Zealand Pharma A/s · OMXCOP:ZEAL
Zealand Pharma A/s — Investor Presentation (January 2019)
47 slides from Zealand Pharma A/s's investor presentation, Jan 4, 2019
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: Zealand in brief
Zealand in brief Danish Biotech Founded in Copenhagen (HQ) in 1998 with U.S. subsidiary Leading Peptide Platform A world leading peptide platform, with two product candidates brought to market 4 Late Stage Programs Accelerating several late stage programs to launch new products into major markets in
Slide 3: 2018 Achievements
2018 Achievements Glepaglutide for SBS: Phase 3 Program ongoing Dasiglucagon HypoPal® rescue pen: Positive results reported from two Phase 3 trials Dasiglucagon for congenital hyperinsulinism: Phase 3 program initiated Dasiglucagon for dual hormone pumps: New agreement with Beta Bionics to initiate
Slide 4: We change lives with next generation peptide therapeutics
We change lives with next generation peptide therapeutics Changing Lives We work every day with patient communities and thought leaders to change the lives of patients with severe unmet medical needs Transforming Peptides We leverage our 20 years of leading R&D experience to transform peptides into
Slide 5: Developing next generation peptide therapeutics
Developing next generation peptide therapeutics Sources of innovation The Zealand peptide platform Therapeutic opportunities GLP-2 analogs GLP-1 analog GLP1-Glu agonist Amylin analog Cutting-edge peptide drug candidates Peptide libraries Glucagon analog • • • • Physical stability Chemical stability
Slide 6: Optimizing value through internal drug development and partnerships
Optimizing value through internal drug development and partnerships Optimizing execution across the value chain Contract Manufacturing Organizations (CMOs) Academic and Scientific Institutions Contract Research Organizations (CROs) Distribution Partners Maintaining full control and value potential E
Slide 7: Three Phase 3 programs and a promising early pipeline
Three Phase 3 programs and a promising early pipeline 1 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 365m in outstanding milestones; 2 Partnered with Boehringer Ingelheim. Zealand eligible for EUR 283m in outstanding milestones 7 Product CandidateIndication Pre-clinical Phase 1 Phas
Slide 8: Marianne lives with short bowel syndrome
Marianne lives with short bowel syndrome and is dependent on daily parenteral support I \ I I It I ZEALAND PHARMA
Slide 9: Glepaglutide: a long-acting GLP-2 analog for short bowel syndrome
Glepaglutide: a long-acting GLP-2 analog for treatment short bowel syndrome of Effective and well-tolerated in Phase 2, suggesting a fast and reliable treatment1 We aspire to reduce the burden of living with short bowel syndrome by offering glepaglutide as a best-in-class GLP-2 treatment Unique drug
Slide 10: Short bowel syndrome is a chronic and debilitating disease
Short bowel syndrome is a chronic and debilitating disease Europe1,2 affecting up to 40,000 people in the U.S. and Rare and severe disease Impaired intestinal absorption, diarrhea and metabolic complications 3 Life-long dependency Complex parenteral support to survive and risk of life-threatening in
Slide 11: Superior effect of glepaglutide in pre-clinical intestinal models
