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Yahoo
15-05-2025
- Business
- Yahoo
AMGN Q1 Earnings Call: Product Pipeline and Margin Expansion Drive Outperformance
Biotech company Amgen (NASDAQ:AMGN) reported Q1 CY2025 results topping the market's revenue expectations , with sales up 9.4% year on year to $8.15 billion. The company expects the full year's revenue to be around $35 billion, close to analysts' estimates. Its non-GAAP profit of $4.90 per share was 15% above analysts' consensus estimates. Is now the time to buy AMGN? Find out in our full research report (it's free). Revenue: $8.15 billion vs analyst estimates of $8.03 billion (9.4% year-on-year growth, 1.5% beat) Adjusted EPS: $4.90 vs analyst estimates of $4.26 (15% beat) Adjusted EBITDA: $4.99 billion vs analyst estimates of $4.67 billion (61.2% margin, 6.7% beat) The company reconfirmed its revenue guidance for the full year of $35 billion at the midpoint Management reiterated its full-year Adjusted EPS guidance of $20.60 at the midpoint Operating Margin: 14.5%, up from 13.3% in the same quarter last year Free Cash Flow Margin: 12%, up from 6.2% in the same quarter last year Market Capitalization: $141 billion Amgen's first quarter results were shaped by broad-based volume growth and new product launches across general medicine, rare diseases, inflammation, and oncology. Management highlighted the performance of 14 products with double-digit growth, as well as strong uptake of new biosimilars. CEO Robert Bradway emphasized, 'We delivered multiple positive Phase III readouts, initiated four new Phase III studies, and launched three new products or indications.' Looking ahead, Amgen's full-year guidance centers on further execution in its late-stage clinical pipeline and continued momentum in recently launched therapies. CFO Peter Griffith noted increased R&D investment to support assets such as MariTide, a potential obesity therapy, and ongoing expansion in the biosimilars portfolio. Management also acknowledged uncertainties from tariffs and tax policy, stating the company's manufacturing investments position it to adapt as needed. Amgen's management attributed the quarter's performance to the breadth of its product portfolio and significant progress in clinical development. Key growth areas included cardiovascular, bone health, rare disease, and oncology, with biosimilars delivering meaningful contributions. Broad product portfolio growth: Fourteen medicines delivered double-digit sales growth, spanning cardiovascular, bone health, rare disease, and oncology. Amgen's biosimilars segment generated over $700 million in revenue, up 35% year over year. General medicine expansion: Products like Repatha and EVENITY benefited from improved patient access, expanded prescriber base, and direct-to-consumer initiatives. Management cited ongoing clinical trials targeting large, underserved populations in cardiovascular and obesity-related diseases. Rare disease launches: UPLIZNA launched as the first FDA-approved treatment for IgG4-related disease, with early physician adoption. TEPEZZA expanded internationally, including approvals and launches in Japan and a positive regulatory opinion in Europe. Oncology pipeline momentum: Bispecific T cell engagers such as BLINCYTO and IMDELLTRA showed continued adoption and positive clinical data. IMDELLTRA demonstrated survival benefits in small cell lung cancer, with new Phase III studies underway. Biosimilars market penetration: Recent biosimilar launches, including PAVBLU and WEZLANA, were met with positive reception from prescribers. The company's approach focused on early U.S. launches and reliable supply to capture market share. Management's outlook for the remainder of the year is anchored by ongoing clinical advancement and new launches, while cautioning about external factors such as tariffs and increased R&D investment. Pipeline advancement: Significant late-stage studies for therapies like MariTide in obesity and Olpasiran in cardiovascular disease are expected to drive future growth, with management increasing R&D spending to support these programs. Expanding biosimilars: New biosimilar launches and further commercialization efforts are anticipated to diversify revenue streams and address pricing pressures in core therapy areas. External policy risks: Management flagged potential headwinds from evolving tax and tariff policies, emphasizing Amgen's historical ability to adapt through manufacturing investments and operational agility. Terence Flynn (Morgan Stanley): Asked about key data expectations for MariTide at the ADA meeting. Management said data would focus on 52-week efficacy and tolerability but not new long-term results. Salveen Richter (Goldman Sachs): Inquired about UPLIZNA's commercial strategy for IgG4-related disease. Amgen outlined targeted outreach to rheumatologists and plans for broader physician engagement. Michael Yee (Jefferies): Pressed on MariTide's tolerability and competition from oral obesity drugs. Management expressed confidence in design for efficacy and tolerability, with ongoing development of oral options. Trung Huynh (UBS): Questioned Repatha's position amid new competition. Amgen stressed product profile advantages and improved patient access, with room for multiple therapies in the market. David Amsellem (Piper Sandler): Asked what will drive growth for TEPEZZA. Management pointed to expanded prescriber education and international launches, with potential future benefit from a subcutaneous form. In coming quarters, the StockStory team will monitor (1) progress and data releases from late-stage clinical trials, especially for MariTide and bemarituzumab; (2) commercial adoption and prescriber uptake of newly launched therapies like UPLIZNA in IgG4-related disease and PAVBLU in biosimilars; and (3) updates on international expansion of key rare disease drugs. Execution in R&D and navigating policy changes will also be important indicators of Amgen's trajectory. Amgen currently trades at a forward P/E ratio of 13×. In the wake of earnings, is it a buy or sell? Find out in our free research report. Market indices reached historic highs following Donald Trump's presidential victory in November 2024, but the outlook for 2025 is clouded by new trade policies that could impact business confidence and growth. While this has caused many investors to adopt a "fearful" wait-and-see approach, we're leaning into our best ideas that can grow regardless of the political or macroeconomic climate. Take advantage of Mr. Market by checking out our Top 5 Strong Momentum Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. 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Associated Press
27-02-2025
- Business
- Associated Press
On Growth Path for a Decade plus: Strong Launch Execution driving Company Growth
Revenue in 2024 increased to € 6.15 billion, a plus of 17% (+19% CER1), Net sales were up by 15% to € 5.61 billion (+17% CER1) driven by a strong, triple- and double-digit growth performance of newly launched growth drivers: BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO® and ZILBRYSQ® as well as solid contribution from CIMZIA® and BRIVIACT® reaching its peak sales two years ahead of target Underlying profitability (adj. EBITDA2) went up to € 1.48 billion, a plus of 9% (+18% CER1), 24.0% of revenue; Core EPS3 increased to € 4.98 R&D update: Doxecitine and doxribtimine in thymidine Kinase 2 deficiency filed in U.S. – with granted priority review - and in EU; 1st phase 3 with positive results for dapirolizumab pegol in systemic lupus erythematosus (SLE), 2nd phase 3 started; Phase 2a study in atopic dermatitis with UCB9741/galvokimig showed positive and convincing data Sustainability with significant improvement in patient access, CO2 reduction and ESG ratings Financial guidance for 2025: Revenue expected to grow to € 6.5-6.7 billion, adjusted EBITDA2 to reach 30% of revenue, Core EPS3 in the range of € 6.80-7.40 ATLANTA, Feb. 27, 2025 /PRNewswire/ -- UCB Full-Year Report 2024, Brussels (Belgium) – regulated information Jean-Christophe Tellier, CEO UCB says: 'Our 2024 performance demonstrates that we are progressing on our path of growth for a decade+ and underlines our unwavering commitment to ensuring people with severe diseases can