Cinacalcet Hydrochloride

The North Carolina facility cited in the FDA's Form 483 produces inhalers and dermatology products. Aurobindo's manufacturing operations have once again landed the Indian drugmaker in hot water with the U.S. FDA.Aurobindo's subsidiary Aurolife Pharma received a Form 483 from the FDA outlining 11 observations at a U.S. production plant, the Indian drugmaker said in a filing late last week. The exact nature of the infractions remain unclear, as the FDA has not published the document.The regulatory rebuke follows an inspection at Aurolife's Raleigh, North Carolina, manufacturing facility that ran from March 24 through April 10, Aurobindo explained in a filing (PDF) Friday with the National Stock Exchange of India and BSE, formerly known as the Bombay Stock Exchange. The facility produces inhalers and dermatology products.In its filing, the company characterized the regulator's observations as “procedural in nature” and said that it will promptly submit a response to the FDA detailing corrective measures at the plant. “We do not expect this development to have any material impact on the current business operations or existing supplies from this facility,” Aurobindo said. Aurobindo is no stranger to FDA scrutiny. In late 2024, the company recalled more than 103,000 bottles of cinacalcet tablets thanks to unacceptable levels of the potential carcinogen N-nitroso Cinacalcet. The drug is used to treat hyperparathyroidism in patients with chronic kidney disease who are on dialysis.At the same time, the company also recalled an undisclosed amount of the high blood pressure drug nebivolol, also due to the presence of excess levels of a nitrosamine drug substance-related impurity. Meanwhile, last August, the FDA slammed Aurobindo’s Eugia manufacturing unit near Hyderabad, India, with a warning letter after the site had received an official action indicated (OAI) notice in May. An OAI designation is a sort of precursor to more formal reprimands from the FDA indicating that a facility risks running afoul of regulatory and administrative requirements and could pose a danger to public health.At the time of its warning letter in August, Eugia had been cited with four Form 483s at various facilities throughout India since late 2023. In December 2023, the FDA also issued a citation for a plant in New Jersey that Aurobindo said it planned to sell.

THOUSAND OAKS, Calif. , Feb. 4, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year of 2024 versus comparable periods in 2023. "Robust growth in sales and earnings throughout 2024 reflects the momentum of our business. With strong performance globally, we are investing heavily in our rapidly advancing pipeline to deliver innovative therapies across our four 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," "free cash flow" (computed by subtracting capital expenditures from operating cash flow), "EBITDA, or earnings before interest, taxes, depreciation and amortization" (computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income) and "debt leverage ratio" (calculated as the ratio of GAAP total debt to EBITDA) 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 Rare Disease Except for TAVNEOS ® , the products listed below were added through the acquisition of Horizon on Oct. 6, 2023. Inflammation Oncology Established Products Product Sales Detail by Product and $Millions, except percentages Q4 '24 Q4 '23 YOY Δ U.S ROW TOTAL TOTAL TOTAL Repatha ® $         315 $         291 $         606 $         417 45 % EVENITY ® 325 106 431 318 36 % Prolia ® 775 390 1,165 1,107 5 % TEPEZZA ®(1) 456 4 460 448 3 % KRYSTEXXA ®(1) 346 — 346 272 27 % UPLIZNA ®(1) 93 8 101 65 55 % TAVNEOS ® 76 5 81 44 84 % Ultra-Rare products (1) 205 9 214 164 30 % TEZSPIRE ® 296 — 296 177 67 % Otezla ® 514 110 624 629 (1 %) Enbrel ® 1,008 7 1,015 1,015 — % AMJEVITA ® /AMGEVITA ™ 153 141 294 160 84 % BLINCYTO ® 245 