Trastuzumab--ANNS(Synthon BV)

AstraZeneca and Daiichi Sankyo’s ENHERTU is the first and only HER2-directed medicine to improve progression-free survival over global standard of care in a Phase III trial in this setting WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the DESTINY-Lung04 Phase III trial showed ENHERTU ® (fam-trastuzumab deruxtecan-nxki) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment of patients with unresectable, locally advanced or metastatic HER2 -mutant non-squamous non-small cell lung cancer (NSCLC). The trial will continue as planned to evaluate secondary endpoints including overall survival. The global standard of care for patients with HER2- mutant NSCLC in the 1st-line metastatic setting is a combination of immunotherapy and platinum-based chemotherapy. 1-3 However, many patients do not respond to 1st-line treatment and experience disease progression, underscoring the need for additional treatment options. 3-7 Approximately 2-4% of patients with NSCLC have tumors with a HER2 mutation. 8-10 Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Our oncology pipeline continues to advance with DESTINY-Lung04 becoming the first Phase III trial to demonstrate a progression-free survival benefit versus the global standard of care in this 1st-line setting, supporting the potential for ENHERTU to move earlier in the treatment of HER2 -mutant non-small cell lung cancer. This aggressive lung cancer often affects younger patients and has historically had limited 1st-line targeted treatment options, making these positive results an important step forward in bringing additional effective therapies to patients at metastatic diagnosis when there is the greatest opportunity to improve outcomes.” John Tsai, Global Head, R&D, Daiichi Sankyo, said: “ENHERTU is already established as the first and only antibody drug conjugate for the 2nd-line treatment of HER2 -mutant metastatic non-small cell lung cancer. The positive results seen in DESTINY-Lung04 show that treatment with ENHERTU in the 1st-line setting delays disease progression compared to the global standard of care, highlighting its potential to improve outcomes for patients earlier in the treatment of metastatic disease.” The safety pro ENHERTU observed in DESTINY-Lung04 was generally consistent with its known profile, with no new safety concerns identified. The DESTINY-Lung04 data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. ENHERTU is currently approved to treat patients with previously treated metastatic NSCLC whose tumors have activating HER2 ( ERBB2 ) mutations, and to treat patients with HER2-positive solid tumors, including HER2-overexpressing metastatic NSCLC, who have received prior treatment and who have no satisfactory treatment options. ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Enhertu U.S. Indications and Important Safety Information Indications ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for: HER2-Positive Early Breast Cancer - As neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test followed by a taxane, trastuzumab, and pertuzumab (THP) - As adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment HER2-Positive Metastatic Breast Cancer - In combination with pertuzumab as first-line treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer, as determined by an FDA-authorized test - As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or, in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy HER2-Low and HER2-Ultralow Metastatic Breast Cancer - As monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-authorized test, that has progressed on one or more endocrine therapies in the metastatic setting - As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer, as determined by an FDA-authorized test, who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy HER2-Mutant Unresectable or Metastatic Non-Small Cell Lung Cancer (NSCLC) - As monotherapy for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-authorized test, and who have received a prior systemic therapy This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. HER2-Positive Locally Advanced or Metastatic Gastric Cancer - As monotherapy for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen HER2-Positive (IHC 3+) Unresectable or Metastatic Solid Tumors - As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Important Safety Information WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY Interstitial lung disease (ILD) and pneumonitis, including severe, life-threatening, and fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception. Contraindications None. Warnings and Precautions Interstitial Lung Disease / Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose 1 level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. In the adjuvant HER2+ breast cancer setting, if drug-induced ILD is suspected, rule out radiotherapy-related pneumonitis. If only radiotherapy-related pneumonitis is suspected, consider interruption of ENHERTU for Grade 2 and permanently discontinue ENHERTU for Grade ≥3. HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Median time to first onset was 5.5 months (range: 0.9 to 31.5). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.9% of patients treated with ENHERTU. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), ILD occurred in 12% of patients. Median time to first onset was 8.0 months (range: 0.6 to 33.8). Fatal outcomes due to ILD and/or pneumonitis occurred in 0.5% of patients treated with ENHERTU in combination with pertuzumab. ENHERTU followed by THP In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, ILD occurred in 4.4% of patients. Median time to first onset was 2.7 months (range: 1.1 to 6.0). Fatal outcomes due to ILD and/or pneumonitis occurred in 1 patient (0.3%) treated with ENHERTU followed by THP. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21). Neutropenia Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] 38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by 1 level. HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and Solid Tumors (Including IHC 3+) (5.4 mg/kg) ENHERTU as Monotherapy In patients treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Nineteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 939). Febrile neutropenia was reported in 1% of patients. ENHERTU in Combination with Pertuzumab In patients treated with ENHERTU 5.4 mg/kg in combination with pertuzumab (N=431), decreased neutrophil count occurred in 79% of patients. Median time to first onset was 22 days (range: 5 to 994). Twenty-nine percent had Grade 3 or 4 decreased neutrophil count. Febrile neutropenia was reported in 2.6% of patients. ENHERTU followed by THP In patients treated with ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11, a decrease in neutrophil count was reported in 58% of patients. Seventeen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 42 days (range: 11 to 165). Febrile neutropenia was reported in 0.9% of patients. HER2-Positive Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg) In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients. Left Ventricular Dysfunction Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular dysfunction (LVD) has been observed with anti-HER2 therapies, including ENHERTU. Assess left ventricular ejection fraction (LVEF) prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVD through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is 20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of 20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF 6 months and 39% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (73%), nausea (72%), decreased hemoglobin (67%), decreased neutrophil count (65%), decreased lymphocyte count (60%), fatigue (55%), decreased platelet count (48%), increased aspartate aminotransferase (46%), increased alanine aminotransferase (43%), increased blood alkaline phosphatase (39%), vomiting (38%), alopecia (37%), constipation (32%), decreased blood potassium (32%), decreased appetite (31%), diarrhea (30%), and musculoskeletal pain (24%). ENHERTU in Combination with Pertuzumab The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg in combination with pertuzumab intravenously every 3 weeks in 431 patients in DESTINY-Breast07 (n=50), and DESTINY-Breast09 (n=381). Among these patients, 86% were exposed for >6 months and 73% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were decreased white blood cell count (86%), decreased hemoglobin (80%), decreased neutrophil count (79%), nausea (74%), increased alanine aminotransferase (65%), diarrhea (64%), increased aspartate aminotransferase (63%), decreased lymphocyte count (61%), decreased platelet count (55%), increased blood alkaline phosphatase (54%), decreased blood potassium (54%), fatigue (53%), alopecia (48%), vomiting (46%), upper respiratory tract infection (32%), constipation (31%), decreased appetite (31%), decreased weight (28%), musculoskeletal pain (23%), increased blood bilirubin (23%), and abdominal pain (22%). HER2-Positive Early Breast Cancer DESTINY-Breast11 The safety of ENHERTU followed by THP was evaluated in 320 patients with HER2-positive (IHC 3+ or ISH+) early breast cancer who received at least 1 dose of ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11. ENHERTU was administered by intravenous infusion once every three weeks for 4 cycles