Zealand Pharma A/S · OMXCOP:ZEAL
Zealand Pharma A/S — Q1 2021 Earnings Presentation
20 slides from Zealand Pharma A/S's earnings presentation, May 12, 2021
Slide 1: First Quarter 2021 Report
First Quarter 2021 Report Zealand Pharma 12 May 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: Zegalogue approval a step toward fully integrated biotech
With the Zegalogue approval we have taken another important step in pursuing our ambition as a fully integrated biotech Invest in innovative peptide research platform 5x25 and robust pipeline Have 5 commercialized products by 2025 Optimize commercial operations Secure strong financial situation DKK
Slide 4: Four strategic objectives for a successful launch of ZEGALOGUE
Four strategic objectives to ensure a successful launch of ZEGALOGUE Establish a clear and distinct product positioning with HCPs, Presence patients, and caregivers Focused execution during the “back to school” season Precision prioritizing high-value customer segments Establish favorable market acc
Slide 5: ZEGALOGUE will launch at the right time in a growing market
ZEGALOGUE will launch at the right time in a growing market that is driven by innovation Launch timed to capture Rescue market growing with Innovation driven market with ‘Back to school’ seasonality new entrants new entrants capturing share TRx Units Dispensed (M) 1.2 +60% Rx Volume Lift +10% +6% We
Slide 6: ZEGALOGUE (dasiglucagon) injection: The First and Only Glucagon Analog
ZEGALOGUE ® (dasiglucagon) injection: The First and Only Glucagon Analog • Patients consistently recovered with a single dose1,2,3 • 10-minute median time to blood glucose recovery across all three phase 3 trials1,2,3 • 99% of patients in the main adult phase 3 trial recovered within 15 minutes1,2 •
Slide 7: Indication and Important Safety Information
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 contraindicated in patien
Slide 8: Management
Management Finance & Support Matt Dallas Chief Financial Officer US Business & Operations Emmanuel Dulac Frank Sanders Chief Executive Officer Research & Development Adam Steensberg Chief Medical Officer Technical Development & Operations Ivan M. Møller People & Organization Christina S. Bredal Busi
Slide 9: Significant pipeline evolution and a commitment to continue to deliver
Significant pipeline evolution and a commitment to continue to deliver Preclinical Phase 1 Phase 2 Phase 3 Approved/ Cleared Metabolic V-Go® Wearable Insulin Delivery Type 2 Diabetes management ZEGALOGUE® (dasiglucagon) injection Severe hypoglycemia in diabetes Dasiglucagon S.C. Continuous Infusion
Slide 10: Dasiglucagon investigated in CHI through comprehensive phase 3 program
Dasiglucagon is currently being investigated for use in CHI through the conduct of a comprehensive phase 3 program aimed to address the unmet need in this area Trial 17109 – Completed* Trial 17103 - Ongoing Open-label extension study 17106 - Ongoing 12 patients, age 7 days-12 months. Maximum 44 pati
Slide 11: Bihormonal Bionic Pancreas Pivotal Trial with dasiglucagon in iLet
The Bihormonal Bionic Pancreas Pivotal Trial (BH BPPT) is being conducted to investigate the administration of dasiglucagon in the iLet in adults and children with type 1 diabetes Primary endpoint ADULTS (≥ 18y) Bihormonal with Dasiglucagon (BHBP) • A1C superiority of BH n ~ 350 Insulin-Only iLet (I
Slide 12: BI 456906 long-acting GLP-1-Glu dual agonist in Phase 2
BI 456906, a long-acting GLP-1-Glu dual agonist is being investigated in Phase 2 as a potential therapeutic option for 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 COMPLET
Slide 13: Pre-clinical pipeline in obesity and metabolic diseases progressing towards Phase 1
Pre-clinical pipeline in obesity and other metabolic diseases progressing towards Phase 1 ZP8396, amylin analog alone and in ZP6590, GIP agonist alone and in combination with GLP-1 combination with GLP-1 Vehicle Vehicle Start of ZP Amylin GLP-1 analogue analogue treatment ZP Amylin analogue ZP GIP 7
Slide 14: Glepaglutide – Pivotal Phase 3 trial progressing toward results in 2022
Glepaglutide – Pivotal Phase 3 trial progressing toward results expected in 2022 Glepaglutide – Long-acting stable GLP-2 analog 1Q 2021 presentation 12 May 2021 14
Slide 15: Dapiglutide – Phase 1b trial progressing; results expected in 2021
Dapiglutide – Phase 1b trial progressing; results expected in 2021 Dapiglutide1 - 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 shown to be well-tolerated in
Slide 16: Income statement
Income statement DKK million Q1 2021 Q1 2020 Revenue DKK 47.8 DKK 12.4 Gross margin 24.1 12.4 Research and Development expenses -135.3 -164.5 Sales and Marketing Expenses -81.9 0.0 Administrative Expenses -67.6 -25.1 Operating result -260.9 -177.2 Net financial items 19.8 -3.2 Result before tax -241
Slide 17: Strong balance sheet allows for continued investments
Strong balance sheet allows for continued investments Net Operating Expenses as of March 31, 2021 Cash position as of March 31, 2021 DKK 284.8 million / USD 44.9 million DKK 1.6 billion / USD 252.9 million DKK thousand DKK thousand 1,200,000 1,800,000 1,600,000 1,000,000 1,400,000 800,000 1,200,000
Slide 18: 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 19: Zealand Pharma in 2021
Zealand Pharma in 2021 Historical year as the company becomes a fully integrated biopharmaceutical company Plan for a successful launch of Zegalogue® and optimize commercialization Execute on our robust late-stage clinical pipeline Advance our early-stage programs into the clinic Maintain a strong f
Slide 20: Q&A session
Q&A session• 1Q 2021 presentation 12 May 2021 20