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Introduction & Market Context
Oncopeptides AB (STO:ONCO) reported a strong start to 2025, with significant sales growth and expansion in key European markets, according to the company’s Q1 2025 earnings presentation on May 15. The Swedish biotech company, which is celebrating its 25th anniversary this year, focuses on developing therapies for difficult-to-treat hematological diseases, with its lead product Pepaxti® currently marketed in Europe and the UK.
The company’s stock closed at SEK 2.02 on the presentation day, down 3.27% despite the positive results, suggesting investors may have already priced in the growth expectations or remain cautious about the path to profitability.
Quarterly Performance Highlights
Oncopeptides reported net sales of SEK 13.3 million for Q1 2025, representing a 160% increase compared to SEK 5.1 million in Q1 2024 and a 34% sequential increase from Q4 2024. The company maintained stable operating expenses at SEK 74.0 million, identical to the same period last year and significantly reduced from Q4 2024.
As shown in the following financial summary, the company improved its operating loss (EBIT) to SEK -59.8 million from SEK -65.7 million in the prior-year period:
"We’ve seen a stronger than expected start in Italy with maintained momentum in Germany and Spain," said CEO Sofia Heigis during the presentation. The company highlighted that it remains on track to achieve cash flow positivity by the end of 2026, with its current cash position of SEK 107.3 million supplemented by an unused credit line of SEK 20 million.
European Commercialization Progress
The company’s European growth strategy is built on several key drivers, including innovative pricing strategies in Germany, Austria, Spain, and Italy, national guideline updates, and increasing real-world data supporting Pepaxti’s efficacy and safety profile. The quarterly sales trend shows consistent growth since the product’s European launch:
Oncopeptides has made significant progress in securing market access across its target European countries. The company reported that more than 400 patients have been treated with Pepaxti since its EMA approval in 2022, with sales now established in all key markets as of Q1 2025.
The geographic expansion over time demonstrates the company’s successful market penetration strategy:
Italy represents a particularly important growth opportunity, with the company receiving a positive reimbursement decision and recording its first sales in Q1. Oncopeptides has already unlocked access in more than 70% of Italian regions at the hospital level, ahead of the company’s internal timeline:
In Spain, the company has achieved near-complete regional access at 95%, with Pepaxti being recognized among the "100 Best Ideas of the Year" by Actualidad Económica:
Germany continues to be a strong market for Oncopeptides, with growing demand and an increasing number of prescribers. The company’s focus on peer-to-peer exchange has helped expand its geographic footprint within the country:
Pipeline and Future Growth Opportunities
Beyond its current European commercialization efforts, Oncopeptides is pursuing several growth avenues. The company received positive news when the U.S. FDA lifted the clinical hold on its next-generation drug OPD5, potentially reopening the U.S. market opportunity.
Oncopeptides is also advancing partnership discussions for the Japanese market, having confirmed alignment with the Japanese regulatory agency PMDA and validated the high unmet need with Japanese key opinion leaders.
The company’s pipeline assets include the PDC platform, which offers potential improvements in risk/benefit profile compared to Pepaxti, and the SPIKE platform, which aims to create effective and tolerable immunotherapies:
Supporting the company’s commercial efforts are new real-world data publications that demonstrate Pepaxti’s effectiveness in treating multiple myeloma. Recent studies showed an overall response rate of 55% in a U.S. dataset and 37% in an Italian dataset, reinforcing the product’s clinical value proposition:
Financial Outlook
Oncopeptides maintains that its current cash position, following a recent rights issue, should be sufficient to reach cash flow positivity by the end of 2026. However, this projection depends on continued sales growth and successfully concluding a partnership in Japan.
The company’s operating expenses remained stable year-over-year at SEK 74 million, with selling and marketing costs slightly increasing from SEK 27.7 million to SEK 28.5 million as the company established its Italian organization. R&D costs were stable at SEK 28.7 million compared to SEK 28.2 million in Q1 2024, but significantly decreased from SEK 43.2 million in Q4 2024, reflecting the absence of ongoing studies.
With a European market potential estimated at over SEK 1.5 billion and expanding geographic reach, Oncopeptides appears positioned for continued growth, though the path to profitability remains a key focus for investors as the company works to translate its sales momentum into positive cash flow over the next 18 months.
Full presentation:
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