Leuprolide Acetate

In the news release, FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma's Biosimilar to NEUPOGEN® (filgrastim), issued 17-Feb-2026 by Accord BioPharma over PR Newswire, we are advised by the company that changes have been made. The complete, corrected release follows, with additional details at the end: FDA Approves FILKRI™ (filgrastim-laha), Accord BioPharma’s Biosimilar to NEUPOGEN® (filgrastim) FILKRI completes Accord BioPharma's comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio alongside UDENYCA ® (pegfilgrastim-cbqv ) RALEIGH, N.C. , Feb. 17, 2026 /PRNewswire/ -- Accord BioPharma , the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved FILKRI™ (filgrastim-laha), a biosimilar to NEUPOGEN ® (filgrastim), for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients with severe chronic neutropenia; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome). 1 The approval of FILKRI marks the sixth product in Accord BioPharma's growing portfolio of FDA-approved biosimilars, following the company's acquisition last year of UDENYCA ® (pegfilgrastim-cbqv), a biosimilar to Neulasta ® (pegfilgrastim), 2 as well as the seventh approved product in the overall portfolio. With the addition of FILKRI, Accord BioPharma now offers physicians in the U.S. a comprehensive granulocyte colony-stimulating factor (G-CSF) portfolio with both long-acting (UDENYCA) and short-acting (FILKRI) biosimilar options to meet the needs of patients, providers, and practices. 1,2 Accord has applied for and expects to receive a permanent Q-code from the U.S. Centers for Medicare & Medicaid Services (CMS), which will standardize and facilitate the billing and reimbursement process across hospital outpatient, ambulatory surgery center, and physician office settings of care. Tackling Vital Healthcare Needs Neutropenia is a common and potentially serious complication of cancer treatment and occurs when white blood cells called neutrophils—which serve as a major line of defense against bacterial and fungal infections—fall below normal levels. This reduction increases a person's risk of developing an infection. Granulocyte colony-stimulating factor, or G-CSF, is a growth factor that stimulates the production and release of neutrophils in the body. By accelerating neutrophil recovery, G-CSF can help reduce the duration of neutropenia. 3,4 FILKRI belongs to the G-CSF class and is a growth factor manufactured by recombinant DNA technology. FILKRI works by regulating the production of neutrophils within the bone marrow. 1 "Cancer patients often face significant challenges with treatment-related neutropenia, which can lead to serious infections, treatment delays, and dose reductions that may compromise therapeutic outcomes," said Chrys Kokino, President, Accord North America. "With FILKRI alongside UDENYCA, the provider-preferred option over Neulasta and all other biosimilars,* we now offer healthcare providers a complete G-CSF portfolio with short- and long-acting biosimilar options. This positions Accord BioPharma as a committed partner in oncology supportive care, expanding access to high-quality biologics." Demonstrated Biosimilarity and Safety Profile FILKRI was approved based on two randomized studies in healthy adults, with pharmacokinetics (PK)/pharmacodynamics (PD) assessed in one study and safety and immunogenicity evaluated in both, compared with reference product NEUPOGEN. These studies demonstrated the biosimilarity in PD and PK parameters between FILKRI and NEUPOGEN and showed overall safety and immunogenicity similar to NEUPOGEN. 5 FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors, such as filgrastim products or pegfilgrastim products. 1 Expanding Access: Accord BioPharma's Biosimilar Vision Accord BioPharma believes deeply in the power of biosimilars to reshape the future of treatment. With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape across several priority therapeutic areas by introducing biosimilars to the U.S. market. As part of this commitment, Accord BioPharma is rapidly expanding its U.S. portfolio with a strategic goal to launch 20 biosimilar products by 2030, solidifying its position as a reliable partner delivering more affordable, high-quality biologic alternatives. In addition to developing and marketing their own biosimilar products, the company is strategically collaborating with select partners around the world to bring more biosimilars to the U.S. market as swiftly as possible. "This approval of FILKRI demonstrates our steadfast dedication to expanding access to cost-effective biologic treatments in the critically important field of oncology," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "We're proud to have one of the largest biosimilar pipelines within the industry. With Accord BioPharma, we're positioning ourselves as a dependable partner in the United States—one that's deeply committed to understanding stakeholder priorities and revolutionizing patient access." Current Portfolio of Brands The company's current commercial portfolio includes the full UDENYCA franchise, including the UDENYCA prefilled syringe, autoinjector, and on-body injector, IMULDOSA ® (ustekinumab-srlf), a biosimilar to Stelara ® (ustekinumab), HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin ® (trastuzumab), and CAMCEVI ® (leuprolide) 42 mg injectable emulsion. 