Superior effect of glepaglutide in pre-clinical intestinal models GLP-2 increases intestinal weight Glepaglutide increases intestinal length3 200 ** 80 ** ** ** 150 60 100 40 50 20 0 0 Low High Veh 1 mg/kg 3 mg/kg 10 mg/kg Veh 10 mg/kg Dose Apraglutide (30/300 nmol/kg/day) 1 Teduglutide (30/300 nmol
Slide 12: Strong Phase 2 data with increases in intestinal absorption
Strong Phase 2 data with clinically significant increases in intestinal absorption following 3 weeks’ glepaglutide treatment Change in wet weight absorption (g/day)1 Clear dose-response on multiple endpoints1 • Significant increase in intestinal fluid and energy absorption • Significant reduction in
Slide 13: Opportunity to take majority share of a potential >$1.5 billion market
Opportunity to take majority share of a potential > $1.5 billion market with glepaglutide Estimated number of treated SBS patients and market value potential across major markets Major growth drivers for GLP-2 treatments Increasing SBS patient prevalence5 Improving GLP-2 treatments options Improving
Slide 14: ZP7570 as next generation therapy for short bowel syndrome
ZP7570 as next generation therapy for patients with short bowel syndrome – Phase 1 initiation in 2019 Superior pre-clinical effects on small intestine surface area2 ZP7570 • Novel long-acting GLP-1/ GLP-2 dual peptide agonist Once weekly dosing Concept proven in SBS patients1 IP protection until at
Slide 15: Dasiglucagon
Dasiglucagon • • • • Novel stable glucagon analog Fast onset-of-action Unique stability in liquid formulation Suitable for multiple indication Diabetes care HypoPal® rescue pen for severe hypoglycemia Positive results in pivotal Phase 3 For illustration only Automated diabetes care with a dual hormo
Slide 16: Dasiglucagon has the potential to be the fastest-acting rescue treatment
Dasiglucagon has the potential to be the fastest-acting rescue treatment for severe hypoglycemia
Slide 17: Dasiglucagon HypoPal: a stable glucagon analog for fast rescue
Dasiglucagon HypoPal® – a stable glucagon analog for fast rescue treatment of severe hypoglycemia For illustration only We aspire to offer the HypoPal® Rescue Pen as the fastest treatment option for severe hypoglycemia Fast onset of action confirmed in Phase 3 One dose from age 6 in a ready-to-use a
Slide 18: Severe hypoglycemia is one of the most feared complications of insulin therapy
Severe hypoglycemia is one of the most feared complications insulin therapy1 for diabetes patients on For illustration only ~6 million people Are insulin-treated type 1 diabetes or type 2 diabetes patients in the U.S. alone2 Underutilization of currently available glucagon rescue kits • >85% of trai
Slide 19: Phase 3 results demonstrated fast and effective rescue from hypoglycemia
Phase 2 results demonstrated fast and effective rescue from dasiglucagon1 hypoglycemia with 0.6 mg Plasma Glucose (mg/d ) 300 250 200 150 100 50 Time (h) 0 -----+----1 --+------------- ---- ------ 5 0 2 3 4 6 1 Diabetes Care. 2018 Mar:41(3)531-537 ZEALAND PHARMA Dasiglucagon 0.1 mg .....-Dasiglucago
Slide 20: Strong Phase 3 results confirm fast rescue from hypoglycemia
hypoglycemia1 Strong Phase 3 results confirm fast rescue from For illustration only 82 subj 43 subj 43 subj Log-rank test vs placebo p<0.001 82 subj 43 subj 43 subj Fisher’s exact test p<0.001 1 Company announcement No. 23/2018, Zealand Pharma achieves primary and key secondary endpoints in pivotal
Slide 21: Glucagon rescue market could reach >$1 billion in the U.S.
