Lurbinectedin

– Renee Gala named as President and CEO, effective August 11 – – Total revenues of $1.05 billion in 2Q25 – – Xywav ® revenues grew 13% year-over-year, with robust net patient adds of 625 quarter-over-quarter – – Zepzelca ® granted Priority Review in 1L ES-SCLC – DUBLIN, Aug. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced financial results for the second quarter of 2025 and updated financial guidance for 2025. "It has been a privilege to lead Jazz over my 22-year tenure. I am proud of what we have achieved on behalf of patients and confident that our new President and CEO, Renee Gala, will build on Jazz's momentum and serve as a catalyst in driving long-term growth," said Bruce Cozadd, chairman and chief executive officer, Jazz Pharmaceuticals. "We continue to see significant opportunity across our diversified portfolio in sleep, epilepsy, and oncology, as evidenced by the strong performance this quarter from our sleep portfolio with robust continued growth from Xywav in both narcolepsy and IH. We remain confident in the outlook of the business driven by multiple anticipated near-term oncology catalysts that each represent significant opportunities to drive greater revenue and create long-term value, most notably the top-line data readout for zanidatamab from the HERIZON-GEA-01 trial and upcoming PDUFA dates for dordaviprone and Zepzelca." Key Highlights Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25. Ziihera ® granted conditional marketing authorization by the European Commission in 2L BTC. Zepzelca and atezolizumab (Tecentriq®) combination granted U.S. FDA Priority Review for 1L maintenance treatment of ES-SCLC based on positive data from IMforte trial; PDUFA action date of October 7, 2025. 2025 Financial Guidance Updating total revenue range to $4.15 - $4.30 billion representing 4% growth at the midpoint. Raising lower end of net (loss)/income and (loss)/earnings per share ranges due to reductions in SG&A and R&D and improvement in the effective tax rate ranges. Business Updates Commercial Updates Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution: Xywav net product sales increased 13% to $415.3 million in 2Q25 compared to 2Q24. Meaningful Xywav net patient adds in 2Q25 (approximately 625 patients) with approximately 15,225 active Xywav patients exiting 2Q25, comprised of: Approximately 10,600 narcolepsy patients. Approximately 4,625 idiopathic hypersomnia (IH) patients, with 400 net patient adds. Presented data at the SLEEP 2025 meeting including results from the Phase 4 open-label XYLO trial showing that a switch from high-sodium oxybate to the same dose of low-sodium oxybate was associated with clinically meaningful reductions in blood pressure. Additionally, two presentations from the DUET trial evaluating sleep architecture demonstrated the effectiveness of Xywav on improvements in sleep quality among patients with IH or narcolepsy. Xywav, which the U.S. Food and Drug Administration (FDA) describes as clinically superior to Xyrem ® by means of greater safety, is the only low-sodium oxybate, the #1 branded treatment for narcolepsy1 and the only FDA-approved therapy to treat IH. Xyrem (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties: Xyrem net product sales were $35.3 million in 2Q25. Royalties from high-sodium oxybate AGs were $54.1 million in 2Q25. Epidiolex®/ Epidyolex® (cannabidiol): Epidiolex/Epidyolex net product sales increased 2% to $251.7 million in 2Q25 compared to 2Q24; underlying demand continues to be strong with year-over-year net product sales growth impacted by a number of factors, including inventory dynamics in the U.S. compared to 2Q24. Outside of the U.S., Epidyolex is approved in more than 35 countries. Remain confident in achieving blockbuster status for Epidiolex/Epidyolex in 2025. Rylaze®/ Enrylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn): Rylaze/Enrylaze net product sales decreased 7% to $100.7 million in 2Q25 compared to 2Q24. While updates to pediatric treatment protocols for acute lymphoblastic leukemia (ALL) have been broadly adopted, pediatric asparaginase use as a class remains below levels seen prior to protocol implementation; Rylaze use within the asparaginase class remains broadly stable. Zepzelca (lurbinectedin): Zepzelca net product sales decreased 8% to $74.5 million in 2Q25 compared to 2Q24. This decrease was driven by increased competition in second-line (2L) small cell lung cancer (SCLC) and treatment protocol updates delaying progression of first-line (1L) limited-stage SCLC patients to the 2L setting. Zepzelca and atezolizumab were granted U.S. FDA Priority Review for 1L extensive-stage (ES) SCLC in the maintenance setting with a Prescription Drug User Fee Act (PDUFA) action date of October 7, 2025. Potentially practice-changing data from the Phase 3 IMforte trial have been submitted to the National Comprehensive Cancer Network® (NCCN®) for consideration. Ziihera® (zanidatamab-hrii): Ziihera net product sales were $6.0 million in 2Q25 following product launch in December 2024. The Company was granted conditional marketing authorization by the European