6,7 Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for HERCESSI. Accord BioPharma has received FDA approval on three additional products: CAMCEVI ® (leuprolide) ETM (every three months), OSVYRTI ® (denosumab-desu), a biosimilar to PROLIA ® (denosumab), and JUBEREQ ® (denosumab-desu), a biosimilar to XGEVA ® (denosumab). 8,9 The company plans to announce the commercial launch of these products later this year. Please refer to the Important Safety Information and full Prescribing Information for these products, and to the Boxed Warning for OSVYRTI. Contact: abipr@accordhealthcare.com IMPORTANT SAFETY INFORMATION FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. Splenic Rupture: Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome (ARDS): ARDS has been reported in patients receiving filgrastim products . Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS . Discontinue FILKRI in patients with ARDS. Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products . The majority of reported events occurred upon initial exposure . Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment . Permanently discontinue FILKRI in patients with serious allergic reactions. Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products . Discontinue FILKRI if sickle cell crisis occurs. Glomerulonephritis: Has occurred in patients receiving filgrastim products . Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy . Generally, events resolved after dose reduction or discontinuation of filgrastim products . If causality is likely, consider dose-reduction or interruption of FILKRI. Alveolar Hemorrhage and Hemoptysis: Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization . Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication. Capillary Leak Syndrome (CLS): CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed . Patients with symptoms should be closely monitored and receive appropriate treatment. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Patients with Severe Chronic Neutropenia (SCN ): Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered. Patients with Breast and Lung Cancer : MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. Thrombocytopenia: Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts. Leukocytosis: Patients with Cancer Receiving Myelosuppressive Chemotherapy : White blood cell counts ≥ 100,000/mm 2 were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm 2 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI. Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days. Cutaneous Vasculitis: Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products . Most reports involved patients with SCN receiving long-term filgrastim therapy . Hold FILKRI therapy in patients with cutaneous vasculitis . FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased. Potential Effect on Malignant Cells: FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Simultaneous Use with Chemotherapy and Radiation Not Recommended: The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established . Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy . The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy . Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy. Nuclear Imaging: Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging. Aortitis: Aortitis has been reported in patients receiving filgrastim products . It may occur as early as the first week after start of therapy . Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) . Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected. The most common adverse reactions in patients: with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea with AML (≥ 2% difference in incidence) are pain, epistaxis and rash with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash with severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia INDICATIONS FILKRI is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) To report SUSPECTED ADVERSE REACTIONS, contact Accord BioPharma Inc at 1-866-941-7875 or FDA at 1-800-FDA-1088 or . FILKRI is supplied as single-dose prefilled syringes for subcutaneous or intravenous use in 300 mcg/0.5 mL and 480 mcg/0.8 mL strengths. For more information, please see the full Prescribing Information . About Accord BioPharma Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., seeks to provide affordable, accessible, patient-centric therapies in oncology, immunology, and critical care. With a focus on improving the patient experience, Accord BioPharma goes beyond the biology of medicine to see disease from the patients' perspective and develop high-quality therapies that impact patients' lives. Accord BioPharma believes in the ability of biosimilars to increase access and options for patients and deliver savings to the U.S. healthcare system, and is striving to offer one of the deepest biosimilar portfolios in the industry. For more information, visit AccordBioPharma.com . *Based on cumulative average of prescriptions written from September 2025 - January 2026, according to IQVIA drug distribution data. References: FILKRI ® (filgrastim-laha) injection. Prescribing Information. Accord BioPharma. UDENYCA ® (pegfilgrastim-cbqv). Prescribing Information. Accord BioPharma. Simpson, P. Clinical Implications and Future Research of Neutrophils in Health and Disease. Immunome Research 2024;20(3): 1-2. Link, H. Current state and future opportunities in granulocyte colony‑stimulating factor (G‑CSF). Supportive Care in Cancer 2022;30:7067–7077. Accord BioPharma. Data on file. IMULDOSA ® (ustekinumab-srlf). Prescribing Information. Accord BioPharma. HERCESSI™ (trastuzumab-strf). Prescribing Information. Accord BioPharma. OSVYRTI ® (denosumab-desu). Prescribing Information. Accord BioPharma. JUBEREQ ® (denosumab-desu). Prescribing Information. Accord BioPharma. All trademarks, logos, and brand names are the property of their respective owners. Correction:  An earlier version of this release had the incorrect link to the full Prescribing Information. View original content to download multimedia: SOURCE Accord BioPharma

Consolidated net revenue of € 2,618.4 million for full year 2025, +11.8% or +8.3% on a like-for-like basis (3) at constant exchange rates (CER) EBITDA (1) of € 991.1 million, +14.5%, margin on net revenue of 37.8% Adjusted net income (2) of € 651.1 million, +14.5%, margin on net revenue of 24.9% Net income of € 443.6 million, +6.5% Free cash flow (4) of € 558.8 million, +€ 23.7 million reflecting strong EBITDA partially offset by U.S. inventory build-up, higher interests and income tax paid Net debt (5) at € 2,037.3 million, just below 2.1x EBITDA FY 2026 financial targets: Net revenue € 2,730-€2,800 million with FX headwind of ~-3.5% ; EBITDA (1) € 995-€1,030 million, margin +/- 36.5% ; Adjusted net income (2) € 655-€ 685 million, margin +/- 24.0% In January 2026, the Group received a B‑ rating with ‘Prime’ status from ISS ESG, recognizing its leading sustainability performance within the industry Milan, February 17, 2026 – The Board of Directors of Recordati S.p.A. has reviewed and approved the preliminary consolidated financial statements for 2025. The Group’s final consolidated annual financial statements for 2025 will be submitted to the Board of Directors for approval on March 19, 2026. Rob Koremans, Chief Executive Officer of Recordati, commented: “2025 was another year of solid progress across the business, reflecting the strength of our execution. We delivered once again on our financial targets despite a challenging macroenvironment, including increased FX headwinds. During the year, we further strengthened our portfolio through strategic partnerships in both Rare Diseases and Specialty and Primary Care. There is excellent momentum in Rare Diseases, which continues to be a key driver of growth and value creation for the Group. We are excited by Isturisa’s opportunity to address the broader Cushing’s syndrome market, with uptake accelerating in the U.S. With such a strong foundation in place, we expect 2026 to be another year of disciplined execution as we continue to deliver on our strategic objectives, maintain sector-leading margins and create sustainable value for all our stakeholders.” Financial highlights Consolidated net revenue for full year 2025 was € 2,618.4 million, up 11.8% versus full year 2024 or 8.3% on a like-for-like (3) basis at CER, driven by solid contribution from both Specialty & Primary Care and Rare Diseases. The adverse FX impact for full year 2025 was € 64.2 million (-2.7%). Specialty & Primary Care revenue was € 1,477.9 million for full year 2025, up 2.0% or 3.8% on a like-for-like basis (3) at CER (+1.6% excluding Türkiye). This reflects continued positive performance of all core therapeutic areas (promoted product evolution index of 105), despite a slight slowdown in relevant market growth. In particular, the Urology and Cardiovascular franchises grew 2.5% and 2.8%, respectively, while the Gastrointestinal franchise grew 