Zealand Pharma A/S · OMXCOP:ZEAL
Zealand Pharma A/S — JP Morgan Healthcare Conference 2016
28 slides from Zealand Pharma A/S's conference presentation, January 2016
Slide 1: Accelerating our business from peptides to patients
Accelerating our business from peptides to patients Britt Meelby Jensen President and CEO JP Morgan Healthcare Conference January 2016 Zealand Pharma A/S
Slide 2: Disclaimer
Disclaimer This presentation does not constitute or form part of and should not be construed as, an offer to sell or issue or the solicitation of an offer to buy or acquire securities of Zealand Pharma A/S “Zealand” in any jurisdiction or an inducement to enter into investment activity. No part of t
Slide 3: Zealand - A maturing biotech from peptide to patient
Zealand - A maturing biotech from peptide to patient Established scientific expertise: Novel peptide-based medicines Two medicines on the market/submitted: Lyxumia® (Type 2 diabetes) and LixiLan (Type 2 diabetes) - both by Sanofi Mature out-licensed portfolio: 5 products with Sanofi, Helsinn and Boe
Slide 4: Zealand's portfolio - Overview
Zealand’s portfolio - Overview Product / indication Preclinical Phase I Phase II Phase III Reg Marketed Out-licensed products Lyxumia® (lixisenatide) - ex-US Type 2 diabetes Lixisenatide - US Type 2 diabetes Lixilan (lixisenatide/insulin glargine combination) Type 2 diabetes Elsiglutide Chemotherapy
Slide 5: Significant progress across the portfolio in 2015
Significant progress across the portfolio in 2015 Product Status Key 2015 achievements Lyxumia® • Clean CV safety profile established (ELIXA) Marketed • Positive insulin intensification effect (GetGoal Duo II) (lixisenatide) Lixisenatide - US Submitted • US NDA accepted for review in Q3 Lixilan • Po
Slide 6: Zealand share price performance and turnover
Zealand share price performance and turnover - 85% share price increase in 2015 400 2000 Zealand Pharma monthly turnover Zealand Pharma 1800 350 Nasdaq Biotechnology OMX Nordic Healthcare 1600 300 Euro Stoxx Pharmaceuticals & Biotechnology Monthly turnover (DKKm) 1400 250 1200 DKK 200 1000 800 150 6
Slide 7: Strategic focus: From peptide to patient - Accelerated value creation
Strategic focus: From peptide to patient - Accelerated value creation Advance proprietary medicines to registration where clinical pathway is suitable, supported by milestone/royalty revenues Focus on specialty disease areas where peptides have strong potential, exploring opportunities for fast trac
Slide 8: Our business model: Value creation through a growing proprietary pipeline and license revenue
Our business model: Value creation through a growing proprietary pipeline and license revenue Out-licensed Portfolio Peptide drug discovery and development platform » – Milestones and royalties Funding Addressing >18 years experience Growing Proprietary Portfolio unmet patient » in turning peptides
Slide 9: Three strong license collaborations - Validation and funding
Three strong license collaborations - Validation and funding Partner Two agreements: Product and disease focus • Lixisenatide (Lyxumia®) Elsiglutide (GLP-2) • Glucagon/GLP-1 • Lixilan • Undisclosed target Chemotherapy induced Cardiometabolic diseases Type 2 Diabetes diarrhea Milestone Total: USD 275
Slide 10: Lyxumia (lixisenatide) for Type 2 diabetes
Lyxumia® (lixisenatide) for Type 2 diabetes - First Zealand invented medicine on the market Lixisenatide GLP-1 market growth: >25% (CAGR)* Market value 2015: USD ~3 billion 2020: Est. USD 7 billion ● Only once-daily prandial GLP-1 ● Launched in 40 countries (Lyxumia®) ● US: Submitted, PDUFA in Q3 20
Slide 11: LixiLan for Type 2 diabetes - Lixisenatide and insulin glargine combination product
LixiLan for Type 2 diabetes - Lixisenatide and insulin glargine combination product Fixed-dose, single-injection combination of Lixisenatide Pronounced prandial glucose Positive Phase III results control Lantus (insulin + ● Significant HbA1c reduction over both insulin glargine) glargine alone and o
Slide 12: Four exciting proprietary medicines in clinical development
Four exciting proprietary medicines in clinical development Danegaptide Glucagon analogue (ZP4207) in a Rescue pen Reduce mortality and heart failure following ST- elevated Myocardial Infarction, by reducing Provide diabetes patients on insulin an easy-to- ischemic reperfusion injury use rescue from
Slide 13: Danegaptide for reperfusion injuries - Addressing a big medical challenge for AMI patients
Danegaptide for reperfusion injuries - Addressing a big medical challenge for AMI patients Myocardial infarction Severe long-term (AMI) is a serious event Acute action saves lives complications remain » » One of the most common Fast restoration of blood flow to Today’s challenge: The cardiac events
Slide 14: Danegaptide - Reduces infarct size in AMI models
Danegaptide - Reduces infarct size in AMI models Acute Myocardial ischemia Danegaptide reduces reperfusion Myocardial ischemia injury in pig AMI model1 60 p<0.05 50 % Infarct size p<0.05 40 30 20 10 » 0 Essential for Reperfusion IFR Post-conditioning Danegaptide patient survival injuries when Contro
