Gubra A/s · OMXCOP:GUBRA
Gubra A/s — Gubra A S — FY2024 Earnings Presentation
37 slides from Gubra A/s's earnings presentation, Feb 28, 2025
Slide 1: Full-Year 2024 Investor Presentation
SHARE TICKER: GUBRA l NASDAQ COPENHAGEN FULL-YEAR 2024 INVESTOR PRESENTATION 28 FEBRUARY 2025 Present from Gubra: Henrik Blou, CEO Louise S. Dalbøge, CSO Kristian Borbos, CFO INVESTOR CONFERENCE CALL 28 February 2025, 10:00am CET Follow live via: https://events.q4inc.com/attendee/975975221 DIAL-IN N
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: Gubra at a glance: CRO services and Discovery & Partnerships
CRO SERVICES DISCOVERY & ~260 30% PARTNERSHIPS Specialized pre-clinical Discovery, design, and contract research and development of peptide- EMPLOYEES YEARLY development services based drug candidates DECEMBER 2024 REVENUE GROWTH* for the pharma and with the aim of entering biotech industry. partner
Slide 4: 2024 in review – strong performance across Gubra
2024 in review – strong performance across Gubra OUTLOOK START 2024 RESULTS 2024 CRO organic revenue growth 10-15% 31% CRO adj. EBIT-margin 25-28% 30% D&P: Number of new partnerships 1-2 1 D&P: Amylin SAD results Yes ✓ 4
Slide 5: Key operational highlights
Key operational highlights UCN2 31% Amylin Amylyx REVENUE GROWTH HEALTHY PARTNERSHIP WEIGHT LOSS CRO BUSINESS MAD results in Apr Preparing for the clinic Partnership with Amylyx 2024: Strong growth + Positive Phase 1 SAD data + Preclinical tox ongoing + Develop a novel long-acting + Obesity and kidn
Slide 6: Strategic priorities and aspirations towards 2030
Strategic priorities and aspirations towards 2030 PIPELINE AND MODELS TECH INNOVATION CORE RESEARCH ENGINE ESG + Develop pipeline further, also + Accelerate innovation by + Excellence in operations – one fully + Serve as an inspiration for outside of obesity establishing “TechBio Lab” unit fully opt
Slide 7: Our Discovery & Partnerships business (D&P)
Our Discovery & Partnerships 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 r
Slide 8: R&D Pipeline
R&D Pipeline Partnered and internal programs (Drug Discovery and onwards) *Oct 31, 2024 discontinued in obesity by Boehringer Ingelheim (BI). BI is exploring the potential for the compound in other disease areas. 8 **Post-bariatric hypoglycemia
Slide 9: GUBamy
AMYLIN GUBAMY Once-weekly amylin analogue for the treatment of obesity 9
Slide 10: SAD study results – conclusions; ongoing Phase 1 MAD
SAD study results* – conclusions Ongoing Phase 1 Multiple Ascending Dose (MAD) 1 GUBamy was well tolerated with adverse events being predominantly GI related, mild, and transient. 2 GUBamy had a favourable pharmacokinetic profile with a half-life of 11 days supporting once weekly dosing. 3 A single
Slide 11: GUB-UCN2
UCN2 GUB-UCN2 High quality weight loss with once weekly UCN2 analogue 11
Slide 12: 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 13: 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 + No amyloid fibril formation in mouse, rat and minipig support once-weekly dosing in humans + High chemical stability + H
Slide 14: 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 15: UCN2: Planning for clinical testing
UCN2: Planning for clinical testing • GMP-production of UCN2 API has been initiated • Non-clinical toxicity programme ongoing • Planning for Phase 1 clinical study to start in late 2025/early 2026 15
