UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
March 11, 2021
Commission File Number: 001 - 38178
Zealand Pharma A/S
(Exact Name of Registrant as Specified in Its Charter)
Sydmarken 11
2860 Søborg (Copenhagen)
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ¨ Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ¨
Furnished as Exhibit 99.1 to this Report on Form 6-K is a company announcement of Zealand Pharma: on Track for Potential First Product Launch and Establishing Commercial Operations in the United States
Furnished as Exhibit 99.2 to this Report on Form 6-K is the Company’s slide presentation for the full year 2020 report
Exhibits 99.1 and 99.2 to this report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, or the Securities Act, or the Exchange Act.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Zealand Pharma A/S | |||
By: | /s/ Matthew Dallas | ||
Name: | Matthew Dallas | ||
Title: | Chief Financial Officer |
Date: March 11, 2021
2 |
EXHIBIT INDEX
Exhibit No. |
Description | |
99.2 | Full year 2020 report slide deck |
3 |
Exhibit 99.1
Company announcement – No. 12 / 2021
Zealand Pharma: on Track for Potential First Product Launch and Establishing Commercial Operations in the United States
Full Year Results for 2020
Copenhagen, March 11, 2021 – Zealand Pharma A/S (“Zealand”) (NASDAQ: ZEAL) (CVR-no. 20 04 50 78), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, announced financial results for the 12-month period from January 1 to December 31, 2020.
In 2020, a number of significant milestones were achieved by Zealand Pharma, including filing the company’s first New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the dasiglucagon auto-injector and pre-filled syringe and establishing a commercial organization in the U.S. through the integration of staff and assets from the Valeritas acquisition and the hiring of key external talent. With the growth, Zealand’s total number of employees has increased by approximately 50%. In addition, the company continues to progress on the early and late-stage clinical pipeline and strengthened its balance sheet by securing a total of DKK 795 million in private placements.
Financial results for the full year 2020
· | Revenue of DKK 353.3 million / USD 54.2 million (2019: DKK 41.3 million / USD 6.2 million). |
· | Net operating expenses of DKK 1,092.1 million / USD 166.9 million (2019: DKK 629.3 million / USD 94.2 million). |
· | Operating result for the year of DKK -792.4 million / USD -121.1 million (2019: DKK -587.9 million / USD -88.1 million). |
· | Cash including marketable securities amounted to DKK 1,257.6 million / USD 192.2 million at year-end (2019: DKK 1,380.5 million / USD 206.8 million). |
Business highlights and updates for Q4 2020 and the period thereafter
· | Dasiglucagon auto-injector and pre-filled syringe for severe hypoglycemia: Strengthened US commercial operations and continued to progress commercial launch readiness ahead of potential FDA approval. |
· | Announced data from first Phase 3 trial for dasiglucagon in congenital hyperinsulinism (CHI). |
· | Dapiglutide for the treatment of Short Bowel Syndrome: Dosed first patients in phase 1b multiple ascending dose study. |
· | Strengthened the US commercial model by adding robust business analytics capabilities and a modernized digital and virtual marketing mix. |
· | In January of 2021, secured a total of gross DKK 749.0 million through a direct issue and private placement of approximately 4.0 million new shares to institutional and professional investors, including participation from the CEO and CFO of Zealand Pharma. |
· | In March of 2021 the company hosted a virtual R&D day and Q&A session focusing on the company’s R&D strategy, peptide platform and early and late-stage clinical portfolio. |
Emmanuel Dulac, President and Chief Executive Officer at Zealand Pharma, comments:
“2020 was a pivotal year for Zealand Pharma as transformed from a research and development-focused organization to a fully integrated commercial biopharmaceutical company. We continue to progress our late-stage clinical pipeline across both our metabolic and gastrointestinal franchises and to advance our early-stage pipeline. We are on schedule with our US launch readiness activities in preparation for a potential FDA approval later this month and we are targeting the commercial launch of dasiglucagon auto-injector and pre-filled syringe for severe hypoglycemia in late June.”
