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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2018
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or
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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FOR THE TRANSITION PERIOD FROM
TO
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Massachusetts
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04-3039129
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(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
|
50 Northern Avenue, Boston, Massachusetts
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02210
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|
(Address of principal executive offices)
|
(Zip Code)
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Large accelerated filer
x
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Accelerated filer
o
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Non-accelerated filer
o
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Smaller reporting company
o
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Emerging growth company
o
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(Do not check if a smaller reporting company)
|
||
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Common Stock, par value $0.01 per share
|
254,830,232
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Class
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Outstanding at April 20, 2018
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Page
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||
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||
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Condensed Consolidated Statements of Operations - Three Months Ended March 31, 2018 and 2017
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Condensed Consolidated Statements of Comprehensive Income - Three Months Ended March 31, 2018 and 2017
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Condensed Consolidated Balance Sheets - March 31, 2018 and December 31, 2017
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Condensed Consolidated Statements of Shareholders' Equity and Noncontrolling Interest - Three Months Ended March 31, 2018 and 2017
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Condensed Consolidated Statements of Cash Flows - Three Months Ended March 31, 2018 and 2017
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Three Months Ended March 31,
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||||||
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2018
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2017
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||||
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Revenues:
|
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|
||||
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Product revenues, net
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$
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637,729
|
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$
|
480,622
|
|
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Royalty revenues
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1,356
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|
|
1,551
|
|
||
|
Collaborative revenues
|
1,714
|
|
|
232,545
|
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||
|
Total revenues
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640,799
|
|
|
714,718
|
|
||
|
Costs and expenses:
|
|
|
|
||||
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Cost of sales
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71,613
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|
46,988
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|
||
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Research and development expenses
|
310,553
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|
|
273,563
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|
||
|
Sales, general and administrative expenses
|
129,808
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|
|
113,326
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|
||
|
Restructuring (income) expenses
|
(76
|
)
|
|
9,999
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|
||
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Total costs and expenses
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511,898
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|
443,876
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|
||
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Income from operations
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128,901
|
|
|
270,842
|
|
||
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Interest expense, net
|
(11,097
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)
|
|
(16,765
|
)
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||
