Zealand Pharma A/S · OMXCOP:ZEAL
Zealand Pharma A/S — Investor Presentation (January 2024)
54 slides from Zealand Pharma A/S's investor presentation, January 2024
Slide 1: Pioneering next-generation peptide therapeutics
Pioneering next- generation peptide therapeutics Zealand Pharma January 2024
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: About Zealand Pharma
About Zealand Pharma• Corporate Presentation 3
Slide 4: We are an international biotech company headquartered in Denmark
About ZP 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 • ~260 employees globally as of December 31, 2023 Listed on NASDAQ CPH (ZEAL.CO) • Market Cap on 12/31/2023: DKK 21
Slide 5: Our R&D pipeline aims to change lives with next-generation peptide therapeutics
About ZP Our research and development pipeline aims to change lives with next-generation peptide therapeutics 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 ZP6590 (GIP rec
Slide 6: We strive to be the world's best peptide drug discovery and development company
About ZP We strive to be the world’s best peptide drug discovery and development company Glepaglutide Designed Survodutide3 GLP-2 analog GCGR/GLP1R novel peptide modalities • Stabilized • Acylation for • Long-acting long half-life Dasiglucagon2 Optimized ZP10000 Dapiglutide formulation space α4β7 in
Slide 7: In 2024 we are expanding efforts to advance our pipeline of differentiated obesity assets
About ZP In 2024 we are expanding efforts to advance our pipeline of differentiated obesity assets Petrelintide Dapiglutide Survodutide2 (amylin analog) (GLP-1R/GLP-2R) (GCGR/GLP-1R) Ph1b 16-week MAD clinical trial Ph2a DREAM clinical trial data1 data Ph2 NASH clinical trial data Ph2b trial initiati
Slide 8: 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 8
Slide 9: We believe in a shift from maximizing weight loss towards quality of weight loss
Obesity We believe in a shift from maximizing weight loss towards quality of weight loss and effects on comorbidities… Segment characteristics and drivers 5% Intensive lifestyle therapy Payer-reimbursed segment (prescriber-driven) First-generation weight-loss Key drivers 10% medications • Relative w
Slide 10: Success of future weight-loss medications will be determined by differentiation
Obesity …and that success of future weight-loss medications will be determined by differentiation on multiple fronts Examples of differentiation factors GLP-1 mono GLP-1 backbone GLP-1/GIP Effects on obesity-related comorbidities GLP-1/GCGa Improved tolerability by addressing GI side effects GLP-1/G
Slide 11: Zealand Pharma has a rich obesity pipeline of differentiated product candidates
Obesity Zealand Pharma has a rich obesity pipeline of differentiated product candidates Developed with GLP-1 receptor Initially developed as monotherapy agonist foundation but with potential for combination GLP-1 • Increase insulin sensitivity • Delay gastric emptying • Decrease appetite + Glucagon
Slide 12: Survodutide activates both GLP-1 and glucagon receptors
Obesity Survodutide Survodutide, targeting obesity and NASH, activates both GLP-1 and glucagon receptors Design of molecule Positioning opportunities and differentiation Survodutide is a 29-amino-acid peptide, based on the hormone Obesity – potential for ~20–25% weight loss and oxyntomodulin with du
Slide 13: 16-week Phase 2 trial in T2DM reduced HbA1c and body weight
Obesity Survodutide In a 16-week Phase 2 trial in T2DM, survodutide effectively reduced HbA1c and body weight Change in HbA1c Change body weight 0 0.0 0 -0.25% -1.20% -0.5 -0.5 -2 Mean (SE) absolute Mean (SE) relative change (%) change (%) -1.0 -1.0 -4 -1.47% -5.40% -1.5 -1.5 -6 -2.0 -2.0 -1.88% -8
Slide 14: 46-week Phase 2 obesity trial reduced body weight by up to 18.7%
Obesity Survodutide In a 46-week Phase 2 trial in obesity, survodutide dose-dependently reduced body weight by up to 18.7% Phase 2 trial of survodutide in people who were overweight or had obesity Mean relative change at Week 46 (%) 0 -2 Placebo -2.0% (n=76) -4 change in body weight (%) Adjusted mea
Slide 15: Survodutide Phase 2 obesity trial showed no unexpected safety findings
Obesity Survodutide Treatment with survodutide in the Phase 2 obesity trial showed no unexpected safety findings • As expected, GI disorders were the most frequent drug-related AEs • Most treatment discontinuations occurred during the rapid dose escalation phase (up to Week 20) and may be mitigated
Slide 16: Survodutide reduced blood pressure at Week 46
Obesity Survodutide Survodutide reduced blood pressure by up to 8.6 mmHg (systolic) and up to 4.8 mmHg (diastolic) at Week 46 Systolic blood pressure Diastolic blood pressure 0 0 Adjusted mean (95% CI) absolute Adjusted mean (95% CI) absolute change from baseline (mmHg) change from baseline (mmHg) -
Slide 17: Phase 3 program SYNCHRONIZE in obesity has been initiated
