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Changing Lives with Next Generation Peptide Therapeutics

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Changing Lives with Next Generation Peptide Therapeutics Changing lives with next generation peptide therapeutics Zealand Pharma Corporate Presentation May 2019 Forward-looking statements This presentation contains information pertaining to Zealand Pharma A/S (“Zealand"). Neither Zealand nor its management, directors, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the information contained in this presentation or any other information transmitted or made available to the viewer or recipient hereof, whether communicated in written or oral form. This presentation does not constitute or form part of, and should not be construed as, an offer to sell or issue or the solicitation of an offer to buy or acquire Zealand securities, in any jurisdiction, or an inducement to enter into investment activity, nor shall there be any sale of Zealand securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No part of this presentation, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. This presentation contains forward-looking statements that reflect management's current views with respect to Zealand's product candidates' development, clinical and regulatory timelines and anticipated results, market opportunity, potential financial performance and other statements of future events or conditions. Although Zealand believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. Accordingly, results could differ materially from those set out in the forward-looking statements as a result of various factors, many of which are beyond Zealand’s control. No reliance should be made on such forward-looking statements. Zealand does not intend to update the presentation, including the forward-looking statements contained therein, following distribution, beyond what is required by applicable law or applicable stock exchange regulations if and when circumstances arise that lead to changes compared to the date when these statements were provided. 1 Zealand Pharma in brief Danish Biotech Leading Peptide Platform Three Phase 3 Programs Founded in Copenhagen (HQ) in 1998, A world leading peptide platform, Accelerating several late stage opened U.S. subsidiary 2018 with two medicines on the market programs to launch new products into major markets in 2 to 4 years Expanding Capabilities Experienced Team Dual Nasdaq Listing Transforming into a fully integrated 153 employees of which Traded in Copenhagen biotech company with 87% are in R&D and New York (ZEAL) U.S. commercial organization 2 We change lives with next generation peptide therapeutics Changing Transforming Engaging Approaching Lives Peptides Partnerships Commercialization We work every day with We leverage our 20 years of We engage with development We are building a fully patient communities and experience discovering and and commercial partners to integrated commercial thought leaders to change the developing peptide drugs to enhance innovation and organization with U.S. lives of people with severe transform peptide projects into expand opportunities across operations to market our own medical conditions next generation therapeutics markets and therapeutics areas therapies for rare diseases 3 Developing next generation peptide therapeutics Sources of innovation The Zealand peptide platform Therapeutic opportunities GLP-2 GLP-1 analog analog Peptide libraries Novel peptide drug candidates GLP-1/Glu Glucagon agonist • Physical stability analog Amylin analog • Chemical stability Bio-active peptides GIP • Solubility analog GLP-1/GLP-2 • Potency agonist GIP/GLP-1 Venoms agonist Ion channel blockers Complement C3 inhibitor 4 Optimizing value through internal drug development and partnerships Academic and Contract Research Contract Manufacturing Optimizing Scientific Institutions Organizations (CROs) Organizations (CMOs) Distribution Partners execution across the value chain Internal Drug Development Maintaining full control and value potential Peptide Early and Late Stage Approved Research Platform Drug Development Medicines to Patients Expanding the innovation platform Drug development in Strategic Partnerships 5 2019 Objectives Accelerate our late-stage pipeline • Glepaglutide for short bowel syndrome: 60-80 patients enrolled in Phase 3, on track for 2020 results • Dasiglucagon HypoPal® rescue pen: Clinical program completion and NDA submission to the FDA • Dasiglucagon for dual-hormone pumps: Phase 2 completion • Dasiglucagon for congenital hyperinsulinism: Phase 3 program advancement Advance our early pipeline • Once-weekly