Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Q3 2024 Earnings Presentation
23 slides from Zealand Pharma A/s's earnings presentation, Nov 7, 2024
Slide 1: Q3 2024 Presentation
Q3 2024 Presentation Zealand Pharma
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: Significant progress across obesity pipeline
Significant progress across obesity pipeline Petrelintide Dapiglutide Survodutideb (amylin analog) (dual GLP-1/GLP-2 receptor agonist) (dual GCG/GLP-1 receptor agonist) Presented extremely encouraging Reported positive topline data from Boehringer Ingelheim announced weight loss and tolerability dat
Slide 4: GLP-1RA-based therapies are effective at reducing weight in PwO, but are associated with GI tolerability issues
GLP-1RA-based therapies are effective at reducing weight in PwO, but are associated with GI tolerability issues1 There is a significant unmet need for alternative treatment options with different mechanisms of action Today, two QW GLP-1RA-based therapies are Petrelintide represents an alternative ap
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 candidatea Partnered Pre-clinical Phase 1 Phase 2 Phase 3 Registration , Dapiglutide (GLP-1R/GLP-2R dual agonist) Obesity Obesity Petrelintide (amylin analog) Obesity Obesity ZP6590 (GIP receptor agonist) Obesity
Slide 6: Design of Phase 1b MAD trial Part 2 with petrelintide
Obesity Petrelintide Design of Phase 1b MAD trial Part 2 with petrelintide A randomized, double-blind, placebo-controlled, Phase 1b, MAD trial of petrelintide – Part 21,2 Aim: to evaluate the safety, tolerability, PK and PD of multiple SC doses of petrelintide, with dose escalation Dose escalation w
Slide 7: Substantial weight loss was observed with petrelintide at 16 weeks in the Phase 1b MAD trial Part 2
Obesity Petrelintide Substantial weight loss was observed with petrelintide at 16 weeks in the Phase 1b MAD trial Part 2 Observed mean (95% CI) percent change from baseline in body weight 2 Petrelintide 2.4 mg Petrelintide 4.8 mg 0 -2 -8.6% -4 Change from baseline (%) -6 -8 -4.8% -10 Baseline: 98.1
Slide 8: High levels of study treatment completion and adherence with dose escalation within cohorts
Obesity Petrelintide High levels of study treatment completion and adherence with dose escalation within cohorts 0.6 1.2 2.4 mg 0.6 1.2 2.4 3.6 4.8 mg 1.0 2.0 4.0 6.0 7.5 9.0 mg Due to other Due to AEs 1 reasons 2 Due to other 3 reasons 4 Participants 5 6 7 8 9 10 11 12 0 2 4 6 8 10 12 14 16 0 2 4 6
Slide 9: Vast majority of TEAEs reported by petrelintide-treated patients were mild
Obesity Petrelintide Vast majority of TEAEs reported by petrelintide- treated patients were mild Only one petrelintide-treated participant discontinued treatment due to TEAEs 100% 100% 92% E=58 92% E=95 12 Placebo (N=12) E=62 12 E=63 12 11 11 Petrelintide 2.4 mg (N=12) 10 Number of participants Petr
Slide 10: Petrelintide treatment appeared safe and was well-tolerated at all dose levels in the 16-week trial
Obesity Petrelintide Petrelintide treatment appeared safe and was well-tolerated at all dose levels in the 16-week trial All GI TEAEs were mild, except for one event of moderate nausea and moderate vomiting in one participant 12 Nausea 12 Vomiting Number of participants 10 10 8 8 6 33% 33% 6 E=6 E=1
Slide 11: Continuing development of petrelintide as monotherapy through a comprehensive Phase 2b trial
Obesity Petrelintide Continuing development of petrelintide as monotherapy through a comprehensive Phase 2b trial A randomized, double-blind, placebo-controlled, Phase 2b trial with petrelintide to be initiated in Q4 2024 Aim: to evaluate change in body weight with multiple doses of petrelintide ver
Slide 12: Placebo-adjusted mean weight loss of up to 8.3% with dapiglutide in 13-week Part 1 of Phase 1b trial
Dapiglutide Obesity Dapiglutide Placebo-adjusted mean weight loss of up to 8.3% with dapiglutide in 13-week Part 1 of Phase 1b trial The 13-week Phase 1b trial evaluated higher doses Next steps include topline results from 28-week of dapiglutide than prior clinical trialsa trial and initiation of Ph
