Vertex Reports Second Quarter 2024 Financial Results

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Algemeen advies 07/08/2024 06:50
— Product revenue of $2.65 billion, a 6% increase compared to Q2 2023 —

— Company raises full year product revenue guidance to $10.65 to $10.85 billion —

— FDA accepted NDA for vanzacaftor triple in CF with Priority Review and PDUFA target action date of January 2, 2025; additionally, MAA submissions validated in EU and U.K. —

— FDA accepted NDA for suzetrigine (VX-548) for moderate-to-severe acute pain with Priority Review and PDUFA target action date of January 30, 2025 —

— Advancing broad and deep clinical pipeline with multiple milestones expected in H2:24 —

BOSTON--(BUSINESS WIRE)--Aug. 1, 2024-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the second quarter ended June 30, 2024, and raised its full year product revenue guidance to $10.65 to $10.85 billion.

“Vertex delivered another strong quarter of revenue growth coupled with outstanding execution across the business, and we are increasing our full year product revenue guidance,” said Reshma Kewalramani, M.D., Chief Executive Officer, and President of Vertex. “Our focus for the second half of the year remains on commercial execution in CF and the global launch of CASGEVY, readying for the upcoming potential launches of the vanzacaftor triple in CF and suzetrigine in acute pain, while rapidly advancing a robust pipeline that is poised to deliver value for patients and shareholders for the long term.”

Second Quarter 2024 Results

Product revenue increased 6% to $2.65 billion compared to the second quarter of 2023, primarily driven by the continued strong performance of TRIKAFTA®/KAFTRIO®, including in younger age groups. Net product revenue in the second quarter of 2024 increased 7% to $1.61 billion in the U.S. and increased 5% to $1.03 billion outside the U.S., compared to the second quarter of 2023.

Combined GAAP and Non-GAAP R&D and SG&A expenses were $1.3 billion and $978 million, respectively, compared to $1.0 billion and $928 million, respectively, in the second quarter of 2023. The increases were due to increased investments to support launches of Vertex's therapies globally and continued investment in support of multiple programs that have advanced in mid- and late-stage clinical development.

Acquired IPR&D expenses were $4.4 billion compared to $111 million in the second quarter of 2023 due to $4.4 billion of Acquired IPR&D (AIPR&D) expenses associated with Vertex’s acquisition of Alpine Immune Sciences.

GAAP and Non-GAAP effective tax rates were (6.0)% and (10.0)%, respectively, compared to 21.2% and 21.0%, respectively, for the second quarter of 2023, primarily due to the impact of non-deductible AIPR&D expenses, which drove Vertex’s pre-tax loss in the second quarter of 2024. Please refer to Note 1 for further details on Vertex’s GAAP to Non-GAAP tax adjustments.

GAAP and Non-GAAP net losses were $3.6 billion and $3.3 billion, respectively, compared to net income of $916 million and $1.0 billion for the second quarter of 2023, respectively, given the impact of the Alpine AIPR&D expense in the second quarter of 2024.

Cash, cash equivalents and total marketable securities as of June 30, 2024 were $10.2 billion, compared to $13.7 billion as of December 31, 2023. The reduction in Vertex’s cash, cash equivalent and marketable securities balance compared to December 31, 2023, was due to the cash consideration paid to acquire Alpine in the second quarter of 2024, partially offset by positive cash flows provided by other operating activities.

Full Year 2024 Financial Guidance

Vertex today raised its full year product revenue guidance from $10.55-$10.75 billion to $10.65-$10.85 billion. Vertex’s product revenue guidance includes expectations for continued growth in CF as well as for the launch of CASGEVY® in approved indications and geographies. Given the impact of the Alpine acquisition, for 2024, Vertex is now providing guidance for both combined GAAP and Non-GAAP R&D and SG&A expenses and for AIPR&D expenses. Vertex continues to expect combined Non-GAAP R&D and SG&A expenses to be in a range of $4.2 billion to $4.3 billion for the full year. This includes Vertex’s expectations for continued investment in multiple mid- and late-stage clinical development programs and commercial and manufacturing capabilities and the inclusion of Alpine operating expenses for the remainder of 2024. Vertex now expects 2024 AIPR&D expenses of approximately $4.6 billion for the full year, including the Alpine acquisition-related charge in the second quarter of 2024.

Vertex’s updated financial guidance is summarized below:
https://news.vrtx.com/news-releases/news-release-details/vertex-reports-second-quarter-2024-financial-results



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