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Vertex Reports Third Quarter 2025 Financial Results

— Total revenue of $3.08 billion, an 11% increase compared to Q3 2024 —

— Refined full year financial guidance: total revenue guidance now $11.9 to $12.0 billion and total combined non-GAAP R&D, AIPR&D, and SG&A expense guidance now $5.0 to $5.1 billion —

— R&D pipeline continues to make progress: five programs in pivotal development and povetacicept Phase 3 IgAN trial full enrollment complete; on track to submit first module of povetacicept IgAN BLA to FDA by end of 2025 —

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the third quarter ended September 30, 2025, and refined full year 2025 financial guidance.


“Vertex delivered strong results across the board in the third quarter, extending our leadership in CF, continuing to build global momentum for CASGEVY, and advancing the launch of JOURNAVX in acute pain,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “We also delivered strong progress across the R&D pipeline, with completion of enrollment in the Phase 3 study of povetacicept in IgAN, initiation of the Phase 2/3 study of povetacicept in primary membranous nephropathy, as well as advancement of several programs in research and earlier-stage clinical development. For the remainder of 2025, we are focused on executing the ongoing launches, initiating the povetacicept BLA submission in IgAN for potential U.S. accelerated approval, advancing the pipeline, and preparing for new launches in additional disease areas.”

Third Quarter 2025 Results

Total revenue increased 11% to $3.08 billion compared to the third quarter of 2024, primarily driven by the continued performance of cystic fibrosis (CF) therapies and early contributions from the three ongoing launches. In the U.S., total revenue increased 15% to $1.98 billion due to continued strong CF patient demand, including for ALYFTREK; contributions from CASGEVY and JOURNAVX; and favorable net pricing in CF versus the prior year. Outside the U.S., total revenue increased 4% to $1.10 billion due to solid performance across multiple geographies.

Combined GAAP and non-GAAP R&D, Acquired IPR&D and SG&A expenses were $1.5 billion and $1.3 billion, respectively, compared to $1.3 billion and $1.1 billion, respectively, in the third quarter of 2024. The increases were primarily due to increased R&D investment in support of multiple mid- and late-stage clinical development programs, increased commercial investment to support the launch of JOURNAVX in acute pain, and higher AIPR&D.

GAAP and non-GAAP effective tax rates were 16.6% and 17.6%, respectively, compared to 14.6% and 19.8%, respectively, for the third quarter of 2024. In each of the third quarters of 2025 and 2024, the tax rate benefited from increased R&D tax credits.

GAAP and non-GAAP net income were $1.1 billion and $1.2 billion, respectively, compared to $1.0 billion and $1.1 billion, respectively, for the third quarter of 2024, primarily driven by increased product revenue partially offset by increased operating expenses.

Cash, cash equivalents, and total marketable securities as of September 30, 2025, were $12.0 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.

Full Year 2025 Financial Guidance

Vertex today refined its full year 2025 revenue guidance with total revenue now expected to be $11.9 to $12.0 billion, which assumes continued growth in CF, including the global launch of ALYFTREK; continued uptake of CASGEVY in multiple regions; and early contributions from the U.S. launch of JOURNAVX. Vertex is also revising full year 2025 guidance for combined GAAP and non-GAAP operating expenses. Combined GAAP and non-GAAP R&D, AIPR&D, and SG&A expenses are now expected to be approximately $5.65 to $5.8 billion and $5.0 to $5.1 billion, respectively. This revised outlook accounts for acceleration of povetacicept programs and increased investment in sales and marketing initiatives for JOURNAVX in acute pain. In addition, Vertex lowered its prior non-GAAP effective tax rate guidance of 20.5% to 21.5% to a new range of 17% to 18% to incorporate several one-time tax benefits. These include one-time tax benefits recognized in the third quarter of 2025 from Alpine-related R&D tax credits, as well as anticipated recognition in the fourth quarter of 2025 of previously deferred tax benefits. This financial guidance also includes an immaterial cost impact from tariffs in 2025 based on currently known tariff rates and regulations.