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Other income (expense), net
|
96,838
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|
|
(544
|
)
|
||
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Income before (benefit from) provision for income taxes
|
214,642
|
|
|
253,533
|
|
||
|
(Benefit from) provision for income taxes
|
(12,659
|
)
|
|
3,985
|
|
||
|
Net income
|
227,301
|
|
|
249,548
|
|
||
|
Income attributable to noncontrolling interest
|
(17,038
|
)
|
|
(1,792
|
)
|
||
|
Net income attributable to Vertex
|
$
|
210,263
|
|
|
$
|
247,756
|
|
|
|
|
|
|
||||
|
Amounts per share attributable to Vertex common shareholders:
|
|
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|
||||
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Net income:
|
|
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|
||||
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Basic
|
$
|
0.83
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|
|
$
|
1.01
|
|
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Diluted
|
$
|
0.81
|
|
|
$
|
0.99
|
|
|
Shares used in per share calculations:
|
|
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||||
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Basic
|
253,231
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246,024
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Diluted
|
258,526
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248,700
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Three Months Ended March 31,
|
||||||
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2018
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|
2017
|
||||
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Net income
|
$
|
227,301
|
|
|
$
|
249,548
|
|
|
Changes in other comprehensive loss:
|
|
|
|
||||
|
Unrealized holding (losses) gains on marketable securities, net of tax of zero and $(1.0) million, respectively
|
(460
|
)
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|
3,534
|
|
||
|
Unrealized losses on foreign currency forward contracts, net of tax of $0.3 million and $0.9 million, respectively
|
(862
|
)
|
|
(6,681
|
)
|
||
|
Foreign currency translation adjustment
|
(2,729
|
)
|
|
(2,001
|
)
|
||
|
Total changes in other comprehensive loss
|
(4,051
|
)
|
|
(5,148
|
)
|
||
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Comprehensive income
|
223,250
|
|
|
244,400
|
|
||
|
Comprehensive income attributable to noncontrolling interest
|
(17,038
|
)
|
|
(1,792
|
)
|
||
|
Comprehensive income attributable to Vertex
|
$
|
206,212
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|
|
$
|
242,608
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March 31,
|
|
December 31,
|
||||
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2018
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2017
|
||||
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Assets
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||||
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Current assets:
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||||
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Cash and cash equivalents
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$
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1,995,893
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$
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1,665,412
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Marketable securities
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481,124
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423,254
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||
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Restricted cash and cash equivalents (VIE)
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9,573
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1,489
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Accounts receivable, net
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327,294
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281,343
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Inventories
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117,346
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111,830
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Prepaid expenses and other current assets
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109,886
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165,635
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Total current assets
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3,041,116
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2,648,963
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Property and equipment, net
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800,670
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789,437
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Intangible assets