Slide 15: Danegaptide - Phase II PoC trial results in Q1 2016
Danegaptide - Phase II PoC trial results in Q1 2016 600 pt’s < 12 hours after AMI (and ongoing STE) Primary Endpoint: 200 + 200 Danegaptide 200 Placebo Reduction in TIMI flow reperfusion injury 2-3 Primary PCI infarct size1 other stenosis >70% Intention to treat analysis group Trial powered to (
Slide 16: ZP1848 for Short Bowel Syndrome (SBS) - A growing disease area of high unmet medical needs
ZP1848 for Short Bowel Syndrome (SBS) - A growing disease area of high unmet medical needs Healthy person SBS patient SBS prevalence increasing due to higher awareness and improving care: Length Length EU= ~10,000-20,000 patients1 ~8.5m/~25ft <2m/~6.5ft US= ~10,000-20,000 patients2 Treatment options
Slide 17: ZP1848 - A long-acting GLP-2 analogue for liquid formulation
ZP1848 - A long-acting GLP-2 analogue for liquid formulation ZP1848 has shown to significantly Comparison of ZP1848 and Teduglutide increase small intestinal mass over GLP-2 analogue1 Parameter ZP18481 Teduglutide2 Structure 39-aa 33-aa ZP1848 GLP-2 analogue 125 Half-life 14 -17 hours 1.3 - 2 hours
Slide 18: ZP1848 ready for Phase II - Dosing of first SBS patients planned for Q1 2016
ZP1848 ready for Phase II - Dosing of first SBS patients planned for Q1 2016 Phase II trial design: Double-blind, Proof-of-Concept, dose-finding trial (N=18) CROSSOVER High Med/low Screening Wash Follow- and Medium High/low out up recruitment Low High/med T1 T2 T3 T4 Timeline (days) -21 0 21 49 70 1
Slide 19: ZP4207 Stable glucagon analogue - For better control of hypoglycemia in diabetes
ZP4207 Stable glucagon analogue - For better control of hypoglycemia in diabetes Single dose for acute treatment Multiple-dose use: Two different regiments Ready-to-use rescue pen for treatment Dual-hormone artificial pancreas device of severe hypoglycemia (insulin + glucagon), providing a fully aut
Slide 20: ZP4207 - Severe hypoglycemia in diabetes remains a challenge
ZP4207 (stable glucagon analogue) - Severe hypoglycemia in diabetes remains a challenge A severe hypoglycemic event: Abnormal drop in blood sugar Acute and life threatening condition » The most feared side effect associated with Risks associated with severe hypoglycemia, insulin treatment of diabete
Slide 21: The hypoglycemia market is growing and under-penetrated
The hypoglycemia market is growing - and under- penetrated as current rescue kits are difficult to use US Glucagon Market 2014: USD ~224 The market is significantly million1 underpenetrated .. H1’14 to H2’15 value growth (USD million) 140 120 132 100 108 80 60 40 20 “.. the complexity of the kit is
Slide 22: ZP4207 - Successful Phase I results pave the way for the next clinical activities
ZP4207 - Successful Phase I results pave the way for the next clinical activities Rescue Pen Phase Ia trial, part 2: Cross-over in T1D patients For illustration only Increase in blood glucose in healthy volunteers and in patients with Type 1 diabetes Safe and well tolerated » Initiation of Phase
Slide 23: Financial profile, 9m results and 2015 guidance
Financial profile, 9m results and 2015 guidance - Milestones, royalties and a solid cash position Revenue Net operating expenses Cash and equivalents EURm Royalty income Milestone income EURm Admin expenses R&D EURm 35 25 80 28 20 60 21 15 40 14 10 7 5 20 0 0 0 2010 2011 2012 2013 2014 2010 2011 201
Slide 24: Zealand's Senior Management and Board of Directors
Zealand’s Senior Management and Board of Directors Senior Management Board of Directors Britt Meelby Jensen Mats Blom Hanne Leth Hillman Martin Nicklasson Rosemary Crane Catherine Moukheibir President & CEO SVP & CFO SVP for IR & Chairman Vice Chairman Communications Adam Steensberg Keld Fosgerau Ca
Slide 25: Expected event outlook: Out-licensed portfolio
Expected event outlook: Out-licensed portfolio 2016 H1 H2 Lixisenatide (Lyxumia®) Quarterly royalty revenue reports Regulatory decision by the FDA (Q3) Lixilan FDA decision on acceptance of LixiLan NDA for priority review (Q1) Planned regulatory submission by Sanofi in Europe (Q1) Presenta
Slide 26: Expected event outlook: Proprietary pipeline
Expected event outlook: Proprietary pipeline 2016 H1 H2 Danegaptide Topline results from Phase II Proof-of-Concept trial (Q1) ZP1848 (GLP-2) Start dosing of patients in the Phase II Proof-of-Concept trial (Q1) Phase II trial update ZP4207 (glucagon) rescue pen Start clinical Phase II trial R
Slide 27: Zealand's portfolio - Indicative 12 months' outlook
Zealand’s portfolio – Indicative 12 months’ outlook Product / indication Preclinical Phase I Phase II Phase III Reg Marketed Out-licensed products and partnered projects Lyxumia® (lixisenatide) - ex-US Type 2 diabetes Lixisenatide - US Type 2 diabetes Lixilan (lixisenatide/insulin glargine combinati
Slide 28: Thank you for your attention!
Thank you for your attention! Zealand Pharma A/S page 28
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