live the best life that they can, as free as possible from challenges of disease. We are proud to reaching more than 3.1 million patients globally with severe immunological and neurological conditions. As a result of our continuous execution, our five growth drivers tripled their combined net sales to more than € 1.3 billion in 2024. For growth beyond the decade, we are reporting progress from our clinical pipeline where we are studying 9 innovative, potential medicines with expected news flow in 2025. In 2024, we improved access to our medicines and achieved SBTi validation for our Net Zero Targets. Our efforts were recognized by Sustainalytics ranking UCB first in Biotechnology and the Carbon Disclosure Project with an A- for climate and water security.' UCB's FY 2024 financial results Sandrine Dufour, CFO UCB says: '2024 has been a successful year, showcasing UCB's innovation and strong execution capabilities, resulting in robust financial performance and reaching the € 6 billion mark ahead of target. Once again, we have met our financial guidance. We will continue our growth trajectory by supporting product launches, investing in breakthrough innovations, and strategically positioning our portfolio for continuous growth. Our financial guidance for 2025 continues the growth trend and anticipates a like-for-like significant increase over 2024, considering the portfolio evolution in 2024 and confirms our 30% adjusted EBITDA margin ambition.' Regulatory and Clinical Pipeline Update UCB continuously innovates and strives to find new ways to deliver solutions to people living with severe immunological and neurological diseases, reflected in a clinical development pipeline encompassing now one phase 4 (post-approval) asset, one asset under regulatory review, four phase 3 projects, four phase 2 projects - addressing different patient populations. The updated timelines for UCB's clinical development program, also reflecting regulatory updates and pipeline progress since July 1, 2024, up to the publication date of this report, are shown below. For more information, please visit Regulatory Update In July 2024, UCB received National Medical Products Administration (NMPA) approval for BIMZELX® for treatment of ankylosing spondylitis (AS) in China, followed by an approval in September for the treatment of non-radiographic axial spondyloarthritis (nr-axSpA). In November 2024, UCB and the biopharma company Bioray signed an agreement for commercialization of BIMZELX® in China, advancing access to patients. In August 2024, the European Commission granted marketing authorization for two 320 mg device presentations of BIMZELX®. The pre-filled syringe and pre-filled pen each contain 320 mg of bimekizumab in a volume of 2 mL and provide alternatives to the currently available 160 mg in a volume of 1 mL injection options. In September 2024, U.S. Food and Drug Administration (FDA) approved BIMZELX® for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). Bimekizumab-bkzx is the first approved treatment for these three indications that is designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). These newly approved indications follow the first U.S. approval for BIMZELX® in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In September 2024, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved BIMZELX® for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). In October 2024, the FDA approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of BIMZELX®. These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration. In November 2024, the FDA approved BIMZELX® for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Bimekizumab-bkzx is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A). The milestone marks the fifth indication for bimekizumab-bkzx in the U.S. in 2024, underscoring UCB's commitment to raising standards of care across a range of IL-17 mediated diseases. In January 2025, the Japanese Ministry of Health, Labor and Welfare (MHLW) approved the 320 mg/2mL Autoinjector for BIMZELX®. Clinical Pipeline Update The phase 2a study with rozanolixizumab in severe fibromyalgia syndrome showed statistically significant superiority to placebo but did not meet predefined criteria for progression. The reduction in IgG levels and the safety profile were consistent with what was observed in the myasthenia gravis population. UCB decided not to pursue a Phase 3 program for rozanolixizumab in severe fibromyalgia and to terminate this program. UCB9741/ galvokimig - a bispecific investigational antibody designed to target IL-13 and IL-17A & IL-17 F, which are key mediators of inflammation. The phase 2a study in moderate-to-severe atopic dermatitis - a type of eczema, which is the most common inflammatory skin disease - showed positive and convincing proof-of-concept data – to be presented at an upcoming scientific meeting in 2025. UCB is evaluating the next steps in the development program. UCB1381/ donzakimig - a bispecific investigational antibody designed to target IL-13 and IL-22, a key mediator of inflammation and important in maintenance of skin barrier integrity. Recruitment for the Phase 2a study in atopic dermatitis (AtD) is progressing slower than anticipated, leading to an updated timeline with results now expected in the second half of 2025. Minzasolmin, a phase 2a investigational, oral small molecule, alpha-synuclein misfolding inhibitor, developed in partnership with Novartis for early Parkinson's disease, did not meet its primary and secondary clinical endpoints in the ORCHESTRA proof-of-concept study. No new safety risks were identified, and the program was terminated. The findings from this study have been submitted to an upcoming scientific meeting and will be submitted for publication in a peer-reviewed journal. The data generated to date will enhance understanding of alpha-synuclein misfolding inhibition and aid in the advancement of future treatments. Bepranemab showed encouraging phase 2a study results in early Alzheimer's disease providing first evidence of biological and clinical effect of a mid-domain tau-targeting disease-modifying therapy. In the full study population, the primary endpoint was not met, however in key secondary endpoints bepranemab showed positive results. In pre-defined patient subgroups, consistent treatment benefit was shown across multiple primary and secondary outcome measures. UCB is evaluating next steps in the development program. At the end of 2024, regulatory submissions of doxecitine and doxribtimine in thymidine Kinase 2 deficiency (TK2d) occurred as planned and were accepted in February 2025 for review by the European and U.S. authorities. In the U.S., the application has been granted a priority review, Breakthrough Therapy Designation and Rare Pediatric Disease Designation. Following the acquisition of Zogenix, Inc. in 2022, UCB continued the development of Doxecitine and Doxribtimine, a pyrimidine nucleoside potential therapy for patients with TK2d, a rare, progressive, debilitating and often life-threatening genetic mitochondrial disease characterized by progressive and severe muscle weakness. Worldwide, there is no approved treatment available. UCB expects regulatory feedback and potential approvals by the end of 2025. The phase 3 study to evaluate the efficacy and safety of bimekizumab in Chinese study participants with moderate to severe plaque psoriasis (PSO) reported positive results. All primary and secondary endpoints were met, and safety observations were generally consistent with previous bimekizumab PSO studies. Submission to the Chinese regulatory authorities is planned for H2 2025. Recruitment for the phase 3 study with Fenfluramine (5-HT agonist) in the treatment of CDKL5 deficiency disorder (CDD) has required more time than anticipated. CDD is a rare developmental epileptic encephalopathy with onset in early infancy caused by mutations in the CDKL5 gene. The main clinical symptoms are early-onset, intractable epilepsy and neurodevelopmental delay impacting cognitive, motor, speech, and visual function. The study is now fully recruited, and first headline results are expected in H1 2025. In November 2024, UCB and partner Biogen presented detailed results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L drug