“None of this would be possible without the support of the healthcare community, the patients enrolled in our clinical trials and the dedication and resilience of our employees. Their commitment to our mission has been exceptional this past year, overcoming the challenges presented by COVID-19. Amid a global pandemic, the Zealand team accomplished our strategic objectives of building our own commercial organization in the U.S. while continuing industry-leading research and development. I am proud of what the team has done and look forward to what we will accomplish together in 2021 and beyond.”
Financial guidance
In 2021, Zealand Pharma expects net product revenue from the sales of its commercial products of DKK 220 million +/-10% compared to 2020 of DKK 161.3 million.
In 2021, Zealand Pharma expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, Zealand Pharma does not intend to provide guidance on such revenue.
Net operating expenses in 2021 are expected to be DKK 1,250 million +/-10% compared to 2020 of DKK 1,092.1 million.
Pipeline
Zealand Pharma is a world leader in peptide drug discovery and design, building upon 20 years of experience in understanding and exploiting peptide design. If approved by the FDA, the dasiglucagon auto-injector and pre-filled syringe could become the first dasiglucagon-based medicine made available to people with severe hypoglycemia. Zealand is also developing dasiglucagon in congenital hyperinsulinism (CHI) and announced data from the first Phase 3 trial in the program, trial 17109, in December 2020. This trial evaluated children from 3 months to 12 years old with more than three hypoglycemic events per week despite previous near-total pancreatectomy and/or maximum medical therapy. Dasiglucagon on top of standard of care (SOC) did not significantly reduce the rate of hypoglycemia compared to SOC alone when assessed by the primary endpoint, intermittent self-measured plasma glucose. However, hypoglycemia was reduced by 40–50% with dasiglucagon as compared to SOC alone when assessed by blinded continuous glucose monitoring. Dasiglucagon treatment was assessed to be well tolerated in the study and 31 out of 32 patients continued into the long-term extension study.
Zealand is conducting additional analyses and engaging with regulatory authorities to discuss the results of 17109 while awaiting the outcome of a second Phase 3 trial in neonates up to 12 months old with CHI. The Company also plans to initiate a Phase 2 study in 2021 evaluating a low dose of dasiglucagon administered by a pen in people with Type 1 diabetes as a non-caloric alternative to manage plasma glucose.
Zealand is collaborating with Beta Bionics on the iLet® bionic pancreas device, which also uses dasiglucagon, and the companies plan to initiate a pivotal Phase 3 trial in the second half of 2021, which will consist of one pivotal trial in adults with Type 1 diabetes (T1D) and one pivotal trial in children with T1D. Approximately 350 adults and 350 children will be randomized into the trials. The primary outcome measure is superiority on HbA1c of the bihormonal iLet configuration using dasiglucagon over the insulin only iLet configuration at week 26.
In addition, Zealand is broadening its pipeline of metabolic therapies to also target obesity and non-alcoholic steatohepatitis (NASH). Alongside partner Boehringer Ingelheim (BI), Zealand progressed the clinical development of BI-456909 in 2020 with the initiation of a Phase 2 trial in type 2 diabetes and obesity and has plans to also pursue development in NASH.
Zealand also made progress in the clinical development of its gastrointestinal program, with Short Bowel Syndrome (SBS) as the foundation of this franchise. Though COVID-19 impacted patient recruitment for the Phase 3 trial of glepaglutide in SBS, the trial continues to enroll patients. EASE-SBS 1 is the pivotal Phase 3 trial with a planned enrolment of 129 patients with SBS. They will be treated for six months whereafter they are offered a further 2-year treatment with glepaglutide in an extension trial, EASE-SBS 2. The primary endpoint is the absolute reduction in parenteral support achieved by the end of the trial, with results expected in 2022.