9.9%, driven by the strong in-market performance of several products in the portfolio, both prescription and OTC. Rare Diseases revenue was € 1,081.4 million for full year 2025, up 29.7% as compared to full year 2024, or 16.6% on a like-for-like (3) basis at CER, driven by strong volume growth across all three franchises. The Endocrinology franchise achieved net revenue of € 394.1 million, an increase of 22.5%, reflecting an acceleration of new patient uptake of Isturisa ® in the U.S. in the second half of 2025 with approximately 1,400 net active patients at the end of the year, as well as double-digit growth of Signifor ® . The Hema-Oncology franchise achieved net revenue of € 414.9 million, growing by 63.8%, reflecting the contribution of Enjaymo ® of € 146.3 million (+26.7% vs full year 2024 proforma (6) ), and driven by strong growth of Sylvant ® and Qarziba ® . The Metabolic franchise achieved net revenue of € 272.5 million, sustaining mid-single digit growth of 5.2%, driven by Carbaglu ® and Panhematin ® . Adjusted operating income (7) was € 774.9 million for full year 2025, up 13.2% over full year 2024, and 29.6% of net revenue versus 29.2% in the previous year. Operating income was € 670.8 million for full year 2025, up 5.0% over full year 2024, absorbing gross margin-related non-cash charges of € 66.8 million as compared to € 37.5 million for full year 2024, arising from the unwind of the fair value step up of acquired Rare Diseases inventory including € 62.5 million for Enjaymo ® . Non-recurring costs were € 37.3 million for full year 2025, versus € 8.0 million for full year 2024. These costs reflect primarily the continued optimization of the Specialty and Primary Care commercial organization, mainly in Italy and Spain. The non‑recurring costs also include a one‑off provision of €12.8 million (8) related to the settlement of a litigation case with AIFA concerning prior years payback for Urorec ® . Additionally, non‑recurring items include the impact of the ongoing voluntary liquidation of the Rare Diseases subsidiary in China, following the rejection of the National Reimbursement Drug List approval for Isturisa ® . The availability of Qarziba ® and Sylvant ® in the territory continues to be provided through a local distributor. EBITDA (1) was € 991.1 million for full year 2025, up 14.5% compared to full year 2024, with margin on net revenue of 37.8%. The improvement over the prior year was driven by a positive business mix and strong operating performance across both business units, despite the significant foreign exchange headwinds and higher investments to support the U.S. launch of the expanded Isturisa ® label, the continued development of Enjaymo ® and ongoing geographic expansion in Rare Diseases. Financial expenses were € 89.5 million for full year 2025, down by € 2.1 million as compared to full year 2024. New loans obtained in 2024, related to the acquisition of Enjaymo ® , and in 2025 led to an increase in interest expenses of € 17.4 million. Net exchange gains over the period were € 15.0 million (mainly unrealized and driven by the devaluation of the U.S. dollar), against net FX losses of € 9.3 million in FY 2024. This was partly offset by € 5.3 million of net monetary losses from hyperinflation accounting (compared to a loss of € 6.7 million in full year 2024) mainly driven by the net effect of the revaluation of Turkish balance sheet items. Adjusted Net Income was € 651.1 million, 24.9% of revenue, up by 14.5% compared to full year 2024. This growth reflects improvements in adjusted operating income as well as lower financial expenses partially offset by higher income taxes. Net income was € 443.6 million, 16.9% of revenue, increasing by 6.5% versus full year 2024, mainly driven by the higher operating income and lower financial expenses. Free cash flow (4) was € 558.8 million for full year 2025, an increase of € 23.7 million versus full year 2024, with strong EBITDA partially offset by higher working capital absorption (mainly driven by higher U.S. inventory levels), higher interests and income tax paid. Net debt (5) as of December 31, 2025 was € 2,037.3 million, or leverage of just below 2.1x EBITDA, compared to net debt of € 2,154.3 million on December 31, 2024, following dividend payments of € 267.6 million, treasury shares purchased for € 112.5 million (net of proceeds from exercising stock options), the upfront payment for Vazkepa ® rights of USD 25 million and the upfront payment for Inrebic ® rights of USD 11 million. Shareholders’ equity was € 1,919.8 million. Pipeline Update On April 15, 2025, the U.S. Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) for Isturisa ® (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. This was an expansion of the previous indication for the treatment of patients with Cushing’s disease, which is a sub-type of Cushing’s syndrome. The Isturisa ® indication expansion was supported by the extensive Isturisa ® clinical development program, which included over 350 patients. In addition, during the second quarter of 2025, Isturisa ® was granted regulatory approval in both Canada and Russia. A Phase IV study to assess the efficacy and safety of osilodrostat in adults with mild hypercortisolemia and uncontrolled hypertension (HTN) due to Cushing’s syndrome is expected to start in 2026. During the second quarter of 2025, an investigator-sponsored clinical trial (IST) was initiated to investigate the safety, dose and early signs of effect for dinutuximab beta (Qarziba ® ) in combination with chemotherapy for the treatment of patients with GD2-positive Ewing sarcoma. On July 28, 2025, the European Commission issued a positive decision and granted marketing authorization, under exceptional circumstances, for Maapliv ® , a solution of amino acids intended for the treatment of maple syrup urine disease (MSUD) presenting with an acute decompensation episode in patients from birth who are not eligible for an oral and enteral branched-chain amino acids (BCAA)-free formulation. The Company completed enrollment of the pasireotide Phase 2 trial for the treatment of post-bariatric hypoglycemia in August 2025. Top-line results are expected in the second quarter of 2026. Following the meeting with the U.S. Food and Drug Administration (FDA) in early September, a potential U.S. biologics license application (BLA) pathway was established with the FDA for Qarziba ® requiring an additional set of clinical data from the ongoing BEACON-2 investigator-sponsored trial. Results of the interim analysis are expected in the first half of 2028 and are expected to form the basis, together with existing clinical data, for a potential regulatory filing. On January 5, 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Eligard ® for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localized and locally advanced hormone dependent prostate cancer in combination with radiotherapy. The other lifecycle management programs are progressing in line with plans. Corporate Development On June 24, 2025, Recordati announced a licensing and supply agreement with Amarin to commercialize the marketed cardiovascular medicine, Vazkepa ® (icosapent ethyl) across 59 countries, focused in Europe. Vazkepa ® is indicated to reduce the risk of cardiovascular events in statin-treated adult patients at high cardiovascular risk with elevated triglycerides and either established cardiovascular disease or diabetes with at least one other cardiovascular risk factor. Vazkepa ® is expected to achieve over € 40 million in revenues in 2027 and to be EBITDA positive from 2026. Under the terms of the agreement, Recordati paid Amarin an upfront cash payment of USD 25 million. On December 17, 2025, Recordati announced the exclusive license agreement with Impact Biomedicines, Inc., a Bristol Myers Squibb subsidiary, and the related supply agreement with Celgene Logistics Sàrl to commercialize Inrebic ® (fedratinib dihydrochloride monohydrate) in Japan. Impact Biomedicines, Inc. will retain exclusive rights to develop and commercialize Inrebic® in the rest of the world. Inrebic ® is an oral kinase inhibitor with activity against wild-type and mutationally activated JAK2 to suppress the pathological features of myelofibrosis patients. Inrebic ® received regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan in June 2025 for the treatment of myelofibrosis and is expected to launch in mid 2026. Under the terms of the agreement, Recordati paid Impact Biomedicines, Inc. an upfront payment of USD 11 million. On January 29, 2026, Recordati announced a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in collaboration with Recordati, and if approved, Recordati will lead global commercialization. mRNA-3927 is a post proof-of-concept, investigational product aimed to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia. If approved, this could be the first disease-modifying treatment option on the market for this severe disease. mRNA-3927 is currently being evaluated in a potential registrational clinical study. The target patient enrollment has been reached, with a potential data readout expected by the end of 2026. Under the terms of the agreement, Recordati will pay Moderna an upfront payment of USD 50 million and up to an additional USD 110 million in near-term development and regulatory milestones. Moderna is also eligible to receive commercial and sales milestones, as well as tiered royalties on annual net sales. Recordati does not expect any significant impact on its EBITDA prior to a potential launch. Business outlook The financial