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Vertex Reports Fourth Quarter and Full Year 2023 Financial Results

— Full year product revenue of $9.87 billion, an 11% increase compared to full year 2022 —

— Company provides full year 2024 product revenue guidance of $10.55 to $10.75 billion —

— CASGEVYTM approved in the U.S., Great Britain, the Kingdom of Saudi Arabia and Bahrain —

— Vertex on track to submit new drug applications (NDAs) to the FDA by mid-2024 for both VX-548 in Acute Pain and the Vanzacaftor Triple in CF —

— Broad and deep clinical-stage pipeline continues to advance across 10 disease areas —

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the fourth quarter and full year ended December 31, 2023 and provided full year 2024 financial guidance.


“2023 was a transformative year for Vertex as we continued our strong performance, including 11% revenue growth, combined with significant advancement across the business. We expanded our leadership in CF, diversified our commercial opportunity with CASGEVY regulatory approvals in multiple regions, and rapidly advanced a broad pipeline with multiple additional near-term potential launch opportunities in disease areas outside of CF,” said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. “Our progress in 2023 lays the foundation for the anticipated regulatory submissions for the vanzacaftor triple and VX-548 by mid-2024 and sets us on a path to expand our business in CF and beyond, beginning with the commercialization of CASGEVY in multiple geographies.”

Fourth Quarter 2023 Results

Product revenue increased 9% to $2.52 billion compared to the fourth quarter of 2022, primarily driven in the U.S. by the continued performance of TRIKAFTA, including the uptake in children with CF 2 to 5 years of age, and in ex-U.S. markets by the continued strong uptake of TRIKAFTA/KAFTRIO, including label extensions in younger age groups. Net product revenue in the fourth quarter of 2023 increased 8% to $1.57 billion in the U.S. and increased 12% to $943 million outside the U.S., compared to the fourth quarter of 2022.

Combined GAAP and Non-GAAP R&D, Acquired IPR&D and SG&A expenses were $1.2 billion and $1.0 billion, respectively, compared to $984 million and $872 million, respectively, in the fourth quarter of 2022. The increases were due to increased investment in support of multiple programs that have advanced in mid- and late-stage clinical development and the costs to support launches of Vertex’s therapies globally. Combined GAAP R&D, Acquired IPR&D and SG&A expenses also included increased stock-based compensation expense compared to the fourth quarter of 2022.

GAAP effective tax rate was 15.6% compared to 24.0% for the fourth quarter of 2022 based on increased benefits from R&D tax credits and a lower provision from uncertain tax positions.

Non-GAAP effective tax rate was 16.3% compared to 18.5% for the fourth quarter of 2022 as a result of increased benefits from R&D tax credits for the current year. Please refer to Note 1 for further details on our GAAP to Non-GAAP tax adjustments.

GAAP and Non-GAAP net income increased by 18% and 12%, respectively, compared to the fourth quarter of 2022, primarily due to higher interest income and lower taxes.

Full Year 2023 Results

Product revenue increased 11% to $9.87 billion compared to 2022, primarily driven by the continued strong uptake of TRIKAFTA/KAFTRIO in ex-U.S. markets, including label extensions in younger age groups, and the continued performance of TRIKAFTA in the U.S, including the ongoing launch in children with CF 2 to 5 years of age. Net product revenue in 2023 increased 6% to $6.04 billion in the U.S. and increased 18% to $3.83 billion outside the U.S., compared to 2022.

Combined GAAP and Non-GAAP R&D, Acquired IPR&D and SG&A expenses were $4.83 billion and $4.24 billion, respectively, compared to $3.60 billion and $3.07 billion, respectively, in 2022. The increases were due to increased investment in support of multiple programs that have advanced in mid- and late-stage clinical development, the costs to support launches of Vertex’s therapies globally, and increased acquired IPR&D expenses.

GAAP effective tax rate was 17.4% compared to 21.5% in 2022, largely as a result of higher U.S. R&D tax credits for the current and prior years.

Non-GAAP effective tax rate was 19.4% compared to 20.8% in 2022, also largely as a result of higher U.S. R&D tax credits for the current year. Please refer to Note 1 for further details on our GAAP to Non-GAAP tax adjustments.

GAAP and Non-GAAP net income increased by 9% and 3%, respectively, compared to 2022, primarily due to higher interest income and lower taxes.

Cash, cash equivalents and total marketable securities as of December 31, 2023 were $13.7 billion, compared to $10.9 billion as of December 31, 2022. The increase was primarily due to income from operations that was driven by strong revenue growth, and interest income, partially offset by income tax payments and repurchases of our common stock pursuant to our share repurchase program.

