Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — H1 2019 Earnings Presentation
16 slides from Zealand Pharma A/s's earnings presentation, Aug 16, 2019
Slide 1: Business & Financial Highlights
Business& FinancialHighlights Emmanuel Dulac President and Chief Executive Officer 2
Slide 2: A pivotal moment for Zealand Pharma
A pivotal moment for Zealand Pharma Approaching commercialization Establishing operations in the U.S. Accelerating late stage development Robust product pipeline including three late stage programs Establishing our Peptide Platform Founded in 1998 World-leading peptide platform, with two medicines b
Slide 3: Key Performance Metrics
Key Performance Metrics Financial results for H1 2019 Business highlights for Q2 2019 and the period thereafter • Endpoints achieved in confirmatory Phase 3 study with dasiglucagon HypoPal® rescue pen Unprecedented glycemic control demonstrated in Phase 2 home-use clinical trial testing the iLet™ bi
Slide 4: Focus on our team
Focus on our team • VP, Global Medical Affairs 5 Commercial Operations Initiated build-out of U.S. medical and commercial organization Ongoing recruitment for •President, Zealand Pharma U.S. •VP, U.S. Market Access •VP, Business Unit Lead •Sr. Dir./VP, U.S. Strategy, Planning and Operations Organiza
Slide 5: Maintaining financial strength to support our clinical programs
Maintaining financial strength to support our clinical programs Net Operating Expenses1 Strong cash position R&D and Administrative Expenses DKKm Cash and cash equivalents, restricted cash and marketable securities DKKm $m2 107 $m2 213 1.400 700 1.200 91 183 600 1.000 76 152 500 800 61 122 400 600 4
Slide 6: R&D Highlights
R&DHighlights Adam Steensberg Chief Medical & Development Officer 7
Slide 7: Three Phase 3 programs and a promising early pipeline
Three Phase 3 programs and a promising early pipeline Glepaglutide GLP-2 Analog Short bowel syndrome ZP7570 GLP-1/GLP-2 Dual Agonist Short bowel syndrome Dasiglucagon Rare Diseases Congenital hyperinsulinism Dasiglucagon Dual-hormone Pump Therapy Diabetes management GLP-1/GLU Dual Agonist Obesity/Ty
Slide 8: Glepaglutide for short bowel syndrome pivotal Phase 3 trial on track for 2020
Glepaglutide for short bowel syndrome pivotal Phase 3 trial is on-track for 2020 results Pivotal Phase 3 Phase 2 results Evaluate once-and twice-weekly glepaglutide dosing over 24 weeks 1 Naimi, R.M., et al. Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short
Slide 9: Dasiglucagon HypoPal rescue pen for severe hypoglycemia on track for early 2020
Dasiglucagon HypoPal® rescue pen for treatment of severe hypoglycemia on-track for early 2020 Potential for fastest rescue from hypoglycemia NDA submission Progress toward NDA Filing For illustration only 2018 Immunogenicity Phase 3 results Pivotal Phase 3 results 2019 Confirmatory Phase 3 results P
Slide 10: Superior glycemic control with dual hormone pump using dasiglucagon
Superior glycemic control with dual hormone pump using dasiglucagon for automated management of diabetes Phase 2 home-use clinical trial testing the iLet™ Bionic Pancreas using Dasiglucagon1 + The iLet™ device GEN 42 Dasiglucagon 4 mg/ml Phase 2 iLet™ gen 3.2 results 1 Beta Bionics and Zealand Pharm
Slide 11: Dasiglucagon for congenital hyperinsulinism addresses a significant medical need
Dasiglucagon for congenital hyperinsulinism (CHI) addresses a significant medical need Prevention and treatment of hypoglycemia in pediatric patients with CHI, 7 days of age and older First Phase 3 in up to 32 children with CHI Second Phase 3 in up to 12 neonates with CHI Age 3 months to 12 years Pr
Slide 12: Closing Remarks
ClosingRemarks Emmanuel Dulac President and Chief Executive Officer 13
Slide 13: 2019 Objectives
2019 Objectives • Glepaglutide for short bowel syndrome: 60-80 patients randomized in Phase 3, on track for 2020 results Accelerate our late-stage pipeline • Dasiglucagon HypoPal® rescue pen: Clinical program completion and NDA submission to the FDA • • Dasiglucagon for dual-hormone pumps: Phase 2 c
Slide 14: Zealand Pharma in 2019
Zealand Pharma in 2019 First dosing of patients in Patients enrolled in Phase 3 pivotal Phase 3 with dasiglucagon (CHI) extension with glepaglutide (SBS) Positive Phase 2 results with dasiglucagon (dual hormone artificial pancreas) Collaboration Positive confirmatory Phase Phase 1 initiation with ZP
Slide 15: Q&A Upcoming investor presentations
Q&A Upcoming investor presentations Morgan Stanley 17th Annual Global Healthcare Conference, New York Bryan Garnier 7th European Healthcare Conference, Paris Jefferies Healthcare Conference, London September November November 10 12 20 16
Slide 16: Upcoming investor presentations
Upcoming investor presentati ‘conference, New York September 10 ZEALAND PHARMA