentive payments Pension schemes (defined contribution plans) Other payroll and staff-related costs 168,237 13,715 13,420 14,227 141,661 17,478 11,065 9,779 Total 209,599 179,973 The amount is charged as: Research and development expenses Administrative expenses 170,575 39,024 153,525 26,458 Total 209,599 179,983 Average number of employees 169 146 For remuneration to the Board of Directors please refer to note 6 to the consolidated financial statements.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 93 Notes Note 4 – Information on staff and remuneration (continued) Other short term benefits Warrant compensation expenses Pension contribution DKK thousand Base salary Bonus Total 2019 Remuneration to the Executive Management Emmanuel Dulac¹ Adam Sinding Steensberg² Britt Meelby Jensen³ Mats Blom³ 3,100 2,807 1,745 655 9,072 1,032 419 248 620 505 175 66 855 269 60 61 832 2,304 0 1,677 14,479 6,917 2,399 2,707 Total 8,307 10,771 1,366 1,245 4,813 26,502 Other Corporate Management⁴ 3,889 1,512 389 5 1,074 6,869 Total 3,889 1,512 389 5 1,074 6,869 Total 12,196 12,283 1,755 1,250 5,887 33,371 2018 Remuneration to the Executive Management Britt Meelby Jensen Mats Blom Restated 0 1,888 Restated 7,441 6,075 4,189 2,621 2,513 1,031 419 262 320 273 Total 6,810 3,544 681 593 1,888 13,516 Other Corporate Management 6,689 2,653 604 1,035 4,471 15,452 Total 6,689 2,653 604 1,035 4,471 15,452 Total 13,499 6,197 1,285 1,628 6,359 28,968 ¹ ² 3 Emmanuel Dulac was appointed as CEO at April 25, 2019. Former Interim CEO Adam Sinding Steensberg was appointed EVP, R&D and CMO at April 25, 2019. Former CEO Britt Meelby Jensen and former CFO Mats Blom resigned from Zealand at February 28, 2019 and March 28, 2019, respectively. 4 Other Corporate Management in 2019 comprised three members (2018 and 2017: Two).

 

 

 

 

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94 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 94 Notes Note 4 – Information on staff and remuneration (continued) The 2010 employee incentive program Please refer to the consolidated financial statements, note 6. The 2015 employee incentive program Program of 2015 05/may/15 Program of 2015 05/may/15 Program of 2015 05/Apr/16 Program of 2015 05/Apr/16 Program of 2015 15/Jul/16 Program of 2015 06/Apr/17 Program of 2015 06/Apr/17 Program of 2015 25/Aug/17 Program of 2015 25/Aug/17 Program of 2015 22/May/18 Program of 2015 10/Apr/19 Program of 2015 13/Jun/19 Total Number of warrants Outstanding at January 1, 2019 Granted during the year Forfeited during the year Exercised during the year Expired during the year 0 0 0 0 0 342,250 0 -9,050 -242,550 0 321,750 0 -40,250 -71,425 0 0 0 0 0 0 40,000 0 -40,000 0 0 381,000 0 -88,750 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 510,000 0 -92,000 0 0 0 397,750 -17,500 0 0 0 168,388 -26,716 0 0 1,595,000 566,138 -314,266 -313,975 0 Outstanding at December 31, 2019 0 90,650 210,075 0 0 292,250 0 0 0 418,000 380,250 141,672 1,532,897 Specified as follows: Executive Management Other employees 0 0 45,000 45,650 60,000 150,075 0 0 0 0 57,000 235,250 0 0 0 0 0 0 65,000 353,000 0 380,250 117,894 23,778 344,894 1,188,003 Total 0 90,650 210,075 0 0 292,250 0 0 0 418,000 380,250 141,672 1,532,897 Number of warrants Outstanding at January 1, 2018 Granted during the year Forfeited during the year Exercised during the year Expired during the year 100,000 0 -100,000 0 0 349,750 0 0 -7,500 0 328,750 0 -7,000 0 0 85,434 0 -85,434 0 0 40,000 0 0 0 0 405,500 0 -24,500 0 0 93,392 0 -93,392 0 0 14,566 0 -14,566 0 0 6,608 0 -6,608 0 0 0 615,500 -105,500 0 0 0 0 0 0 0 0 0 0 0 0 1,424,000 655,500 -437,000 -7,500 0 Outstanding at December 31, 2018 0 342,250 321,750 0 40,000 381,000 0 0 0 510,000 0 0 1,635,000 Specified as follows: Executive Management Other employees 0 0 75,000 267,250 25,000 296,750 0 0 0 40,000 57,000 324,000 0 0 0 0 0 0 60,000 450,000 0 0 0 0 217,000 1,418,000 Total 0 342,250 321,750 0 40,000 381,000 0 0 0 510,000 0 0 1,635,000

