Company announcement - No. 28 / 2023
Zealand Pharma Announces Financial Results for the First Half of 2023
Strong progress across R&D pipeline and significant strengthening of the balance sheet
- Boehringer Ingelheim to move into Phase 3 trials with GCGR/GLP-1R dual agonist survodutide (BI456906) in obesity following positive Phase 2 data
- Encouraging weight loss and tolerability data from long-acting amylin analog ZP8396
- Regulatory submission of NDA to the US FDA for dasiglucagon in congenital hyperinsulinism and submission of MAA to EMA for dasiglucagon for the treatment of severe hypoglycemia
- Strengthened balance sheet with DKK 1.5 billion, resulting in a runway to mid-2026
Copenhagen, Denmark, August 17, 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 six months ended June 30, 2023 and provided a corporate update.
Strong progress in obesity portfolio and execution of regulatory submissions for dasiglucagon
Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said: "The first six months of 2023 have been phenomenal for Zealand Pharma, with impressive clinical data readouts from our obesity portfolio, including presentations at ADA for survodutide and our amylin analog ZP8396, regulatory submissions for dasiglucagon, and a strengthened balance sheet.
"We look forward to an eventful second half of the year as well, which we expect among other events will include the regulatory submission to the FDA for glepaglutide in SBS, a potential partnership agreement for dasiglucagon in CHI, and initiation by Boehringer Ingelheim of the Phase 3 program with survodutide in obesity."
Key financial results for H1 2023
| DKK million | H1 2023 | H1 2022* |
| Revenue | 24.0 | 36.3 |
| Net operating expenses1 | -388.1 | -470.5 |
| Net operating result | -364.0 | -434.1 |
| Net financial items | -152.0 | -61.8 |
| Cash position2 | 1,692 | 1,178 |
| Funding available incl. undrawn committed RCF3 | 2,042 | 1,178 |
*Comparative numbers are adjusted for discontinued operations.
Notes:
- Net operating expenses consist of R&D, S&M, G&A and other operating items.
- Cash position includes cash, cash equivalents and marketable securities.
- RCF = Revolving Credit Facility provided by Danske Bank.
Highlights in the second quarter 2023
Obesity
- Survodutide: Presented results from Phase 2 dose-finding clinical trial with survodutide (formerly BI 456906), a glucagon/glucagon-like peptide-1 receptor (GCGR/GLP-1R) dual agonist, in people living with overweight or obesity. Survodutide achieved up to 18.7% mean weight loss from baseline after 46 weeks based on the actual maintenance dose. Up to 40% of people who reached the highest two doses of survodutide in the trial achieved a weight loss of at least 20%. The safety and tolerability profile of survodutide was in line with other incretin-based pharmacotherapies. The data were presented at the 2023 American Diabetes Association's (ADA) 83rd Scientific Sessions.
- ZP8396: Presented results from Phase 1a single ascending dose (SAD) trial of long-acting amylin analog ZP8396. Healthy participants with a mean BMI of 25.8 treated with ZP8396 had dose-dependent and sustained 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 approximately 10 days, which supports once-weekly dose administration. ZP8396 was well tolerated in this study, with no serious or severe adverse events (AEs) and no withdrawals. The data were presented at the ADA 83rd Scientific Sessions.
- ZP8396: Initiated 16-week multiple ascending dose (MAD) trial with long-acting amylin analog ZP8396, Part 2 of the Phase 1b trial. Based on the mild adverse event profile observed in the 6-week Part 1 of the MAD trial, Zealand has progressed ZP8396 into 16 weeks of dosing to explore significantly higher exposure levels of ZP8396 using a dose up-titration scheme.
- Dapiglutide: Initiated 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 the 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 the first half of 2024.
Rare diseases
- Dasiglucagon (CHI): Submitted new drug application (NDA) to the US Food and Drug Administration (FDA) for dasiglucagon for the treatment of congenital hyperinsulinism. The submission is based on the results from two pivotal Phase 3 trials and interim results from an ongoing long-term extension trial.
