GROWING THE BUSINESS WITH 2015 AS A CATALYST YEAR

Transcription

1 ZEALAND GROWING THE BUSINESS WITH 2015 AS A CATALYST YEAR US Roadshow June 2015 ZEALAND PHARMA

2 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 this presentation, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. This presentation contains forward-looking statements that reflect management s current views with respect to certain future events and potential financial performance. Although Zealand believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. Accordingly, results could differ materially from those set out in the forward-looking statements as a result of various factors many of which are beyond Zealand's control. This presentation does not imply that Zealand has undertaken to revise these forward-looking statements, beyond what is required by applicable law or applicable stock exchange regulations if and when circumstances arise that will lead to changes compared to the date when these statements were provided. 2

3 ZEALAND AT A GLANCE Pioneering leaders in the design and development of novel peptide medicines 3-pronged strategy: Build on peptide expertise, grow the proprietary pipeline, leverage through partnering Agile and dynamic R&D organisation with a patientcentric focus on innovation First medicine on the market, Lyxumia Broad pipeline with several others in development Solid financial position: Cash of DKK 524 / EUR 70.2 million (end Q1 15) 3

4 ZEALAND PEPTIDE EXPERTISE SPANS THE R&D VALUE CHAIN Peptide medicine is a growing class with unexplored potential: DISCOVERY DISCOVERY PRECLINICAL CLINICAL D DEVELOPMENT Peptides regulate important physiological functions Peptides have high biologic specificity and selectivity Advantageous efficacy and safety characteristics Identification: ~6,800 synthesized Zealand peptides Design: ~1,250 active patents, 311 issued patents Clinical trials: 10 Zealand peptides advanced into the clinic 4

5 PARTNERED PORTFOLIO AND PROPRIETARY PIPELINE Portfolio of outlicensed products and partnered programs OWNERSHIP COMPOUND / INDICATION PRECLINICAL PHASE I PHASE II PHASE III REG. MARKETED LYXUMIA (LIXISENATIDE) - ex-us Type 2 diabetes LYXUMIA (LIXISENATIDE) - US Type 2 diabetes LYXUMIA /LANTUS combination (LixiLan) Type 2 diabetes ELSIGLUTIDE Chemotherapy induced diarrhea Glucagon/GLP-1 dual agonists diabetes/obesity Proprietary pipeline Undisclosed target Cardio-metabolic area DANEGAPTIDE Myocardial ischemic reperfusion injury ZP GLUCAGON RESCUE PEN Acute, severe hypoglycemia ZP GLUCAGON MULTIPLE-DOSE USE - Mild to moderate hypoglycemia ZP2929 Diabetes/obesity Several peptide projects and indications 5

6 OUTLICENSED PRODUCTS AND PARTNERED PROGRAMS: LYXUMIA (SANOFI) LIXILAN (SANOFI) ELSIGLUTIDE (HELSINN) TWO PRECLINICAL PROGRAMS (BOEHRINGER INGELHEIM) 96

7 LYXUMIA : FIRST ZEALAND PRODUCT ON THE MARKET Lyxumia (lixisenatide) for Type 2 Diabetes GLP-1 receptor agonist invented by Zealand Developed and marketed by Sanofi under global license agreement First and only once-daily short acting GLP-1 agonist Significant HbA1c lowering Beneficial effect on body weight Pronounced effect on gastric emptying Pronounced lowering of post-prandial glucose (PPG) 7

8 THE GLP-1 MARKET CONTINUES TO GROW WITH BIGGEST POTENTIAL IN THE US Value of total GLP-1 market in 2014: USD ~2.5 billion Geographical mix Japan / Korea China Europe 22% 3% 2% 73% America GLP-1 market volume growth of 10% in 2014 GLP-1 class make up ~7% of the total diabetes market GLP-1 market estimated to exceed USD 7 billion by 2020 CAGR of 19% Source: IMS data and market reports 8

9 LYXUMIA - STATUS AND OUTLOOK Regulatory: Approved in over 50 countries worldwide (ex-us) US NDA submission by Sanofi planned for Q Commercial: Launched by Sanofi in over 35 countries Additional launches planned in 2015 Revenue: Lyxumia sales in 2014 of EUR 27 million (+214%) Zealand royalty revenue in 2014 of DKK 20 / EUR 3 million Q royalty revenue DKK 6.3 / 0.8 mio. (+67%) 9

