Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Q1 2018 Earnings Presentation
19 slides from Zealand Pharma A/s's earnings presentation, May 16, 2018
Slide 1: Forward-looking statements
Forward-looking statements This presentation contains information pertaining to Zealand Pharma A/S (“Zealand"). Neither Zealand nor its management, directors, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the inform
Slide 2: Agenda
Agenda Business highlights By Britt Meelby Jensen, President & CEO Financial highlights By Mats Blom, EVP & CFO 2018 outlook By Britt Meelby Jensen, President & CEO 3
Slide 3: Two marketed products and an attractive late-stage clinical pipeline
Two marketed products and an attractive late-stage clinical pipeline Preclinical Phase 1 Phase 2 Phase 3 Registration Marketed products2 GLP-1/GLU1 dual agonist Obesity/type 2 diabetes Dasiglucagon HypoPal® rescue pen Acute, severe hypoglycemia GLP-1/GLP-2 Dual agonist Glepaglutide GLP-2 analog Shor
Slide 4: Business highlights
Business highlights By Britt Meelby Jensen, President & CEO 5
Slide 5: Business highlights
Business highlights Glepaglutide Short bowel syndrome Detailed Phase 2 data presented at the ASPEN conference in U.S. New clinical evidence supports potential for a once-weekly drug Successful End-of-Phase 2 meeting with FDA Dasiglucagon HypoPal® rescue pen First Phase 3 trial sucessfully meet its p
Slide 6: Glepaglutide for short bowel syndrome – positive Phase 2 results presented at ASPEN
Glepaglutide for short bowel syndrome – positive Phase 2 results presented at the ASPEN conference in U.S., January 2018 Phase 2 study design Phase 2 data highlights1 • Decrease in fecal wet weight output • Increase in intestinal wet weight and electrolyte absorption • Increase in urine production •
Slide 7: Phase 2 primary endpoint: significant decreases in fecal wet weight output
Phase 2 primary endpoint: significant output in the 1 mg and 10 mg groups decreases in fecal wet weight Absolute fecal wet weight output reduction (g/day)1 Relative fecal wet weight output reduction (%)1 p=0.0002 p=0.27 p=0.002 8
Slide 8: Increases in urine production observed in the Phase 2 trial
Increases in urine production observed in the Phase 2 trial is important to guide reductions in parenteral support Absolute change in urine weight (g/day) Relative change in urine weight (%) % Insert relative uptake % % 9
Slide 9: Glepaglutide – pharmacokinetic results support less frequent dosing
Glepaglutide – pharmacokinetic results support potential for less dosing frequent Results from pharmacokinetic trial reported in January 2018 supports potential for weekly dosing1 Pharmacokinetic results • Twice weekly dosing ensures exposure levels at and above the exposure levels obtained followin
Slide 10: Successful End-of-Phase 2 meeting with FDA, pivotal Phase 3 trial planned H2 2018
Successful End-of-Phase 2 meeting with FDA, on track for initiation of pivotal Phase 3 trial in H2 2018 Phase 3, double-blind, placebo controlled trial in 130 SBS patients evaluating safety and efficacy of twice and once weekly glepaglutide over 24 weeks of dosing Screening Follow-up Run-in Treatmen
Slide 11: Dasiglucagon – first Phase 3 for HypoPal rescue pen reported positive results
Dasiglucagon – first Phase 3 for the HypoPal® rescue pen reported positive results Positive results from first Phase 3 trial during the quarter. Results from pivotal Phase 3 expected in H2 2018. The first Phase 3 trial was to evaluate the immunogenicity of repeated single doses of dasiglucagon in 90
Slide 12: Dasiglucagon for congenital hyperinsulinism – FDA approved IND for two Phase 3 trials
Dasiglucagon for congenital hyperinsulism of two Phase 3 trials – FDA approved IND for initiation The Phase 3 trials are set to start in H2 2018 • The U.S. Food and Drug Administration (FDA) approved Zealand’s Investigational New Drug (IND) application for initiation of two Phase 3 clinical trials •
Slide 13: Soliqua 100/33 continues to grow
Soliqua® 100/33 continue to grow Weekly prescriptions of Fixed-dose combination of GLP-1 analog (Lyxumia®/Adlyxin®) and basal insulin (Lantus®) Increasing Sanofi royalties based on Soliqua® 100/33 uptake Average weekly prescriptions (TRx)2 4000 Soliqua® 100/33 Launched in the U.S. in 2017 3500 3000
Slide 14: Financial highlights
Financial highlights By Mats Blom, EVP & CFO 15
Slide 15: Q1 2018 financial results
Q1 2018 financial results Highlights Q1 2018 • Royalty revenue: DKK 11 million / USD 2 million • Net operating expenses: DKK 92 million / USD 15 million Cash position • DKK 567 million / USD 94 million • Includes DKK 6 million / USD 1 million restricted cash 16 DKK ‘000 Q1 2018 Q1 2017 FY 2017 Incom
Slide 16: 2018 outlook
2018 outlook By Britt Meelby Jensen, President & CEO 17
Slide 17: 2018 will be a significant year with upcoming value-driving catalysts
2018 will be a significant year with upcoming value-driving catalysts News flow: rest of 2018 Glepaglutide Dasiglucagon Other Dasiglucagon HypoPal® rescue pen Acute, severe hypoglycemia Pivotal Phase 3 results Glepaglutide GLP-2 analog Short bowel syndrome Phase 3 initiation Soliqua® 100/331 Sales u
Slide 18: Q&A session
Q&A session Upcoming Investor presentations Jefferies Global Healthcare Conference, New York, U.S. 5-8 June , 2018 InvestorDagen, Aarhus, Denmark June 12, 2018 Goldman Sachs Annual Global Healthcare Conference, Palos Verdes, U.S. June 12-14, 2018 LSP Biocapital Diabetes Conference, Münich, Germany J
Slide 19: Q&A session
Q&A session, (ZEAL 8 ZEALAND PHARMA ig ges ~ Upcoming Investor presentations mmm, . Jet s Global Healthcare Conference, New York, U.S. _cchilligatmee 5-8 June , 2018 InvestorDagen, Aarhus, Denmark _June-42, 2018 - - Goldman Sachs Annual Global Healthcare Conference, Palos Verdes, U:S. rie June 12-14