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 95 Notes Note 4 – Information on staff and remuneration (continued) Note 7 – Basic and diluted earnings per share The 2019 long-term incentive program (LTIP) for Corporate Management The result and weighted average number of ordinary shares used in the calculation of basic and diluted result per share are as follows: 2019 2018 Restated1 2018 DKK thousand 2019 Number of shares At January 1 Granted during the year Vested during the year Forfeited during the year 0 19,853 0 -3,150 0 0 0 0 Net result for the year Net result used in the calculation of basic and diluted earnings/losses per share -570,167 498,512 -570,167 498,512 At December 31 16,703 0 Weighted average number of ordinary shares Weighted average number of treasury shares 33,866,709 -64,223 30,754,948 -64,223 Weighted average number of ordinary shares used in the calculation of basic earnings/losses per share 33,802,486 30,690,725 Note 5 – Financial income Weighted average number of ordinary shares used in the calculation of basic and diluted earnings/losses per share 33,802,486 30,696,404 DKK thousand 2019 2018 Basic earning/loss per share (DKK) -16.87 16.24 Interest income from financial assets measured at amortized costs Fair value adjustments of Other investments and Marketable securities Dividend, Marketable securities Exchange rate adjustments 5,387 2,846 878 5,644 3,269 0 1,020 8,615 Diluted earning/loss per share (DKK) -16.87 16.24 Regarding a specification of potential ordinary shares, which are dilutive or antidilutive, please refer to note 11 to the consolidated financial statements. Total financial income 14,755 12,904 Note 6 – Financial expenses DKK thousand 2019 2018 Other financial expenses Fair value adjustments of Marketable securities Loss on sale of Marketable securities Exchange rate adjustments 3,137 0 0 0 1,242 1,389 881 0 Total financial expenses 3,137 3,512

 

 

 

 