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29,000
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29,000
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Goodwill
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50,384
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50,384
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Other assets
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31,804
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28,230
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Total assets
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$
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3,952,974
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$
|
3,546,014
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Liabilities and Shareholders’ Equity
|
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|
||||
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Current liabilities:
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|
||||
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Accounts payable
|
$
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74,062
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$
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73,994
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|
Accrued expenses
|
411,231
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|
|
443,961
|
|
||
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Capital lease obligations, current portion
|
16,919
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|
|
22,531
|
|
||
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Early access sales accrual
|
268,446
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|
232,401
|
|
||
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Other liabilities, current portion
|
56,654
|
|
|
34,373
|
|
||
|
Total current liabilities
|
827,312
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|
807,260
|
|
||
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Capital lease obligations, excluding current portion
|
16,911
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|
20,496
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|
||
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Deferred tax liability
|
9,636
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|
6,341
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|
||
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Construction financing lease obligation, excluding current portion
|
561,295
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|
|
563,406
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|
||
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Advance from collaborator, excluding current portion
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79,537
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|
78,431
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|
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Other liabilities, excluding current portion
|
27,462
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|
|
27,774
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|
||
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Total liabilities
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1,522,153
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|
|
1,503,708
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|
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Commitments and contingencies
|
|
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|
Shareholders’ equity:
|
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|
||||
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Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding
|
—
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|
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—
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|
||
|
Common stock, $0.01 par value; 500,000,000 shares authorized; 254,934,949 and 253,253,362 shares issued; and 254,867,865 and 253,253,362 shares outstanding, respectively
|
2,541
|
|
|
2,512
|
|
||
|
Additional paid-in capital
|
7,314,369
|
|
|
7,157,362
|
|
||
|
Accumulated other comprehensive loss
|
(39,743
|
)
|
|
(11,572
|
)
|
||
|
Accumulated deficit
|
(4,876,111
|
)
|
|
(5,119,723
|
)
|
||
|
Total Vertex shareholders’ equity
|
2,401,056
|
|
|
2,028,579
|
|
||
|
Noncontrolling interest
|
29,765
|
|
|
13,727
|
|
||
|
Total shareholders’ equity
|
2,430,821
|
|
|
2,042,306
|
|
||
|
Total liabilities and shareholders’ equity
|
$
|
3,952,974
|
|
|
$
|
3,546,014
|
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Income (Loss) |
|
Accumulated Deficit
|
|
Total Vertex
Shareholders’ Equity |
|
Noncontrolling
Interest |
|
Total
Shareholders’ Equity |
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Balance at December 31, 2016
|
248,301
|
|
|
$
|
2,450
|
|
|
$
|
6,506,795
|
|
|
$
|
21,173
|
|
|
$
