Dinutuximab

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced its financial results for the quarter and year ended December 31, 2025. Full year 2025 revenues rose to a record $3.18 billion, reflecting 11% growth over 2024. “As we close out another remarkable year with record total revenue for the fourth year in a row, I extend my thanks to our Unitherians whose unwavering commitment to innovation and excellence fuels our mission,” said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. “Looking ahead, our ADVANCE OUTCOMES and TETON-1 clinical programs are on the cusp of unveiling pivotal data that could unlock significant new treatment options for patients, launching a period of transformational growth for UT.” Michael Benkowitz, President and Chief Operating Officer of United Therapeutics, added, “This was an exceptional year for our commercial organization, highlighted by strong double‑digit revenue growth and disciplined execution by our teams. Tyvaso continued its impressive trajectory in a growing market where we are steadily increasing our share of voice. Looking ahead, we believe our commercial strength, differentiated therapies, and expanding market opportunities position us well to continue delivering durable double‑digit revenue growth.” Fourth Quarter and Full Year 2025 Financial Results Key financial highlights include (in millions, except per share data): Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 Total revenues $ 790.2 $ 735.9 $ 3,182.7 $ 2,877.4 Net income $ 364.3 $ 301.3 $ 1,334.7 $ 1,195.1 Net income, per basic share $ 8.41 $ 6.74 $ 30.13 $ 26.44 Net income, per diluted share $ 7.70 $ 6.19 $ 27.86 $ 24.64 Revenues The table below presents the components of total revenues (dollars in millions): Three Months Ended December 31, Dollar Change Percentage Change Year Ended December 31, Dollar Change Percentage Change 2025 2024 2025 2024 Net product sales: Tyvaso DPI® $ 338.6 $ 273.2 $ 65.4 24 % $ 1,292.5 $ 1,033.6 $ 258.9 25 % Nebulized Tyvaso® 125.7 142.7 (17.0 ) (12 )% 585.7 586.8 (1.1 ) — % Total Tyvaso 464.3 415.9 48.4 12 % 1,878.2 1,620.4 257.8 16 % Remodulin®(1) 128.0 134.5 (6.5 ) (5 )% 526.8 538.1 (11.3 ) (2 )% Orenitram® 121.2 107.8 13.4 12 % 496.9 434.3 62.6 14 % Unituxin® 62.3 67.5 (5.2 ) (8 )% 226.8 238.7 (11.9 ) (5 )% Adcirca® 7.8 4.7 3.1 66 % 30.0 23.8 6.2 26 % Other 6.6 5.5 1.1 20 % 24.0 22.1 1.9 9 % Total revenues $ 790.2 $ 735.9 $ 54.3 7 % $ 3,182.7 $ 2,877.4 $ 305.3 11 % (1) Net product sales include sales of infusion devices, including the Remunity® and RemunityPRO™ Pumps. Fourth Quarter 2025 Compared to Fourth Quarter 2024. Total Tyvaso revenues grew by 12 percent to $464.3 million in the fourth quarter of 2025, compared to $415.9 million in the fourth quarter of 2024. The growth in Tyvaso DPI revenues resulted primarily from an increase in quantities sold of $63.5 million, primarily due to continued growth in the number of patients following the product’s launch and, to a lesser extent, increased commercial utilization following implementation of the Medicare Part D benefit redesign under the Inflation Reduction Act (IRA). The decrease in Nebulized Tyvaso revenues resulted primarily from a decrease in quantities sold. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $10.3 million, driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. Full Year 2025 Compared to Full Year 2024. Total Tyvaso revenues grew by 16 percent to $1,878.2 million in 2025, compared to $1,620.4 million in 2024, driven by growth in Tyvaso DPI revenues. The growth in Tyvaso DPI revenues resulted from an increase in quantities sold of $268.5 million, primarily due to continued growth in the number of patients following the product’s launch and, to a lesser extent, increased commercial utilization following implementation of the Medicare Part D benefit redesign under the IRA. The growth in Orenitram revenues resulted primarily from an increase in quantities sold of $46.0 million, driven, at least in part, by increased commercial utilization following the implementation of the Medicare Part D benefit redesign under the IRA. The table below presents the breakdown of total revenues between the United States and rest-of-world (ROW) (in millions): Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 U.S. ROW Total U.S. ROW Total U.S. ROW Total U.S. ROW Total Net product sales: Tyvaso DPI $ 338.3 $ 0.3 $ 338.6 $ 272.8 $ 0.4 $ 273.2 $ 1,291.8 $ 0.7 $ 1,292.5 $ 1,033.2 $ 0.4 $ 1,033.6 Nebulized Tyvaso 118.9 6.8 125.7 136.4 6.3 142.7 531.9 53.8 585.7 545.5 41.3 586.8 Total Tyvaso 457.2 7.1 464.3 409.2 6.7 415.9 1,823.7 54.5 1,878.2 1,578.7 41.7 1,620.4 Remodulin(1) 104.3 23.7 128.0 118.0 16.5 134.5 448.9 77.9 526.8 464.2 73.9 538.1 Orenitram 121.2 — 121.2 107.8 — 107.8 496.9 — 496.9 434.3 — 434.3 Unituxin 55.9 6.4 62.3 61.8 5.7 67.5 214.7 12.1 226.8 219.6 19.1 238.7 Adcirca 7.8 — 7.8 4.7 — 4.7 30.0 — 30.0 23.8 — 23.8 Other 6.4 0.2 6.6 4.2 1.3 5.5 22.8 1.2 24.0 19.1 3.0 22.1 Total revenues $ 752.8 $ 37.4 $ 790.2 $ 705.7 $ 30.2 $ 735.9 $ 3,037.0 $ 145.7 $ 3,182.7 $ 2,739.7 $ 137.7 $ 2,877.4 (1) Net product sales include sales of infusion devices, including the Remunity and RemunityPRO Pumps. Expenses Cost of sales. The table below summarizes cost of sales by major category (dollars in millions): Three Months Ended December 31, Dollar Change Percentage Change Year Ended December 31, Dollar Change Percentage Change 2025 2024 2025 2024 Category: Cost of sales $ 102.3 $ 74.8 $ 27.5 37 % $ 380.5 $ 304.3 $ 76.2 25 % Share-based compensation expense(1) 1.1 1.1 — — % 3.9 5.4 (1.5 ) (28 )% Total cost of sales $ 103.4 $ 75.9 $ 27.5 36 % $ 384.4 $ 309.7 $ 74.7 24 % (1) See Share-based compensation section below for discussion. Cost of sales, excluding share-based compensation. The increase in cost of sales for the quarter and year ended December 31, 2025, as compared to the same periods in 2024, was primarily due to increases in: (1) royalty expense resulting from a growth in revenues; (2) inventory reserve expense; and (3) the cost of products and services sold. Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions): Three Months Ended December 31, Dollar Change Percentage Change Year Ended December 31, Dollar Change Percentage Change 2025 2024 2025 2024 Category: External research and development(1) $ 62.7 $ 63.7 $ (1.0 ) (2 )% $ 245.8 $ 217.5 $ 28.3 13 % Internal research and development(2) 57.3 50.3 7.0 14 % 212.3 183.6 28.7 16 % Share-based compensation expense(3) 8.9 6.7 2.2 33 % 32.3 29.1 3.2 11 % Other(4) 10.6 13.1 (2.5 ) (19 )% 59.6 50.8 8.8 17 % Total research and development expense $ 139.5 $ 133.8 $ 5.7 4 % $ 550.0 $ 481.0 $ 69.0 14 % (1) External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before regulatory approval of the relevant product. (2) Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before regulatory approval, and internal facilities-related expenses, including depreciation, related to research and development activities. (3) See Share-based compensation section below for discussion. (4) Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products, adjustments