followed by THP for 4 cycles. The median duration of treatment was 5.6 months (range: 0.7 to 9.1) for patients who received ENHERTU followed by THP. Serious adverse reactions occurred in 11% of patients receiving ENHERTU followed by THP, including COVID-19 (0.9%) and ILD/pneumonitis (0.6%). Fatal adverse reactions occurred in 0.6% of patients, including ILD/pneumonitis and death not otherwise specified (1 patient each). In patients treated with ENHERTU followed by THP, the permanent discontinuation of ENHERTU due to adverse reactions occurred in 1.3%, of which ILD/pneumonitis accounted for 0.6%. Dose interruptions of ENHERTU due to adverse reactions occurred in 11% of patients. The most frequent adverse reactions (>2%) associated with dose interruption were decreased neutrophil count and COVID-19. Dose reductions of ENHERTU occurred in 2.5% of patients treated with ENHERTU. The most common (≥20%) adverse reactions in patients treated with ENHERTU followed by THP, including laboratory abnormalities, were decreased hemoglobin (83%), increased alanine aminotransferase (79%), increased aspartate aminotransferase (74%), decreased white blood cell count (67%), nausea (65%), peripheral neuropathy (59%), diarrhea (59%), decreased neutrophil count (58%), alopecia (48%), fatigue (41%), decreased lymphocyte count (40%), rash (31%), musculoskeletal pain (30%), decreased blood potassium (29%), constipation (29%), vomiting (29%), stomatitis (23%), and decreased appetite (20%). DESTINY-Breast05 The safety of ENHERTU was evaluated in 806 patients with HER2-positive breast cancer with residual invasive disease following neoadjuvant HER2-targeted therapy who then received at least one dose of ENHERTU 5.4 mg/kg. ENHERTU was administered by intravenous infusion once every three weeks for 14 cycles. The median duration of treatment was 10 months (range: 0.7 to 16) for patients who received ENHERTU. Serious adverse reactions occurred in 17% of patients receiving ENHERTU. Serious adverse reactions in ≥1% of patients who received ENHERTU were ILD/pneumonitis, radiation pneumonitis, pneumonia, and platelet count decreased. Fatal adverse reactions occurred in 0.4% of patients including ILD/pneumonitis (2 patients) and respiratory tract infection (1 patient). Permanent discontinuation of ENHERTU due to an adverse reaction occurred in 18% of patients. The adverse reaction which resulted in permanent discontinuation of ENHERTU >2% included ILD/pneumonitis. Dose interruptions of ENHERTU due to an adverse reaction occurred in 50% of patients. Adverse reactions which required dosage interruptions in >2% included radiation pneumonitis, neutrophil count decreased, COVID-19, white blood cell count decreased, ILD/pneumonitis, platelet count decreased, upper respiratory tract infection, fatigue, cough, and pyrexia. Dose reductions of ENHERTU due to an adverse reaction occurred in 26% of patients. Adverse reactions which required dose reductions in >2% of patients included nausea, fatigue, platelet count decreased, ILD/pneumonitis, and neutrophil count decreased. The most common (≥20%) adverse reactions, including laboratory abnormalities, in patients receiving ENHERTU were decreased white blood cell count (80%), decreased lymphocyte count (72%), decreased neutrophil count (72%), nausea (71%), decreased hemoglobin (61%), increased aspartate aminotransferase (60%), fatigue (54%), increased alanine aminotransferase (53%), decreased platelet count (46%), increased blood alkaline phosphatase (39%), constipation (32%), vomiting (31%), decreased blood potassium (27%), diarrhea (23%), musculoskeletal pain (23%), and decreased appetite (20%). ILD was reported in 17% of patients receiving ENHERTU, which included COVID-19 pneumonia, interstitial lung disease, lung opacity, organizing pneumonia, pneumocystis jirovecii pneumonia, pneumonia, and pneumonitis which was adjudicated as ILD (irrespective of causality). Adjudicated drug-related ILD for ENHERTU was 10% for all Grades and 0.9% for Grades 3 or 4. HER2-Positive Metastatic Breast Cancer DESTINY-Breast09 The safety of ENHERTU 5.4 mg/kg in combination with pertuzumab was evaluated in DESTINY-Breast09, a randomized, three-arm, multicenter study including 763 patients with HER2-positive (IHC 3+ or ISH+) unresectable or metastatic breast cancer. Three hundred eighty-one patients received ENHERTU in combination with pertuzumab and 382 patients received THP (taxane [docetaxel or paclitaxel], trastuzumab, and pertuzumab). Among patients who received ENHERTU in combination with pertuzumab, the median duration of treatment was 22 months (range: 0.3 months to 44.5 months). Serious adverse reactions occurred in 27% of patients receiving ENHERTU in combination with pertuzumab. Serious adverse reactions in >1% of patients were diarrhea, pneumonia, febrile neutropenia, hypokalemia, vomiting, ILD, pulmonary embolism, and sepsis. Fatalities due to adverse reactions occurred in 3.4% of patients including pneumonia (n=3), ILD (n=2), sepsis (n=2), pulmonary embolism, septic shock, acute kidney injury, dyspnea, febrile neutropenia, and intestinal ischemia (1 patient each). Contacts Media Inquiries Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