targets for full year 2026 are as follows: Net revenue between € 2,730 and € 2,800 million with FX headwind of ~-3.5% EBITDA (1) between € 995 and € 1,030 million; margin of +/- 36.5% Adjusted net income (2) between € 655 and € 685 million; margin of +/- 24.0% The full year 2027 targets (9) remain unchanged, with strong organic growth complemented by bolt-on BD and M&A. (1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS (2) Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3, monetary net gains/losses from hyperinflation (IAS 29), net of tax effects. (3) Proforma growth calculated excluding revenue of Vazkepa® for FY 2025 (Specialty & Primary Care) and Enjaymo® for both FY 2025 and FY 2024 (Rare Diseases) (4) Total cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options. (5) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives. (6) Comparing FY 2025 revenue (which considers also the margin retained by Sanofi’s on in market sales for those countries where it was still holding the MA) with proforma FY 2024 revenue also including sales totally realized by Sanofi. (7) Net income before income taxes, financial income and expenses and non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3. (8) The provision has been revised since September to reflect the terms of the final settlement agreement with AIFA (9) FY 2027 targets: Net Revenue €3,000 - €3,200 million, EBITDA €1,140 - €1,225 million, Adjusted Net Income €770- €820 million, excluding potential impact from tariffs and/or most favored nation pricing policies in the U.S. Conference Call Recordati will host a conference call on February 18 th , at 2:00 p.m. CET ( 1:00 p.m. GMT ) to present the results for full year 2025. Please find the pre-registration link here with all the dial-in details and a calendar invitation to follow. Alternatively, if not pre-registered, the dial-in numbers for the conference call are: Italy + 39 02 802 09 11, toll free 800 231 525 UK + 44 1 212818004, toll free (44) 0 800 0156371 USA +1 718 7058796, toll free (1) 1 855 2656958 France +33 1 70918704 Germany +49 6917415712 Participants are invited to dial in 10 minutes before the start of the conference call. If operator assistance is required to connect, please dial *0. The slides that will be referenced during the call will be available at under Investors/Company Presentations. Recordati is an international pharmaceutical group listed on the Italian Stock Exchange (XMIL: REC), with roots dating back to a family-run pharmacy in Northern Italy in the 1920s. We are uniquely structured to provide treatments across specialty and primary care, and rare diseases. Our fully integrated operations span clinical development, chemical and finished product manufacturing, commercialization and licensing. We operate in approximately 150 countries across EMEA, the Americas and APAC with over 4,500 employees. We believe that health is a fundamental right, not a privilege. Today, our purpose of “unlocking the full potential of life” aims at empowering individuals to live life to the fullest, whether addressing common health challenges or the rarest. Investor Relations Eugenia Litz eugenia.litz@recordati.com Gianluca Saletta saletta.g@recordati.it Media Relations Laura Conti conti.l@recordati.it Rebecca Kerr rebecca.kerr@recordati.com This document contains forward-looking statements relating to future events and future operating, economic and financial results of the Recordati group. By their nature, forward-looking statements involve risk and uncertainty because they depend on the occurrence of future events and circumstances. Actual results may therefore differ materially from forecasts for a variety of reasons, most of which are beyond the Recordati group ’ s control. The information on the pharmaceutical specialties and other products of the Recordati group contained in this document is intended solely as information on the activities of the Recordati Group, and, as such, it is not intended as a medical scientific indication or recommendation, or as advertising . DECLARATION BY THE FINANCIAL REPORTING OFFICER The Financial Reporting Officer, Niccolò Giovannini, declares, pursuant to paragraph 2 of Article 154- bis of the Consolidated Law on Finance, that the accounting information contained in this press release corresponds to the Company’s documentation, books and accounting records. RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S.p.A. Registered Office Via Matteo Civitali, 1 20148 Milano, Italy Tel. +39 02 487871 Fax +39 02 40073747 Share Capital € 26.140.644,50 fully paid-up Milano, Monza, Brianza and Lodi Comp. Reg. No. 00748210150 Tax Code/VAT No. 00748210150 Milano R.E.A. No. 401832 Company subject to the Management and Coordination Activity of Rossini Luxembourg S.àr.l