Amgen(AMGN) - 2024 Q4 - Annual Results

Financial Performance - For Q4 2024, total revenues increased 11% to $9.1 billion compared to Q4 2023, with product sales growing 11$33.4 billion, with product sales growing 19% primarily due to 23% volume growth[3]. - Amgen reported Q4 2024 total revenues of $9,086 million, a 10.9$8,196 million in Q4 2023[64]. - Product sales for Q4 2024 reached $8,716 million, up 11.3$7,833 million in Q4 2023[64]. - For the full year 2024, total revenues were $33,424 million, compared to$28,190 million in 2023, reflecting an 18.6% growth[64]. Earnings Per Share (EPS) - GAAP EPS for Q4 2024 decreased 18% to $1.16, while for the full year, GAAP EPS decreased 39$7.56, mainly due to higher operating expenses and mark-to-market losses[3][4]. - Non-GAAP EPS for Q4 2024 increased 13% to $5.31, and for the full year, it increased 6$19.84, driven by higher revenues[7]. - Non-GAAP diluted EPS for the twelve months ended December 31, 2024, was $19.84, up from$18.65 in 2023, representing an increase of 6.4%[68]. - Amgen's GAAP diluted EPS guidance for the year ending December 31, 2025, is projected to be between $10.89 and$12.14, with non-GAAP diluted EPS guidance ranging from $20.00 to$21.20[71]. Cash Flow - Free cash flow for the full year 2024 was $10.4 billion, up from$7.4 billion in 2023, attributed to business performance and timing of working capital items[7]. - The company generated a record $4.4 billion of free cash flow in Q4 2024, compared to$0.3 billion in Q4 2023, driven by improved business performance and lower transaction expenses[20]. - Operating cash flow for Q4 2024 was $4.8 billion, significantly higher than$0.5 billion in Q4 2023[22]. - Free cash flow for the twelve months ended December 31, 2024, was $10,394 million, compared to$7,359 million in 2023, marking an increase of 41.5%[69]. Sales Performance - Repatha sales increased 45% year-over-year to $606 million in Q4 2024, with full year sales up 36$460 million in sales for Q4 2024 and $1.9 billion for the full year, being the first approved treatment for thyroid eye disease in the U.S. and Japan[11]. - TAVNEOS sales increased 84$81 million, with full year sales up 111%[11]. - Established products generated $500 million in sales for Q4 2024, a decrease of 29$8,716 million, an 11% increase from $7,833 million in Q4 '23[15]. - For FY '24, total product sales were$32,026 million, a 19% increase compared to $26,910 million in FY '23[16]. Operating Expenses - Total operating expenses increased by 29$5.964 billion, a 25% increase from $4.784 billion in FY 2023[21]. - Non-GAAP operating expenses for the full year 2024 totaled$18,396 million, compared to $14,791 million in 2023, an increase of 24.0$4.5 billion in 2024, with total debt outstanding at $60.1 billion as of December 31, 2024[24]. - Long-term debt decreased to$56,549 million in Q4 2024 from $63,170 million in Q4 2023[65]. - Amgen's total stockholders' equity was$5,877 million in Q4 2024, down from $6,232 million in Q4 2023[65]. - The debt leverage ratio as of December 31, 2024, was 4.5, calculated from total GAAP debt of$60,099 million and EBITDA of $13,356 million[70]. Research and Development - R&D expenses rose by 12% in Q4 '24, driven by higher spending in later-stage clinical programs[17]. - The company is planning for MARITIME, a broad Phase 3 program across multiple indications, with the first studies expected to begin in H1 2025[30]. - UPLIZNA demonstrated an 87% reduction in IgG4-RD flares in the Phase 3 MITIGATE study, meeting all primary and key secondary endpoints[34]. - The FDA accepted the regulatory submission for the Phase 3 MITIGATE study with a PDUFA action date of April 3, 2025[34]. - Rocatinlimab's ROCKET Phase 3 program has enrolled over 3,300 patients, with data readouts anticipated in H1 2025[39]. - TEZSPIRE showed a statistically significant reduction in nasal polyp size and congestion compared to placebo, with regulatory submission expected in H1 2025[39]. - A Phase 3 study of Nplate for chemotherapy-induced thrombocytopenia is ongoing, with final analysis planned for H1 2025[49]. - IMDELLTRA received accelerated approval in the U.S. for extensive-stage small cell lung cancer, with multiple ongoing Phase 3 studies[42]. - LUMAKRAS was approved in January 2025 for use in combination with Vectibix for KRAS G12C-mutated metastatic colorectal cancer[46]. - The Phase 2 study of fipaxalparant in diffuse cutaneous systemic sclerosis did not meet primary or secondary endpoints, leading to discontinuation of further development[34]. - The company plans to initiate Phase 3 studies in patients with moderate-to-very severe COPD in H1 2025[34].