- Glepaglutide (SBS): Completed the interim analyses of EASE-2, EASE-3, and EASE-4 clinical trials of glepaglutide in patients with short bowel syndrome (SBS). Zealand Pharma is on track to submit the NDA to the US FDA in the second half of 2023. The submission will be based on EASE-1 and interim results from EASE-2, EASE-3 and EASE-4.
Type 1 diabetes
- Dasiglucagon (severe hypoglycemia): Submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for dasiglucagon for the treatment of severe hypoglycemia in adults, adolescents and children aged six years or older with diabetes. Dasiglucagon injection was approved under the brand name Zegalogue® by the US FDA on March 22, 2021, for the treatment of severe hypoglycemia in pediatric and adult people with diabetes aged six years and above. In September 2022, Zealand entered into a global license and development agreement with Novo Nordisk to commercialize Zegalogue®. The MAA submission triggered a milestone payment to Zealand of DKK 15 million.
Financing
- 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 and the loan agreement is now terminated. The repayment is refinanced through a new undrawn Credit Facility provided by Danske Bank and expected near-term upcoming milestones from existing partners.
Events after the reporting date
- ZP8396: Announced topline results in July 2023 from 6-week MAD trial with long-acting amylin analog ZP8396, Part 1 of the Phase 1b trial. Low doses of 0.6 and 1.2 mg ZP8396 administered once-weekly for six weeks led to 5.3% and 5.1% mean weight loss compared to 2.6%, 3.6% and 4.2% mean weight loss following single doses of 0.7, 1.4 and 2.4 mg ZP8396, reported from the SAD trial. Based on the mild AE profile observed in the 6-week MAD trial, Zealand has initiated Part 2 of the MAD trial, a 16-week study exploring significantly higher doses of ZP8396 using a dose up-titration scheme.
- Survodutide: Announced advancement into three global Phase 3 trials in obesity. On August 17, Boehringer Ingelheim announced their decision to advance to Phase 3 in people living with overweight or obesity with initiation expected in the second half of 2023.
Upcoming events next 12 months
- Glepaglutide in 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 and engage in more detailed partnership discussions.
- Dasiglucagon in CHI. In the second half of 2023, Zealand aims to enter into a partnership agreement for the commercialization of dasiglucagon in CHI.
- Survodutide in obesity. Boehringer Ingelheim expects to start enrolment of patients in the Phase 3 clinical program with survodutide in people living with overweight or obesity in the second half of 2023, with details on the trials to be disclosed prior to their initiation.
- 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, 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. Topline results from the ongoing investigator-initiated Phase 2 trial DREAM are expected in the first half of 2024.
- ZP8396, long-acting amylin analog. In the first half of 2024, Zealand expects to report topline results from the 16-week MAD trial.
- ZP6590, GIP analog. Zealand expects to complete pre-clinical activities in 2023 and advance this program into first-in-human clinical trials in the first half of 2024.
- ZP10068, Complement Inhibitor. Zealand expects to complete pre-clinical activities in the second half of 2023 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 expects the Kv1.3 ion channel blocker to be Phase 1-ready in the first half of 2024 and to initiate first-in-human clinical trials in 2024.
Financial guidance for 2023
- Guidance unchanged from March 2, 2023
| DKK million | 2023 Guidance | 2022 Actual |
| Revenue anticipated from existing and new license and partnership agreements | No guidance due to uncertain size and timing | 104 |
| Net operating expenses4 | 800-900 | 941 |
| Notes: 4. Financial guidance based on foreign exchange rates as of August 17, 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 six 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.
Telephone dial-in information and a unique personal access PIN will be provided upon registration at https://register.vevent.com/register/BI08d950a0d12f438da57a04a02449f692. 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/5hqhqe4i. 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.
Zealand Pharma® is a registered trademark of Zealand Pharma A/S.
Contacts:
| Adam Lange |
| Investor Relations Officer |
| Zealand Pharma |
| Email: ALange@zealandpharma.com |
| Anna Krassowska, PhD |
| Vice President, Investor Relations & Corporate Communications |
| Zealand Pharma |
| Email: AKrassowska@zealandpharma.com |