Commission for Ziihera as monotherapy for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy. Corporate Development Chimerix Acquisition: The Company completed its acquisition of Chimerix, Inc in April 2025 (Chimerix Acquisition), adding dordaviprone to its late-stage pipeline. Dordaviprone is a novel first-in-class small molecule treatment in development for H3 K27M-mutant diffuse glioma, a rare, high-grade brain tumor that most commonly affects children and young adults. Key Pipeline Highlights Zanidatamab: The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 4Q25. New data presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting from an ongoing Phase 2 trial of zanidatamab in combination with physician's choice chemotherapy for the first-line treatment of HER2-positive metastatic GEA showed a median overall survival of 36.5 months after four-years of follow-up along with a 15.2 month median progression-free survival in patients who were centrally confirmed as HER2-positive. In August 2025, the Company initiated the Phase 2 EmpowHER-BC-208 trial to evaluate zanidatamab in patients with HER2-positive neoadjuvant and adjuvant breast cancer. Dordaviprone: A New Drug Application for accelerated approval of dordaviprone in recurrent H3 K27M-mutant diffuse glioma was accepted and granted Priority Review by FDA. FDA has set a target PDUFA action date of August 18, 2025. The ongoing Phase 3 ACTION trial is evaluating dordaviprone in newly diagnosed, non-recurrent H3 K27M-mutant diffuse glioma patients following radiation treatment, potentially extending its use into the first-line setting. Share Repurchases of Approximately $125 Million The Company resumed repurchases of its ordinary shares in the second quarter of 2025 as part of the Company's previously authorized and announced repurchase program. Under this share repurchase program, the Company is authorized to repurchase its ordinary shares for up to an aggregate purchase price of $500 million, exclusive of any brokerage commissions. As of June 30, 2025, $225 million remained outstanding under this authorization, reflecting the purchase of shares worth approximately $125 million during the second quarter of 2025. Financial Highlights ____________________________ GAAP net loss for 2Q25 was $(718.5) million, or $(11.74) per diluted share, compared to GAAP net income of $168.6 million, or $2.49 per diluted share, for 2Q24. Non-GAAP adjusted net loss for 2Q25 was $(504.8) million, or $(8.25) per diluted share, compared to non-GAAP adjusted net income of $360.7 million, or $5.25 per diluted share, for 2Q24. The GAAP and non-GAAP adjusted net loss in 2Q25 included acquired in-process research and development (IPR&D) expense of $905.4 million representing the value allocated to dordaviprone in the Chimerix Acquisition, which impacted our results by $14.78 per share and $14.75 per share on a GAAP and non-GAAP adjusted basis, respectively. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release. Total Revenues Total revenues increased 2% in 2Q25 compared to the same period in 2024. Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was $761.2 million in 2Q25, an increase of 3% compared to $738.3 million in 2Q24. The increase in 2Q25 was due to higher Xywav and Epidiolex/Epidyolex net product sales, partially offset by decreased Xyrem net product sales. Oncology net product sales were $274.1 million in 2Q25, a decrease of 1% compared to $277.3 million in 2Q24. The decrease in 2Q25 was primarily due to lower net product sales of Rylaze/Enrylaze and Zepzelca, partially offset by the inclusion of Ziihera net product sales. Operating Expenses and Effective Tax Rate _________________________ _________________________ Changes in operating expenses in 2Q25 over the prior year period are primarily due to the following: Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 2Q25 compared to 2Q24, primarily due to changes in product mix. Cost of product sales, on a GAAP basis, included a higher acquisition accounting inventory fair value step-up expense in 2Q25 as compared to 2Q24. Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 2Q25 compared to 2Q24, primarily due to compensation-related expenses driven by higher headcount in support of our commercial portfolio. Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 2Q25 compared to 2Q24, primarily due to lower clinical study costs primarily related to zanidatamab, as a result of timing of clinical trial activities, and JZP385 following discontinuation of this program, partially offset by the addition of costs relating to dordaviprone following the Chimerix Acquisition. Acquired IPR&D in 2Q25, on a GAAP and non-GAAP adjusted basis, represents the value allocated to dordaviprone in the Chimerix Acquisition. Cash Flow and Balance Sheet As of June 30, 2025, cash, cash equivalents and investments were $1.7 billion, and the outstanding principal balance of the Company's long-term debt was $5.4 billion. In addition, the Company had undrawn borrowing capacity under a revolving credit facility of $885.0 million. For the six months ended June 30, 2025, the Company generated $518.6 million of cash from operations reflecting strong business performance and continued financial discipline. In April 2025, the Company acquired Chimerix for a total consideration of $944.2 million, which was funded with cash and cash equivalents. 