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Vertex Reports Third-Quarter 2019 Financial Results

– Product revenues of $950 million, a 21% increase compared to Q3 2018 –

– Continued progression of pipeline of investigational medicines in multiple diseases –

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the third quarter ended September 30, 2019 and reiterated its full-year 2019 total product revenue guidance.

“2019 has been a year of significant progress for Vertex across all parts of our business. With the historic approval of TRIKAFTA, we are now one step closer to providing treatment for up to 90% of all people with CF. We’ve also had tremendous success bringing our CF medicines to more patients globally with reimbursement agreements recently reached in England, Spain, Australia, and Scotland, and through label expansions to younger patients,” said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. “The company also continues to successfully execute on our strategy of creating transformative medicines for serious diseases through serial innovation. The rapid progress of our pipeline is expected to yield proof-of-concept data in multiple diseases in 2020, which will position Vertex for continued growth in the years ahead.”

Third-Quarter 2019 Financial Highlights

 

Three Months Ended September 30,

 

%

 

2019

 

2018

 

Change

 

(in millions, except per share amounts)

Total product revenues, net

$

950

 

 

 

$

783

 

 

 

21%

KALYDECO

$

249

 

 

 

$

246

 

 

 

 

ORKAMBI

$

297

 

 

 

$

282

 

 

 

 

SYMDEKO/SYMKEVI

$

404

 

 

 

$

255

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GAAP Operating income

$

99

 

 

 

$

206

 

 

 

(52)%

Non-GAAP Operating income

$

403

 

 

 

$

295

 

 

 

37%

 

 

 

 

 

 

 

 

 

 

GAAP Net income

$

58

 

 

 

$

129

 

 

 

(55)%

Non-GAAP Net income

$

322

 

 

 

$

282

 

 

 

14%

 

 

 

 

 

 

 

 

 

 

GAAP Net income per share – diluted

$

0.22

 

 

 

$

0.50

 

 

 

(56)%

Non-GAAP Net income per share – diluted

$

1.23

 

 

 

$

1.09

 

 

 

13%

 

Total product revenues increased 21% compared to the third quarter of 2018, primarily driven by the global uptake of SYMDEKO and SYMKEVI in patients ages 12 and older.

GAAP net income decreased compared to the third quarter of 2018, primarily driven by a $175 million upfront payment as part of Vertex’s recently expanded collaboration with CRISPR Therapeutics, and was partially offset by the strong growth in total product revenues.

Non-GAAP net income increased compared to the third quarter of 2018, driven by the strong growth in total product revenues, and was partially offset by increased operating expenses and income taxes.

Cash, cash equivalents and marketable securities as of September 30, 2019 were $4.0 billion, an increase of approximately $800 million compared to $3.2 billion as of December 31, 2018.

Third-Quarter 2019 Expenses

 

Three Months Ended September 30,

 

2019

 

2018

 

(in millions)

Combined GAAP R&D and SG&A expenses

$

716

 

 

 

$

468

 

 

Combined Non-GAAP R&D and SG&A expenses

$

416

 

 

 

$

379

 

 

 

 

 

 

 

 

 

 

GAAP R&D expense

$

556

 

 

 

$

331

 

 

Non-GAAP R&D expense

$

290

 

 

 

$

274

 

 

 

 

 

 

 

 

 

 

GAAP SG&A expense

$

160

 

 

 

$

137

 

 

Non-GAAP SG&A expense

$

127

 

 

 

$

105

 

 

 

 

 

 

 

 

 

 

GAAP income taxes

$

13

 

 

 

$

8

 

 

Non-GAAP income taxes

$

84

 

 

 

$

5

 

 

Combined GAAP R&D and SG&A expenses increased compared to the third quarter of 2018, primarily due to the $175 million upfront payment to CRISPR Therapeutics.

Combined Non-GAAP R&D and SG&A expenses increased compared to the third quarter of 2018, primarily due to the incremental investment to support the global use of Vertex’s medicines and the expansion of Vertex’s pipeline in CF and other new disease areas.

GAAP and Non-GAAP income taxes increased significantly compared to the third quarter of 2018 due to Vertex’s release of its valuation allowance on the majority of its deferred tax assets in the fourth quarter of 2018. GAAP and non-GAAP income taxes in the third quarter of 2019 include a provision for income taxes on Vertex’s pre-tax income using an estimated effective tax rate approximating statutory rates. This provision for income taxes includes a significant non-cash charge due to Vertex’s ability to offset its pre-tax income against previously benefited net operating losses. Refer to “Supplemental Income Tax Information” for discussion of the cash versus non-cash components of Vertex’s provision for income taxes.

