On November 11, 2025 The Board of Directors of Recordati S.p.A. reported the Group’s Interim results on 30th September 2025, representing additional voluntary financial reporting. The Report was prepared using the assessment, measurement and recognition criteria prescribed by international accounting standards (IFRS). The Group’s Interim Report dated 30th September 2025 will be available on November 14th at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info (www.1Info.it).
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Rob Koremans, Chief Executive Officer of Recordati, commented: "We are very pleased with the excellent progress we have achieved in the first nine months across the business, especially in Rare Diseases and the strong traction of Isturisa with the expanded label. After a thorough analysis of the Cushing’s syndrome market, we are now confident to double our peak year sales expectations for Isturisa to greater than € 1.2 billion as we invest in and target the non-overt patient population, unlocking tremendous additional potential. We are excited about the opportunities ahead and assured in our ability to continue executing on our strategy and creating incremental value for all our stakeholders."
Financial highlights
Consolidated net revenue for the first nine months of 2025 was € 1,956.2 million, up 12.2% versus the first nine months of 2024 or 8.1% on a like-for-like(3) basis at CER, driven by strong business momentum across both Specialty & Primary Care and Rare Diseases. The adverse FX impact for the first nine months of 2025 was € 35.5 million (-2.0%).
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
www.recordati.com
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
Specialty & Primary Care revenue was € 1,129.9 million for the first nine months of 2025, up 3.2% or 5.0% on a like-for-like basis(3) at CER (+2.5% excluding Türkiye). This reflects continued strong performance of all core therapeutic areas (promoted product evolution index of 104), despite slight slowdown in relevant market growth (Italy, Cough & Cold and lack of a price increase in Türkiye to date). In particular, the Urology and Cardiovascular franchises grew by mid-single digit rates, while the Gastrointestinal franchise grew at high-single digit rates driven by the strong in-market performance of several products in the portfolio, both prescription and OTC.
Rare Diseases revenue was € 782.2 million for the first nine months of 2025, up 29.2% as compared to the first nine months of 2024, or 14.1% 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 € 283.6 million, an increase of 18.4%, reflecting strong new patient uptake of Isturisa in the U.S. with over 1,200 net active patients and double-digit growth of Signifor. The Hema-Oncology franchise achieved net revenue of € 301.3 million, growing by 71.4%, reflecting the contribution of Enjaymo of € 104 million (+24.7% vs the first nine months of 2024 pro-forma(8)), and driven by strong growth of Sylvant and Qarziba. The Metabolic franchise achieved net revenue of €
197.3 million, growing by 3.7%, driven by Carbaglu and Panhematin.
Adjusted operating income(9) was € 591.1 million for the first nine months of 2025, up 9.6% as compared to the first nine months of 2024 and 30.2% of net revenue. Operating income was €
496.7 million in the first nine months of 2025, down 1.5% over the first nine months of 2024, absorbing gross margin-related non-cash charges of € 62.5 million versus € 28.1 million in the first nine months of 2024, arising mostly from the unwind of the fair value step up of the acquired Enjaymo inventory and additional amortization. Non-recurring costs were € 32.0 million versus €
7.3 million in the first nine months of 2024 and include, beside the costs for further optimization of the Specialty and Primary Care commercial organization in Italy and Spain, also a one-off provision in the third quarter of 2025 of € 14.1 million for a litigation settlement with AIFA (Italian health authorities) related to prior years’ payback for Urorec.
EBITDA(1) was € 743.9 million for the first nine months of 2025, up 11.8% compared to the first nine months of 2024, with margin of 38.0% of net revenue. Strong revenue performance was partially offset by a higher level of investments to support the launches of the Isturisa expanded label in the U.S. and Enjaymo, and to support continued geographic expansion.
Financial expenses were € 67.4 million, up 8.1% as compared to the same period of the previous year. New loans taken out during 2024 to fund the acquisition of Enjaymo and in 2025 resulted in an increase in interest expense of € 14.1 million, while net exchange gains over the period amounted to € 10.9 million (mainly unrealized and driven by the devaluation of the U.S. dollar), against net FX losses of € 2.8 million in the first nine months of 2024.
Adjusted net income(2) was € 493.1 million, 25.2% of revenue, up by 10.7% compared to the same period of 2024, with higher operating performance partially offset by the increase in financial expenses and the tax rate. Net income was € 326.3 million, 16.7% of net revenue, down 3.6% versus the prior year, reflecting non-cash charges arising from the acquisition of Enjaymo, higher non-recurring cost and higher tax rate.
Free cash flow(4) was € 396.8 million for the first nine months of 2025, a decrease of € 37.5 million versus the first nine months of 2024, with higher EBITDA more than offset by higher working capital absorption (mainly driven by higher U.S. stock levels) and higher interests and income tax paid.
Net debt(5) as of September 30, 2025 was € 2,032.2 million, or leverage of 2.1x EBITDA pro-forma(6),
compared to net debt of € 2,154.3 million on December 31, 2024, following dividend payment of €
138.5 million, treasury shares purchased for € 101.4 million (net of proceeds from exercising stock
options) and the upfront payment for Vazkepa rights of USD$ 25 million.
