AGENDA. Business highlights Significant progress with late stage clinical programs heading towards filing. Britt Meelby Jensen

Transcription

1 AGENDA Business highlights Significant progress with late stage clinical programs heading towards filing The Zealand peptide platform World leading expertise delivering differentiated peptide-based drug candidates Glepaglutide A potential best-in-class GLP-2 for treatment of short bowel syndrome Dasiglucagon A novel glucagon analog with potential to disrupt diabetes care & rare diseases Closing remarks Driving success in 2018 and beyond with short and long term value drivers Britt Meelby Jensen Andrew Parker Adam Steensberg / David F. Mercer Followed by Q&A session Adam Steensberg / Jessica Castle Followed by Q&A session Britt Meelby Jensen Followed by Q&A session 1

2 Glepaglutide Long-acting GLP-2 analog in development for the treatment of short bowel syndrome (SBS) 2 25 January, 2018

3 Short bowel syndrome a chronic and debilitating disease Affects 20 40,000 people across US and Europe 1 Normal person Length of gastrointestinal tract: ~ 8.5 m/~ 25 ft SBS patient Length of gastrointestinal tract: < 2 m/~ 6.5 ft 2 Impaired intestinal absorption, diarrhea and metabolic complications Life-long therapy with complex daily parenteral support 3 1. Transparency Market Research; Short Bowel Syndrome Market, 2017; 2. Jeppesen PB. J Parenteral Enteral Nutr. 2014;38 (supplement 1):8S-13S. Zealand data on file; ZP-SBS User Research

4 Clear need for better treatment options for SBS 1 Reduction in parenteral needs Remove need for parenteral support Increased absorption of nutrition and fluids Less diarrhea and/or ostomy output Reduction in treatment complexity 4 1. Transparency Market Research; Short Bowel Syndrome Market, 2017

5 Glepaglutide is a long-acting GLP-2 analog based on Zealand s proprietary SIP technology Native GLP-2 An endogenous peptide hormone released from intestinal cells in response to eating Works locally to maintain a healthy gut Short half-life (minutes) Glepaglutide Stable GLP-2 analog Forms depot at the injection site Potential for once-weekly dosing 5

6 6 Key glepaglutide Phase 2 results presented at the ASPEN Nutrition Science & Practice Conference

7 The objective of the Phase 2 trial was to evaluate efficacy, safety and tolerability of three different doses of glepaglutide in patients with SBS Glepaglutide was given subcutaneously once daily in doses of 0.1 mg, 1.0 mg and 10 mg 18 SBS patients were enrolled in the trial Metabolic balance studies before and after each treatment period: 3 days collection of all intake and output 7

8 Primary endpoint: Significant decreases in fecal wet weight output in the 1 mg and 10 mg groups Absolute reduction (g/day) Relative reduction (%) p=0.27 p=0.002 p=

9 The reduction in fecal wet weight output was the result of significant increases in intestinal absorption Absolute change in wet weight absorption (g/day) Absolute change in absorption of Sodium (mmol/day) Insert relative uptake 9

10 Increases in urine production is an important secondary endpoint as it guides reductions in parenteral support, which will be the primary endpoint in Phase 3 Absolute change in urine weight (g/day) Relative change in urine weight (%) % Insert relative uptake % % 10

11 Conclusions from the glepaglutide Phase 2 results, presented at ASPEN In patients with SBS, daily subcutaneous doses of 1 mg and 10 mg glepaglutide Significantly decreased fecal wet weight output Significantly increased intestinal wet weight and electrolyte absorption Significantly increased urine production Glepaglutide, at all 3 doses, was observed to be safe and well tolerated in the trial 11

12 Pharmacokinetic trial was initiated in 2017 to investigate half-life and potential for up to weekly dosing ClinicalTrials.gov Identifier: NCT

13 Pharmacokinetic results reported January 23, 2018 support potential for once weekly dosing 1 Twice weekly dosing ensure exposure levels at and above the exposure levels obtained following 1 mg/day Exposure following once weekly dosing will fluctuate around exposure levels obtained following 1 mg/day illustrative Planned to be launched in easy-to-use auto-injector Company Press Release No. 5/2018,. Simulation based on preliminary non QA-checked PK-data;.2. In Development by company

14 Zealand is well prepared to initiate Phase 3 in 2018 Protocol developed with Principal Investigators and Key Opinion Leaders 5 investigator and expert meetings hosted > 10 sites U.S. & Canada > 10 sites Europe Trial feasibility study has identified +20 committed and high potential centers Clinical research organization awarded the trial Regulatory approval of clinical protocol expected Q

15 An experienced team of Principal Investigators for Phase 3 Lead International Principal Investigator (PI) Professor Palle Bekker Jeppesen Europe PI s U.S. / Canada PI s Professor Gert van Wanten Professor David F. Mercer Professor George Lambrecht Professor Douglas Seidner 15

16 Glepaglutide Phase 3 clinical trial set to start in 2018 Phase 3, double-blind, placebo controlled trial in SBS patients evaluating safety and efficacy of twice and once weekly glepaglutide over 24 weeks of dosing Screening Run-in Treatment Follow-up Primary endpoint: Number of subjects having at least a 20% reduction in parenteral support (PS) at 6 months 1:1:1 randomization Glepaglutide twice a week Glepaglutide once a week Key secondary endpoints: Relative reduction in PS Fluid composite effect Fraction of patients achieving one day off PS Placebo -8 to Weeks from first treatment Not yet confirmed with regulators 16

17 Dr. David F. Mercer M.D., Ph.D. Professor of Surgery and Director of Intestinal Rehabilitation Program at University of Nebraska Medical Center Specialty in liver and small bowel transplantation Principal Investigator of studies in pediatric subjects with intestinal failure and short bowel syndrome 17

18 Glepaglutide Phase 3 ready to start in 2018 with focus on fast to market Our ambition is to reduce the burden of living with short bowel syndrome by offering glepaglutide as the best GLP-2 treatment 18

19 Glepaglutide has potential to become best-in-class GLP-2 treatment for patients with SBS Unmet needs of SBS patients Reduction in parenteral needs Glepaglutide Phase 2 results Increase in urine production as surrogate Remove need for parenteral support Increase in urine production as surrogate Increase absorption of nutrition and fluids Increase in intestinal fluid and energy absorption Less diarrhea and/or ostomy output Reduction in fecal wet weight output Reduction in treatment complexity Ready-to-use formulation 19

20 The short bowel syndrome market is a significant opportunity The U.S. SBS GLP-2 market expected to grow significantly > 4,000 patients 2,3 Opportunity with glepaglutide Launch expected in 2021/22 in the U.S. and EU < 1,000 patients 1 Increasing prevalence 4 > 1,500 patients 2,3 Broader patient segments Better treatments 2 Capture significant share of market with improved treatment option Expand the market to new patient segments Market value estimate: USD > 300 million Market value estimate: USD > 1 billion Shire PLC. FY 2015 results presentation; 2. Transparency Market Research; Short Bowel Syndrome Market, 2017, number of patients estimated by dividing with U.S. average price: 3. Truven Redbook, WAC price forecasted with single digit annual growth rate and estimated 20-25% discount; 4. SBS prevalence doubled in one decade due to increased awareness and improved care (Brandt, 2016, Journal of Parenteral and Enteral Nutrition)

21 Next steps for glepaglutide Phase 3 initiation in 2018 Partnerships outside U.S. and EU Phase 3 results in 2020 US and EU regulatory fillings in 2020/