Filgrastim (Amgen)

CHICAGO, IL, USA I October 31, 2024 I Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”) to market and distribute three biosimilars in the U.S. The agreement covers biosimilars for oncology medications pegfilgrastim and filgrastim as well as follitropin alpha in the fertility space. “We are pleased to expand our biosimilars portfolio with this licensing agreement, which will allow us to deliver three more significant medications to patients in the U.S. at fair and sustainable prices,” said Tom Shea, Chief Executive Officer of Meitheal. “This expansion furthers our commitment to delivering cost-saving innovation to patients and the broader healthcare system.” Follitropin alpha is a form of recombinant human follicle-stimulating hormone (FSH) and is used to stimulate follicle development in women and spermatogenesis in men during fertility treatment. The infertility treatment market is large and growing – a branded formulation of FSH generated $847 million in sales in 2023 1 and there are currently no biosimilars for the gonadotropin follitropin alpha available in the U.S. As a result, follitropin alpha has the potential to fulfill the significant unmet need for more affordable treatment options for women trying to conceive. Pegfilgrastim and filgrastim are bone marrow stimulants that support white blood cell production for patients receiving certain cancer treatments. The medications work by binding to G-CSF receptors to stimulate the proliferation, differentiation, and activation of neutrophils to fight infection. Filgrastim is dosed subcutaneously or intravenously daily for up to 14 days during a chemotherapy treatment cycle. Pegfilgrastim, a longer-acting form of treatment, is dosed subcutaneously once per treatment cycle. The U.S. market for pegfilgrastim and filgrastim is estimated at over $2.5 billion. 2 “We are pleased that Meitheal will be developing and commercializing follitropin alpha, pegfilgrastim, and filgrastim in the U.S. and that our partnership will increase access to these critical medications,” said Eric Tang, President of HKF. “We are continuing to invest in biosimilar innovation and we look forward to supporting Meitheal’s growing capabilities and portfolio in this important space.” Meitheal’s parent company and related entities have invested over $300 million in capital and R&D in recent years to support sustainable product supply, including investing $30 million in a monoclonal antibody drug substance facility. This agreement adds three biosimilars, bringing Meitheal’s total biosimilar portfolio to eight treatments. ABOUT MEITHEAL PHARMACEUTICALS Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of October 2024, Meitheal, directly or through its partners, has 18 products in the research and development phase, 6 additional products planned for launch in 2024, and 21 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked #2 on Crain’s Fast 50 in Chicago 2024 and also among the top 100 Crain’s Best Places to Work in Chicago in 2022, 2023 and 2024, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of NKF, founded in 2010. ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. 1 Merck KGaA Annual Report 2023. https://www.emdgroup.com/en/annualreport/2023/_assets/downloads/entire-emd-ar23.pdf (Last Accessed October 28, 2024). 2 IQVIA, September 2024. SOURCE: Meitheal Pharmaceuticals

THOUSAND OAKS, Calif. , Oct. 30, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the third quarter of 2024. "Strong growth in sales and earnings this quarter reflects the momentum we're building throughout our business. We continue to invest heavily in our rapidly advancing pipeline, with a focus on delivering innovative therapies across our core therapeutic areas," said Robert A. Bradway , chairman and chief executive officer. Key results include: References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Oncology Inflammation Rare Disease Except for TAVNEOS ® , the products listed below were added through the acquisition of Horizon on Oct. 6, 2023 . Established Products Product Sales