Company announcement - No. 26 / 2024

Zealand Pharma Announces Financial Results for the First Quarter of 2024

Strong performance in the first quarter of 2024 paving the way for important data read-outs across differentiated obesity assets in the second quarter.

• Strong topline results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASH
• PDUFA date for glepaglutide in SBS set by US FDA for December 22, 2024
• PDUFA date for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA) set by US FDA for October 8, 2024
• Cash runway extended into 2027 through private placement of shares to institutional investors in January 2024 for gross proceeds of DKK 1.45 billion

Copenhagen, Denmark, May 16, 2024 – 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 three months ended March 31, 2024, and provided a corporate update.

Strong start to eventful 2024

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

“I am very pleased with the continued advancement of our business in the first months of 2024. Our partner Boehringer Ingelheim reported impressive topline data from the Phase 2 trial with survodutide in MASH and recruitment into the Phase 3 trials in obesity is progressing very well. With our pipeline of wholly owned and differentiated obesity candidates, I am truly excited about the upcoming data read-outs for petrelintide and dapiglutide. In rare diseases, we have potential approvals in the US later in the year for both glepaglutide in short bowel syndrome and dasiglucagon in congenital hyperinsulinism. Backed by a solid financial position, we will continue to invest in our R&D programs, including preparations for comprehensive Phase 2b trials with our differentiated obesity candidates.”

Key financial results for Q1 2024

Notes:      1.   Net operating expenses consist of R&D, S&M, G&A and other operating items.       2.   Cash position includes cash, cash equivalents and marketable securities, as well as Tranche A of EIB loan disbursed in Q1 2024.      3.   RCF = Revolving Credit Facility provided by Danske Bank.        

Highlights in the first quarter 2024

Obesity and MASH

• Survodutide, a glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced positive results from Phase 2 trial in MASH. The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in metabolic dysfunction-associated steatohepatitis (MASH) after 48 weeks without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 18.2% with placebo. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. These results will be presented at the European Association for the Study of the Liver (EASL) congress in Milan, Italy on June 7, 2024.

Rare diseases

• Glepaglutide, GLP-2 analog: US FDA has granted a Prescription Drug User Fee Act (PDUFA) date of December 22, 2024. Zealand’s new drug application (NDA) is for glepaglutide administered twice weekly for the treatment of short bowel syndrome (SBS) with intestinal failure.

Financial

• Solid financial position. Directed share issue of 3,761,740 new shares to two reputable institutional investors through a private placement for gross proceeds of DKK 1.45 billion, extending the cash runway into 2027. Tranche A of the EUR 90 million loan facility with the European Investment Bank (EIB), representing EUR 50 million, was disbursed and made available to Zealand in March 2024.

Events after the reporting date

Rare diseases

• Dasiglucagon (CHI): US FDA has granted a PDUFA date of October 8, 2024 for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA). The regulatory review is being conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks, whereas Part 2 relates to use beyond three weeks. Supporting the review of Part 2, the US FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Submission of Part 2 of the NDA is moved into the second half of 2024.

Chronic Inflammation

• ZP10068, Complement C3 Inhibitor: Alexion has discontinued development of ZP10068 citing business reasons and plans to return the pre-clinical asset to Zealand.

Upcoming events in 2024

Obesity

• Petrelintide, amylin analog. In the second quarter of 2024, Zealand expects to report topline results from Part 2 of the multiple ascending dose (MAD) trial that is evaluating petrelintide 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.
• Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the second quarter of 2024, Zealand anticipates topline results from the 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, evaluating higher doses of dapiglutide compared to the prior 4-week MAD trial and the investigator-led DREAM trial.
• Survodutide in MASH. Boehringer Ingelheim will present results from the Phase 2 trial with survodutide in MASH at the EASL congress in Milan, Italy on June 7, 2024.

Rare diseases

• Glepaglutide in SBS. In parallel with the regulatory review process, Zealand is engaging in partnership discussions for future commercialization.
• Dasiglucagon in CHI. Zealand is engaging in partnership discussions for future commercialization of the product. In parallel, Zealand intends to make the product available to patients in the US, contingent on an approval by the FDA in October 2024 for up to three weeks of dosing (Part 1 of NDA).

Chronic Inflammation

• ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate the first-in-human clinical trial of ZP9830 in the second half of 2024.

Financial guidance for 2024

• Guidance unchanged from February 27, 2024

Notes:      4.   Financial guidance based on foreign exchange rates as of May 16, 2024.

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 three months of 2024 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/BI3bf842a335dd49a79930cafce733506c. The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/ee4aippx. 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

Q2 2024                        August 15, 2024Q3 2024                        November 7, 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:

Adam LangeInvestor Relations OfficerZealand PharmaEmail: ALange@zealandpharma.com

Anna Krassowska, PhDVice President, Investor Relations & Corporate CommunicationsZealand PharmaEmail: AKrassowska@zealandpharma.com

Attachment

• Zealand Pharma - Q1 2024 Interim Report - 20240516