Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — FY2020 Earnings Presentation
17 slides from Zealand Pharma A/s's earnings presentation, Mar 11, 2021
Slide 1: Full Year 2020 Report Zealand Pharma
Full Year 2020 Report Zealand Pharma 11 March 2021
Slide 2: Forward-looking statements
Forward - looking statements • This presentation contains information pertaining to Zealand Pharma A/S (“Zealand”). Neither Zealand nor its management, dire cto rs, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the
Slide 3: Established Commercial Operations Ahead of Potential Product Launch And Continued To Advance Pipeline
Established Commercial Operations Ahead of Potential Product Launch And Continued To Advance Pipeline 3 Business highlights for Q4 2020 and subsequent events • Dasiglucagon auto - injector and pre - filled syringe for severe hypoglycemia: Strengthened US commercial operations and continued to progre
Slide 4: Zealand Pharma is facing an exciting 2021
Zealand Pharma is facing an exciting 2021 4 Launch Dasiglucagon Auto - Injector & Prefilled Syringe and optimize commercialization Advance our early pipeline Execute launch readiness program for Dasiglucagon Auto - Injector and Prefilled Syringe Launch Dasiglucagon Auto - Injector & Prefilled Syring
Slide 5: Significant pipeline evolution and a commitment to continue to deliver
5 Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed Dasiglucagon Auto - Injector and Prefilled Syringe Dasiglucagon S.C. Continuous Infusion Dasiglucagon Bi - Hormonal Artificial Pancreas Pump Dasiglucagon Adjustable Mini - Dose BI 456906 GLP - 1/GLU Dual Agonist 1 ZP 8396
Slide 6: Dasiglucagon in congenital hyperinsulinism trials
6 Trial 17109 – Completed* Trial 17103 - Ongoing Open - label extension study 17106 - Ongoing * Dasiglucagon on top of standard of care (SOC) did not significantly reduce the rate of hypoglycemia compared to SOC alone when assessed by i ntermittent self - measured plasma glucose (primary endpoint).
Slide 7: Phase 2 home-use trial of iLet bionic pancreas using dasiglucagon
7 1 S. Russell et al. 2020. Conference. DIABETES TECHNOLOGY & THERAPEUTICS. Page A - 53. 2 The iLet ® bionic pancreas is an investigational device limited by Federal (or United States) law to investigational use. Not available for sale. Phase 2 home - use clinical trial testing the iLet ® bionic pan
Slide 8: BI 456806 GLP-1/Glucagon dual agonist in Phase 2
BI 456806, a long - acting GLP - 1 - Glu dual agonist is in Phase 2 as a potential novel treatment of T2D, obesity and NASH 8 Boehringer - Ingelheim is progressing the development of Zealand’s dual agonist BI 456906* Phase 1: PK/safety Japanese HV Phase 1b: MAD Obese/OW; 16 weeks Phase 1a: SAD trial
Slide 9: Pre-clinical pipeline in obesity and other metabolic diseases
Pre - clinical pipeline in obesity and other metabolic diseases are designed for dual pharmacology Dual agonist (one molecule – two actions) • BI456906 – GLP - 1/Glucagon receptor - agonist 9 Zealand Pharma addresses dual pharmacology from several angles Amylin analog and GIP agonist induce more wei
Slide 10: Glepaglutide – Pivotal Phase 3 trial progressing toward results in 2022
10 • Reduction in weekly parenteral support (PS volume) • >20% reduction in PS volume • Reduction in weekly days on PS Trial design Primary and key secondary endpoints • Double - blind, placebo controlled trial in 129 SBS patients evaluating safety and efficacy of once and twice weekly dosing over 2
Slide 11: Dapiglutide – Long-acting GLP-1/GLP-2 dual agonist
11 1 pINN and data on file; 2 IP protection until at least 2037; 3 Madsen et al, Regulatory Peptides 184 (2013) 30 - 39 Dapiglutide 1,2 - Long - acting GLP - 1/GLP - 2 dual agonist Clinical progress Clinical experience with short - term GLP - 1 and GLP - 2 combination treatment in SBS 3 Phase 1a (SA
Slide 12: Pre-clinical pipeline for IBD and other chronic inflammatory diseases
Pre - clinical pipeline for IBD and other chronic inflammatory diseases • Blockage of Kv1.3 ion channels on T effector memory cells involved in auto - immunity and chronic inflammation • Optimized for selectivity, potency and stability • In preparation for IND enabling toxicology studies 12 ZP9830,
Slide 13: Income statement
DKK million FY 2020 FY 2019 Revenue DKK 353.3 DKK 41.3 Gross margin 262.7 40.9 Research and Development expenses - 604.1 - 561.4 Sales and Marketing Expenses - 285.3 0.0 Administrative Expenses - 202.8 - 67.9 Operating result - 792.4 - 587.9 Net financial items - 47.3 11.3 Result before tax - 839.7
Slide 14: Strong balance sheet allows for continued investments
14 Net Operating Expenses DKK 1,092.1 million / USD 166.9 million Cash position 1 DKK 1.28 billion / USD 192.2 million 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 2016 2017 2018 2019 2020 R&D expenses G&A expenses Sales & Marketing expenses 0 200,000 400,000 600,000 800,000 1,000,000 1,200
Slide 15: 2021 financial guidance
2021 financial guidance • In 2021, Zealand Pharma expects net product revenue from the sales of its commercial products of DKK 220 million +/ - 10% compared to 2020 of DKK 161.3 million. • In 2021, Zealand Pharma expects revenue from existing license agreements. However, since such revenue is uncert
Slide 16: 2020 was a significant year for Zealand Pharma
2020 was a significant year for Zealand Pharma 16 We are passionate about transforming patients’ lives through peptide innovation and novel treatment solutions 5 commercialized products by 2025 Commercial foundation established Late - stage assets and robust early pipeline Employees License partners
Slide 17: Q&A session
Q&A session • 11 March 2021 FY 2020 presentation 17