Zealand Pharma Announces Financial Results for the First Nine Months of 2023

Company announcement - No. 38 / 2023

Zealand Pharma Announces Financial Results for the First Nine Months of 2023

Strong progress across obesity pipeline, first PDUFA date for dasiglucagon in CHI in 2023 and solid financial position

• Boehringer Ingelheim advances GCGR/GLP-1R dual agonist survodutide (BI456906) into Phase 3 trials in obesity
• Zealand presents amylin analog ZP8396 6-week trial results at ObesityWeek and initiates GLP-1R/GLP-2R dual agonist dapiglutide 13-week dose titration trial
• Zealand to host Obesity R&D Event in London on December 5th
• Dasiglucagon for congenital hyperinsulinism granted Priority Review with December 30, 2023 PDUFA date for up to three weeks of dosing; plans to make product available in the US as soon as possible following potential approval
• Revenue recognized for expected milestone payments from existing partnerships of EUR 30 million and USD 10 million respectively, contributing to the solid financial position

Copenhagen, Denmark, November 9, 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 the interim report for the nine months ended September 30, 2023, and provided a corporate update.

Building momentum into 2024

Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said:

“Survodutide advancing into global Phase 3 trials in obesity by Boehringer Ingelheim is a significant step for Zealand. At the same time, I am truly excited about the acceleration we are seeing with our pipeline of wholly owned and differentiated obesity candidates. We look forward to sharing more of the scientific and clinical rationale behind these assets at our Obesity R&D Event on December 5. Finally, we will end this transformative year with a planned NDA submission for glepaglutide in short bowel syndrome and the first PDUFA date for dasiglucagon in congenital hyperinsulinism.”

Key financial results for Q3 2023 year-to-date

Recent highlights

Rare diseases

• Dasiglucagon (CHI): FDA granted a priority review for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing with a Prescription Drug User Fee Act (PDUFA) date on December 30, 2023. The regulatory review will be conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks. Part 2 relates to use beyond three weeks, in support of which the FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets, included as a secondary outcome measure in the Phase 3 program.

Obesity

• Survodutide (BI 456906), a glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced Phase 3 program in people living with overweight or obesity. SYNCHRONIZE™-1 and SYNCHRONIZE™-2 are designed to evaluate survodutide in people living with overweight or obesity without and with type 2 diabetes, respectively. SYNCHRONIZE™-CVOT is a long-term cardiovascular safety trial of survodutide in people living with overweight or obesity with cardiovascular disease, chronic kidney disease or with risk factors for cardiovascular disease. The Phase 3 trials include a longer treatment period (76 weeks) and a higher maximum maintenance dose (6.0 mg) compared with Phase 2.
• ZP8396, a long-acting amylin analog: Presented results at Obesity Week from 6-week MAD trial. In Part 1 of the Phase 1b trial, low doses of up to 1.2 mg ZP8396 administered once weekly for only six weeks led to reductions in body weight of up to 5.3% in healthy lean and overweight participants (mean body weight of 82 kg and BMI of 25.4) and were well tolerated with a mostly mild adverse event profile.
• Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist: Initiated 13-week dose titration trial. The trial is evaluating dapiglutide in healthy overweight or obese participants (eligible BMI 27.0–39.9) and aims to include higher maximum maintenance doses than were used in the prior 4-week MAD trial and the ongoing investigator-led DREAM trial.

Financial

• Solid financial position. Milestone payments from existing partnerships were recognized in the third quarter of 2023, with cash inflow expected in the fourth quarter of 2023, contributing to the company’s solid financial position. These potential milestones include EUR 30 million from Boehringer Ingelheim associated with survodutide and USD 10 million from Sanofi associated with lixisenatide.

Obesity R&D Event for investors and analysts

• Zealand management together with key external experts in the obesity field, Professor Daniel Drucker, Professor Louis Aronne, and Professor Carel Le Roux, will be hosting an Obesity R&D event in London on December 5th to discuss the scientific rationale and clinical potential of the company’s differentiated product candidates. Please visit https://www.zealandpharma.com/event/zealand-pharmas-obesity-rd-event/ to register for this event.

Upcoming events next 12 months

Rare diseases

• Dasiglucagon in CHI. The FDA has granted a December 30, 2023, PDUFA date for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric patients 7 days of age and older with congenital hyperinsulinism (CHI) for up to three weeks of dosing. If approved, Zealand plans to make dasiglucagon available to healthcare professionals and patients in the US as soon as possible. In addition, the company expects to submit Part 2 of the NDA that includes analyses of CGM data to support the use of dasiglucagon in CHI beyond three weeks in the first half of 2024. Zealand continues to engage in partnership discussions for commercialization of the product.
• Glepaglutide in SBS. In the fourth quarter of 2023, Zealand expects to submit an NDA to the FDA for glepaglutide administered via autoinjector for the treatment of short bowel syndrome with intestinal failure and subsequently engage in more detailed partnership discussions.

Obesity

• Survodutide in NASH. Boehringer Ingelheim and Zealand Pharma expect to report topline results from the Phase 2 trial with survodutide in NASH in the first half of 2024.
• Dapiglutide. In the first half of 2024, Zealand anticipates topline results from the ongoing investigator-led DREAM trial that aims to evaluate the potential for weight loss following 12 weeks of treatment and gain key mechanistic insights into the effects of dapiglutide on inflammatory markers. In the second half of 2024, Zealand expects topline results from the 13-week dose titration trial.
• ZP8396, amylin analog. In the first half of 2024, Zealand expects to report topline results from Part 2 of the MAD trial that is evaluating ZP8396 in participants with overweight or obesity (eligible BMI 27.0–39.9), including higher doses compared with Part 1 and over a longer 16-week treatment period.
• ZP6590, GIP analog. Zealand has completed pre-clinical activities to support potential first-in-human clinical trials in 2024.

Chronic inflammation

• ZP10068, Complement Inhibitor. Zealand has completed pre-clinical and CMC activities for the investigational long-acting complement inhibitor. Subsequent regulatory, clinical and development efforts will be led and conducted by Alexion.
• ZP9830, Kv1.3 Ion Channel Blocker. Zealand has completed pre-clinical activities for the Kv1.3 ion channel blocker to support potential first-in-human clinical trials in 2024.

Financial guidance for 2023

• Guidance unchanged from March 2, 2023

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 through the first nine months of 2023 followed by a Q&A session. Participating in the call will be Chief Executive Officer, Adam Steensberg; Chief Financial Officer, Henriette Wennicke; and Chief Medical Officer, David Kendall. The conference call will be conducted in English.

To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BId73e050fc44d47be81015697a873e070. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/b9gpnynv. 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/.

Financial Calendar for 2024

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 a number of 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. For more information about Zealand’s business and activities, please visit www.zealandpharma.com.

Forward-Looking Statements

This company announcement 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 pre-clinical and clinical trials and the reporting of data therefrom and the company’s Upcoming Events and Financial Guidance for 2023. 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.

Zealand Pharma® is a registered trademark of Zealand Pharma A/S.

Contacts:

Attachment

• Zealand Pharma - Q3YTD2023 Interim Report - 20231109