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 13, 2021
Slide 1: First Half 2021 Report Zealand Pharma
First Half 2021 Report Zealand Pharma 12 August 2021
Slide 2: Forward looking statement
1H 2021 presentation 12 August 2021 2 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 t
Slide 3: Zealand Pharma in 2021
3 Launch of Zegalogue ® with an optimized commercial team Advance our early - stage programs into the clinic Execute on our robust late - stage clinical pipeline Maintain a strong financial and organizational position Zealand Pharma in 2021 Historical year as the company becomes a fully integrated b
Slide 4: Ambition as a fully integrated biopharmaceutical company: 5x25
With the ZEGALOGUE® approval we have taken another important step in pursuing our ambition as a fully integrated biopharmaceutical company Have 5 commercialized products by 2025 5x25 Fully operational US infrastructure High prescriber coverage Established relationships with KOLs and HCPs Optimize co
Slide 5: ZEGALOGUE provides an attractive treatment option for patients and providers
ZEGALOGUE ® provides an attractive treatment option for patients and providers alike 5 99% of patients in the main adult phase 3 trial recovered within 15 minutes All pivotal phase 3 studies reported the same median time to recovery Recovery Consistent 1H 2021 presentation 12 August 2021 Median time
Slide 6: ZEGALOGUE Indication and Important Safety Information
ZEGALOGUE ® Indication and Important Safety Information 6 INDICATION ZEGALOGUE (dasiglucagon) injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with di abetes aged 6 years and above. IMPORTANT SAFETY INFORMATION Contraindications ZEGALOGUE is contraindic
Slide 7: Patient Support Powered by e-Resources
Patient Support Powered by e - Resources Eligible commercially insured patients may pay as little as $25 for up to two ZEGALOGUE® devices per fill at pharmacies nationwide • Available to patients with all insurance coverage types: Commercial, Medicare, Medicaid, or no insurance • Benefits verificati
Slide 8: Pipeline and licensed partnerships
8 1 Licensed to Boehringer Ingelheim: EUR 345 million outstanding potential development, regulatory and commercial milestones + h ig h single to low double digit % royalties on global sales 2 Licensed to AstraZeneca: USD 610 million potential development, regulatory and commercial milestones + high
Slide 9: Type 1 diabetes management with dasiglucagon
9 iLet ® bihormonal bionic pancreas (investigational device) Low - dose pen (investigational device) Creating a paradigm shift in type 1 diabetes management - utilizing dasiglucagon to achieve glycemic goals and quality of life Severe hypoglycemia Exercise - induced hypoglycemia 1 Automated glucose
Slide 10: Rare diseases: Congenital Hyperinsulinism, Short Bowel Syndrome
Rare diseases 1H 2021 presentation 12 August 2021 10 Congenital Hyperinsulinism Short Bowel Syndrome
Slide 11: Addressing unmet medical needs in CHI and SBS
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 1H 2021 presentation 12 August 2021 11 Congenital Hyperinsulinism (CHI) Short Bowel Syndrome (SBS) 1 https://www.orpha.net/consor/cgi - bin/ (not including tra
Slide 12: Dasiglucagon CHI phase 3 trials
1H 2021 presentation 12 August 2021 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 p
Slide 13: Glepaglutide pivotal trial EASE SBS 1 on track for 2022 results
Glepaglutide pivotal phase 3 trial, EASE SBS 1, on track for 2022 results 13 EASE SBS 4 Ph3b trial initiation expected Q3 2021 • Open label trial assessing long - term glepaglutide effects on fluid and energy uptake 1H 2021 presentation 12 August 2021
Slide 14: Dapiglutide long-acting GLP-1/GLP-2 dual agonist
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 (SAD)
Slide 15: Obesity
Obesity • 1H 2021 presentation 12 August 2021 15
Slide 16: Obesity requires additional treatment options
Obesity is a complex metabolic disease requiring additional treatment options - 650 million adults and 124 million children and adolescents suffering from obesity 1 Dual - pharmacology holds great promise as a potential treatment option in obesity 1 Kumanyika S et al., N Engl J Med (2020) 383:2197 -
Slide 17: BI 456906 in three parallel Phase 2 trials
BI 456906* being investigated in three individual , parallel, Phase 2 trials targeting diabetes, obesity and NASH 17 ~1000 patients planned for enrollment in the Phase 2 program Phase 1: PK/safety Japanese HV Phase 1b: MAD Obese/OW; 16 weeks Phase 1a: SAD trial Healthy Volunteers Phase 2: Type 2 dia
Slide 18: Amylin analogs as combination therapies for obesity
18 Amylin analogs hold potential as combination therapies for obesity Cagrilintide - amylin analog in development for treatment of obesity by Novo Nordisk 1 ZP8396 - amylin analog in preclinical development for treatment of obesity by Zealand Pharma 2 1 Novo Nordisk Q2, financial results investor pr
Slide 19: Financials
Financials • 1H 2021 presentation 12 August 2021 19
Slide 20: Income statement
Income statement 1H 2021 presentation 12 August 2021 20 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
Slide 21: Net operating expenses and cash position
Net Operating Expenses as of June 30, 2021 DKK 616.6 million / USD $98.5 million Cash position as of June 30, 2021 DKK 1.28 billion / USD 205.0 million 0 200,000 400,000 600,000 800,000 1,000,000 1,200,000 2017 2018 2019 2020 1H 2021 R&D expenses G&A expenses Sales & Marketing expenses 0 200,000 400
Slide 22: 2021 financial guidance
2021 financial guidance 1H 2021 presentation 12 August 2021 22 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 lice
Slide 23: Zealand Pharma in 2021
23 Launch of Zegalogue ® with an optimized commercial team Advance our early - stage programs into the clinic Execute on our robust late - stage clinical pipeline Maintain a strong financial and organizational position Zealand Pharma in 2021 Historical year as the company becomes a fully integrated
Slide 24: Zealand Pharma expected news flow
Clinical • Completion of Dapiglutide Phase I program • Completion of CHI Phase III program • Initiation of BHAP Phase III program • BI 456901 Phase 1b 16 week weight lose data • Initiation of Amylin Phase I program Corporate Presentation 24 Zealand Pharma expected news flow 2021 2022 Financial • Q3
Slide 25: Q&A session
Q&A session • 1H 2021 presentation 12 August 2021 25