Slide 1: Q3 2024 Report
Q3 2024 REPORT November 7, 2024 1
Slide 2: Important: You must read the following before continuing
© oncopeptides IMPORTANT: You must read the following before continuing. The following applies to this document, the oral presentation of the information in this document by Oncopeptides AB (the “Company”) or any person on behalf of the Company, and any question-and-answer session that follows the o
Slide 3: Presenters
Presenters Sofia Heigis Henrik Bergentoft CEO CFO 3
Slide 4: Where we are right now
Where we are right now KEY Q3 HIGHLIGHTS OTHER HIGHLIGHTS • Revenues of SEK 8.5m in Q3 2024 JULY-SEPTEMBER (SEK 2.8m in Q3 2023), cash position • Oncopeptides announced that the of SEK 250m. first patient has entered study • On track to cash flow positivity evaluating the real-world at end of 2026.
Slide 5: Financial Update
FINANCIAL UPDATE Henrik Bergentoft Chief Financial Officer 5
Slide 6: Financial summary
Financial summary 2023 ‘one off items’ o Reversal of return MSEK July-Sept July-Sept Jan-Sept Jan-Sept reserve in the USA of 2024 2023 2024 2023 24 MSEK in 2023 – underlying full year Net sales 8.6 2.8 21.7 29.9 revenue amounts to COGS -0.7 1.9 -1.9 1.9 5.6 MSEK. Gross profit 7.8 4.7 19.8 31.7 o Clo
Slide 7: Operating expenses
Operating expenses * Excluding refund for clinical studies of 43 MSEK MSEK 120 • R&D, decreased from 49 MSEK in Q3-23 to 22 MSEK in 90 Q3 -24 MSEK 100 • Above excluding refund of 43 MSEK in 2023 * 70 MSEK • No studies currently ongoing. 80 • S&M, increased from 29 MSEK in Q3 -23 to 30 MSEK in Q3 -24
Slide 8: Liquidity
MSEK Liquidity 450 400 350 • Cash was 250 MSEK by end of Q3-24 250 300 MSEK • Rights issue completed in May 2024 infused 270 MSEK after issue related costs. 250 • Operating cash in Q3 includes a negative timing 200 effect of in and out going VAT payments of 105 MSEK, corresponding positive effect in
Slide 9: Commercial Update
COMMERCIAL UPDATE Sofia Heigis Chief Executive Officer 9
Slide 10: Drivers of European growth in Q4 2024 and onwards moving toward profitability end 2026
Drivers of European growth in Q4 2024 and onwards moving toward profitability end 2026 ✓ Innovative price negotiated in Germany, Austria, ✓ Sales pickup in Spain during 2nd half of 2024. Spain – Italy progressing according to plan ✓ Focus on being cost-effective. ✓ National Guideline updates in Germ
Slide 11: European Launch Sequence
European Launch Sequence Our ambition: launch as fast as possible with a price reflecting our innovation – providing patient and shareholder value. Market Access plan Phase I proceeding according to plan. ≈55% Phase II - completed Phase I and II expected to take company to Phase II profitability. -
Slide 12: From authorization to sales in European markets
From authorization to sales in European markets Process between receiving marketing authorization and healthcare professional uptake Value dossier and Cost effectiveness Price negotiations Regional access KOL engagement benefit discussion Marketing Healthcare authorization professional received upta
Slide 13: Roadmap to commercialization in Europe
Roadmap to commercialization in Europe Objective: maximized value for patients and shareholders 1 2 3 4 Marketing Value dossier and Cost effectiveness Healthcare Price negotiations Regional access authorization KOL engagement benefit discussion professional uptake Simplified Sweden Netherlands Norwa
Slide 14: Key Market Deep Dive
KEY MARKET DEEP DIVE 14
Slide 15: Our key markets – a comparison
Our key markets – a comparison GERMANY SPAIN ITALY • Clinical experience at launch: 1 • 15 KOLs with previous • Clinical experience at launch: 16 KOL with experience from Early experience from Early Access KOL with experience from Early Access use use Access use • Recruiting clinical trial sites: 0
Slide 16: Efficacy, Safety, Quality of Life
EFFICACY Pepaxti + dex showed clinically meaningful efficacy and a manageable safety profile in patients with heavily pre-treated RRMM, including those with TCR and EMD1 SAFETY QUALITY OF LIFE The safety profile of Pepaxti primarily Treatment with Pepaxti + dex in consists of hematological adverse p
Slide 17: Germany – where we are
Germany – where we are CRITICAL SUCCESS BARRIERS FACTORS IN GERMANY OPPORTUNITIES One (1) Key Opinion Leader with clinical Key Opinion Leaders with positive 9/17 Key Opinion Leaders today have gained experience at launch in Germany clinical experience positive clinical experience First national guid
Slide 18: Germany is a scattered market with 900+ accounts and 2,000+ MM treaters
Germany is a scattered market with 900+ accounts and 2,000+ MM treaters 18
Slide 19: Heatmap Germany
Heatmap Germany ✓ Focused on the most population dense areas ✓ In regions with generated clinical experience in key accounts sales uptake accelerate ✓ Regions starting to generate experience 2H of 2023 stand for the majority of sales ✓ Several regions started to gain experience in Q2-Q3 and are expe
Slide 20: Pepaxti experience at key accounts & focused regional peer-to-peer exchange accelerate adoption
Pepaxti experience at key accounts & focused regional peer-to-peer exchange accelerate Pepaxti adoption in that region Cumulative Pepaxti vials by selected regions 100 90 80 70 60 First order from key 50 account 2 – Jan’24 First order from key account 1 – Nov’23 40 30 First order from key 20 First o
Slide 21: Our potential
OUR POTENTIAL NEXT STEP VALUE DRIVERS Pipeline assets Our pipeline contains promising assets in terms of new platforms. A high global unmet medical need Pepaxti in rest of creates sales potential – current focus the world is on Japan and China. PEPAXTI IN EUROPE Market potential approx. 1.5+ billion
Slide 22: Pipeline assets
Pipeline assets SPiKE: A platform with exciting potential • Small Polypeptide based innate Killer Engager (SPiKE) immunotherapy takes advantage of natural killer (NK) cells, the immune system’s first-line of defense against viruses and other foreign cells (e.g. cancer cells). • The SPiKE platform pr
Slide 23: Q&A
Q&A 23
Slide 24: Bringing hope through science
Bringing hope through science © oncopeptides