Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Q1 2023 Earnings Presentation
16 slides from Zealand Pharma A/s's earnings presentation, May 11, 2023
Slide 1: Q1 2023 Interim Report
Q1 2023 Interim Report Zealand Pharma May 11, 2023
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 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharm
Slide 3: Continuing strong momentum in 2023 with significant pipeline progress and strengthening of balance sheet
Continuing strong momentum in 2023 with significant pipeline progress and strengthening of balance sheet Positive topline results from Positive topline results from Patient enrollment opened to Phase 2 trial of GCGR/GLP-1 dual Phase 1a SAD trial with long- Phase 2 investigator-led trial of agonist*
Slide 4: In 2023 we have three key strategic objectives focused on maximizing the value potential of our pipeline
In 2023 we have three key strategic objectives focused on maximizing the value potential of our pipeline 1 Progress rare disease assets 2 3 Engage in strategic Advance obesity portfolio toward regulatory submission partnership discussions Dasiglucagon for congenital BI 4569061 (GCGR/GLP-1R) Rare dis
Slide 5: Our R&D pipeline addresses unmet medical needs across several therapeutic areas
Our R&D pipeline addresses unmet medical needs across several therapeutic areas Product Candidate* Preclinical Phase 1 Phase 2 Phase 3 Registration , diseases Dasiglucagon: S.C. Continuous Infusion Congenital Hyperinsulinism Rare Glepaglutide (GLP-2 Analog) Short Bowel Syndrome BI 456906 (GCGR/GLP-1
Slide 6: Dasiglucagon has potential to address shortcomings of current management of Congenital Hyperinsulinism
Dasiglucagon has potential to address shortcomings of current management of Congenital Hyperinsulinism • CHI is a rare disease that affects babies and children • Dasiglucagon administered as a continuous subcutaneous infusion via a wearable pump system • NDA submission expected in Q2 2023 Investigat
Slide 7: Glepaglutide Phase 3 clinical program focused on regulatory submission in H2 2023
Glepaglutide Phase 3 clinical program focused on regulatory submission in H2 2023 Phase 3a pivotal trial EASE 1 Placebo, once and twice NCT03690206 weekly treatment (~24 weeks) Phase 3 extension trials EASE 2 Once and twice weekly long-term NCT03905707 treatment (~104 weeks) EASE 3 Once weekly long-
Slide 8: Targeting obesity with differentiated candidates
Targeting obesity with differentiated candidates Dual pharmacology with a GLP-1 Single pharmacology as receptor agonist foundation combinable alternative modality GLP-1 Designed for administering • Increase insulin sensitivity as a “loose combination” • Delay gastric emptying or co-formulation with
Slide 9: BI456906: body weight loss up to mean of 14.9% from baseline at 46 weeks
BI456906: body weight loss up to mean of 14.9% from baseline at 46 weeks • Phase 2 dose-finding study in people with obesity or overweight, including 20 weeks of dosing escalation and 26 weeks maintenance • Primary endpoint: Percentage change in body weight from baseline to week 46 • Efficacy: dose-
Slide 10: ZP8396 amylin: body weight loss up to mean of 4.2% from baseline after single dose
ZP8396 amylin: body weight loss up to mean of 4.2% from baseline (4.8% placebo-corrected) after single dose • Phase 1a first-in-human, single ascending dose (SAD) study designed to assess safety, pharmacokinetic (PK) and pharmacodynamic effects of ZP8396 in healthy lean and overweight people • Parti
Slide 11: Dapiglutide is a dual GLP-1/GLP-2 receptor agonist targeting energy intake and low-grade inflammation
Dapiglutide is a dual GLP-1/GLP-2 receptor agonist targeting energy intake and low-grade inflammation Rationale • Target weight loss that exceeds that seen for GLP-1 receptor agonism alone • Maintain (or improve) glycemic control • Improve intestinal barrier function to potentially reduce chronic lo
Slide 12: Q1 2023 Profit & Loss
Q1 2023 Profit & Loss DKK million Q1 2023 Q1 2022 P&L reflecting Zealand’s ambition to be leading peptide drug discovery and development company while commercializing products through partnerships Revenue 13.6 11.0 • Revenue of DKK 14 million in Q1 2023 driven by agreement with Novo Nordisk Gross ma
Slide 13: Strong cash position allows for investments in R&D, extending runway to mid-2026
Strong cash position allows for investments in R&D, extending runway to mid-2026 DKK million Cash position of DKK 2,502 million as of April 4, 20231 3.000 2.502 2,502 2.500 2.000 1.500 1.500 1.178 1.002 1,002 197 21 1.000 500 0 Cash position Cash Other cash Cash position Capital raise Cash position
Slide 14: 2023 financial guidance
2023 financial guidance • Guidance unchanged from March 2, 2023 DKK million 2023 2022 Guidance Actual Revenue anticipated from existing and new license and No guidance 104 partnership agreements due to uncertain size and timing Net operating expenses1 800 - 900 941 Notes 1. Net operating expenses co
Slide 15: On track to deliver on our strategic priorities in 2023
On track to deliver on our strategic priorities in 2023 Progress rare Engage in disease Advance strategic assets toward obesity partnership regulatory portfolio discussions submissions 15
Slide 16: Q&A session
Q&A session• 1Q 2023 presentation 11 May 2023 16