Sutimlimab

Consolidated net revenue of € 680.0 million in the first quarter of 2025, +11.9% or +7.2% on a like-for-like basis(3) and at constant exchange rates (CER)EBITDA(1) of € 270.2 million, +10.7%, margin on revenue of 39.7% Adjusted net income(2) of € 175.5 million, +7.2% Net income of € 125.0 million, +1.2% Free cash flow(4) of € 158.8 million, +€ 11.7 million vs prior yearNet debt(5) at € 2,020.8 million, just below 2.2x EBITDA pro-forma(6)Isturisa® granted expanded approval by the FDA for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome, supporting peak year sales increase to € 550-650 million; Signifor® LAR approved in China for the treatment of patients with acromegalyFY 2025 financial targets confirmedPositive momentum of the Group expected to continue as reflected in the FY 2027 financial targets approved on April 28th, with double-digit growth across all key metricsPerformance share plan 2023-2025: assignment of rights provided under the third cycle Milan, 8th May 2025 – The Board of Directors of Recordati S.p.A. approved the Group’s Interim Report as of 31st March 2025, representing additional voluntary financial reporting(7). The Report was prepared using the assessment, measurement and recognition criteria prescribed by international accounting standards (IFRS). The financial statements as of 31st March 2025 will be available by 15th May 2025 at the company’s offices and on the company’s website (www.recordati.it) and can also be viewed on the authorised storage system 1Info (www.1Info.it). Rob Koremans, Chief Executive Officer of Recordati, commented: “2025 is off to a strong start, marked by solid execution across the business and disciplined cost management. We are pleased with the recent timely FDA approval for the expanded indication of Isturisa® and a favorable label which supports yet another upgrade to our peak year sales target. Furthermore, the three-year plan targets provided last week signal expectations for continued strength in the business as we continue to execute on our proven strategy of driving organic growth across Specialty & Primary Care and Rare Diseases, complemented by value-creating business development and targeted lifecycle management opportunities.” Q1 2025 Financial highlights Consolidated net revenue for the first quarter of 2025 was € 680.0 million, up 11.9% versus the first quarter of 2024 or 7.2% on a like-for-like(3) basis at CER. This was driven by strong business momentum across both Specialty & Primary Care and Rare Diseases. The adverse FX impact for the first quarter of 2025 was € 3.7 million (-0.6%). Specialty & Primary Care revenue was € 408.6 million for the first quarter of 2025, up 3.3% or 5.0% at CER (+2.3% excluding Türkiye) against a very robust first quarter of 2024. This reflects the strong performance of all core therapeutic areas, offsetting softer performance of Cough & Cold, due to a weaker flu season in Russia and Türkiye. In particular, the Gastrointestinal franchise grew double-digits thanks to the strong in-market performance of several products in the portfolio, and both the Urology and Cardiovascular franchises grew by solid mid-single digit rates.Rare Diseases revenue was € 254.8 million for the first quarter of 2025, up 29.0% as compared to the first quarter of 2024, or 11.5% 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 € 87.4 million, an increase of 18.0%, reflecting continued growth of Isturisa®, driven mostly by continued new patient uptake across geographies and double-digit growth of Signifor®. The Hema-Oncology franchise achieved net revenue of € 95.8 million, growing by 64.3%, reflecting the contribution of Enjyamo® of € 31.9 million (+16.2% vs the first quarter of 2024 pro-forma(8)), and driven by strong growth of Sylvant® in the U.S. and Europe with growth of Qarziba® affected by the adverse phasing of shipments. The Metabolic franchise achieved net revenue of € 71.6 million, growing by 9.8% and driven by Carbaglu® (also reflecting positive phasing) and Panhematin®. Adjusted operating income(9) was € 219.2 million for the first quarter of 2025, up 8.5% as compared to the first quarter of 2024 and 32.2% of net revenue, reflecting amortization charges related to the Enjaymo® acquisition. Operating income was € 195.8 million in the first quarter of 2025, up 4.7% over the first quarter of 2024, absorbing gross margin-related non-cash charges of € 22.4 million (versus € 