Copenhagen, Denmark — 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
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 expenses1 800-900 941
Notes:
1. Net operating expenses consist of R&D, S&M, G&A and other operating items
Financial guidance based on foreign exchange rates as of March 2, 2023
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.