Cinacalcet Hydrochloride

THOUSAND OAKS, Calif. , May 1, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the first quarter of 2025. "Demand for our products was strong globally in the first quarter. Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects," 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 in the attached reconciliations. Refer to Non-GAAP Financial Measures below for further discussion. Product Sales Performance General Medicine Rare Disease Inflammation Oncology Established Products Product Sales Detail by Product and Geographic Region $Millions, except percentages Q1 '25 Q1 '24 YOY Δ U.S ROW TOTAL TOTAL TOTAL Repatha ® $         343 $         313 $         656 $         517 27 % EVENITY ® 320 122 442 342 29 % Prolia ® 720 379 1,099 999 10 % TEPEZZA ® 365 16 381 424 (10 %) KRYSTEXXA ® 236 — 236 235 0 % UPLIZNA ® 82 9 91 80 14 % TAVNEOS ® 77 13 90 51 76 % Ultra-Rare products (1) 171 8 179 169 6 % TEZSPIRE ® 285 — 285 173 65 % Otezla ® 343 94 437 394 11 % Enbrel ® 504 6 510 567 (10 %) AMJEVITA ® /AMGEVITA ™ 4 132 136 168 (19 %) WEZLANA ™ /WEZENLA ™ 123 27 150 1 * PAVBLU ® 99 — 99 — N/A BLINCYTO ® 273 97 370 244 52 % Vectibix ® 135 132 267 247 8 % KYPROLIS ® 216 108 324 376 (14 %) LUMAKRAS ® /LUMYKRAS ™ 55 30 85 82 4 % XGEVA ® 360 206 566 561 1 % Nplate ® 201 112 313 317 (1 %) IMDELLTRA ® /IMDYLLTRA ™ 79 2 81 — N/A MVASI ® 138 41 179 202 (11 %) Aranesp ® 91 249 340 349 (3 %) Parsabiv ® 50 38 88 105 (16 %) Neulasta ® 109 20 129 118 9 % Other products (2) 283 57 340 397 (14 %) Total product sales $      5,662 $      2,211 $      7,873 $      7,118 11 % * Change in excess of 100% N/A = not applicable (1) Ultra-Rare products consist of RAVICTI ® , PROCYSBI ® , ACTIMMUNE ® , BUPHENYL ® and QUINSAIR ® . (2) Consists of Aimovig ® , AVSOLA ® , KANJINTI ® , RIABNI ® , EPOGEN ® , BEKEMV ™ , NEUPOGEN ® , IMLYGIC ® , Corlanor ® , RAYOS ® , Sensipar ® /Mimpara ™ , DUEXIS ® and PENNSAID ® , where Biosimilars total $171 million in Q1 '25 and $175 million in Q1 '24. Operating Expense, Operating Margin and Tax Rate Analysis On a GAAP basis: On a non-GAAP basis: $Millions, except percentages GAAP Non-GAAP Q1 '25 Q1 '24 YOY Δ Q1 '25 Q1 '24 YOY Δ Cost of Sales $   2,968 $   3,200 (7 %) $   1,420 $   1,340 6 % % of product sales 37.7 % 45.0 % (7.3) pts 18.0 % 18.8 % (0.8) pts Research & Development $   1,486 $   1,343 11 % $   1,475 $   1,317 12 % % of product sales 18.9 % 18.9 % — pts 18.7 % 18.5 % 0.2 pts Selling, General & Administrative $   1,687 $   1,808 (7 %) $   1,655 $   1,712 (3 %) % of product sales 21.4 % 25.4 % (4.0) pts 21.0 % 24.1 % (3.1) pts Other $      830 $      105 * $        — $        — N/A Total Operating Expenses $   6,971 $   6,456 8 % $   4,550 $   4,369 4 % Operating Margin Operating income as % of product sales 15.0 % 13.9 % 1.1 pts 45.7 % 43.2 % 2.5 pts Tax Rate 12.3 % (66.2) % 78.5 pts 14.6 % 15.4 % (0.8) pts pts: percentage points * = Change in excess of 100% N/A = not applicable Cash Flow and Balance Sheet $Billions, except shares Q1 '25 Q1 '24 YOY Δ Operating Cash Flow $         1.4 $         0.7 $         0.7 Capital Expenditures $         0.4 $         0.2 $         0.2 Free Cash Flow $         1.0 $         0.5 $         0.5 Dividends Paid $         1.3 $         1.2 $         0.1 Share Repurchases $          — $          — $          — Average Diluted Shares (millions) 541 536 5 Note: Numbers may not add due to rounding $Billions 3/31/25 12/31/24 YTD Δ Cash and Cash Equivalents $         8.8 $       12.0 $        (3.2) Debt Outstanding $       57.4 $       60.1 $        (2.7) Note: Numbers may not add due to rounding 2025 Guidance For the full year 2025, the Company expects: This guidance includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. First 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 