Full-Year 2019 Financial Guidance

Vertex today reiterated its 2019 revenue guidance that was updated on October 21, 2019. A summary of the company’s current financial expectations is below:

 

 

Current FY 2019

 

Previous FY 2019

 

 

 

 

 

 

 

 

 

TOTAL product revenues

 

Unchanged

 

 

$

3.70 to 3.75 billion

 

 

 

 

 

 

 

 

 

Combined GAAP R&D and SG&A expenses

$

2.35 to 2.45 billion

 

 

$

2.25 to 2.40 billion

 

Combined Non-GAAP R&D and SG&A expenses

 

Unchanged

 

 

$

1.65 to 1.70 billion

 

Non-GAAP effective tax rate

 

Unchanged

 

 

 

21% to 22%

 

Clinical Development

Cystic Fibrosis (CF):

Alpha-1 Antitrypsin (AAT) Program:

Sickle Cell Disease and Beta Thalassemia:

APOL1-Mediated Kidney Diseases:

Pain:

Investments in External Innovation

Type 1 Diabetes:

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) revenues and expenses related to business development transactions including collaboration agreements, asset acquisitions and consolidated variable interest entities, (iii) gains or losses related to the fair value of the company’s strategic investments, (iv) acquisition-related costs and (v) other adjustments. The company’s non-GAAP financial results also exclude from its provision for or benefit from income taxes the estimated tax impact related to its non-GAAP adjustments to pre-tax income described above. These results are provided as a complement to results provided in accordance with GAAP because 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. Management also uses these non-GAAP financial measures to establish budgets and operational goals that are communicated internally and externally and to manage the company’s business and to evaluate its performance. The company adjusts, where appropriate, for both revenues and expenses in order to reflect the company’s operations. The company provides guidance regarding product revenues in accordance with GAAP and provides guidance regarding combined research and development and sales, general, and administrative expenses on both a GAAP and non-GAAP basis. The company also provides guidance regarding its anticipated income taxes as a percentage of pre-tax income on a non-GAAP basis. The guidance regarding GAAP research and development expenses and sales, general and administrative expenses does not include estimates associated with any potential future business development activities. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial information.

 

Vertex Pharmaceuticals Incorporated

Third-Quarter Results

Consolidated Statements of Operations

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2019

 

2018

 

2019

 

2018

Revenues:

 

 

 

 

 

 

 

Product revenues, net………………………………………………………………………………………

$

949,828

 

 

$

782,511

 

 

$

2,747,461

 

 

$

2,170,152

 

Collaboration and royalty revenues………………………………………………………………………………………

 

 

2,024

 

 

2,095

 

 

7,339

 

Total revenues……………………………………………………………………………………

949,828

 

 

784,535

 

 

2,749,556

 

 

2,177,491

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of sales………………………………………………………………………………………

131,914

 

 

111,255

 

 

362,746

 

 

287,250

 

Research and development expenses………………………………………………………………………………………

555,948

 

 

330,510

 

 

1,274,529

 

 

978,595

 

Sales, general and administrative expenses………………………………………………………………………………………

159,674

 

 

137,295

 

 

463,221

 

 

404,406

 

Change in fair value of contingent consideration………………………………………………………………………………………

2,959

 

 

 

 

2,959

 

 

 

Restructuring income………………………………………………………………………………………

 

 

(174

)

 

 

 

(188

)

Total costs and expenses……………………………………………………………………………………

850,495

 

 

578,886

 

 

2,103,455

 

 

1,670,063

 

Income from operations………………………………………………………………………………………..

99,333

 

 

205,649

 

 

646,101

 

 

507,428

 

Interest income………………………………………………………………………………………

17,628

 

 

10,543

 

 

51,319

 

 

24,381

 

Interest expense………………………………………………………………………………………

(14,548

)

 

(18,686

)

 

(44,253

)

 

(53,727

)

Other (expense) income, net (1)

(31,747

)

 

(60,995

)

 

64,802

 

 

89,662

 

Income from operations before provision for income taxes…………………………………………………………………………………….

70,666

 

 

136,511

 

 

717,969

 

 

567,744

 

Provision for income taxes (2)………………………………………………………………………………………

13,148

 

 

8,055

 

 

124,393

 

 

5,737

 

Net income………………………………………………………………………………………..

57,518

 

 

128,456

 

 

593,576

 

 

562,007

 

Loss (income) attributable to noncontrolling interest (3)…………………………………………………………………………………..

 

 

290

 

 

 

 

(15,638

)

Net income attributable to Vertex………………………………………………………………………………………..

