Vertex(VRTX) - 2025 Q4 - Annual Results

Financial Performance - Full year total revenue for 2025 was $12.0 billion, a 9% increase compared to 2024; fourth quarter total revenue was $3.19 billion, a 10% increase compared to Q4 2024[1][3][8] - In the U.S., total revenue for 2025 increased 13% to $7.55 billion, driven by strong CF patient demand and higher realized net prices[3][8] - Vertex reported total revenues of $3,190.0 million for the three months ended December 31, 2025, an increase of 9.6% compared to $2,912.0 million for the same period in 2024[40] - GAAP net income for Q4 2025 was $1.2 billion, compared to $913 million in Q4 2024, primarily driven by increased product revenue[7] - Vertex's net income for the twelve months ended December 31, 2025, was $3,953.2 million, compared to a net loss of $535.6 million for the same period in 2024[40] - GAAP operating income for Q4 2025 was $1,205.9 million, compared to $1,026.0 million in Q4 2024, representing a 17.5% increase[48] - Non-GAAP operating income for the twelve months ended December 31, 2025 was $5,263.1 million, up from $695.6 million in 2024, indicating a significant growth[48] - GAAP net income for the twelve months ended December 31, 2025 was $3,953.2 million, compared to a net loss of $535.6 million in 2024[48] - Cash, cash equivalents, and marketable securities increased to $6,608.1 million as of December 31, 2025, from $6,115.9 million in 2024, showing a growth of 8.1%[51] - Total assets rose to $25,643.0 million in 2025, up from $22,533.2 million in 2024, reflecting a 13.4% increase[51] Revenue Guidance and Expectations - The company provides full year 2026 total revenue guidance of $12.95 billion to $13.1 billion, with non-CF products expected to contribute $500 million or more in revenue[1][13][14] - Vertex's financial guidance for combined GAAP R&D, AIPR&D and SG&A expenses in 2026 is $6.3 to $6.45 billion, including approximately $100 million of anticipated AIPR&D expenses[14][15] - The company anticipates over $500 million in non-CF product revenue in 2026, indicating a focus on expanding its product portfolio[54] Product Development and Approvals - Vertex expects to submit for approval of ALYFTREK in children 2 to 5 years of age in the first half of 2026, following positive pivotal study results[18] - Vertex initiated the rolling BLA filing for U.S. accelerated approval of povetacicept in IgAN in Q4 2025, with interim analysis data expected in the first half of 2026[24][27] - The company expects to complete the Phase 2 portion of the OLYMPUS study for povetacicept in mid-2026, with the Phase 3 portion anticipated to start thereafter[30] - Vertex plans to initiate a Phase 2 proof-of-concept study for povetacicept in gMG in the first half of 2026[30] - Vertex completed enrollment in the AMPLITUDE Phase 2/3 trial of inaxaplin and expects to share interim analysis data in late 2026 or early 2027[30] - The AGLOW study, evaluating VX-407 in patients with specific PKD1 gene variants, is expected to complete enrollment by the end of 2026, targeting approximately 30,000 patients[36] Research and Development Expenses - Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses for Q4 2025 were $1.52 billion and $1.36 billion, respectively, compared to $1.46 billion and $1.30 billion in Q4 2024[4] - Vertex's combined non-GAAP R&D, AIPR&D, and SG&A expenses for the twelve months ended December 31, 2025, were $5,118.2 million, a decrease from $8,821.7 million in 2024[46] Strategic Partnerships and Coverage - Vertex secured commercial coverage for JOURNAVX with all three national PBMs, providing access for over 200 million individuals across commercial and government payers[20] - The company has received multiple designations for zimislecel, including RMAT and Fast Track from the FDA, and PRIME from the EMA[30] - Vertex entered into an exclusive global license agreement with WuXi Biologics for the development of a trispecific T cell engager for autoimmune diseases, currently in preclinical development[35] Product Revenue Performance - Product revenues from TRIKAFTA/KAFTRIO were $2,572.5 million for the three months ended December 31, 2025, a decrease of 5.4% from $2,720.8 million in the same period of 2024[43] - Expectations for continued growth in cystic fibrosis (CF) treatments include increasing patient access through new approvals and reimbursement agreements[54]