Zealand Pharma CPSE:ZEAL Stock Report

Zealand Pharma A/S Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients with Short Bowel Syndrome (Ease 1)

Zealand Pharma Presents Data from Phase 3 Trial of Dasiglucagon in Congenital Hyperinsulinism At the 60Th Annual Espe Meeting

Zealand Pharma A/S announced that clinical results from the two-part Phase 3 trial of dasiglucagon for the treatment of congenital hyperinsulinism (CHI) in newborns and infants up to 12 months of age were presented at the 60th annual European Society for Paediatric Endocrinology (ESPE) meeting, held in Rome, September 15-17, 2022. Topline results from Part 1 of the trial were previously announced in May 2022 (Company Announcement No. 22 /2022). The abstracts of the oral presentations are available at eurospe.org and the data are summarized as follows: Title: Dasiglucagon Significantly Reduces Requirement for Intravenous Glucose in Children with Congenital Hyperinsulinism ages 7 Days to 12 Months Authors: Diva D. De Leon, Indraneel Banerjee, David M. Kendall, Sune Birch, Eva Bøge, Jelena Ivkovic & Paul S. Thornton Presentation Highlights: In Part 1 of the Phase 3 trial, dasiglucagon significantly reduced the requirement for intravenous (IV) glucose to maintain glycemia in neonates and infants with CHI and reduced glucose requirements to levels that potentially allow for discontinuation of IV glucose support. -- Dasiglucacagon significantly reduced the mean IV glucose infusion rate (GIR) in the last 12 hours of the 48 hour treatment period by 55% as compared to placebo (4.3 mg/kg/min for dasiglucagon and 9.4 mg/kg/min for placebo with a treatment difference of 5.2 mg/kg/min; p=0.0037). Dasiglucagon also reduced GIR over the entire 48-hour treatment period by 3.5 mg/kg/min compared to placebo (p=0.0107). -- Dasiglucagon treatment resulted in a reduction of 31 g/day in total carbohydrate intake (IV and gastric) compared to placebo (107 g/day for dasiglucagon vs 138 g/day for placebo; p = 0.024), a 22% reduction in carbohydrate calories. -- Dasiglucagon was observed to be well tolerated in Part 1 of the trial, with skin reactions and gastrointestinal disturbances as the most frequently reported adverse events (no serious adverse events reported). itle: Dasasiglucagon Treatment Over 21 days in Infants with Congenital Hyperinsunism Results in Glycaemic Stabability and Reduces Requirement for Intravenous Glucose Authors: Indraneel Banerjee, Diva D. De Leon, David M. Kendall, Sune Birch, Eva Bøge, Jelena Ivkovic & Paul S. Thornton Presentation Highlights: In the 21-day open-label Part 2 of the Phase 3 trial, continuous subcutaneous infusion of dasiglucagon in infants with CHI reduced IV glucose requirements, time in hypoglycaemia and enabled discontinuation of IV glucose in most infants, obviating the need for subtotal pancreatectomy for glycaemic stability. Dasigcacagon enabled reduction and either periodic or permanent discontinuation of IV glucose infusion in 10 out of 12 infants. -- Seven infants, who did not require pancreatectomy, were completely weaned off IV glucose at the completion of the trial. -- During the 21-day treatment with dasiglucagon, continuous glucose monitoring (CGM) measures of hypoglycaemia trended lower with median time <70 mg/dL reduced from 7.0% to 5.2% and <54 mg/dL reduced from 1.9% to 0.88%. There was no increase in hyperglycaemia. -- The safety profile of dasiglucagon in Part 2 was consistent with Part 1, with no adverse event requiring discontinuation of treatment and no serious adverse events reported.

Zealand Pharma A/S Announces Chief Financial Officer Changes

Zealand Pharma A/S announced the appointment of Henriette Wennicke as Zealand's Chief Financial Officer starting November 1, 2022. Henriette Wennicke comes to Zealand with broad finance and business experience at large organizations, including in healthcare, where she has led financial planning and R&D portfolio management. She is currently the Vice President and Head of Investor Relations and Treasury at GN Store Nord, a global leader in intelligent audio solutions, listed on the Nasdaq Copenhagen. Previously, Henriette Wennicke was Vice President and Head of Global Finance at GN Hearing. Henriette Wennicke started her career at Novo Nordisk, where she held various finance positions of increasing responsibility within the R&D organization during her 10-year tenure. Henriette Wennicke holds an M.Sc. in Finance and Strategic Management from Copenhagen Business School. She will succeed Matthew Dallas, who joined Zealand as CFO in 2019, and will leave the company at the end of August. Lykke Rømer, Vice President, Head of Finance and Accounting will assume the responsibilities of the CFO on an interim basis.

Zealand Pharma A/S Revises Revenue Guidance for the Full Year of 2022

Zealand Pharma A/S revised revenue guidance for the full year of 2022. Net product revenue from the sales of Zegalogue is expected to be DKK 11.5 million +/- 10%. This is a reduction of DKK 7.5 million from updated guidance issued on May 12, 2022, reflecting the completion of the Asset Purchase Agreement for V-Go with MannKind Corporation. The company will no longer provide guidance on net product revenue associated with sales from that program.

Zealand Pharma Announces Voluntary Delisting of American Depositary Shares from the Nasdaq Global Select Market

Zealand Pharma A/S announced it has given formal notice to Nasdaq of the company’s intention to voluntarily remove its American Depositary Shares (ADSs) from listing on the New York-based Nasdaq Global Select Market. One ADS currently represents one ordinary share in Zealand Pharma, and the company’s ADSs account for less than 1.5% of the total share capital. The company’s ordinary shares will continue to be listed on Nasdaq Copenhagen, which is the primary source of liquidity and trading flexibility for Zealand shares. According to public filings, approximately 80% of institutional investors holding Zealand’s ordinary shares listed on the Nasdaq Copenhagen are based outside of Denmark, including in the U.S., underscoring its viability for global investors. Zealand has been listed on the Nasdaq Copenhagen since November 2010 under the ticker ZEAL.CO and trades in DKK. The company subsequently listed its ADSs on the Nasdaq Global Select Market in the U.S. in August 2017 under the ticker ZEAL and trades in USD.