candidate, demonstrating significant clinical improvement in disease activity in people living with moderate-to-severe systemic lupus erythematosus (SLE). The safety profile of dapirolizumab pegol was generally consistent with previous studies. In December 2024, UCB and Biogen initiated the second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY, with first headline results expected in 2028. In September, UCB started BE BOLD, a head-to-head post-approval Phase 4 study, comparing bimekizumab, an IL-17A and IL-17F inhibitor, with risankizumab, an IL-23 inhibitor, in the treatment of adults with active psoriatic arthritis (PsA). BE BOLD is the first head-to-head study in PsA evaluating the superiority of an IL-17A and IL-17F inhibitor to an IL-23 inhibitor. First headline results are expected in H2 2026. All other clinical studies are continuing as planned. Sustainability In 2024, patient access to reimbursement of UCB's medicines improved to 82% (from 68%) across all countries where UCB operates. UCB advanced the CO2 reduction efforts and achieved SBTi validation for its Net Zero Targets. This performance is recognized by various ESG ratings, with Sustainalytics ranking UCB first in the Biotechnology sector and the Carbon Disclosure Project awarding an A- score for both, climate and water security. Net sales break-down for UCB's five growth drivers, CIMZIA® and BRIVIACT® Due to rounding, some financial data may not add up in the tables BIMZELX® (bimekizumab) the first and only IL-17A & IL-17F inhibitor, is available to people living with psoriasis in 47 countries. It is also available to people living with active psoriatic arthritis (PsA), with active ankylosing spondylitis (AS) in more than 40 countries – the U.S. approval and launch occurred September 2024 - and active non-radiographic axial spondyloarthritis (nr-axSpA) in Europe and in Japan. BIMZELX® for people living with hidradenitis superativa was approved and launched in Europe (Germany, Austria) in April 2024, in September in Japan and in the U.S. in November 2024. More than 49 700 patients accessed the product by the end of 2024. FINTEPLA® (fenfluramine) reached over 7 600 patients and their families living with seizures associated with rare epileptic syndromes, offering a foundational therapy in Dravet Syndrome and a recognized option in Lennox-Gastaut Syndrome at the end of 2024. Partner Nippon Shinyaku in Japan books the in-market sales. FINTEPLA® was added to the UCB portfolio in March 2022. Following a settlement in a patent dispute in late 2023, UCB is now considering Q4 2033 as the loss of exclusivity in the U.S. € million 2024 2023 Act CER1 U.S. 294 201 46 % 46 % Europe 41 21 93 % 92 % Japan 2 1 >100% >100% International markets 2 3 -16 % -16 % Total Fintepla® 340 226 50 % 50 % RYSTIGGO® (rozanolixizumab-noli), a new treatment option for people living with generalized myasthenia gravis (gMG) providing rapid and durable efficacy, was launched in the U.S. in July 2023, in Japan late 2023 and Europe early 2024. RYSTIGGO® reached more than 1 200 people living with gMG by the end of 2024. € million 2024 2023 Act CER1 U.S. 184 19 >100% >100% Europe 8 - N/A N/A Japan 10 - N/A N/A International markets - - N/A N/A Total Rystiggo® 202 19 >100% >100% ZILBRYSQ® (zilucoplan) the first and only once-daily subcutaneous, targeted C5 complement inhibitor reached more than 560 people living with myasthenia gravis (gMG) by the end of 2024 and is being launched in the U.S., Europe and Japan since April 2024. € million 2024 2023 Act CER1 U.S. 56 - N/A N/A Europe 8 - N/A N/A Japan 8 - N/A N/A International markets - - N/A N/A Total Zilbrysq® 72 - N/A N/A EVENITY® (romosozumab) since launch globally reached more than 900 000 (2023: 600 000) women living with postmenopausal osteoporosis at high risk of fracture. Net sales in Europe increased by 71% to € 103 million (+71% CER) after € 60 million in 2023. EVENITY® is being launched successfully globally by Amgen, Astellas and UCB since 2019, with net sales outside Europe reported by the partners. The worldwide net contribution from EVENITY® is recognized under 'Other operating income'. CIMZIA® (certolizumab pegol) reached more than 220 000 people living with inflammatory TNF mediated diseases. The net sales performance was driven by global volume growth (+5%), overcompensated by net price decline mainly in the U.S. market. Since February 2024 and in the U.S., CIMZIA® is no longer patent protected. The patent in Europe expired in October 2024 and will expire in Japan in 2026. There is no biosimilar competition, neither today nor expected near-term. € million 2024 2023 Act CER1 U.S. 1 289 1 364 -5 % -5 % Europe 436 428 2 % 1 % Japan 28 39 -26 % -20 % International markets 280 257 9 % 15 % Total Cimzia® 2 033 2 087 -3 % -2 % BRIVIACT® (brivaracetam) was used by over 232 000 people living with epilepsy and increased net sales to € 686 million, achieving its peak sales target of 'at least € 600 million' well before 2026. This is driven by continued growth in all regions where BRIVIACT® is available to patients. In June 2024, BRIVIACT® was approved in Japan as monotherapy and adjunctive therapy in the treatment of partial onset seizures. € million 2024 2023 Act CER1 U.S. 540 445 21 % 21 % Europe 120 110 10 % 9 % Japan 1 - N/A N/A International markets 24 21 14 % 16 % Total Briviact® 686 576 19 % 19 % 2024 FY financial highlights Due to rounding, some financial data may not add up in the tables. Actual1 Variance € million 2024 2023 Actual rates CER2 Revenue 6 152 5 252 17 % 19 % Net sales 5 613 4 867 15 % 17 % Royalty income and fees 78 77 1 % 1 % Other revenue 461 308 50 % 50 % Adjusted Gross Profit 4 819 4 033 19 % 22 % Gross Profit 4 400 3 545 24 % 27 % Marketing and selling expenses -2 075 -1 594 30 % 30 % Research and development expenses -1 781 -1 630 9 % 9 % General and administrative expenses - 272 - 230 18 % 18 % Other operating income/expenses (-) 564 566 0 % 0 % Adjusted EBIT 836 657 27 % 47 % Impairment, restructuring and other income/expenses (-) 488 - 53 >-100% >-100% EBIT (operating profit) 1 324 604 >100% >100% Net financial expenses (-) - 161 - 163 -1 % -2 % Profit before income taxes 1 163 441 >100% >100% Income tax expenses (-) - 98 - 98 0 % 4 % Profit from continuing operations 1 065 343 >100% >100% Profit/loss (-) from discontinued operations 0 0 N/A N/A Profit 1 065 343 >100% >100% Attributable to UCB shareholders 1 065 343 >100% >100% Adjusted EBITDA 1 476 1 349 9 % 18 % Capital expenditure (including intangible assets) 322 316 2 % Net debt (-) -1 454 -2 177 -33 % Operating cash flow from continuing operations 1 242 761 63 % Weighted average number of shares – non diluted (million) 190 190 0 % EPS (€ per weighted average number of shares – non diluted) 5.61 1.81 >100% >100% Core EPS (€ per weighted average number of shares – non diluted) 4.98 4.20 19 % 32 % 1 Due to rounding, some financial data may not add up in the tables included in this management report 2 CER = constant exchange rates 'The statutory auditor has issued an unqualified report with no emphasis of matter paragraph dated 26 February 2025 on the company's consolidated accounts as of and for the year ended 31 December 2024 and has confirmed that the accounting data reported in the accompanying press release is consistent, in all material respects, with the accounts from which it has been derived.' Revenue in 2024 increased to € 6 152 million (+17%; +19% CER1) and net sales went up to € 5 613 million (+15%; +17% CER1). This growth was driven by the strong, triple- and double-digit growth of UCB's growth drivers: BIMZELX®, EVENITY®, FINTEPLA®, RYSTIGGO® and ZILBRYSQ® as well as the solid performance from CIMZIA® and the strong contribution from BRIVIACT®, reaching its peak sales target of 'at least € 6oo million' well ahead of the 2026 target. Royalty income and fees were € 78 million (1%; 1% CER1) and other revenue went up by 50% (+50% CER1) to € 461 million driven by the successful completion of the sale of rights to two established brands for Europe and selected countries in Latin-America and Asia-Pacific in November 2024, leading to other revenue of € 157 million. Also, the termination of the partnership for minzasolmin (see above) lead to additional termination revenue of € 92 million (termination