2025 Financial Guidance Jazz Pharmaceuticals has updated its full-year 2025 financial guidance as follows: ___________________________ Conference Call Details Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2025 second quarter results. Interested parties may register for the call in advance here or via the Investors section of the Jazz Pharmaceuticals website at . To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at . About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Non-GAAP Financial Measures To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP (also referred to as adjusted or non-GAAP adjusted) financial measures in this press release and the accompanying tables. In particular, the Company presents non-GAAP adjusted net income (loss) (and the related per share measure) and its line-item components, as well as certain non-GAAP adjusted financial measures derived therefrom, including non-GAAP adjusted gross margin percentage and non-GAAP adjusted effective tax rate. Non-GAAP adjusted net income (loss) (and the related per share measure) and its line-item components exclude from GAAP reported net income (loss) (and the related per share measure) and its line-item components certain items, as detailed in the reconciliation tables that follow, and in the case of non-GAAP adjusted net income (loss) (and the related per share measure), adjust for the income tax effect of the non-GAAP adjustments. In this regard, the components of non-GAAP adjusted net income (loss), including non-GAAP adjusted cost of product sales, SG&A expenses and R&D expenses, are income statement line items prepared on the same basis as, and therefore components of, the overall non-GAAP adjusted net income (loss) measure. The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts and that each of these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period, to its forward-looking guidance, and to identify operating trends in the Company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the Company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles in the reconciliation tables that follow. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the first quarter of 2025, the Company is no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures. For purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Caution Concerning Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2025 financial guidance and the Company's expectations related thereto, including with respect to anticipated catalysts; expectations with respect to the transition of the CEO role; anticipated multiple near-term pipeline catalysts that each represent significant opportunities to drive greater revenue and create long-term value; expectations that Epidiolex will achieve blockbuster status in 2025; anticipated benefits and expenses relating to the Company's acquisition of Chimerix; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto; the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of dordaviprone in recurrent H3 K27M-mutant diffuse glioma and extend to use in first-line patients; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA; and the Company's development, regulatory and commercialization strategy; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto, including Zepzelca's potential to change current practice in 1L ES-SCLC and dordaviprone's potential to be a meaningful and durable revenue opportunity; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions; planned or anticipated regulatory submissions and filings, and the anticipated timing thereof; potential regulatory approvals; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Rylaze and Epidiolex/Epidyolex and other marketed products; the introduction of new products into the U.S. market that compete with, or otherwise disrupt the market for the Company's products and product candidates; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates; obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; geopolitical events, including international tariffs and trade restrictions and the conflict between Russia and Ukraine and related sanctions; macroeconomic conditions, including global financial markets, rising interest rates and inflation and recent and potential banking disruptions; regulatory initiatives and changes in tax laws; market volatility; protecting and enhancing the Company's intellectual property rights and the Company's commercial success being dependent upon the Company obtaining, maintaining and defending intellectual property protection and exclusivity for its products and product candidates; the ability of the parties to obtain court approval of certain Xyrem class action settlement agreements and the risk that the Company may incur other charges or cash expenditures not currently contemplated due to unanticipated events that may occur, including