Detail by Product and Geographic Region $Millions, except percentages Q3 '24 Q3 '23 YOY Δ U.S. ROW TOTAL TOTAL TOTAL Repatha ® $         281 $         286 $         567 $         406 40 % EVENITY ® 289 110 399 307 30 % Prolia ® 683 362 1,045 986 6 % BLINCYTO ® 237 90 327 220 49 % Vectibix ® 132 150 282 252 12 % KYPROLIS ® 238 140 378 349 8 % LUMAKRAS ® /LUMYKRAS ™ 53 45 98 52 88 % XGEVA ® 373 168 541 519 4 % Nplate ® 345 111 456 419 9 % IMDELLTRA ™ 36 — 36 — N/A MVASI ® 136 59 195 213 (8 %) TEZSPIRE ® 269 — 269 161 67 % Otezla ® 460 104 564 567 (1 %) Enbrel ® 817 8 825 1,035 (20 %) AMJEVITA ® /AMGEVITA ™ 28 138 166 152 9 % TEPEZZA ®(1) 482 6 488 — N/A KRYSTEXXA ®(1) 310 — 310 — N/A UPLIZNA ®(1) 74 32 106 — N/A TAVNEOS ® 74 6 80 37 * Ultra-Rare products (1) 180 8 188 — N/A EPOGEN ® 33 — 33 50 (34 %) Aranesp ® 105 232 337 323 4 % Parsabiv ® 32 38 70 95 (26 %) Neulasta ® 84 26 110 124 (11 %) Other products (2) 228 53 281 281 — % Total product sales $      5,979 $      2,172 $      8,151 $      6,548 24 % N/A = not applicable *Change in excess of 100% (1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , QUINSAIR ® and BUPHENYL ® (2) Consists of (i) Aimovig ® , RIABNI ® , KANJINTI ® , AVSOLA ® , NEUPOGEN ® , IMLYGIC ® , BEKEMV ™ , Corlanor ® , WEZLANA ™ /WEZENLA ™ and Sensipar ® /Mimpara ™ , where Biosimilars total $148 million in Q3 '24 and $104 million in Q3 '23; and (ii) Horizon-acquired products including RAYOS ® and PENNSAID ® Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis for the third quarter: On a non-GAAP basis for the third quarter: $Millions, except percentages GAAP Non-GAAP Q3 '24 Q3 '23 YOY Δ Q3 '24 Q3 '23 YOY Δ Cost of Sales $   3,310 $   1,806 83 % $   1,454 $   1,137 28 % % of product sales 40.6 % 27.6 % 13.0 pts 17.8 % 17.4 % 0.4 pts Research & Development $   1,450 $   1,079 34 % $   1,440 $   1,070 35 % % of product sales 17.8 % 16.5 % 1.3 pts 17.7 % 16.3 % 1.4 pts Selling, General & Administrative $   1,625 $   1,353 20 % $   1,565 $   1,293 21 % % of product sales 19.9 % 20.7 % (0.8) pts 19.2 % 19.7 % (0.5) pts Other $        71 $      644 (89 %) $        — $        — N/A Total Operating Expenses $   6,456 $   4,882 32 % $   4,459 $   3,500 27 % Operating Margin operating income as % of product sales 25.1 % 30.9 % (5.8) pts 49.6 % 52.0 % (2.4) pts Tax Rate 8.7 % 11.1 % (2.4) pts 13.4 % 16.1 % (2.7) pts pts: percentage points N/A = not applicable Cash Flow and Balance Sheet $Billions, except shares Q3 '24 Q3 '23 YOYΔ Operating Cash Flow $         3.6 $         2.8 $         0.8 Capital Expenditures $         0.3 $         0.2 $         0.0 Free Cash Flow $         3.3 $         2.5 $         0.8 Dividends Paid $         1.2 $         1.1 $         0.1 Share Repurchases $         0.0 $          — $         0.0 Average Diluted Shares (millions) 542 538 4 Note: Numbers may not add due to rounding $Billions 9/30/24 12/31/23 YTD Δ Cash and Investments $         9.0 $       10.9 $        (1.9) Debt Outstanding $       60.4 $       64.6 $        (4.2) Note: Numbers may not add due to rounding 2024 Guidance For the full year 2024, the Company now expects: Third Quarter Product and Pipeline Update The Company provided the following updates on selected product and pipeline programs: General Medicine MariTide (maridebart cafraglutide, AMG 133) AMG 513 Olpasiran (AMG 890) Repatha Oncology IMDELLTRA BLINCYTO Xaluritamig (AMG 509) AMG 193 Bemarituzumab Nplate LUMAKRAS/LUMYKRAS Inflammation TEZSPIRE Rocatinlimab (AMG 451/KHK4083) Otezla Blinatumomab Inebilizumab Efavaleukin alfa (AMG 592) Ordesekimab (AMG 714/PRV-015) AMG 104 (AZD8630) Rare Disease TAVNEOS TEPEZZA KRYSTEXXA UPLIZNA Dazodalibep Daxdilimab Fipaxalparant Biosimilars TEZSPIRE is being developed in collaboration with AstraZeneca. AMG 104 is being developed in collaboration with AstraZeneca. Rocatinlimab, formerly AMG 451/KHK4083, is being developed in collaboration with Kyowa Kirin. Ordesekimab, formerly AMG 714 and also known as PRV-015, is being developed in collaboration with Provention Bio , a Sanofi Company . For the purposes of the collaboration, Provention Bio conducts a clinical trial and leads certain development and regulatory activities for the program. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. EYLEA is a registered trademark of Regeneron Pharmaceuticals, Inc. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the third quarters of 2024 and 2023, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2024 EPS and tax guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, divestitures, restructuring and certain other items from the related GAAP financial measures. Management has presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the third quarters of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's normal and recurring business activities by facilitating comparisons of results of normal and recurring business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity. The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. About Amgen Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions . Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average ® , and it is also part of the Nasdaq-100 Index ® , which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization. For more information, visit Amgen.com and follow Amgen on X , LinkedIn , Instagram , TikTok , YouTube and Threads . Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen . All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla ® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), our acquisitions of Teneobio, Inc. , ChemoCentryx, Inc. , or Horizon (including the prospective performance and outlook of Horizon's business, performance and opportunities and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition, and any projected impacts from the Horizon acquisition on our acquisition-related expenses going forward), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen , including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico , and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our environmental, social and governance objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. CONTACT: Amgen , Thousand Oaks Elissa Snook , 609-251-1407 (media) Justin Claeys , 805-313-9775 (investors) Amgen Inc. Consolidated Statements of Income - GAAP (In millions, except per-share data) (Unaudited) Three months ended September 30 , Nine months ended September 30 , 2024 2023 2024 2023 Revenues: Product sales $    8,151 $    6,548 $  23,310 $  19,077 Other revenues 352 355 1,028 917 Total revenues 8,503 6,903 24,338 19,994 Operating expenses: Cost of sales 3,310 1,806 9,746 5,339 Research and development 1,450 1,079 4,240 3,250 Selling, general and administrative 1,625 1,353 5,218 3,905 Other 71 644 187 874 Total operating expenses 6,456 4,882 19,391 13,368 Operating income 2,047 2,021 4,947 6,626 Other income (expense): Interest expense, net (776) (759) (2,408) (2,054) Other income, net 1,830 685 1,288 2,431 Income before income taxes 3,101 1,947 3,827 7,003 Provision for income taxes 271 217 364 1,053 Net income $    2,830 $    1,730 $    3,463 $    5,950 Earnings per share: Basic $      5.27 $      3.23 $      6.45 $    11.12 Diluted $      5.22 $      3.22 $      6.40 $    11.06 Weighted-average shares used in calculation of earnings per share: Basic 537 535 537 535 Diluted 542 538 541 538 Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) September 30 , December 31 , 2024 2023 (Unaudited) Assets Current assets: Cash and cash equivalents $                9,011 $              10,944 Trade receivables, net 7,317 7,268 Inventories 7,362 9,518 Other current assets 3,076 2,602 Total current assets 26,766 30,332 Property, plant and equipment, net 6,156 5,941 Intangible assets, net 28,920 32,641 Goodwill 18,658 18,629 Other noncurrent assets 10,383 9,611 Total assets $              90,883 $              97,154 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $              16,768 $              16,949 Current portion of long-term debt 3,544 1,443 Total current liabilities 20,312 18,392 Long-term debt 56,854 63,170 Long-term deferred tax liabilities 