expenses are recognized in research and development expenses). Gross profit before 'amortization of intangible assets linked to sales' was € 4 819 million (+19%; +22% CER1) and showed an even better performance than the topline, reflecting the improved product mix. The adjusted gross margin reached 78.3% and improvement over 2023 when the adjusted grow margin was 76.8%. Gross profit after 'amortization of intangible assets linked to sales' reached € 4 400 million – with an improved gross margin of 71.5% after 67.5%. Operating expenses increased to € 3 564 million (+23%; +23% CER1) reflecting significantly higher marketing and selling expenses, moderately increased research and development expenses, higher general and administration expenses and a stable 'other operating income'. Also, the accounting effect of long-term incentives (LTI), driven by the strong share price performance, impacted the different operating expenses and increased the total operating expenses by € 82 million or 2.3% of the total operating expenses. Total operating expenses are consisting of: 30% higher marketing and selling expenses of € 2 075 million (+30% CER1) reflecting focused and significant investments behind the global launch activities for UCB's five growth drivers: Global BIMZELX® launch activities in up to five indications, global launch activities for FINTEPLA® in two indications, global RYSTIGGO® and ZILBRYSQ® launch activities for people living with generalized myasthenia gravis (gMG) and the ongoing expansion of EVENITY® in Europe, reaching more and more patients. 9% higher research and development expenses of € 1 781 million (+9% CER1) reflect the continued investments in UCB's innovative R&D pipeline with 10 different study programs encompassing today one phase 4 (post-approval) asset, one asset under regulatory review, four phase 3 projects, four phase 2 projects - addressing ten different patient populations - as well as ongoing earlier research activities. The R&D ratio reached 29% in 2024 after 31% in 2023 due to strong revenue growth. 18% higher general and administrative expenses of € 272 million (+18% CER) driven by one-time expenses and additional external resources for the new growth organization model implemented at UCB in summer 2024 and by the above-mentioned accounting effect of LTI. other operating income was stable at € 564 million following € 566 million in 2023 driven by the net contribution of € 481 million (+31%) from EVENITY®, compensating a significantly lower other operating income. EVENITY® is being launched successfully globally by Amgen, Astellas and UCB since 2019, with net sales outside Europe reported by the partners. Hence, the net earnings contribution from outside Europe is reflected here. In 2023, the sale of a portfolio of established brands in Europe (€ 145 million) was reported as other operating income. In 2024, two established brands were sold, however reported as other revenue following the IFRS accounting standards. Underlying operational profitability – adjusted EBITDA2 – increased by 9% to € 1 476 million (+18% CER1) reflecting double-digit revenue growth and higher operating expenses. The adjusted EBITDA ratio for 2024 (in % of revenue) reached 24.0%, after 25.7% in 2023. Total impairment, restructuring and other income/expenses was an income of € 488 million driven by the successful closing of the divestment of UCB's mature neurology and allergy portfolio in China and the Zhuhai manufacturing facility, announced in November 2024. In 2023, UCB reported expenses of € 53 million. Net financial expenses reached € 161 million after € 163 million in 2023. Higher funding expenses were compensated by an increase of returns on cash investments and reduction of net foreign exchange losses. Income tax expenses remained stable at € 98 million. The average effective tax rate was 8% compared to 22% in 2023 impacted by the above-mentioned divestment in China - adjusted for this the effective tax rate would be 14% and includes the continued and sustainable use of R&D incentives and the recognition of deferred tax assets on losses. Driven by double-digit revenue growth, higher operating expenses reflecting the strong investments behind the launches and the significant contribution from the gain on disposals, the profit of the Group amounted to € 1 065 million after € 343 million (>100%; >100% CER1). Core earnings per share, adjusted for the after-tax impact of to be adjusted items, the financial one-offs, the after-tax contribution from discontinued operations and the net amortization of intangibles linked to sales, reached € 4.98 after € 4.20 in 2023 based on stable 190 million weighted average shares outstanding. Dividend – the Board of Directors of UCB proposes a dividend of €1.39 per share (gross), +2%. Financial Guidance 2025 - The year 2025 will be marked by ongoing global launches and in-market performance of the five growth drivers BIMZELX®, RYSTIGGO®, ZILBRYSQ®, FINTEPLA® and EVENITY®, supported by the solid performance of BRIVIACT® and despite expected pricing pressure for CIMZIA®. For 2025, UCB is aiming for an increase of revenues to the range of € 6.5 - € 6.7 billion representing a year over year like-for-like3 significant increase over 2024, considering the portfolio evolution in 2024. UCB will continue to invest behind launches around the globe to offer potential new solutions for people living with severe diseases and remains committed to invest into research and development advancing its early- and late-stage development pipeline. At the same time, UCB will continue to be cost disciplined and, as in the past, to actively manage the tail of its portfolio. Underlying profitability, adjusted EBITDA, is expected to reach 30% of revenue. Core earnings per share are expected in the range of € 6.80 – 7.40 per share – based on an average of 190 million shares outstanding. The figures for the financial guidance 2025 as mentioned above are calculated on the same basis as the actual figures for 2024. Today, UCB will host a conference call/video webcast at 08.00 (EST) / 13.00 (GMT) / 14.00 (CET) For further information, contact UCB: About UCB UCB, Brussels, Belgium ( is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9 000 people in approximately 40 countries, the company generated revenue of € 6.1 billion in 2024. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news Forward looking statements This document contains forward-looking statements, including, without limitation, statements containing the words 'potential', 'believes', 'anticipates', 'expects', 'intends', 'plans', 'seeks', 'estimates', 'may', 'will', 'continue' and similar expressions. These forward-looking statements are based on current plans, estimates and beliefs of management. All statements, other than statements of historical facts, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial information, expected legal, arbitration, political, regulatory or clinical results or practices and other such estimates and results. By their nature, such forward-looking statements are not guaranteeing future performance and are subject to known and unknown risks, uncertainties, and assumptions which might cause the actual results, financial condition, performance or achievements of UCB, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements contained in this document. Important factors that could result in such differences include but are not limited to: global spread and impacts of wars, pandemics and terrorism, the general geopolitical environment, climate change, changes in general economic, business and competitive conditions, the inability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing, costs associated with research and development, changes in the prospects for products in the pipeline or under development by UCB, effects of future judicial decisions or governmental investigations, safety, quality, data integrity or manufacturing issues, supply chain disruption and business continuity risks; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, product liability claims, challenges to patent protection for products or product candidates, competition from other products including biosimilars or disruptive technologies/business models, changes in laws or regulations, exchange