Zealand Pharma A/S

Thank you for joining us today to discuss Zeeland's first quarter results for 2021. I'm Matt Dallas, Senior Vice President, Chief Financial Officer at Zeeland. With me today are Zeeland's President and Chief Executive Officer, Emmanuel Dubac, and Chief Medical Officer, Adam Steensburg. After the prepared remarks, we will open the call to take your questions. You can find the related company announcement and additional supporting information on our website at zeelandpharma.com. I'd like to point out that we will be making forward-looking statements that are subject to risk and uncertainties. These statements are valid only as of today, and the company assumes no obligation to update them except as required by law. Please refer to recent filings for a more complete picture of risk and other factors. With that, I will turn the call over to President and CEO, Emmanuel Douac.

Thank you, Matt. And thanks to everyone for joining today. The first quarter brought one of the most significant milestones in Zealand pharma's history, the US FDA approval of Zegalog. indicated for the treatment of people with diabetes who are at risk of severe hyperglycemia. Our first FDA approval as a company and our first approval in the Dazuclagon franchise. This marks a key turning point in our evolution from a research and development focused organization to a fully integrated biopharmaceutical company with a goal of five commercial products by 2025. Turning to slide four and five, Under the leadership of Frank Sanders, president of Zeed and Pharma US, we have been steadily optimizing our commercial organization over the last year in preparation for the launch of Zegalog in late June. Through established relationships with KOLs and HCPs, as well as high prescriber coverage, we are on track with our launch readiness preparation and believe this initial launch will put us in a strong position to further build out our commercial organization. To ensure a successful launch, we have four strategic objectives. The first is to establish a clear and distinct product position with HCPs, patients, and caregivers. Second, we will focus on the back to school season to execute a focused launch that targets and prioritizes high volume customer segments. Third, we are working closely with top national and regional payers, pharmacy benefit managers, and health systems to establish market access and make it simple for patients and providers to acquire product. And fourth, we are committed to providing a patient support program to ensure education and access for patients and caregivers. Turning to slide six and seven. There is a significant unmet medical need in the treatment of severe hypoglycemia. And with the arrival of newcomers, we have seen an increasing utilization of rescue therapies. For your reference, we have indication in important safety information for Zegalog. A copy of the full PI is available on Zegalog.com slash prescribing information. We believe Zegalog will be an important new option for people with diabetes to consider in the management of potential consequences of their disease. Turning to slide eight, In parallel with Zegalog's approval and upcoming launch, we continue to make exciting progress across our pipeline and thoughtfully build our organization. I am excited to announce that we have strengthened our internal team with the appointment of Christina Sonnenborg-Bredau to a newly created role of head of people and organization. A new role will bring Denmark and US HR functions and internal communications together in a single elevated global function, and be instrumental as we continue to attract and retain the most talented employees. I will now turn it over to our Head of Research and Development, Adam Stinberg, to discuss our pipeline in greater detail. Adam?

Thank you, Emmanuel. Please turn to slide nine. And as just mentioned, Emanuel, our preparations for the Zika-locked late June loans are being executed while we in parallel continue to advance our pipeline programs, which range from a late stage to preclinical candidates in a variety of metabolic and GI indications. Turning to slide 10, we continue to pursue other indications for dashy-gluargon. Among the most advanced clinical programs is the study evaluating continuous infusion of dasyluogon in children with congenital hyperinsulinism, or CHI, which is an ultra-rare disease caused by a defect in the pancreatic beta cells. And later this year, we expect the results from the second phase 3 trial in the CHI children aged 7 days to 1 year. Please turn to slide 11. In collaboration with Beta Bionics, we plan to initiate the pivotal phase three trial program for the bi-hormonal islet bionic pancreas device, which utilizes dasigluagin in the second half of this year. We plan to enroll approximately 350 adults and 350 children with type one diabetes and randomize them into the trial. And these trials are expected to form the basis for an NDA submission to the US FDA for use of basic luergon in bi-hormonal artificial pancreas systems. Please turn to slide 12. As Emmanuel mentioned earlier, we have also broadened our pipeline of metabolic therapies to target obesity and non-alcoholic steatohepatitis. Our clinical development partner, Berger Ingelheim, recently initiated two additional phase two trials for the GLP-1 gluagon dual agonist, BI456906, in adults who are either overweight or obese, or for adults with NASH. And we believe that our dual agonist has the potential to achieve increased weight loss via improvements of the patient's metabolism, and also has the potential to alleviate NASH by reducing upstream hepatic steatosis. And we expect BI to complete the phase 2 trial in people with type 2 diabetes and to communicate the results from the 16-week phase 1B trial later this year. Turning to slide 13, we also have two assets in preclinical development for obesity, both of which have shown additive weight loss effects when co-injected with GLP-1 analogs in preclinical models. And we anticipate starting phase 1 trials with our long-acting amine analog ZP8396 later in the year and expect to bring our long-acting GIP analog ZP6590 into phase 1 trials in 2022. In addition to the continued advancement of our metabolic candidates, we have also made significant progress in the clinical development of our gastrointestinal programs and recently announced new preclinical candidates in this space. Please turn to slide 14. Lipaglutide is our long-acting tier 2 analog with a half-life of approximately 50 hours, which is being developed in a disposable ultrainjector. We are progressing with patient enrollment in the pubertal phase 3 trial, which will evaluate once- and twice-weekly dosing of lipaglutide versus placebo over 26 weeks, and we expect the results from the trial in 2022. Please turn to slide 15. We are making good progress also with our long-acting GLP-1-2 dual agonist that people tried, where we expect results from the Phase 1b trial later this year. While GLP-2 mainly stimulates intestinal absorption capacity, GLP-1 slows down intestinal motility thereby potentially contributing positively to enhanced absorption. And I will now turn over to our CFO, Matt Dallas, to walk us through our first quarter financials. Matt.