On July 29, 2025 Recordati S.p.A. reported the interim financial statements as of June 30, 2025, pursuant to Art. 154-ter of Italian Legislative Decree 58/1998 and subsequent amendments, prepared in accordance with said Decree and the CONSOB Issuers Regulation (Press release, Recordati, JUL 29, 2025, View Source [SID1234654605]). The statements were prepared in accordance with International Accounting Standard (IAS) 34 requirements for interim reporting, based on the assessment, measurement and recognition criteria set by the IFRSs. The interim financial statements on June 30, 2025 – as well as the Independent Auditors’ report on such statements – will be available within the legal deadline 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: "The strong performance in the first half of 2025 reflects solid execution across the business, with robust revenue growth and disciplined cost management. The licensing and supply agreement with Amarin to commercialize Vazkepa in Europe reinforces our commitment to the SPC business and further strengthens our core Cardiovascular franchise. We believe there is much potential ahead and feel confident in our ability to deliver the financial objectives that we have set ourselves, despite increasing FX headwinds."

H1 2025 Financial highlights

Consolidated net revenue for the first half of 2025 was € 1,323.8 million, up 11.7% versus the first half of 2024 or 7.8% 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 half of 2025 was € 23.2 million (-2.0%).

Specialty & Primary Care revenue was € 774.4 million for the first half of 2025, up 2.6% or 5.1% at CER (+2.6% excluding Türkiye). This reflects the strong performance of all core therapeutic areas, offsetting softer performance of Cough & Cold, which partially recovered in the second quarter of 2025. In particular, the Gastrointestinal and Cardiovascular franchises grew by mid- to high-single digit rates, thanks to the strong in-market performance of several products in the portfolio, with slight growth of the Urology franchise, reflecting strong Eligard sell-in in the first half of 2024.

Rare Diseases revenue was € 515.7 million for the first half of 2025, up 29.2% as compared to the first half of 2024, or 12.8% 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 € 178.2 million, an increase of 16.6%, reflecting continued strong growth of Isturisa, with over 1,000 net active patients in the U.S., and double-digit growth of Signifor. The Hema-Oncology franchise achieved net revenue of € 200.7 million, growing by 71.2%, reflecting the contribution of Enjaymo of € 69.4 million (+26.4% vs the first half of 2024 pro-forma(7)), and driven by strong growth of Sylvant and Qarziba. The Metabolic franchise achieved net revenue of € 136.8 million, growing by 5.9%, driven by Carbaglu and Panhematin.

Adjusted operating income(8) was € 394.7 million for the first half of 2025, up 7.3% as compared to the first half of 2024 and 29.8% of net revenue, reflecting amortization charges related to the Enjaymo acquisition. Operating income was € 331.0 million in the first half of 2025, down 2.2% over the first half of 2024, absorbing gross margin-related non-cash charges of € 46.9 million (versus € 27.0 million in the first half of 2024), arising mostly from the unwind of the fair value step up of the acquired Enjaymo inventory. Non-recurring costs were € 16.7 million versus € 2.4 million in the first half of 2024, mainly related to the further optimization of the SPC commercial organization in Italy and Spain (reduction of approximately 80 commercial heads).

EBITDA(1) was € 496.3 million for the first half of 2025, up 9.6% compared to the first half of 2024, with margin of 37.5% of net revenue. Strong revenue performance was partially offset by a higher level of investments to support the launch of the recently approved label extension to Cushing’s syndrome for Isturisa in the U.S. (which was granted by the FDA on April 15, 2025), the integration of Enjaymo and to support continued geographic expansion.

Financial expenses were € 46.7 million, substantially aligned to those of the same period the previous year. New loans taken out during 2024 to fund the acquisition of Enjaymo caused an increase in interest expense of € 9.4 million, while net exchange gains over the period amounted to € 7.5 million (mainly unrealized and driven by the devaluation of the U.S. dollar), against net FX losses of € 7.5 million in the first half of 2024.

Adjusted net income(2) was € 327.8 million, 24.8% of revenue, up by 8.9% compared to the same period of 2024, with higher operating performance partially offset by the increase in the tax rate (mainly following the expiry of the patent box benefit in Italy). Net income was € 216.1 million, 16.3% of net revenue, down 4.1% versus the prior year, reflecting higher gross margin-related non-cash charges arising mostly from the unwind of the fair value step up of the acquired Enjaymo inventory and higher non-cash amortization charges related to Enjaymo rights, and higher non-recurring costs.

Free cash flow(4) was € 256.8 million for the first half of 2025, substantially aligned with the first half of 2024, driven by higher EBITDA which was partially offset by working capital absorption (reflecting higher U.S. stock levels) and higher income tax paid.

Net debt(5) as of June 30, 2025 was € 2,127.1 million, or leverage of just below 2.3x EBITDA pro-forma(6), compared to net debt of € 2,154.3 million on December 31, 2024, following the May dividend payment of € 137.6 million and upfront payment for Vazkepa.

Shareholders’ equity was € 1,870.5 million.

Pipeline and Corporate Development

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.

On April 22, 2025, Recordati received approval for Signifor LAR in China for the treatment of acromegaly, expanding its Rare Diseases portfolio in China following the prior approvals of Isturisa and Carbaglu.

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.

During the second quarter of 2025, a clinical trial 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 other lifecycle management programs are progressing in line with plans.

Business outlook

With a robust start to the year, and despite increased FX headwinds, the financial targets for FY 2025 as set out in February are confirmed for the year, implying double-digit growth across all key metrics:

Net revenue between € 2,600 and 2,670 million
EBITDA(1) between € 970 and 1,000 million; margin +/- 37.5%
Adjusted net income(2) between € 640 and 670 million; margin +/- 25.0%

The Group now expects FX headwinds for FY 2025 of approximately –3%, significantly higher than expected at the start of the year (-1%).

(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 Enjaymo for H1 2025
(4) Total cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options and performance shares.
(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 July to November 2024 (when it still was propriety of Sanofi) to EBITDA
(7) Comparing 1H 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 1H 2024 revenue totally realized by Sanofi
(8) 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.

Conference Call

Recordati will host a conference call tomorrow, July 30th, at 2:00 p.m. CEST (1:00 p.m. GMT) to present the results for the first half of 2025. Please find the pre-registration link here with all the dial-in details and a calendar invitation to follow.