|
(5,373,836
|
)
|
|
$
|
1,156,582
|
|
|
$
|
181,609
|
|
|
$
|
1,338,191
|
|
|
Cumulative effect adjustment for adoption of new accounting guidance
|
—
|
|
|
—
|
|
|
9,371
|
|
|
—
|
|
|
(9,371
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||||
|
Other comprehensive loss, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(5,148
|
)
|
|
—
|
|
|
(5,148
|
)
|
|
—
|
|
|
(5,148
|
)
|
|||||||
|
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
247,756
|
|
|
247,756
|
|
|
1,792
|
|
|
249,548
|
|
|||||||
|
Issuance of common stock under benefit plans
|
590
|
|
|
9
|
|
|
31,019
|
|
|
—
|
|
|
—
|
|
|
31,028
|
|
|
—
|
|
|
31,028
|
|
|||||||
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
69,790
|
|
|
—
|
|
|
—
|
|
|
69,790
|
|
|
—
|
|
|
69,790
|
|
|||||||
|
Other VIE activity
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(616
|
)
|
|
(616
|
)
|
|||||||
|
Balance at March 31, 2017
|
248,891
|
|
|
$
|
2,459
|
|
|
$
|
6,616,975
|
|
|
$
|
16,025
|
|
|
$
|
(5,135,451
|
)
|
|
$
|
1,500,008
|
|
|
$
|
182,785
|
|
|
$
|
1,682,793
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
Balance at December 31, 2017
|
253,253
|
|
|
$
|
2,512
|
|
|
$
|
7,157,362
|
|
|
$
|
(11,572
|
)
|
|
$
|
(5,119,723
|
)
|
|
$
|
2,028,579
|
|
|
$
|
13,727
|
|
|
$
|
2,042,306
|
|
|
Cumulative effect adjustment for adoption of new accounting guidance
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,120
|
)
|
|
33,349
|
|
|
9,229
|
|
|
—
|
|
|
9,229
|
|
|||||||
|
Other comprehensive loss, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,051
|
)
|
|
—
|
|
|
(4,051
|
)
|
|
—
|
|
|
(4,051
|
)
|
|||||||
|
Net income
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
210,263
|
|
|
210,263
|
|
|
17,038
|
|
|
227,301
|
|
|||||||
|
Repurchases of common stock
|
(67
|
)
|
|
(1
|
)
|
|
(11,250
|
)
|
|
—
|
|
|
—
|
|
|
(11,251
|
)
|
|
—
|
|
|
(11,251
|
)
|
|||||||
|
Issuance of common stock under benefit plans
|
1,682
|
|
|
30
|
|
|
89,656
|
|
|
—
|
|
|
—
|
|
|
89,686
|
|
|
—
|
|
|
89,686
|
|
|||||||
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
78,601
|
|
|
—
|
|
|
—
|
|
|
78,601
|
|
|
—
|
|
|
78,601
|
|
|||||||
|
Other VIE activity
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(1,000
|
)
|
|
(1,000
|
)
|
|||||||
|
Balance at March 31, 2018
|
254,868
|
|
|
$
|
2,541
|
|
|
$
|
7,314,369
|
|
|
$
|
(39,743
|
)
|
|
$
|
(4,876,111
|
)
|
|
$
|
2,401,056
|
|
|
$
|
29,765
|
|
|
$
|
2,430,821
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net income
|
$
|
227,301
|
|
|
$
|
249,548
|
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
|
Stock-based compensation expense
|
78,136
|
|
|
69,439
|
|
||
|
Depreciation expense
|
16,343
|
|
|
14,850
|
|
||
|
Write-downs of inventories to net realizable value
|
3,619
|
|
|
3,787
|
|
||
|
Deferred income taxes
|
3,587
|
|
|
1,212
|
|
||
|
Impairment of property and equipment
|
—
|
|
|
1,946
|
|
||
|
Unrealized gain on equity securities
|
(95,458
|
)
|
|
—
|
|
||
|
Other non-cash items, net
|
5,827
|
|
|
(5,152
|
)
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable, net
|
(13,473
|
)
|
|
(7,798
|
)
|
||
|
Inventories
|
(8,208
|
)
|
|
(7,894
|
)
|
||
|
Prepaid expenses and other assets
|
25,482
|
|
|
(44,498
|
)
|
||
|
Accounts payable
|
2,154
|
|
|
717
|
|
||
|
Accrued expenses and other liabilities
|
7,347
|
|
|
(10,465
|
)
|
||
|
Net cash provided by operating activities
|
252,657
|
|
|
265,692
|
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of marketable securities
|
(38,653
|
)
|
|
(248,273
|
)
|
||
|
Maturities of marketable securities
|
94,365
|
|
|
98,393
|
|
||
|
Expenditures for property and equipment
|
(29,279
|
)
|
|
(11,099
|
)
|
||
|
Investment in equity securities
|
(21,500
|
)
|
|
—
|
|
||
|
Net cash provided by (used in) investing activities
|
4,933
|
|
|
(160,979
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Issuances of common stock under benefit plans
|
88,403
|
|
|
11,249
|
|
||
|
Repurchase of common stock
|
(10,000
|
)
|
|
—
|
|
||
|
Payments on revolving credit facility
|
—
|
|
|
(300,000
|
)
|
||
|
Advance from collaborator
|
2,500
|
|
|
5,000
|
|
||
|
Payments on capital lease obligations
|
(9,197
|
)
|
|
(4,703
|
)
|
||
|
Proceeds related to construction financing lease obligation
|
9,566
|
|
|
—
|
|
||
|
Repayments of advanced funding
|
(1,182
|
)
|
|
(994
|
)
|
||
|
Other financing activities
|
(1,134
|
)
|
|
(117
|
)
|
||
|
Net cash provided by (used in) financing activities
|
78,956
|
|
|
(289,565
|
)
|
||
|
Effect of changes in exchange rates on cash
|
1,656
|
|
|
1,388
|
|
||
|
Net increase (decrease) in cash and cash equivalents
|
338,202
|
|
|
(183,464
|
)
|
||
|
Cash, cash equivalents and restricted cash—beginning of period
|
1,667,526
|
|
|
1,231,707
|
|
||
|
Cash, cash equivalents and restricted cash—end of period
|
$
|
2,005,728
|
|
|
$
|
1,048,243
|
|
|
|
|
|
|
||||
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
|
Cash paid for interest
|
$
|
16,825
|
|
|
$
|
17,527
|