in connection with certain Xyrem class action settlement agreements, and the risk that the Company is unable to reach settlement agreements with other Xyrem antitrust plaintiffs that are not party to certain Xyrem class action settlement agreements; delays or problems in the supply or manufacture of the Company's products and product candidates; complying with applicable U.S. and non-U.S. regulatory requirements, including those governing the research, development, manufacturing and distribution of controlled substances; government investigations, legal proceedings and other actions; identifying and consummating corporate development transactions, financing these transactions and successfully integrating acquired product candidates, products and businesses, including Chimerix and the acquired product candidate dordaviprone; the Company's ability to realize the anticipated benefits of its corporate development transactions and its collaborations and license agreements with third parties; the sufficiency of the Company's cash flows and capital resources; the Company's ability to achieve targeted or expected future financial performance and results and the uncertainty of future tax, accounting and other provisions and estimates; the Company's ability to meet its projected long-term goals and objectives, in the time periods that the Company anticipates, or at all, and the inherent uncertainty and significant judgments and assumptions underlying the Company's long-term goals and objectives; fluctuations in the market price and trading volume of the Company's ordinary shares; the timing and availability of alternative investment opportunities; and other risks and uncertainties affecting the Company, including those described from time to time under the caption "Risk Factors" and elsewhere in Jazz Pharmaceuticals' Securities and Exchange Commission filings and reports, including the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as supplemented by the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and future filings and reports by the Company, including the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. Other risks and uncertainties of which the Company is not currently aware may also affect the Company's forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. ________________________________________________ Contacts: Investors: Jack Spinks Executive Director, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717 Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948 SOURCE Jazz Pharmaceuticals plc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Basel, 24 July 2025 Group sales grew by 7%1 at constant exchange rates (CER; 4% in CHF), driven by strong demand for medicines.Pharmaceuticals Division sales rose by 10% (6% in CHF), with Phesgo (breast cancer), Xolair (food allergies), Hemlibra (haemophilia A), Vabysmo (severe eye diseases) and Ocrevus (multiple sclerosis) being the top growth drivers.Diagnostics Division sales were stable (-3% in CHF) as strong demand for pathology solutions and blood screening tests offset the impact of healthcare pricing reforms in China.Core operating profit increased by 11% (6% in CHF), driven by higher sales and effective cost management.Core earnings per share showed significant growth of 12% (8% in CHF); IFRS net income jumped by 23% (17% in CHF).Outlook for 2025 confirmed.Highlights: US approval for Susvimo for diabetic retinopathy, a potentially blinding eye diseaseEU approval for Itovebi for a type of advanced breast cancer and Evrysdi tablet for spinal muscular atrophyCHMP recommendation for EU label update for Phesgo for breast cancer to allow at-home administrationAdvancement of key molecules into phase III development: prasinezumab for early-stage Parkinsonߴs disease and zosurabalpin for life-threatening bacterial infectionsPositive data on several therapies: Lunsumio and Polivy combination and Columvi for blood cancer, Tecentriq for lung cancer, Itovebi and Perjeta for breast cancer and fenebrutinib for multiple sclerosis and NXT007 for haemophilia AIntroduction of innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severityAnnouncement of new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technologyUS approval for VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify a form of lung cancer in patients eligible for targeted treatmentUS Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer Outlook for 2025 confirmedRoche (SIX: RO, ROG; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER). Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2025 2024 At CER1 In CHF Group sales 30,944 29,848 7 4 Pharmaceuticals Division 23,985 22,637 10 6 Diagnostics Division 6,959 7,211 0 -3 Core operating profit 12,010 11,293 11 6 Core EPS – diluted (CHF) 11.08 10.23 12 8 IFRS net income 7,832 6,697 23 17 Roche CEO Thomas Schinecker: “Roche’s strong growth momentum continued in the second quarter, driven by the strong growth of 11% at constant exchange rates in our Pharmaceuticals Division. We received numerous important approvals and reported positive data in disease areas with high unmet medical need. Over the past six months, we have made significant progress in our pipeline and advanced four potentially practice-changing therapies into the final phase of clinical development, based on encouraging data: NXT007 in haemophilia A, trontinemab in Alzheimer’s disease, prasinezumab in early-stage Parkinson’s disease, and zosurabalpin, a novel antibiotic that could become the first in over 50 years to tackle a type of bacteria that has become resistant to most other treatments. We are confident in our continued strong momentum and resilience of our business due to our innovative on-market portfolio and pipeline. Based on these strong results, we confirm our full-year outlook.” Group resultsIn the first half of 2025, Roche achieved sales growth of 7% (4% in CHF) to CHF 30.9 billion due to strong demand for pharmaceutical products. Core operating profit increased by 11% (6% in CHF) to CHF 12.0 billion, driven by higher sales and effective cost management. The appreciation of the Swiss franc against most currencies, notably the US dollar, had an adverse impact on the results when reported in Swiss francs compared to constant exchange rates. Core earnings per share increased by 12% (8% in CHF). IFRS net income increased by 23% (17% in CHF) to CHF 7.8 billion, driven by the strong operating performance and lower impairment charges related to intangible assets. Sales in the Pharmaceuticals Division increased by 10% (6% in CHF) to CHF 24.0 billion, with medicines for severe diseases continuing their strong growth. The top five growth drivers – Phesgo, Xolair, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 10.6 billion. This represents an increase of CHF 1.7 billion at CER compared to the first half of 2024. This more than compensated for the total decrease of CHF 0.3 billion (CER) in sales of the ‘loss of exclusivity (LOE)’ products – the decline in sales of Avastin (various types of cancer), Herceptin (breast and gastric cancer), MabThera/Rituxan (blood cancer, rheumatoid arthritis), Lucentis (severe eye diseases) and Esbriet (lung disease) was partially offset by an increase in sales of Actemra/RoActemra (rheumatoid arthritis). In the United States, sales rose by 10% due to continued growth of Xolair and continuing uptake of Hemlibra, Ocrevus, Vabysmo and Phesgo. This growth more than compensated for the decline in sales of medicines with expired patents. Sales in Europe grew 5% as the continued roll-out of Vabysmo and the continuing uptake of Ocrevus, Polivy and Phesgo more than compensated for lower sales of Perjeta (breast cancer) due to ongoing conversion of patients to Phesgo and the impact of biosimilar competition on Actemra/RoActemra sales. In Japan, sales increased by 5%, mainly due to the strong uptake of Phesgo, Vabysmo and PiaSky (paroxysmal nocturnal haemoglobinuria). Sales growth was partially offset by the decline in sales of Perjeta due to continued conversion of patients to Phesgo and of Avastin because of biosimilar erosion. Sales in the International region grew by 14%, led by Phesgo, Hemlibra, Xofluza (influenza), Vabysmo and Elevidys (Duchenne muscular dystrophy). In China, sales rose by 9%, driven by the uptake of Phesgo, strong sales of Xofluza and the roll-out of Polivy and Vabysmo. The Diagnostics Division’s sales remained stable (-3% in CHF) at CHF 7.0 billion as growth in demand for pathology solutions and blood screening tests offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region increased by 5%, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales increased by 6%, with growth across customer areas. Sales in Asia-Pacific decreased by 15% due to healthcare pricing reforms in China. Latin America sales grew by 14%. Pharmaceuticals: key developments Compound Milestone Regulatory ItovebiBreast cancer European Commission approves Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation Approval based on INAVO120 data showing that the regimen based on Itovebi more than doubled progression-free survival compared with palbociclib and fulvestrant alone. Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need.Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis. More information: Media Release, 23 July 2025 EvrysdiSpinal muscular atrophy Evrysdi tablet approved by European Commission as first and only tablet for spinal muscular atrophy (SMA) Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with SMA.Evrysdi tablet offers the same efficacy and safety demonstrated in available oral solution.Evrysdi is the only non-invasive disease-modifying SMA treatment, with more than 18,000 people with SMA treated globally to date. More information: Media Release, 4 June 2025 SusvimoSevere eye diseases FDA approves Susvimo for diabetic retinopathy Susvimo can help people with diabetic retinopathy maintain their vision and prevent progression to blindness with only one treatment every nine months.The innovative technology of Susvimo via the Port Delivery Platform may offer an alternative to regular eye injections in the US.Diabetic retinopathy affects almost 10 million people in the US and is the third FDA-approved indication for