14.3 million in the first quarter of 2024), arising mostly from the unwind of the fair value step up of the acquired Enjaymo® inventory. Non-recurring costs were € 1.1 million versus € 0.8 million in the first quarter of 2024.EBITDA(1) was € 270.2 million for the first quarter of 2025, up 10.7% compared to the first quarter of 2024, with margin of 39.7% of net revenue. Strong revenue performance was partially offset by a higher level of investments ahead of the Isturisa® label expansion in the U.S. and for continued geographic expansion.Financial expenses were € 30.9 million, up by € 5.2 million compared to the previous year, mainly due to the new loans taken out during 2024 to fund the acquisition of Enjaymo®. Net exchange losses over the period amounted to € 1.8 million, as compared to net losses of € 2.7 million in the first quarter of 2024. The impact of hyperinflation was negative € 2.0 million versus € 3.2 million in losses in the first quarter of 2024. Adjusted net income(2) was € 175.5 million, 25.8% of revenue, up by 7.2% compared to the same period of 2024, with higher operating income partially offset by an increase in interest expenses and the tax rate. Net income was € 125.0 million, 18.4% of net revenue, an increase of 1.2% versus the prior year, reflecting the positive operating performance offset by higher amortization charges, financial expenses and income taxes. Free cash flow(4) was € 158.8 million for the first quarter of 2025, an increase of € 11.7 million versus the first quarter of 2024, driven by higher EBITDA which was partially offset by working capital growth (in line with revenue) and interests paid. Net debt(5) as of March 31, 2025 was € 2,020.8 million, or leverage of just below 2.2x EBITDA pro-forma(6), compared to net debt of € 2,154.3 million on December 31, 2024. Shareholders’ equity was € 1,977.7 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 is 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. Supported by the favorable expanded label, on April 28th, as part of the mid-term plan update, the Group further increased its peak year sales target for Isturisa® to a range of € 550 to € 650 million (from a previous range of € 500 to € 600 million). 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®. 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 millionEBITDA(1) between € 970 and 1,000 million; margin +/- 37.5%Adjusted net income(2) between € 640 and 670 million; margin +/- 25.0% On April 28th, the Group also set out its financial targets for FY 2027, which reflect continued strong organic growth of the current highly-diversified portfolio and include also, as customary for the Group, the projected contribution of acquisitions and new licenses that could be finalized over the plan period for either commercial products or products in late-stage development or launch: Net revenue between € 3,000 and 3,200 millionEBITDA(1) between € 1,140 and 1,225 million; margin ≥38%Adjusted net income(2) between € 770 and 820 million; margin +/- 25.5% Net Debt remains targeted between 1.7-2.0x EBITDA, with flexibility to go temporarily up to a maximum of close to 3x for high-quality acquisition opportunities of scale. There are no changes to the capital allocation and progressive dividend policy of the Group. The full details of the 2025-2027 three-year plan targets can be accessed here Additional resolutions Performance share plan 2023-2025: assignment of rights provided under the third cycle With reference to the incentive plan of Recordati known as “Performance Share Plan 2023-2025” (the “Plan”) approved by the Company’s Shareholders’ Meeting on 21st April 2023, notice is hereby given that today the Board of Directors of the Company, upon proposal of the Company’s Remuneration and Nominations Committee - to the extent of its competence and in accordance with the provisions of the relevant regulations - resolved to grant to Beneficiaries of the Plan a total of no. 511,380 rights (the “Rights”) to receive a certain number of ordinary shares of the Company – to be defined on the basis of the implementation of the Plan with respect to the Vested Rights – falling within the third allocation cycle of the Plan, of which no. 24,537 Rights to the Chief Executive Officer of Recordati. For more information on the Plan (10), please refer to the related Information Document, which can be retrieved on the Company’s website in the “Governance” section