|
|
Cash paid for income taxes
|
$
|
1,897
|
|
|
$
|
1,164
|
|
|
Capitalization of costs related to construction financing lease obligation
|
$
|
3,716
|
|
|
$
|
12,549
|
|
|
Issuances of common stock from employee benefit plans receivable
|
$
|
2,124
|
|
|
$
|
19,847
|
|
|
|
Balance as of
|
|
|
|
Balance as of
|
||||||
|
|
December 31, 2017
|
|
Adjustments
|
|
January 1, 2018
|
||||||
|
Assets
|
(in thousands)
|
||||||||||
|
Accounts receivable, net
|
$
|
281,343
|
|
|
$
|
29,881
|
|
|
$
|
311,224
|
|
|
Inventories
|
111,830
|
|
|
(90
|
)
|
|
111,740
|
|
|||
|
Prepaid expenses and other current assets
|
165,635
|
|
|
(17,166
|
)
|
|
148,469
|
|
|||
|
Total assets
|
$
|
3,546,014
|
|
|
$
|
12,625
|
|
|
$
|
3,558,639
|
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
|
|
|
|||||
|
Accrued expenses
|
$
|
443,961
|
|
|
$
|
8,586
|
|
|
$
|
452,547
|
|
|
Early access sales accrual
|
232,401
|
|
|
(7,273
|
)
|
|
225,128
|
|
|||
|
Other liabilities, current portion
|
34,373
|
|
|
2,083
|
|
|
36,456
|
|
|||
|
Accumulated other comprehensive loss
|
(11,572
|
)
|
|
949
|
|
|
(10,623
|
)
|
|||
|
Accumulated deficit
|
(5,119,723
|
)
|
|
8,280
|
|
|
(5,111,443
|
)
|
|||
|
Total liabilities and shareholders’ equity
|
$
|
3,546,014
|
|
|
$
|
12,625
|
|
|
$
|
3,558,639
|
|
|
|
As of March 31, 2018
|
||||||||||
|
|
As Reported
under ASC 606 |
|
Balances
without Adoption of ASC 606 |
|
Effect of Change
Higher/(Lower) |
||||||
|
Assets
|
(in thousands)
|
||||||||||
|
Accounts receivable, net
|
$
|
327,294
|
|
|
$
|
294,142
|
|
|
$
|
33,152
|
|
|
Inventories
|
117,346
|
|
|
117,414
|
|
|
(68
|
)
|
|||
|
Prepaid expenses and other current assets
|
109,886
|
|
|
128,818
|
|
|
(18,932
|
)
|
|||
|
Total assets
|
$
|
3,952,974
|
|
|
$
|
3,938,822
|
|
|
$
|
14,152
|
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
|
|
|
|
||||
|
Accrued expenses
|
411,231
|
|
|
408,014
|
|
|
3,217
|
|
|||
|
Early access sales accrual
|
268,446
|
|
|
278,957
|
|
|
(10,511
|
)
|
|||
|
Other liabilities, current portion
|
56,654
|
|
|
48,026
|
|
|
8,628
|
|
|||
|
Accumulated other comprehensive loss
|
(39,743
|
)
|
|
(41,148
|
)
|
|
1,405
|
|
|||
|
Accumulated deficit
|
(4,876,111
|
)
|
|
(4,887,524
|
)
|
|
11,413
|
|
|||
|
Total liabilities and shareholders’ equity
|
$
|
3,952,974
|
|
|
$
|
3,938,822
|
|
|
$
|
14,152
|
|
|
|
Three Months Ended March 31, 2018
|
||||||||||
|
|
As Reported
under ASC 606 |
|
Balances
without Adoption of ASC 606 |
|
Effect of Change
Higher/(Lower) |
||||||
|
|
(in thousands)
|
||||||||||
|
Product revenues, net
|
$
|
637,729
|
|
|
$
|
633,064
|
|
|
$
|
4,665
|
|
|
Cost of sales
|
71,613
|
|
|
70,081
|
|
|
1,532
|
|
|||
|
Income from operations
|
128,901
|
|
|
125,768
|
|
|
3,133
|
|
|||
|
Net income attributable to Vertex
|
$
|
210,263
|
|
|
$
|
207,130
|
|
|
$
|
3,133
|
|
|
|
|
|
|
|
|
||||||
|
Amounts per share attributable to Vertex common shareholders:
|
|
|
|
|
|
||||||
|
Net income:
|
|
|
|
|
|
||||||
|
Basic
|
$
|
0.83
|
|
|
$
|
0.82
|
|
|
$
|
0.01
|
|
|
Diluted
|
$
|
0.81
|
|
|
$
|
0.80
|
|
|
$
|
0.01
|
|
|
|
Three Months Ended March 31, 2018
|
|
Three Months Ended March 31, 2017
|
||||||||||||
|
|
Beginning of period
|
|
End of period
|
|
Beginning of period
|
|
End of period
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Cash and cash equivalents
|
$
|
1,665,412
|
|
|
$
|
1,995,893
|
|
|
$
|
1,183,945
|
|
|
$
|
1,003,679
|
|
|
Restricted cash and cash equivalents (VIE)
|
1,489
|
|
|
9,573
|
|
|
47,762
|
|
|
44,564
|
|
||||
|
Prepaid expenses and other current assets
|
625
|
|
|
262
|
|
|
—
|
|
|
—
|
|
||||
|
Cash, cash equivalents and restricted cash per statement of cash flows
|
$
|
1,667,526
|
|
|
$
|
2,005,728
|
|
|
$
|
1,231,707
|
|
|
$
|
1,048,243
|
|
|
B.
|
Revenue Recognition
|
|
|
Balance at January 1, 2018
(ASC 606 adoption)
|
|
Additions
|
|
Deductions
|
|
Balance at
March 31, 2018
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Three Months Ended March 31, 2018
|
|
|
|
|
|
|
|
||||||||
|
Contract liabilities:
|
|
|
|
|
|
|
|
||||||||
|
Other liabilities, current portion
|
$
|
1,654
|
|
|
$
|
12,983
|
|
|
$
|
—
|
|
|
$
|
14,637
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018 (as reported under ASC 606)
|
|
2017 (as reported under ASC 605)
|
||||
|
|
(in thousands)
|
||||||
|
KALYDECO
|
$
|
249,539
|
|
|
$
|
185,715
|
|
|
ORKAMBI
|
354,066
|
|
|
294,861
|
|
||
|
SYMDEKO
|
34,124
|
|
|
—
|
|
||
|
Other
|
—
|
|
|
46
|
|
||
|
Total product revenues, net
|
$
|
637,729
|
|
|
$
|
480,622
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018 (as reported under ASC 606)
|
|
2017 (as reported under ASC 605)
|
||||
|
|
(in thousands)
|
||||||
|
United States
|
$
|
482,667
|
|
|
$
|
599,126
|
|
|
Outside of the United States
|
|
|
|
||||
|
Europe
|
131,895
|
|
|
92,358
|
|
||
|
Other
|
26,237
|
|
|
23,234
|
|
||
|
Total revenues outside of the United States
|
158,132
|
|
|
115,592
|
|
||
|
Total revenues
|
$
|
640,799
|
|
|
$
|
714,718
|
|
|
C.
