Zealand Pharma A/S · OMXCOP:ZEAL
Zealand Pharma A/S — Investor Presentation (March 2023)
44 slides from Zealand Pharma A/S's investor presentation, March 2023
Slide 1: Pioneering next generation peptide therapeutics
Pioneering next generation peptide therapeutics Zealand Pharma March 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: About Zealand Pharma
About Zealand Pharma• Corporate Presentation 3
Slide 4: Our mission is to change lives with next generation peptide therapeutics
Our mission is to change lives with next generation peptide therapeutics Advance potential Lead in rare diseases Be a key player in Create a paradigm shift treatments options for with high unmet need – fast-developing obesity in Type 1 diabetes chronic inflammatory CHI and SBS treatment space manage
Slide 5: We are an international biotech company headquartered in Denmark
We are an international biotech company headquartered in Denmark Founded in 1998 • Peptide platform validated through two approved products marketed by Sanofi and Novo Nordisk • ~210 FTEs globally end of year 2022 Listed on NASDAQ CPH (ZEAL.CO) • Market Cap on 12/31/2022: DKK 10.3B (~USD $1.5B) • 51
Slide 6: We strive to be the world's best peptide drug discovery and development company
We strive to be the world’s best peptide drug discovery and development company Glepaglutide Designed BI 4569062 GLP-2 analog GCGR/GLP1R without either human • Stabilized • Acylation for or natural equivalent • Long-acting long half-life Dasiglucagon2 Optimized ZP 10000 Dapiglutide formulation space
Slide 7: 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 8: In 2022 we delivered on our strategic objectives and achieved significant pipeline progress
In 2022 we delivered on our strategic objectives and achieved significant pipeline progress Announced V-Go® sale strategy to to MannKind Corporate highlights prioritize R&D Zegalogue® partnership and restructure with Novo Nordisk ✓ Implemented operational commercial efficiencies & cost reductions op
Slide 9: In 2023 we have three key strategic objectives
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 filings partnership discussions Dasiglucagon for congenital BI 4569062 (GCGR/GLP-1R) Rare diseas
Slide 10: Rare Diseases
Rare Diseases• We aspire to lead in SBS and CHI, and expand into intestinal rehabilitation and transient hyperinsulinism to alleviate disease burden for as many patients as possible Corporate Presentation 10
Slide 11: Congenital Hyperinsulinism (CHI) is a severe, ultra-rare genetic disorder
Congenital Hyperinsulinism (CHI) is a severe, ultra-rare genetic disorder with significant impact on patients’ QoL CHI is an ultra-rare disease in newborns and children • 1 in 28-50,000 newborns per year are diagnosed with genetically determined CHI in the US and EU1,2 • CHI can cause serious episod
Slide 12: Dasiglucagon has potential to address shortcomings of current management of CHI
Dasiglucagon has potential to address shortcomings of current management of CHI Current treatments for CHI are associated with significant limitations Dasiglucagon for subcutaneous infusion* and clinical barriers Cited by healthcare providers as greatest limitations5: • Glucagon analog designed to a
Slide 13: Two phase 3 trials support potential of dasiglucagon in management of CHI
Two phase 3 trials support potential of dasiglucagon in management of CHI Trial 17103: Dasiglucagon significantly Trial 17109: Dasiglucagon reduced time in reduced the requirement for IV glucose hypoglycemia by ~50% and hypoglycemic in a hospital setting events by 37-40% in a homecare setting IV Glu
Slide 14: Opportunity to treat up to 800 patients with diffuse CHI at ultra-rare disease price
Opportunity to treat up to 800 patients with diffuse CHI at ultra-rare disease price levels in the US Patients eligible for dasiglucagon Ultra-rare disease therapy analogues with clear treatment in the US clinical value command premium prices in US5 Annual treatment cost (k$) Diffuse CHI patients 1.