Shareholders’ equity was € 1,927.8 million.
Isturisa 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.
The Company today upgraded its peak year sales estimate for Isturisa to greater than € 1.2 billion (from a previous range of € 550 – € 650 million) based on a decision to actively pursue the non-overt Cushing’s syndrome market which is included in the current expanded U.S. label. The non-overt Cushing’s syndrome patient population typically does not present clinical characteristics, but an unmet medical need remains with cardiometabolic co-morbidities such as hypertension or diabetes. These patients are treated by community endocrinologists, selected primary care physicians and cardiologists. At peak, the total opportunity is potentially over four-fold the number of eligible patients for treatment from approximately 7,000 patients today to approximately 30,000 patients, driven by better diagnosis and treatment of the non-overt Cushing’s syndrome patient population.
On the basis of the expanded label, the Company is increasing commercial and medical activities, headcount and real-world evidence studies. In addition, the Company will initiate a Phase IV randomized controlled study in 2026 to assess the efficacy and safety of osilodrostat in adults with mild hypercortisolemia and uncontrolled hypertension due to Cushing’s syndrome. Additional investments behind Isturisa in the U.S. will ramp up to a total of approximately € 40 million – € 50 million per year.
Pipeline Update
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.
Following the Committee for Medicinal Products for Human Use (CHMP) positive opinion earlier this year, 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 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.
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 was approved in 2021 in the EU and UK and in 2022 in Switzerland based on the REDUCE-IT study, a Phase 3 Cardiovascular Outcomes Trial (CVOT) performed in over 8,000 patients with statistically significant and clinically meaningful results in Major Adverse Cardiovascular Events (MACE).
Vazkepa is currently commercialized in 11 European countries, generated net sales of € 12 million in 2024 and is expected to achieve over € 40 million in revenues in 2027 and to be EBITDA positive from 2026. The expected revenue in 2025 is less than € 10 million with a slightly negative impact at the EBITDA level, reflecting the commercial investments required to sustain the expected future growth. Under the terms of the agreement, Recordati paid Amarin an upfront cash payment of US$ 25 million.
Business outlook
Strong performance across the business expected to deliver FY 2025 results in line with original guidance(10) (lower half of range) despite challenging macro environment (FX of approx. -3%, expected to continue into 2026)
In FY 2026, Rare Diseases are expected to approach 50% of Total Revenues:
Rare Diseases: high double-digit growth at CER, with accelerating Isturisa uptake (behind broader label and activities to target non-overt patient population) and strong momentum of other key growth assets
Specialty & Primary Care: low single-digit growth at CER (returning to mid- single digit in 2027), reflecting also loss of Cardicor license (~ € 35 million/ year)
FY 2026 margins to reflect additional investments behind Isturisa and adverse FX.
The FY 2027 targets(11) remain unchanged, with strong organic growth complemented by bolt-on BD and M&A.
Updated peak year sales expectations for Isturisa doubled to over € 1.2 billion (from € 550 – 650 million).
Interim dividend 2025
The Board of Directors has resolved to distribute an interim dividend for 2025 of € 0.63 per share (gross of applicable withholding taxes), payable to shareholders holding shares on the ex-dividend date. Treasury shares held by the Company on that date are excluded.
The interim dividend will be paid starting 26 November 2025, with record date 25 November 2025, and coupon no. 36. Shareholders must be registered by 24 November 2025 to be eligible.
The Independent Auditor, EY S.p.A., has issued the opinion required under Art. 2433-bis, paragraph 5 of
the Italian Civil Code, which is available at the Company’s registered office.
The Directors’ Report and the financial statements of Recordati S.p.A. as of 30 June 2025, which form the basis for the Board’s decision to distribute the interim dividend, are available at the Company’s registered office and website (www.recordati.com), and can also be accessed via the authorized storage system 1Info (www.1Info.it).
(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) Pro-forma growth calculated excluding revenue of Enjaymoand Vazkepa for 9M 2025
(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) Pro-forma calculated by adding Enjaymo’s estimated contribution from October to November 2024 (when it still was propriety of Sanofi) to EBITDA
(7) Please note that Italian Legislative Decree 25/2016, which implements Directive 2013/50/EU, no longer stipulates the submission of an interim management report, which was previously required in terms of paragraph 5 of Art. 154-ter of Italian Legislative Decree 58/1998.
(8) Comparing the first nine months 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 the first nine months 2024 revenue totally realized by Sanofi.
(9) 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.
(10) FY 2025 original guidance range announced on February 13, 2025: Net Revenue € 2,600 – € 2,670 million; EBITDA
€ 970 – €1,000 million; Adjusted Net Income € 640 – €670 million
(11) 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 favoured nation pricing policies in the U.S.
Conference Call
Recordati will host a conference call tomorrow, November 12th, at 2:00 p.m. CET (1:00 p.m. GMT) to present the results for the first nine months of 2025. Please find the pre-registration link here with all the dial-in details and a calendar invitation to follow.
(Press release, Recordati, NOV 11, 2025, View Source [SID1234659757])