|
Collaborative Arrangements and Acquisitions
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(in thousands)
|
||||||
|
Loss attributable to noncontrolling interest before provision for income taxes and changes in fair value of contingent payments
|
$
|
557
|
|
|
$
|
1,547
|
|
|
Provision for income taxes
|
6,405
|
|
|
391
|
|
||
|
Increase in fair value of contingent payments
|
(24,000
|
)
|
|
(3,730
|
)
|
||
|
Net income attributable to noncontrolling interest
|
$
|
(17,038
|
)
|
|
$
|
(1,792
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(in thousands)
|
||||||
|
Parion
|
$
|
—
|
|
|
$
|
(2,830
|
)
|
|
BioAxone
|
(24,000
|
)
|
|
(900
|
)
|
||
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
|
|
(in thousands)
|
||||||
|
Restricted cash and cash equivalents (VIE)
|
$
|
9,573
|
|
|
$
|
1,489
|
|
|
Intangible assets
|
29,000
|
|
|
29,000
|
|
||
|
Deferred tax liability
|
9,636
|
|
|
4,756
|
|
||
|
Noncontrolling interest
|
29,765
|
|
|
13,727
|
|
||
|
D.
|
Earnings Per Share
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(in thousands, except per share amounts)
|
||||||
|
Basic net income attributable to Vertex per common share calculation:
|
|
|
|
||||
|
Net income attributable to Vertex common shareholders
|
$
|
210,263
|
|
|
$
|
247,756
|
|
|
Less: Undistributed earnings allocated to participating securities
|
(99
|
)
|
|
(406
|
)
|
||
|
Net income attributable to Vertex common shareholders—basic
|
$
|
210,164
|
|
|
$
|
247,350
|
|
|
|
|
|
|
||||
|
Basic weighted-average common shares outstanding
|
253,231
|
|
|
246,024
|
|
||
|
Basic net income attributable to Vertex per common share
|
$
|
0.83
|
|
|
$
|
1.01
|
|
|
|
|
|
|
||||
|
Diluted net income attributable to Vertex per common share calculation:
|
|
|
|
||||
|
Net income attributable to Vertex common shareholders
|
$
|
210,263
|
|
|
$
|
247,756
|
|
|
Less: Undistributed earnings allocated to participating securities
|
(97
|
)
|
|
(401
|
)
|
||
|
Net income attributable to Vertex common shareholders—diluted
|
$
|
210,166
|
|
|
$
|
247,355
|
|
|
|
|
|
|
||||
|
Weighted-average shares used to compute basic net income per common share
|
253,231
|
|
|
246,024
|
|
||
|
Effect of potentially dilutive securities:
|
|
|
|
||||
|
Stock options
|
3,248
|
|
|
2,037
|
|
||
|
Restricted stock and restricted stock units (including PSUs)
|
2,013
|
|
|
627
|
|
||
|
Employee stock purchase program
|
34
|
|
|
12
|
|
||
|
Weighted-average shares used to compute diluted net income per common share
|
258,526
|
|
|
248,700
|
|
||
|
Diluted net income attributable to Vertex per common share
|
$
|
0.81
|
|
|
$
|
0.99
|
|
|
|
Three Months Ended March 31,
|
||||
|
|
2018
|
|
2017
|
||
|
|
(in thousands)
|
||||
|
Stock options
|
1,633
|
|
|
8,303
|
|
|
Unvested restricted stock and restricted stock units (including PSUs)
|
4
|
|
|
807
|
|
|
E.
|
Fair Value Measurements
|
|
Level 1:
|
Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
|
|
Level 2:
|
Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.
|
|
Level 3:
|
Unobservable inputs based on the Company’s assessment of the assumptions that market participants would use in pricing the asset or liability.
