Vertex Reports Fourth Quarter and Full Year 2025 Financial Results

On February 12, 2026 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported consolidated financial results for the fourth quarter and full year ended December 31, 2025, and provided its full year 2026 financial guidance.

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"2025 marked a year of strong revenue growth, commercial diversification, and pipeline advancement," said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. "Our focus in 2026 remains on executing across the CF franchise, bringing CASGEVY to more patients around the globe and continuing to launch JOURNAVX, as we also prepare for the anticipated near‑term commercialization of povetacicept in IgAN. With expanding leadership in CF, exciting commercial momentum, and multiple mid- and late-stage programs advancing, Vertex is well positioned to deliver long‑term value for patients and shareholders."

Fourth Quarter 2025 Results

Total revenue increased 10% to $3.19 billion compared to the fourth quarter of 2024, primarily driven by the continued performance of cystic fibrosis (CF) therapies and additional growth from diversification into additional disease areas. In the U.S., total revenue increased 12% to $2.06 billion due to continued strong CF patient demand, including for ALYFTREK; a modest benefit from CF channel inventory; higher realized net prices in CF versus the prior year; and contributions from CASGEVY and JOURNAVX. Outside the U.S., total revenue increased 5% to $1.13 billion due to solid CF performance across multiple geographies and increased CASGEVY revenue.

Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses were $1.52 billion and $1.36 billion, respectively, in the fourth quarter of 2025, compared to $1.46 billion and $1.30 billion, respectively, for the fourth quarter of 2024. These increases were primarily due to commercial investment to support the launch of JOURNAVX in acute pain.

GAAP and non-GAAP effective tax rates were 10.5% and 13.5%, respectively, compared to 19.7% and 21.3%, respectively, for the fourth quarter of 2024. In the fourth quarter of 2025, the tax rates incorporated a one-time benefit from recognition of previously deferred tax credits and a change in estimated prior-year liabilities.

GAAP and non-GAAP net income were $1.2 billion and $1.3 billion, respectively, compared to $913 million and $1.0 billion, respectively, for the fourth quarter of 2024, primarily driven by increased product revenue.

Full Year 2025 Results

Total revenue of $12.0 billion increased 9% compared to 2024, primarily driven by the continued performance of CF therapies and early contributions from the three ongoing launches. In the U.S., total revenue increased 13% to $7.55 billion due to continued strong CF patient demand, including for ALYFTREK, and higher realized net prices in CF versus the prior year; as well as contributions from CASGEVY and JOURNAVX. Outside the U.S., total revenue increased 3% to $4.45 billion due to solid CF performance across multiple geographies and contributions from CASGEVY.

Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses were $5.8 billion and $5.1 billion, respectively, compared to $9.7 billion and $8.8 billion, respectively, in 2024. The decreases were primarily due to $4.4 billion of AIPR&D expenses associated with Vertex’s acquisition of Alpine Immune Sciences incurred in the second quarter of 2024, partially offset by increased R&D investment in support of multiple mid- and late-stage clinical development programs and increased commercial investment to support the launch of JOURNAVX.

GAAP and non-GAAP effective tax rates were 14.9% and 17.3%, respectively, compared to 315.5% and 91.0%, respectively, in 2024. In 2025, the effective tax rates were lower than U.S. statutory rates primarily due to one-time benefits from recognition of previously deferred tax credits and Alpine-related R&D tax credits. The GAAP effective tax rate also included excess tax benefits related to stock-based compensation.

GAAP and Non-GAAP net income were $4.0 billion and $4.7 billion, respectively, compared to a GAAP net loss of $(536) million and non-GAAP net income of $111 million, respectively, for 2024, reflecting the Alpine AIPR&D in 2024 and increased product revenue partially offset by increased operating expenses.

Cash, cash equivalents, and total marketable securities as of December 31, 2025, were $12.3 billion, compared to $11.2 billion as of December 31, 2024. The increase was primarily due to cash flows from operating activities, partially offset by repurchases of Vertex’s common stock pursuant to its share repurchase programs.

(Press release, Vertex Pharmaceuticals, FEB 12, 2026, View Source [SID1234666032])

DATROWAY® Supplemental New Drug Application Submitted in Japan for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy

On February 12, 2026 Daiichi Sankyo (TSE: 4568) reported the company has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for DATROWAY (datopotamab deruxtecan) for the treatment of adult patients with hormone receptor negative and HER2 negative unresectable or recurrent breast cancer, a subtype commonly referred to as triple negative breast cancer (TNBC).