Vertex’s financial guidance is summarized below:

 

Current FY 2025

 

Previous FY 2025

 

 

 

 

Total revenue

$11.9 to $12.0 billion

 

$11.85 to $12.0 billion

 

 

 

 

Combined GAAP R&D, AIPR&D and SG&A expenses *

$5.65 to $5.8 billion

 

$5.55 to $5.7 billion

Combined non-GAAP R&D, AIPR&D and SG&A expenses *

$5.0 to $5.1 billion

 

$4.9 to $5.0 billion

Non-GAAP effective tax rate

17% to 18%

 

20.5% to 21.5%

 

*The difference between the combined GAAP R&D, AIPR&D and SG&A expenses and the combined non-GAAP R&D, AIPR&D and SG&A expenses guidance relates primarily to $650 million to $700 million of stock-based compensation expense.

**Combined GAAP and Non-GAAP R&D, AIPR&D and SG&A expenses guidance includes approximately $100 million of AIPR&D expenses.

Key Business Highlights

Marketed Products

Cystic Fibrosis (CF) Portfolio

Vertex has worked for more than 20 years to discover and develop medicines to treat the underlying cause of CF. Vertex CFTR modulators can treat nearly 95 percent of all people living with CF in core markets and are approved for patients as young as one month old. ALYFTREK, the newest marketed CFTR modulator, is approved in the U.S., the United Kingdom (U.K.), the European Union (EU), Canada, New Zealand, and Switzerland for the treatment of patients 6 years and older. Vertex anticipates that the number of CF patients taking its medicines will continue to grow through new approvals and reimbursement agreements, treatment of younger patients, increased survival, and expansion into additional geographies. Recent progress includes:

CASGEVY for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)

CASGEVY is a non-viral, ex vivo, CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT that has been shown to reduce or eliminate vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved in the U.S., Great Britain, the EU, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain (Bahrain), Qatar, Canada, Switzerland, and the United Arab Emirates (UAE) for the treatment of both SCD and TDT. In total, there are more than 60,000 eligible patients in these countries, including approximately 37,000 in North America and Europe and more than 23,000 in the Middle East. Recent highlights include:

JOURNAVX (suzetrigine) for the treatment of moderate-to-severe acute pain

JOURNAVX is a first-in-class, oral, selective, non-opioid NaV1.8 pain signal inhibitor, approved in the U.S. for the treatment of moderate-to-severe acute pain.

Select Clinical-Stage Pipeline Programs

Cystic Fibrosis

Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Peripheral Neuropathic Pain (PNP)

Type 1 Diabetes (T1D)

Vertex is evaluating stem cell-derived, fully differentiated islet cell therapies for patients suffering from T1D, with the goal of developing a potential one-time functional cure for this disease.

IgA Nephropathy (IgAN), Primary Membranous Nephropathy (pMN), and Other B Cell-Mediated Diseases

Vertex is developing povetacicept for multiple diseases. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which play key roles in the pathogenesis of multiple B cell-mediated diseases. Povetacicept represents a potentially best-in-class approach to control B cell activity in IgAN and pMN and has pipeline-in-a-product potential.

APOL1-Mediated Kidney Disease (AMKD)

Vertex has discovered and advanced multiple oral, small molecule inhibitors of APOL1 function, pioneering a new class of medicines that targets the underlying cause of this genetic kidney disease.

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Vertex is developing small molecule correctors that restore function to the variant polycystin 1 (PC1) protein, with the goal of addressing the underlying cause of ADPKD.

Myotonic Dystrophy Type 1 (DM1)

Vertex is evaluating multiple approaches that target the underlying cause of DM1. Vertex’s lead approach, VX-670, is an oligonucleotide linked to a cyclic peptide, which holds the potential to promote effective delivery into cells and address the causal biology of DM1.

Additional Earlier Stage R&D Programs

Consistent with its overall strategy, Vertex takes a portfolio approach to all of its programs, with additional assets or approaches in CF, SCD, TDT, pain, AMKD, T1D, DM1, and ADPKD in earlier stages of development. Additionally, Vertex is working on preclinical molecules with the potential to expand its leadership in existing disease areas, including assets targeting improved immunosuppression for zimislecel, gentler conditioning for CASGEVY, and inhibition of NaV1.7 in pain.