Total global revenues of $1.7 billion for the second quarter, an increase of 30% from the prior year BRUKINSA (zanubrutinib) global revenues of $1.2 billion for the second quarter, an increase of 31% from the prior year Diluted GAAP Earnings per American Depository Share (ADS) of $2.05 for the second quarter; non-GAAP diluted Earnings per ADS of $3.84 for the second quarter Raised 2026 total revenue guidance to $6.6 to $6.8 billion; GAAP operating income of $1 to $1.1 billion, non-GAAP operating income of $1.7 to $1.8 billion SAN CARLOS, Calif.--(BUSINESS WIRE)-- $ONC #BeOne -- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the second quarter of 2026. John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said: “These strong second-quarter results underscore our continued growth as a global oncology leader. Our foundational hematology franchise, led by BRUKINSA, continues to gain momentum as we advance one of the industry’s deepest and most diverse pipelines. With differentiated capabilities spanning drug discovery, clinical development, manufacturing, and commercialization, we are well positioned for our next phase of global growth.” (Amounts in thousands of U.S. dollars and unaudited) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 % Change 2026 2025 % Change Net product revenues $ 1,679,794 $ 1,302,076 29 % $ 3,167,123 $ 2,410,606 31 % Other revenue $ 25,277 $ 13,224 91 % $ 51,386 $ 21,973 134 % Total revenue $ 1,705,071 $ 1,315,300 30 % $ 3,218,509 $ 2,432,579 32 % GAAP income from operations $ 325,047 $ 87,885 270 % $ 574,949 $ 98,987 481 % Adjusted income from operations* $ 503,029 $ 274,945 83 % $ 917,423 $ 414,302 121 % GAAP net income $ 237,007 $ 94,320 151 % $ 464,364 $ 95,590 386 % Adjusted net income* $ 444,497 $ 252,822 76 % $ 819,539 $ 388,959 111 % GAAP basic EPS per ADS $ 2.12 $ 0.87 144 % $ 4.17 $ 0.89 369 % Adjusted basic EPS per ADS* $ 3.98 $ 2.33 71 % $ 7.37 $ 3.61 104 % GAAP diluted EPS per ADS $ 2.05 $ 0.84 144 % $ 4.01 $ 0.85 372 % Adjusted diluted EPS per ADS* $ 3.84 $ 2.25 71 % $ 7.08 $ 3.48 103 % Free Cash Flow* $ 435,344 $ 219,772 98 % $ 595,891 $ 207,447 187 % *For an explanation of our use of non-GAAP financial measures, refer to the “Note Regarding Use of Non-GAAP Financial Measures” section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release. Second Quarter 2026 Financial Results ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Product Revenue totaled $1.7 billion for the second quarter of 2026, representing growth of 29% compared to the prior-year period. BRUKINSA: Global sales totaled $1.2 billion for the second quarter of 2026, representing growth of 31% compared to the prior-year period; U.S. sales of BRUKINSA totaled $893 million in the second quarter of 2026, representing growth of 31% compared to the prior-year period. TEVIMBRA (tislelizumab): Global sales totaled $229 million in the second quarter of 2026, representing growth of 18% compared to the prior-year period. Amgen in-licensed products: Global sales totaled $157 million in the second quarter of 2026, representing growth of 25% compared to the prior-year period. Gross Margin as a percentage of global product sales for the second quarter of 2026 was 90%, compared to 87% in the prior-year period on a GAAP basis. The gross margin percentage increased due to a proportionally higher sales mix of global BRUKINSA compared to other products in the Company’s portfolio. Gross margin also benefited from productivity improvements resulting in lower costs for both BRUKINSA and TEVIMBRA. Operating Expenses The following table summarizes operating expenses for the second quarter of 2026: GAAP Non-GAAP (unaudited, in thousands, except percentages) Q2 2026 Q2 2025 % Change Q2 2026 Q2 2025 % Change Research and development $ 612,280 $ 524,896 17 % $ 533,950 $ 444,057 20 % Selling, general and administrative $ 593,214 $ 537,913 10 % $ 500,674 $ 441,655 13 % Total operating expenses $ 1,205,494 $ 1,062,809 13 % $ 1,034,624 $ 885,712 17 % The following table summarizes operating expenses for the first half of 2026: GAAP Non-GAAP (unaudited, in thousands, except percentages) Q2 YTD 2026 Q2 YTD 2025 % Change Q2 YTD 2026 Q2 YTD 2025 % Change Research and development $ 1,153,504 $ 1,006,783 15 % $ 999,854 $ 865,252 16 % Selling, general and administrative $ 1,148,311 $ 997,201 15 % $ 972,667 $ 837,166 16 % Total operating expenses $ 2,301,815 $ 2,003,984 15 % $ 1,972,521 $ 1,702,418 16 % Research and Development (R&D) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to advancing early clinical programs into late stage and preclinical programs into the clinic. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled $23.3 million and $0.5 million in the second quarter of 2026 and 2025, respectively. Selling, General and Administrative (SG&A) Expenses increased for the second quarter of 2026 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support commercial growth. SG&A expenses as a percentage of product sales were 35% for the second quarter of 2026, compared to 41% in the prior-year period. Net Income and Basic/Diluted Earnings Per Share GAAP net income for the second quarter of 2026 was $237 million, an increase of $143 million over the prior-year period, primarily attributable to revenue growth and improved operating leverage. Adjusted net income was $444 million, an increase of $192 million over the prior-year period. For the second quarter of 2026, basic and diluted earnings per share were both $0.16 per share and $2.12 and $2.05 per American Depositary Share (ADS), respectively, compared to basic and diluted earnings per share of $0.07 and $0.06 per share and $0.87 and $0.84 per ADS in the prior-year period. On an adjusted basis, basic and diluted earnings per share was $0.31 and $0.30 per share and $3.98 and $3.84 per ADS, respectively, compared to $0.18 and $0.17 per share and $2.33 and $2.25 per ADS in the prior-year period. Free Cash Flow for the second quarter of 2026 was $435 million, representing an increase of $216 million over the prior-year period. For further details on BeOne’s Second Quarter 2026 Financial Statements, please see BeOne’s Quarterly Report on Form 10-Q for the second quarter of 2026 filed with the U.S. Securities and Exchange Commission. Updated Full Year 2026 Guidance BeOne’s financial guidance is summarized below: Prior FY 2026 Guidance Current FY 2026 Guidance 1 Total revenue $6.3B - $6.5B $6.6B - $6.8B GAAP gross margin % High-80% range High-80% range GAAP operating expenses 2 (combined R&D and SG&A) $4.7B - $4.9B $4.8B - $5.0B GAAP operating income 2 $750M - $850M $1.0B - $1.1B Non-GAAP operating income 2,3 $1.45B- $1.55B $1.7B-$1.8B 1 Assumes August 1, 2026 foreign exchange rates. 2 Does not assume any potential new, material business development activity or unusual/non-recurring items. 3 Non-GAAP operating income is a financial measure that excludes from the corresponding GAAP measure costs related to share-based compensation, depreciation and amortization expense. Guidance assumes that Non-GAAP expenses track overall expense growth. BeOne’s total revenue guidance for full year 2026 of $6.6 billion to $6.8 billion includes expectations for strong revenue growth driven by BRUKINSA’s leadership position in the U.S. and continued global expansion in both Europe and other important rest of world markets. Gross margin percentage is expected to be in the high-80% range and includes the impact of product mix and a full year of 2026 productivity improvements. Guidance for combined operating expenses on a GAAP basis includes expectations of investment to support growth. The Company is providing the following additional guidance on items impacting net income and earnings per ADS: Other income (expense) : Estimated range of $25 million to $50 million in expense, includes interest amortization from Royalty Pharma arrangement. Income tax outlook : Earnings may provide sufficient positive evidence to reverse certain valuation allowances in 2026, resulting in a material tax benefit when recognized; the timing and magnitude of a potential reversal is uncertain; prior to reversal, income tax expense should trend with earnings per historical relationship. See Form 10-Q for additional updates on income tax uncertainties. Diluted ADS outstanding : The Company expects diluted ADSs outstanding of approximately 118 million. Second Quarter 2026 Business Highlights Core Marketed Products BRUKINSA (zanubrutinib) Achieved positive topline results from the Phase 3 MANGROVE study in combination with rituximab demonstrating unprecedented progression-free survival (PFS) superiority versus bendamustine plus rituximab in adult patients with previously untreated mantle cell lymphoma (MCL). Reported long-term 78-month follow-up data from the Phase 3 SEQUOIA study, which continue to demonstrate sustained PFS benefit for the treatment of adult patients with