Nadofaragene firadenovec-vncg

Ferring's total revenues for 2025 exceeded €2.5 billion, an increase of 10% from 2024, mainly driven by our flagship product Menopur ® Continued ramp-up in the US for Adstiladrin ® , our novel gene-based therapy for bladder cancer, confirming its position as Ferring’s second major growth driver Commitment to sustainability demonstrated by SBTi approval of our targets to reduce greenhouse gas emissions, and by our programme to reduce maternal deaths in low- and lower middle-income countries SAINT-PREX, Switzerland--(BUSINESS WIRE)--Ferring today published its 2025 Annual Report and Sustainability Report . The company achieved total revenues of over €2.5 billion in 2025, an increase of 7% over the previous year at actual exchange rates (AER) and 10% at constant exchange rates (CER). These were mainly driven by our flagship product Menopur ® (menotropins for injection) in reproductive medicine, and the ramp-up in the US of our breakthrough gene-based therapy for non-muscle invasive bladder cancer, Adstiladrin ® (nadofaragene firadenovec-vncg). Operating expenses were contained to an increase of €61 million year-on-year (i.e. +5% at AER and +7% at CER), and this includes significant non-recurring items (notably impairment charges and restructuring provisions). Underlying operating expenses remained well-controlled, with increased investments targeted to support the growth of Adstiladrin and other opportunities. Thus, operating profit for the year reached €167 million, a decrease of -€24 million (‑13%) versus the prior year at AER, while remaining flat at CER - with the difference being driven by the weaker US dollar. Following a focus on improving cash conversion after several heavy investments, free cash flow generation approached neutral despite currency headwinds from the weaker US dollar. This represents a substantial improvement compared to the previous year, and a significant step towards sustainable cash generation. Jean-Frédéric Paulsen, Chairman of the Board of Directors and Chief Executive Officer, said: “This was a pivotal year as we continued evolving our business to become stronger, more agile and more resilient, and importantly we got back to free cash flow neutral. Moreover, in 2025, we introduced an enterprise model designed to create greater value for patients and customers while supporting sustainable growth. This reflects our long-term commitment to serving patients’ need, and fostering an environment where people can learn, grow and perform at their best.” Ferring has always conducted business responsibly by seeking to protect the environment, create value for society, and uphold our high standards of ethics and governance. In 2025, we passed a major milestone when our targets for reducing greenhouse gas (GHG) emissions were approved by the Science Based Targets initiative (SBTi). This globally recognised standard ensures corporate goals are aligned with international climate policy. During the year, we succeeded in reducing our Scope 1 and 2 GHG emissions by 4.3% and Scope 3 emissions by 19%. Access to affordable healthcare is embedded in Ferring’s purpose and strategic priorities. The Project Family™: Safe Birth initiative aims to reduce maternal deaths in low- and lower middle-income countries by enabling wider access to Carbetocin Ferring (carbetocin, room-temperature stable formulation). In 2025, we worked with partners to supply around 1.7 million doses of this life-saving medicine at an affordable access price, while gaining further approvals in seven low- and lower middle-income countries. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately owned specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in gastroenterology and urology and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,500 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at , or connect with us on LinkedIn , Instagram and YouTube . Contacts For more information, please contact Carine Julen Senior Manager, Corporate Communications & Public Affairs carine.julen@ferring.com

Pfizer Europe MA EEIG withdrew its EU marketing authorization application for Zumrad (sasanlimab), a subcutaneous PD-1–blocking monoclonal antibody being developed with bacillus Calmette-Guérin (BCG) for BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC), according to an EMA questions and answers document. The EMA said Pfizer withdrew the application on February 13, 2026, after the agency had evaluated the initial dossier and was assessing the company’s responses to CHMP questions. In its provisional view at the time of withdrawal, the EMA said Zumrad could not have been authorized based on the available data. The agency cited concerns that major changes were made while the pivotal study was ongoing, and that the statistical method used to determine efficacy was also changed, which the EMA said increased the chance of concluding benefit. The EMA also questioned whether the primary effectiveness measure—assessed by investigators in a setting where “researchers and participants knew which treatment was being given”—was appropriate, and said it was unclear whether the effect size represented a meaningful patient benefit. The agency added that outcomes such as overall survival did not support the primary endpoint finding, and that adding sasanlimab to BCG resulted in more side effects, including immune-related events, plus more BCG interruptions and discontinuations. Pfizer told the EMA it withdrew the application to allow for additional data collection and analyses to address the agency’s questions and concerns, and said there were no consequences for patients in ongoing clinical trials using Zumrad. The application was supported by a main study in 1,055 adults with high-risk NMIBC who were BCG-naïve or had not received BCG within the prior two years. In the study, Zumrad plus BCG was compared with BCG alone. Sasanlimab was administered once every four weeks for up to two years, while BCG was given weekly for six weeks followed by maintenance across five cycles, the EMA said. The primary measure was time free of events including recurrence or worsening, presence of cancer cells in the bladder lining, or death from any cause; overall survival was also evaluated. Pfizer has previously publicly disclosed positive Phase III results for sasanlimab plus BCG in high-risk NMIBC (the CREST program), including publication of CREST data in Nature Medicine, but the EMA document indicates the agency’s review focused on whether the evidence package was sufficient for authorization as filed. From a treatment-landscape perspective, NMIBC drug development has accelerated in BCG-unresponsive disease, where the US FDA has approved multiple non-surgical options, including pembrolizumab (Keytruda) for BCG-unresponsive high-risk NMIBC with carcinoma in situ (CIS) (2020), nadofaragene firadenovec (Adstiladrin) gene therapy (2022), and nogapendekin alfa inbakicept-pmln (Anktiva) with BCG (2024). Mechanistically, Zumrad targets the PD-1 checkpoint on T cells, aiming to prevent tumor-driven immune suppression via PD-L1/PD-L2 binding and thereby enhance anti-tumor immune activity—an approach that has reshaped systemic oncology but has faced design and endpoint challenges in earlier-stage, bladder-sparing NMIBC trials where recurrence-based measures, investigator assessment, and intravesical therapy schedules can meaningfully influence interpretability.