Siltuximab

– Rapid, deep, and durable reductions in high-sensitivity C-reactive protein (hs-CRP) through Day 90 achieved across all pacibekitug arms with high statistical significance as compared to placebo (p<0.0001 for all arms) – – Pacibekitug becomes the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing in a clinical trial, achieving >85% hs-CRP reductions from baseline in the 50 mg quarterly arm – – Overall incidence rates of adverse events and serious adverse events in the pacibekitug groups were comparable to placebo through the data extract date – – Results from TRANQUILITY support the advancement of pacibekitug into a potential Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease and a planned Phase 2 proof-of-concept trial in abdominal aortic aneurysm – – Conference call and webcast to be held today, May 20 at 8:30 a.m. ET – NEW YORK, May 20, 2025 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced positive topline results from its ongoing Phase 2 TRANQUILITY trial evaluating quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein (hs-CRP), a biomarker associated with elevated cardiovascular risk, and chronic kidney disease (CKD). The TRANQUILITY trial is the starting point of Tourmaline’s clinical development program for pacibekitug for the potential treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. “We are thrilled with the data emerging from the TRANQUILITY trial and the remarkable consistency of signal across all endpoints evaluated. All active arms achieved rapid, deep, and durable reductions in hs-CRP, and overall incidence rates of adverse events and serious adverse events were comparable between pacibekitug and placebo. Importantly, this is the first time that pacibekitug or any IL-6 inhibitor has been tested in a clinical trial with quarterly dosing. It is well-recognized that less frequent administration has the potential to enhance patient adherence and ultimate clinical benefit,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “Given the strength of the data, we look forward to accelerating development of pacibekitug within atherosclerotic cardiovascular disease and abdominal aortic aneurysm. We anticipate sharing additional data from the TRANQUILITY trial at an upcoming medical conference.” “There is strong evidence suggesting that elevated levels of high-sensitivity C-reaction protein (hs-CRP) are a predictor of increased cardiovascular risk, and quarterly subcutaneous administration of pacibekitug in the TRANQUILITY trial demonstrated large and significant reductions in hs-CRP levels through Day 90,” said Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital, the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York, and Chair of Tourmaline’s Cardiovascular Scientific Advisory Board (for which he is compensated). “Based upon these results, pacibekitug merits testing in future Phase 3 trials for cardiovascular risk reduction.” TRANQUILITY Topline Results: TRANQUILITY Trial Design TRANQUILITY (NCT06362759) is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial in patients with elevated hs-CRP and CKD stage 3 or 4. Participants were stratified by CKD stage and randomly assigned to receive subcutaneously administered pacibekitug 25 mg quarterly, 50 mg quarterly, or 15 mg monthly, or placebo, for a treatment period of 6 months. Participants are then followed for a period of 6 additional months. The prespecified primary endpoint of the TRANQUILITY trial is median time-averaged percent change in hs-CRP through Day 90, adjusting for baseline hs-CRP levels. The key secondary endpoint is the percentage of participants achieving time-averaged hs-CRP below 2 mg/L through Day 90. Additional prespecified endpoints include the aforementioned hs-CRP endpoints at Day 90 (i.e., using single-timepoint analyses) as well as the percentage of participants achieving hs-CRP reductions of 50% or greater. The prespecified primary analysis population includes participants who entered the study with a baseline hs-CRP of at least 1.9 mg/L (calculated as the average of Screening and Day 1 values), had at least one post-baseline hs-CRP assessment, and received all planned study drug doses during the primary evaluation period. The data in this analysis reflect a data extract date of April 23, 2025 from the ongoing trial. TRANQUILITY Baseline CharacteristicsA total of 143 participants were enrolled in the TRANQUILITY trial. Of this total, 126 participants comprised the primary analysis