$

57,518

 

 

$

128,746

 

 

$

593,576

 

 

$

546,369

 

 

 

 

 

 

 

 

 

Amounts per share attributable to Vertex common shareholders:

 

 

 

 

 

 

 

Net income:

 

 

 

 

 

 

 

Basic………………………………………………………………………………………

$

0.22

 

 

$

0.51

 

 

$

2.32

 

 

$

2.15

 

Diluted………………………………………………………………………………………

$

0.22

 

 

$

0.50

 

 

$

2.28

 

 

$

2.11

 

Shares used in per share calculations:

 

 

 

 

 

 

 

Basic………………………………………………………………………………………

256,946

 

 

254,905

 

 

256,289

 

 

254,096

 

Diluted………………………………………………………………………………………

260,473

 

 

259,788

 

 

260,182

 

 

258,972

 

 

Reconciliation of GAAP to Non-GAAP Net Income

Third-Quarter Results

(in thousands, except per share amounts)

(unaudited)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2019

 

2018

 

2019

 

2018

GAAP net income attributable to Vertex………………………………………………………………………………………..

$

57,518

 

 

$

128,746

 

 

$

593,576

 

 

$

546,369

 

Stock-based compensation expense……………………………………………………………………………………

85,420

 

 

85,532

 

 

268,898

 

 

246,104

 

Decrease (increase) in fair value of strategic investments (1)………………………………………………………………………………..

31,216

 

 

61,159

 

 

(68,862

)

 

(88,217

)

Increase in fair value of contingent consideration (3)………………………………………………………………………………..

2,959

 

 

200

 

 

2,959

 

 

23,100

 

Collaborative revenues and expenses (4)………………………………………………………………………………..

203,777

 

 

1,779

 

 

262,286

 

 

4,777

 

Acquisition-related costs (5) and other adjustments………………………………………………………………………………..

11,459

 

 

1,398

 

 

12,690

 

 

3,520

 

Total non-GAAP adjustments to pre-tax income…………………………………………………………………………….

334,831

 

 

150,068

 

 

477,971

 

 

189,284

 

Estimated income taxes related to non-GAAP adjustments to pre-tax income (6)………………………………………………………………………………..

(70,849

)

 

3,114

 

 

(126,951

)

 

(13,715

)

Non-GAAP net income attributable to Vertex……………………………………………………………………………

$

321,500

 

 

$

281,928

 

 

$

944,596

 

 

$

721,938

 

 

 

 

 

 

 

 

 

Amounts per diluted share attributable to Vertex common shareholders:

 

 

 

 

 

 

 

Net income:

 

 

 

 

 

 

 

GAAP……………………………………………………………………………………

$

0.22

 

 

$

0.50

 

 

$

2.28

 

 

$

2.11

 

Non-GAAP……………………………………………………………………………………

$

1.23

 

 

$

1.09

 

 

$

3.63

 

 

$

2.79

 

Shares used in diluted per share calculations:

 

 

 

 

 

 

 

GAAP and Non-GAAP……………………………………………………………………………………

260,473

 

 

259,788

 

 

260,182

 

 

258,972

 

Reconciliation of GAAP to Non-GAAP Revenues and Expenses

Third-Quarter Results

(in thousands)

(unaudited)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2019

 

2018

 

2019

 

2018

GAAP total revenues………………………………………………………………………………………..

$

949,828

 

 

$

784,535

 

 

$

2,749,556

 

 

$

2,177,491

 

Collaborative revenues (4)……………………………………………………………………………………

 

 

(680

)

 

(158

)

 

(3,540

)

Non-GAAP total revenues……………………………………………………………………………….

$

949,828

 

 

$

783,855

 

 

$

2,749,398

 

 

$

2,173,951

 

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2019

 

2018

 

2019

 

2018

GAAP cost of sales…………………………………………………………………………………

$

131,914

 

 

$

111,255

 

 

$

362,746

 

 

$

287,250

 

Stock-based compensation expense……………………………………………………………………………………

(1,337

)

 

(1,259

)

 

(4,178

)

 

(3,263

)

Non-GAAP cost of sales……………………………………………………………………………

$

130,577

 

 

$

109,996

 

 

$

358,568

 

 

$

283,987

 

 

 

 

 

 

 

 

 

GAAP research and development expenses………………………………………………………………………………………..

$

555,948

 

 

$

330,510

 

 

$

1,274,529

 

 

$

978,595

 

Stock-based compensation expense……………………………………………………………………………………

(52,504

)

 

(52,918

)

 

(167,851

)

 

(153,018

)

Collaborative expenses (4)………………………………………………………………………………..