Non-GAAP Financial Measures

In this press release, Vertex’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. In particular, non-GAAP financial results and guidance exclude from Vertex’s pre-tax income (loss) (i) stock-based compensation expense, (ii) intangible asset amortization expense, (iii) gains or losses related to the fair value of the company’s strategic investments, (iv) increases or decreases in the fair value of contingent consideration, (v) acquisition-related costs, (vi) an intangible asset impairment charge, and (vii) other adjustments. The company’s non-GAAP financial results also exclude from its provision for income taxes the estimated tax impact related to its non-GAAP adjustments to pre-tax income (loss) described above and certain discrete items. These results should not be viewed as a substitute for the company’s GAAP results and are provided as a complement to results provided in accordance with GAAP. Management believes these non-GAAP financial measures help indicate underlying trends in the company’s business, are important in comparing current results with prior period results and provide additional information regarding the company’s financial position that the company believes is helpful to an understanding of its ongoing business. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally, to manage the company’s business and to evaluate its performance. The company’s calculation of non-GAAP financial measures likely differs from the calculations used by other companies. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.

The company provides guidance regarding combined R&D, AIPR&D and SG&A expenses and effective tax rate on a non-GAAP basis. Unless otherwise noted, the guidance regarding combined R&D, AIPR&D and SG&A expenses does not include estimates associated with any potential future business development transactions, including collaborations, asset acquisitions and/or licensing of third-party intellectual property rights. The company does not provide guidance regarding its GAAP effective tax rate because it is unable to forecast with reasonable certainty the impact of excess tax benefits related to stock-based compensation and the possibility of certain discrete items, which could be material.

Vertex Pharmaceuticals Incorporated

Consolidated Statements of Income (Loss)

(unaudited, in millions, except per share amounts)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

2025

 

 

 

2024

 

 

 

2025

 

 

 

2024

 

Revenues:

 

 

 

 

 

 

 

Product revenues, net

$

3,076.4

 

 

$

2,771.9

 

 

$

8,780.6

 

 

$

8,108.1

 

Other revenues

 

 

 

 

 

 

 

30.7

 

 

 

 

Total revenues

 

3,076.4

 

 

 

2,771.9

 

 

 

8,811.3

 

 

 

8,108.1

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales

 

414.8

 

 

 

392.6

 

 

 

1,185.3

 

 

 

1,107.1

 

Research and development expenses

 

977.7

 

 

 

875.9

 

 

 

2,935.8

 

 

 

2,631.6

 

Acquired in-process research and development expenses

 

54.5

 

 

 

15.0

 

 

 

76.5

 

 

 

4,540.9

 

Selling, general and administrative expenses

 

445.1

 

 

 

371.8

 

 

 

1,266.1

 

 

 

1,086.7

 

Intangible asset impairment charge

 

 

 

 

 

 

 

379.0

 

 

 

 

Change in fair value of contingent consideration

 

(1.9

)

 

 

0.3

 

 

 

1.2

 

 

 

0.7

 

Total costs and expenses

 

1,890.2

 

 

 

1,655.6

 

 

 

5,843.9

 

 

 

9,367.0

 

Income (loss) from operations

 

1,186.2

 

 

 

1,116.3

 

 

 

2,967.4

 

 

 

(1,258.9

)

Interest income

 

125.7

 

 

 

132.2

 

 

 

369.0

 

 

 

469.9

 

Interest expense

 

(3.3

)

 

 

(7.5

)

 

 

(10.0

)

 

 

(27.8

)

Other expense, net

 

(9.8

)

 

 

(16.9

)

 

 

(14.2

)

 

 

(71.2

)

Income (loss) before provision for income taxes

 

1,298.8

 

 

 

1,224.1

 

 

 

3,312.2

 

 

 

(888.0

)

Provision for income taxes

 

215.9

 

 

 

178.7

 

 

 

550.1

 

 

 

560.6

 

Net income (loss)

$

1,082.9

 

 

$

1,045.4

 

 

$

2,762.1

 

 

$

(1,448.6

)

 

 

 

 

 

 

 

 

Net income (loss) per common share:

 

 

 

 

 

 

 

Basic

$

4.24

 

 

$

4.05

 

 

$

10.77

 

 

$

(5.61

)

Diluted

$

4.20

 

 

$

4.01

 

 

$

10.68

 

 

$

(5.61

)

Shares used in per share calculations:

 

 

 

 

 

 

 

Basic

 

255.6

 

 

 

258.0

 

 

 

256.4

 

 

 

258.1

 

Diluted

 

257.6

 

 

 

261.0

 

 

 

258.6

 

 

 

258.1

 

Vertex Pharmaceuticals Incorporated

Total Revenues

(unaudited, in millions)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

TRIKAFTA/KAFTRIO

$

2,653.6

 

$

2,585.0

 

$

7,740.2

 