treatment-naïve chronic lymphocytic leukemia (CLL), at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) annual meetings. BEQALZI (sonrotoclax) Received U.S. Food and Drug Administration (FDA) accelerated approval for the treatment of adult patients with relapsed or refractory (R/R) MCL, after at least two lines of systemic therapy, including a BTK inhibitor. TEVIMBRA (tislelizumab) Achieved Japan regulatory approval for the treatment of adult patients with first-line gastric cancer. ZIIHERA (zanidatamab) Announced New England Journal of Medicine publication of full results from the Phase 3 HERIZON-GEA-01 study plus chemotherapy, with and without TEVIMBRA, versus trastuzumab plus chemotherapy as first-line treatment for advanced/metastatic HER2+ gastroesophageal adenocarcinoma (GEA). Select Clinical-Stage Programs Hosted an investor event at ASCO highlighting proof-of-concept data for three solid tumor programs, including BGB-43395 (CDK4 inhibitor), BGB-B2033 (GPC3x4-1BB bispecific antibody), and BG-C9074 (B7-H4 antibody-drug conjugate). Hematology Tacabrutideg (BTK CDAC): Achieved last patient enrolled for Phase 3 CaDAnCe-303 (China-only) study (BGB-16673-303) in post-BTKi R/R CLL. BG-75202 (KAT6 A/B inhibitor): Achieved first patient enrolled into monotherapy cohort for Phase 1 study for the treatment of adult patients with acute myeloid leukemia. Breast and Gynecological Cancers BGB-43395 (CDK4 inhibitor): Initiated Phase 3 study in combination with letrozole for the treatment of adult patients with first-line HR-positive, HER2-negative metastatic breast cancer. Gastrointestinal Cancers BGB-58067 (MTA-cooperative PRMT5 inhibitor): Received U.S. FDA Orphan Drug Designation for the treatment of adult patients with pancreatic ductal adenocarcinoma. Lung Cancer BON-110 (PD-1xVEGF-AxCTLA-4 trispecific antibody) 1 : Initiated first-in-human study. Anticipated R&D Milestones Programs Milestones Timing BRUKINSA Regulatory submissions for the treatment of adult patients with first-line MCL in the U.S., Europe, China and Japan. 2H 2026 TEVIMBRA U.S. FDA regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy 2H 2026 China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with ZIIHERA and chemotherapy. 1H 2027 ZIIHERA China regulatory action for the treatment of adult patients with first-line HER2-positive GEA in combination with chemotherapy, with or without TEVIMBRA. 1H 2027 Tacabrutideg (BTK CDAC) Phase 2 potential submission (if data support) for the treatment of adult patients with R/R CLL. 2H 2026 BG-C9074 (B7-H4 ADC) Phase 3 study initiation for the treatment of adult patients with first-line ovarian cancer in maintenance setting. 2H 2026 BGB-B2033 (GPC3x4-1BB bispecific antibody) Pivotal Phase 3 study initiation in second-line hepatocellular carcinoma. 2H 2026 Corporate Updates Announced a $300 million expansion of the Company’s flagship clinical and commercial-stage manufacturing and research and development center at the Princeton West Innovation Campus in Hopewell, New Jersey, to add small molecule manufacturing capabilities. Appointed Felix J. Baker, Ph.D.; Elizabeth F. Mooney; and Charles L. Sawyers, M.D., to the Company’s Board of Directors. BeOne’s Earnings Results Webcast The Company’s earnings conference call for the second quarter 2026 will be broadcast via webcast at 8:00 a.m. ET on Wednesday, August 5, 2026, and will be accessible through the Investors section of BeOne’s website at . Supplemental information in the form of a slide presentation, transcript of prepared remarks, and a replay of the webcast will also be available. About BeOne BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before. To learn more about BeOne, please visit and follow us on LinkedIn , X , Facebook and Instagram . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding: BeOne’s continued growth as a global oncology leader; BeOne’s pipeline catalysts; BeOne’s full year 2026 guidance; BeOne’s expectations regarding continued global expansion and investment to support growth; upcoming R&D milestones to be achieved by BeOne; the timing of clinical and regulatory developments and data readouts; and BeOne’s plans, commitments, aspirations and goals under the caption “About BeOne.