Zealand Pharma Announces Financial Results for the First Quarter of 2023

Company announcement - No. 20 / 2023

Zealand Pharma Announces Financial Results for the First Quarter of 2023

• Positive topline data from obesity portfolio
• On track for two regulatory submissions targeting rare diseases
• Strengthened balance sheet with DKK 1.5 billion in April resulting in a runway to mid-2026

Copenhagen, Denmark, May 11, 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 three months ended March 31, 2023 and provided a corporate update.

Delivered clinical results and strengthened balance sheet

Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said: "These first months of 2023 were exceptional for Zealand Pharma, with impressive clinical data readouts from our obesity portfolio, continuous progress toward regulatory filings for our rare disease assets and a capital raise of DKK 1.5 billion bringing in new specialist investors.

“We are excited by the outlook for the year which we expect will be catalyst rich, including clinical data presentations at scientific conferences and initiation and reporting of new clinical studies across the obesity pipeline and regulatory submissions for our two rare disease programs.”

Key financial results for Q1 2023

Notes:
1. Net operating expenses consist of R&D, S&M, G&A and other operating items

*In April 2023, Zealand received gross proceeds of DKK 1.5 billion in connection with a private placement of new shares. Under the current assumptions Zealand projects its existing financial resources will be sufficient to fund operations until mid-2026.

Highlights in the first quarter 2023

• Announced positive topline results from Phase 1a single ascending dose (SAD) trial of long-acting amylin analog ZP8396. Healthy participants with a mean BMI of 25.8 were treated with either subcutaneous ZP8396 or placebo (across 7 dose cohorts). Participants treated with ZP8396 had dose-dependent reductions in mean body weight of up to 4.2% from baseline. Placebo-treated participants had a mean body weight increase of 0.6%. The plasma half-life of ZP8396 was 230 hours, which supports once-weekly dose administration. ZP8396 was well tolerated in this study, with no serious or severe adverse events (AEs) and no withdrawals. Zealand will present the results from the SAD trial at the upcoming American Diabetes Association (ADA) 83rd Scientific Sessions in June 2023.

Events after the reporting date

• Announced positive topline results from Phase 2 clinical trial with BI 456906, a glucagon receptor/glucagon-like peptide-1 receptor (GCGR/GLP-1R) dual agonist, in people living with obesity or overweight. BI 456906 achieved up to 14.9% weight loss from baseline after 46 weeks (including 20 weeks dosing escalation and 26 weeks fixed dose maintenance period). The analysis was based on the planned maintenance dose assigned at randomization regardless of whether the planned dose was reached during the first 20-week dose escalation phase. The safety and tolerability profile of BI 456906 was in line with other incretin-based pharmacotherapies. Full results, including an analysis using the actual maintenance dose administered regardless of assignment at randomization, indicating even greater weight loss, will be presented at the upcoming ADA 83rd Scientific Sessions in June 2023. Boehringer Ingelheim is engaging in parallel with regulatory authorities to discuss plans for Phase 3 trials in people living with obesity or overweight.
• Opened patient enrollment to DREAM, a Phase 2 investigator-led clinical trial of dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist in people with obesity. The DREAM trial aims to evaluate potential for weight loss following 12 weeks and gain key mechanistic insights into the effects of dapiglutide on inflammatory markers. Zealand expects the trial to complete in 2024.
• Completed the 6-month interim analysis of EASE-2, the long-term safety and efficacy extension trial of glepaglutide in patients with short bowel syndrome (SBS). Ninety-six participants continued into the EASE-2 from EASE-1. Participants continued their assigned treatment from EASE-1 with glepaglutide 10 mg once or twice weekly, while patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once or twice weekly. At six months, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement. Data also demonstrated that additional patients on both doses weaned off parenteral support successfully. Glepaglutide appeared to be safe and well-tolerated in EASE-2, with a profile consistent with that observed in EASE-1. Both EASE-2 and EASE-3 long-term extension trials are ongoing. Zealand recently also completed the interim analysis of EASE-4, assessing the long-term effects of glepaglutide on intestinal fluid and energy uptake, and anticipates presenting these results at a future scientific conference.
• Strengthened balance sheet and extended runway to mid-2026. In April, Zealand received gross proceeds of DKK 1.5 billion from a directed issue and private placement of 6,578,948 new shares. In May 2023, Zealand repaid the Oberland Capital loan in full. With this final repayment, the loan agreement with Oberland Capital is now terminated. The repayment is refinanced through a new Credit Facility provided by Danske Bank and expected near-term upcoming milestones from existing partners. For further information on the capital increase and repayment of Oberland loan refer to note 11 in the attached financial statement. Zealand’s projected financial runway remains until mid-2026.

Upcoming events

• Dasiglucagon in congenital hyperinsulinism (CHI). In the second quarter of 2023, Zealand expects to submit a new drug application (NDA) to the FDA for dasiglucagon treatment in the management of CHI.
• Glepaglutide in short bowel syndrome (SBS). In the second half of 2023, Zealand anticipates submitting an NDA to the FDA for glepaglutide administered via autoinjector for the treatment of SBS with intestinal failure.
• ZEGALOGUE® (dasiglucagon) for injection. Under the global license and development agreement with Novo Nordisk for Zegalogue®, Zealand is responsible for submitting a marketing authorization application (MAA) to the European Medicines Agency (EMA), planned for the second quarter of 2023.
• ZP8396, long-acting amylin analog. In the second half of the year, Zealand expects to report topline results from the ongoing 6-week multiple ascending dose (MAD) trial and initiate a 16-week dose titration trial.
• Dapiglutide, GLP-1/GLP-2 receptor dual agonist. Zealand expects to initiate a 13-week dose titration trial in people with obesity in the second half of 2023.
• ZP6590, GIP analog. Zealand expects to advance this program into first-in-human clinical trials in the second half of 2023.

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 three 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.

Conference ID: 7578501

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/tdxqkqw9. 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/.

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. that includes Boston. 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 preclinical 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.

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

Attachment

• Zealand Pharma - Q1 2023 Interim Report - 20230511