136 381 241 58 % Vectibix ® 134 112 246 251 (2 %) KYPROLIS ® 236 136 372 350 6 % LUMAKRAS ® /LUMYKRAS ™ 53 32 85 77 10 % XGEVA ® 369 192 561 527 6 % Nplate ® 221 116 337 386 (13 %) IMDELLTRA ® 67 — 67 — N/A MVASI ® 108 65 173 188 (8 %) EPOGEN ® 19 — 19 55 (65 %) Aranesp ® 90 218 308 319 (3 %) Parsabiv ® 39 36 75 89 (16 %) Neulasta ® 72 26 98 239 (59 %) Other products (2) 294 67 361 295 22 % Total product sales $      6,509 $      2,207 $      8,716 $      7,833 11 % N/A = not applicable (1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , QUINSAIR ® and BUPHENYL ® . (2) Consists of (i) Aimovig ® , KANJINTI ® , AVSOLA ® , RIABNI ® , PAVBLU ™ , NEUPOGEN ® , WEZLANA ™ /WEZENLA ™ , BEKEMV ™ , IMLYGIC ® , Corlanor ® and Sensipar ® /Mimpara ™ , where Biosimilars total $218 million in Q4 '24 and $135 million in Q4 '23; and (ii) Horizon-acquired products including RAYOS ® , PENNSAID ® and DUEXIS ® . $Millions, except percentages FY '24 FY '23 YOY Δ US ROW TOTAL TOTAL TOTAL Repatha ® $      1,139 $      1,083 $      2,222 $      1,635 36 % EVENITY ® 1,131 432 1,563 1,160 35 % Prolia ® 2,885 1,489 4,374 4,048 8 % TEPEZZA ®(1) 1,835 16 1,851 448 * KRYSTEXXA ®(1) 1,185 — 1,185 272 * UPLIZNA ®(1) 314 65 379 65 * TAVNEOS ® 256 27 283 134 * Ultra-Rare products (1) 726 32 758 164 * TEZSPIRE ® 972 — 972 567 71 % Otezla ® 1,699 427 2,126 2,188 (3 %) Enbrel ® 3,288 28 3,316 3,697 (10 %) AMJEVITA ® /AMGEVITA ™ 202 559 761 626 22 % BLINCYTO ® 800 416 1,216 861 41 % Vectibix ® 519 526 1,045 984 6 % KYPROLIS ® 948 555 1,503 1,403 7 % LUMAKRAS ® /LUMYKRAS ™ 214 136 350 280 25 % XGEVA ® 1,507 718 2,225 2,112 5 % Nplate ® 970 486 1,456 1,477 (1 %) IMDELLTRA ® 115 — 115 — N/A MVASI ® 449 278 727 800 (9 %) EPOGEN ® 125 — 125 226 (45 %) Aranesp ® 386 956 1,342 1,362 (1 %) Parsabiv ® 203 153 356 362 (2 %) Neulasta ® 318 113 431 848 (49 %) Other products (2) 1,115 230 1,345 1,191 13 % Total product sales $    23,301 $      8,725 $    32,026 $    26,910 19 % * Change in excess of 100% N/A = not applicable (1) Horizon-acquired products, and the Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , BUPHENYL ® and QUINSAIR ® . (2) Consists of (i)Aimovig ® ,KANJINTI ® ,RIABNI ® ,AVSOLA ® ,NEUPOGEN ® ,Corlanor ® , IMLYGIC ® ,BEKEMV ™ , PAVBLU ™ , WEZLANA ™ /WEZENLA ™ and Sensipar ® /Mimpara ™ , where Biosimilars total $725 million in FY '24 and $490 million in FY '23; and (ii) Horizon-acquired products including RAYOS ® , PENNSAID ® and DUEXIS ® . Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: On a non-GAAP basis: $Millions, except percentages GAAP Non-GAAP Q4 '24 Q4 '23 YOY Δ Q4 '24 Q4 '23 YOY Δ Cost of Sales $   3,112 $   3,112 — % $   1,536 $   1,278 20 % % of product sales 35.7 % 39.7 % (4.0) pts 17.6 % 16.3 % 1.3 pts Research & Development $   1,724 $   1,534 12 % $   1,698 $   1,494 14 % % of product sales 19.8 % 19.6 % 0.2 pts 19.5 % 19.1 % 0.4 pts Selling, General & Administrative $   1,878 $   2,274 (17 %) $   1,819 $   1,764 3 % % of product sales 21.5 % 29.0 % (7.5) pts 20.9 % 22.5 % (1.6) pts Other $        61 $          5 * $        — $        — N/A Total Operating Expenses $   6,775 $   6,925 (2 %) $   5,053 $   4,536 11 % Operating Margin operating income as % of product sales 26.5 % 16.2 % 10.3 pts 46.3 % 46.7 % (0.4) pts Tax Rate 19.8 % 10.0 % 9.8 pts 14.8 % 15.9 % (1.1) pts pts: percentage points * change in excess of 100% N/A = not applicable $Millions, except percentages GAAP Non-GAAP FY '24 FY '23 YOY Δ FY '24 FY '23 YOY Δ Cost of Sales $ 12,858 $   8,451 52 % $   5,736 $   4,573 25 % % of product sales 40.1 % 31.4 % 8.7 pts 17.9 % 17.0 % 0.9 pts Research & Development $   5,964 $   4,784 25 % $   5,878 $   4,700 25 % % of product sales 18.6 % 17.8 % 0.8 pts 18.4 % 17.5 % 0.9 pts Selling, General & Administrative $   7,096 $   6,179 15 % $   6,782 $   5,518 23 % % of product sales 22.2 % 23.0 % (0.8) pts 21.2 % 20.5 % 0.7 pts Other $      248 $      879 (72 %) $        — $        — N/A Total Operating Expenses $ 26,166 $ 20,293 29 % $ 18,396 $ 14,791 24 % Operating Margin operating income as % of product sales 22.7 % 29.3 % (6.6) pts 46.9 % 49.8 % (2.9) pts Tax Rate 11.3 % 14.5 % (3.2) pts 14.5 % 16.5 % (2.0) pts pts: percentage points N/A = not applicable Cash Flow and Balance Sheet $Billions, except shares Q4 '24 Q4 '23 YOY Δ FY '24 FY '23 YOY Δ Operating Cash Flow $         4.8 $         0.5 $         4.2 $     11.5 $       8.5 $      3.0 Capital Expenditures $         0.4 $         0.2 $         0.1 $       1.1 $       1.1 $      0.0 Free Cash Flow $         4.4 $         0.3 $         4.1 $     10.4 $       7.4 $      3.0 Dividends Paid $         1.2 $         1.1 $         0.1 $       4.8 $       4.6 $      0.3 Share Repurchases $         0.2 $          — $         0.2 $       0.2 $        — $      0.2 Average Diluted Shares (millions) 542 540 2 541 538 3 Note: Numbers may not add due to rounding $Billions 12/31/24 12/31/23 YTD Δ Cash and Investments $       12.0 $       10.9 $         1.0 Debt Outstanding $       60.1 $       64.6 $        (4.5) Note: Numbers may not add due to rounding 2025 Guidance For the full year 2025, the Company expects: Fourth 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 Rare Disease TAVNEOS TEPEZZA KRYSTEXXA UPLIZNA Dazodalibep Daxdilimab Fipaxalparant Inflammation TEZSPIRE Rocatinlimab (AMG 451/KHK4083) Otezla Blinatumomab Inebilizumab Ordesekimab (AMG 714/PRV-015) AMG 104 (AZD8630) Oncology BLINCYTO IMDELLTRA Xaluritamig (AMG 509) AMG 193 Bemarituzumab LUMAKRAS/LUMYKRAS Nplate 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. OPDIVO is a registered trademark of Bristol-Myers Squibb Company. KEYTRUDA is a registered trademark of Merck & Co., Inc. OCREVUS is a registered trademark of Genentech, Inc. Non-GAAP Financial Measures In this news release, management has presented its operating results for the fourth quarters and full years 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 2025 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 fourth quarters and full years of 2024 and 2023. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP. Management has also presented Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and debt leverage ratio for 2024, both of which are non-GAAP financial measures. EBITDA is computed by adding interest expense, provision for income taxes, and depreciation and amortization expense to GAAP net income. Debt leverage ratio is calculated as the ratio of GAAP total debt to EBITDA. 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 believes its debt leverage ratio provides a supplemental operating metric for the full year period as it compares the amount of cash generated by our operations for the year. 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 , 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 December 31, Twelve months ended December 31, 2024 2023 2024 2023 Revenues: Product sales $    8,716 $    7,833 $  32,026 $  26,910 Other revenues 370 363 1,398 1,280 Total revenues 9,086 8,196 33,424 28,190 Operating expenses: Cost of sales 3,112 3,112 12,858 8,451 Research and development 1,724 1,534 5,964 4,784 Selling, general and administrative 1,878 2,274 7,096 6,179 Other 61 5 248 879 Total operating expenses 6,775 6,925 26,166 20,293 Operating income 2,311 1,271 7,258 7,897 Other income (expense): Interest expense, net (747) (821) (3,155) (2,875) Other (expense) income, net (782) 402 506 2,833 Income before income taxes 782 852 4,609 7,855 Provision for income taxes 155 85 519 1,138 Net income $       627 $       767 $    4,090 $    6,717 Earnings per share: Basic $      1.17 $      1.43 $      7.62 $    12.56 Diluted $      1.16 $      1.42 $      7.56 $    12.49 Weighted-average shares used in calculation of earnings per share: Basic 537 535 537 535 Diluted 542 540 541 538 Amgen Inc. Consolidated