Susvimo, which is also approved for treating neovascular or ‘wet’ age-related macular degeneration and diabetic macular oedema. More information: Media Release, 22 May 2025 ColumviBlood cancer Update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the phase III STARGLO study.There is an urgent need for effective, immediately available therapies that are broadly accessible to people with transplant-ineligible R/R DLBCL.This first-of-its-kind Columvi combination could provide a much-needed, off-the-shelf and fixed-duration treatment option for patients who face poor prognosis.The clinical and disease characteristics of the overall population enrolled in this multiregional clinical trial are representative and applicable to US patients. More information: Media Release, 20 May 2025 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2025 2024 2025 2024 At CER In CHF Pharmaceuticals Division 23,985 22,637 100.0 100.0 10 6 United States 12,670 11,882 52.8 52.5 10 7 Europe 4,566 4,425 19.0 19.5 5 3 Japan 1,425 1,366 5.9 6.0 5 4 International 5,324 4,964 22.3 22.0 14 7 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % OcrevusMultiple sclerosis 3,506 8 2,462 5 706 12 - - 338 19 HemlibraHaemophilia A 2,421 17 1,324 11 493 7 183 8 421 66 VabysmoEye diseases (nAMD, DME, RVO) 2,067 18 1,450 9 378 33 70 31 169 118 TecentriqCancer immunotherapy 1,733 -1 819 -6 434 3 174 -4 306 13 Perjeta2Breast cancer 1,613 -12 677 1 282 -16 37 -44 617 -18 Xolair2Asthma, food allergies 1,445 34 1,445 34 - - - - - - Actemra/RoActemra2RA, COVID-19 1,279 4 619 7 308 -14 152 5 200 26 PhesgoBreast cancer 1,197 55 348 39 401 15 90 80 358 182 Kadcyla2Breast cancer 1,037 9 396 7 266 -6 45 -2 330 28 EvrysdiSpinal muscular atrophy 869 7 309 12 292 4 46 5 222 5 AlecensaLung cancer 802 8 276 20 133 -7 100 5 293 7 PolivyBlood cancer 730 46 327 32 160 90 99 8 144 88 MabThera/Rituxan2Blood cancer, RA 630 -8 387 -6 70 -8 7 -14 166 -11 Herceptin2Breast and gastric cancer 560 -21 121 -10 150 -1 4 -51 285 -32 Activase/TNKase2Cardiac diseases 550 -4 527 -3 - - - - 23 -25 Avastin2Various cancer types 522 -17 156 -20 26 -40 76 -25 264 -9 Gazyva/Gazyvaro2Blood cancer 490 14 253 20 121 1 17 20 99 14 Pulmozyme2Cystic fibrosis 239 11 167 22 34 -12 - -18 38 -3 CellCept2Immunosuppressant 196 2 9 -17 65 12 24 35 98 -6 Madopar2Parkinson’s disease 193 1 - - 46 -5 - - 147 4 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone SBX sequencing technologyGenetic disorders Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology The strategic collaboration with Broad Clinical Labs will explore and develop applications using Roche’s SBX sequencing technology, with an initial focus on critically ill newborns and their parents.Whole-genome sequencing can help diagnose babies with suspected genetic disorders, such as cystic fibrosis and sickle cell disease.This project will explore how this technology could become part of routine clinical practice for newborns, as well as its use in other research applications. More information: Media Release, 23 May 2025 VENTANA MET (SP44) RxDx AssayLung cancer FDA approves VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for targeted treatment The VENTANA MET (SP44) RxDx Assay detects the MET (also known as c-Met) protein, which is over-expressed in some patients with non-squamous non-small cell lung cancer.The MET protein serves as a predictive biomarker for the likelihood of a patient’s response to c-Met-targeted therapy.As the leader in companion diagnostics, Roche offers a broad CDx portfolio that helps enable informed clinical decisions and improved patient outcomes. More information: Media Release, 14 May 2025 Elecsys PRO-C3 testLiver fibrosis Roche introduces the innovative Elecsys PRO-C3 test to improve precision in evaluating liver fibrosis severity Elecsys PRO-C3, used with the ADAPT formula (age, diabetes status, PRO-C3, platelets), assesses the severity of liver fibrosis – a disease responsible for approximately one in every 25 deaths worldwide.The test delivers results in just 18 minutes on Roche’s cobas analysers, providing a fast and reliable diagnostic method.The test enables earlier identification of patients with significant liver fibrosis, potentially improving outcomes through timely management and access to emerging therapies. More information: Media Release, 6 May 2025 VENTANA TROP2 (EPR20043) RxDx deviceLung cancer FDA grants Roche Breakthrough Device Designation for the first AI-driven companion diagnostic for non-small cell lung cancer The VENTANA TROP2 (EPR20043) RxDx device is an immunohistochemistry assay combined with a digital pathology algorithm to determine patient treatment. The device uses AI-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods. This Breakthrough Device Designation demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology. More information: Media Release, 29 April 2025 Chest pain triage algorithmAcute coronary syndrome Roche receives CE mark for its chest pain triage algorithm to enhance detection of acute coronary syndrome Roche, in collaboration with Universitätsklinikum Heidelberg, has developed a chest pain triage algorithm – a CE-marked IVD medical device set to transform cardiac care.This novel algorithm offers a standardised assessment, helping emergency room doctors to make confident clinical decisions in ruling in or ruling out heart attacks (acute myocardial infarction).Cardiovascular disease causes a third of worldwide deaths, with chest pain being the second highest reason for emergency department visits. More information: Media Release, 23 April 2025 PhesgoBreast cancer CHMP recommends EU label update for Phesgo to allow administration outside clinical settings Positive recommendation is based on clinical, real-world and bioequivalence data supporting feasibility and safety of the administration of Phesgo outside clinical settings, for example at home.Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings.Phesgo has the potential to reduce treatment administration costs by up to 80% in Western Europe, and 85% of patients prefer subcutaneous over intravenous administration. More information: Media Release, 30 April 2025 Phase III, pivotal and other key read-outs AstegolimabChronic obstructive pulmonary disease (COPD) Roche provides update on astegolimab in chronic obstructive pulmonary disease The pivotal phase IIb ALIENTO study met the primary endpoint of a statistically significant reduction in the annualised exacerbation rate (AER) at 52 weeks when astegolimab was given every two weeks.The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks.The safety profile of astegolimab was consistent with previously reported data, with no new safety signals identified. More information: Media Release, 21 July 2025 NXT007Haemophilia A Early data suggest NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest-dose groups in people with haemophilia A.The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden.Three phase III clinical studies on NXT007, a next-generation bispecific antibody, are set to begin in 2026. More information: Media Release, 23 June 2025 Lunsumio and PolivyBlood cancer Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma Pivotal phase III SUNMO study demonstrated an 11.5-month median progression-free survival – three times longer than R-GemOx.This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community care.These data demonstrate Roche’s commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma. More information: Media Release, 20 June 2025 PrasinezumabParkinson’s disease Roche to advance prasinezumab into phase III development for early-stage Parkinson’s disease Results from phase IIb PADOVA and longer-term follow-up data suggest clinical benefit on top of symptomatic treatment in early-stage Parkinson’s disease.Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody targeting a known biological driver of Parkinson’s disease progression.Parkinson’s disease affects over 10 million people globally and significant unmet need remains. More information: Media Release, 16 June 2025 TecentriqLung cancer Tecentriq combined with lurbinectedin shows significant survival benefit in extensive-stage small cell lung cancer (ES-SCLC) 46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options.First phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival. Data were presented in an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet. More information: Media Release, 3 June 2025 ItovebiBreast cancer New data show Itovebi significantly extended survival in a certain type of HR-positive advanced breast cancer The regimen based on Itovebi reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer, compared with palbociclib and fulvestrant alone.The PIK3CA mutation is found in approximately 40% of HR-positive advanced breast cancers and is associated with a poor prognosis.New data were presented in an oral session at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine. More information: Media Release, 31 May 2025 FenebrutinibMultiple sclerosis Fenebrutinib maintains near-complete suppression of disease activity and disability progression for up to two years in people with relapsing multiple sclerosis Patients on fenebrutinib had low relapse rates with data showing no active brain lesions or disability progression after nearly two years of treatment.Phase III studies for fenebrutinib in relapsing and primary progressive multiple sclerosis are expected to start reading out at year end. More information: Media Release, 30 May 2025 ColumviBlood cancer New two-year follow-up data show Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) patients Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant.89% of patients whose cancer had fully responded at the end of treatment with Columvi in combination with chemotherapy were still alive and 82% showed no signs of cancer one year post-treatment.Timely initiation of effective therapy at relapse or after initial therapy failure is critical for this aggressive, life-threatening disease. Results demonstrate the potential of the Columvi combination as a much-needed, off-the-shelf and fixed-duration treatment option. More information: Media Release, 23 May 2025 PerjetaBreast cancer Ten-year APHINITY