Slide 16: 2024 financial results – Discovery & Partnerships
DISCOVERY & PARTNERSHIPS 2024 financial results Total adjusted costs DKKm Revenue DKKm 155 46 117 36 + Revenue up 25% y/y + Revenue increase partly due to recognition of milestone payment from collaborations 2023 2024 2023 2024 + Total costs increasing as a number of projects are pushed forward in p
Slide 17: Our CRO business
CRO BUSINESS OVERVIEW OF GUBRA’S DISEASE AREAS AND SERVICE OFFERING Our CRO business 3D Imaging Diabetes Liver Lungs (NASH/MASH) + Specialised in the pre-clinical phase with a stronghold in metabolic and fibrotic diseases 2D Histology + Highly ranked translatable rodent models Obesity Kidney Brain (
Slide 18: 2024 financial results – CRO business
CRO BUSINESS CRO revenue (organic) Q4 DKKm Q3 Q2 31% 2024 financial results 220 Q1 169 58 45 55 44 49 Revenue 41 39 59 + Strong organic growth – up 31% year-over-year 2023 2024 + Obesity and Kidney strongest growth drivers Q4 CRO adjusted EBIT* Q3 CRO adjusted EBIT-margin* DKKm Q2 Earnings Q1 44% 30
Slide 19: Financial outlook and guidance
Financial outlook and guidance Outlook Mid-term Guidance items 2025 Guidance CRO segment Organic revenue growth 10-20% 10% annually EBIT-margin 25-31% n/a Discovery & Partnership segment Total costs1 DKK 230-250 million n/a 1) Total costs are cost of sales and operating costs 19
Slide 20: Appendix
ubr. Appendix
Slide 21: GUBamy
GUBamy GUBamy Once-weekly amylin analogue for the treatment of obesity 21
Slide 22: GUBamy could be positioned as both an addition and an alternative to incretin-based therapies
GUBamy could be positioned as both an addition and an alternative to incretin-based therapies + Extensive need GUBamy as GUBamy as for alternative stand-alone combination therapies therapy therapy 22
Slide 23: Amylin: An important player in appetite regulation
Amylin: An important player in appetite regulation Amylin From pancreas to the brain Decreases food intake Reduces blood glucose + Amylin is a 37 amino acid peptide Delays gastric emptying hormone. It is produced in the Decreases glucagon secretion pancreatic β-cells and co-secreted with insulin in
Slide 24: GUBamy holds potential to become the next generation weight management therapy
GUBamy holds potential to become the next generation weight management therapy GUBamy § Balanced Long half-life Body weight loss Physical and Very long receptor profile (T½) alone and in chemical stable patent exclusivity (AMYR and CTR) combination at neutral pH 24
Slide 25: Phase 1a
Phase 1a Study results a jw G Hoty il
Slide 26: Phase 1 Single Ascending Dose (SAD) in healthy men
Phase 1 Single Ascending Dose (SAD) in healthy men NCT06144684 (Phase 1, Part 1) 6.0 mg + Randomized + Double-blind within cohorts 4.75 mg + Placebo-controlled 3.5 mg + Single subcutaneous administration + Single site (CRO in UK) 2.0 mg + 8 subj. per cohort 1.0 mg (2 placebo & 6 GUBamy) + 48 subject
Slide 27: Study population: Healthy males normal to overweight
Study population: Healthy males normal to overweight Baseline characteristics Placebo GUBamy GUBamy GUBamy GUBamy GUBamy GUBamy (all) 0.5 mg 1.0 mg 2.0 mg 3.5 mg 4.75 mg 6.0 mg n 12 6 6 6 6 6 6 Mean age, years (range) 35.7 34.8 38.0 43.5 48.8 40.2 32.0 (23-53) (22-51) (24-50) (28-53) (33-55) (34-46)
Slide 28: GUBamy Phase 1a SAD key study endpoints