rate fluctuations, changes or uncertainties in tax laws or the administration of such laws, and hiring, retention and compliance of its employees. There is no guarantee that new product candidates will be discovered or identified in the pipeline, or that new indications for existing products will be developed and approved. Movement from concept to commercial product is uncertain; preclinical results do not guarantee safety and efficacy of product candidates in humans. So far, the complexity of the human body cannot be reproduced in computer models, cell culture systems or animal models. The length of the timing to complete clinical trials and to get regulatory approval for product marketing has varied in the past and UCB expects similar unpredictability going forward. Products or potential products which are the subject of partnerships, joint ventures or licensing collaborations may be subject to disputes between the partners or may prove to be not as safe, effective or commercially successful as UCB may have believed at the start of such partnership. UCB's efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB's products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB's data and systems. Given these uncertainties, the public is cautioned not to place any undue reliance on such forward-looking statements. These forward-looking statements are made only as of the date of this document, and do not reflect any potential impacts from the evolving event or risk as mentioned above as well as any other adversity, unless indicated otherwise. The company continues to follow the development diligently to assess the financial significance of these events, as the case may be, to UCB. UCB expressly disclaims any obligation to update any forward-looking statements in this document, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. SOURCE UCB
Associated Press
04-02-2025
- Business
- Associated Press
AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2024 FINANCIAL RESULTS
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: For the fourth quarter, total revenues increased 11% to $9.1 billion in comparison to the fourth quarter of 2023. Product sales grew 11%, primarily driven by 14% volume growth. Excluding sales from our Horizon Therapeutics (Horizon) acquisition, product sales grew 10%, driven by volume growth of 15%. Ten products delivered at least double-digit sales growth in the fourth quarter, including Repatha® (evolocumab), BLINCYTO® (blinatumomab), TEZSPIRE® (tezepelumab-ekko), EVENITY® (romosozumab-aqqg) and TAVNEOS® (avacopan). Our performance included $1.2 billion of sales from our rare disease products, driven by several first-in-class, early-in-lifecycle medicines, including TEPEZZA® (teprotumumab-trbw), KRYSTEXXA® (pegloticase), UPLIZNA® (inebilizumab-cdon) and TAVNEOS®. For the full year, total revenues increased 19% to $33.4 billion in comparison to the full year of 2023. Product sales grew 19%, primarily driven by 23% volume growth, partially offset by 2% lower net selling price. Excluding sales from our Horizon acquisition, product sales grew 7%, driven by volume growth of 11%. Ten products delivered at least double-digit sales growth for the full year, including Repatha®, TEZSPIRE®, EVENITY®, BLINCYTO® and TAVNEOS®. 21 products achieved record sales for the full year. GAAP earnings per share (EPS) decreased 18% from $1.42 to $1.16 for the fourth quarter, primarily driven by mark-to-market losses on our equity investments, partially offset by higher revenues. For the full year, GAAP EPS decreased 39% from $12.49 to $7.56, primarily driven by higher operating expenses, including amortization expense from Horizon acquisition-related assets and incremental operating expenses from Horizon, and overall mark-to-market losses on our equity investments in 2024, partially offset by higher revenues. For the fourth quarter, GAAP operating income increased from $1.3 billion to $2.3 billion, and GAAP operating margin increased 10.3 percentage points to 26.5%. For the full year, GAAP operating income decreased from $7.9 billion to $7.3 billion, and GAAP operating margin decreased 6.6 percentage points to 22.7%. Non-GAAP EPS increased 13% from $4.71 to $5.31 for the fourth quarter, driven by higher revenues, partially offset by higher operating expenses. For the full year, non-GAAP EPS increased 6% from $18.65 to $19.84, driven by higher revenues, partially offset by higher operating expenses, including incremental operating expenses from Horizon, and higher interest expense. For the fourth quarter, non-GAAP operating income increased from $3.7 billion to $4.0 billion, and non-GAAP operating margin decreased 0.4 percentage points to 46.3%. For the full year, non-GAAP operating income increased from $13.4 billion to $15.0 billion, and non-GAAP operating margin decreased 2.9 percentage points to 46.9%. The Company generated $10.4 billion of free cash flow for the full year versus $7.4 billion in 2023, driven by business performance and timing of working capital items, primarily collections, partially offset by higher net interest expense. 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 Repatha® (evolocumab) sales increased 45% year-over-year to $606 million in the fourth quarter, primarily driven by volume growth. Full year sales increased 36%, primarily driven by 43% volume growth, partially offset by 10% lower net selling price. For 2025, we expect lower declines in net selling price. EVENITY® (romosozumab-aqqg) sales increased 36% year-over-year to $431 million in the fourth quarter and 35% for the full year, driven by volume growth. Prolia® (denosumab) sales increased 5% year-over-year to $1.2 billion in the fourth quarter and 8% for the full year, driven by volume growth. For 2025, we expect sales erosion driven by biosimilar competition. Rare Disease Except for TAVNEOS®, the products listed below were added through the acquisition of Horizon on Oct. 6, 2023. TEPEZZA® (teprotumumab-trbw) generated $460 million of sales in the fourth quarter and $1.9 billion for the full year. TEPEZZA is the first and only approved treatment for thyroid eye disease (TED) in the U.S. and Japan. KRYSTEXXA® (pegloticase) generated $346 million of sales in the fourth quarter and $1.2 billion for the full year. KRYSTEXXA is the first and only FDA-approved treatment for chronic refractory gout. UPLIZNA® (inebilizumab-cdon) generated $101 million of sales in the fourth quarter and $379 million for the full year. UPLIZNA is used to treat adults with neuromyelitis optica spectrum disorder (NMOSD). TAVNEOS® (avacopan) generated $81 million of sales in the fourth quarter. Sales increased 84% year-over-year in the fourth quarter and 111% for the full year, primarily driven by volume growth. TAVNEOS is a first-in-class treatment for severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis). Ultra-Rare products, which consist of RAVICTI® (glycerol phenylbutyrate), PROCYSBI® (cysteamine bitartrate), ACTIMMUNE® (interferon gamma-1b), QUINSAIR® (levofloxacin) and BUPHENYL® (sodium phenylbutyrate), generated $214 million of sales in the fourth quarter and $758 million for the full year. Inflammation TEZSPIRE® (tezepelumab-ekko) sales increased 67% year-over-year to $296 million in the fourth quarter and 71% for the full year, primarily driven by volume growth. Otezla® (apremilast) sales decreased 1% year-over-year to $624 million in the fourth quarter, driven by 7% lower net selling price, partially offset by 5% volume growth. Sales decreased 3% for the full year, primarily driven by 8% lower net selling price, partially offset by 3% volume growth. Enbrel® (etanercept) sales were flat year-over-year at $1.0 billion in the fourth quarter as 7% favorable changes to estimated sales deductions were offset by lower net selling price. Full year sales decreased 10%, driven by lower net selling price. For 2025, we expect continued declining net selling price and relatively flat volumes. We expect Otezla and Enbrel to follow the historical pattern of lower sales in the first quarter relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles. AMJEVITA®/AMGEVITA™ (adalimumab) sales increased 84% year-over-year to $294 million in the fourth quarter and 22% for the full year, driven by volume