10 ELIXA CV OUTCOME TRIAL : TOP-LINE RESULTS SUPPORT LIXISENATIDE NDA FILING ELIXA: Lixisenatide (Lyxumia ) cardio-vascular safety outcome study Evaluate the cardio-vascular safety of lixisenatide compared to placebo in a high-risk adult population with Type 2 diabetes, who recently experienced an acute coronary syndrome event. Top-line results (March 2015) show: No additional cardiovascular risk related to treatment with lixisenatide First CV outcome trial for a GLP-1 receptor agonist to report Substantial data set from +6,000 high-risk patients Detailed results to be presented at ADA on 8 June 2015 Results supports Sanofi s planned re-submission of lixisenatide in the US in Q

11 LIXILAN - ONCE DAILY INJECTION LYXUMIA /LANTUS COMBINATION PRODUCT LYXUMIA IS AN IDEAL PARTNER TO BASAL INSULIN Treatment effects on fasting and post-prandial glucose Results from Phase IIB trial in 323 Type 2 diabetes patients insufficiently controlled on insulin: Insulin treatment alone HbA1c lowering to 6.3% Weight loss (1.2 kg) No additional hypos compared to Lantus Less frequent nausea and vomiting compared to what has been reported for the GLP-1 Rapid Acting class Insulin + GLP-1 treatment Blood glucose treated Blood glucose untreated 11

12 LIXILAN - PHASE III RESULTS EXPECTED IN Q LIXILAN Phase III program: Potential positioning: LixiLan-O: Study in patients insufficiently controlled on oral anti-diabetic medication (OAD): ~1,150 patients First injectable after OAD failure in Type 2 diabetes ~5.5 mio patients not at target on OAD* LixiLan-L: Study evaluates the effect of LixiLan compared to treatment with Lantus alone: ~700 patients Conversion of patients not at target on basal therapy ~4 mio patients uncontrolled on basal therapy* Sanofi has announced planned regulatory submission of LixiLan in Q in the US and in Q in Europe * Source: 2017 projections based on international model from Adelphi. Number of patients in the US 12

13 SANOFI COLLABORATION - TERMS Global license agreement on lixisenatide (Lyxumia ) and any lixisenatide combination product Sanofi has global development and commercial rights All financing covered by Sanofi Milestones to Zealand 1) : Up to USD 275 million in total, of which USD 160 million is outstanding Royalties on global sales 1): Tiered, low double-digit percentages for Lyxumia (lixisenatide) AND fixed low doubledigit on full net sales of any lixisenatide combination product 1) Zealand pays 13% of its revenue on lixisenatide to Alkermes (formerly owned by Elan) and 0.5% to SIP technology inventor 13

14 ELSIGLUTIDE A NOVEL GLP-2 AGONIST ADDRESSING MAJOR NEED IN CANCER THERAPY Chemotherapy Induced Diarrhea (CID) A serious challenge in cancer therapy, mainly related to 5-FU based chemotherapy regimens* 5-FU based chemotheraphy regimens can result up to 50-80% of patients developing CID** CID leads to: dehydration, hospitalization, markedly reduced quality of life, and sub-optimal cancer treatment No effective treatments available today * The 5-FU regiment is standard first line chemotherapy in colorectal cancer ** Source: Stein, Voigt and Jordan, Ther. Adv. Med. Oncol. (2010) 14

15 ELSIGLUTIDE - A NOVEL GLP-2 AGONIST IN PHASE IIB Global Phase IIb trial initiated by Helsinn in February 2015 Evaluates elsiglutide in 600 colorectal cancer patients on 5-FU chemo regiments Includes exploratory arm with 120 patients treated also with a marketed monoclonal antibody Results from Phase II expected in H Global rights licensed to Helsinn, a leading company in cancer supportive care: Up to DKK 1,040 / EUR 140 million in milestones (DKK 119 / EUR 16 million received) High single digit percentage of global sales 15

16 TWO RESEARCH AND DEVELOPMENT COLLABORATIONS WITH BOEHRINGER INGELHEIM (BI) Glucagon/GLP-1 dual agonists (GGDAs) for Type 2 diabetes/obesity (June 2011) Novel peptide therapeutics for cardiometabolic diseases (July 2014) Agreement: Milestone payments: BI has global rights to novel peptide therapeutics (Zealand retains co-promotion rights in Scandinavia) Up to EUR 376 million (EUR 365 million remaining) AND Additional payments if other glucagon /GLP-1 dual agonists advances Up to 4.5 years of joint identification, characterisation and PC preparation BI has global rights to novel peptide therapeutics (Zealand retains co-promotion rights in Scandinavia) Up to EUR 295 million in total for lead peptide candidate AND Additional potential payments if other peptides advances Royalties on global sales Tiered high single to low double digit percentages Tiered percentages on all products marketed under the agreement NOTE: BI covers all financing 16