data show regimen based on Perjeta reduced the risk of death by 17% in people with HER2-positive early-stage breast cancer Long-term follow-up in this curative setting demonstrated clinically meaningful survival benefit when adjuvant Perjeta was added to Herceptin and chemotherapy.21% reduction in the risk of death was seen in the pre-specified subgroup of people with lymph node-positive disease. More information: Media Release, 13 May 2025 Other Executive changes Changes to the Roche Enlarged Corporate Executive Committee Johannes (Hans) Clevers, MD, PhD, Head of Roche Pharma Research and Early Development (pRED) and member of the Enlarged Corporate Executive Committee, will be retiring from Roche. Barbara Schädler, Head of Group Communications and member of Roche’s Enlarged Corporate Executive Committee, will retire from the company at the end of the year. More information: Media Release, 30 June 2025 ElevidysDuchenne muscular dystrophy Roche provides safety update on Elevidys gene therapy for Duchenne muscular dystrophy in non-ambulatory patients After a thorough clinical review, the benefit-risk profile of Elevidys in non-ambulatory patients with Duchenne has been re-assessed following two cases of fatal acute liver failure.Effective immediately, dosing of non-ambulatory patients, irrespective of age, is paused in the clinical setting; dosing of non-ambulatory patients is discontinued in the commercial setting.Roche is working closely with relevant health authorities, investigators and prescribing physicians to ensure they are informed and patient care is being appropriately modified.The benefit-risk profile of Elevidys treatment in ambulatory Duchenne patients remains positive and treatment guidance is unchanged. More information: Media Release, 15 June 2025 XofluzaInfluenza The New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission Detailed results from the CENTERSTONE trial show treatment with Xofluza reduced the odds of transmission, or spread, of the influenza virus from an infected person to household members by 32%.CENTERSTONE is the first global phase III trial that demonstrates the benefit of an antiviral in reducing the spread of a respiratory virus.Reducing the spread of infection within households could help limit transmission within institutions and communities, potentially easing the burden of both seasonal and pandemic influenza on healthcare systems. More information: Media Release, 25 April 2025 Diagnostics sales Sales CHF millions As % of sales % change January–June 2025 2024 2025 2024 At CER In CHF Diagnostics Division 6,959 7,211 100.0 100.0 0 -3 Customer areas3 Core Lab 3,839 4,072 55.2 56.5 -2 -6 Molecular Lab 1,250 1,257 18.0 17.4 3 -1 Near Patient Care 1,018 1,094 14.6 15.2 -3 -7 Pathology Lab 852 788 12.2 10.9 12 8 Regions Europe, Middle East, Africa 2,485 2,431 35.7 33.7 5 2 North America 2,235 2,163 32.1 30.0 6 3 Asia-Pacific 1,729 2,102 24.9 29.2 -15 -18 Latin America 510 515 7.3 7.1 14 -1 More information on Roche performance in the first half of 2025: HY 2025 Finance ReportHY 2025 presentationAppendix with tables About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References[1] Unless otherwise stated, all growth rates and comparisons to the previous year in this document are at constant exchange rates (CER: average rates 2024) and all total figures quoted are reported in CHF.[2] Products launched before 2015.[3] Core Lab: diagnostics solutions in the areas of immunoassays, clinical chemistry and CustomBiotech.Molecular Lab: diagnostics solutions for pathogen detection and monitoring, donor screening, sexual health and genomics, genomic tumour profiling.Near Patient Care: diagnostics solutions in emergency rooms, medical practices and directly with patients, including integrated personalised diabetes management.Pathology Lab: diagnostics solutions for tissue biopsies and companion diagnostics.In 2025, sales in the Pathology Lab customer area include sales previously reported in the Molecular Lab customer area to foster business transparency and harmonisation in the use of solutions in the area of cervical intraepithelial neoplasia technology (CINtec). The comparative information for 2024 has been restated accordingly.In 2025, sales in the Core Lab customer area include sales previously reported in the Near Patient Care customer area to centralise digital healthcare solutions within Roche Information Solutions. The comparative information for 2024 has been restated accordingly Cautionary statement regarding forward-looking statementsThis document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Dr Rebekka SchnellPhone: +41 79 205 27 03 Kirti PandeyPhone: +49 172 636 72 62 Yvette PetillonPhone: +41 79 961 92 50 Roche Investor Relations Dr Bruno EschliPhone: +41 61 687 52 84e-mail: bruno.eschli@roche.com Dr Sabine BorngräberPhone: +41 61 688 80 27e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 688 48 14e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 32 17e-mail: kalm.loren@gene.com Attachments Media Investor Release Roche HY results 2025 English Communications appendix tables_HY 2025_Sales_Results