Slide 15: Short Bowel Syndrome (SBS) is a rare, chronic and debilitating condition
Short Bowel Syndrome (SBS) is a rare, chronic and debilitating condition High unmet medical need • SBS is a rare, chronic and debilitating condition resulting in impaired intestinal absorptive capacity1, 2 • SBS is associated with significant medical complications including liver and renal failure,
Slide 16: Glepaglutide is being developed as a next generation GLP-2 therapy for patients with SBS
Glepaglutide is being developed as a next generation GLP-2 therapy for patients with SBS Gattex® (teduglutide): Glepaglutide: only currently available GLP-2 treatment a long-acting stable GLP-2 analog* • Effective half-life of 1.3 hours at steady state • Forms depot at the injection site • 0.05 mg/k
Slide 17: Glepaglutide significantly reduced weekly PS volume at Week 24 in EASE SBS-1
Glepaglutide significantly reduced weekly PS volume at Week 24 versus placebo in the EASE SBS-1 trial Clinical response was significantly higher Glepa 10 mg TW (N=35) with twice weekly glepaglutide compared to Glepa 10 mg OW (N=34)* * placebo (p=0.0243): Placebo (N=36) • 65.7% twice weekly glepaglut
Slide 18: Glepaglutide continues to be evaluated in Phase 3 long term extension studies
Glepaglutide continues to be evaluated in Phase 3 long term extension studies in SBS Phase 3a pivotal trial EASE 1 Placebo, once and twice • 102 of 106 patients completed EASE 1 NCT03690206 weekly treatment (~24 weeks) • 96 patients continued into the ongoing safety and efficacy extension trials Pha
Slide 19: Global teduglutide sales of ~$700M with significant room for patient expansion
Global teduglutide sales of ~$700M, with US price of $515k/year and significant room for patient expansion Global Teduglutide Sales1,2 (USD Millions) Estimated US SBS-IF Patients3 ~7.500 690 US Sales +20% 606 SBS-IF Pediatric patients ~2.500 EU/Can Sales 568 Currently ~1,500 Japan & RoW Sales patien
Slide 20: Obesity
Obesity• We aspire to be a key player in the fast-developing obesity treatment space, achieving meaningful weight loss and addressing long-term complications such as NASH Corporate Presentation 20
Slide 21: Obesity is a complex metabolic disease requiring additional treatment options
Obesity is a complex metabolic disease requiring additional treatment options 650 million adults and 124 million children and adolescents suffering from obesity1 Dual-pharmacology holds great promise Zealand Pharma’s peptide approach in treatment of obesity % Dual agonists (one molecule – two action
Slide 22: 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 23: BI 456906 is a dual glucagon/GLP-1 receptor agonist
BI 456906 is a dual glucagon/GLP-1 receptor agonist targeting energy intake and expenditure Status • Co-invented with Boehringer Ingelheim (EUR 345 million in outstanding potential development, regulatory and commercial milestones to Zealand plus high single to low double digit % royalties on global
Slide 24: BI 456906 reduced bodyweight by up to 13.7% at 16 weeks in Phase 1 trial in obesity
BI 456906 reduced bodyweight by up to 13.7% at 16 weeks in Phase 1 trial in obesity 5 Key Phase 1 observations: Bodyweight change from baseline 0 • Enrolled adults with a BMI of 27–<40 -5 kg/m2 and bodyweight of ≥70 kg / ≥80 kg (females/males) (%) -10 • Bodyweight reductions of up to 6.6% -15 after
Slide 25: BI 456906 reduced HbA1c and bodyweight in patients with type 2 diabetes
BI 456906 reduced HbA1c and bodyweight in patients with type 2 diabetes over 16 weeks Mean absolute change (%) HbA1c 0 –0.25% Placebo Baseline: 7.9–8.2% -0,5 Placebo -1 BI 456906 0.3 mg qw BI 456906 0.9 mg qw -1,5 –1.47% Semaglutide* 1.0 mg qw BI 456906 1.8 mg qw –1.88% BI 456906 1.8 mg qw -2 BI 456
Slide 26: Phase 2 clinical program to evaluate BI 456906 conducted by Boehringer Ingelheim
Phase 2 clinical program to evaluate BI 456906 being conducted by Boehringer Ingelheim People with T2D on stable metformin therapy ✓ Glycemic control T2D1 16 weeks results at EASD 2022 NCT04153929 Primary endpoint: change in HbA1c ✓ Body weight results at (N=413) Secondary endpoint: changes in bodyw
Slide 27: Dapiglutide is a dual GLP-1/GLP-2 receptor agonist
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 28: Dapiglutide showed body weight loss up to 4.3% over 4 weeks in Phase 1
Dapiglutide showed body weight loss up to 4.3% over 4 weeks in Phase 1 MAD trial in healthy subjects Key Phase 1b observations: • Dose-dependent delay in gastric emptying, reduction in plasma glucose and insulin concentration • Predictable PK profile with mean half life of 123-129 hours across four
Slide 29: ZP 8396 is a long-acting amylin analog targeting energy intake