$

7,517.8

ALYFTREK

 

247.0

 

 

 

 

457.7

 

 

Other product revenues (1)

 

175.8

 

 

186.9

 

 

582.7

 

 

590.3

Product revenues, net

 

3,076.4

 

 

2,771.9

 

 

8,780.6

 

 

8,108.1

Other revenues

 

 

 

 

 

30.7

 

 

Total revenues

$

3,076.4

 

$

2,771.9

 

$

8,811.3

 

$

8,108.1

 

1: In the three and nine months ended September 30, 2025, “Other product revenues” included $16.9 million and $61.5 million from CASGEVY, respectively, and $19.6 million and $32.9 million, respectively, from JOURNAVX. In the three and nine months ended September 30, 2024, “Other product revenues” included $2.0 million from CASGEVY and no revenues from JOURNAVX. The remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.

Vertex Pharmaceuticals Incorporated

Reconciliation of GAAP to Non-GAAP Financial Information

(unaudited, in millions, except percentages)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

2025

 

 

 

2024

 

 

 

2025

 

 

 

2024

 

GAAP cost of sales

$

414.8

 

 

$

392.6

 

 

$

1,185.3

 

 

$

1,107.1

 

Stock-based compensation expense

 

(2.8

)

 

 

(1.9

)

 

 

(7.9

)

 

 

(5.5

)

Intangible asset amortization expense

 

(5.0

)

 

 

(5.0

)

 

 

(15.1

)

 

 

(15.1

)

Non-GAAP cost of sales

$

407.0

 

 

$

385.7

 

 

$

1,162.3

 

 

$

1,086.5

 

 

 

 

 

 

 

 

 

GAAP research and development expenses

$

977.7

 

 

$

875.9

 

 

$

2,935.8

 

 

$

2,631.6

 

Stock-based compensation expense

 

(116.0

)

 

 

(111.0

)

 

 

(315.7

)

 

 

(327.5

)

Intangible asset amortization expense

 

(0.6

)

 

 

(0.9

)

 

 

(1.9

)

 

 

(0.9

)

Acquisition-related costs (2)

 

 

 

 

 

 

 

 

 

 

(172.3

)

Non-GAAP research and development expenses

$

861.1

 

 

$

764.0

 

 

$

2,618.2

 

 

$

2,130.9

 

 

 

 

 

 

 

 

 

Acquired in-process research and development expenses

$

54.5

 

 

$

15.0

 

 

$

76.5

 

 

$

4,540.9

 

 

 

 

 

 

 

 

 

GAAP selling, general and administrative expenses

$

445.1

 

 

$

371.8

 

 

$

1,266.1

 

 

$

1,086.7

 

Stock-based compensation expense

 

(76.1

)

 

 

(71.7

)

 

 

(204.7

)

 

 

(197.7

)

Acquisition-related costs (2)

 

 

 

 

 

 

 

 

 

 

(36.5

)

Non-GAAP selling, general and administrative expenses

$

369.0

 

 

$

300.1

 

 

$

1,061.4

 

 

$

852.5

 

 

 

 

 

 

 

 

 

Combined non-GAAP R&D, AIPR&D and SG&A expenses

$

1,284.6

 

 

$

1,079.1

 

 

$

3,756.1

 

 

$

7,524.3

 

 

 

 

 

 

 

 

 

GAAP other expense, net

$

(9.8

)

 

$

(16.9

)

 

$

(14.2

)

 

$

(71.2

)

Decrease in fair value of strategic investments

 

2.6

 

 

 

10.8

 

 

 

12.2

 

 

 

50.5

 

Non-GAAP other expense, net

$

(7.2

)

 

$

(6.1

)

 

$

(2.0

)

 

$

(20.7

)

 

 

 

 

 

 

 

 

GAAP provision for income taxes

$

215.9

 

 

$

178.7

 

 

$

550.1

 

 

$

560.6

 

Tax adjustments (3)

 

47.8

 

 

 

104.0

 

 

 

240.0

 

 

 

283.8

 

Non-GAAP provision for income taxes

$

263.7

 

 

$

282.7

 

 

$

790.1

 

 

$

844.4

 

Contacts

Vertex Contacts:
Investor Relations:
Susie Lisa, CFA, 617-341-6108

Manisha Pai, 617-961-1899

Miroslava Minkova, 617-341-6135

Media:
617-341-6992

mediainfo@vrtx.com

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