(203,777

)

 

(2,619

)

 

(262,444

)

 

(8,079

)

Acquisition-related costs (5) and other adjustments………………………………………………………………………………..

(10,122

)

 

(1,388

)

 

(10,122

)

 

(3,128

)

Non-GAAP research and development expenses……………………………………………………………………………

$

289,545

 

 

$

273,585

 

 

$

834,112

 

 

$

814,370

 

 

 

 

 

 

 

 

 

GAAP sales, general and administrative expenses…………………………………………………………………………………….

$

159,674

 

 

$

137,295

 

 

$

463,221

 

 

$

404,406

 

Stock-based compensation expense……………………………………………………………………………………

(31,579

)

 

(31,355

)

 

(96,869

)

 

(89,823

)

Collaborative expenses (4)………………………………………………………………………………..

 

 

(289

)

 

 

 

(1,704

)

Acquisition-related costs (5) and other adjustments………………………………………………………………………………..

(1,337

)

 

(184

)

 

(2,568

)

 

(580

)

Non-GAAP sales, general and administrative expenses……………………………………………………………………………

$

126,758

 

 

$

105,467

 

 

$

363,784

 

 

$

312,299

 

 

 

 

 

 

 

 

 

Combined non-GAAP R&D and SG&A expenses……………………………………………………………………………

$

416,303

 

 

$

379,052

 

 

$

1,197,896

 

 

$

1,126,669

 

 

 

 

 

 

 

 

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

2019

 

2018

 

2019

 

2018

GAAP other (expense) income, net…………………………………………………………………………………….

$

(31,747

)

 

$

(60,995

)

 

$

64,802

 

 

$

89,662

 

Decrease (increase) in fair value of strategic investments (1)………………………………………………………………………………..

31,216

 

 

61,159

 

 

(68,862

)

 

(88,217

)

Non-GAAP other (expense) income, net……………………………………………………………………………

$

(531

)

 

$

164

 

 

$

(4,060

)

 

$

1,445

 

 

 

 

 

 

 

 

 

GAAP provision for income taxes…………………………………………………………………………………….

$

13,148

 

 

$

8,055

 

 

$

124,393

 

 

$

5,737

 

Estimated income taxes related to non-GAAP adjustments to pre-tax income (6)………………………………………………………………………………..

70,849

 

 

(3,193

)

 

126,951

 

 

7,647

 

Non-GAAP provision for income taxes (2)……………………………………………………………………………

$

83,997

 

 

$

4,862

 

 

$

251,344

 

 

$

13,384

 

 

 

Condensed Consolidated Balance Sheets

(in thousands)

(unaudited)

 

 

September 30, 2019

 

December 31, 2018

Assets

 

 

 

Cash, cash equivalents and marketable securities………………………………………………………………………………………………………………….

$

3,996,331

 

 

$

3,168,242

 

Accounts receivable, net………………………………………………………………………………………………………………….

443,315

 

 

409,688

 

Inventories………………………………………………………………………………………………………………….

162,306

 

 

124,360

 

Property and equipment, net………………………………………………………………………………………………………………….

733,509

 

 

812,005

 

Goodwill………………………………………………………………………………………………………………….

447,525

 

 

50,384

 

Deferred tax assets………………………………………………………………………………………………………………….

1,415,511

 

 

1,499,672

 

Other assets………………………………………………………………………………………………………………….

316,056

 

 

181,547

 

Total assets………………………………………………………………………………………………………………….

$

7,514,553

 

 

$

6,245,898

 

 

 

 

 

Liabilities and Shareholders’ Equity

 

 

 

Accounts payable and accrued expenses………………………………………………………………………………………………………………….

$

1,266,311

 

 

$

1,069,886

 

Finance lease liabilities………………………………………………………………………………………………………………….

578,624

 

 

596,638

 

Contingent consideration………………………………………………………………………………………………………………….

175,000

 

 

 

Other liabilities………………………………………………………………………………………………………………….

241,224

 

 

144,171

 

Shareholders’ equity………………………………………………………………………………………………………………….

5,253,394

 

 

4,435,203

 

Total liabilities and shareholders’ equity………………………………………………………………………………………………………………….

$

7,514,553

 

 

$

6,245,898

 

 

 

 

 

Common shares outstanding………………………………………………………………………………………………………………….

257,265

 

 

255,172

 

 

Contacts

Investors:
Michael Partridge, 617-341-6108

or

Zach Barber, 617-341-6470

or

Leah Gibson, 617-961-1507

Media:
617-341-6992

mediainfo@vrtx.com

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