ZP 8396 is a long-acting amylin analog targeting energy intake Rationale • Achieve weight loss • Maintain glycemic control • Potential as monotherapy or in combination with other peptides to enhance weight loss MoA • Reduces food intake (increases satiety), improves glycemic control and targets post
Slide 30: Potent bodyweight effects of amylin analog ZP8396 with semaglutide in obese rats
Potent bodyweight effects of amylin analog ZP8396 with semaglutide in diet-induced obese rats Start of ZP8396 treatment Key preclinical observations: • ZP8396 reduced body weight as monotherapy1 • ZP8396 potentiates weight loss effects of semaglutide even when given after achieving maximal effect fr
Slide 31: ZP6590 is a long-acting GIP receptor agonist
ZP6590 is a long-acting GIP receptor agonist targeting energy intake and nausea Rationale • Potentiate weight loss effects when combined other peptides, including GLP-1 receptor agonists • Anti-emetic properties may improve tolerance to GLP-1 receptor agonists MoA • Reduces food intake (suppresses a
Slide 32: ZP6590 potentiates the effect of semaglutide on body weight loss in obese mice
ZP6590 potentiates the effect of semaglutide therapy on body weight loss in diet-induced obese mice Vehicle Key preclinical observations: Vehicle/ZP6590–day 14 • ZP6590 monotherapy had ZP6590 negligible effect on body weight • ZP6590 potentiated equivalent weight loss when added after semaglutide ac
Slide 33: Type 1 Diabetes
Type 1 Diabetes• We aspire to create a paradigm shift in type 1 diabetes management by reaching higher glycemic goals and drive better outcomes and quality of life Corporate Presentation 33
Slide 34: We aim to shift the paradigm in the management of T1D using dasiglucagon
We aim to shift the paradigm in the management of T1D by using dasiglucagon Severe hypoglycemia Exercise-induced Automated glucose hypoglycemia* management* Mini-dose pen iLet® bihormonal bionic pancreas (investigational device) (investigational device) Severe hypoglycemia Physical activity is , Onl
Slide 35: Chronic Inflammation
Chronic Inflammation• Advance innovative treatments against chronic inflammatory diseases by adding clinical benefits to existing treatments: improved efficacy outcomes, better safety/tolerability or reduced treatment burden Corporate Presentation 35
Slide 36: Our pre-clinical pipeline targets chronic inflammatory diseases
Our pre-clinical pipeline targets chronic inflammatory diseases with significant unmet medical needs Complement C3 inhibitor (ZP10068) Kv1.3 blocker (ZP9830) α4β7 integrin inhibitor for IBD • Partnered with Alexion for complement • Targeting a broad set of chronic • Our lead oral peptide project dri
Slide 37: Additional company information
Additional company information• Corporate Presentation 37
Slide 38: Profit & Loss
Profit & Loss DKK million 2022 2021 P&L reflecting Zealand’s ambition to be leading peptide drug discovery and development company while commercializing products through partnerships Revenue 104.0 108.5 • Revenue of DKK 104 million in 2022 driven by development agreement with Gross margin 104.0 97.6
Slide 39: Strong cash position allows for investments in R&D
Strong cash position allows for investments in R&D DKK million Cash position of DKK 1,178 million 1.428 1.500 1.178 1,178 842 1.000 1.061 500 469 0 Cash position Cash invested1 Oberland Gross proceeds Cash position 2018 2019 2020 2021 2022 year-end 2021 year-end 2022 Securities Cash & cash equivalen
Slide 40: 2023 financial guidance
2023 financial guidance 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 other operati
Slide 41: Management
Management Finance & Business Development David Kendall Adam Steensberg Chief Executive Officer Henriette Wennicke Chief Medical Officer Chief Financial Officer People & Organization Operations Legal & IP Christina S. Bredal Ivan M. Møller Ravinder S. Chahil Chief Operating Officer General Counsel
Slide 42: Appendix
Appendix• Corporate Presentation 42
Slide 43: Dasiglucagon phase 3 clinical trial program in CHI
Dasiglucagon phase 3 clinical trial program represents the largest and broadest CHI population studied Age: 3 months - 12 years Trial 171091 Currently treated with standard of care (+/- surgery) with NCT03777176 persistent hypoglycemia (N=32) 4-week comparison + 4-week open label Trial 171062 Age:
Slide 44: Phase 3 pivotal EASE-SBS trial completed
Phase 3 pivotal EASE-SBS 1 trial completed • Randomized, double-blind, placebo-controlled Phase 3 trial • Evaluated the safety and efficacy of once and twice weekly dosing of 10 mg glepaglutide over 24 weeks of treatment Primary endpoint: N=106 Optimized & Stabilized* Twice weekly glepaglutide • Red