Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Q3 2017 Earnings Presentation
27 slides from Zealand Pharma A/s's earnings presentation, Nov 8, 2017
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 2017 and outlook Business highlights Financial highlights Britt Meelby Jensen, CEO Britt Meelby Jensen, CEO Adam Steensberg, EVP & CMO Mats Blom, EVP & CFO
Slide 3: Listing on the Nasdaq Global Select Market in the U.S.
Listing on the Nasdaq Global Select Market in the U.S. 5,031,250 shares issued as ADS’s, trading on Nasdaq Global Select Market in New York A total of 30,718,652 shares 16.4% are issued as ADS’s 83.6% on the Copenhagen stock exchange Total gross proceeds amount to DKK 567 million/USD 90 million Dual
Slide 4: Business highlights in Q3 2017 and the period hereafter
Business highlights in Q3 2017 and the period hereafter First patients dosed in Phase 1 trial in amylin program triggering a EUR 4 million milestone payment First patients dosed in Phase 1 trial in GLP1/ glucagon program Boehringer Ingelheim Orphan designation granted in the U.S. Clinical trial init
Slide 5: Soliqua 100/33 is a strategic priority product for Sanofi with growing prescriptions
Soliqua® 100/33 is a strategic priority product for Sanofi with growing prescriptions Strong commitment by Sanofi As the first marketed GLP-1/insulin combination in the U.S., Sanofi continues to educate physicians U.S. payer coverage increased by 4%-point over the previous quarter. Access now secure
Slide 6: Increase in revenue from Soliqua 100/33 royalties is expected to accelerate
Increase in revenue from Soliqua® 100/33 royalties is expected to accelerate in coming years Royalty revenue from Sanofi partnership* DKKm Royalty revenue from Soliqua® 100/33 increased by 37% over the previous quarter Continued growth expected, driven by: Weekly increase in prescriptions Increasing
Slide 7: Glepaglutide obtained orphan drug designation in the U.S.
Glepaglutide obtained orphan drug designation in the U.S. Glepaglutide – a long acting GLP-2 analog for short bowel syndrome (SBS) Orphan drug designation benefits Potential for seven years of market exclusivity Relief from user fees, e.g. PDUFA fee Tax credits for clinical trial costs Office of Orp
Slide 8: Positive glepaglutide Phase 2 results provided foundation for Phase 3
Positive glepaglutide Phase 2 results provided foundation for progressing into Phase 3 development Phase 2 data highlights: Up to 30% decrease in fecal wet weight output Effects on several secondary endpoints Indication of a significantly longer half-life of glepaglutide Detailed data will be presen
Slide 9: Trial initiated to evaluate weekly dosing of glepaglutide
A trial has been initiated to evaluate potential for weekly dosing of glepaglutide, topline results in Q1 Objective is to determine optimal dose frequency for Phase 3 Top-line results expected in Q1 2018 Program on track for Phase 3 initiation mid-2018 Clinical PK trial design (n=75)
Slide 10: Zealand dasiglucagon franchise
Automated diabetes care with a dual-hormone pump Pump treatment for chronic low blood sugar (CHI) Three dasiglucagon treatment options in development Rescue pen for severe hypoglycemia Status Phase 3 ongoing Phase 2a completed Phase 1 completed Zealand dasiglucagon franchise
Slide 11: Phase 3 trial initiated with dasiglucagon for severe hypoglycemia
Phase 3 trial initiated with dasiglucagon for severe hypoglycemia, with patient enrolment completed Phase 3 immunogenicity trial (n=90) Rescue pen for severe hypoglycemia Phase 2 data presented at ADA and EASD End-of-phase 2 meeting with FDA in June 2017 Meeting with MHRA in EU in October 2017 Resul
Slide 12: Phase 3 pivotal trial to be initiated in 2017 with dasiglucagon
Phase 3 pivotal trial will be initiated in 2017 with dasiglucagon for severe hypoglycemia Phase 3 pivotal efficacy trial (n=156) Rescue pen for severe hypoglycemia Recue from insulin induced hypoglycemia Primary endpoint: Time to 20 mg/dl increase in plasma glucose versus placebo Results expected in
Slide 13: Progression towards Phase 2b with dasiglucagon in dual-hormone Artificial Pancreas
Progression towards Phase 2b with dasiglucagon in dual-hormone Artificial Pancreas Phase 2a Pump study to evaluate performance of the iLetTM algoritm with dasiglucagon Hypoglycemic challenge by fasting, higher basal insulin rates and exercise Phase 2a Micro-dose and Pump trials concluded in Q2 2017
Slide 14: Orphan drug designation for dasiglucagon in EU and U.S. for congenital hyperinsulinism
Orphan drug designation for dasiglucagon in both the EU and the U.S. for congenital hyperinsulinism A treatment option in development for congenital hyperinsulinism (CHI), covering several congenital disorders caused by gene mutations Orphan drug designation awarded in the EU in May and in the U.S.
