Slide 1: H1-2024 investor presentation
Share ticker: Gubra NASDAQ Copenhagen H1-2024 investor presentation 22 August 2024 Present from Gubra: Henrik Blou, CEO Louise S. Dalbøge, CSO Kristian Borbos, CFO Investor conference call 22 August 2024, 10:00am CET Follow live via: Gubra Earnings release Q2-2024 - Events Platform - Q4 (q4inc.com)
Slide 2: Forward looking statements
Forward looking statements Matters discussed in this presentation may constitute forward-looking statements. Forward-looking statements are statements that are not historical facts and that can be identified by words such as “believe“, “expect“, “anticipate“, “intends“, “estimate“, “will“, “may“, “c
Slide 3: The Gubra Hybrid Business Model
235 Employees June 2023 The Gubra Hybrid Business Model 51% CRO revenue from the US CRO Discovery & H1 2024 Services Partnerships Specialized pre-clinical Discovery, design and contract research and development of 30% development services peptide-based drug Yearly revenue growth (CAGR) for the pharm
Slide 4: Continued strong progress – across Gubra
Continued strong progress – across Gubra 34% Amylin Amylin UCN2 BI#2 Revenue growth CRO business SAD MAD Healthy weight loss Triple agonist H1 2024: Strong growth Extension to all cohorts Starting MAD Planning for clinic Entering the clinic Obesity main driver Key cohorts (1-4) Regulatory approval P
Slide 5: Our CRO business
CRO business OVERVIEW OF GUBRA’S DISEASE AREAS AND SERVICE OFFERING Our CRO business 3D Imaging Diabetes Liver Lungs Heart • Specialised in the pre-clinical phase with a (NASH/MASH) (CVD) stronghold in metabolic and fibrotic diseases • Highly ranked translatable rodent models 2D Histology • End-to-e
Slide 6: CRO business H1-2024 results
CRO business Revenue (organic) Q1 DKKm Q2 H1-2024 results 34% 107.5 Revenue 80.1 49.0 • Strong organic growth – up 34% year-over-year 41.4 • Growth across disease areas 58.5 38.7 • Obesity strongest growth driver H1-2023 H1-2024 Adjusted EBIT* Q2 Adjusted EBIT-margin* DKKm Q1 Earnings 32.1% 63% 26.5
Slide 7: Our Discovery & Partnership business (D&P)
Our Discovery & Partnership business (D&P) • Discovery, design and development of peptide-based drug candidates • Through our streaMLine platform we can: • Accelerate clinical candidate identification • Enhance potential for stronger patent protection • Portfolio approach to partnering to balance ri
Slide 8: R&D Pipeline
R&D Pipeline Currently tested in clinical trial NCT05751226 by Boehringer Ingelheim alone or given in Partnered and internal programs (Drug Discovery and onwards) combination with semaglutide or survodutide Phase 1 started July 2024 5 Active Partnerships 3 in Clinical testing 8 Obesity Projects 8
Slide 9: GUBamy
GUBamy GUBamy Once-weekly amylin analogue for the treatment of obesity 9
Slide 10: GUBamy: Significant potential as a novel obesity treatment
GUBamy Significant potential as a novel treatment option for patients with obesity Amylin • Amylin is a 37 amino acid peptide hormone. It is produced in the pancreatic β-cells and co- secreted with insulin in response to meal ingestion • Plays an important role in maintaining glucose and energy home
Slide 11: GUBamy weight loss in obese rats: 4-week combination study
GUBamy weight loss in obese rats: 4-week combination study Relative body weight Key takeaways 105 Vehicle Lean Vehicle DIO • Additive weight loss in obese rats when Tirzepatide GUBamy was combined with GLP-1 95 Body weight (%) containing molecules: Semaglutide Survodutide GUBamy • Semaglutide (GLP-1
Slide 12: Phase 1 study SAD and MAD
Phase 1 study SAD and MAD ClinicalTrials.gov NCT06144684 Study setup • Randomized, placebo-controlled SAD and MAD studies at one site in Nottingham, UK • Primary objective: Safety and tolerability (Incidence of Adverse Events) • Secondary objectives: Characterize the pharmacokinetics (PK) and invest
Slide 13: High quality weight loss with Once weekly UCN2 analogues
GUB- UCN2 High quality weight loss with Once weekly UCN2 analogues 13
Slide 14: Time to focus on healthy weight loss
Time to focus on healthy weight loss Treatment paradigm for future obesity treatment TODAY: FUTURE: Loss of lean mass Healthy weight loss 100 100 90 Fat mass Fat mass 90 Lean mass Lean mass • Maximize loss of fat mass 80 80 70 Lost weight (%) Lost weight (%) 70 60 60 50 50 • While preserving/increas
Slide 15: Selective long-acting UCN2 analogues
Selective long-acting UCN2 analogues Ready for development Selective receptor profile Excellent physical and Pharmacokinetics: chemical stability: + Allometric scaling from data in mouse, rat and minipig + No amyloid fibril formation support once-weekly dosing in humans + High chemical stability + H
Slide 16: GUB-UCN2 eliminates lean mass loss induced by other anti-obesity agents in DIO rats
GUB-UCN2 eliminates lean mass loss induced by other anti-obesity agents in DIO rats Sustained body weight Increased lean mass Decreased fat mass Relative body weight Lean mass change from baseline Fat mass change from baseline 110 Lean mass change from baseline (g) Fat mass change from baseline (g)
Slide 17: UCN2: Planning for clinical testing
UCN2: Planning for clinical testing • GMP-production of UCN2 API has been initiated • Non-clinical toxicity programme expected to start in late 2024 • Planning for Phase 1 clinical study to start in late 2025/early 2026 17
Slide 18: Collaboration project #2 with Boehringer Ingelheim in Phase 1
Triple agonist Collaboration project #2 with Boehringer Ingelheim in Phase 1 18
Slide 19: 2nd collaboration obesity project with BI in the clinic
2nd collaboration obesity project with BI in the clinic ClinicalTrials.gov NCT06352437 • Second obesity partnership with Boehringer Ingelheim (BI) in human clinical testing (start July 2024) • First-in-class triple agonist peptide • BI responsible for development and commercialisation • Gubra entitl
Slide 20: D&P business H1-2024 results
D&P business Total adjusted costs* Revenue DKKm DKKm H1-2024 results 68.8 21.8 • Decrease in partnership revenue vs. H1 2023 52.3 13.1 • Development milestone for BI collaboration 2 triggered in July 2024 – revenue to be recognised in Q3-2024 H1-2023 H1-2024 H1-2023 H1-2024 • Total costs increasing
Slide 21: Financial outlook and guidance
Financial outlook and guidance New outlook Previous outlook Results Mid-term Guidance items 20243 2024 H1 2024 guidance CRO segment Organic revenue growth 23-28% 15-20% 34% 10% annually Adjusted EBIT-margin1 29-32% 28-31% 32% 35-40% Discovery & Partnership segment Number of new partnerships per year