The Company also completed the first Phase 1 trial for dapiglutide, a potential next generation of SBS treatment, and initiated another Phase 1 multiple-ascending dose trial. This ongoing trial is evaluating once-weekly doses of dapiglutide and Zealand is currently at the second dose level with results of this trial expected later this year.
In its early pipeline, Zealand regained the worldwide rights to the amylin-analog program from BI, and the Company expects to start clinical development for this program in 2021. The Company’s continued collaboration with Alexion Pharmaceuticals is focused on preventing the detrimental effects of overactive C3 function in patients with complement driven diseases such as C3G, and the companies will look to initiate a Phase 1 trial of their C3 inhibitor in 2022.
In Zealand’s GIP-program, which has potential for development in multiple major diseases and comprises mono-, dual-, and triple-agonists, the company selected the lead molecule and progressed towards clinical development while also progressing its Alpha4Beta7-program, which has the potential to provide Zealand’s first-ever oral peptide therapeutic, and a Kv1.3 ion channel blocker toward Phase 1 initiation.
Zealand Pharma’s Annual Report 2020
This announcement is a summary and is qualified by, and should be read in conjunction with, Zealand’s Annual Report for 2020, published on March 11, 2021. A PDF version of the Annual Report will be available for download from Zealand’s website.
Conference call March 11, 2021, at 4:00 PM CET (10:00 AM EDT)
Zealand’s management will host a conference call on March 11, 2021 at 4:00 PM CET (10:00 AM EDT) to present the full-year results and the Annual Report for 2020. Presenting during the call will be President and Chief Executive Officer Emmanuel Dulac, Senior Vice President and Chief Financial Officer Matt Dallas, and Executive Vice President and Chief Medical Officer Adam Steensberg. The presentation will be followed by a Q&A session.
The conference call will be conducted in English, and the dial-in numbers are:
Denmark, Copenhagen | +45 32 72 04 17 |
United Kingdom | +44 (0) 844 481 9752 |
United States | +1 646 741 3167 |
France, Paris | +33 (0) 170 700 781 |
Netherlands, Amsterdam | +31 (0) 207 956 614 |
Confirmation Code: | 3077735 |
A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, https://edge.media-server.com/mmc/p/7daetm5k, also accessible from the Investor section of Zealand’s website (www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the start.
A recording of the event will be available on the Investor section of Zealand’s website following the call.
For further information, please contact:
Zealand Pharma Investor Relations
Maeve Conneighton
Argot Partners
investors@zealandpharma.com
Zealand Pharma Media Relations
David Rosen
Argot Partners
media@zealandpharma.com
NOTE: Exchange rates used: 31 Dec 2020 = 6.54 and 31 Dec 2019 = 6.67
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s robust pipeline of investigational medicines includes three candidates in late stage development, and one candidate being reviewed for regulatory approval in the United States. Zealand markets V-Go®, an all-in-one basal-bolus insulin delivery option for people with diabetes. License collaborations with Boehringer Ingelheim and Alexion Pharmaceuticals create opportunity for more patients to potentially benefit from Zealand-invented peptide therapeutics. Zealand was founded in 1998 in Copenhagen, Denmark, and has presence throughout the U.S. that includes key locations in New York, Boston, and Marlborough (MA). For more information about Zealand’s business and activities, please visit www.zealandpharma.com.
Forward-Looking Statements
This announcement may contain forward-looking statements, including “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, that are based on the beliefs and assumptions and on information currently available to management of Zealand, including with respect to the company’s anticipated revenue and expenses for 2021 and potential product approval by the FDA. All statements other than statements of historical fact contained in this announcement are forward-looking statements, including statements regarding the anticipated final terms of the Investment. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Zealand's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Zealand's Annual Report on Form 20-F for the year ended December 31, 2019 filed with the SEC on March 13, 2020 and subsequent reports that Zealand has filed or will file with the SEC. Forward-looking statements represent Zealand's beliefs and assumptions only as of the date of this announcement. Although Zealand believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, Zealand assumes no obligation to publicly update any forward-looking statements for any reason after the date of this announcement to conform any of the forward-looking statements to actual results or to changes in its expectations.
