Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — H1 2021 Earnings Presentation
25 slides from Zealand Pharma A/s's earnings presentation, Aug 12, 2021
Slide 1: First Half 2021 Report
First Half 2021 Report Zealand Pharma 12 August 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: With the ZEGALOGUE approval we have taken another important step in pursuing our ambition
With the ZEGALOGUE® approval we have taken another important step in pursuing our ambition as a fully integrated biopharmaceutical company 5x25 Invest in innovative peptide research platform and robust pipeline Have 5 commercialized products by 2025 Optimize commercial operations Secure strong finan
Slide 5: ZEGALOGUE provides an attractive treatment option for patients and providers alike
ZEGALOGUE® provides an attractive treatment option for patients and providers alike 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 patients in the main adult phase
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: Patient Support Powered by e-Resources
Patient Support Powered by e-Resources Patient Support • Available to patients with all insurance coverage types: Commercial, Medicare, Medicaid, or Eligible commercially insured no insurance patients may pay as little as $25 for • Benefits verification of insurance coverage within 24 hours up to tw
Slide 8: Strong pipeline with significant value potential
Strong pipeline with significant value potential Product Candidate Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed diabetes Dasiglucagon Bi-Hormonal Artificial Pancreas Pump Type 1 Diabetes management Type 1 Dasiglucagon Mini-Dose Pen T1D exercise-induced hypo , Dasiglucagon S.C. Continuou
Slide 9: Creating a paradigm shift in type 1 diabetes management
Creating a paradigm shift in type 1 diabetes management - utilizing dasiglucagon to achieve glycemic goals and quality of life Severe hypoglycemia Exercise-induced Automated glucose hypoglycemia1 management2 Low-dose pen iLet® bihormonal bionic pancreas (investigational device) (investigational devi
Slide 10: Rare diseases
Rare diseases Congenital Hyperinsulinism Short Bowel Syndrome 1H 2021 presentation 12 August 2021 10
Slide 11: We aim to create options to address unmet medical needs
We aim to create options to address unmet medical needs - Gearing up for Phase 3 data readouts for our rare disease franchise in CHI and SBS Congenital Hyperinsulinism (CHI) Short Bowel Syndrome (SBS) • Dasiglucagon s.c. infusion pump • Glepaglutide pen injection • Ultra rare and devastating genetic
Slide 12: Completion of the Phase 3 program for dasiglucagon in Congenital Hyperinsulinism expected in 2021
Completion of the Phase 3 program for investigating dasiglucagon in Congenital Hyperinsulism expected in 2021 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 pa
Slide 13: Glepaglutide pivotal phase 3 trial, EASE SBS 1, on track for 2022 results
Glepaglutide pivotal phase 3 trial, EASE SBS 1, on track for 2022 results EASE SBS 4 Ph3b trial initiation expected Q3 2021 • Open label trial assessing long-term glepaglutide effects on fluid and energy uptake Ini ti at ed 1H 21 3Q 21 i nit iat ion 1H 2021 presentation 12 August 2021 13
Slide 14: Dapiglutide is being investigated as a potential treatment for SBS and wider GI diseases
Dapiglutide is currently being investigated as a potential treatment option for 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 surfa
Slide 15: Obesity
Obesity• 1H 2021 presentation 12 August 2021 15
Slide 16: 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 as a Zealand Pharma’s peptide approach potential treatment option in obesity Dual agonists (one mo
Slide 17: BI 456906 being investigated in three parallel Phase 2 trials in diabetes, obesity and NASH
BI 456906* being investigated in three individual , parallel, Phase 2 trials targeting diabetes, obesity and NASH A long-acting, acylated GLP-1-glucagon dual-acting ~1000 patients planned for enrollment peptide agonist in the Phase 2 program BI 456906 BI 456906 Phase 1a: SAD trial Completed Healthy
Slide 18: Amylin analogs hold potential as combination therapies for obesity
Amylin analogs hold potential as combination therapies for obesity Cagrilintide - amylin analog in development for ZP8396 - amylin analog in preclinical treatment of obesity by Novo Nordisk1 development for treatment of obesity by Zealand Pharma2 • Long-acting, acylated amylin analog • Designed to a
Slide 19: Financials
Financials• 1H 2021 presentation 12 August 2021 19
Slide 20: Income statement
Income statement DKK million 1H 2021 1H 2020 Revenue DKK 132.1 DKK 233.4 Gross margin 65.8 205.4 Research and Development expenses -285.0 -291.7 Sales and Marketing Expenses -202.9 -74.9 Administrative Expenses -128.8 -70.7 Net Operating Expenses -616.6 -437.2 Net Operating Result -550.8 -230.9 Net
Slide 21: Strong balance sheet allows for continued investments
Strong balance sheet allows for continued investments Net Operating Expenses as of June 30, 2021 Cash position as of June 30, 2021 DKK 616.6 million / USD $98.5 million DKK 1.28 billion / USD 205.0 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
Slide 22: 2021 financial guidance
2021 financial guidance No change to financial guidance issued on March 11, 2021 In 2021, Zealand Pharma expects net product revenue from the sales of its commercial products of DKK 220 million +/-10% In 2021, Zealand Pharma expects revenue from existing license agreements. However, since such reven
Slide 23: 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 24: Zealand Pharma expected news flow
Zealand Pharma expected news flow Clinical Financial • Completion of Dapiglutide Phase I program • Q3 Earnings Release – November 11, 2021 • Completion of CHI Phase III program • Initiation of BHAP Phase III program 2021 • BI 456901 Phase 1b 16 week weight lose data • Initiation of Amylin Phase I pr
Slide 25: Q&A session
Q&A session• 1H 2021 presentation 12 August 2021 25