17 ZEALAND S PIPELINE OF PROPRIETARY PRODUCTS: DANEGAPTIDE GLUCAGON RESCUE PEN (ZP4207) GLUCAGON MULTIPLE DOSE (ZP4207) ZP

18 DANEGAPTIDE FOR CARDIAC REPERFUSION INJURIES Reperfusion injuries results from Acute Myocardial Infarction (AMI) Treatment of AMI today: PCI (Percutaneous Coronary Intervention) procedures, incl balloon dilatation, to effectively restore blood flow 80% of AMI patients undergo timely PCI procedures Overall survival up from 40% to over 90% Today s therapeutic challenge: Several AMI patients have impaired cardiac function due to tissue damage Patients with severe AMI (STEMI) have an elevated risk of a second cardiac event Trial results for PCI treated STEMI patients: months mortality rate of 3-5% 18

19 DANEGAPTIDE - FOR PREVENTION OF ISCHEMIC REPERFUSION INJURIES Danegaptide - A novel peptide therapeutic, invented and wholly-owned by Zealand Shown to prevent tissue damage and to reduce infarct size in disease models of myocardial reperfusion injuries (pigs and dogs) Shown a very good safety and tolerability profile, with evidence from Phase I clinical program with 153 subjects Target product profile First ever medicine to protect heart tissue against ischemic reperfusion injuries (IRI) It is about what life you survive to 1 st objective: Improve treatment outcome and QoL for AMI patients after PCI 2 nd objective: Protect other organs against IRI (acute kidney failure/organ transplants) 19

20 DANEGAPTIDE - EVALUATED IN A PHASE II POC TRIAL BY ZEALAND Phase II trial conducted with world-leading cardiac center at Rigshospitalet: Trial design: Single-center, double-blind, randomized, placebo-controlled Enrolment: Up to 600 patients with severe AMI (STEMI), who will receive treatment with high or low dose danegaptide or placebo 600 STEMI Patients < 12 hours Danegaptide 200 Placebo Primary PCI Intention to treat analysis group (TIMI flow 0-1) Danegaptide 70 Placebo Primary endpoint: MSI* by cmri day 1 & 90 ~85% (>510 patients) of the enrolment target has been met Trial on track towards expected completion in Q Study results expected available in early 2016 * MSI: Myocardial Salvage Index 20

21 GLUCAGON RESCUE PEN (ZP4207) FOR ACUTE, SEVERE HYPOGLYCEMIA Hypoglycemia events The no. 1 fear for diabetes patients annual visits to the emergency room by US diabetic adults due to an acute hypoglycemia event* ADA and EASD recommend all patients on insulin therapy to carry a glucagon hypoglycemia rescue kit at all times Hypoglycemia - untapped market potential: Annual sales of current glucagon products: USD 300 million Estimated 5% penetration Sub-optimal product offerings Type 1 Diabetes patients WW: 17 million US: 3 million Type 2 diabetes patients on insulin WW: ~25 million US: 6 million * Source: Data from 2011, ADA, Center for Disease Control and Prevention

22 ZP4207 NOVEL STABLE GLUCAGON PRODUCT Current medication Lilly Future medication Ready-to use rescue pen with liquid glucagon formulation Novo Nordisk Vial with powder and a syringe Multiple steps required before injection Difficult for non-professionals to use One pen ready to use One click Wholly-owned by Zealand with patent protection until PTE Patients rescued immediately are less often hospitalized and has less complications 22

23 ZP4207 GLUCAGON RESCUE PEN TWO PARTS PHASE I CLINICAL TRIAL ONGOING ZP4207 is a novel analogue to human glucagon, invented and wholly-owned by Zealand with unique stability and solubility Phase I initiated by Zealand in November 2014 with a highly specialized diabetes center in Germany Results from the Phase I study expected Q Part I: Completed Part II: Completed Enrolment: 64 healthy volunteers 20 patients with Type 1 diabetes Treatment: Objective: Single-ascending doses of ZP4207 or glucagon Evaluate safety and tolerability (PE) and various PK-PD measurements of ZP4207 compared to native glucagon Select single dosing of ZP4207 in cross over design with glucagon as comparator Evaluate PK-PD measures of ZP4207 and its effect to increase blood glucose levels after insulin induced hypoglycemia 23

24 ZP4207 MULTI-DOSE USE TWO PRODUCT ROUTES Multiple dose pen Treatment of mild to moderate hypoglycemia May also serve as rescue pen for severe hypoglycemia Artificial pancreas Dual-hormone (insulin glucagon) integrated with glucose sensor: 24