population. Baseline characteristics were generally balanced between groups. Key baseline characteristics of the primary analysis population are as follows: PacibekitugPlacebon=3125 mg quarterlyn=3150 mg quarterlyn=3015 mg monthlyn=34Age, years72 (62, 77)73 (66, 76)70 (61, 78)65 (60, 73)Female21 (68%)17 (55%)19 (63%)21 (62%)ASCVD15 (48%)16 (52%)20 (67%)7 (21%)Diabetes21 (68%)16 (52%)20 (67%)19 (56%)Body-mass index, kg/m233.4 (29.7, 36.3)32.2 (28.1, 35.6)35.1 (30.7, 39.8)33.4 (30.2, 36.3)eGFR, mL/min/1.73m243.5 (33.5, 53.0)37.5 (33.0, 47.0)48.0 (36.5, 56.5)42.5 (36.0, 57.0)IL-6, pg/mL4.91 (3.32, 5.93)4.62 (2.87, 7.30)5.56 (3.58, 10.03)4.86 (2.39, 7.83)hs-CRP, mg/L3.60 (2.70, 5.10)3.90 (2.35, 5.55)5.18 (3.60, 7.35)4.73 (3.80, 7.40) Data provided are median (interquartile range) or n (%). eGFR: estimated glomerular filtration rate. TRANQUILITY Pharmacodynamic DataKey pharmacodynamic data for the primary analysis population are as follows (p<0.0001 for all comparisons to placebo): PacibekitugPlacebon=3125 mg quarterlyn=3150 mg quarterlyn=3015 mg monthlyn=34Change from baseline analyses:Median time-averaged percent reduction in hs-CRP through Day 90 (primary endpoint)15%75%86%85%Median percent reduction in hs-CRP at Day 9012%70%85%89%Responder rate analyses:Percentage of participants achieving time-averaged hs-CRP < 2 mg/L through Day 9026%81%80%88%Percentage of participants achieving hs-CRP < 2 mg/L at Day 9013%77%83%88%Percentage of participants achieving time-averaged hs-CRP reduction >= 50% through Day 9019%81%87%94%Percentage of participants achieving hs-CRP reduction >= 50% at Day 9016%81%90%91% Results of post-hoc sensitivity analyses of the primary endpoint in the intention-to-treat (ITT) population, i.e., all randomized participants, were highly consistent with the primary analyses above. TRANQUILITY Safety DataAs of the data extract date, the cumulative incidence of any adverse event (AE) was 54% in the pooled pacibekitug group, compared with 56% in the placebo group. The most common AEs in the pooled pacibekitug group, defined as those occurring in at least 3 pacibekitug-treated participants, were urinary tract infection (4%), COVID-19 (3%), dizziness (3%), and viral upper respiratory tract infection (3%). The majority of AEs were mild or moderate in severity and were single occurrences in one participant each. The overall incidence of any serious adverse event (SAE) was 10% in the pooled pacibekitug group versus 11% in the placebo group. Incidence rates of infection (24% vs 22%) and serious infection (4% vs 3%) were similar in the pooled pacibekitug group compared with the placebo group. There was no increase in AE incidence with higher pacibekitug doses. There was one death, a fatal case of COVID-19, that occurred in the 25 mg quarterly arm. There were no Grade 2 or higher injection site reactions. There were no cases of confirmed Grade 3 or higher neutropenia and no cases of confirmed Grade 2 or higher thrombocytopenia. No clinically meaningful median percent changes in LDL cholesterol, triglycerides, or total cholesterol to HDL cholesterol ratio were observed in pacibekitug arms compared to placebo. Cumulative safety data from the TRANQUILITY trial as of the data extract date are as follows: PacibekitugPlacebon=36Pooledn=10525 mg quarterlyn=3550 mg quarterlyn=3515 mg monthlyn=35AEs 20 (56%)57 (54%)20 (57%)18 (51%)19 (54%)SAEs 4 (11%)10 (10%)6 (17%)2 (6%)2 (6%)AEs leading to discontinuation02 (2%)01 (3%)1 (3%)Infection8 (22%)25 (24%)10 (29%)9 (26%)6 (17%)Serious infection 1 (3%)4 (4%)4 (11%)00Death01 (1%)*1 (3%)*00Injection site reaction Grade 2+00000Neutropenia Grade 21 (3%)2 (2%)1 (3%)01 (3%)Neutropenia Grade 3+ 00000Thrombocytopenia Grade 2+ 00000 Safety analysis population n=141.*: Fatal case of COVID-19. Future Development Plans for Pacibekitug in Cardiovascular Inflammation:Tourmaline continues to make progress in advancing the clinical development strategy for pacibekitug in cardiovascular inflammation and assessing potential Phase 3 trial designs in patients with ASCVD. Tourmaline expects to provide further information on a potential Phase 3 cardiovascular outcomes trial in ASCVD later in 2025 following discussions with regulatory authorities. Additionally, Tourmaline plans to initiate a Phase 2 proof-of-concept trial in patients with abdominal aortic aneurysm (AAA) in the second half of 2025. AAA is a common, serious vascular condition characterized by weakening and progressive enlargement of the