Slide 15: Phase 1 with novel long-acting amylin analog initiated
Phase 1 with novel long-acting amylin analog initiated in August for once weekly dosing Skarbaliene et al. Keystone meeting, Copenhagen, Denmark, 2017 The arrows below the graphs represent dosing schedule. The lines below the graphs represent significant difference (p < 0.05) vs. vehicle. ZP4982 is
Slide 16: Phase 1 with novel GLP-1/glucagon dual agonist initiated
Phase 1 with novel GLP-1/glucagon dual agonist initiated in August for once weekly dosing Strong pre-clinical data supports treatment for obesity (and diabetes) Phase 1 results expected in 2018 Daugaard et al, ADA, Orlando FL, USA, 2010 ZP2929 is not an active project in the collaboration with BI bu
Slide 17: Two new research collaborations initiated, in line with strategy
Two new research collaborations initiated, in line with strategy Zealand has initiated two new research collaborations, focused on identifying novel peptides that act on targets relevant to specialty gastro-intestinal and metabolic diseases Orbit Discovery has a technology that enables generation of
Slide 18: Agenda
Agenda 2017 and outlook Business highlights Financial highlights Britt Meelby Jensen, CEO Britt Meelby Jensen, CEO Adam Steensberg, EVP & CMO Mats Blom, EVP & CFO
Slide 19: Financial highlights for the first nine months of 2017
Financial highlights for the first nine months of 2017 Revenue DKK 128.5 million/ USD 20.4 million Cash position DKK 780.6 million/ USD 123.8 million 30 September, 2017 Net operating expenses DKK 251.7 million/ USD 39.9 million Net result DKK -162.3 million/ USD -25.7 million US IPO Gross proceeds D
Slide 20: Financial results for the first nine months of 2017
Financial results for the first nine months of 2017 Income statement (DKK '000) 2017 2016 2016 Q1-Q3 Q1-Q3 Full year Revenue (royalties and milestone payments) 128,500 54,272 234,778 Royalty expenses -13,107 -7,091 -31,459 Research and development expenses -221,204 -190,381 -268,159 Administrative e
Slide 21: Agenda
Agenda 2017 and outlook Business highlights Financial highlights Britt Meelby Jensen, CEO Britt Meelby Jensen, CEO Adam Steensberg, EVP & CMO Mats Blom, EVP & CFO
Slide 22: Achieved milestones for our product candidates in 2017
Achieved milestones for our product candidates in 2017 Product candidate Indication Development stage Preclinical Phase 1 Phase 2 Phase 3 Registration 2017 milestone Glepaglutide GLP-2 analog Dasiglugacon Rescue pen Amylin analog1 GLP1-GLU1 dual agonist Short bowel syndrome Acute, severe hypoglycemi
Slide 23: Revised financial guidance for 2017
Revised financial guidance for 2017 DKK USD Revenue from milestone payments 101 million* 15 million* Royalty revenue from Sanofi collaboration* * No guidance Net operating expenses 375-385 million (reduced) 59-62 million (reduced) *Milestones received from partners. ** Zealand does not guide on roya
Slide 24: News flow for rest of 2017 and 2018
Adlyxin/Lyxumia News flow for rest of 2017 and 2018 Q4 2017 H1 2018 Glepaglutide Detailed Phase 2 trial results presentation Glepaglutide Top-line PK results on dose frequency for Phase 3 Glepaglutide Initiation of Phase 3 H2 2018 Dasiglucagon – rescue pen Initiation of second Phase 3 trial Dasigluc
Slide 25: Events and Financial Calendar
Events and Financial Calendar Upcoming events Jefferies Healthcare Conference, London 15 November Bryan, Garnier & Co Healthcare Conference, Paris 16 December Carnegie Healthcare Day, New York 5 December Citi Global Healthcare Conference, New York 6 December Guggenheim Conference, Boston 13 December
Slide 26: Events and Financial Calendar
Events and Financial Calendar Upcoming events Jefferies Healthcare Conference, London 15 November Bryan, Garnier & Co Healthcare Conference, Paris 16 December Carnegie Healthcare Day, New York 5 December Citi Global Healthcare Conference, New York 6 December Guggenheim Conference, Boston 13 December
Slide 27: Q&A