growth, partially offset by lower net selling price. Oncology BLINCYTO® (blinatumomab) sales increased 58% year-over-year to $381 million in the fourth quarter and 41% for the full year, primarily driven by volume growth. Vectibix® (panitumumab) sales decreased 2% year-over-year to $246 million in the fourth quarter, driven by 5% unfavorable foreign exchange impact and 4% lower volume, partially offset by higher net selling price. Sales increased 6% for the full year, driven by 8% higher net selling price and 4% volume growth, partially offset by unfavorable foreign exchange impact. KYPROLIS® (carfilzomib) sales increased 6% year-over-year to $372 million in the fourth quarter and 7% for the full year, driven by volume growth outside the U.S. LUMAKRAS®/LUMYKRAS™ (sotorasib) sales increased 10% year-over-year to $85 million in the fourth quarter, primarily driven by volume growth. Sales increased 25% for the full year, driven by volume growth and favorable changes to estimated sales deductions. XGEVA® (denosumab) sales increased 6% year-over-year to $561 million in the fourth quarter, driven by volume growth. Sales increased 5% for the full year, driven by higher net selling price. For 2025, we expect sales erosion driven by biosimilar competition. Nplate® (romiplostim) sales decreased 13% year-over-year to $337 million in the fourth quarter. Excluding a fourth quarter 2023 U.S. government order of $62 million, Nplate sales grew 4% year-over-year in the fourth quarter, driven by volume growth. Full year sales decreased 1%. U.S. government orders were $128 million in 2024 compared to $286 million in 2023. Excluding these U.S. government orders, Nplate sales grew 12% year-over-year for the full year, driven by 8% volume growth and 6% higher net selling price. IMDELLTRA® (tarlatamab-dlle) generated $67 million of sales in the fourth quarter. Sales increased 86% quarter-over-quarter, driven by volume growth and inventory levels. IMDELLTRA is the first and only FDA-approved bispecific T-cell engager (BiTE®) therapy for the treatment of extensive-stage small cell lung cancer (ES-SCLC). MVASI® (bevacizumab-awwb) sales decreased 8% year-over-year to $173 million in the fourth quarter and 9% for the full year. Established Products Our established products, which consist of EPOGEN® (epoetin alfa), Aranesp® (darbepoetin alfa), Parsabiv® (etelcalcetide) and Neulasta® (pegfilgrastim), generated $500 million of sales in the fourth quarter. Sales decreased 29% year-over-year for the fourth quarter, driven by volume declines, unfavorable changes to estimated sales deductions and lower net selling price. Sales decreased 19% for the full year, driven by volume declines, lower net selling price and unfavorable changes to estimated sales deductions. Product Sales Detail by Product and Geographic Region $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: Total Operating Expenses decreased 2% year-over-year for the fourth quarter and increased 29% for the full year. Cost of Sales as a percentage of product sales decreased 4.0 percentage points for the fourth quarter primarily driven by lower amortization expense from the fair value step-up of inventory acquired from Horizon, partially offset by changes in our sales mix, and higher profit share and royalty expense. For the full year, cost of sales as a percentage of product sales increased 8.7 percentage points driven by higher amortization expense from Horizon acquisition-related assets and, to a lesser extent, higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. Research & Development (R&D) expenses increased 12% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower research and early pipeline spend. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. Selling, General & Administrative (SG&A) expenses decreased 17% for the fourth quarter primarily driven by lower Horizon acquisition-related expenses. SG&A expenses increased 15% for the full year primarily driven by expenses from the acquired Horizon business and other commercial expenses, partially offset by lower Horizon acquisition-related expenses incurred in 2024. Other operating expenses for the full year primarily consisted of impairment charges associated with in-process R&D (IPR&D) intangible assets related to our Teneobio, Inc. acquisition in 2021 and expenses related to cost-savings initiatives incurred in 2024. Operating Margin as a percentage of product sales increased 10.3 percentage points to 26.5% for the fourth quarter and decreased 6.6 percentage points to 22.7% for the full year. Tax Rate increased 9.8 percentage points in the fourth quarter and decreased 3.2 percentage points for the full year. The fourth quarter tax rate increase was related to deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries and prior year favorable items, partially offset by the change in earnings mix as a result of the fourth quarter 2024 unrealized losses on our strategic equity investments (primarily BeiGene). The full year tax rate decrease was due to the change in earnings mix, including the net unrealized impacts of our strategic equity investments (primarily BeiGene), partially offset by the deferred tax adjustments associated with the U.S. minimum tax on the earnings of our foreign subsidiaries. On a non-GAAP basis: Total Operating Expenses increased 11% year-over-year for the fourth quarter and increased 24% for the full year. Cost of Sales as a percentage of product sales increased 1.3 percentage points for the fourth quarter driven by changes in our sales mix, and higher profit share and royalty expense. Cost of sales as a percentage of product sales increased 0.9 percentage points for the full year driven by higher profit share and royalty expense, partially offset by the Puerto Rico excise tax. R&D expenses increased 14% for the fourth quarter driven by higher spend in later-stage clinical programs, partially offset by lower spend in research and early pipeline. R&D expenses increased 25% for the full year driven by higher spend in later-stage clinical programs and marketed products support, including spend from Horizon-acquired programs. SG&A expenses increased 3% for the fourth quarter driven by higher general and administrative expenses. SG&A expenses increased 23% for the full year primarily driven by expenses from the acquired Horizon business and other marketed product expenses. Operating Margin as a percentage of product sales decreased 0.4 percentage points to 46.3% for the fourth quarter and decreased 2.9 percentage points to 46.9% for the full year. Tax Rate decreased 1.1 percentage points for the fourth quarter and decreased 2.0 percentage points for the full year. The fourth quarter tax rate decrease was primarily due to the change in earnings mix and net favorable items as compared to the prior year. The full year tax rate decrease was primarily due to the change in earnings mix as a result of the inclusion of the Horizon business and net favorable items as compared to the prior year. $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 The Company generated a record $4.4 billion of free cash flow in the fourth quarter of 2024 versus $0.3 billion in the fourth quarter of 2023, driven by timing of tax payments, timing of working capital, primarily collections, lower transaction expenses compared to the fourth quarter of 2023, which included significant costs tied to the closing of the Horizon acquisition, and business performance. The Company generated $10.4 billion of free cash flow for the full year 2024 versus $7.4 billion in 2023. The Company's fourth quarter 2024 dividend of $2.25 per share was declared on October 25, 2024, and was paid on December 9, 2024, to all stockholders of record as of November 18, 2024, representing a 6% increase from the same period in 2023. During the fourth quarter, there were no repayments or extinguishments of debt. For the full year 2024, the Company reduced principal debt outstanding by $4.5 billion. For the fourth quarter and full year, the Company repurchased 0.7 million shares of common stock at a total cost of $200 million. Cash and investments totaled $12.0 billion and debt outstanding totaled $60.1 billion as of December 31, 2024. Debt leverage was approximately 4.5 times EBITDA as of December 31, 2024. $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: Total revenues in the range of $34.3 billion to $35.7 billion. On a GAAP basis, EPS in the range of $10.89 to $12.14, and a tax rate in the range of 11.0% to 12.5%. On a non-GAAP basis, EPS in the range of $20.00 to $21.20, and a tax rate in the range of 15.0% to 16.0%. Capital expenditures to be approximately $2.3 billion. Share repurchases not to exceed $500 million. 