1,711 2,354 Long-term tax liabilities 2,280 4,680 Other noncurrent liabilities 2,199 2,326 Total stockholders' equity 7,527 6,232 Total liabilities and stockholders' equity $              90,883 $              97,154 Shares outstanding 538 535 Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) Three months ended September 30 , Nine months ended September 30 , 2024 2023 2024 2023 GAAP cost of sales $       3,310 $       1,806 $       9,746 $       5,339 Adjustments to cost of sales: Acquisition-related expenses (a) (1,856) (668) (5,546) (2,008) Certain net charges pursuant to our restructuring and cost-savings initiatives — (1) — (36) Total adjustments to cost of sales (1,856) (669) (5,546) (2,044) Non-GAAP cost of sales $       1,454 $       1,137 $       4,200 $       3,295 GAAP cost of sales as a percentage of product sales 40.6 % 27.6 % 41.8 % 28.0 % Acquisition-related expenses (a) (22.8) (10.2) (23.8) (10.5) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 0.0 (0.2) Non-GAAP cost of sales as a percentage of product sales 17.8 % 17.4 % 18.0 % 17.3 % GAAP research and development expenses $       1,450 $       1,079 $       4,240 $       3,250 Adjustments to research and development expenses: Acquisition-related expenses (b) (10) (9) (60) (27) Certain net charges pursuant to our restructuring and cost-savings initiatives — — — (17) Total adjustments to research and development expenses (10) (9) (60) (44) Non-GAAP research and development expenses $       1,440 $       1,070 $       4,180 $       3,206 GAAP research and development expenses as a percentage of product sales 17.8 % 16.5 % 18.2 % 17.0 % Acquisition-related expenses (b) (0.1) (0.2) (0.3) (0.1) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 0.0 (0.1) Non-GAAP research and development expenses as a percentage of product sales 17.7 % 16.3 % 17.9 % 16.8 % GAAP selling, general and administrative expenses $       1,625 $       1,353 $       5,218 $       3,905 Adjustments to selling, general and administrative expenses: Acquisition-related expenses (c) (60) (47) (255) (138) Certain net charges pursuant to our restructuring and cost-savings initiatives — (13) — (13) Total adjustments to selling, general and administrative expenses (60) (60) (255) (151) Non-GAAP selling, general and administrative expenses $       1,565 $       1,293 $       4,963 $       3,754 GAAP selling, general and administrative expenses as a percentage of product sales 19.9 % 20.7 % 22.4 % 20.5 % Acquisition-related expenses (c) (0.7) (0.8) (1.1) (0.7) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 (0.2) 0.0 (0.1) Non-GAAP selling, general and administrative expenses as a percentage of product sales 19.2 % 19.7 % 21.3 % 19.7 % GAAP operating expenses $       6,456 $       4,882 $      19,391 $      13,368 Adjustments to operating expenses: Adjustments to cost of sales (1,856) (669) (5,546) (2,044) Adjustments to research and development expenses (10) (9) (60) (44) Adjustments to selling, general and administrative expenses (60) (60) (255) (151) Certain net charges pursuant to our restructuring and cost-savings initiatives (d) — (16) 4 (183) Certain other expenses (e) (71) (628) (191) (691) Total adjustments to operating expenses (1,997) (1,382) (6,048) (3,113) Non-GAAP operating expenses $       4,459 $       3,500 $      13,343 $      10,255 Three months ended September 30 , Nine months ended September 30 , 2024 2023 2024 2023 GAAP operating income $       2,047 $       2,021 $       4,947 $       6,626 Adjustments to operating expenses 1,997 1,382 6,048 3,113 Non-GAAP operating income $       4,044 $       3,403 $      10,995 $       9,739 GAAP operating income as a percentage of product sales 25.1 % 30.9 % 21.2 % 34.7 % Adjustments to cost of sales 22.8 10.2 23.8 10.7 Adjustments to research and development expenses 0.1 0.2 0.3 0.2 Adjustments to selling, general and administrative expenses 0.7 1.0 1.1 0.8 Certain net charges pursuant to our restructuring and cost-savings initiatives (d) 0.0 0.2 0.0 1.0 Certain other expenses (e) 0.9 9.5 0.8 3.7 Non-GAAP operating