Full Year 2024 Financial Guidance

Vertex today provided full year 2024 financial guidance. Vertex’s product revenue guidance of $10.55 billion to $10.75 billion includes expectations for continued growth in CF as well as the launch of CASGEVY in approved indications and geographies. Vertex’s combined Non-GAAP R&D, Acquired IPR&D and SG&A expense guidance of $4.3 billion to $4.4 billion includes expectations for continued investment in our multiple mid and late-stage clinical development programs, commercial and manufacturing capabilities, and approximately $125 million of upfront and milestone payments.

Vertex’s financial guidance is summarized below:

 

FY 2024

 

 

Total product revenues

$10.55 to $10.75 billion

 

 

Combined GAAP R&D, Acquired IPR&D and SG&A expenses (2)

$4.9 to $5.1 billion

Combined Non-GAAP R&D, Acquired IPR&D and SG&A expenses (2)

$4.3 to $4.4 billion

Non-GAAP effective tax rate

20% to 21%

Key Business Highlights

Marketed Products

Cystic Fibrosis (CF) Portfolio

Vertex anticipates the number of CF patients taking our medicines will continue to grow, including through new approvals and reimbursement for the treatment of younger patients. Recent and anticipated progress includes:

Sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT): CASGEVY

Potential Near-Term Launch Opportunities

Vertex is preparing for the following near-term potential new product launches:

Select Clinical-Stage R&D Pipeline

Vertex is delivering on a diversified pipeline of potentially transformative medicines for serious diseases utilizing a range of modalities. Recent and anticipated progress for select programs in clinical development is summarized below.

Cystic Fibrosis

Vertex continues to pursue a nebulized mRNA therapy for the more than 5,000 patients who do not make CFTR protein and cannot benefit from CFTR modulators, as well as next-in-class, small molecule, oral CFTR modulators.

Sickle Cell Disease and Beta Thalassemia

Peripheral Neuropathic Pain (PNP)

Acute Pain

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 target an underlying genetic driver of kidney disease.

Type 1 Diabetes (T1D)

Vertex is evaluating cell therapies using stem cell-derived, fully differentiated, insulin-producing islet cells to replace the endogenous insulin-producing islet cells that are destroyed in people with T1D, with the goal of developing a potential one-time functional cure for this disease.

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 (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 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, Acquired IPR&D and SG&A expenses and effective tax rate on a non-GAAP basis. Unless otherwise noted, the guidance regarding combined GAAP and non-GAAP R&D, Acquired IPR&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

(in millions, except per share amounts)(unaudited)

 

 

Three Months Ended

December 31,

 

Twelve Months Ended

December 31,

 

2023

 

2022

 

2023

 

2022

Product revenues, net

$

2,517.7

 

 

$

2,302.7

 

 

$

9,869.2

 

 

$

8,930.7

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales

 

368.0

 

 

 

283.3

 

 

 

1,262.2

 

 

 

1,080.3

 

Research and development expenses

 

824.6

 

 

 

694.1

 

 

 

3,162.9

 

 

 

2,540.3

 

Acquired in-process research and development expenses

 

17.8

 

 

 

22.6

 

 

 

527.1

 

 

 

115.5

 

Selling, general and administrative expenses

 

369.1

 

 

 

267.4

 

 

 

1,136.6

 

 

 

944.7

 

Change in fair value of contingent consideration

 

(50.3

)

 

 

1.8

 

 

 

(51.6

)

 

 

(57.5

)

Total costs and expenses

 

1,529.2

 

 

 

1,269.2

 

 

 

6,037.2

 

 

 

4,623.3

 

Income from operations

 

988.5

 

 

 

1,033.5

 

 

 

3,832.0

 

 

 

4,307.4

 

Interest income

 

179.5

 

 

 

86.0

 

 

 

614.7

 

 

 

144.6

 

Interest expense

 

(10.6

)

 

 

(11.6

)

 

 

(44.1

)

 

 

(54.8

)

Other expense, net

 

(9.8

)

 

 

(31.1

)

 

 

(22.8

)

 

 

(164.8

)

Income before provision for income taxes

 

1,147.6

 

 

 

1,076.8

 

 

 

4,379.8

 

 

 

4,232.4

 

Provision for income taxes

 

178.8

 

 

 

257.9

 

 

 

760.2

 

 

 

910.4

 

Net income

$

968.8

 

 

$

818.9

 

 

$

3,619.6

 

 

$

3,322.0

 

 

 

 

 

 

 

 

 

Net income per common share:

 

 

 

 

 

 

 

Basic

$

3.76

 