GLP-1/GLU: Phase 1 clinical results for obesity/type 2 diabetes1 • Once-weekly Amylin analog: Phase 1 trial initiation for obesity/type 2 diabetes2 • Long-acting GLP-1/GLP-2 dual agonist (ZP7570) for SBS: Phase 1 trial initiation • Complement C3 inhibitor: Pre-clinical development towards Phase 1 initiation in 20203 Expand our strong financial and • Value-adding partnerships for selected fully-owned drug candidates concluded organizational position • Organizational preparedness for commercialization and expansion of U.S. presence • Disciplined financial management with tight cost control 6 1 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 365m in outstanding milestones; 2 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 283m in outstanding milestones. 3 Partnered with Alexion Pharmaceuticals: Zealand eligible for USD 610m in outstanding milestones. Three Phase 3 programs and a promising early pipeline Product Candidate Indication Pre-clinical Phase 1 Phase 2 Phase 3 Registration Glepaglutide GLP-2 Analog Short bowel syndrome ZP7570 GLP-1/GLP-2 Dual Agonist Short bowel syndrome Dasiglucagon HypoPal® Rescue Pen Severe hypoglycemia Dasiglucagon Rare Diseases Congenital hyperinsulinism Dasiglucagon Dual-hormone Pump Therapy Diabetes management GLP-1/GLU Dual Agonist Obesity/Type 2 diabetes1 Amylin Analog Obesity/Type 2 diabetes2 Complement C3 Inhibitor Undisclosed3 GIP/GLP-1/Glucagon Mono/Dual/Triple Undisclosed Ion Channel Blockers Undisclosed 7 1 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 365m in outstanding milestones; 2 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 283m in outstanding milestones. 3 Partnered with Alexion Pharmaceuticals: Zealand eligible for USD 610m in outstanding milestones. Marianne lives with short bowel syndrome and is dependent on daily parenteral support 8 Short bowel syndrome is a chronic and debilitating disease affecting up to 40,000 people in the U.S. and Europe1,2 Rare and severe disease Normal person SBS patient Impaired intestinal absorption, Length of Length of diarrhea and metabolic complications3 gastrointestinal tract gastrointestinal tract ~ 8.5 m /~ 25 ft < 2 m /~ 6.5 ft5 Life-long dependency Complex parenteral support to survive and risk of life-threatening infections and extra-organ impairment4 Need for better treatments Faster and reliable treatment for reduction of parenteral support needs 1 Jeppesen P. Expert Opin Orphan Drugs; 1:515-25; 2 Transparency Market Research; Short Bowel Syndrome Market, 2017; 3 Amiot A et al. Clin Nutr 2013;32:368–74; Boland E et al. Am J Surg 2010;200:690–3; 4 Torres C. Current Paediatr 2006;16:291–7; Bielawska B. 9 Nutrients 2017;9:466–79; Pironi L et al. Clin Nutr 2016;352:247–307; Hofstetter S et al. Curr Med Res Opin 2013;29:495–504; 5 Jeppesen PB. J Parenteral Enteral Nutr. 2014;38 (supplement 1):8S-13S. Zealand data on file; ZP-SBS User Research Glepaglutide: a long-acting GLP-2 analog for treatment of short bowel syndrome We aspire to reduce the Effective and well-tolerated in Phase 2, suggesting a fast and reliable treatment1 burden of living with short bowel syndrome by offering Unique drug profile with effective half-life of ~50 hours glepaglutide as a best-in- class GLP-2 treatment Targets once-weekly dosing in an autoinjector Phase 3 ongoing with results expected in 2020 For illustration only 10 1 Zealand Pharma corporate announcement – No. 21/2017 and No. 5/2018 Superior effect of glepaglutide in pre-clinical intestinal models GLP-2 increases intestinal weight Glepaglutide increases intestinal length3 200 80 ** ** ** ** 60 150 40 100 (cm) 20 50 Small Intestinal length Intestinal Small (% over vehicle) increase Small Intestine Wet Intestine Weight Small 0 0 Low High Veh 1 mg/kg 3 mg/kg 10 mg/kg Veh 10 mg/kg Dose 26 w dosing 6 w recovery Apraglutide (30/300 nmol/kg/day) 1 1 Teduglutide (30/300 nmol/kg/day) 26 week dosing followed by 6 week recovery in Wistar rats Glepaglutide (22/225 nmol/kg/day) 2 Data presented Glerup et al., 2018 at UEGW (P0586) Teduglutide (25/250 nmol/kg/day) 2 1- 5 days dosing SD rats. Extracted from Hargrove et al., DDW poster 2011 (Sa1376) 2- 7 day dosing in Wistar rats. Data on file at Zealand (studies 10-176, 11-019 ) 11 1 Extracted from Hargrove et al., DDW poster 2011 (Sa1376). 5 days dosing in SD rats; 2 Zealand data on file (studies 10-176, 11-019). 7 days dosing in Wistar rats; 3 Glerup et al., 2018 at UEGW (P0586) dosing in dogs. Strong Phase 2 data with increases in intestinal absorption following 3 weeks glepaglutide treatment Change in wet weight absorption (g/day)1 Clear dose-response on multiple endpoints1 • Increase in
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