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Introduction & Market Context
Formycon AG (FRA:ETR:FYB) presented its first quarter 2025 financial results on May 12, highlighting a significant revenue decline while emphasizing strategic progress in its transformation into a commercial-stage biosimilar company. The German biotech firm, currently trading at €22.70, saw its shares decline following the earnings release as investors digested the 70% year-over-year revenue drop.
The company’s presentation focused on its strategic positioning as a "pure-play biosimilar company" with a clear path toward commercial growth and sustainable profitability, despite the challenging quarterly financials.
Quarterly Performance Highlights
Formycon reported first quarter 2025 revenue of €5.3 million, down sharply from €17.7 million in the same period last year. The company attributed this decline primarily to the absence of milestone payments that had boosted Q1 2024 results, when €11.2 million in milestone revenue for FYB202 was recognized.
The revenue composition has shifted significantly, with development compensation representing €4.0 million of Q1 2025 revenue, while royalties from FYB201 and FYB202 contributed the remaining €1.3 million. This contrasts with Q1 2024, when milestone payments dominated the revenue mix.
Despite the revenue challenges, Formycon highlighted several key operational achievements during the quarter, including regulatory approvals for its Stelara® biosimilar (FYB202/Otulfi®) in Canada and the UK, and for its Eylea® biosimilar (FYB203/AHZANTIVE®) in the EU and UK. The company also secured new commercialization partnerships with Teva for parts of Europe and with Lotus Pharmaceutical (TADAWUL:2070) for the APAC region.
Detailed Financial Analysis
The financial performance deterioration extended beyond revenue to profitability metrics. Formycon reported an EBITDA of -€13.2 million for Q1 2025, compared to -€5.5 million in Q1 2024, representing a €7.7 million decline. Similarly, adjusted EBITDA worsened to -€11.8 million from -€1.2 million in the prior-year period.
Cost of sales remained relatively stable at €14.8 million (versus €14.1 million in Q1 2024), while R&D expenses held steady at €5.4 million. Other expenses increased by €1.0 million to €5.2 million, which the company attributed to workforce expansion and salary increases.
Formycon’s balance sheet showed some deterioration, with total assets decreasing by €18.7 million (-2%) to €753.0 million as of March 31, 2025. The equity ratio remained solid at 58.3%, though it declined by 1.5 percentage points from year-end 2024. Cash and cash equivalents fell by €8.9 million (-21%) to €32.9 million during the quarter.
The cash flow statement revealed that operating activities generated €9.1 million, driven by improvements in trade receivables and prepayments that offset the negative EBITDA. However, investing activities consumed €16.8 million, primarily for development costs related to FYB206, the company’s Keytruda® biosimilar candidate. Working capital stood at €29.4 million at quarter-end.
Strategic Initiatives
Formycon emphasized its strategic transformation into a commercial-stage company with multiple products in key global markets. The company highlighted the commercial launch of its Stelara® biosimilar in the US and EU during the quarter, and its Eylea® biosimilar approvals in the EU and UK.
A notable development was the tailored clinical approach for the Keytruda® biosimilar candidate FYB206, which will proceed without a comparative efficacy (Phase-III) study, potentially accelerating development timelines and reducing costs.
The company also pointed to its inclusion in the TecDAX Index of Deutsche Börse as validation of its market position and growth potential.
Forward-Looking Statements
Despite the weak first quarter, Formycon maintained its full-year 2025 guidance, projecting revenue of €55 to €65 million and EBITDA between -€20 and -€10 million. The company expects significant revenue acceleration in the second half of the year as commercial launches gain traction.
For the remainder of 2025, Formycon anticipates several additional commercial and operational milestones, including the approval of its Lucentis® biosimilar in Latin America, commercial launches of its Stelara® biosimilar in Canada and the UK, and new commercialization partnerships for both its Eylea® and Keytruda® biosimilars. The company also plans to disclose details of its FYB208 immunology biosimilar candidate.
The company’s presentation emphasized its focus on pipeline execution and commercial growth, with the goal of achieving sustainable profitability as its pipeline matures. However, investors appear cautious, with the stock trading near its 52-week low of €19.18, reflecting concerns about the near-term financial performance despite the strategic progress.
Full presentation:
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