Slide 13: Survodutide shows best-in-class potential in MASH Phase 2 trial
MASH Survodutide Survodutidea GCG/GLP-1 receptor dual agonist shows best-in-class potential in MASH Phase 2 trial Phase 2 biopsy-driven trial in people with MASH1 Improvement in liver fibrosis with no worsening of MASH Paired biopsy results (F2/F3)2 Participants showing improvement in MASH Actual wi
Slide 14: Phase 3 program with survodutide in MASH has been initiated
MASH Survodutide Phase 3 program with survodutide in MASH has been initiated Inclusion criteria Study design Primary endpoint • Diagnosis of MASHa and biopsy- • N=1,800 Part 1: 52 weeks LIVERAGETM 1 proven fibrosis stage F2-F3 • 1:1 ratio (6.0 mg or placebo) • MASH resolution without worsening of li
Slide 15: Regulatory status in the US for our rare disease programs
Rare Dapiglutide diseases Regulatory status in the US for our rare disease programs Dasiglucagon in CHI: Glepaglutide in SBS-IF: Regulatory submissions expected in Q4 2024 PDUFA date December 22, 2024 Glucagon receptor agonist designed to allow for GLP-2 receptor agonist designed to be administered
Slide 16: Near-term commercial opportunities through rare disease franchise
Rare Dapiglutide diseases Near-term commercial opportunities through rare disease franchise Congenital hyperinsulinism (CHI) Short bowel syndrome (SBS) • Ultra-rare disease in newborns and children • Rare disease resulting in impaired intestinal absorptive • CHI can cause serious episodes of hypogly
Slide 17: Opportunity for establishing a new foundational therapy for weight management
Obesity Opportunity for establishing a new foundational therapy for weight management Clear societal impact Unmet needs today Opportunities Patient perceptive The obesity pandemic represents Eligible patients in the US the greatest healthcare ~2% receiving prescriptions for ~2/3 of adults want to lo
Slide 18: The target product profile of petrelintide holds potential to address the needs of patients and HCPs
Obesity Petrelintide The target product profile of petrelintide holds potential to address the needs of patients and HCPs Establishing petrelintide as the future foundational therapy for weight management Target product profile: Market benefit: 1 GLP-1RA-like weight loss (~15-20%) Vast majority of p
Slide 19: Q3 2024 YTD Profit & Loss
Q3 2024 YTD Profit & Loss DKK million Q3-24 YTD Q3-23 YTD P&L reflecting Zealand’s investment in its Revenue 53.6 319.6 differentiated assets targeting obesity • Revenue of DKK 54 million is mainly driven by the license and Cost of goods sold -7.5 -5.2 development agreement with Novo Nordisk for Zeg
Slide 20: Strong cash position of DKK 9.2 billion enables significant investments in our obesity programs
Strong cash position of DKK 9.2 billion enables significant investments in our obesity programs Secured cash of DKK 8.6 billion in 2024 through capital raises and the EIB loan facilitya 9,195 DKK million 511 6,789 8,684 1,633 373 449 -750 1,427 1,184 -277 Cash position Cash flow from Other cash Net
Slide 21: 2024 financial guidance
2024 financial guidance DKK million 2024 2023 Guidance Actuals Revenue anticipated from existing and new license and No guidance 343 partnership agreements due to uncertain size and timing Net operating expensesa 1,250 – 1,350 896 aNet operating expenses consist of R&D, S&M, G&A and other operating
Slide 22: Exciting news flow with many potential catalysts expected in the near term
Exciting news flow with many potential catalysts expected in the near term NON-EXHAUSTIVE Q4 2024 H1 2025 Petrelintide Petrelintide Initiate Phase 2b trial (overweight/obesity without T2D) Complete enrollment in Phase 2b trial (overweight/obesity without T2D) Dasiglucagon (CHI) Petrelintide Resubmit
Slide 23: Q&A
Q&A Q3 2024 November 7, 2024 23