 

$

3.19

 

 

$

14.05

 

 

$

12.97

 

Diluted

$

3.71

 

 

$

3.15

 

 

$

13.89

 

 

$

12.82

 

Shares used in per share calculations:

 

 

 

 

 

 

 

Basic

 

257.7

 

 

 

256.9

 

 

 

257.7

 

 

 

256.1

 

Diluted

 

260.9

 

 

 

260.3

 

 

 

260.5

 

 

 

259.1

 

 

Vertex Pharmaceuticals Incorporated

Product Revenues

(in millions)(unaudited)

 

 

Three Months Ended

December 31,

 

Twelve Months Ended

December 31,

 

2023

 

2022

 

2023

 

2022

TRIKAFTA/KAFTRIO

$

2,333.3

 

$

2,021.5

 

$

8,944.7

 

$

7,686.8

Other CF products

 

184.4

 

 

281.2

 

 

924.5

 

 

1,243.9

Product revenues, net

$

2,517.7

 

$

2,302.7

 

$

9,869.2

 

$

8,930.7

 

Vertex Pharmaceuticals Incorporated

Reconciliation of GAAP to Non-GAAP Financial Information

(in millions, except percentages)(unaudited)

 

 

Three Months Ended

December 31,

 

Twelve Months Ended

December 31,

 

2023

 

2022

 

2023

 

2022

GAAP cost of sales

$

368.0

 

 

$

283.3

 

 

$

1,262.2

 

 

$

1,080.3

 

Stock-based compensation expense

 

(2.1

)

 

 

(2.4

)

 

 

(7.5

)

 

 

(9.4

)

Intangible asset amortization expense

 

(1.7

)

 

 

 

 

 

(1.7

)

 

 

 

Non-GAAP cost of sales

$

364.2

 

 

$

280.9

 

 

$

1,253.0

 

 

$

1,070.9

 

 

 

 

 

 

 

 

 

GAAP research and development expenses

$

824.6

 

 

$

694.1

 

 

$

3,162.9

 

 

$

2,540.3

 

Stock-based compensation expense

 

(123.0

)

 

 

(68.0

)

 

 

(354.9

)

 

 

(297.9

)

Intangible asset impairment charge (3)

 

 

 

 

 

 

 

 

 

 

(13.0

)

Acquisition-related costs (4)

 

(2.8

)

 

 

(2.8

)

 

 

(11.3

)

 

 

(24.9

)

Non-GAAP research and development expenses

$

698.8

 

 

$

623.3

 

 

$

2,796.7

 

 

$

2,204.5

 

 

 

 

 

 

 

 

 

Acquired in-process research and development expenses

$

17.8

 

 

$

22.6

 

 

$

527.1

 

 

$

115.5

 

 

 

 

 

 

 

 

 

GAAP selling, general and administrative expenses

$

369.1

 

 

$

267.4

 

 

$

1,136.6

 

 

$

944.7

 

Stock-based compensation expense

 

(83.5

)

 

 

(41.1

)

 

 

(218.8

)

 

 

(184.0

)

Acquisition-related costs (4)

 

 

 

 

(0.7

)

 

 

 

 

 

(13.9

)

Non-GAAP selling, general and administrative expenses

$

285.6

 

 

$

225.6

 

 

$

917.8

 

 

$

746.8

 

 

 

 

 

 

 

 

 

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

$

1,002.2

 

 

$

871.5

 

 

$

4,241.6

 

 

$

3,066.8

 

 

 

 

 

 

 

 

 

GAAP other expense, net

$

(9.8

)

 

$

(31.1

)

 

$

(22.8

)

 

$

(164.8

)

Decrease in fair value of strategic investments

 

0.4

 

 

 

6.0

 

 

 

0.6

 

 

 

149.1

 

Non-GAAP other expense, net

$

(9.4

)

 

$

(25.1

)

 

$

(22.2

)

 

$

(15.7

)

 

 

 

 

 

 

 

 

GAAP provision for income taxes

$

178.8

 

 

$

257.9

 

 

$

760.2

 

 

$

910.4

 

Tax adjustments (1)

 

35.5

 

 

 

(36.3

)

 

 

194.7

 

 

 

101.7

 

Non-GAAP provision for income taxes

$

214.3

 

 

$

221.6

 

 

$

954.9

 

 

$

1,012.1

 

 

GAAP effective tax rate

 

15.6

%

 

24.0

%

 

17.4

%

 

21.5

%

Non-GAAP effective tax rate

 

16.3

%

 

18.5

%

 

19.4

%

 

20.8

%

 

Contacts

Vertex:
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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