Zealand Pharma A/S · OMXCOP:ZEAL
Zealand Pharma A/S — 9M 2021 Earnings Presentation
25 slides from Zealand Pharma A/S's earnings presentation, Nov 11, 2021
Slide 1: 9M 2021 Interim report
9M 2021 Interim report Zealand Pharma 11 November 2021
Slide 2: Forward looking statement
Forward looking statement This presentation contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commerciali
Slide 3: Zealand Pharma in 2021
Zealand Pharma in 2021 Historical year as the company becomes a fully integrated biopharmaceutical company Launch of Zegalogue® with an optimized commercial team Execute on our robust late-stage clinical pipeline Advance our early-stage programs into the clinic Maintain a strong financial and organi
Slide 4: Our mission is to change lives with next generation peptide therapeutics
Our mission is to change lives with next generation peptide therapeutics 2025 ambition 5 commercialized products A continuously growing pipeline Advance potential Create a paradigm shift Key player in fast- Lead in SBS and CHI treatments options in Type 1 diabetes developing obesity rare diseases fo
Slide 5: 10 Minutes Consistent Recovery
Establish ZEGALOGUE® as an attractive option for the treatment of Severe Hypoglycemia in patients ages 6 and older 10 Minutes Median time to blood glucose recovery of 10 minutes in adults and children Consistent All pivotal phase 3 studies reported the same median time to recovery Recovery 99% of pa
Slide 6: ZEGALOGUE Indication and Important Safety Information
ZEGALOGUE ® Indication and Important Safety Information INDICATION ZEGALOGUE (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. IMPORTANT SAFETY INFORMATION Contraindications ZEGALOGUE is contraindicate
Slide 7: ZEGALOGUE demand and utilization in Q3 2021
ZEGALOGUE® demand and utilization in Q3 2021 ~3800 ~515 unique prescription claims* prescribers*ᵼ ~1.9 average units ~62% repeat dispensed per Rx* prescribers* Sources: *Symphony weekly data, ᵼ Symphony True Benefit Design, ᵼ Zealand HUB Internal Prescription and Copay Utilization, through 9/30/2021
Slide 8: ZEGALOGUE market access coverage is being established quickly
ZEGALOGUE® market access coverage in being established quickly Setting the stage for an acceleration of prescription volume growth in 2022 % Covered Lives* – Commercial and Medicaid 70 70 In Q1 2022, ~130M Commercial and ~50M 50 50 Medicaid recipients will have access to ZEGALOGUE® with 16 10 favora
Slide 9: Our Pipeline – therapeutic areas with high unmet medical needs
Our Pipeline – 4 therapeutic areas with high unmet medical needs Product Candidate* Preclinical Phase 1 Phase 2 Phase 3 Registration diabetes Dasiglucagon Bi-Hormonal Artificial Pancreas Pump Type 1 Type 1 Diabetes management Dasiglucagon Low-Dose Pen T1D exercise-induced hypo , Dasiglucagon S.C. Co
Slide 10: Normalizing glycemia in Type 1 Diabetes with dasiglucagon in Bi-Hormonal iLet
Type 1 Diabetes Normalizing glycemia in Type 1 Diabetes with dasiglucagon in Bi-Hormonal iLet® Artificial Pancreas One study found that only ~20% of people with Type 1 90% of subjects on Bihormonal iLet® Bionic Diabetes in the US achieve ADA therapy goal of Pancreas3 had a CGM glucose < 154 mg/dL2 H
Slide 11: Bihormonal Bionic Pancreas Pivotal Phase 3 Clinical Program
Type 1 Diabetes Bihormonal Bionic Pancreas Pivotal Phase 3 Clinical Program on track for initiation in Q4 21 Test Run 13 weeks 60 subjects Safety/iLet® performance RCTs to be initiated after 20 pediatric and 20 adult subjects treated for 3 weeks Adult RCT Primary End-point(26 weeks) Long-Term Safety
Slide 12: Gearing up for results from second Phase 3 trial for dasiglucagon in CHI
Gearing up for results from second Phase 3 trial for dasiglucagon in CHI Trial 17109 Trial 17103 Trial 17106 32 patients 12 patients Up to 44 patients (>1 (3 months-12 years old) (7 days-12 months old) month old) Hypo-prone, maximum Patients from 17109 and Newly diagnosed, therapy, incl. pancreatic
Slide 13: Collaboration agreements with DEKA Research and Development Corp.