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96 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 96 Notes Note 8 – 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. Voting rights Company summary Domicile Ownership Zealand Pharma A/S subsidiaries: ZP Holding SPV K/S ZP General Partner 1 ApS Zealand Pharma US, Inc. Encycle Therapeutics, Inc. ZP SPV 3 K/S ZP General Partner 3 ApS Denmark Denmark United States Canada Denmark Denmark 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% DKK thousand Cost at January 1, 2019 Additions 380 2,221 Cost at December 31, 2019 2,601 Value adjustments at January 1, 2019 Value adjustments for the year 0 0 ZP Holding SPV K/S subsidiaries: ZP SPV 1 K/S ZP General Partner 2 ApS Denmark Denmark 100% 100% 100% 100% Value adjustments at December 31, 2019 0 Carrying amount at December 31, 2019 2,601 Pursuant to section 146(1) 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 1 K/S and ZP Holding SPV K/S. Cost at January 1, 2018 Additions 380 0 The financial statements of the two companies are fully consolidated in the consolidated finan-cial statements of Zealand Pharma A/S. Cost at December 31, 2018 380 No income has been received from subsidiaries during the year (2018: Dividend of DKK 1,000.0 million). Value adjustments at January 1, 2018 Value adjustments for the year 0 0 Value adjustments at December 31, 2018 0 Note 9 – Other investments Carrying amount at December 31, 2018 380 Please refer to note 15 to the consolidated financial statements.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 97 Notes Note 10 – Prepaid expenses Note 14 – Other liabilities The increase in Prepaid expenses of DKK 18.8 million from 2018 to 2019 is primarily related to higher insurance costs because of the increased liability risk from the late stage pipeline and ongoing clinical trials. DKK thousand 2019 2018 Severance payment Employee benefits Investment in Beta Bionics Other payables 170 34,446 0 29,783 925 34,940 22,803 15,086 Note 11 – Other receivables Total other liabilities 64,399 73,754 DKK thousand 2019 2018 VAT Other 5,448 2,488 2,771 332 Note 15 – Contingent assets, liabilities and other contractual obligations Total other receivables 7,936 3,103 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. Note 12 – Cash and cash equivalents Please refer to note 25 to the consolidated financial statements for information on contractual obligations. DKK thousand 2019 2018 DKK USD EUR 698,666 299,695 21,450 309,482 95,025 399,796 Total cash and cash equivalents 1,019,811 804,303 Note 13 – Share capital Please refer to note 21 to the consolidated financial statements.

 

 

 

 

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98 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 98 Notes Note 16 – Financial risks Please refer to note 26 to the consolidated financial statements. Restated 2018 DKK thousand 2019 Contractual maturity (liquidity risk) A breakdown of the Company’s aggregate liquidity risk on financial assets and liabilities is given below. Categories of financial instruments Deposits Trade receivables Receivables from subsidiaries Other receivables Cash and cash equivalents 8,968 733 3,271 7,936 1,019,811 2,762 3,274 0 3,103 804,303 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. Financial assets measured at amortized cost 1,040,719 813,442 Marketable securities Other investments 299,448 35,557 298,611 32,582 Financial assets measured at fair value through profit or loss 335,005 331,193 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. Trade payables Payables to subsidiaries Lease liabilities Other liabilities 57,082 0 85,760 64,399 32,409 546 0 73,754 < 12 months DKK thousand 1-5 Years >5 years Total Trade payables Leasing Other liabilities 57,082 7,692 64,399 0 23,359 0 0 54,709 0 57,082 85,760 64,399 Financial liabilities measured at amortized cost 207,241 106,709 The fair value of marketable securities is based on Level 1 in the fair value hierarchy. Total financial liabilities at December 31, 2019 129,173 23,359 54,709 207,241 The fair value of other investments is based on level 3 in the fair value hierarchy. At December 31, 2019 and 2018, the carrying amount of other financial assets and financial liabilities approximated the fair value. Trade payables Payables to subsidiaries Other liabilities 32,409 546 73,754 0 0 0 0 0 0 32,409 546 73,754 Total financial liabilities at December 31, 2018 106,709 0 0 106,709 All cash flows are undiscounted and include all liabilities under contracts.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 99 Notes Note 17 – Transactions with related parties Note 20 – Allocation of result The parent company had receivables from Group subsidiaries of DKK 3,271 thousand at De-cember 31, 2019 (2018: payables of DKK 546 thousand). In 2019, interest paid by the parent company to subsidiaries amounted to DKK 0 thousand (2018: DKK 0 thousand). The Board of Directors proposes that the parent company’s 2019 net result of DKK -570.2 million (2018: net result of DKK 498.5 million) be carried forward to next year by transfer to retained loss. Note 18 – Adjustments for non-cash items Note 21 – Significant events after the balance sheet date Restated 2018 Please refer to note 30 in the consolidated financial statements. DKK thousand 2019 Depreciation Warrant compensation expenses Income tax receipt Income tax expense Financial income Financial expenses Exchange rate adjustments 13,682 13,796 -5,497 0 -9,227 3,137 -7,916 4,508 17,400 0 43,722 0 1,389 -8,514 Note 22 – Approval of the annual report Please refer to note 31 in the consolidated financial statements. Total adjustments 7,975 58,505 Note 19 – Change in working capital DKK thousand 2019 2018 Increase/decrease in receivables Increase/decrease in payables Adjustment for non-cash investing activities Adjustment for cash outflow for investment in Beta Bionics -29,616 20,029 -7,932 22,803 -5,745 16,995 0 0 Change in working capital 5,284 11,250