Exhibit 99.2
Full Year 2020 Report Zealand Pharma 11 March 2021
Forward - looking statements • This presentation contains information pertaining to Zealand Pharma A/S (“Zealand”). Neither Zealand nor its management, dire cto rs, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the information contained in this presentation or any other information transmitted or made available to the viewer or recipient her eof, whether communicated in written or oral form. • This presentation does not constitute or form part of, and should not be construed as, an offer to sell or issue or the solic ita tion of an offer to buy or acquire Zealand securities, in any jurisdiction, or an inducement to enter into investment activity, nor shall there b e any sale of Zealand securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registratio n or qualification under the securities laws of any such state or jurisdiction. No part of this presentation, nor the fact of its distribution, sho uld form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. • This presentation contains forward - looking statements that reflect management’s current views with respect to Zealand’s product candidates’ development, clinical and regulatory timelines and anticipated results, market opportunity, potential financial perf ormance and other statements of future events or conditions. Although Zealand believes that the expectations reflected in such forward - looki ng statements are reasonable, no assurance can be given that such expectations will prove to have been correct. Accordingly, result s could differ materially from those set out in the forward - looking statements as a result of various factors, many of which are beyond Zealand’s control. No reliance should be made on such forward - looking statements. • Zealand does not intend to update the presentation, including the forward - looking statements contained therein, following distri bution, beyond what is required by applicable law or applicable stock exchange regulations if and when circumstances arise that lead to changes compared to the date when these statements were provided. 11 March 2021 FY 2020 presentation 2
Established Commercial Operations Ahead of Potential Product Launch And Continued To Advance Pipeline 3 Business highlights for Q4 2020 and subsequent events • Dasiglucagon auto - injector and pre - filled syringe for severe hypoglycemia: Strengthened US commercial operations and continued to progress commercial launch readiness ahead of potential FDA approval. • Announced data from first Phase 3 trial for dasiglucagon in congenital hyperinsulinism (CHI). • Dapiglutide for the treatment of Short Bowel Syndrome: Dosed first patients in phase 1b multiple ascending dose study. • Strengthened the US commercial model by adding robust business analytics capabilities and a modernized digital and virtual marketing mix. • In January of 2021, secured a total of gross DKK 749.0 million through a direct issue and private placement of approximately 4.0 million new shares to institutional and professional investors, including participation from the CEO and CFO of Zealand Pharma. • In March of 2021 the company hosted a virtual R&D day and Q&A session focusing on the company’s R&D strategy, peptide platform and early and late - stage clinical portfolio. 11 March 2021 FY 2020 presentation
