Zealand Pharma A/S

Thank you, operator. Welcome and thank you for joining us today to discuss Zeeland's first staff 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 and Head of Development, Adam Steensberg. After the prepared remarks, we will open the call to take your questions. Our President of Zeeland Pharma U.S., Frank Sanders, will also be available to take your questions during the Q&A session. You can find the related company announcement and additional supporting information on our website at zionpharma.com. I'd like to point out that we'll 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 obligations to update them, except as required by law. Please refer to recent findings for a more complete picture of risk and other factors. With that, I will turn the call over to President and CEO Emmanuel Dulac. Emmanuel Dulac Thank you, Matt.

And thanks to everyone for joining today. Please now turn to slide three. This first half of 2021 was transformational for Zeeland. The FDA approval, followed by the Zegalog commercial launch in the treatment of severe hypoglycemia for people with diabetes age six and above, were two historical milestones and two firsts for the company. In parallel, during the same period, we continue to drive sustained progress across our pipeline and towards our vision of becoming a fully integrated, independent biotech company. Turning to slide four, Adam Stinsberger, CMO, will detail the progress made on the pipeline in a minute, while I will discuss now in more detail the improvements made to our organization and strategy. This progress allows us to focus our attention on key strategic priorities for the second half of the year and reinforces our confidence in the goal of having five commercialized products by 2025. Regarding the launch of Zegalog, let me start with slide five, which illustrates some of Zegalog's key attributes. Research indicates that diabetes patients face the challenge of avoiding hypoglycemic events, and that they and their loved ones often live in the fear of one of these events materializing. Rescue solutions such as Zegalog provide an attractive treatment option for true patients and providers alike. who can feel confident that they are prepared to address a potential severe hypoglycemic event. Throughout the summer, a commercial team in the U.S. has worked tirelessly with national and regional payers, pharmacy benefit managers, and health systems to ensure that patients across the country have access options for Zegalog. We have established a strong presence and presented new data at several medical meetings. We are launching more than a drug with Zegalog. we are also launching a company. And all our employees are excited and highly engaged behind the challenge. Slide six is for your reference on the indication and important safety information for Zegalog. A copy of the full PI is available on www.zegalog.com slash prescribing information. And I am delighted to show you on slide seven some background related to the patient support capabilities deployed by Zealand to ensure patient access with Zegalog at the point of launch. In support of our commitment to patient access, we initiated Zealand Pharma Connected Care, a comprehensive patient support program designed to offer affordability, reimbursement, and educational resource to help address the diverse needs of patients and caregivers. The program includes components such as an available copay saving cards for eligible commercially insured patients and the opportunity to receive home prescription delivery. We believe Zegalog is an important treatment option for people with diabetes to manage potential severe hypoglycemic events. And we look forward to continuing this work to ensure that Zegalog is available to the people who need it. Finally, slide eight is showing how profound and rapidly the company is continuing its growth. In the first half of the year, we have seen strong momentum within our pipeline and progress across multiple clinical development programs. For those familiar with our pipeline, they will appreciate the continued progress of pipeline candidates shown on this slide. We now have four pipeline focused areas, which makes our potential reach wider and allows us to improve the depth of our expertise in each therapeutic area and help us better manage our portfolio. The four areas of focus are type 1 diabetes with two marketed drugs and two mid-late-stage programs, rare disease with two late-stage and one mid-stage programs, our newly defined obesity franchise, which includes the collaboration with BI, and our amylin and GIB programs. We're expecting to see data readouts and initiation of new clinical activities in obesity in the second half of this year. And finally, our inflammation franchise with early but potentially promising assets. The acceleration in the build of our pipeline within these four focused areas is a reflection of how productive our research is and clearly shows how we plan to prioritize our investments going forward. I'll now turn it over to our CMO and head of research and development, Adam Stinsberg, to discuss our pipeline in greater details. Adam?