Balance Sheets - GAAP (In millions) December 31, December 31, 2024 2023 (Unaudited) Assets Current assets: Cash and cash equivalents $              11,973 $              10,944 Trade receivables, net 6,782 7,268 Inventories 6,998 9,518 Other current assets 3,277 2,602 Total current assets 29,030 30,332 Property, plant and equipment, net 6,543 5,941 Intangible assets, net 27,699 32,641 Goodwill 18,637 18,629 Other noncurrent assets 9,930 9,611 Total assets $              91,839 $              97,154 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $              19,549 $              16,949 Current portion of long-term debt 3,550 1,443 Total current liabilities 23,099 18,392 Long-term debt 56,549 63,170 Long-term deferred tax liabilities 1,616 2,354 Long-term tax liabilities 2,349 4,680 Other noncurrent liabilities 2,349 2,326 Total stockholders' equity 5,877 6,232 Total liabilities and stockholders' equity $              91,839 $              97,154 Shares outstanding 537 535 Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 GAAP cost of sales $       3,112 $       3,112 $      12,858 $       8,451 Adjustments to cost of sales: Acquisition-related expenses (a) (1,576) (1,834) (7,122) (3,842) Certain net charges pursuant to our restructuring and cost-savings initiatives — — — (36) Total adjustments to cost of sales (1,576) (1,834) (7,122) (3,878) Non-GAAP cost of sales $       1,536 $       1,278 $       5,736 $       4,573 GAAP cost of sales as a percentage of product sales 35.7 % 39.7 % 40.1 % 31.4 % Acquisition-related expenses (a) (18.1) (23.4) (22.2) (14.3) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 0.0 (0.1) Non-GAAP cost of sales as a percentage of product sales 17.6 % 16.3 % 17.9 % 17.0 % GAAP research and development expenses $       1,724 $       1,534 $       5,964 $       4,784 Adjustments to research and development expenses: Acquisition-related expenses (b) (26) (28) (86) (55) Certain net charges pursuant to our restructuring and cost-savings initiatives — (12) — (29) Total adjustments to research and development expenses (26) (40) (86) (84) Non-GAAP research and development expenses $       1,698 $       1,494 $       5,878 $       4,700 GAAP research and development expenses as a percentage of product sales 19.8 % 19.6 % 18.6 % 17.8 % Acquisition-related expenses (b) (0.3) (0.3) (0.2) (0.2) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 (0.2) 0.0 (0.1) Non-GAAP research and development expenses as a percentage of product sales 19.5 % 19.1 % 18.4 % 17.5 % GAAP selling, general and administrative expenses $       1,878 $       2,274 $       7,096 $       6,179 Adjustments to selling, general and administrative expenses: Acquisition-related expenses (c) (59) (510) (314) (648) Certain net charges pursuant to our restructuring and cost-savings initiatives — — — (13) Total adjustments to selling, general and administrative expenses (59) (510) (314) (661) Non-GAAP selling, general and administrative expenses $       1,819 $       1,764 $       6,782 $       5,518 GAAP selling, general and administrative expenses as a percentage of product sales 21.5 % 29.0 % 22.2 % 23.0 % Acquisition-related expenses (c) (0.6) (6.5) (1.0) (2.4) Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 0.0 (0.1) Non-GAAP selling, general and administrative expenses as a percentage of product sales 20.9 % 22.5 % 21.2 % 20.5 % GAAP operating expenses $       6,775 $       6,925 $      26,166 $      20,293 Adjustments to operating expenses: Adjustments to cost of sales (1,576) (1,834) (7,122) (3,878) Adjustments to research and development expenses (26) (40) (86) (84) Adjustments to selling, general and administrative expenses (59) (510) (314) (661) Certain net charges pursuant to our restructuring and cost-savings initiatives (d) (40) (2) (36) (185) Certain other expenses (e) (21) (3) (212) (694) Total adjustments to operating expenses (1,722) (2,389) (7,770) (5,502) Non-GAAP operating expenses $       5,053 $       4,536 $      18,396 $      14,791 Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 GAAP operating income $       2,311 $       1,271 $       7,258 $       7,897 Adjustments to operating expenses 1,722 2,389 7,770 5,502 Non-GAAP operating income $       4,033 $       3,660 $      15,028 $      13,399 GAAP operating income as a percentage of product sales 26.5 % 16.2 % 22.7 % 29.3 % Adjustments to cost of sales 18.1 23.4 22.2 14.4 Adjustments to research and development expenses 0.3 0.4 0.2 0.3 Adjustments to selling, general and administrative expenses 0.6 6.5 1.0 2.6 Certain net charges pursuant to our restructuring and cost-savings initiatives (d) 0.5 0.1 0.1 0.7 Certain other expenses (e) 0.3 0.1 0.7 2.5 Non-GAAP operating income as a percentage of product sales 46.3 % 46.7 % 46.9 % 49.8 % GAAP interest expense, net $        (747) $        (821) $      (3,155) $      (2,875) Adjustments to interest expense, net: Interest expense on acquisition-related debt (f) — 19 — 807 Non-GAAP interest expense, net $        (747) $        (802) $      (3,155) $      (2,068) GAAP other (expense) income, net $        (782) $          402 $          506 $       2,833 Adjustments to other (expense) income, net Interest income and other expenses on acquisition-related debt (f) — (18) — (625) Net losses (gains) from equity investments (g) 875 (217) 182 (1,522) Total adjustments to other (expense) income, net 875 (235) 182 (2,147) Non-GAAP other income, net $            93 $          167 $          688 $          686 GAAP income before income taxes $          782 $          852 $       4,609 $       7,855 Adjustments to income before income taxes: Adjustments to operating expenses 1,722 2,389 7,770 5,502 Adjustments to interest expense, net — 19 — 807 Adjustments to other income, net 875 (235) 182 (2,147) Total adjustments to income before income taxes 2,597 2,173 7,952 4,162 Non-GAAP income before income taxes $       3,379 $       3,025 $      12,561 $      12,017 GAAP provision for income taxes $          155 $            85 $          519 $       1,138 Adjustments to provision for income taxes: Income tax effect of the above adjustments (h) 537 404 1,544 846 Other income tax adjustments (i) (192) (7) (236) (1) Total adjustments to provision for income taxes 345 397 1,308 845 Non-GAAP provision for income taxes $          500 $          482 $       1,827 $       1,983 GAAP tax as a percentage of income before taxes 19.8 % 10.0 % 11.3 % 14.5 % Adjustments to provision for income taxes: Income tax effect of the above adjustments (h) 0.7 6.1 5.1 2.0 Other income tax adjustments (i) (5.7) (0.2) (1.9) 0.0 Total adjustments to provision for income taxes (5.0) 5.9 3.2 2.0 Non-GAAP tax as a percentage of income before taxes 14.8 % 15.9 % 14.5 % 16.5 % GAAP net income $          627 $          767 $       4,090 $       6,717 Adjustments to net income: Adjustments to income before income taxes, net of the income tax effect 2,060 1,769 6,408 3,316 Other income tax adjustments (i) 192 7 236 1 Total adjustments to net income 2,252 1,776 6,644 3,317 Non-GAAP net income $       2,879 $       2,543 $      10,734 $      10,034 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 December 31, 2024 Three months ended December 31, 2023 GAAP Non-GAAP GAAP Non-GAAP Net income $           627 $        2,879 $           767 $        2,543 Weighted-average shares for diluted EPS 542 542 540 540 Diluted EPS $          1.16 $          5.31 $          1.42 $          4.71 Twelve months ended December 31, 2024 Twelve months ended December 31, 2023 GAAP Non-GAAP GAAP Non-GAAP Net income $        4,090 $      10,734 $        6,717 $      10,034 Weighted-average shares for diluted EPS 541 541 538 538 Diluted EPS $          7.56 $        19.84 $        12.49 $        18.65 (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 