|
|
|
Fair Value Measurements as of March 31, 2018
|
||||||||||||||
|
|
|
|
Fair Value Hierarchy
|
||||||||||||
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Financial instruments carried at fair value (asset position):
|
|
|
|
|
|
|
|
||||||||
|
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Money market funds
|
$
|
921,007
|
|
|
$
|
921,007
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Government-sponsored enterprise securities
|
4,989
|
|
|
4,989
|
|
|
—
|
|
|
—
|
|
||||
|
Corporate debt securities
|
7,927
|
|
|
—
|
|
|
7,927
|
|
|
—
|
|
||||
|
Commercial paper
|
50,669
|
|
|
—
|
|
|
50,669
|
|
|
—
|
|
||||
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Corporate equity securities
|
188,857
|
|
|
188,857
|
|
|
—
|
|
|
—
|
|
||||
|
Government-sponsored enterprise securities
|
4,995
|
|
|
4,995
|
|
|
—
|
|
|
—
|
|
||||
|
Corporate debt securities
|
218,213
|
|
|
—
|
|
|
218,213
|
|
|
—
|
|
||||
|
Commercial paper
|
69,059
|
|
|
—
|
|
|
69,059
|
|
|
—
|
|
||||
|
Prepaid and other current assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
540
|
|
|
—
|
|
|
540
|
|
|
—
|
|
||||
|
Other assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
31
|
|
|
—
|
|
|
31
|
|
|
—
|
|
||||
|
Total financial assets
|
$
|
1,466,287
|
|
|
$
|
1,119,848
|
|
|
$
|
346,439
|
|
|
$
|
—
|
|
|
Financial instruments carried at fair value (liability position):
|
|
|
|
|
|
|
|
||||||||
|
Other liabilities, current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
$
|
(15,370
|
)
|
|
$
|
—
|
|
|
$
|
(15,370
|
)
|
|
$
|
—
|
|
|
Other liabilities, excluding current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
(850
|
)
|
|
—
|
|
|
(850
|
)
|
|
—
|
|
||||
|
Total financial liabilities
|
$
|
(16,220
|
)
|
|
$
|
—
|
|
|
$
|
(16,220
|
)
|
|
$
|
—
|
|
|
|
Fair Value Measurements as of December 31, 2017
|
||||||||||||||
|
|
|
|
Fair Value Hierarchy
|
||||||||||||
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Financial instruments carried at fair value (asset position):
|
|
|
|
|
|
|
|
||||||||
|
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Money market funds
|
$
|
614,951
|
|
|
$
|
614,951
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Government-sponsored enterprise securities
|
12,678
|
|
|
12,678
|
|
|
—
|
|
|
—
|
|
||||
|
Commercial paper
|
57,357
|
|
|
—
|
|
|
57,357
|
|
|
—
|
|
||||
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Corporate equity securities
|
74,821
|
|
|
74,821
|
|
|
—
|
|
|
—
|
|
||||
|
Government-sponsored enterprise securities
|
2,303
|
|
|
2,303
|
|
|
—
|
|
|
—
|
|
||||
|
Corporate debt securities
|
265,867
|
|
|
—
|
|
|
265,867
|
|
|
—
|
|
||||
|
Commercial paper
|
80,263
|
|
|
—
|
|
|
80,263
|
|
|
—
|
|
||||
|
Prepaid and other current assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
13
|
|
|
—
|
|
|
13
|
|
|
—
|
|
||||
|
Total financial assets
|
$
|
1,108,253
|
|
|
$
|
704,753
|
|
|
$
|
403,500
|
|
|
$
|
—
|
|
|
Financial instruments carried at fair value (liability position):
|
|
|
|
|
|
|
|
||||||||
|
Other liabilities, current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
$
|
(13,642
|
)
|
|
$
|
—
|
|
|
$
|
(13,642
|
)
|
|
$
|
—
|
|
|
Other liabilities, excluding current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
(866
|
)
|
|
—
|
|
|
(866
|
)
|
|
—
|
|
||||
|
Total financial liabilities
|
$
|
(14,508
|
)
|
|
$
|
—
|
|
|
$
|
(14,508
|
)
|
|
$
|
—
|
|
|
F.