 

 

 

 

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100 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 100 Alternative performance measures for the Group (non-audited) Net operating expenses Net operating expenses consist of research, development and administrative expenses less government grants and research funding (which are included in other operating income). Net operating expenses is used to show the total cost level, excluding costs related to revenue, i.e. royalty expenses. This is used to show the cost level that needs to be covered by revenues minus royalty expenses in order to show an operating profit. The table below shows a reconcil-iation of net operating expenses for the years ended 2019, 2018 and 2017: Restated 2018 Restated 2017 DKK thousand 2019 Research and development expenses Administrative expenses Government grants and research funding 561,423 67,881 -444 438,219 43,543 -630 323,949 47,443 -607 Net operating expenses 628,860 481,132 370,785 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 2019, 2018 and 2017: Restated 2018 Restated 2017 DKK thousand 2019 Cash (outflow)/inflow from operating activities Less purchase of property, plant and equipment -409,455 -21,036 -461,420 -4,038 -278,746 -7,226 Free cash flow -430,491 -465,458 -285,972

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 101 Statement of the Board of Directors and Executive Management The Board of Directors and Executive Management have today discussed and approved the Annual Report of Zealand Pharma A/S for the financial year January 1 – December 31, 2019. parent company’s operations and cash flows for the financial year January 1 – December 31, 2019. In our opinion, the Management’s review includes a fair review of the development of the Group’s and the parent company’s operations and economic conditions, the results for the year, and the Group’s and the parent company’s financial position, as well as a review of the principal risks and uncertainties to which the Group and the parent company are exposed. The consolidated financial statements and parent company financial statements have been prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional requirements under the Danish Financial Statements Act. We consider the accounting policies used to be appropriate. In our opinion, the financial statements give a true and fair view of the Group’s and the parent company’s financial position as of December 31, 2019, and of the results of the Group’s and the We recommend that the Annual Report be approved at the Annual General Meeting. Søborg, March 12, 2020 Executive Management Emmanuel Dulac President and Chief Executive Officer Matthew Douglas Dallas Senior Vice President and Chief Financial Officer Adam Sinding Steensberg Executive Vice President, Research & Development, and Chief Medical Officer Board of Directors Alf Gunnar Martin Nicklasson Chairman Kirsten Aarup Drejer Vice Chairman Jeffrey Berkowitz Board member Bernadette Connaughton Board member Leonard Kruimer Board member Alain Munoz Board member Michael John Owen Board member Hanne Heidenheim Bak Board member Employee elected Jens Peter Stenvang Board member Employee elected

 

 

 

 

