Slide 1: Year-End Report 2024
YEAR-END REPORT 2024 February 27, 2025 1
Slide 2: Important: You must read the following before continuing
© oncopeptides 25 years 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 foll
Slide 3: Presenters
Presenters Sofia Heigis Henrik Bergentoft CEO CFO 3
Slide 4: Where we are right now
Where we are right now FINANCIALS HIGHLIGHTS • During 2024 Oncopeptides successfully completed a consultation with the Japanese regulator PMDA • Net sales of SEK for Pepaxti, confirming alignment on the regulatory pathway in Japan. 9.9m in Q4 2024 EVENTS OCTOBER-DECEMBER (SEK 5.3m in Q4 2023), cash
Slide 5: Financial Update
FINANCIAL UPDATE Henrik Bergentoft Chief Financial Officer 5
Slide 6: Financial summary
Financial summary MSEK Oct-Dec Oct-Dec Jan-Dec Jan-Dec 2023 one off items 2024 2023 2024 2023 - Reversal of return reserve in Net sales 9.9 5.3 31.6 35.2 the USA of 24 MSEK – underlying revenue amounts to COGS -0.7 -0.8 -2.7 1.1 10.9 MSEK. Gross profit 7.8 4.7 29.0 36.3 - Closed clinical study Expen
Slide 7: Operating expenses
Operating expenses MSEK 120 • S&M, increased from 35 MSEK in Q4 -23 to 43 94 MSEK in Q4 -24 MSEK 84 100 MSEK • Progressing in Europe with sales in Germany, Austria, Greece and Spain and preparations for Italy based on approved price. 80 • G&A decreased from 16 to 8 MSEK, mainly due to cost reduction
Slide 8: Liquidity
MSEK Liquidity 450 400 350 • Cash was 179 MSEK by end of 2024 300 • Cash position in line with 250 179 expectations MSEK 200 • Liquidity position after rights issue estimated to last until cash flow 150 positive end of 2026 100 50 0 Q1´22Q2´22Q3´22Q4´22Q1´23Q2´23Q3´23Q4´23Q1'24Q2'24Q3'24Q4'24 8
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, ✓ 85 % regional access secured in Spain, sales starting Spain and Italy. to pickup during 2H of 2024. ✓ National Guideline updates in Germany, Spain. ✓ Italy expe
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: Italy – our third key market now with national reimbursement
Italy – our third key market now with national reimbursement • Clinical experience at launch: 16 KOL with experience from Early Access use Next Step: 20 Regions to unlock • Recruiting clinical trial sites: 10 • Patients in clinical trials: 79 • EAP patients: 86 • Number of MM prescribers: ≈ 240 • Nu
Slide 15: Heatmap Germany
Heatmap Germany ✓ Germany is a scattered market - 2500 patients treated by 2000 prescribers. ✓ Positive clinical experience in a key account leads to acceleration of sales in that territory due to peer-to-peer recommendations. ✓ 10/12 key accounts with KOLs are now activated and has gained positive
Slide 16: Our Potential
OUR POTENTIAL NEXT STEP VALUE DRIVERS Encouraging first signals as we renew effort Pipeline assets in USA with OPD5. A high global unmet medical need creates sales potential: Pepaxti in rest of ✓ Japan is our primary focus. ✓ South Korean partner submitted to Regulatory the world authorities ahead o
Slide 17: Advanced negotiations with partner. Alignment with PMDA
Advanced negotiations with partner. Alignment with PMDA – Regulatory Confirmed high unmet need by 17 Agency. Japanese KOLs.
Slide 18: Global commercialization progress
Global commercialization progress || Pepaxti available a Commercialization pending || Partnership discussions © oncopeptides 28 years
Slide 19: OPD5 progress
OPD5 progress • Now: Exploratory discussions with the U.S. Food and Drug Administration (FDA). • Potential: improved risk/benefit profile and enhanced intellectual property protection vs. Pepaxti. • Next step: a clinical development path based on advice from the FDA. “The results indicate that melfl
Slide 20: 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 21: Q&A
Q&A 21
Slide 22: Bringing hope through science
Bringing hope through science © oncopeptides