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) MariTide is a differentiated peptide-antibody conjugate that activates the glucagon like peptide 1 (GLP-1) receptor and antagonizes gastric inhibitory polypeptide receptor (GIPR). In November 2024, data were presented from Part 1 of a Phase 2 chronic weight management study in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. MariTide demonstrated robust weight loss at 52 weeks without a weight loss plateau, significant improvements in cardiometabolic parameters, and is the first obesity treatment with monthly or less frequent dosing to demonstrate safe and effective weight loss in a Phase 2 study. Part 2 of the Phase 2 chronic weight management study is ongoing in adults who are living with overweight or obesity, with or without Type 2 diabetes mellitus. Data readout is anticipated in H2 2025. A Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus is enrolling adults living with and without obesity. Data readout is anticipated in H2 2025. Planning for MARITIME, a broad Phase 3 program across multiple indications remains on track with the first studies expected to begin in H1 2025. AMG 513 A Phase 1 study of AMG 513 in people living with obesity was placed on clinical hold by the U.S. Food and Drug Administration (FDA). Discussions are underway on a path forward to reopen the study. Olpasiran (AMG 890) Olpasiran is a potentially best-in-class small interfering ribonucleic acid (siRNA) molecule that reduces lipoprotein(a) (Lp(a)) synthesis in the liver. The OCEAN(a)-Outcomes trial, a Phase 3 cardiovascular (CV) outcomes study, is ongoing in patients with atherosclerotic CV disease and elevated Lp(a). A Phase 3 CV outcomes study in patients with elevated Lp(a) and at high risk for a CV event is expected to be initiated in H2 2025 / H1 2026. Repatha VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, is ongoing in patients at high CV risk without prior myocardial infarction or stroke. Data readout is event driven and anticipated in H2 2025. EVOLVE-MI, a Phase 4 study of Repatha administered within 10 days of an acute myocardial infarction to reduce the risk of CV events, is ongoing. Rare Disease TAVNEOS A Phase 3, open-label study of TAVNEOS in combination with rituximab or a cyclophosphamide-containing regimen is enrolling patients from 6 years to < 18 years of age with active ANCA-associated vasculitis (Granulomatosis with Polyangiitis (GPA) / Microscopic Polyangiitis (MPA)). TEPEZZA Regulatory review is underway in multiple additional geographies including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025. A Phase 3 study of TEPEZZA in Japan is enrolling patients with chronic or low clinical activity score TED. A Phase 3 study evaluating the subcutaneous route of administration of teprotumumab is enrolling patients with TED. KRYSTEXXA Data were presented in November 2024 from the AGILE study evaluating the safety, tolerability and efficacy of KRYSTEXXA administered with a shorter infusion duration in patients with uncontrolled gout receiving methotrexate as co-administration: Safety and efficacy data from the 60-minute infusion duration cohort of the AGILE trial are similar to the MIRROR randomized clinical trial and current administration of KRYSTEXXA with methotrexate over at least 120 minutes. U.S. Regulatory filing for AGILE is underway. UPLIZNA In January 2025, the FDA granted UPLIZNA Orphan Drug Designation for the treatment of generalized myasthenia gravis (gMG) based upon data from the Phase 3 MINT study. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025. In November 2024, data were presented and simultaneously published in the New England Journal of Medicine from the Phase 3 MITIGATE study evaluating UPLIZNA compared to placebo in patients with immunoglobin G4-related disease (IgG4-RD). In this study, UPLIZNA demonstrated a statistically significant 87% reduction in IgG4-RD flares, this primary endpoint and all key secondary endpoints were met. The safety results in the placebo-controlled period were consistent with the established safety profile of UPLIZNA. The FDA accepted the regulatory submission for the Phase 3 MITIGATE study under priority review with a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2025. Dazodalibep Dazodalibep is a fusion protein that inhibits CD40L. Two Phase 3 studies of dazodalibep in Sjögren's disease are enrolling patients. The first study is in patients with moderate-to-severe systemic disease activity, and the second study is in patients with moderate-to-severe symptomatic burden and low systemic disease activity. Daxdilimab Daxdilimab is a fully human monoclonal antibody targeting immunoglobulin-like transcript 7 (ILT7). A Phase 2 study of daxdilimab is ongoing in patients with moderate-to-severe active primary discoid lupus erythematosus refractory to standard of care. A Phase 2 study of daxdilimab is ongoing in patients with dermatomyositis and antisynthetase inflammatory myositis. Fipaxalparant Fipaxalparant is a lysophosphatidic acid receptor 1 (LPAR1) antagonist. A Phase 2 study of fipaxalparant in patients with diffuse cutaneous systemic sclerosis is complete. The study did not meet the primary or secondary endpoints. Further development of fipaxalparant in this indication will be discontinued. Inflammation TEZSPIRE The Company is planning to initiate Phase 3 studies in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and a BEC ≥ 150 cells/µl. Study initiation is anticipated in H1 2025. In December, the Company announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps: Patients treated with TEZSPIRE had a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo. The safety profile and tolerability of TEZSPIRE in the trial were consistent with the known profile of the medicine. Regulatory submission is anticipated in H1 2025. A Phase 3 study of TEZSPIRE is enrolling patients with eosinophilic esophagitis. In severe asthma, the WAYFINDER Phase 3b study is complete and the PASSAGE Phase 4 real-world effectiveness study is ongoing. The SUNRISE Phase 3 study will be discontinued due to limited enrollment. Rocatinlimab (AMG 451/KHK4083) Rocatinlimab is a first-in-class T-cell rebalancing monoclonal antibody targeting the OX40 receptor. The eight study ROCKET Phase 3 program evaluating rocatinlimab in patients with moderate-to-severe atopic dermatitis (AD) has enrolled over 3300 patients. Enrollment is now complete in seven studies. Key milestones from the ROCKET Phase 3 program: ROCKET SHUTTLE is a 24-week study evaluating rocatinlimab in combination with topical corticosteroids and/or topical calcineurin inhibitors in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025. ROCKET IGNITE is a 24-week study evaluating rocatinlimab monotherapy in adult patients with moderate-to-severe AD. Data readout is anticipated in H1 2025. ROCKET ASCEND is a study evaluating rocatinlimab maintenance therapy in adult and adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025. ROCKET ASTRO is a 52-week study evaluating rocatinlimab in adolescent patients with moderate-to-severe AD. Data readout is anticipated in H2 2025. A Phase 2 study of rocatinlimab is enrolling patients with moderate-to-severe asthma. A Phase 3 study of rocatinlimab is enrolling patients with prurigo nodularis. Otezla In November 2024, we made six data presentations at the American College of Rheumatology (ACR). Notable highlights include: Otezla reduces axial inflammation in patients with psoriatic arthritis (PsA) as assessed by CANDEN Magnetic Resonance Imaging Scoring, results From the Phase 4 MOSAIC study. FOREMOST oligoarticular PsA data presentations (4 posters), including 48-week data and data at 16 weeks showing that Otezla was associated with fewer patients progressing from < 4 to > 4 active joints when compared to placebo suggesting that Otezla reduced the