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102 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 102 Independent Basis for opinion We conducted our audit in accordance with Interna-tional Standards on Auditing (ISAs) and the additional requirements applicable in Denmark. Our responsi-bilities under those standards and requirements are further described in the Auditor’s responsibilities for the audit of the consolidated financial statements and the parent financial statements section of this auditor’s report. We are independent of the Group in accordance with the International Ethics Standards Board of Accountants' Code of Ethics for Professional Accountants (IESBA Code) and the additional require-ments applicable in Denmark, and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit evi-dence we have obtained is sufficient and appropriate to provide a basis for our opinion. To the shareholders of Zealand Pharma A/S auditor’s report Opinion We have audited the consolidated financial state-ments and the parent financial statements of Zealand Pharma A/S for the financial year January 1 – De-cember 31, 2019 which comprise the income state-ment, statement of comprehensive income, state-ment of financial position, statement of changes in equity, statement of cash flows and notes, including a summary of significant accounting policies, for the Group as well as for the Parent. The consolidated financial statements and the parent financial state-ments are prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional requirements of the Danish Financial Statements Act. To the best of our knowledge and belief, we have not provided any prohibited non-audit services as referred to in Article 5(1) of Regulation (EU) No 537/2014. In our opinion, the consolidated financial statements and the parent financial statements give a true and fair view of the Group’s and the Parent’s financial position at December 31, 2019, and of the results of their operations and cash flows for the financial year January 1 – December 31, 2019 in accordance with International Financial Reporting Standards as adopted by the EU and additional requirements of the Danish Financial Statements Act. We were first appointed auditors of Zealand Pharma A/S on April 29, 2014 for the financial year 2014. We have been reappointed annually by decision of the general meeting for a total contiguous engagement period of six years up to and including the financial year 2019. Our opinion is consistent with our audit book com-ments issued to the Audit Committee and the Board of Directors.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 103 Refer to notes 1, 2 and 23 in the consolidated finan-cial statements. Key audit matters Key audit matters are those matters that, in our pro-fessional judgement, were of most significance in our audit of the consolidated financial statements and the parent financial statements for the financial year January 1 – December 31, 2019. These matters were addressed in the context of our audit of the consol-idated financial statements and the parent financial statements as a whole, and in forming our opinion thereon, and we do not provide a separate opinion on these matters. the market price. For the lead target, the agreement provides the potential for development-related milestones of up to USD 115 million, as well as up to USD 495 million in sales-related milestones and the potential for high single-to low double-digit royalty payments. We have identified this transaction as a key audit matter as there is significant accounting judgement taken by Management regarding the initial account-ing for this transaction and as this is a significant transaction that is out of the scope of the normal business undertaken by Zealand Pharma A/S. Management has allocated the non-refundable up-front fee to the combined license and research and development services and is recognized as revenue along with provision of the research and develop-ment services under the lead program. Expenses incurred to provide the services are recognized when incurred. Further, the premium over the market share price on the Zealand Pharma A/S shares subscribed by Alexion, DKK 12.7 million, is attributed to the agreement as further consideration and consequent-ly also recognized over the period over which the research and development services are provided. How the matter was addressed in the audit Based on our risk assessment procedures focused on the Group’s business process and internal controls for significant unusual transactions during the year, we tested the appropriateness of the recognition and disclosures related to the transaction. We read the Collaboration Agreement as well as Management’s accounting memo and discussed it with Manage-ment and evaluated the related accounting treatment including disclosures. We obtained Management’s calculation of the accounting impact of the transac-tion and evaluated the validity of the calculation by testing the accuracy and completeness of the inputs to such calculation. Collaboration Agreement with Alexion Pharmaceuticals, Inc. On March 20, 2019 Zealand Pharma A/S entered into a Collaboration Agreement with Alexion Phar-maceuticals, Inc. (“Alexion”). Under the terms of the agreement, Alexion and Zealand Pharma A/S entered into an exclusive collaboration for the discovery and development of subcutaneously delivered peptide therapies directed to up to four complement path-way targets. Zealand Pharma A/S leads the joint discovery and research efforts through the preclinical stage and Alexion leads development efforts begin-ning with Investigational New Drug filing and Phase 1 studies. The agreement provides Alexion with exclu-sive worldwide licenses and commercial rights to the peptide therapies developed in the collaboration. In total for the year ended December 31, 2019, Alexion has paid USD 40 million (DKK 262.9 million) that has affected equity by DKK 85.6 million from the equity investment excluding the additional premi-um and deferred revenue by DKK 177.3 million. Of this DKK 177.3 million of initially deferred revenue at the time of the transaction in March 2019, DKK 37.4 million of Revenue has been recognized for the year ended December 31, 2019, and DKK 139.9 million remains recorded in Deferred Revenue as of Decem-ber 31, 2019. Statement on the Management review Management is responsible for the Management review. Our opinion on the consolidated financial statements and the parent financial statements does not cover the Management review, and we do not express any form of assurance conclusion thereon. Zealand Pharma A/S received a non-refundable up-front fee of USD 25 million for the first target and Alexion made a concurrent USD 15 million equity investment in Zealand Pharma A/S at a premium to

