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sec.gov/Archives/edgar/data/1674988/000110465921065242/tm2116130d2_ex99-1.htm 2024-01-22 17:28 EX - 99.1 2 tm2116130d2_ex99-1.htm EXHIBIT 99.1 Company announcement - No. 29/2021 ZEAL & ZEALAND PHARMA Exhibit 99.1 Interim report for Q1 2021 Zealand Pharma receives first FDA approval and prepares for launch of Zegalogue® ( dasiglucagon ) injection Financial results for the first quarter of 2021 Revenue : DKK 47.8 million / USD 7.5 million ( DKK 12.4 million / USD 1.8 million in the first three months of 2020 ) . Net operating expenses : DKK -284.8 million / USD -44.9 million ( DKK -189.7 million / USD -27.8 million in the first three months of 2020 ) . Net operating result : DKK -260.9 million / USD -41.1 million ( DKK -177.2 million / USD -26.0 million in the first three months of 2020 ) . Cash , cash equivalents , and marketable securities : DKK 1,604.1 million / USD 252.9 million as of March 31 , 2021 ( March 31 , 2020 : DKK 1,290.6 million / USD 189.4 million ) . Business highlights for the first quarter of 2021 and subsequent events Received approval from U.S. Food and Drug Administration ( FDA ) for Zegalogue® ( dasiglucagon ) injection , for the treatment of severe hypoglycemia in people with diabetes . Zegalogue has been approved in pediatric and adult patients with diabetes aged 6 years and above . The approval was based on efficacy results from three randomized , double - blind , placebo - controlled multicenter Phase 3 studies of Zegalogue in children aged 6 to 17 and in adults with type 1 diabetes . The primary endpoint was successfully achieved across the adult and pediatric studies with a significantly faster median time to blood glucose recovery of only 10 minutes following Zegalogue administration compared to 30-45 minutes placebo . In the main Phase 3 adult trial 99 % of patients recovered within 15 minutes . In these Phase 3 trial results the most common adverse events reported ( ≥2 % ) were nausea , vomiting , headache , diarrhea and injection site pain in adults ; and nausea , vomiting , headache and injection site pain in pediatric patients . The approval was received from the FDA four days ahead of the scheduled PDUFA date . Zealand is planning to launch Zegalogue in the U.S. in late June . Zealand Pharma announced the initiation by partner Boehringer Ingelheim of two Phase 2 trials for BI 456906. In April 2021 , Zealand announced the initiation of two Phase 2 trials for the GLP - 1 / glucagon dual agonist for adults who are overweight or obese and for adults with non - alcoholic steatohepatitis ( NASH ) . The compound is already being investigated in an ongoing Phase 2 study in people with type 2 diabetes mellitus . The new study is to investigate if there are additional benefits on both chronic weight management , and NASH to prevent progression to cirrhosis compared to currently available . Five X Twenty - five ( “ 5x25 ” ) . In March the company presented its five - year R & D strategy to roadmap the corporate goal of five commercialized products by 2025 ( " 5x25 " ) augmenting our industry leading peptide platform with phage display , computerized molecular design and oral peptide technologies . In addition , the company demonstrated continued progression on Zealand's fully owned peptide pipeline with expansions into IBD and Obesity . Announced the promotion of Christina Sonnenborg Bredal to Head of People & Organization . Christina joined Zealand in 2020 and will now lead the Denmark and US People & Organization functions , as well as Internal Communications . The newly created position will optimize Zealand's people and organizational strategy globally and locally , accelerate its focus on developing talent , and optimize processes and communications as the company continues to grow . Christina will report to CEO Emmanuel Dulac and be a member of the company's Corporate Management Team . Secured a total of DKK gross 749.0 million through a direct issue and private placement of new shares . The financing , completed in January , provides Zealand with additional funding to continue supporting the Company's development pipeline and prepare the Company for the commercial launch of Zegalogue in the U.S. in late June of 2021 . https://www.sec.gov/Archives/edgar/data/1674988/000110465921065242/tm2116130d2_ex99-1.htm 1/23