and twelve months ended December 31, 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the three months ended December 31, 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. For the twelve months ended December 31, 2023, the adjustments related primarily to noncash amortization of intangible assets acquired from business acquisitions. (c) For the three and twelve months ended December 31, 2024 and 2023, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. (d) For the three and twelve months ended December 31, 2024 and 2023, the adjustments related to separation costs associated with our restructuring plan and other cost-savings initiatives. (e) For the twelve months ended December 31, 2024, the adjustments related primarily to impairment charges for IPR&D intangible assets related to our Teneobio, Inc. acquisition from 2021. For the twelve months ended December 31, 2023, the adjustments related primarily to a net IPR&D intangible asset impairment charge for AMG 340. (f) For the three and twelve months ended December 31, 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 twelve months ended December 31, 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. For the twelve months ended December 31, 2023, the adjustments related primarily to our BeiGene equity fair value adjustment. (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 twelve months ended December 31, 2024, was 20.7% and 19.4%, respectively, compared to 18.6% and 20.3% 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 December 31, Twelve months ended December 31, 2024 2023 2024 2023 Net cash provided by operating activities $    4,771 $       538 $    11,490 $      8,471 Net cash used in investing activities (402) (27,089) (1,046) (26,204) Net cash (used in) provided by financing activities (1,407) 2,754 (9,415) 21,048 Increase (decrease) in cash and cash equivalents 2,962 (23,797) 1,029 3,315 Cash and cash equivalents at beginning of period 9,011 34,741 10,944 7,629 Cash and cash equivalents at end of period $   11,973 $   10,944 $    11,973 $    10,944 Three months ended December 31, Twelve months ended December 31, 2024 2023 2024 2023 Net cash provided by operating activities $    4,771 $       538 $    11,490 $      8,471 Capital expenditures (371) (249) (1,096) (1,112) Free cash flow $    4,400 $       289 $    10,394 $      7,359 Amgen Inc. Reconciliation of GAAP Net Income to EBITDA and Debt Leverage Ratio Calculation (Dollars in millions) (Unaudited) Twelve months ended December 31, 2024 GAAP Net Income $                                   4,090 Depreciation and amortization 5,592 Interest expense, net 3,155 Provision for income taxes 519 EBITDA (a) $                                 13,356 As of December 31, 2024 Current portion of long-term debt $                                   3,550 Long-term debt 56,549 Total GAAP Debt $                                 60,099 As of December 31, 2024 Total GAAP Debt $                                 60,099 EBITDA $                                 13,356 Debt leverage ratio 4.5 (a) 2024 EBITDA includes amortization of inventory step-up of $2.4 billion and net losses from equity investments of $182 million. Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2025 (Unaudited) GAAP diluted EPS guidance $ 10.89 — $ 12.14 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 9.06 — 9.11 Non-GAAP diluted EPS guidance $ 20.00 — $ 21.20 * The known adjustments are presented net of their related tax impact, which amount to approximately $1.54 per share. (a) The adjustments 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, 2025 (Unaudited) GAAP tax rate guidance 11.0 % — 12.5 % Tax rate of known adjustments discussed above 3.5 % — 4.0 % Non-GAAP tax rate guidance 15.0 % — 16.0 % View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-fourth-quarter-and-full-year-2024-financial-results-302367906.html SOURCE Amgen