abdominal aorta that can result in rupture and death. There is no approved medical therapy to slow or halt the growth of AAA. IL-6-driven inflammation is considered a critical mechanism promoting aneurysm expansion. The therapeutic potential of IL-6 inhibition for the treatment of AAA is supported by human genetic studies, epidemiological evidence, and mouse models of AAA. “Both monthly and quarterly dosing of pacibekitug achieved significant, rapid, and sustained IL-6 pathway inhibition, as shown by robust reductions in hs-CRP in TRANQUILITY. We are excited to advance the development of pacibekitug to address significant unmet needs of patients with high-risk cardiovascular diseases driven by inflammation, including ASCVD and AAA,” said Emil deGoma, MD, Senior Vice President of Medical Research at Tourmaline. Conference Call and Webcast Information:Tourmaline will host a live conference call and webcast to discuss these results beginning at 8:30 a.m. ET today, May 20, 2025. Members of Tourmaline management will be joined by Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York. Dr. Bhatt also serves as the Chair of Tourmaline’s Cardiovascular Scientific Advisory Board (for which he is compensated). To register for this event, please click here or visit the Events and Presentations section of Tourmaline’s website. A replay of the event will be available on Tourmaline’s website following the event. It is recommended that participants register at least 15 minutes in advance of the event. About Tourmaline Bio:Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is pacibekitug. For more information about Tourmaline Bio and pacibekitug, please visit https://www.tourmalinebio.com or follow us on LinkedIn or X. About Pacibekitug:Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Excluding ongoing trials, pacibekitug was previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future. Cautionary Note Regarding Forward-Looking Statements:Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as “believe,” “designed to,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Tourmaline’s current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of pacibekitug, including the potential best-in-class profile of pacibekitug and the anticipated progression of pacibekitug into future clinical trials; the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for pacibekitug, including the timing of a planned Phase 2 proof-of-concept clinical trial in patients with AAA and of Phase 3 clinical trial readiness in ASCVD, as well as reporting of data therefrom and additional details regarding the planning thereof; the timing of future announcements regarding Tourmaline’s development plans and the content of such announcements; the timing and likelihood of seeking regulatory approval for Tourmaline’s product candidates, including pacibekitug; the unmet need in Tourmaline’s target indications and the potential for pacibekitug to address such unmet need; and the timing and potential to expand pacibekitug into additional indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include additional safety events occurring after the data extract date of April 23, 2025, as participants complete their trial visits and follow-up throughout the course of the trial; a review of the full dataset (including the post-April 23, 2025 dataset), after the trial has completed, which may cause our analysis following completion of the trial to differ from the analysis as of the data extract date presented above; uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline’s current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline’s current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials and clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline’s current or future product candidates and/or current or future target indications; the risk that Tourmaline’s current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline’s estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions on Tourmaline’s business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline’s Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (“SEC”) on May 2, 2025 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Media Contact:Scient PRSarah MishekSMishek@ScientPR.com Investor Contact:Meru AdvisorsLee M. Sternlstern@meruadvisors.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b1cc4485-af32-46c2-9fdb-144f4e1e573f

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.