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeOne’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”), as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. BeOne’s financial guidance is based on estimates and assumptions that are subject to significant uncertainties. Condensed Consolidated Statements of Operations (U.S. GAAP) (Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (Unaudited) (Unaudited) Revenues Product revenue, net $ 1,679,794 $ 1,302,076 $ 3,167,123 $ 2,410,606 Other revenue 25,277 13,224 51,386 21,973 Total revenues 1,705,071 1,315,300 3,218,509 2,432,579 Cost of sales - products 174,530 164,606 341,745 329,608 Gross profit 1,530,541 1,150,694 2,876,764 2,102,971 Operating expenses: Research and development 612,280 524,896 1,153,504 1,006,783 Selling, general and administrative 593,214 537,913 1,148,311 997,201 Total operating expenses 1,205,494 1,062,809 2,301,815 2,003,984 Income from operations 325,047 87,885 574,949 98,987 Interest income 27,900 11,492 55,564 24,342 Interest expense (39,739 ) (7,995 ) (72,626 ) (14,997 ) Other (expense) income, net (749 ) 8,167 13,787 12,117 Income before income taxes 312,459 99,549 571,674 120,449 Income tax expense 75,452 5,229 107,310 24,859 Net income $ 237,007 $ 94,320 $ 464,364 $ 95,590 Earnings per share Basic $ 0.16 $ 0.07 $ 0.32 $ 0.07 Diluted $ 0.16 $ 0.06 $ 0.31 $ 0.07 Weighted-average shares outstanding—basic 1,450,485,552 1,408,166,754 1,446,490,904 1,399,159,898 Weighted-average shares outstanding—diluted 1,505,361,900 1,463,277,401 1,505,389,182 1,454,296,475 Earnings per American Depositary Share (“ADS”) Basic $ 2.12 $ 0.87 $ 4.17 $ 0.89 Diluted $ 2.05 $ 0.84 $ 4.01 $ 0.85 Weighted-average ADSs outstanding—basic 111,575,812 108,320,520 111,268,531 107,627,684 Weighted-average ADSs outstanding—diluted 115,797,069 112,559,800 115,799,168 111,868,960 Select Condensed Consolidated Balance Sheet Data (U.S. GAAP) (Amounts in thousands of U.S. Dollars) As of June 30, December 31, 2026 2025 (unaudited) (audited) Assets: Cash, cash equivalents and restricted cash $ 5,280,674 $ 4,609,647 Accounts receivable, net 1,056,177 865,080 Inventories 732,603 608,227 Property, plant and equipment, net 1,643,286 1,641,678 Total assets $ 9,175,615 $ 8,188,573 Liabilities and equity: Accounts payable $ 470,299 $ 479,035 Accrued expenses and other payables 1,264,264 1,109,120 R&D cost share liability 6,182 64,345 Sale of future royalty liability 906,313 906,956 Debt 1,073,059 1,019,206 Total liabilities 4,001,617 3,827,379 Total equity $ 5,173,998 $ 4,361,194 Select Condensed Consolidated Statements of Cash Flows (U.S. GAAP) (Amounts in thousands of U.S. Dollars) Three Months Ended June 30, Six Months Ended June 30, 2026 2025 2026 2025 (unaudited) (unaudited) Cash, cash equivalents and restricted cash at beginning of period $ 4,853,425 $ 2,530,591 $ 4,609,647 $ 2,638,747 Net cash provided by operating activities 462,820 263,598 664,156 307,680 Net cash used in investing activities (49,353 ) (66,605 ) (94,863 ) (188,546 ) Net cash (used in) provided by financing activities (6,054 ) 35,025 62,578 1,248 Net effect of foreign exchange rate changes 19,836 23,477 39,156 26,957 Net increase in cash, cash equivalents, and restricted cash 427,249 255,495 671,027 147,339 Cash, cash equivalents and restricted cash at end of period $ 5,280,674 $ 2,786,086 $ 5,280,674 $ 2,786,086 Note Regarding Use of Non-GAAP Financial Measures BeOne provides certain non-GAAP financial measures, including Adjusted Operating Expenses, Adjusted Operating Loss, Adjusted Net Income, Adjusted Earnings Per Share, Free Cash Flow and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeOne’s operating performance. Adjustments to BeOne’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. Non-GAAP adjustments are tax effected to the extent there is U.S. GAAP current tax expense. The Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. BeOne maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeOne believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeOne’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of BeOne’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeOne’s management uses for planning and forecasting purposes and measuring BeOne’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by BeOne may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies. RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES (Amounts in thousands of U.S. Dollars, except for per share and per ADS data) (unaudited) Three Months Ended Six Months Ended June 30, June 30, 2026 2025 2026 2025 Reconciliation of GAAP to adjusted cost of sales - products: GAAP cost of sales - products $ 174,530 $ 164,606 $ 341,745 $ 329,608 Less: Depreciation 5,520 3,321 9,846 5,934 Less: Amortization of intangibles 1,592 5,749 3,334 6,922 Less: Other — 893 — 893 Adjusted cost of sales - products $ 167,418 $ 154,643 $ 328,565 $ 315,859 Reconciliation of GAAP to adjusted research and development: GAAP research and development $ 612,280 $ 524,896 $ 1,153,504 $ 1,006,783 Less: Share-based compensation cost 58,536 64,392 112,392 106,159 Less: Depreciation 19,794 16,447 41,258 35,372 Adjusted