Oncopeptides (ONCO) Q4 2024 earnings summary

Executive summary

• Q4 2024 net sales reached SEK 9.9 million, up 35% from Q3 and 87% YoY, with strong momentum in Germany and Spain, and Italy set for commercialization in H1 2025.

• Full-year 2024 net sales were SEK 31.6 million, tripling from 2023 (SEK 10.9 million, adjusted), driven by expanded European market access.

• Cash position at year-end was SEK 179 million, supporting operations and plans for cash flow positivity by end of 2026.

• Regulatory milestones achieved: Italian reimbursement approval, regulatory alignment and advanced licensing negotiations in Japan, and South Korean partner filing for approval.

• Real-world data for Pepaxti published, supporting efficacy and safety, and positive FDA feedback on pipeline molecule OPD5.

Financial highlights

• Q4 2024 net sales: SEK 9.9 million (Q4 2023: SEK 5.3 million); full-year 2024: SEK 31.6 million (2023: SEK 10.9 million, adjusted).

• Q4 gross profit: SEK 7.8 million; full-year gross profit: SEK 29.0 million.

• Q4 operating loss: SEK -83.3 million; Q4 net loss: SEK -83.4 million; full-year net loss: SEK -284.6 million.

• Operating expenses for 2024: SEK 390 million, with R&D and S&M costs both at SEK 43 million in Q4; G&A costs decreased to SEK 8 million.

• Cash and cash equivalents at year-end: SEK 179 million.

Outlook and guidance

• On track for cash flow positivity by end of 2026, contingent on sales growth and new partnerships.

• Profitability expected from core European markets: Germany, Spain, Italy, Austria, and Switzerland.

• Italy expected to begin sales in H1 2025 following reimbursement approval.

• 2025 operating expenses expected to remain flat versus 2024, with R&D costs decreasing and sales/marketing costs rising slightly.

• Sufficient liquidity projected if sales and licensing deals progress as planned; additional financing options under consideration.