under “Remuneration”. (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 Q1 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 April to November 2024 (when it still was propriety of Sanofi) to EBITDA(7) You are reminded 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 Legislative Decree 58/1998(8) Comparing Q1 2025 revenue (which considers also the margin retained by Sanofi’s in market sales for those countries where it was still holding the MA) with Q1 2024 revenue realized in total 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) Table No. 1 referred to in paragraph 4.24 of Annex 3A, Schedule 7, of the Issuers' Regulations No. 11971/1999 will be published in accordance with the procedures and the terms set forth in Article 84-bis, paragraph 5, letter a), of the Issuers' Regulations. Conference Call Recordati will host a conference call today, May 8th, at 4:00 p.m. CEST (3:00 p.m. GMT) to present the results for the first quarter of 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 525UK + 44 1 212818004, toll free (44) 0 800 0156371USA +1 718 7058796, toll free (1) 1 855 2656958France +33 1 70918704Germany +49 6917415712 Participants are invited to dial in 10 minutes before conference time. If conference operator assistance is required to connect, please dial *0. The slides that will be referenced during the call will be available at www.recordati.com under Investors/Company Presentations. The audio conference live webcast will also be available at the following link 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 4,580 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 +44 7824 394 750 Eugenia.Litz@recordati.comGianluca Saletta +39 348 979 4876 saletta.g@recordati.itMedia Relations ICR Healthcare US:Alexis Feinberg +1 203 939 2225 Alexis.feinberg@icrhealthcare.comUK, Europe & Rest of World:Jessica Hodgson +44 7561 424 788jesica.hodgson@icrhealthcare.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 those forecast 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. RECORDATI GROUP Summary of the consolidated results,prepared in accordance with International Financial Reporting Standards (IFRS)(€ thousands) INCOME STATEMENTFirst quarter 2025First quarter 2024Change %NET REVENUE679,960607,82011.9Cost of sales(221,188)(192,260)15.0GROSS PROFIT458,772415,56010.4Selling expenses(139,742)(120,959)15.5Research and development expenses(80,117)(67,318)19.0General and administrative expenses(41,648)(35,506)17.3Other income/(expenses), net(1,499)(4,878)(69.3)OPERATING INCOME195,766186,8994.7Financial income/(expenses), net(30,906)(25,750)20.0PRE-TAX INCOME164,860161,1492.3Income taxes(39,819)(37,554)6.0NET INCOME 125,041123,5951.2Adjusted gross profit (1)481,165429,85511.9Adjusted operating income (2)219,236202,0288.5Adjusted net income (3)175,464163,6647.2EBITDA (4)270,158244,04110.7Net income attributable to: Equity holders of the Parent125,041123,5951.2Non-controlling interests00n.s.EARNINGS PER SHARE (euro) Basic(5)0.6060.5991.2Diluted(6)0.5980.5911.2(1) Gross profit adjusted from impact of 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. (2) Net income before income taxes, financial income and expenses, 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 3. (3) 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.(4) 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 3.(5) Earnings per share (EPS) are based on average shares outstanding during the respective period, 206,355,324 in 2025 and 206,213,410 in 2024. These amounts are calculated deducting treasury shares in the portfolio, the average of which was 3,041,684 shares in 2025 and 2,911,746 shares in 2024.(6) Diluted earnings per share is calculated by taking into account rights granted to employees.COMPOSITION OF NET REVENUEFirst quarter 2025First quarter 2024Change % Total revenue679,960607,82011.9 Italy95,96091,5944.8 International584,000516,22613.1 RECORDATI GROUP(€ thousands) Reconciliation of Net income to EBITDA(1) First quarter 2025First quarter 2024Net income125,041123,595Income taxes39,81937,554Financial income/(expenses), net30,90625,750Non-recurring expenses1,077834Non-cash charges from PPA inventory uplift22,39314,295Adjusted operating income(2)219,236202,028Depreciation, amortization and write-downs50,92242,013EBITDA(1)270,158244,041 Reconciliation of Net income to Adjusted Net income(3) First quarter 2025First quarter 2024Net income125,041123,595Amortization and write-downs of intangible assets(excluding software)40,98833,996Tax effect(9,692)(7,728)Non-recurring operating expenses1,077834Tax effect(286)(209)Non-cash charges from PPA inventory uplift22,39314,295Tax effect(5,599)(3,574)Monetary net (gain)/losses from hyperinflation (IAS29)2,0293,230Tax effect(487)(775)Adjusted net income(3)175,464163,664 (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 3.