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
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, directors, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the info
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 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 progress com
Slide 4: Zealand Pharma is facing an exciting 2021
Zealand Pharma is facing an exciting 2021 Launch Dasiglucagon Auto-Injector & Prefilled Advance our early pipeline Syringe and optimize commercialization Advance pre-clinical drug candidates towards Phase 1 initiation Execute launch readiness program for Dasiglucagon Auto-Injector and Prefilled Syri
Slide 5: Significant pipeline evolution and a commitment to continue to deliver
Significant pipeline evolution and a commitment to continue to deliver Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed Dasiglucagon Auto-Injector and Prefilled Syringe Severe hypoglycemia Dasiglucagon S.C. Continuous Infusion Congenital hyperinsulinism Dasiglucagon Bi-Hor
Slide 6: Zealand has a comprehensive Phase 3 program to address the unmet need in CHI
Congenital hyperinsulinism Zealand has a comprehensive Phase 3 program to address the unmet need in CHI Trial 17109 – Completed* Trial 17103 - Ongoing Open-label extension study 17106 - Ongoing 12 patients, age 7 days-12 months. Maximum 44 patients, 32 patients, age 3 months-12 years. First patients
Slide 7: Glycemic data from phase 2 study supports decision to move to phase 3 with bihormonal bionic pancreas
Glycemic data from phase 2 study supports decision to move to phase 3 with bihormonal bionic pancreas Phase 2 home-use clinical trial testing Phase 3 trial initiation expected in H2 2021 based the iLet® bionic pancreas using Dasiglucagon1 on positive EoP2 meeting with the FDA Insulin-Only Bihormonal
Slide 8: BI 456806, a long-acting GLP-1-Glu dual agonist is 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 Boehringer-Ingelheim is progressing the development of Zealand’s dual agonist BI 456906* Phase 1a: SAD trial COMPLETED Healthy Volunteers Phase 1b: MAD COMPLETED Obese/OW; 16 weeks P
Slide 9: Pre-clinical pipeline in obesity and other metabolic diseases are designed for dual pharmacology
Pre-clinical pipeline in obesity and other metabolic diseases are designed for dual pharmacology Zealand Pharma addresses dual Amylin analog and GIP agonist induce more weight loss in combination pharmacology from several angles with GLP-1 versus GLP-1 alone in preclinical obesity model Dual agonist
Slide 10: Glepaglutide – Pivotal Phase 3 trial progressing toward results in 2022
Glepaglutide – Pivotal Phase 3 trial progressing toward results in 2022 Trial design • Double-blind, placebo controlled trial in 129 SBS patients evaluating safety and efficacy of once and twice weekly dosing over 24 weeks Primary and key secondary endpoints • Reduction in weekly parenteral support
Slide 11: Dapiglutide has potential to treat SBS as well as a wider range of gastrointestinal diseases
Dapiglutide has potential to treat SBS as well as a wider range of gastrointestinal diseases Dapiglutide1,2 - Long-acting GLP-1/GLP-2 Vehicle Clinical progress GLP-2 agonist dual agonist GLP1/GLP-2 dual agonist Phase 1a (SAD) Small intestine - Total surface2 area 1000 p<0.001 *** • Dapiglutide was c
Slide 12: Pre-clinical pipeline for IBD and other chronic inflammatory diseases
Pre-clinical pipeline for IBD and other chronic inflammatory diseases ZP9830, Kv1.3 blocker for T cell ZP10000, an α4β7 integrin inhibitor Complement C3 peptide inhibitor – driven chronic inflammatory for oral delivery outlicenced to Alexion diseases incl. IBD • Blockage of Kv1.3 ion channels on T e
Slide 13: Income statement
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
Slide 14: Strong balance sheet allows for continued investments
Strong balance sheet allows for continued investments Net Operating Expenses Cash position1 DKK 1,092.1 million / USD 166.9 million DKK 1.28 billion / USD 192.2 million DKK thousand DKK thousand 1,200,000 1,600,000 1,400,000 1,000,000 1,200,000 800,000 1,000,000 600,000 800,000 600,000 400,000 400,0
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 uncertai
Slide 16: 2020 was a significant year for Zealand Pharma
2020 was a significant year for Zealand Pharma We are passionate about transforming 5x25 patients’ lives through peptide innovation and novel treatment solutions 329 5 commercialized products by 2025 Employees Offices in Copenhagen, New York, Boston Fully integrated biotech with U.S. commercial pres
Slide 17: Q&A session
Q&A session• FY 2020 presentation 11 March 2021 17