Zealand Pharma Announces Full Year Results for 2022

Company announcement – No. 1 / 2023

Zealand Pharma Announces Full Year Results for 2022

• Successful organizational transformation and progress across the R&D pipeline
• Two regulatory submissions anticipated in programs targeting rare diseases
• Strong momentum within obesity portfolio with key data expected during 2023

Copenhagen, Denmark March 2, 2023 – Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced financial results for the 12-month period from January 1 to December 31, 2022 and provided a corporate update.

Organizational transformation and progress across the pipeline

Adam Steensberg, President and Chief Executive at Zealand Pharma said: "We are proud of the exceptional progress Zealand made last year. In 2022, we changed strategy to focus on our core peptide R&D expertise, secured partnerships for our marketed products, and achieved key milestones across our clinical pipeline.

"2023 looks to be a very exciting year for Zealand. We have three key strategic objectives focused on maximizing the value potential of our pipeline. Firstly, we are progressing our two rare disease assets towards regulatory submissions later in the year. Secondly, for the obesity portfolio we expect significant progress across all four assets. Specifically, Boehringer Ingelheim is planning to share the results of the Phase 2 obesity trial of BI 456906 in the coming months, while engaging in parallel with Health Authorities to discuss plans for Phase 3. Finally, we are actively engaging in partnership discussions aligned with our change in strategy.”

Financial results for the full year 2022

• Revenue: DKK 104.0 million (DKK 108.5 million in the year 2021).
• Net operating expenses: DKK -941.1 million (DKK -881.9 million in the year 2021).
• Net operating result: DKK -837.2 million (DKK -784.3 million in the year 2021).
• Net financial items: DKK -88.3 million (DKK 25.4 million in the year 2021).
• Net result from Discontinued Operations: DKK -236.5 million (DKK -263.2 million in the year 2021).
• Cash, cash equivalents, and marketable securities: DKK 1,117.8 million as of December 31, 2022 (December 31, 2021: DKK 1,428 million).
• Under current planning assumptions, Zealand projects its existing capital resources will be sufficient to fund operations until the middle of 2024.

Financial guidance

R&D events in 2023

Rare Diseases

• Dasiglucagon in congenital hyperinsulinism (CHI). In the first half of 2023, Zealand expects to submit a new drug application (NDA) to the FDA for dasiglucagon treatment in the management of CHI based on data from the full Phase 3 program that comprises two completed randomized trials and a long-term extension trial that is ongoing.
• Glepaglutide, a long-acting GLP-2 analog in short bowel syndrome (SBS). Results from the EASE-1 Phase 3 trial in SBS patients with intestinal failure have been accepted for presentation at scientific conferences in the first half of 2023. The EASE-2 and EASE-3 long-term safety and efficacy extension trials are ongoing, with the first interim data expected in the first half of the year as the company decided to include analysis from at least 24 weeks of treatment from EASE-2. In addition, EASE-4, assessing long-term effects of glepaglutide on intestinal fluid and energy uptake is also expected to read out in the first half of the year. Based on data from the full EASE clinical trial program, Zealand anticipates submitting an NDA to the FDA in the second half of 2023 for glepaglutide administered via autoinjector for the treatment of SBS.

Obesity

• BI 456906, a novel glucagon/GLP-1 receptor dual agonist (co-invented with Boehringer Ingelheim). In December 2022, Boehringer Ingelheim completed a Phase 2, randomized, double blind, dose-finding clinical trial of BI 456906 compared with placebo in people living with overweight/obesity (BMI = 27 kg/m²) without type 2 diabetes (NCT04667377). The primary endpoint of this trial is the percentage change in body weight at week 46 compared with placebo. Boehringer Ingelheim is planning to share the results of the trial with the scientific community in the coming months. Boehringer Ingelheim is engaging in parallel with Health Authorities to discuss plans for Phase 3 trials for people living with overweight/obesity.
• Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist. A Phase 2 investigator-led clinical trial in people with obesity, named DREAM, to be conducted in collaboration with Zealand is expected to begin in the first half of 2023. The DREAM trial aims to gain key mechanistic insights into the effects of dapiglutide in patients, with data expected in 2024. Separately, in the second half of 2023, Zealand expects to initiate a 13-week dose titration trial in people with obesity.
• ZP8396, a long-acting amylin analog. Zealand is evaluating ZP8396 in Phase 1 clinical trials. The company anticipates presenting full results from the single ascending dose (SAD) study (NCT05096598) at a scientific congress in the first half of 2023. In the second half of the year, Zealand expects to report topline results from the ongoing 6-week multiple ascending dose (MAD) trial (NCT05613387) and initiate a 16-week dose titration trial.
• ZP6590, a long-acting GIP analog. Zealand anticipates advancing ZP6590 into a Phase 1 SAD trial in healthy volunteers in the second half of 2023.

