Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — H1 2024 Earnings Presentation
18 slides from Zealand Pharma A/s's earnings presentation, Aug 15, 2024
Slide 1: H1 2024 Presentation
H1 2024 Presentation Zealand Pharma August 15, 2024
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Phar
Slide 3: Phenomenal H1 2024 with substantial capital raise enabling further investments in obesity assets
Phenomenal H1 2024 with substantial capital raise enabling further investments in obesity assets Petrelintide Survodutidea Upsized equity offering (amylin analog) (dual GCG/GLP-1 receptor agonist) Reported very encouraging topline Boehringer Ingelheim presented Strengthened the balance sheet data on
Slide 4: GLP-1RA-based therapies are effective at reducing weight in PwO, but are associated with GI tolerability issues
GLP-1RA-based therapies are effective at reducing weight in PwO, but are associated with GI tolerability issues1 There is a significant unmet need for alternative treatment options with different mechanisms of action Rx Today, two QW GLP-1RA-based Petrelintide represents an alternative therapies are
Slide 5: Our R&D pipeline addresses unmet medical needs across several therapeutic areas
Our R&D pipeline addresses unmet medical needs across several therapeutic areas Product candidatea Partnered Pre-clinical Phase 1 Phase 2 Phase 3 Registration , Dapiglutide (GLP-1R/GLP-2R dual agonist) Obesity Obesity Petrelintide (amylin analog) Obesity Obesity ZP6590 (GIP receptor agonist) Obesity
Slide 6: Trial design: Petrelintide Phase 1b MAD Part 2
Trial design: Petrelintide Phase 1b MAD Part 2 A randomized, double-blind, placebo-controlled, Phase 1b, MAD trial of petrelintide – Part 21,2 Aim: to evaluate the safety, tolerability, PK and PD of multiple SC doses of petrelintide, with dose escalation D1 D2 D3 D4 D5 D6 (6 weeks) D1 D2 D3 D4 D5 (8
Slide 7: Most participants were male and had a BMI at the lower end of the eligible range
Most participants were male and had a BMI at the lower end of the eligible range Petrelintide Phase 1b MAD trial Part 2: baseline characteristics1,2 Gender Age Weight BMI 79% of participants Median 49 years Median 92.4 kg Median 29.2 kg/m2 were male (eligible range: 27.0–39.9 kg/m2) Baseline charact
Slide 8: Substantial weight loss was observed with petrelintide at 16 weeks in the Phase 1b MAD trial Part 2
Substantial weight loss was observed with petrelintide at 16 weeks in the Phase 1b MAD trial Part 2 Petrelintide Phase 1b MAD trial Part 2: change from baseline in body weight at Week 161,2 Petrelintide Petrelintide Petrelintide Petrelintide treatment resulted in a Placebo QW DG 1 QW DG 2 QW DG 3 QW
Slide 9: Petrelintide treatment appeared safe and was well-tolerated at all dose levels in the 16-week trial
Petrelintide treatment appeared safe and was well-tolerated at all dose levels in the 16-week trial Proportion of participants reporting nausea or vomiting in the 16-week trial1 No serious or severe AEs reported2 33.3% 33.3% Proportion of participants reporting nausea (%) 30 All GI AEs were mild and
Slide 10: Continuing development of petrelintide as monotherapy through a comprehensive Phase 2b trial
Continuing development of petrelintide as monotherapy through a comprehensive Phase 2b trial A randomized, double-blind, placebo-controlled, Phase 2b trial with petrelintide to be initiated in H2 2024 Aim: to evaluate change in body weight with multiple doses of petrelintide versus placebo Dose Safe
Slide 11: Survodutide GCG/GLP-1 receptor dual agonist shows best-in-class potential in MASH Phase 2 trial
Survodutidea GCG/GLP-1 receptor dual agonist shows best-in-class potential in MASH Phase 2 trial Phase 2 biopsy-driven trial in people with MASH1 Improvement in liver fibrosis with no worsening of MASH Paired biopsy results (F2/F3)2 Participants showing improvement in MASH Actual without worsening o
Slide 12: In H2 2024, topline results for dapiglutide are expected from Part 1 of the Phase 1b dose-titration trial
In H2 2024, topline results for dapiglutide are expected from Part 1 of the Phase 1b dose-titration trial The Phase 1b trial is evaluating higher doses of dapiglutide than the previous 4-week MAD trial and DREAMa N=54, men and women aged 18–64 years Population BMI 27.0–39.9 kg/m2 Duration 13 weeks f
Slide 13: In H2 2024, we have regulatory decisions in the US for both our rare disease programs
In H2 2024, we have regulatory decisions in the US for both our rare disease programs Dasiglucagon in CHI: PDUFA date for NDA Part 1 Glepaglutide in SBS-IF: PDUFA date for up to three weeks of dosing (October 8, 2024) (December 22, 2024) Submission of NDA Part Mid-cycle meeting with US FDA completed
Slide 14: H1 2024 Profit & Loss
H1 2024 Profit & Loss DKK million H1 2024 H1 2023 P&L reflecting Zealand’s investment in its Revenue 49.2 24.0 differentiated assets targeting obesity Cost of goods sold -14.1 - • Revenue of DKK 49 million is mainly driven by the license and development agreement with Novo Nordisk for Zegalogue®. Gr
Slide 15: Capital raise in June 2024 raising gross proceeds of DKK 7 billion allows for further investments in R&D
Capital raise in June 2024 raising gross proceeds of DKK 7 billion allows for further investments in R&D Strong cash position of DKK ~10 billion enables significant investments in our obesity programs 9,748 DKK million 6,789 7,155 373 1,633 1,427 449 -455 -19 2,592 1,184 Cash position Cash flow from
Slide 16: 2024 financial guidance updated
2024 financial guidance updated DKK million 2024 2024 2023 Guidance Guidance Actual 15 August 2024 27 February 2024 Revenue anticipated from existing and new No guidance No guidance license and partnership agreements due to uncertain size and due to uncertain size and 343 timing timing Net operating
Slide 17: We are well on track to deliver on our priorities for 2024
We are well on track to deliver on our priorities for 2024 Petrelintide Dapiglutide Survodutideb (amylin analog) (GLP-1R/GLP-2R) (GCGR/GLP-1R) ✓ Ph1b 16-week MAD clinical trial ✓ Ph2a DREAM clinical trial dataa data ✓ Ph2 MASH clinical trial data Ph2b trial initiation Ph1b 13-week dose-titration cli
Slide 18: Q&A
e880 ZEALAND PHARMA Q&A H1 2024 15 August, 2024 18