25 ZP4207 MULTIPLE-DOSE VERSION IN PHASE I SUPPORTED BY HELMSLEY GRANT Treatment of mild to moderate hypoglycemia Eligible for use as essential component in an artificial pancreas (dual-hormone pump system) Initial clinical and preclinical activities supported by USD 1.8 million grant from the Helmsley Charitable Trust Phase I trial design Trial conducted at a highly specialized diabetes center in Germany Enrolment: Treatment: Objective: 24 healthy volunteers Three cohorts of different daily doses of ZP4207, each over 5 days. Primarily evaluate safety and tolerability after multiple dosing Secondary endpoints will measure the pharmacokinetics and pharmacodynamics (blood sugar levels) after multiple dosing 25

26 NEWS OUTLOOK 26 26

27 2015 EVENT OUTLOOK: PARTNERED PORTFOLIO Lyxumia for Type 2 diabetes - Marketed globally ex-us in license collaboration with Sanofi: Q2: Results from ELIXA cardiovascular study - REALIZED Q2: Full results from the ELIXA CVOT and the Get Goal Duo-2 presented at ADA Q3: Regulatory submission in the US Q2-Q4: Quarterly reports on royalty revenue from Sanofi s sales and commercial status LixiLan (fixed-ratio combination of Lyxumia and Lantus ) for Type 2 diabetes - Phase III - in license collaboration with Sanofi: Q3: Study completion and results from Phase III (Lixilan-O and Lixilan-L) Q4: Regulatory submission in the US Q1-16: Regulatory submission in EU 27

28 2015 EVENT OUTLOOK: PARTNERED PORTFOLIO Elsiglutide for chemotherapy-induced diarrhea Phase IIb development - partnership with Helsinn: Q1: First patients dosed in Phase IIb study - REALIZED Q1-16: Complete enrolment of patients in observational multiplecenter study Boehringer Ingelheim glucagon/glp-1 dual agonist Q4: Advancement of new lead candidate towards clinical development Boehringer Ingelheim second collaboration Q4: Start of preclinical development and related milestones to Zealand 28

29 2015 EVENT OUTLOOK: PROPRIETARY PIPELINE Danegaptide for cardiac reperfusion injuries In Phase II development Q4: Completion of Phase II P-o-C study (600 patients) Q1 16: Phase II results ZP4207 rescue pen for severe diabetes hypoglycemia In Phase I development Q2: Initiation of part 2 of Phase I trial - REALIZED Q2: Trial completion and results from full clinical Phase I trial ZP4207 multi-dose version for mild to moderate hypoglycemia in diabetes In Phase I development Q2: Phase I multiple-dose clinical trial initiated first subjects dosed - REALIZED H2: Completion and results from clinical Phase I trial Proprietary pipeline expansion Q2: Presentation of data on novel Zealand invented therapeutic peptides at ADA Q3-Q4: Advancement of new clinical assets 29

30 FINANCIALS AND SHARE INFO 30 30

31 FINANCIAL HIGHLIGHTS INCOME STATEMENT (DKK '000) Q1 Q1 Full year Revenue (milestones and Lyxumia royalty) 6,339 84, ,773 Royalty expenses ,474-13,776 Gross profit 5,485 73, ,997 Research and development expenses -51,796-36, ,036 Administrative expenses -7,490-7,989-39,826 Other operating income 4, ,328 Operating result -49,513 28,608-73,537 Financial net -6, ,047 Tax 0 0 7,500 Net result for the period (after tax) -55,548 28,850-64,990 HIGHLIGHTS Q CASH AND SECURITIES Royalty revenue: DKK 6.3 / EUR 0.8 million DKK /EUR 70.2 million Net operating expenses: DKK 55.0/ EUR 7.4 million Net result: DKK -55.5/ EUR -7.4 million 31

32 FINANCIAL GUIDANCE FOR 2015 REVENUE EXPECTATIONS Growing royalty payments from Sanofi on global sales of Lyxumia in 2015 Specific guidance on the level of royalty payments cannot be provided as Sanofi has given no guidance on 2015 sales Additional potential revenue from partner milestone payments of up to DKK 140 / EUR 19 million OPERATING EXPENSES Net operating expenses for 2015 are expected at a range of DKK / EUR million 32

33 SHARE & OWNERSHIP INFORMATION Listed (Nov 10) on NASDAQ Copenhagen: ZEAL Total no. of issued shares: 23.4m No. of shares outstanding (ex. treasury): 22.8m Share price (1 June 2015): DKK 106 Market Cap (1 June 2015): DKK 2.5bn/ EUR 332m Cash and equivalents (end Q1 15): DKK 524m/ EUR 70m > 10% ownership: Sunstone BI & LS Venture Funds, DK LD Pensions, DK 33