to the fair value of our contingent consideration obligations, and costs to acquire certain in-process research and development assets. During the year ended December 31, 2025, we recorded (a) $42.2 million in expense related to milestone payments for drug delivery device and formulation technologies; and (b) $10.8 million in expense related to adjustments to the fair value of contingent consideration obligations for manufactured organ and organ alternative projects. During the year ended December 31, 2024, we recorded $40.2 million and $8.0 million in expense related to upfront non-refundable licensing payments for drug delivery device technologies and ex vivo lung perfusion technology, respectively. Research and development, excluding share-based compensation. The increase in research and development expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to: (1) increased expenditures related to manufactured organ and organ alternative projects; and (2) increased expenditures for drug delivery device and formulation technologies. Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions): Three Months Ended December 31, Dollar Change Percentage Change Year Ended December 31, Dollar Change Percentage Change 2025 2024 2025 2024 Category: General and administrative(1) $ 128.1 $ 116.3 $ 11.8 10 % $ 501.0 $ 432.8 $ 68.2 16 % Impairment of property, plant, and equipment (PP&E) — — — — % 21.7 — 21.7 NM(3) Litigation accrual 0.8 6.0 (5.2 ) (87 )% 3.0 71.1 (68.1 ) (96 )% Sales and marketing 32.7 27.0 5.7 21 % 118.6 96.3 22.3 23 % Share-based compensation expense(2) 29.0 19.2 9.8 51 % 111.5 109.5 2.0 2 % Total selling, general, and administrative expense $ 190.6 $ 168.5 $ 22.1 13 % $ 755.8 $ 709.7 $ 46.1 6 % (1) Excluding impairment of PP&E and litigation accrual. See Impairment of PP&E and Litigation accrual sections below. (2) See Share-based compensation section below for discussion. (3) Calculation is not meaningful. General and administrative, excluding impairment of PP&E, litigation accrual, and share-based compensation. The increase in general and administrative expense for the quarter ended December 31, 2025, as compared to the same period in 2024, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) consulting expenses. The increase in general and administrative expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) legal expenses related to litigation matters. Impairment of PP&E. During the second quarter of 2025, we recorded a $21.7 million impairment charge to write down the carrying value of certain PP&E. Litigation accrual. During the years ended December 31, 2025 and 2024, we recorded accruals of $3.0 million and $71.1 million, respectively, related to ongoing litigation with Sandoz Inc. We currently do not expect that the amount of any loss in excess of this accrual would be material to our financial results; however, the amount ultimately payable, if any, could be higher or lower than this amount depending on the amount of post judgment interest and the outcome of appeals, as discussed in Note 14—Litigation, to our consolidated financial statements included within our Annual Report on Form 10-K for the year ended December 31, 2025. The litigation accrual is included within selling, general, and administrative in our consolidated statements of operations. Sales and marketing, excluding share-based compensation. The increase in sales and marketing expense for the year ended December 31, 2025, as compared to the same period in 2024, was primarily due to increases in: (1) personnel expense due to growth in headcount; and (2) marketing expenses. Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions): Three Months Ended December 31, Dollar Change Percentage Change Year Ended December 31, Dollar Change Percentage Change 2025 2024 2025 2024 Category: Stock options $ 11.4 8.0 $ 3.4 43 % $ 42.3 $ 29.8 $ 12.5 42 % Restricted stock units 26.6 17.8 8.8 49 % 103.1 79.7 23.4 29 % Share tracking awards plan (STAP) — 0.6 (0.6 ) (100 )% (0.8 ) 32.3 (33.1 ) (102 )% Employee stock purchase plan 1.0 0.6 0.4 67 % 3.1 2.2 0.9 41 % Total share-based compensation expense $ 39.0 $ 27.0 $ 12.0 44 % $ 147.7 $ 144.0 $ 3.7 3 % The increase in share-based compensation expense for the quarter and year ended December 31, 2025, as compared to the same periods in 2024, was primarily due to: (1) an increase in restricted stock unit expense due to a greater number of outstanding performance-based restricted stock units during the quarter and year ended December 31, 2025, as compared to the same periods in 2024; and (2) an increase in stock option expense due to a greater number of unvested and outstanding performance-based stock options during the quarter and year ended December 31, 2025, as compared to the same periods in 2024, partially offset by a decrease in STAP expense, as all remaining STAP awards were exercised during the first quarter of 2025. Other income (expense), net. The changes in other income (expense), net for the quarter and year ended December 31, 2025, as compared to the same periods in 2024, were primarily due to net unrealized gains on equity securities. Income tax expense. Income tax expense was $379.2 million for the year ended December 31, 2025, as compared to $343.9 million for the same period in 2024. Our effective income tax rate was approximately 22 percent for the years ended December 31, 2025 and 2024. Share repurchases. We entered into accelerated share repurchase agreements (ASR agreements) with Citibank, N.A. to repurchase approximately $1.0 billion of our common stock in each August 2025 and March 2024 ($2.0 billion in the aggregate). During the quarter and year ended December 31, 2025, we received 3,882 shares and 2,642,498 shares of our common stock, respectively, under these ASR agreements. During the quarter and year ended December 31, 2024, we received zero and 3,547,374 shares of our common stock, respectively, under these ASR agreements. Webcast We will host a webcast to discuss our fourth quarter and full year 2025 financial results on Wednesday, February 25, 2026, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at https://ir.unither.com/events-and-presentations. A replay of the webcast will also be available at the same location on our website. About United Therapeutics Founded by CEO Martine Rothblatt to discover a cure for her daughter's life-threatening rare disease, pulmonary arterial hypertension, United Therapeutics transforms the treatment of rare diseases and pioneers alternatives to expand the supply of transplantable organs. From our innovative therapies to our groundbreaking manufactured organs, we are bold and unconventional. We move quickly from scientific theory to practical technologies that can save lives. As a public benefit corporation, even our legal structure reflects our commitments. We serve patients, act with integrity, create long-term shareholder value, and operate with sustainable practices that protect the future we are working to build. Forward-Looking Statements Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements related to our anticipated readouts of our ADVANCE OUTCOMES and TETON-1 clinical trials and their impacts, including the possibility that they may result in significant new treatment options for patients or a period of transformational growth for our company; our expectation that we will continue delivering double-digit revenue growth; and our goals of expanding the supply of transplantable organs, developing practical technologies that can save lives, creating long-term shareholder value, and operating with sustainable practices. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of February 25, 2026, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events, or any other reason. ORENITRAM, REMODULIN, REMUNITY, TYVASO, TYVASO DPI, and UNITUXIN are registered trademarks of United Therapeutics Corporation and/or its subsidiaries. REMUNITYPRO is a trademark of United Therapeutics Corporation and/or its subsidiaries. ADCIRCA is a registered trademark of Eli Lilly and Company. UNITED THERAPEUTICS CORPORATION CONSOLIDATED STATEMENTS OF OPERATIONS (In millions, except per share data) Three Months Ended December 31, Year Ended December 31, 2025 2024 2025 2024 (Unaudited) Total revenues $ 790.2 $ 735.9 $ 3,182.7 $ 2,877.4 Operating expenses: Cost of sales 103.4 75.9 384.4 309.7 Research and development 139.5 133.8 550.0 481.0 Selling, general, and administrative 190.6 168.5 755.8 709.7 Total operating expenses 433.5 378.2 1,690.2 1,500.4 Operating income 356.7 357.7 1,492.5 1,377.0 Interest income 43.2 49.3 192.0 199.1 Interest expense (3.1 ) (7.9 ) (19.5 ) (42.9 ) Other income (expense), net 47.2 (2.6 ) 48.9 5.8 Total other income, net 87.3 38.8 221.4 162.0 Income before income taxes 444.0 396.5 1,713.9 1,539.0 Income tax expense (79.7 ) (95.2 ) (379.2 ) (343.9 ) Net income $ 364.3 $ 301.3 $ 1,334.7 $ 1,195.1 Net income per common share: Basic $ 8.41 $ 6.74 $ 30.13 $ 26.44 Diluted $ 7.70 $ 6.19 $ 27.86 $ 24.64 Weighted average number of common shares outstanding: Basic 43.3 44.7 44.3 45.2 Diluted 47.3 48.7 47.9 48.5 SELECTED CONSOLIDATED BALANCE SHEET DATA (In millions) December 31, 2025 2024 Cash, cash equivalents, and marketable investments $ 4,697.0 $ 4,742.3 Total assets 7,880.0 7,364.0 Total liabilities 783.8 920.0 Total stockholders' equity 7,096.2 6,444.0 Category: Earnings

达妥昔单抗B注射液1个疗程费用是多少达妥昔单抗B注射液（Dinutuximab Beta）1个疗程费用约为30-50万元人民币。该药为进口生物制剂，规格为20mg/10ml/瓶。标准治疗方案为5个疗程，每个疗程持续35天，需连续输注10天，每日剂量为100mg/m²体表面积。按成人标准体表面积计算，单个疗程需使用约5-8瓶药物，仅药品费用即达30万元以上。该药已纳入2023年国家医保目录，属于乙类药品，医保报销比例约为50%-70%，患者自付部分降至10-20万元/疗程。 但医保报销需满足严格条件：仅限于经一线治疗失败的复发或难治性高危神经母细胞瘤患者，且需在指定医疗机构使用。未达医保条件或选择院外购药的患者需全额自费，年治疗费用可达150-250万元。达妥昔单抗B注射液耐药了再吃什么达妥昔单抗B注射液耐药后，目前尚无标准统一的后线治疗方案，需根据患者具体情况选择个体化策略。再次使用或联合用药：部分患者停药一段时间后重新使用可能恢复敏感性，或联合化疗药物（如拓扑替康、环磷酰胺）增强疗效。更换免疫治疗药物：可考虑使用抗GD2单抗的其他类型药物，如达妥昔单抗（Dinutuximab，美国产）或那昔妥单抗（Naxitamab），但需注意交叉耐药可能性。靶向联合治疗：联合ALK抑制剂（如克唑替尼）用于ALK突变阳性患者，或联合BCL-2抑制剂（如维奈克拉）增强凋亡诱导。细胞治疗：CAR-T细胞治疗（靶向GD2或CD19）及双特异性抗体是当前临床试验重点方向，适用于多线治疗失败患者。放射免疫治疗：¹³¹I-omburtamab等放射性标记抗体可用于中枢神经系统转移病灶。耐药后治疗选择需依赖分子病理检测（如MYCN扩增、ALK突变状态）及既往治疗反应评估，建议转诊至儿童肿瘤专科中心制定方案。达妥昔单抗B注射液是什么药达妥昔单抗B注射液是一种靶向GD2糖蛋白的单克隆抗体药物，适用于12月龄及以上既往接受过一线治疗但疗效不佳的高危神经母细胞瘤患者。药理机制：神经母细胞瘤细胞表面高表达GD2抗原，该药与GD2结合后通过抗体依赖性细胞介导的细胞毒作用（ADCC）及补体依赖性细胞毒作用（CDC）杀伤肿瘤细胞。关键临床数据：在APN311-302关键性III期研究中，达妥昔单抗B联合白细胞介素-2（IL-2）治疗组3年无事件生存率为57%，总生存率为73%，较历史对照组显著提升。用法用量：每个疗程第1-5天及第8-12天静脉输注，每日100mg/m²，持续10天，每35天重复一次，共5个疗程。输注前需使用镇痛药、抗组胺药及皮质类固醇预处理，以减轻严重疼痛、发热、过敏反应等常见不良反应。禁忌与注意事项：对活性成分过敏者禁用；活动性严重感染、急性基线器官功能不全患者需延迟治疗；常见3-4级不良反应包括神经毒性（周围神经病变）、毛细血管渗漏综合征及骨髓抑制，需在具备重症监护条件的医疗机构使用。