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DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being developed and commercialized by Daiichi Sankyo in Japan.

The sNDA is based on data from the TROPION-Breast02 phase 3 trial presented at the 2025 European Society for Medical Oncology (#ESMO25) Congress. In the trial, DATROWAY demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) compared to investigator’s choice of chemotherapy as first-line treatment for patients with metastatic TNBC for whom immunotherapy was not an option.

"Metastatic triple negative breast cancer is highly aggressive and has one of the worst prognoses of any subtype of breast cancer," said Yuki Abe, PhD, Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "We are working as quickly as possible with the Japan health authority to make DATROWAY the first TROP2 directed antibody drug conjugate to become available in Japan for first-line triple negative breast cancer, addressing the unmet need for the seventy percent of patients in this setting who are not candidates for immunotherapy."

Additional regulatory submissions for DATROWAY in breast and lung cancer are underway globally.

About TROPION-Breast02
TROPION-Breast02 is a global, multicenter, randomized, open-label phase 3 trial evaluating the efficacy and safety of DATROWAY versus investigator’s choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, carboplatin or eribulin) in patients with previously untreated locally recurrent inoperable or metastatic TNBC for whom immunotherapy was not an option. This included patients whose tumors did not express PD-L1 as well as patients with PD-L1 expressing tumors who could not receive immunotherapy due to prior exposure in early-stage disease, comorbidities or immunotherapy not being accessible in their geography. Enrollment included patients with de novo or recurrent disease, regardless of disease-free interval, and those with poor prognostic factors such as stable brain metastases.

The dual primary endpoints of TROPION-Breast02 are PFS as assessed by blinded independent central review and OS. Secondary endpoints include PFS as assessed by investigator, objective response rate, duration of response, disease control rate, pharmacokinetics and safety.

TROPION-Breast02 enrolled 644 patients at sites in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov.

About Triple Negative Breast Cancer
TNBC accounts for approximately 15% of all breast cancer cases, with an estimated 345,000 diagnoses globally each year.1,2 In Japan, an estimated 12,700 cases of TNBC were diagnosed in 2024. 3,4 TNBC is diagnosed more frequently in younger and premenopausal women, and is more prevalent in Black and Hispanic women.5,6,7 Metastatic TNBC is the most aggressive type of breast cancer and has one of the worst prognoses, with median OS of just 12 to 18 months and only about 15% of patients living five years following diagnosis.8,9

While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of HER2, TNBC tests negative for all three.1 Due to its aggressive nature and absence of common breast cancer receptors, TNBC is characteristically difficult to treat.1 For patients with metastatic disease with PDL1 expressing tumors, the addition of immunotherapy to chemotherapy has improved outcomes in the firstline setting.2,3 However, for approximately 70% of patients with metastatic TNBC who are not candidates for immunotherapy, chemotherapy remains the only approved first-line treatment. 4,5

TROP2 is a protein broadly expressed in several solid tumors, including TNBC.6 TROP2 is associated with increased tumor progression and poor survival in patients with breast cancer.7,8

About DATROWAY
DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

DATROWAY (6 mg/kg) is approved in more than 40 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial.

About the DATROWAY Clinical Development Program
A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, TNBC and urothelial cancer. The program includes eight phase 3 trials in lung cancer, five phase 3 trials in breast cancer and one phase 2/3 trial in urothelial cancer evaluating DATROWAY as a monotherapy and in combination with other cancer treatments in various settings.

About the Daiichi Sankyo and AstraZeneca Collaboration
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU (trastuzumab deruxtecan) in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY.

About the ADC Portfolio of Daiichi Sankyo
The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo.

The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include ENHERTU and DATROWAY, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo.

An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING.

Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

(Press release, Daiichi Sankyo, FEB 12, 2026, View Source [SID1234665015])

Ipsen delivers strong results in 2025, driven by solid execution across all therapeutic areas, and provides 2026 guidance

On February 12, 2026 Ipsen, a global specialty-care biopharmaceutical company, reported its financial results for the full year (FY) 2025 and for the fourth quarter of 2025.

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(Press release, Ipsen, FEB 12, 2026, View Source [SID1234663550])

FY 2025 results

On February 12, 2026 Ipsen reported full year 2025 results.

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(Presentation, Ipsen, FEB 12, 2026, View Source [SID1234663546])

Orion Full-Year 2025 Result Presentation

On February 12, 2026 Orion reported Full-Year 2025 Results.

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(Presentation, Orion, FEB 12, 2026, View Source [SID1234663023])