Zealand Pharma is facing an exciting 2021 4 Launch Dasiglucagon Auto - Injector & Prefilled Syringe and optimize commercialization Advance our early pipeline Execute launch readiness program for Dasiglucagon Auto - Injector and Prefilled Syringe Launch Dasiglucagon Auto - Injector & Prefilled Syringe (assuming NDA approval in March 2021) Deliver on net revenue target for Dasiglucagon Auto - Injector and Prefilled Syringe Deliver on net revenue target for V - Go TM Execute on clinical pipeline Dasiglucagon Auto - Injector and Prefilled Syringe: Potential NDA approval from U.S. FDA – PDUFA date 27 March Dasiglucagon for dual - hormone artificial pancreas pump: Initiate Phase 3 study Dasiglucagon for congenital hyperinsulinism: Deliver second phase III in 2021 and prepare NDA/MAA for execution in 2022 – ongoing Glepaglutide for short bowel syndrome: Continue patient enrolment in Phase 3 study – ongoing Dapiglutide for short bowel syndrome: Complete MAD Phase 1 program Advance pre - clinical drug candidates towards Phase 1 initiation Initiate new pre - clinical projects Develop our next generation peptide platform Maintain a strong financial and organizational position Secured a total of DKK gross 749.0 million through a direct issue and private placement of new shares – January 2021 Ensure disciplined financial management and productive investments Focus company on operational performance and organizational health 11 March 2021 FY 2020 presentation
5 Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed Dasiglucagon Auto - Injector and Prefilled Syringe Dasiglucagon S.C. Continuous Infusion Dasiglucagon Bi - Hormonal Artificial Pancreas Pump Dasiglucagon Adjustable Mini - Dose BI 456906 GLP - 1/GLU Dual Agonist 1 ZP 8396 Amylin Analog ZP 6590 GIP Agonist Glepaglutide GLP - 2 Analog Dapiglutide GLP - 1/GLP - 2 Dual Agonist ZP 9830 Kv1.3 Ion Channel Blocker ZP 10000 ɑ4 β7 Integrin Inhibitor Complement C3 Inhibitor 2 Type 1 Diabetes management Congenital hyperinsulinism Severe hypoglycemia Short Bowel Syndrome Obesity Obesity SBS+ Undisclosed Obesity/ NASH/T2D IBD+ Metabolic GI & Inflammation PBH/ T1D exercise - induced hypo IBD Significant pipeline evolution and a commitment to continue to deliver 1 Licensed to Boehringer Ingelheim: EUR 345 million outstanding potential development, regulatory and commercial milestones + h ig h single to low double digit % royalties on global sales 2 Licensed to Alexion: USD 610 million potential development, regulatory and commercial milestones + high single to low double digits % royalties on ne t sales 11 March 2021 FY 2020 presentation
6 Trial 17109 – Completed* Trial 17103 - Ongoing Open - label extension study 17106 - Ongoing * Dasiglucagon on top of standard of care (SOC) did not significantly reduce the rate of hypoglycemia compared to SOC alone when assessed by i ntermittent self - measured plasma glucose (primary endpoint). However, hypoglycemia was reduced by 40 – 50% when assessed by blinded continuous glucose monitoring (exploratory analysis). Dasiglucagon treatment was assessed to be safe and well tolerated in the study. 31 out of 32 patients have continued into the long - term extension study Congenital hyperinsulinism 32 patients, age 3 months - 12 years. Trial completed Hypo - prone, maximum therapy, incl. pancreatic surgery 8 weeks of treatment (4 weeks follow - up) 12 patients, age 7 days - 12 months. First patients enrolled; phase 3 trial readout expected in 2021 Newly diagnosed, dependent on IV glucose 25 days of treatment (4 weeks follow - up) Maximum 44 patients, age 1 month onwards Patients from 17109 and 17103 with ongoing positive benefit/risk Allows for long - term data Zealand has a comprehensive Phase 3 program to address the unmet need in CHI 11 March 2021 FY 2020 presentation
7 1 S. Russell et al. 2020. Conference. DIABETES TECHNOLOGY & THERAPEUTICS. Page A - 53. 2 The iLet ® bionic pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale. Phase 2 home - use clinical trial testing the iLet ® bionic pancreas using Dasiglucagon 1 Insulin - Only Bihormonal Mean CGM glucose level 149 mg/dL 139 mg/dL Time spent in range (70 - 180 mg/dL) 71% 79% Mean CGM glucose <154 mg/dL (achieving ADA target for adults) 50% 90% Mean percentage of time CGM glucose < 54 mg/dL 0.6% 0.3% Mean percentage of time CGM glucose < 70 mg/dL 3.6% 2.4% iLet ® bihormonal bionic pancreas (investigational device 2 ) Dasiglucagon 4 mg/ml (investigational) Phase 3 trial initiation expected in H2 2021 based on positive EoP2 meeting with the FDA Glycemic data from phase 2 study supports decision to move to phase 3 with bihormonal bionic pancreas 11 March 2021 FY 2020 presentation