research and development $ 533,950 $ 444,057 $ 999,854 $ 865,252 Reconciliation of GAAP to adjusted selling, general and administrative: GAAP selling, general and administrative $ 593,214 $ 537,913 $ 1,148,311 $ 997,201 Less: Share-based compensation cost 78,931 86,161 148,423 139,845 Less: Depreciation 13,592 10,086 27,187 20,162 Less: Amortization of intangibles 17 11 34 28 Adjusted selling, general and administrative $ 500,674 $ 441,655 $ 972,667 $ 837,166 Reconciliation of GAAP to adjusted operating expenses: GAAP operating expenses $ 1,205,494 $ 1,062,809 $ 2,301,815 $ 2,003,984 Less: Share-based compensation cost 137,467 150,553 260,815 246,004 Less: Depreciation 33,386 26,533 68,445 55,534 Less: Amortization of intangibles 17 11 34 28 Adjusted operating expenses $ 1,034,624 $ 885,712 $ 1,972,521 $ 1,702,418 Reconciliation of GAAP to adjusted income from operations: GAAP income from operations $ 325,047 $ 87,885 $ 574,949 $ 98,987 Plus: Share-based compensation cost 137,467 150,553 260,815 246,004 Plus: Depreciation 38,906 29,854 78,291 61,468 Plus: Amortization of intangibles 1,609 5,760 3,368 6,950 Plus: Other — 893 — 893 Adjusted income from operations $ 503,029 $ 274,945 $ 917,423 $ 414,302 Reconciliation of GAAP to adjusted income tax expense: GAAP income tax expense $ 75,452 $ 5,229 $ 107,310 $ 24,859 Plus: Discrete tax items (49,839 ) 14,210 (53,374 ) 8,737 Plus: Income tax effect of non-GAAP adjustments 20,331 17,466 40,673 28,703 Adjusted income tax expense $ 45,944 $ 36,905 $ 94,609 $ 62,299 Reconciliation of GAAP to adjusted net income: GAAP net income $ 237,007 $ 94,320 $ 464,364 $ 95,590 Plus: Share-based compensation expenses 137,467 150,553 260,815 246,004 Plus: Depreciation 38,906 29,854 78,291 61,468 Plus: Amortization of intangibles 1,609 5,760 3,368 6,950 Plus: Other — 893 — 893 Plus: Impairment of equity investments — 3,118 — 15,494 Plus: Discrete tax items 49,839 (14,210 ) 53,374 (8,737 ) Plus: Income tax effect of non-GAAP adjustments 1 (20,331 ) (17,466 ) (40,673 ) (28,703 ) Adjusted net income $ 444,497 $ 252,822 $ 819,539 $ 388,959 Reconciliation of GAAP to adjusted EPS - basic GAAP earnings per share - basic $ 0.16 $ 0.07 $ 0.32 $ 0.07 Plus: Share-based compensation expenses 0.09 0.11 0.18 0.18 Plus: Depreciation 0.03 0.02 0.05 0.04 Plus: Amortization of intangibles 0.00 0.00 0.00 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.00 0.00 0.00 0.01 Plus: Discrete tax items 0.03 (0.01 ) 0.04 (0.01 ) Plus: Income tax effect of non-GAAP adjustments 1 (0.01 ) (0.01 ) (0.03 ) (0.02 ) Adjusted earnings per share - basic $ 0.31 $ 0.18 $ 0.57 $ 0.28 Reconciliation of GAAP to adjusted EPS - diluted GAAP earnings per share - diluted $ 0.16 $ 0.06 $ 0.31 $ 0.07 Plus: Share-based compensation expenses 0.09 0.10 0.17 0.17 Plus: Depreciation 0.03 0.02 0.05 0.04 Plus: Amortization of intangibles 0.00 0.00 0.00 0.00 Plus: Other 0.00 0.00 0.00 0.00 Plus: Impairment of equity investments 0.00 0.00 0.00 0.01 Plus: Discrete tax items 0.03 (0.01 ) 0.04 (0.01 ) Plus: Income tax effect of non-GAAP adjustments 1 (0.01 ) (0.01 ) (0.03 ) (0.02 ) Adjusted earnings per share - diluted $ 0.30 $ 0.17 $ 0.54 $ 0.27 Reconciliation of GAAP to adjusted earnings per ADS - basic GAAP earnings per ADS - basic $ 2.12 $ 0.87 $ 4.17 $ 0.89 Plus: Share-based compensation expenses 1.23 1.39 2.34 2.29 Plus: Depreciation 0.35 0.28 0.70 0.57 Plus: Amortization of intangibles 0.01 0.05 0.03 0.06 Plus: Other 0.00 0.01 0.00 0.01 Plus: Impairment of equity investments 0.00 0.03 0.00 0.14 Plus: Discrete tax items 0.45 (0.13 ) 0.48 (0.08 ) Plus: Income tax effect of non-GAAP adjustments 1 (0.18 ) (0.16 ) (0.37 ) (0.27 ) Adjusted earnings per ADS - basic $ 3.98 $ 2.33 $ 7.37 $ 3.61 Reconciliation of GAAP to adjusted earnings per ADS - diluted GAAP earnings per ADS - diluted $ 2.05 $ 0.84 $ 4.01 $ 0.85 Plus: Share-based compensation expenses 1.19 1.34 2.25 2.20 Plus: Depreciation 0.34 0.27 0.68 0.55 Plus: Amortization of intangibles 0.01 0.05 0.03 0.06 Plus: Other 0.00 0.01 0.00 0.01 Plus: Impairment of equity investments 0.00 0.03 0.00 0.14 Plus: Discrete tax items 0.43 (0.13 ) 0.46 (0.08 ) Plus: Income tax effect of non-GAAP adjustments 1 (0.18 ) (0.16 ) (0.35 ) (0.26 ) Adjusted earnings per ADS - diluted $ 3.84 $ 2.25 $ 7.08 $ 3.48 Tax effect of Non-GAAP adjustments is based on the statutory tax rate in the relevant tax jurisdiction. Please note that the Company currently records a valuation allowance on its net deferred tax assets, so there is no net impact recorded for deferred tax effects. Contacts Investor Contact Liza Heapes +1 857-302-5663 ir@beonemed.com Media Contact Kyle Blankenship +1 667-351-5176 media@beonemed.com Read full story here