(2) Net income before income taxes, financial income and expenses, 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 3. (3) 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. RECORDATI GROUPSummary of the consolidated results, prepared in accordance with International Financial Reporting Standards (IFRS)(€ thousands) ASSETS31.03.202531.12.2024Property, plant and equipment203,758206,700Intangible assets2,466,6512,513,159Goodwill798,481797,078Other equity investments and securities16,45917,385Other non-current assets14,17114,206Deferred tax assets100,74294,527TOTAL NON-CURRRENT ASSETS3,600,2623,643,055 Inventories488,192506,447Trade receivables603,646516,743Other receivables102,689109,024Other current assets28,28721,387Derivative instruments measured at fair value10,02215,376Cash and cash equivalents333,044322,423TOTAL CURRENT ASSETS1,565,8801,491,400TOTAL ASSETS5,166,1425,134,455 RECORDATI GROUPSummary of the consolidated results, prepared in accordance with International Financial Reporting Standards (IFRS)(€ thousands) EQUITY AND LIABILITIES31.03.202531.12.2024 Share capital26,14126,141Share premium reserve83,71983,719Treasury shares(152,511)(131,570)Reserve for derivative instruments(813)(1,689)Translation reserve(293,326)(274,413)Other reserves64,97964,023Profits carried forward2,248,4171,818,039Net income125,041416,508Interim dividend(123,949)(123,949)Shareholders’ equity attributable to equity holders of the Parent1,977,6981,876,809Shareholders’ equity attributable to non-controlling interests00TOTAL SHAREHOLDERS’ EQUITY1,977,6981,876,809 Loans - due after one year2,049,4232,173,810Provisions for employee benefits20,93821,355Deferred tax liabilities132,087133,422TOTAL NON-CURRENT LIABILITIES2,202,4482,328,587 Trade payables334,446296,698Other payables188,928195,385Tax liabilities121,74993,941Other current liabilities4,8034,693Provisions for risks and charges21,04522,092Derivative instruments measured at fair value5,5375,633Loans - due within one year289,075287,772Short-term debts to banks and other lenders20,41322,845TOTAL CURRENT LIABILITIES985,996929,059TOTAL SHAREHOLDERS’ EQUITY AND LIABILITIES5,166,1425,134,455 RECORDATI GROUPSummary of consolidated results prepared in accordance with International Financial Reporting Standards (IFRS) (€ thousands) CASH FLOW STATEMENTFirst quarter 2025First quarter 2024OPERATING ACTIVITIES Net income125,041123,595Income taxes39,81937,554Net interest25,37019,185Depreciation of property, plant and equipment8,8857,471Amortization of intangible assets42,03732,518Write-downs02,024Equity-settled share-based payment transactions3,9812,766Other non-monetary components28,59420,539Change in other assets and other liabilities(12,745)(14,879)Cash flow generated/(used) by operating activities before change in working capital260,982230,773Change in: - inventories(11,992)(12,006)- trade receivables(79,420)(59,871)- trade payables39,14125,900Change in working capital(52,271)(45,977)Interest received1,3051,420Interest paid(32,878)(20,848)Income taxes paid(12,349)(14,323)Cash flow generated/(used) by operating activities164,789151,045INVESTMENT ACTIVITIES Investments in property, plant and equipment(5,958)(4,824)Disposals of property, plant and equipment11893Investments in intangible assets(2,574)(4,158)Disposals of intangible assets15011Cash flow generated/(used) by investment activities(8,371)(8,078)FINANCING ACTIVITIES Opening of loans469,723Repayment of loans(117,600)(76,873)Payment of lease liabilities(3,185)(3,565)Change in short-term debts to banks and other lenders2,204(65,024)Dividends paid(1,086)(686)Purchase of treasury shares(49,061)(11,964)Sale of treasury shares24,67116,526Cash flow generated/(used) by financing activities(144,053)(71,863)Change in cash and cash equivalents12,36571,104Opening cash and cash equivalents322,423221,812Currency translation effect(1,744)1,735Closing cash and cash equivalents333,044294,651 DECLARATION BY THE FINANCIAL REPORTING OFFICERThe 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.