BI 456806, a long - acting GLP - 1 - Glu dual agonist is in Phase 2 as a potential novel treatment of T2D, obesity and NASH 8 Boehringer - Ingelheim is progressing the development of Zealand’s dual agonist BI 456906* Phase 1: PK/safety Japanese HV Phase 1b: MAD Obese/OW; 16 weeks Phase 1a: SAD trial Healthy Volunteers Phase 2: T2D 350 subjects; 16 wks; Glycemic control, BW Phase 2: Obesity 350 subjects; 46 weeks COMPLETED COMPLETED COMPLETED Expected completion Q3 2021 Phase 2: NASH 240 subjects; 48 weeks Sanchez - Garrido MA et al. Diabetologia 2017 * Licensed to Boehringer Ingelheim: EUR 345 million outstanding potential development, regulatory and commercial milestones + h ig h single to low double digit % royalties on global sales Q3 2022 Q1 2023 11 March 2021 FY 2020 presentation
Pre - clinical pipeline in obesity and other metabolic diseases are designed for dual pharmacology Dual agonist (one molecule – two actions) • BI456906 – GLP - 1/Glucagon receptor - agonist 9 Zealand Pharma addresses dual pharmacology from several angles Amylin analog and GIP agonist induce more weight loss in combination with GLP - 1 versus GLP - 1 alone in preclinical obesity model • ZP8396 allows for co - formulation with other peptides, including GLP - 1 and GIP • Once weekly dosing • Phase 1 anticipated in 2021 • ZP6590 allows for co - formulation with other peptides, including amylin and GLP - 1 • Predicted once weekly subcutaneous dosing • In IND enabling toxicology studies Co - formulation or loose combo of mono agonists • ZP8396 – Amylin analog • ZP6590 – GIP receptor - agonist Time (Study days) Body weight (g) 450 500 550 600 650 700 Vehicle GLP-1 analogue ZP Amylin analogue GLP-1 analogue + ZP Amylin analogue 131 4 7 10 16 19 22 25 28 31 34 Start of ZP Amylin analogue treatment Pre-treatment GLP-1 analogue ZP8396, amylin analog alone and in combination with GLP - 1 ZP6590, GIP agonist alone and in combination with GLP - 1 11 March 2021 FY 2020 presentation
10 • Reduction in weekly parenteral support (PS volume) • >20% reduction in PS volume • Reduction in weekly days on PS Trial design Primary and key secondary endpoints • Double - blind, placebo controlled trial in 129 SBS patients evaluating safety and efficacy of once and twice weekly dosing over 24 weeks Glepaglutide – Pivotal Phase 3 trial progressing toward results in 2022 11 March 2021 FY 2020 presentation
11 1 pINN and data on file; 2 IP protection until at least 2037; 3 Madsen et al, Regulatory Peptides 184 (2013) 30 - 39 Dapiglutide 1,2 - Long - acting GLP - 1/GLP - 2 dual agonist Clinical progress Clinical experience with short - term GLP - 1 and GLP - 2 combination treatment in SBS 3 Phase 1a (SAD) • Dapiglutide was concluded to be well - tolerated in single doses up to 7.5 mg • Most common adverse events were nausea, vomiting and decreased appetite • Plasma half - life of approximately 120 hours • Dose - response relationship on gastric emptying and other biomarkers Phase 1b (MAD) • Once - weekly dosing • Second dosing coho rt completed • Full results expected in 2021 GLP - 1 GLP - 2 GLP - 1+GLP - 2 Reduction in fecal output (g/d) 295 ± 326 387 ± 333 503 ± 366 p<0.001 p<0.001 Dapiglutide has potential to treat SBS as well as a wider range of gastrointestinal diseases 11 March 2021 FY 2020 presentation
