Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Q3 2023 Earnings Presentation
17 slides from Zealand Pharma A/s's earnings presentation, Nov 9, 2023
Slide 1: Q3 2023 Interim Report
Q3 2023 Interim Report Zealand Pharma November 9, 2023
Slide 2: Forward-looking Statements
Forward-looking Statements 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 Phar
Slide 3: Q3 2023 saw strong progress across obesity pipeline and first PDUFA date for dasiglucagon in CHI
Q3 2023 saw strong progress across obesity pipeline and first PDUFA date for dasiglucagon in CHI NON-EXHAUSTIVE Survodutide Announced details on dual GCGR/GLP-1R Phase 3 program Dasiglucagon in congenital hyperinsulinism receptor agonist SYNCHRONIZETM Granted Priority Review with Dec-30, 2023 PDUFA
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 ✓ Survodutide1 (GCGR/GLP-1R) Ra
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 Survodutide (GCGR/GLP
Slide 6: The success of future weight loss therapies will be determined by differentiation on multiple fronts
The success of future weight loss therapies will be determined by differentiation on multiple fronts GLP-1 backbone GLP-1 mono Examples of differentiation factors • Effects on comorbidities to obesity such as CVD, NASH, T2DM, GLP-1/GIP CKD, and OA GLP-1/GCG* • Improved tolerability by addressing GI
Slide 7: The Phase 3 program with survodutide in obesity includes three global registrational trials
The Phase 3 program with survodutide in obesity includes three global registrational trials Inclusion criteria Study design Primary endpoint SYNCHRONIZETM-1 • HbA1c <6.5% (no history of diabetes) • N = 600 • Percentage change in BW from • BMI ≥30 or BMI ≥27 with • 1:1:1 ratio (active 3.6mg, baseline
Slide 8: Very low doses of ZP8396 delivered >5% weight loss after 6 weeks
Very low doses of ZP8396 delivered >5% weight loss after 6 weeks ZP8396 in a low 0.6 mg dose delivered average weight loss of 5.3% after six once-weekly doses Part 1 of Phase 1b multiple ascending dose trial with ZP83961 • Healthy lean and overweight people randomized (7:3) and treated with either Z
Slide 9: In Part 1 of MAD trial, ZP8396 was well tolerated with no serious or severe AEs and no withdrawals
In Part 1 of MAD trial, ZP8396 was well tolerated with no serious or severe AEs and no withdrawals All related adverse events were mild, transient and most had an onset within two days of the first dose Treatment-emergent adverse events (TEAEs) in Part 1 of Phase 1b MAD trial with ZP83961 No. of sub
Slide 10: Results from Part 2 of the trial, exploring higher doses of ZP8396 over 16 weeks are expected in H1 2024
Results from Part 2 of the trial, exploring higher doses of ZP8396 over 16 weeks are expected in H1 2024 We are investigating …over a longer duration …using an up-titration …in 48 people with significantly higher of 16 weeks… scheme… overweight or obesity*… doses of ZP8396… Notes: *) Eligible BMI 27
Slide 11: Priority review for dasiglucagon in CHI for up to three weeks of dosing with PDUFA date December 30, 2023
Priority review for dasiglucagon in CHI for up to three weeks of dosing with PDUFA date December 30, 2023 To make dasiglucagon available to infants and children with CHI as soon as possible, the US FDA recommended conducting the review of the NDA in two parts Part 1 • Up to three weeks of dosing • P
Slide 12: Q3 2023 YTD Profit & Loss
Q3 2023 YTD Profit & Loss DKK million Q3-23 YTD Q3-22 YTD P&L reflecting Zealand’s ambition to be leading peptide drug discovery and development company while commercializing products through partnerships Revenue 319.6 80.1 • Revenue of DKK 320 million is driven by milestones from BI* for survodutid
Slide 13: Solid cash position allows for investments in R&D
Solid cash position allows for investments in R&D DKK million Cash position of DKK 1,932 million as of September 30, 20231 1,932 285 1,932 2.000 -526 350 350 1.500 1.178 1.500 -485 1.000 1.198 -85 500 384 0 Cash Cash Other cash Gross Repayment Cash Expected 2020 2021 2022 30-Sep-23 position 3 flow f
Slide 14: 2023 financial guidance confirmed
2023 financial guidance confirmed 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 consist of R&D, S&M, G&A and oth
Slide 15: Multiple future events and catalysts across several therapeutic areas
Multiple future events and catalysts across several therapeutic areas NON-EXHAUSTIVE Q4 2023 2024 Survodutide Survodutide Initiation of Ph3 trials Topline results from Ph2 trial in NASH Glepaglutide (SBS) ZP8396 (amylin) Regulatory submission to US FDA Topline results from MAD Part 2 Dasiglucagon (C
Slide 16: Obesity R&D Event on December 5, 2023 in London
Obesity R&D Event on December 5, 2023 in London Professor Daniel Drucker Targeting obesity and low-grade inflammation with GLP-1/GLP-2 Professor Louis Aronne Register for in-person or virtual attendance: Amylin as a next-generation weight https://www.zealandpharma.com/event/zealan loss therapy, repr
Slide 17: Q&A session
Q&A session• Q3 2023 presentation November 9, 2023 17