Thank you, Emmanuel. And I'm really pleased with the progress we are making across the pipeline programs that you see here, and I look forward to share more updates on the next slides. So please go to slide nine. Our medical affairs organization has been busy engaging with the medical community ahead of the launch of CEDAWLOG, and I'm pleased with the early feedback, building further confidence that Segaloc is well-positioned to allow more people in need to be equipped with rescue solutions for severe hypoglycemia. The introduction of Segaloc, however, only marks the beginning of our mission to create a paradigm shift in type 1 diabetes management. While we have seen many improvements over the last decade with the introduction of insulin CDMs and insulin pumps, Studies suggest that on average, only 20% of patients achieve their glycemic target in the U.S., and the burden of disease management remains very high. And we believe that the unique features of basic luergon, allowing its use in either a low-dose pen or in the biohormonal artificial pancreas system, holds a great potential to help patients achieve these glycemic goals and also improve their quality of life. In our view, it is now time to start looking at the other end of the glycemic equation, the nose, which drives a lot of anxiety among patients and can be addressed by Dasikluogon. In the last quarter, we initiated an outpatient phase two trial with Dasikluogon low-dose pen aimed at investigating exercise-induced hyperglycemia, which we believe represent an area of significant unmet medical needs. On the bi-hormonal artificial pancreas front, we completed the in-use compatibility test of static organ in the islet pump last quarter, and we are happy to see that beta bionics remains on track for initiating the phase three trial program later this year. Following our end of phase two meeting for this program, we have continued the positive dialogue with FDA and believe we have a good alignment on expectations. All together, we look forward providing further updates on our efforts in diabetes as we progress into the next quarters. Please turn to slide 11 and our rare disease programs in congenital hyperinsulinism and short bowel syndrome. Both indications represent areas of large unmet medical need and reflect CLAM's commitment to make a difference in the lives of people suffering from these conditions. For both programs, we are concluding the Phase III development. If you go to slide 12, you can see the Phase III program investigating dastigluoban and CHI is on track to generate results from the trial in neonates later this year. If this study meets its primary endpoint, we expect to utilize the results from the full Phase III program to support a potential MDA submission to the FDA. Slide 13 provides an overview of our ongoing Phase III program for KlipactroType, with results from the pivotal Phase III trial on track to read out in 2022. In the second quarter of this year, we initiated EAST-SPS-3, where we have utilized the autoinjector pen for once-weekly dosing. This study enrolls patients who have already completed EAST-SPS-1 and 2, and as a result Up to 4.5 years, glipaglutide safety and efficacy data will be generated from the three trials. Later in this quarter, we expect to dose the first patients in EAST-SPS-4, which will evaluate long-term effects of glipaglutide on intestinal absorption and of fluid and energy. On slide 14, you can see our long-acting GLP-1 and 2 dual-acronyms glipaglutide which is being investigated as a potential treatment for SPS, as well as a wider range of gastrointestinal diseases. In the last quarter, we completed dosing of the fourth and last cohort in the phase 1B trial, and results from the study remains on track for later this year. At that time, we also expect to announce the next development steps for the molecule. Please go to slide 16, and our efforts to address obesity, which is a growing and global condition. While medical treatments for obesity have lagged far behind people's aspirations for weight loss and what surgical interventions can provide, we are now seeing a change with recently approved medical treatments that achieve weight loss into the mid-teens percentages. However, since obesity is a complex metabolic disorder, we believe that combination of multiple targets are needed to take weight loss treatment to the next level. At CLIMB, our approach centers around building two functions into a single molecule, like BI456906, all by designing single acting peptide agonists that may be co-formulated with other peptide agonists. On slide 17, we are excited to announce that our partner, Bernadine, has completed enrollment into the first of three phase two trials, supporting our shared and strong commitment towards metabolic diseases. And we look forward to the BCTV conference in November, where BI will present the outcome of the phase one B trial. We believe this molecule, which acts on both the GLB1 and the gluagon receptor, is a strong candidate to potentially address future medical needs in obesity, NASH, and type 2 diabetes. Please go to slide 18, where we change our focus to amylin as a promising new target in obesity. We expect to bring our amylin analog, CP8396, into Phase I clinical development later this year. This molecule has been designed with a pH span that allows for co-formulation with a number of known DLB1 and DLB1-containing molecules. It has a long plasma half-life and has shown weight-loss potential in preclinical models. In this regard, we have been excited to see the weight-loss potential of another amylin analog caglinotide in Phase II and I trials, both as a monotherapy and as combination therapy with semaglutide as presented to the left of this slide. I will now turn over to our CFO Matt Dallas to walk us through our first half financials. Matt.