Type 1 Diabetes

• ZEGALOGUE® (dasiglucagon) for injection. Under the global license and development agreement with Novo Nordisk for Zegalogue®, Zealand is responsible submitting a marketing authorization application (MAA) to the European Medicines Agency (EMA), planned for the first half of 2023.
• Dasiglucagon for Bihormonal Artificial Pancreas (BHAP) systems. Zealand anticipates that Beta Bionics, developer of the investigational Bihormonal iLet® Bionic Pancreas (iLet Duo™), a pocket-sized, dual chamber (insulin and glucagon), autonomous, glycemic control system, will begin the Phase 3 program using dasiglucagon in 2023.

Chronic Inflammatory Disease

• ZP10068, a complement inhibitor. Zealand and Alexion are collaborating on the discovery and development of novel peptide therapies for complement-mediated diseases. In 2023, Zealand expects to complete activities to support advancing ZP10068 into clinical studies. All subsequent regulatory, clinical, and development efforts will be led and conducted by Alexion.

Conference call today at 2 PM CET / 8 AM ET

Zealand’s management will host a conference call today at 2:00 PM CET / 8:00 AM ET to present results for the full year of 2022 and a corporate update followed by a Q&A session. Participating in the call will be Chief Executive Officer Adam Steensberg, Chief Medical Officer David Kendall, and Chief Financial Officer Henriette Wennicke. The conference call will be conducted in English.

Telephone dial-in information and a unique personal access PIN will be provided upon registration at https://register.vevent.com/register/BIc83adcda8b8640ceb3000bb438e603f5. A live listen-only audio webcast of the call, including an accompanying slide presentation, will be accessible at https://edge.media-server.com/mmc/p/zgyjh28r. Participants are advised to register for the call or webcast approximately 10 minutes before the start. A recording of the event will be available following the call on the Investor section of Zealand’s website at https://www.zealandpharma.com/events-cal.

Total number of shares and voting rights in Zealand Pharma A/S as of December 30, 2022

Number of shares (nominal value of DKK 1 each): 51,702,098 which is an increase of 8,067,956 from 43,634,142 as reported on December 30, 2021.

Therefore, the current share capital is (nominal value in DKK): 51,702,098.

Number of voting rights: 51,702,098.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with several pharma companies as well as commercial partnerships for its marketed products.

Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the U.S. that includes Boston. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

Safe Harbor / Forward-Looking Statements

This press release and interim report contains "forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company’s preclinical and clinical trials and the reporting of data therefrom and the company’s Upcoming Events and Financial Guidance for 2022. These forward-looking statements may be identified by words such as "aim,” "anticipate,” "believe,” "could,” "estimate,” "expect,” "forecast,” "goal,” "intend,” "may,” "plan,” "possible,” "potential,” "will,” "would” and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems; unexpected growth in costs and expenses; our ability to effect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty, including due to the ongoing military conflict in Ukraine. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this press release/company announcement and are based on information available to Zealand Pharma as of the date of this release/announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.

Zegalogue® is a registered trademark of Novo Nordisk A/S.

Contacts:
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: ank@zealandpharma.com 

Attachments

• 20220302-Zealand_Pharma-2022-Annual_Report
• 549300ITBB1ULBL4CZ12-2022-12-31-en