Repatha Olpasiran (AMG 890) Rare Disease TAVNEOS TEPEZZA UPLIZNA Dazodalibep Daxdilimab Inflammation TEZSPIRE Rocatinlimab (AMG 451/KHK4083) Blinatumomab Inebilizumab AMG 104 (AZD8630) Oncology BLINCYTO / blinatumomab IMDELLTRA / tarlatamab 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. Xaluritamig, formerly AMG 509, is being developed pursuant to a research collaboration with Xencor, Inc. IDE397 is an investigational MAT2A inhibitor from IDEAYA Biosciences. YL201 is an investigational B7-H3 targeting antibody-drug conjugate being developed by MediLink. 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 first quarters of 2025 and 2024, 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 first quarters of 2025 and 2024. 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 us on X (formerly known as Twitter), 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), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (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), 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, including those resulting from geopolitical relations and government actions. 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. 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, 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 sustainability 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 (Loss) - GAAP (In millions, except per-share data) (Unaudited) Three months ended March 31 , 2025 2024 Revenues: Product sales $    7,873 $    7,118 Other revenues 276 329 Total revenues 8,149 7,447 Operating expenses: Cost of sales 2,968 3,200 Research and development 1,486 1,343 Selling, general and administrative 1,687 1,808 Other 830 105 Total operating expenses 6,971 6,456 Operating income 1,178 991 Other income (expense): Interest expense, net (723) (824) Other income (expense), net 1,518 (235) Income (loss) before income taxes 1,973 (68) Provision for income taxes 243 45 Net income (loss) $    1,730 $     (113) Earnings (loss) per share: Basic $      3.22 $    (0.21) Diluted $      3.20 $    (0.21) Weighted-average shares used in calculation of earnings (loss) per share: Basic 538 536 Diluted 541 536 Amgen Inc Consolidated Balance Sheets - GAAP (In millions) March 31 , December 31 , 2025 2024 (Unaudited) Assets Current assets: Cash and cash equivalents $                8,810 $              11,973 Trade receivables, net 8,132 6,782 Inventories 6,729 6,998 Other current assets 3,258 3,277 Total current assets 26,929 29,030 Property, plant and equipment, net 6,681 6,543 Intangible assets, net 25,724 27,699 Goodwill 18,645 18,637 Other noncurrent assets 11,388 9,930 Total assets $              89,367 $              91,839 Liabilities and Stockholders' Equity Current liabilities: Accounts payable and accrued liabilities $              19,640 $              19,549 Current portion of long-term debt 3,368 3,550 Total current liabilities 23,008 23,099 Long-term debt 54,013 56,549 Long-term deferred tax liabilities 1,510 1,616 Long-term tax liabilities 2,419 2,349 Other noncurrent liabilities 2,210 2,349 Total stockholders' equity 6,207 5,877 Total liabilities and stockholders' equity $              89,367 $              91,839 Shares outstanding 538 537 Amgen Inc. GAAP to Non-GAAP Reconciliations (Dollars in millions) (Unaudited) Three months ended March 31 , 2025 2024 GAAP cost of sales $       2,968 $       3,200 Adjustments to cost of sales: Acquisition-related expenses (a) (1,548) (1,860) Non-GAAP cost of sales $       1,420 $       1,340 GAAP cost of sales as a percentage of product sales 37.7 % 45.0 % Acquisition-related expenses (a) (19.7) (26.2) Non-GAAP cost of sales as a percentage of product sales 18.0 % 18.8 % GAAP research and development expenses $       1,486 $       1,343 