 

 

 

 

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104 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 104 the economic decisions of users taken on the basis of these consolidated financial statements and these parent financial statements. In connection with our audit of the consolidated financial statements and the parent financial state-ments, our responsibility is to read the Management review and, in doing so, consider whether the Man-agement review is materially inconsistent with the consolidated financial statements and the parent fi-nancial statements or our knowledge obtained in the audit or otherwise appears to be materially misstated. solidated financial statements and parent financial statements that are free from material misstatement, whether due to fraud or error. As part of an audit conducted in accordance with ISAs and the additional requirements applicable in Denmark, we exercise professional judgement and maintain professional scepticism throughout the audit. We also: In preparing the consolidated financial statements and the parent financial statements, Management is responsible for assessing the Group’s and the Parent’s ability to continue as a going concern, for disclosing, as applicable, matters related to going concern, and for using the going concern basis of accounting in preparing the consolidated financial statements and the parent financial statements unless Management either intends to liquidate the Group or the Entity or to cease operations, or has no realistic alternative but to do so. Moreover, it is our responsibility to consider whether the Management review provides the information required under the Danish Financial Statements Act. • Identify and assess the risks of material misstate-ment of the consolidated financial statements and the parent financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrep-resentations, or the override of internal control. Based on the work we have performed, we conclude that the Management review is in accordance with the consolidated financial statements and the parent financial statements and has been prepared in ac-cordance with the requirements of the Danish Finan-cial Statements Act. We did not identify any material misstatement of the Management review. Auditor's responsibilities for the audit of the consolidated financial statements and the parent financial statements Our objectives are to obtain reasonable assurance about whether the consolidated financial statements and the parent financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and the additional requirements applicable in Denmark will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggre-gate, they could reasonably be expected to influence Management's responsibilities for the consolidated financial statements and the parent financial statements Management is responsible for the preparation of consolidated financial statements and parent fi-nancial statements that give a true and fair view in accordance with International Financial Reporting Standards as adopted by the EU and additional re-quirements of the Danish Financial Statements Act, and for such internal control as Management deter-mines is necessary to enable the preparation of con-• Obtain an understanding of internal control rele-vant to the audit in order to design audit proce-dures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group’s and the Parent’s internal control. • Evaluate the appropriateness of accounting pol-icies used and the reasonableness of accounting estimates and related disclosures made by Man-agement.

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 105 statements of the current period and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation pre-cludes public disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our re-port because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. • Conclude on the appropriateness of Management’s use of the going concern basis of accounting in preparing the consolidated financial statements and the parent financial statements, and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's and the Parent’s ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the consolidat-ed financial statements and the parent financial statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor’s report. However, future events or condi-tions may cause the Group and the Entity to cease to continue as a going concern. • Obtain sufficient appropriate audit evidence re-garding the financial information of the entities or business activities within the Group to express an opinion on the consolidated financial statements. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our audit opinion. We communicate with those charged with govern-ance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in in-ternal control that we identify during our audit. We also provide those charged with governance with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, related safeguards. Copenhagen, March 12, 2020 Deloitte Statsautoriseret Revisionspartnerselskab Business Registration No 33 96 35 56 • Evaluate the overall presentation, structure and content of the consolidated financial statements and the parent financial statements, including the disclosures in the notes, and whether the consoli-dated financial statements and the parent financial statements represent the underlying transactions and events in a manner that gives a true and fair view. From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consol-idated financial statements and the parent financial Sumit Sudan State-Authorized Public Accountant MNE no mne33716 Kåre Valtersdorf State-Authorized Public Accountant MNE no mne34490

 

 

 

 

