Merck & Co., Inc., Rahway, N.J., USA Announces Second-Quarter 2025 Financial Results

About this update from Jiangsu Hengrui Pharmaceuticals Co., Ltd. Class A

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With these actions, I am confident that we are well positioned to generate near- and long-term value for our shareholders and, most importantly, deliver for our patients."","length":766,"tagName":"p"},{"type":"readMore"},{"type":"text","content":" Financial Summary ","length":17,"tagName":"p"},{"type":"table","headerItems":[],"items":[{"val":[{"colspan":"1","rowspan":"2","style":"vertical-align:bottom;border-right:solid black 1.0pt;border-bottom:solid black 1.0pt;padding-left:5.0px;width:60%;","val":[{"type":"text","content":"$ in millions, except EPS amounts","length":33,"tagName":"p","attribs":{}}]},{"colspan":"4","rowspan":"1","style":"vertical-align:top;border-top:solid black 1.0pt;border-bottom:solid black 1.0pt;border-right:solid black 1.0pt;padding-left:0.0px;","val":[{"type":"text","content":" Second Quarter ","length":14,"tagName":"p","attribs":{}}]}]},{"val":[{"colspan":"1","rowspan":"1","style":"vertical-align:bottom;border-bottom:solid black 1.0pt;border-right:solid black 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Generally Accepted Accounting Principles (GAAP) earnings per share (EPS) assuming dilution was $1.76 and non-GAAP EPS was $2.13. GAAP and non-GAAP EPS in the second quarter of 2025 include a charge of $0.07 per share for an upfront payment to Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) upon closing of a license agreement. Non-GAAP EPS excludes acquisition- and divestiture-related costs, costs related to restructuring programs, and income and losses from investments in equity securities. Non-GAAP EPS in the second quarter of 2025 also excludes tax benefits primarily resulting from favorable audit adjustments. Non-GAAP EPS in the second quarter of 2024 also excludes a tax benefit due to a reduction in reserves for unrecognized income tax benefits, resulting from the expiration of the statute of limitations for assessments related to the 2019 federal tax return year.","length":923,"tagName":"p"},{"type":"text","content":"Year-to-date results can be found in the attached tables.","length":57,"tagName":"p"},{"type":"text","content":" Second-Quarter Sales Performance The following table reflects sales of the Company’s top products and significant performance drivers.","length":134,"tagName":"p"},{"type":"table","headerItems":[],"items":[{"val":[{"colspan":"1","rowspan":"1","style":"vertical-align:bottom;border-right:solid black 1.0pt;padding-left:0.0px;width:20%;","val":[{"type":"text","content":" ","length":6,"tagName":"p","attribs":{}}]},{"colspan":"5","rowspan":"1","style":"vertical-align:bottom;border-top:solid black 1.0pt;border-bottom:solid black 1.0pt;border-right:solid black 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Depository Share, each of which represents eight Verona Pharma ordinary shares, for a total transaction value of approximately $10 billion. Through the acquisition, the Company will add Ohtuvayre, a first-in-class selective dual inhibitor of phosphodiesterase 3 and 4 (PDE3 and PDE4), to its growing cardio-pulmonary pipeline and portfolio.","length":605,"tagName":"p"},{"type":"text","content":"The U.S. Food and Drug Administration (FDA) approved Ohtuvayre in June 2024 for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. It is the first novel inhaled mechanism for the treatment of COPD in more than 20 years. The transaction is anticipated to close in the fourth quarter of 2025.","length":332,"tagName":"p"},{"type":"text","content":" Pipeline and Portfolio Highlights In the second quarter, the Company continued to advance its broad and diverse pipeline with multiple regulatory and clinical milestones.","length":170,"tagName":"p"},{"type":"text","content":"In oncology, the FDA approved KEYTRUDA as part of a therapy regimen for the treatment of certain adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC), based on results from the Phase 3 KEYNOTE-689 trial. This approval is the first perioperative anti-PD-1 treatment regimen for adults with resectable locally advanced HNSCC whose tumors express PD-L1 (CPS ≥1). In addition, the Ministry of Health, Labor and Welfare (MHLW) in Japan approved WELIREG as monotherapy for the treatment of adults with von Hippel-Lindau (VHL) disease-associated tumors, and for adults with unresectable or metastatic RCC that has progressed after chemotherapy.","length":678,"tagName":"p"},{"type":"text","content":"At the 2025 American Society of Clinical Oncology Annual Meeting, the Company announced new research across more than 25 types of cancer in multiple treatment settings. Data were presented for several candidates, including MK-1084, an investigational oral selective KRAS G12C inhibitor, and from the Company’s pipeline of antibody-drug conjugates (ADCs). The Company also presented data from Phase 3 trials evaluating new combination regimens with KEYTRUDA, and longer-term data for studies of KEYTRUDA and WELIREG, with the KEYTRUDA studies including people with earlier stages of cancer.","length":589,"tagName":"p"},{"type":"text","content":"The Company announced results from the Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65) evaluating KEYTRUDA plus chemotherapy, which met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 and in all comers, as well as a secondary endpoint of overall survival (OS) in patients whose tumors express PD-L1. In addition, a pre-specified interim analysis of the Phase 3 KEYNOTE-937 study found that compared to placebo, KEYTRUDA did not show a statistically significant improvement in the primary endpoint of recurrence-free survival for certain patients with hepatocellular carcinoma. Also, a pre-specified interim analysis of the Phase 3 LEAP-014 trial found that KEYTRUDA plus Lenvima, in combination with platinum-based chemotherapy, did not show a statistically significant improvement in its primary endpoint of OS compared to KEYTRUDA plus chemotherapy for the first-line treatment of patients with metastatic esophageal squamous cell carcinoma (ESCC).","length":1069,"tagName":"p"},{"type":"text","content":"In vaccines and infectious diseases, the Company received FDA approval of ENFLONSIA for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. ENFLONSIA is the first and only RSV preventive option administered to infants using the same dose regardless of weight. The CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended ENFLONSIA for the prevention of RSV in infants younger than 8 months of age born during or entering their first RSV season. In addition, the Company announced initiation of the MOBILIZE-1 Phase 3 trial evaluating V181, an investigational single-dose quadrivalent vaccine for the prevention of dengue disease.","length":759,"tagName":"p"},{"type":"text","content":"In addition, the FDA accepted a New Drug Application (NDA) for doravirine/islatravir, an investigational, once-daily, oral, two-drug regimen for the treatment of adults with virologically suppressed HIV-1 based on the Phase 3 MK-8591A-051 and MK-8591A-052 trials. The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 28, 2026. The Company also announced the initiation of the EXPrESSIVE Phase 3 trials for MK-8527, its investigational once-monthly oral candidate for HIV pre-exposure prophylaxis (PrEP).","length":517,"tagName":"p"},{"type":"text","content":"In cardiovascular disease, the Company announced positive topline results from Phase 3 CORALreef HeFH and CORALreef AddOn, the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia already on lipid-lowering therapies, includin...

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