Zepzelca received a marketing authorisation valid throughout the European Union on 29 May 2026, according to the European Medicines Agency, which lists the medicine as authorised for use in the EU. The decision converts the European business of Pharma Mar, S.A. (BME: PHM) from a patchwork of compassionate use programmes and a single commercial market into an authorised product across the bloc, and it changes the shape of the revenue the company reports from its lead compound.
The authorisation covers lurbinectedin used together with atezolizumab as maintenance treatment in adults with extensive-stage small cell lung cancer whose disease has not worsened after treatment with atezolizumab, carboplatin and etoposide. Extensive-stage small cell lung cancer is rare, and Zepzelca was designated an orphan medicine on 26 February 2019.
What the regulator assessed
The EMA based its view on a main study in 483 adults with extensive-stage small cell lung cancer. Patients lived for an average of 13.2 months when Zepzelca was used with atezolizumab as maintenance treatment, compared with 10.6 months on atezolizumab alone. Average time lived without the disease worsening was 5.4 months against 2.1 months.
The agency described the improvement as limited but meaningful for patients whose prognosis is poor, and said the side effects of the combination, while more burdensome than atezolizumab alone, are manageable. Zepzelca is given by infusion into a vein over 1 hour, once every 21 days, until the disease worsens or side effects become unacceptable. Patients receive a corticosteroid and a serotonin antagonist beforehand and granulocyte colony-stimulating factor afterwards. The medicine overview carries reference number EMA/77801/2026 and was first published on 01/06/2026.
The European base the authorisation lands on
Before the authorisation, PharmaMar’s European lurbinectedin revenue came from compassionate use distribution and from commercial sales in Switzerland, which is outside the EU. In 2025 the company reported revenue from Zepzelca in Europe of 37.5 million euros, up 31 percent, of which the compassionate use programme accounted for 26.2 million euros, up 18 percent, and Swiss sales for 11.3 million euros, up 77 percent. In the first half of 2025 the compassionate use figure was 15.4 million euros, up 26 percent and generated mainly in France, with Switzerland contributing 8.4 million euros, up 75 percent.
Everything else in the lurbinectedin revenue line is somebody else’s sales. Oncology royalty income reached 63.8 million euros in 2025, up 4 percent, of which royalties on lurbinectedin sales, mainly from Jazz Pharmaceuticals in the United States, came to 51.6 million euros against 56.1 million euros in 2024. Royalties on trabectedin sales in the United States rose from 4.5 million euros to 11.6 million euros after the medicine’s inclusion in NCCN treatment guidelines there for first line use. In the first half of 2025 royalties totalled 26.4 million euros against 26.5 million euros a year earlier, with Jazz and Luye together accounting for 21.0 million euros and trabectedin partners for 5.4 million euros.
A 2025 carried by items that do not repeat
PharmaMar closed 2025 with total revenue of 221.4 million euros, up 27 percent, EBITDA of 68.1 million euros against 12.0 million euros, and net profit of 75.0 million euros, up 187 percent. Cash and equivalents stood at 167.8 million euros against financial debt of 46.6 million euros.
Recurring revenue, which the company defines as net sales plus royalties from partners, was 143.5 million euros, up 12 percent. The rest, 77.9 million euros, was non-recurring and rose 66 percent. Licensing income of 77.8 million euros broke down as 42.5 million euros, or 50 million dollars, for the milestone on the United States Food and Drug Administration’s full approval of lurbinectedin, 21.3 million euros as the upfront payment on the Japanese licence, 8.6 million euros, or 10 million dollars, on a commercial milestone in the United States trabectedin licence, 4.0 million euros of deferred revenue from the 2019 Jazz agreement and 1.3 million euros from smaller agreements.
The same pattern ran through the first half of 2025, when total revenue of 95.3 million euros grew 18 percent while recurring revenue grew 5 percent to 72.5 million euros. Non-recurring revenue of 23.0 million euros, up 87 percent, included 20.7 million euros from the Japanese lurbinectedin licence signed with Merck. EBITDA was 25.1 million euros against a negative figure of 0.8 million euros, and net profit was 19.4 million euros against 3.5 million euros. Research and development spending was 47.5 million euros, down 7 percent, of which oncology took 44.8 million euros.
Analysis: the authorisation changes the quality of the revenue, not only the size
The EU decision does two distinct things to PharmaMar’s accounts, and only one of them is growth. The first is that European lurbinectedin sales become the company’s own commercial revenue rather than compassionate use distribution, which means they arrive through national pricing and reimbursement processes that run country by country and on their own timetables. An authorisation dated 29 May 2026 is the start of that sequence, not the end of it. France, which the company identified as the main source of compassionate use revenue, is the market where a switch from an existing access programme to reimbursed commercial supply is most visible in the numbers.
The second is a change in revenue quality. In the United States, PharmaMar receives royalties on Jazz Pharmaceuticals’ sales, 51.6 million euros in 2025, and it does not control the price or the commercial effort. In the EU it now holds the authorisation itself, and it describes subsidiaries in Germany, France, Italy, Belgium, Austria and Switzerland. Sales made on its own authorisation carry the selling costs with them. The 2025 European Zepzelca figure of 37.5 million euros is the reference point against which the first authorised periods will be read.
What the disclosures do not establish is any 2026 figure. The last full set the company published covers 2025, and that year was carried by items it identified as non-recurring: a 42.5 million euro FDA milestone, a 21.3 million euro Japanese upfront and an 8.6 million euro commercial milestone. Recurring revenue grew 12 percent in 2025 and 5 percent in the first half of that year. The useful comparison for any 2026 period is therefore recurring revenue against recurring revenue, with the licensing line read separately.
Under article 100 of Ley 6/2023, issuers admitted to trading on a regulated market must publish a half-yearly financial report covering the first six months of the year within three months of the period end, comprising half-yearly financial statements, an interim management report and responsibility declarations. That document, and the country-by-country reimbursement decisions behind the European launch, are where the effect of the 29 May authorisation will first be measurable.