GUBamy Phase 1a SAD key study endpoints Primary Endpoint Safety and tolerability incl. number of treatment-emergent adverse events (TEAEs) Secondary Endpoints (Pharmacokinetic) Pharmacokinetic (PK) evaluation incl. half-life (T½) Exploratory Endpoints (Pharmacodynamic) Change in body weight (%) 28
Slide 29: GUBamy was well tolerated
GUBamy was well tolerated Treatment Emergent Adverse Events (TEAEs) Treatment group Placebo GUBamy GUBamy GUBamy GUBamy GUBamy GUBamy Dose (volume mL) 0 mg 0.5 mg 1 mg 2.0 mg 3.5 mg 4.75 mg 6.0 mg (0.1-1.2 mL) (0.1 mL) (0.2 mL) (0.4 mL) (0.7 mL) (0.95 mL) (1.2 mL) n (%) E n (%) E n (%) E n (%) E n (
Slide 30: Dose dependent GI adverse events
Dose dependent GI adverse events Treatment Emergent Adverse Events (TEAEs) Treatment group Placebo GUBamy GUBamy GUBamy GUBamy GUBamy GUBamy Dose (volume) 0 mg 0.5 mg 1.0 mg 2.0 mg 3.5 mg 4.75 mg 6.0 mg (0.1-1.2 mL) (0.1 mL) (0.2 mL) (0.4 mL) (0.7 mL) (0.95 mL) (1.2 mL) n = 12 n=6 n=6 n=6 n=6 n=6 n=
Slide 31: GUBamy Phase 1a SAD key study endpoints
GUBamy Phase 1a SAD key study endpoints Primary Endpoint Safety and tolerability incl. number of treatment-emergent adverse events (TEAEs) Secondary Endpoints (Pharmacokinetic) Pharmacokinetic (PK) evaluation incl. half-life (T½) Exploratory Endpoints (Pharmacodynamic) Change in body weight (%) 31
Slide 32: Long half-life (11 days) supports weekly dosing
Long half-life (11 days) supports weekly dosing GUBamy shows a favourable pharmacokinetic profile 1000 Plasma concentration (ng/mL) 100 T½ 0.5 mg 1.0 mg 2.0 mg 3.5 mg 10 4.75 mg ≈ 270 hours 6.0 mg (11 days) 1 0 72 144 216 288 360 432 504 576 648 720 792 864 936 1008 Time point (h) A long half-life o
Slide 33: GUBamy Phase 1a SAD key study endpoints
GUBamy Phase 1a SAD key study endpoints Primary Endpoint Safety and tolerability incl. number of treatment-emergent adverse events (TEAEs) Secondary Endpoints (Pharmacokinetic) Pharmacokinetic (PK) evaluation incl. half-life (T½) Exploratory Endpoints (Pharmacodynamic) Change in body weight (%) 33
Slide 34: Dose dependent body weight reduction
Dose dependent body weight reduction Relative weight change from baseline in percentage 4 3 Change from baseline in body weight (%) 2 1 PLACEBO Placebo 0.5 mg 0 1.0 mg 2.0 mg -1 3.5 mg 4.75 mg -2 6.0 mg -3 -4 Pre-dose Day 4 Day 8 Day 15 Day 22 Day 29 Follow-up (Day 43) Time since dosing (day) 34
Slide 35: Sustained body weight reduction for weeks
Sustained body weight reduction for 6 weeks Relative weight change from baseline in percentage (SD) 4 3 Change from baseline in body weight (%) 2 1 Placebo PLACEBO 0 3.5 mg -1 4.75 mg 6.0 mg -2 -3 -4 Pre-dose Day 4 Day 8 Day 15 Day 22 Day 29 Follow-up (Day 43) Time since dosing (day) 35
Slide 36: Phase 1 Multiple Ascending Dose (MAD)
Phase 1 Multiple Ascending Dose (MAD) NCT06144684 (Phase 1, Part 2) Part A Part B (6 weeks dosing) (12 weeks dosing incl. titration) + Randomized + Double-blinded within cohorts Dose 5 + Placebo-controlled Dose 4 + Once weekly subcutaneous dosing Dose 3 + 52 subjects (males and females) Dose 2 + Fir
Slide 37: SAD study conclusions
SAD study conclusions GUBamy dosed once in a dose range from 0.5 mg to 6.0 mg + GUBamy was well tolerated with adverse events being predominantly GI related, mild and transient. + GUBamy had a favourable pharmacokinetic profile with a half-life of 11 days supporting once weekly dosing. + A single do