Obesity Survodutide The Phase 3 program with survodutide in obesity, SYNCHRONIZETM, has been initiated Inclusion criteria Study design Primary endpoint • HbA1c <6.5% (no history of diabetes) • N=600 • Percentage change in body weight SYNCHRONIZETM-11 • BMI ≥30 or BMI ≥27 with • 1:1:1 ratio (3.6 mg,
Slide 18: Significant overlap between obesity and liver disease
Obesity Survodutide There is a significant overlap between obesity and liver disease Obesity is associated with severe comorbidities, for which there are significant unmet medical needs Mental illness Depression Anxiety People who are overweight or have obesity ~15–30%2,3 CVD Pulmonology Hypertensio
Slide 19: Phase 2 NASH trial results expected in H1 2024
Obesity Survodutide Phase 2 results from the NASH trial with survodutide are expected in H1 2024 Survodutide dose group 1 QW Primary endpoint: Histological improvement of NASH without worsening of fibrosis after 48 weeks of treatment Survodutide dose group 2 QW N=295 R Secondary endpoints: • LFC red
Slide 20: Dapiglutide is a potential first-in-class GLP-1R/GLP-2R dual agonist
Dapiglutide Obesity Dapiglutide Dapiglutide is a potential first-in-class GLP-1R/GLP-2R dual agonist for obesity and low-grade inflammation Design of molecule Positioning opportunities and differentiation Dapiglutide is derived from a GLP-2 peptide backbone with Obesity – pursuing ≥20% weight loss a
Slide 21: Obesity increases low-grade inflammation driving comorbidities
Dapiglutide Obesity Dapiglutide People with obesity have increased low-grade inflammation, which drives several related comorbidities Excess fat storage can trigger low-grade systemic Obesity-related low-grade inflammation through reduced intestinal barrier integrity1 inflammation can result in: Obe
Slide 22: Dapiglutide showed dose-dependent weight loss over 4 weeks
Dapiglutide Obesity Dapiglutide Dapiglutide showed dose-dependent mean weight loss of up to 4.3% over 4 weeks in healthy patients Phase 1 multiple ascending dose trial (n=40) Placebo Dapiglutide Dapiglutide Dapiglutide Dapiglutide (n=12) 1.0 mg (n=7) 2.25 mg (n=7) 3.5 mg (n=7) 3.5/6.0 mg (n=7) 2 Cha
Slide 23: H1 2024 results expected from investigator-led DREAM trial
Obesity Dapiglutide In H1 2024, results for dapiglutide are expected from the investigator-led DREAM trial DREAM is evaluating the effects of dapiglutide on body weight, gut permeability, and inflammation1 N=54, men and women aged 18–75 years Population BMI ≥30 kg/m2 Duration 12 weeks Dose Similar t
Slide 24: H2 2024 results expected from 13-week Phase 1b trial
Obesity Dapiglutide In H2 2024, results for dapiglutide are expected from the 13-week Phase 1b dose-titration trial The Phase 1b trial is evaluating higher doses of dapiglutide than the previous 4-week MAD trial and DREAM N=54, men and women aged 18–64 years Population BMI 27.0–39.9 kg/m2 Duration 1
Slide 25: Petrelintide is a potential best-in-class amylin analog
Obesity Petrelintide Petrelintide is a potential best-in-class amylin analog for GLP-1RA-like weight loss with better tolerability Design of molecule Positioning opportunities and differentiation Petrelintide (ZP8396) is a 36-amino-acid acylated peptide, based on the peptide sequence of human amylin
Slide 26: Native amylin is a non-incretin peptide that increases satiety
Obesity Petrelintide Native amylin is a non-incretin peptide that increases satiety in contrast to GLP-1, which reduces appetite Proposed physiological effects of amylin receptor activation1 Pancreas (indirect)a CNS Insulin secretion Leptin sensitivity2 Glucagon Satiety Mechanism of action secretion
Slide 27: Petrelintide significantly reduced fat mass while preserving lean mass in DIO rats
Obesity Petrelintide Petrelintide significantly reduced fat mass Unpublished while preserving lean mass in DIO rats data Change in body weight at Day 30 Change in body composition at Day 30 Fat mass 10 4 Mean (SEM) change in fat mass (% of Mean (SEM) change in body weight (%) body weight) 2 5 0 ***
Slide 28: Single dose of petrelintide resulted in 4.2% weight loss at Day 7
Obesity Petrelintide A single subcutaneous dose of petrelintide 2.4 mg resulted in average weight loss of 4.2% at Day 7 Change in body weight in Phase 1a SAD trial of petrelintide Placebo Petrelintide 0.7 mg Petrelintide 1.4 mg Petrelintide 2.4 mg (n=6) (n=6) (n=6) (n=6) 4 +0.6% Change in body weigh
Slide 29: Low weekly doses of petrelintide resulted in weight loss above 5%
Obesity Petrelintide Six, once-weekly, low doses of petrelintide resulted in average weight loss above 5% Part 1 of the Phase 1b MAD trial of petrelintide Placebo (n=6) Petrelintide 0.6 mg (n=7) Petrelintide 1.2 mg (n=7) 5 Change in body weight (%) 0 -0.4% -5 -5.1% -5.3% -10 Dosing 0 1 2 3 4 5 6 7 8
Slide 30: Petrelintide well-tolerated in Part 1 of the MAD trial
Obesity Petrelintide In Part 1 of the MAD trial, petrelintide was well-tolerated with no serious or severe TEAEs and no withdrawals TEAEs in Part 1 of the Phase 1b MAD trial with petrelintide Placebo Petrelintide 0.6 mg Petrelintide 1.2 mg Number of participants (events) (n=6) (n=7) (n=7) Total AEs