Collaboration agreements with DEKA Research and Development Corp. announced November 5, 2021 • DEKA is a Manchester, NH based research and development company founded in 1982 by Dean Kamen and comprised of engineering, manufacturing and quality assurance professionals • Agreement grants Zealand a wo
Slide 14: Glepaglutide is being developed as a next generation GLP-2 in SBS
Glepaglutide is being developed as a next generation GLP-2 in SBS Glepaglutide1 Phase 2 data showed increases in intestinal a long-acting stable GLP-2 analog absorption following 3-week administration • Forms depot at injection site with Change in wet weight Clear dose-response effective half-life o
Slide 15: Glepaglutide is on track for pivotal Phase 3 results in 2022
Glepaglutide is on track for pivotal Phase 3 results in 2022 The Phase 3 program will provide up to 4.5 years patient exposure to glepaglutide and clinical evidence for efficacy and safety 15 9M 2021 presentation 11 November 2021
Slide 16: Glepaglutide Phase 3 Pivotal Trial
Glepaglutide Phase 3 Pivotal Trial Results of interim analysis expected in Q3 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 parente
Slide 17: Dapiglutide is being investigated as a potential treatment option for SBS
Dapiglutide is being investigated as a potential treatment option for SBS - as well as a wider range of gastrointestinal diseases Dapiglutide 1,2 - Long-acting GLP-1/GLP-2 Vehicle Clinical progress dual agonist GLP-2 agonist Phase 1a (SAD) GLP1/GLP-2 dual agonist • Dapiglutide was well-tolerated in
Slide 18: Obesity is a complex metabolic disease requiring additional treatment options
Obesity is a complex metabolic disease requiring additional treatment options - 650 million adults and 124 million children and adolescents suffering from obesity1 Dual-pharmacology holds great promise Zealand Pharma’s peptide approach in treatment of obesity % Dual agonists (one molecule – two acti
Slide 19: BI 456906 is being investigated in three separate Phase 2 trials
BI 456906* is being investigated in three separate Phase 2 trials targeting diabetes, obesity and NASH Phase 1 Study of Glucagon-like Peptide-1/Glucagon ~1000 patients planned for enrollment Receptor Dual Agonist BI 456906 in Obesity** in the Phase 2 program Phase 1a: SAD trial Completed Healthy Vol
Slide 20: Amylin analogs hold potential as mono- and combination therapy for obesity
Amylin analogs hold potential as mono- and combination therapy for obesity Potent Effects of Amylin Analogue ZP8396 in ZP8396 in development for Combination with Semaglutide in DIO Rats1 treatment of obesity • Long-acting, acylated amylin analog2 • Designed to allow for co- formulation with other pe
Slide 21: Income statement
Income statement DKK million 9M 2021 9M 2020 Revenue DKK 238.6 DKK 290.0 Gross margin 143.6 227.7 Research and Development expenses -426.3 -431.0 Sales and Marketing Expenses -281.7 -172.3 Administrative Expenses -198.3 -111.2 Net Operating Expenses -906.2 -714.5 Net Operating Result -762.6 -449.1 N
Slide 22: Strong balance sheet allows for continued investments
Strong balance sheet allows for continued investments Net Operating Expenses as of Sept. 30, 2021 Cash position as of Sept. 30, 2021 DKK 906.2 million / USD $141.1 million DKK 1.05 billion / USD $163.3 million DKK thousand DKK thousand 1,200,000 1,600,000 1,400,000 1,000,000 1,200,000 800,000 1,000,
Slide 23: 2021 financial guidance
2021 financial guidance • Net product revenue from the sales of commercial products is expected to be DKK 190 million +/- 10%. This is a decrease of DKK 30 million from the guidance issued on March 11, 2021. The reduction in net revenue from the previous guidance is driven by lower-than-expected sal
Slide 24: Our 2025 ambition is to have 5 products on the market
Our 2025 ambition is to have 5 products on the market and a highly valued pipeline leveraging our innovative peptide platform 2 in ’22 5 in ’25 Glepaglutide for SBS Proprietary peptide platform Our vision in Obesity Our vision in Dasiglucagon for CHI Inflammatory diseases Life cycle management Bi-Ho
Slide 25: Q&A session
Q&A session• 9M 2021 presentation 11 November 2021 25