progression from oligoarticular to polyarticular PsA. Blinatumomab Blinatumomab is a BiTE molecule targeting CD19. A Phase 2 study of blinatumomab in autoimmune disease was initiated in patients with systemic lupus erythematosus (SLE). Inebilizumab Inebilizumab is a monoclonal antibody targeting CD19. A Phase 2 study of inebilizumab in autoimmune disease was initiated in patients with SLE. Ordesekimab (AMG 714/PRV-015) Ordesekimab is a monoclonal antibody that binds interleukin-15. A Phase 2b study of ordesekimab, conducted by Provention Bio, a Sanofi Company, in patients with nonresponsive celiac disease was completed as planned and did not meet primary or secondary endpoints. No safety concerns were noted. AMG 104 (AZD8630) AMG 104 is an inhaled anti-thymic stromal lymphopoietin (TSLP) fragment antigen-binding (Fab). A Phase 2 study is enrolling patients with asthma. Oncology BLINCYTO In December 2024, data from a Phase 3 study (AALL1731) conducted by the Children's Oncology Group, were presented and simultaneously published in the New England Journal of Medicine. These data demonstrated that BLINCYTO added to chemotherapy significantly improves disease-free survival in newly diagnosed pediatric patients with National Cancer Institute standard risk B-cell precursor acute lymphoblastic leukemia (B-ALL) of average or higher risk of relapse. Golden Gate, a Phase 3 study of BLINCYTO alternating with low-intensity chemotherapy, is enrolling older adult patients with newly diagnosed Philadelphia chromosome (Ph)-negative B-ALL. A Phase 1/2 study of subcutaneous blinatumomab is ongoing in the dose-expansion and optimization phase in adult patients with relapsed or refractory Ph-negative B-ALL. The Company is planning to advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025. IMDELLTRA IMDELLTRA is a first-in-class delta-like ligand 3 (DLL3) targeting BiTE molecule. In 2024, IMDELLTRA received accelerated approval in the U.S. for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Marketing authorizations have subsequently been granted in Japan and in additional countries, including Canada, Brazil, Israel and Great Britain. The Company is advancing a comprehensive, global clinical development program across extensive-stage and limited-stage small cell lung cancer (SCLC): DeLLphi-304, a Phase 3 study of IMDELLTRA in second-line ES-SCLC, is ongoing. Data readout is anticipated in H1 2025. DeLLphi-305, a Phase 3 study of IMDELLTRA and durvalumab is enrolling patients with first-line ES-SCLC in the maintenance setting. DeLLphi-306, a Phase 3 study of IMDELLTRA following concurrent chemoradiation therapy, is enrolling patients with limited-stage SCLC. DeLLphi-308, a Phase 1b study evaluating subcutaneous tarlatamab, is enrolling patients with second line or later ES-SCLC. DeLLphi-309, a Phase 2 study evaluating alternative intravenous dosing regimens in second-line ES-SCLC, was initiated. DeLLphi-303, a Phase 1b study of IMDELLTRA in combination with a programmed cell death protein ligand-1 (PD-L1) inhibitor, carboplatin and etoposide or separately in combination with PD-L1 alone, is ongoing in patients with first-line ES-SCLC. Xaluritamig (AMG 509) Xaluritamig is a first-in-class bispecific T-cell engager targeting six-transmembrane epithelial antigen of prostate 1 (STEAP1). A Phase 3 study of xaluritamig is enrolling patients with metastatic castrate resistant prostate cancer (mCRPC) who have previously been treated with taxane-based chemotherapy. A Phase 1 monotherapy dose-expansion study of xaluritamig is enrolling mCRPC patients who have not yet received taxane-based chemotherapy and to enroll patients in a fully outpatient treatment setting to further improve administration convenience. A Phase 1 combination of xaluritamig with enzalutamide or abiraterone is enrolling patients with mCRPC in dose-escalation and dose-expansion respectively. A Phase 1b study evaluating neoadjuvant xaluritamig therapy prior to radical prostatectomy is enrolling patients with newly diagnosed localized intermediate or high–risk prostate cancer. A Phase 1b study of xaluritamig is enrolling patients with high-risk biochemically recurrent prostate cancer after definitive therapy. AMG 193 AMG 193 is a first-in-class small molecule methylthioadenosine (MTA)-cooperative protein arginine methyltransferase 5 (PRMT5) inhibitor. A Phase 2 study evaluating the efficacy, safety, tolerability and pharmacokinetics of AMG 193 is enrolling patients with methylthioadenosine phosphorylase (MTAP)-null previously treated advanced non-small cell lung cancer (NSCLC). A Phase 1/1b/2 study of AMG 193 is enrolling patients with advanced MTAP-null solid tumors in the dose-expansion portion of the study. A Phase 1b study of AMG 193 alone or in combination with other therapies is enrolling patients with advanced MTAP-null thoracic malignancies. A Phase 1b study of AMG 193 in combination with other therapies is enrolling patients with advanced MTAP-null gastrointestinal, biliary tract, and pancreatic cancers. A Phase 1/2 study of AMG 193 in combination with IDE397, an investigational methionine adenosyltransferase 2A (MAT2A) inhibitor, is enrolling patients with advanced MTAP-null solid tumors. Bemarituzumab Bemarituzumab is a first-in-class fibroblast growth factor receptor 2b (FGFR2b) targeting monoclonal antibody. FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, is ongoing in patients with first-line gastric cancer. Data readout is anticipated in H1 2025. FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab is ongoing in patients with first-line gastric cancer. Phase 3 data readout is anticipated in H2 2025. FORTITUDE-103, a Phase 1b/2 study of bemarituzumab plus oral chemotherapy regimens with or without nivolumab, is enrolling patients with first-line gastric cancer. FORTITUDE-301, a Phase 1b/2 basket study of bemarituzumab monotherapy, is ongoing in patients with solid tumors with FGFR2b overexpression. LUMAKRAS/LUMYKRAS In January 2025, the FDA approved LUMAKRAS in combination with Vectibix as a targeted, biomarker-driven combination therapy for the treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI, is enrolling patients with first-line KRAS G12C–mutated CRC. Regulatory review by the EMA of the CodeBreaK 200 Phase 3 study of adults with previously treated locally advanced or metastatic KRAS G12C–mutated NSCLC concluded with the conditional status of marketing authorization maintained. CodeBreaK 202 (CB202), a Phase 3 study of LUMAKRAS plus chemotherapy vs. pembrolizumab plus chemotherapy, is enrolling patients with first-line KRAS G12C–mutated and PD-L1 negative advanced NSCLC. The ongoing CB202 study is being conducted to serve as confirmatory study and to support conversion of accelerated/conditional approval to full approval, in the US, EU and other regions where applicable. Nplate The primary analysis of a Phase 3 study of Nplate as supportive care in chemotherapy-induced thrombocytopenia in gastrointestinal malignancies is complete. The Company continues to follow patients through a planned final analysis in H1 2025. Data presentation at a medical congress is anticipated in mid-2025. Biosimilars A randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO® (nivolumab) is enrolling patients with resected stage III or stage IV melanoma in the adjuvant setting. Data readout is anticipated in H2 2025. A randomized, double-blind comparative clinical study of ABP 206 compared with OPDIVO is enrolling patients with treatment-naïve unresectable or metastatic melanoma. A randomized, double-blind pharmacokinetic similarity study of ABP 234 compared with KEYTRUDA® (pembrolizumab) is enrolling patients with early-stage non-squamous non-small cell lung cancer as adjuvant treatment. A randomized, double-blind combined pharmacokinetic/comparative clinical study of ABP 234 compared to KEYTRUDA is enrolling patients with advanced or metastatic non-squamous non-small cell lung cancer. A randomized, double-blind, pharmacokinetic similarity/comparative clinical study of ABP 692 and OCREVUS® (ocrelizumab) was initiated and is currently enrolling patients with relapsing-remitting multiple sclerosis. 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 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: SOURCE Amgen