Pre - clinical pipeline for IBD and other chronic inflammatory diseases • Blockage of Kv1.3 ion channels on T effector memory cells involved in auto - immunity and chronic inflammation • Optimized for selectivity, potency and stability • In preparation for IND enabling toxicology studies 12 ZP9830, Kv1.3 blocker for T cell driven chronic inflammatory diseases incl. IBD ZP10000, an α4β7 integrin inhibitor for oral delivery Complement C3 peptide inhibitor – outlicenced to Alexion • Binding kinetics on par with antibodies • Potential for improved tissue penetration • Formulation for oral administration being optimized • Novel long - acting peptide inhibitor of complement C3 • Attractive target for peptides not addressable by antibodies • Lead molecule half - life extended with improved stability in formulation and excellent binding properties to C3 • USD 610 million potential development, regulatory and commercial milestones + high single to low double digits % royalties on net sales • Concentration - dependent inhibition of pro - inflammatory cytokine release (incl. IFN - g, IL - 2 and IL17A) from stimulated human whole blood* *Data on file. Concentration - dependent effect on pro - inflammatory cytokine release from Thapsigargin stimulated whole blood. **For lengths, cm; for Myeloperoxidase (MPO), units per gram protein. Inflammation score is a composite of observations and r ang es from 0 - 4. Mean ± SEM ***ZP10000 administered QD at 100 mg/kg in lipid - based vehicle via oral gavage to mice. • Oral dosing of ZP10000 reduces colonic lesion & inflammation in pre - clinical IBD disease model*** 11 March 2021 FY 2020 presentation
DKK million FY 2020 FY 2019 Revenue DKK 353.3 DKK 41.3 Gross margin 262.7 40.9 Research and Development expenses - 604.1 - 561.4 Sales and Marketing Expenses - 285.3 0.0 Administrative Expenses - 202.8 - 67.9 Operating result - 792.4 - 587.9 Net financial items - 47.3 11.3 Result before tax - 839.7 - 576.7 Tax - 7.1 5.1 Net result for the period (after tax) DKK - 846.7 DKK - 571.5 Income statement 13 11 March 2021 FY 2020 presentation
14 Net Operating Expenses DKK 1,092.1 million / USD 166.9 million Cash position 1 DKK 1.28 billion / USD 192.2 million 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 2016 2017 2018 2019 2020 R&D expenses G&A expenses Sales & Marketing expenses 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 1,400,000 1,600,000 2016 2017 2018 2019 2020 Cash & cash equivalents Restricted cash Securities DKK/USD exchange rates used: December 31, 2020 = 6.54 and December 31, 2019 = 6.67 DKK thousand DKK thousand Strong balance sheet allows for continued investments 1 Excludes an additional DKK 749 million gross proceeds secured through directed issue in January 2021 FY 2020 presentation
2021 financial guidance • In 2021, Zealand Pharma expects net product revenue from the sales of its commercial products of DKK 220 million +/ - 10% compared to 2020 of DKK 161.3 million. • In 2021, Zealand Pharma expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, Zealand Pharma does not intend to provide guidance on such revenue. • Net operating expenses in 2021 are expected to be DKK 1,250 million +/ - 10% compared to 2020 of DKK 1,092.1 million. 15 DKK million 2020 Guidance 2020 Actual Net operating expenses 950 - 1,000 1,092.1 Net product revenue 150 - 175 161.3 11 March 2021 FY 2020 presentation 2020 financial results vs guidance
2020 was a significant year for Zealand Pharma 16 We are passionate about transforming patients’ lives through peptide innovation and novel treatment solutions 5 commercialized products by 2025 Commercial foundation established Late - stage assets and robust early pipeline Employees License partnerships 5x25 2 4 2020 329 Fully integrated biotech with U.S. commercial presence Boehringer Ingelheim and Alexion Pharmaceuticals Commercial platform in place to launch metabolic and gastrointestinal franchises Three late - stage assets for metabolic diseases, one for GI diseases Offices in Copenhagen, New York, Boston and Marlborough 11 March 2021 FY 2020 presentation
Q&A session • 11 March 2021 FY 2020 presentation 17
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