Slide 31: Part 2 results at higher doses expected in H1 2024
Obesity Petrelintide Results from Part 2 of the trial, exploring higher doses of petrelintide over 16 weeks, are expected in H1 2024 We are investigating significantly higher doses of petrelintide… …over a longer duration of 16 weeks… …using a dose-escalation scheme… …in 48 people who are overweight
Slide 32: ZP6590 is a long-acting GIP receptor agonist
Obesity ZP6590 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 intak
Slide 33: ZP6590 potentiates semaglutide effect in obese mice
Obesity ZP6590 ZP6590 potentiates the effect of semaglutide therapy on body weight loss in diet-induced obese mice Vehicle Key pre-clinical observations: Vehicle/ZP6590–day 14 • ZP6590 monotherapy had ZP6590 negligible effect on body weight • ZP6590 potentiated equivalent weight loss when added afte
Slide 34: 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 34
Slide 35: Congenital Hyperinsulinism is a severe, ultra-rare genetic disorder
Rare diseases CHI 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 ca
Slide 36: Dasiglucagon has potential to address shortcomings of current CHI management
Rare diseases CHI Dasiglucagon has potential to address shortcomings of current management of CHI Current treatments for CHI are Dasiglucagon for subcutaneous infusion* associated with significant limitations Zealand expects to resubmit Part 1 of NDA related and clinical barriers to three weeks of d
Slide 37: Three Phase 3 trials form the basis of the NDA for dasiglucagon in CHI
Rare diseases CHI Three Phase 3 trials form the basis of our NDA submission to the US FDA for dasiglucagon in 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 event
Slide 38: Opportunity to treat up to 800 patients with diffuse CHI
Rare diseases CHI 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$) Diffu
Slide 39: Short Bowel Syndrome is a rare, chronic and debilitating condition
Rare diseases SBS 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 a
Slide 40: Glepaglutide is a next-generation GLP-2 therapy for SBS
Rare diseases 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 injectio
Slide 41: Glepaglutide significantly reduced weekly PS volume in EASE SBS-1
Rare diseases SBS 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=35) placebo (p=0.0243): Placebo (N=36) • 65.7% twice
Slide 42: Glepaglutide Phase 3 program focused on regulatory submission
Rare diseases SBS Glepaglutide Phase 3 clinical program focused on regulatory submission in Q4 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
Slide 43: Global teduglutide sales over $700M with room for patient expansion
Rare diseases SBS 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 CAGR ~7,500 +16% 708 690 Currently ~1,500 US Sales 606 SBS-IF Pediatric patients ~2,500 patients are o
Slide 44: 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 44
Slide 45: Our pre-clinical pipeline targets chronic inflammatory diseases
Inflammation 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 peptid
Slide 46: 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 46
Slide 47: We aim to shift the paradigm in the management of T1D with dasiglucagon
T1DM 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
Slide 48: Additional company information
Additional company information• Corporate Presentation 48
Slide 49: 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 50: 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 51: Cash runway to mid-2026 allows for investments in obesity assets
Cash runway to mid-2026 allows for investments in differentiated obesity assets DKK million Cash position of DKK 1,932 million as of September 30, 20231 670 1,932 285 -526 350 1,178 1,500 -485 -85 Cash position Cash flow from Other cash Gross proceeds Repayment Cash position Expected milestone Loan
Slide 52: Experienced management team
Experienced management team Adam Henriette David Christina S. Ivan M. Ravinder S. Steensberg Wennicke Kendall Bredal Møller Cahill Finance and Business Research & People & Operations Legal & IP Development Development Organization Chief Executive Chief Financial Chief Medical Senior Vice Chief Opera
Slide 53: Multiple events and important catalysts in 2024
Multiple events and important catalysts in 2024 NON-EXHAUSTIVE H1 2024 H2 2024 Survodutide1 Results from Ph2 NASH trial Petrelintide Petrelintide Topline results from 16-week Ph1b MAD trial Initiation of Ph2b trial Dapiglutide Dapiglutide Topline results from Ph2a investigator-initiated trial DREAM
Slide 54: Strongly focused on delivering on our strategic objectives for 2024
Strongly focused on delivering on our strategic objectives for 2024 Advance Ensure regulatory Initiate first-in- obesity progress for rare human trials with portfolio disease assets inflammation assets 54
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