With improved treatment options, the glucagon rescue market could reach > $1 billion in the U.S. alone For illustration only Significant growth expected for rescue treatments Major growth drivers for glucagon rescue treatments Volume in major markets, million rescue treatments ~103 Increasing number
Slide 22: Dasiglucagon for fully automated diabetes care
Improving the lives of insulin-dependent diabetic patients with dasiglucagon for fully automated diabetes care 23
Slide 23: First glucagon analog for fully automated diabetes care
Dasiglucagon could be the first to market glucagon analog for fully automated diabetes care 2 Glucose sensor/CGM2 We aspire to launch dasiglucagon as the first stable glucagon analog for fully automated diabetes care Pre-filled insulin and glucagon cartridges 3 Integrated insulin and glucagon pump a
Slide 24: Phase 2 initiation with leading dual hormone pump developer
Phase 2 initiation with leading dual hormone pump developer Dasiglucagon for dual hormone pumps • Non-exclusive partnership with pump developer Beta Bionics1 • Beta Bionics received IDE approval from FDA in Q2 2018 • Phase 2 trial in the iLet™ Gen 3.2 pump device expected to complete in H1 2019 + •
Slide 25: Automated glucose management with insulin and glucagon
Automated glucose management with insulin and glucagon could increase time in range and reduce risk of hypoglycemia Daily mean plasma glucose levels1 Insulin-only treatment in sensor-augmented pump system Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 Day 10 Day 11 Insulin and glucagon in a d
Slide 26: Chronic toxicology studies support human testing of dasiglucagon
Chronic toxicology of long-term usage studies support human testing of dasiglucagon effects to native glucagon1 Long-term safety and tolerability study of dasiglucagon1 Dasiglucagon demonstrate similar physiological • 26 and 39 week toxicity studies in rats and dogs • Chronic administration was not
Slide 27: Two Phase 2a trials concluded with dasiglucagon for pump use
Two Phase 2a trials studies concluded with dasiglucagon for use in a pump system Phase 2a Microdose trial1 17 Type 1 Diabetes patients at normal or low blood sugar Dasiglucagon effective in doses from 0.03 to 0.6 mg Optimal profile for pump use Phase 2a Pump trial2 • • • • 10 Type 1 Diabetes patient
Slide 28: Paradigm shift in diabetes pump adoption expected
A paradigm shift in diabetes pump adoption expected with fully automated dual hormone pumps 100% Traditional insulin pump systems1 Closed loop insulin pump systems2 Fully-automated dual hormone pumps3 Transformational innovation Incremental innovations 2018 pump adoption4 0% 1 Example: MiniMed 530G
Slide 29: Opportunity for dasiglucagon in dual hormone pump glucagon market
Opportunity for dasiglucagon to capture a USD 1 to 3 billion glucagon market for dual hormone pumps Pump adoption expected to increase rapidly Major market growth drivers for dual hormone pumps Estimated number of pump users, U.S. only1 Increasing number of insulin-treated Type 1 and Type 2 Diabetes
Slide 30: Transforming the lives of children with congenital hyperinsulinism
Transforming the lives of children with congenital hyperinsulinism and their families by offering continues infusion of dasiglucagon 31
Slide 31: Dasiglucagon as long-term treatment for children with CHI
Dasiglucagon as long-term treatment for children with congenital hyperinsulinism newborns and We aspire to transform and the lives of children with CHI Providing a non-surgical treatment option Liquid formulation, stable at room and body temperature First Phase 3 trial initiated EU and U.S. orphan d
Slide 32: Congenital hyperinsulinism is an ultra-rare and devastating disorder
Congenital hyperinsulinism (CHI) is devastating disorder in newborns an ultra-rare and An ultra-rare disease in newborns and children ~300 newborns are diagnosed every year with genetically determined CHI in the U.S. and EU1,2 Persistent episodes of hypoglycemia Most common cause of serious episodes
Slide 33: Dasiglucagon development program targets children with CHI
The dasiglucagon development program targets children with CHI both pre-and post-diagnosis Dasiglucagon infusion for short-term glycemic stabilization Pre-diagnosis • • • Short term therapy for focal and diffuse CHI patients Replacement of diazoxide or glucagon i.v. infusion1 Opportunity to discharg
Slide 34: Proof-of-Concept in CHI established