Adjustments to research and development expenses: Acquisition-related expenses (b) (11) (26) Non-GAAP research and development expenses $       1,475 $       1,317 GAAP research and development expenses as a percentage of product sales 18.9 % 18.9 % Acquisition-related expenses (b) (0.2) (0.4) Non-GAAP research and development expenses as a percentage of product sales 18.7 % 18.5 % GAAP selling, general and administrative expenses $       1,687 $       1,808 Adjustments to selling, general and administrative expenses: Acquisition-related expenses (c) (32) (96) Non-GAAP selling, general and administrative expenses $       1,655 $       1,712 GAAP selling, general and administrative expenses as a percentage of product sales 21.4 % 25.4 % Acquisition-related expenses (c) (0.4) (1.3) Non-GAAP selling, general and administrative expenses as a percentage of product sales 21.0 % 24.1 % GAAP operating expenses $       6,971 $       6,456 Adjustments to operating expenses: Adjustments to cost of sales (1,548) (1,860) Adjustments to research and development expenses (11) (26) Adjustments to selling, general and administrative expenses (32) (96) Impairment of intangible assets (d) (800) (68) Certain net charges pursuant to our restructuring and cost-savings initiatives 1 1 Certain other expenses (31) (38) Total adjustments to operating expenses (2,421) (2,087) Non-GAAP operating expenses $       4,550 $       4,369 Three months ended March 31 , 2025 2024 GAAP operating income $       1,178 $          991 Adjustments to operating expenses 2,421 2,087 Non-GAAP operating income $       3,599 $       3,078 GAAP operating income as a percentage of product sales 15.0 % 13.9 % Adjustments to cost of sales 19.7 26.2 Adjustments to research and development expenses 0.2 0.4 Adjustments to selling, general and administrative expenses 0.4 1.3 Impairment of intangible assets (d) 10.1 1.0 Certain net charges pursuant to our restructuring and cost-savings initiatives 0.0 0.0 Certain other expenses 0.3 0.4 Non-GAAP operating income as a percentage of product sales 45.7 % 43.2 % GAAP other income (expense), net $       1,518 $        (235) Adjustments to other income (expense), net Net (gains) losses from equity investments (e) (1,291) 510 Non-GAAP other income, net $          227 $          275 GAAP income (loss) before income taxes $       1,973 $          (68) Adjustments to income (loss) before income taxes: Adjustments to operating expenses 2,421 2,087 Adjustments to other income (expense), net (1,291) 510 Total adjustments to income (loss) before income taxes 1,130 2,597 Non-GAAP income before income taxes $       3,103 $       2,529 GAAP provision for income taxes $          243 $            45 Adjustments to provision for income taxes: Income tax effect of the above adjustments (f) 217 359 Other income tax adjustments (g) (6) (15) Total adjustments to provision for income taxes 211 344 Non-GAAP provision for income taxes $          454 $          389 GAAP tax as a percentage of income before taxes 12.3 % (66.2) % Adjustments to provision for income taxes: Income tax effect of the above adjustments (f) 2.5 82.2 Other income tax adjustments (g) (0.2) (0.6) Total adjustments to provision for income taxes 2.3 81.6 Non-GAAP tax as a percentage of income before taxes 14.6 % 15.4 % GAAP net income (loss) $       1,730 $        (113) Adjustments to net income (loss): Adjustments to income (loss) before income taxes, net of the income tax effect 913 2,238 Other income tax adjustments (g) 6 15 Total adjustments to net income (loss) 919 2,253 Non-GAAP net income $       2,649 $       2,140 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 (loss) per share: Three months ended March 31, 2025 Three months ended March 31, 2024 GAAP Non-GAAP GAAP Non-GAAP Net income (loss) $        1,730 $        2,649 $         (113) $        2,140 Shares (Denominator): Weighted-average shares for basic earnings (loss) per share 538 538 536 536 Effect of dilutive securities (h) 3 3 — 5 Weighted-average shares for diluted earnings (loss) per share (h) 541 541 536 541 Diluted earnings (loss) per share $          3.20 $          4.90 $        (0.21) $          3.96 (a) The adjustments related to noncash amortization of intangible assets and fair value step-up of inventory acquired from business acquisitions. (b) For the three months ended March 31, 2025 , the adjustment related primarily to noncash amortization of intangible assets acquired from business acquisitions. For the three months ended March 31, 2024 , the adjustment related primarily to acquisition-related costs related to our Horizon acquisition. (c) For the three months ended March 31, 2025 and 2024, the adjustments related primarily to acquisition-related costs related to our Horizon acquisition. (d) For the three months ended March 31, 2025 , the adjustment related to an intangible asset impairment charge for Otezla ® . For the three months ended March 31, 2024 , the adjustment related to a net impairment charge for an in-process R&D asset related to our Teneobio, Inc. acquisition from 2021. (e) For the three months ended March 31, 2025 and 2024, the adjustments related primarily to our BeiGene equity fair value adjustment. (f) 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 months ended March 31, 2025 , was 19.2% compared to 13.8% for the corresponding period of the prior year. (g) The adjustments related to certain acquisition-related, prior-period and other items excluded from GAAP earnings. (h) During periods of net loss, diluted loss per share is equal to basic loss per share as potential common shares are excluded due to their antidilutive effect. Amgen Inc. Reconciliations of Cash Flows (In millions) (Unaudited) Three months ended March 31 , 2025 2024 Net cash provided by operating activities $    1,391 $       689 Net cash used in investing activities (447) (217) Net cash used in financing activities (4,107) (1,708) Decrease in cash and cash equivalents (3,163) (1,236) Cash and cash equivalents at beginning of period 11,973 10,944 Cash and cash equivalents at end of period $    8,810 $    9,708 Three months ended March 31 , 2025 2024 Net cash provided by operating activities $    1,391 $       689 Capital expenditures (411) (230) Free cash flow $       980 $       459 Amgen Inc. Reconciliation of GAAP EPS Guidance to Non-GAAP EPS Guidance for the Year Ending December 31, 2025 (Unaudited) GAAP diluted EPS guidance $ 12.21 — $ 13.46 Known adjustments to arrive at non-GAAP*: Acquisition-related expenses (a) 8.27 — 8.32 Impairment of intangible assets (b) 1.29 Net gains from equity investments (1.87) Other 0.05 Non-GAAP diluted EPS guidance $ 20.00 — $ 21.20 * The known adjustments are presented net of their related tax impact, which amount to approximately $1.77 per share. (a) The adjustments primarily include noncash amortization of intangible assets and fair value step-up of inventory acquired in business acquisitions. (b) The adjustment relates to the Otezla ® intangible asset impairment charge recorded during the first quarter of 2025. 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. The stated guidance also includes the estimated impact of implemented tariffs, but does not account for any tariffs that could be implemented in the future, including potential sector-specific tariffs. 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 % Non-GAAP tax rate guidance 14.5 % — 16.0 % View original content to download multimedia: https://www.prnewswire.com/news-releases/amgen-reports-first-quarter-2025-financial-results-302444435.html SOURCE Amgen