income as a percentage of product sales 49.6 % 52.0 % 47.2 % 51.1 % GAAP interest expense, net $        (776) $        (759) $      (2,408) $      (2,054) Adjustments to interest expense, net: Interest expense on acquisition-related debt (f) — 332 — 788 Non-GAAP interest expense, net $        (776) $        (427) $      (2,408) $      (1,266) GAAP other income, net $       1,830 $          685 $       1,288 $       2,431 Adjustments to other income, net Interest income and other expenses on acquisition-related debt (f) — (313) — (607) Net gains from equity investments (g) (1,608) (170) (693) (1,305) Total adjustments to other income, net (1,608) (483) (693) (1,912) Non-GAAP other income, net $          222 $          202 $          595 $          519 GAAP income before income taxes $       3,101 $       1,947 $       3,827 $       7,003 Adjustments to income before income taxes: Adjustments to operating expenses 1,997 1,382 6,048 3,113 Adjustments to interest expense, net — 332 — 788 Adjustments to other income, net (1,608) (483) (693) (1,912) Total adjustments to income before income taxes 389 1,231 5,355 1,989 Non-GAAP income before income taxes $       3,490 $       3,178 $       9,182 $       8,992 GAAP provision for income taxes $          271 $          217 $          364 $       1,053 Adjustments to provision for income taxes: Income tax effect of the above adjustments (h) 228 271 1,007 442 Other income tax adjustments (i) (33) 23 (44) 6 Total adjustments to provision for income taxes 195 294 963 448 Non-GAAP provision for income taxes $          466 $          511 $       1,327 $       1,501 GAAP tax as a percentage of income before taxes 8.7 % 11.1 % 9.5 % 15.0 % Adjustments to provision for income taxes: Income tax effect of the above adjustments (h) 5.6 4.2 5.4 1.6 Other income tax adjustments (i) (0.9) 0.8 (0.4) 0.1 Total adjustments to provision for income taxes 4.7 5.0 5.0 1.7 Non-GAAP tax as a percentage of income before taxes 13.4 % 16.1 % 14.5 % 16.7 % GAAP net income $       2,830 $       1,730 $       3,463 $       5,950 Adjustments to net income: Adjustments to income before income taxes, net of the income tax effect 161 960 4,348 1,547 Other income tax adjustments (i) 33 (23) 44 (6) Total adjustments to net income 194 937 4,392 1,541 Non-GAAP net income $       3,024 $       2,667 $       7,855 $       7,491 Note: Numbers may not add due to rounding Amgen Inc. GAAP to Non-GAAP Reconciliations (In millions, except per-share data) (Unaudited) The following table presents the computations for GAAP and non-GAAP diluted earnings per share: Three months ended September 30, 2024 Three months ended September 30, 2023 GAAP Non-GAAP GAAP Non-GAAP Net income $        2,830 $        3,024 $        1,730 $        2,667 Weighted-average shares for diluted EPS 542 542 538 538 Diluted EPS $          5.22 $          5.58 $          3.22 $          4.96 Nine months ended September 30, 2024 Nine months ended September 30, 2023 GAAP Non-GAAP GAAP Non-GAAP Net income $        3,463 $        7,855 $        5,950 $        7,491 Weighted-average shares for diluted EPS 541 541 538 538 Diluted EPS $          6.40 $        14.52 $        11.06 $        13.92 (a) The adjustments related primarily to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions. (b) For the three months ended September 30, 2024 , the adjustments related primarily to noncash amortization of intangible assets from business acquisitions. For the nine months ended September 30, 2024 , the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three and nine months ended September 30, 2023 , the adjustments related primarily to noncash amortization of intangible assets from business acquisitions. (c) For the three and nine months ended September 30, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. (d) For the three and nine months ended September 30, 2023 , the adjustments related primarily to separation costs associated with our restructuring plan initiated in early 2023. (e) For the three and nine months ended September 30, 2024 , the adjustments