Proof-of-Concept in CHI established suggestion potential for discharge to home and surgery avoidance Reduction or discontinuation of I.V. glucose infusion in all children Six children were discharged to home during treatment Clinical Proof-of-Concept in children with diffuse CHI 9 diffuse CHI childr
Slide 35: Phase 3 ongoing with one additional trial in 2019
Phase 3 ongoing with one additional trial to be initiated in 2019 Ongoing: Phase 3 trial in up to 32 children with CHI To be initiated: Phase 3 trial in up to 16 neonates with CHI Key inclusion criteria Key Inclusion criteria • • Age 3 months to 12 years Diagnosed with diffuse CHI (+/-near-total pan
Slide 36: Potential to change the life of more than 1,000 children with CHI
Dasiglucagon has the potential to change the life of more than 1,000 children with congenital hyperinsulinism 2018 estimate of diffuse CHI patients in major markets Dasiglucagon as potential first-in-class glucagon analog for short-and long-term glycemic stabilization of children with CHI 1 Estimate
Slide 37: Potential to change the life of more than 1,000 children with CHI
Dasiglucagon has the potential to change the life of more @) than 1,000 children with congenital hyperinsulinism 2018 estimate of diffuse CHI patients in major markets COS ~300 Dasiglucagon as potential first-in-class glucagon analog for short- and long-term glycemic stabilization of children with C
Slide 38: Boehringer Ingelheim partnership program: GLP-1/glucagon analog
Boehringer Ingelheim partnership program: GLP-1/glucagon analog for obesity and type 2 diabetes in Phase 1 Body weight reduction with GLP-1/glucagon dual analog in a model of obesity2 GLP-1/glucagon dual analog in Phase 1b1 • • • • • • Product candidate for obesity/ T2D Potential to improve blood su
Slide 39: Pre-clinical progress in long-acting C3 complement inhibitor
Pre-clinical progress in long-acting C3 complement inhibitor The complement cascade system2 C3 complement inhibitor • Modulation of the complement cascade is clinically validated as therapeutic approach1 • Multiple opportunities for intervention points for novel targeted therapeutics • Novel long-ac
Slide 40: Pre-clinical GIP portfolio
Pre-clinical GIP portfolio with compelling evidence for therapeutic development in multiple major diseases The GIP pre-clinical agonists • GIP MONO agonist with potential in T2D and obesity Vehicle 1 & 2 GLP-1 + Vehicle 2 GLP-1 + ZP GIP high dose GLP-1 + ZP GIP low dose GIP mono agonist2 • GIP/GLP-1
Slide 41: Ion channel blockers
Ion channel blockers Venoms are rich in peptides that act as ion channel blockers Ion Channel blockers • Transmembrane proteins (>400) that control ion flow across membranes in almost all living cells1 Dysregulation implicated in many diseases e.g. autoimmune, metabolic, channelopathies, etc. Peptid
Slide 42: Additional Company Information
Additional Company Information 43
Slide 43: A strong financial position to support our clinical programs
A strong financial position to support our clinical programs Net Operating Expenses increased by 31% to DKK 331 million / $ 51 million Cash position: Total cash and cash equivalents, restricted cash and securities: DKK 1,479 million / $ 229.6 million R&D and Administrative Expenses DKKm Cash and cas
Slide 44: Our Team
Our Team Corporate Management Britt Meelby Jensen President, Chief Executive Officer Mats Blom Executive Vice President, Chief Financial Officer Adam Steensberg Executive Vice President, Chief Medical & Development Officer Andrew Parker Executive Vice President, Chief Science Officer Ivan Møller Sen
Slide 45: Milestones in 2019
Milestones in 2019 Rare diseases Diabetes/Obesity Pre-clinical programs Glepaglutide GLP-2 analog for SBS Phase 3 updates Dasiglucagon HypoPal® Rescue Pen Phase 3 program completed GIP/GLP-1/GLU Pre-clinical update ZP7570 GLP-1/GLP-2 dual agonist Phase 1 initiation Dasiglucagon HypoPal® Rescue Pen N
Slide 46: The Zealand Investment Thesis
The Zealand Investment Thesis Four late stage development product candidates in 2019 expecting to launch into major markets in 2 to 4 years • • • • Glepaglutide for short bowel syndrome in Phase 3 Dasiglucagon HypoPal® Rescue Pen with positive phase 3 results Dasiglucagon for congenital hyperinsulin
Slide 47: The Zealand Investment Thesis
The Zealand Investment Thesis. Four late stage development product candidates in 2019 expecting to launch into major markets in 2 to 4 Baa * Glepaglutide for short bowel syndrome i in Phase 3 * Dasiglucagon HypoPal® Rescue Pen with positive pl results * Dasiglucagon for congenital hyperinsulinism in
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