Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Q3 2018 Earnings Presentation
24 slides from Zealand Pharma A/s's earnings presentation, Nov 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 Introduction Britt Meelby Jensen President & Chief Executive Officer Financial highlights Mats Blom Executive Vice President & Chief Financial Officer Business highlights Adam Steensberg Executive Vice President & Chief Medical and Development Officer Summary and Outlook Britt Meelby Jensen P
Slide 3: Highlights in Q3 2018 and the period thereafter
Highlights in Q3 2018 and the period thereafter Financial strength secured • Royalty sale for USD 205 million Advancements in late stage programs • • Dasiglucagon for severe hypoglycemia: Pivotal Phase 3 trial results Glepaglutide for short bowel syndrome: Pivotal Phase 3 trial initiated Progress in
Slide 4: We have four late stage programs and a promising early pipeline
We have four late stage programs and a promising early pipeline Product Candidate Indication Pre-cclliinniiccaall Phase 1 Phase 2 Phase 3 Registration Glepaglutide GLP-2 analog Short bowel syndrome Elsiglutide GLP-2 analog Undisclosed Dasiglucagon Hypopal® Rescue Pen Severe hypoglycemia Dasiglucagon
Slide 5: Financial highlights
Financial highlights Mats Blom Executive Vice President & Chief Financial Officer 6
Slide 6: In September, we sold royalty streams and milestones for USD 205 million to Royalty Pharma
In September, we sold royalty streams and milestones for USD 205 million to Royalty Pharma, immediately realizing the value Proceeds from royalty transaction USD million (DKK million) Sale of future royalties and two commercial milestones from Soliqua® 100/33 and Lyxumia® to Royalty Pharma 205 (1,31
Slide 7: 2018 financial results in line with plan
2018 financial results in line with plan Restated 8 DKK ‘000 Q1-Q3 2018 Q1-Q3 2017 Restated FY 2017 Income statement Revenue (royalties and milestone payments) Royalty expenses Research and development expenses Administration expenses Other operating income 24,858 125,799 136,322 -3,356 -12,742 -14,
Slide 8: Cash position continues to be strong
Cash position continues to be strong Statement of financial position USD 230 million 9 * DKK 177 million or 13.5% of the proceeds from the royalty sale to be paid to third parties in Q4 2018 Total cash position of DKK 1,479 million / (Sep 30 2018)* DKK ‘000 September 30, 2018 Statement of financial
Slide 9: 2018 financial guidance unchanged
2018 financial guidance unchanged 10 Net Operating Expenses 2018 Net operating expenses reflects an increase in spending on glepaglutide and dasiglucagon Phase 3 clinical trials DKK 475-495 m / USD 73-77 m
Slide 10: Business highlights
Business highlights Adam Steensberg Executive Vice President & Chief Medical and Development Officer 11
Slide 11: Glepaglutide for short bowel syndrome
Glepaglutide for short bowel syndrome We aspire to reduce the burden of living with short bowel syndrome offering glepaglutide as a best-in-class GLP-2 treatment by Glepaglutide • Stable GLP-2 analog • Forms depot at the injection site • Potential for once-weekly dosing with effective t½ of ~50 hour
Slide 12: Glepaglutide (Short bowel syndrome) Pivotal Phase 3 trial initiated
Glepaglutide (Short bowel syndrome) Pivotal Phase 3 trial initiated with once and twice weekly dosing Trial design • Double-blind, placebo controlled trial in 129 SBS patients evaluating safety and efficacy of twice and once weekly glepaglutide over 24 weeks of dosing Screening Follow-up Run-in Trea
Slide 13: Dasiglucagon HypoPal® rescue pen for severe hypoglycemia
Dasiglucagon HypoPal® rescue pen for severe hypoglycemia We aspire to improve rescue treatment for severe hypoglycemia Dasiglucagon • • • Ready-to-use glucagon analog4 Fast onset of action Preferred mode of administration with ready-to-use auto-injector pen Stability at refrigerated temperature (5oC
Slide 14: Dasiglucagon HypoPal® rescue pen Positive results from pivotal Phase 3 trial
Dasiglucagon HypoPal® rescue pen Positive results from pivotal Phase 3 trial Phase 3 trial Objective was to compare the glycemic response observed after administration of dasiglucagon with that of placebo and that of currently marketed glucagon, in powder form for reconstitution prior to injection.