related primarily to impairment charges for in-process R&D assets and changes in the fair values of contingent consideration liabilities, both related to our Teneobio, Inc. acquisition from 2021. For the three and nine months ended September 30, 2023 , the adjustments related primarily to a net impairment charge for AMG 340. (f) For the three and nine months ended September 30, 2023 , the adjustments included (i) interest expense and income on senior notes issued in March 2023 and (ii) debt issuance costs and other fees related to our bridge credit and term loan credit agreements, incurred prior to the closing of our acquisition of Horizon. (g) For the three and nine months ended September 30, 2024 , the adjustments related primarily to our BeiGene equity fair value adjustment. For the three and nine months ended September 30, 2023 , the adjustments related primarily to our Neumora Therapeutics, Inc. and BeiGene equity fair value adjustments, respectively. (h) The tax effect of the adjustments between our GAAP and non-GAAP results takes into account the tax treatment and related tax rate(s) that apply to each adjustment in the applicable tax jurisdiction(s). Generally, the tax impact of adjustments, including the amortization of intangible assets and acquired inventory, gains and losses on our investments in equity securities and expenses related to restructuring and cost-savings initiatives, depends on whether the amounts are deductible in the respective tax jurisdictions and the applicable tax rate(s) in those jurisdictions. Due to these factors, the effective tax rate for the adjustments to our GAAP income before income taxes for the three and nine months ended September 30, 2024 , was 58.6% and 18.8%, respectively, compared to 22.0% and 22.2% for the corresponding periods of the prior year. (i) The adjustments related to certain acquisition items, prior period and other items excluded from GAAP earnings. Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended September 30 , Nine months ended September 30 , 2024 2023 2024 2023 Net cash provided by operating activities $    3,571 $    2,760 $      6,719 $      7,933 Net cash (used in) provided by investing activities (210) (262) (644) 885 Net cash (used in) provided by financing activities (3,651) (2,005) (8,008) 18,294 (Decrease) increase in cash and cash equivalents (290) 493 (1,933) 27,112 Cash and cash equivalents at beginning of period 9,301 34,248 10,944 7,629 Cash and cash equivalents at end of period $    9,011 $   34,741 $      9,011 $    34,741 Three months ended September 30 , Nine months ended September 30 , 2024 2023 2024 2023 Net cash provided by operating activities $    3,571 $    2,760 $      6,719 $      7,933 Capital expenditures (257) (248) (725) (863) Free cash flow $    3,314 $    2,512 $      5,994 $      7,070 Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2024 (Unaudited) GAAP diluted EPS guidance $   8.71 — $   9.56 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 11.33 — 11.38 Net gains from equity investments (1.01) Other 0.12 Non-GAAP diluted EPS guidance $ 19.20 — $ 20.00 * The known adjustments are presented net of their related tax impact, which amount to approximately $2.39 per share. (a) The adjustments primarily include noncash amortization of intangible assets and fair value step-up of inventory acquired in business acquisitions. Our GAAP diluted EPS guidance does not include the effect of GAAP adjustments triggered by events that may occur subsequent to this press release such as acquisitions, asset impairments, litigation, changes in fair value of our contingent consideration obligations and changes in fair value of our equity investments. Reconciliation of GAAP Tax Rate Guidance to Non-GAAP Tax Rate Guidance for the Year Ending December 31, 2024 (Unaudited) GAAP tax rate guidance 9.0 % — 10.5 % Tax rate of known adjustments discussed above 4.5 % — 5.0 % Non-GAAP tax rate guidance 14.0 % — 15.0 % View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-third-quarter-2024-financial-results-302291966.html SOURCE Amgen