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106 Zealand Pharma ∞ Annual Report 2019 Zealand Pharma ∞ Annual Report 2019 106 Other information

 

 

 

 

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Zealand Pharma ∞ Annual Report 2019 107 Sources Company information Zealand Pharma A/S Sydmarken 11 2860 Søborg Denmark Transforming Peptides Congenital hyperinsulinism 1 J. Lau and M. Dunn, Therapeutic peptides: Historical perspectives, current devel-https://www.orpha.net/consor/cgi-bin/ (not including transient cases due to perinatal stress or diabetic mother) Congenital Hyperinsulinism International. Available at: http://congenitalhi.org Thornton PS et al., J Pediatr. 2015;167(2):238-45 Meissner T et al., Long-term follow-up of 114 patients with congenital hyper-insulinism. Eur J Endocrinol 2003;149:43-510 Yorifuji et al. Pediatrics International 2014;56:467 Eljamel et al. Orphanet Journal of Rare Diseases 2018;13:123 1 opment trends, and future directions. Bioorganic & Medicinal Chemistry, version 26, issue 10, 1 June 2018, p. 2700-2707 2 3 4 CVR no.: 20 04 50 78 Pipeline Overview 1 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 366m in outstand-ing milestones Partnered with Boehringer Ingelheim. Zealand eligible for EUR 283m in outstand-ing milestones Partnered with Aexion Pharmaceuticals. Zealand eligible for USD 610m in out-standing milestones Acquired with Encycle Therapeutics 5 Tel: +45 88 77 36 00 Fax: +45 88 77 38 98 6 2 Automated diabetes management Zealand Pharma U.S., Inc. 434 W 33rd Street PH Floor New York, NY 10001 3 ¹ 2 ADA Section 8 2017: p71A ADA Section 6 2017: p60C; p61A Nicole C. Foster, et al, and for the T1D Exchange Clinic Network. Diabetes Technology & Therapeutics. Feb 2019. 4 3 Severe hypoglycemia info@zealandpharma.com www.zealandpharma.com ¹ 2 Kalra 2013, UK Hypoglycemia Study Group American Diabetes Association, diabetes.org cdc.gov and diabetes.org and www.diabetesselfmanagement.com/diabetes-resources/tools-tech/insulin-pumps National Diabetes Statistics Report. CDC. 2014 Company announcement No. 23/2018, Zealand Pharma achieves primary and key secondary endpoints in pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia Company announcement No. 15/2019, Zealand Pharma achieves primary and key secondary endpoints in second pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia Company announcement No. 35/2019, Zealand Pharma achieves primary and key secondary endpoints in pediatric Phase 3 trial with dasiglucagon for severe hypoglycemia Short bowel syndrome ¹ 2 Pironi L et al. Clin Nutr 2016;352:247–307 Jeppesen P. Expert Opinion Orphan Drugs 2013;1:515–25 Bielawska B. Nutrients 2017;9:466–60 Transparency Market Research; Short Bowel Syndrome Market, 2017 Torres C. Current Paediatr 2006;16:291–7; Bielawska B. Nutrients 2017;9:466–79; Pironi L et al. Clin Nutr 2016;352:247–307; Hofstetter S et al. Curr Med Res Opin 2013;29:495–504 3 Established April 1, 1997 3 4 4 5 5 Registered office Gladsaxe 6 Auditors Deloitte Statsautoriseret Revisionspartnerselskab CVR no.: 33 96 35 56 Obesity/Type 2 diabetes 7 ¹ 2 Company announcement No. 29/2019, September 3, 2019 Skarbaliene, J., Pagler, T., Eickelmann, P., and Just, R. Anti-obesity effects of the novel long-acting amylin analogue ZP4982 in high-fat diet fed rats. Poster, the American Diabetes Association’s (ADA) 76th Scientific Sessions, New Orleans, 2016

 

 

 

 

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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 www.zealandpharma.com Design and production: Noted Photos: Jesper Westley