Slide 15: Dasiglucagon for diabetes dual-hormone pump therapy
Dasiglucagon for diabetes dual-hormone pump therapy A future with fully automated diabetes care using dasiglucagon in a dual hormone pump system 2 Glucose sensor/CGM2 Pump device partner Beta Bionics has Pre-filled insulin and glucagon cartridges received IDE approval from FDA 1 3 Integrated insulin
Slide 16: Dasiglucagon for congenital hyperinsulinism (CHI)
Dasiglucagon for congenital hyperinsulinism (CHI) Improving the lives of children with congenital hyperinsulinism providing a nonsurgical treatment option by • • Phase 3 trial with 32 CHI children to initiate Q4 2018 Phase 3 pump collaboration with Roche Diabetes Care • Initiation of second Phase 3
Slide 17: Candidates for Obesity/Type 2 Diabetes in Phase 1
Candidates for Obesity/Type 2 Diabetes in Phase Boehringer Ingelheim1 1 development with GLP-1/glucagon dual acting analog Long-acting amylin analog GLP-1/glucagon dual acting analog1: Body weight reduction in a model of obesity2 Once weekly drug candidate with potential to improve blood sugar and w
Slide 18: GLP-1/GLP-2 dual agonist ready for Phase 1 in 2019
GLP-1/GLP-2 dual agonist ready for Phase 1 in 2019 A potent once-weekly GLP-1/GLP-2 and metabolic diseases dual agonist for treatment of short bowel syndrome and other gastrointestinal Vehicle GLP-2 agonist GLP1/GLP-2 dual agonist GLP-1 effect 1000 800 GLP-1/GLP-2 dual agonist (nmol/kg) 600 400 200
Slide 19: Pre-clinical progress in long-acting C3 complement inhibitor
Pre-clinical progress in long-acting C3 complement The complement system2 inhibitor • Altered activation of the complement cascade is implicated in many immune mediated diseases1 • Peptides may offer greater specificity and administration advantages over other modalities • We have identified novel p
Slide 20: Summary and outlook
Summary and outlook Britt Meelby Jensen President & Chief Executive Officer 21
Slide 21: The Zealand Investment Thesis
The Zealand Investment Thesis Three Phase 3 product candidates in 2018 expecting markets in 2 to 4 years to launch into major • • • Glepaglutide for short bowel syndrome Dasiglucagon HypoPal® rescue pen Dasiglucagon for congenital hyperinsulinism Validated peptide platform with multiple promising op
Slide 22: Milestones through 2019
Milestones through 2019 Glepaglutide Dasiglucagon Early Pipeline Partnered Programs Short bowel syndrome Pivotal Phase 3 updates HypoPal® rescue pen Pediatric Phase 3 results GLP-1/GLP-2 dual agonist Phase 1 initiation GLP-1/GLU dual agonist1 Phase 1b results HypoPal® rescue pen NDA submission Compl
Slide 23: Milestones through 2019
Milestones through 2019 Glepaglutide Dasiglucagon Early Pipeline HypoPal® rescue pen GLP-1/GLP-2 dual agonist Pediatric Phase 3 results Phase 1 initiation Short bowel syndrome Pivotal Phase 3 updates HypoPal® rescue pen Complement C3 inhibitor NDA submission Pre-clinical update Phase 3 initiation (2
Slide 24: Zealand Pharma
ZEAL 8 ZEALAND PHARMA