|
Marketable Securities and Equity Investments
|
|
|
Amortized Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
|
|||||||||
|
|
(in thousands)
|
|||||||||||||||
|
As of March 31, 2018
|
|
|
|
|
|
|
|
|||||||||
|
Available-for-sale debt securities
|
|
|
|
|
|
|
|
|||||||||
|
Cash equivalents:
|
|
|
|
|
|
|
|
|||||||||
|
Money market funds
|
$
|
921,007
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
921,007
|
|
|
|
Government-sponsored enterprise securities
|
4,990
|
|
|
—
|
|
|
(1
|
)
|
|
4,989
|
|
|||||
|
Corporate debt securities
|
7,930
|
|
|
—
|
|
|
(3
|
)
|
|
7,927
|
|
|||||
|
Commercial paper
|
50,680
|
|
|
—
|
|
|
(11
|
)
|
|
50,669
|
|
|||||
|
Total cash equivalents
|
984,607
|
|
|
—
|
|
|
(15
|
)
|
|
984,592
|
|
|||||
|
Marketable securities:
|
|
|
|
|
|
|
|
|||||||||
|
Government-sponsored enterprise securities (matures within 1 year)
|
4,995
|
|
|
—
|
|
|
—
|
|
|
4,995
|
|
|||||
|
Corporate debt securities (matures within 1 year)
|
184,698
|
|
|
—
|
|
|
(648
|
)
|
|
184,050
|
|
|||||
|
Corporate debt securities (matures after 1 year through 5 years)
|
34,383
|
|
|
—
|
|
|
(220
|
)
|
|
34,163
|
|
|||||
|
Commercial paper (matures within 1 year)
|
69,230
|
|
|
—
|
|
|
(171
|
)
|
|
69,059
|
|
|||||
|
Total marketable debt securities
|
293,306
|
|
|
—
|
|
|
(1,039
|
)
|
|
292,267
|
|
|||||
|
Total available-for-sale debt securities
|
1,277,913
|
|
|
—
|
|
|
(1,054
|
)
|
|
1,276,859
|
|
|||||
|
Corporate equity securities
|
64,713
|
|
|
124,144
|
|
|
—
|
|
|
188,857
|
|
|||||
|
Total cash equivalents and marketable securities
|
$
|
1,342,626
|
|
|
$
|
124,144
|
|
|
$
|
(1,054
|
)
|
|
$
|
1,465,716
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
As of December 31, 2017
|
|
|
|
|
|
|
|
|||||||||
|
Available-for-sale debt securities
|
|
|
|
|
|
|
|
|||||||||
|
Cash equivalents:
|
|
|
|
|
|
|
|
|||||||||
|
Money market funds
|
$
|
614,951
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
614,951
|
|
|
|
Government-sponsored enterprise securities
|
12,679
|
|
|
—
|
|
—
|
|
(1
|
)
|
|
12,678
|
|
||||
|
Commercial paper
|
57,371
|
|
|
—
|
|
|
(14
|
)
|
|
57,357
|
|
|||||
|
Total cash equivalents
|
685,001
|
|
|
—
|
|
|
(15
|
)
|
|
684,986
|
|
|||||
|
Marketable securities:
|
|
|
|
|
|
|
|
|||||||||
|
Government-sponsored enterprise securities (matures within 1 year)
|
2,304
|
|
|
—
|
|
|
(1
|
)
|
|
2,303
|
|
|||||
|
Corporate debt securities (matures within 1 year)
|
215,639
|
|
|
—
|
|
|
(363
|
)
|
|
215,276
|
|
|||||
|
Corporate debt securities (matures after 1 year through 5 years)
|
50,697
|
|
|
—
|
|
|
(106
|
)
|
|
50,591
|
|
|||||
|
Commercial paper (matures within 1 year)
|
80,372
|
|
|
—
|
|
|
(109
|
)
|
|
80,263
|
|
|||||
|
Total marketable debt securities
|
349,012
|
|
|
—
|
|
|
(579
|
)
|
|
348,433
|
|
|||||
|
Total available-for-sale debt securities
|
1,034,013
|
|
|
—
|
|
|
(594
|
)
|
|
1,033,419
|
|
|||||
|
Available-for-sale corporate equity securities
|
43,213
|
|
|
31,608
|
|
|
—
|
|
|
74,821
|
|
|||||
|
Total cash equivalents and marketable securities
|
$
|
1,077,226
|
|
|
$
|
31,608
|
|
|
$
|
(594
|
)
|
|
$
|
1,108,240
|
|
|
|
•
|
$92.5 million
related to its equity investment in CRISPR, a publicly traded company. The CRISPR common stock held by the Company has a readily determinable fair value that is recorded in “Marketable securities” on the Company’s condensed consolidated balance sheets. In January 2018, the Company purchased an additional
$21.5 million
of CRISPR’s common shares.
|
|
•
|
$2.9 million
related to its equity investment in Moderna, which is not a publicly traded company that has a readily determinable fair value for its stock. The Company increased the carrying value of its investment in Moderna, which is recorded in “Other assets” on its condensed consolidated balance sheets, to
$23.0 million
as of
March 31, 2018
based on an observable price increase for additional shares privately issued by Moderna in an orderly transaction between market participants.
|
|
G.
|
Accumulated Other Comprehensive Income (Loss)
|
|
|
|
|
Unrealized Holding Gains (Losses), Net of Tax
|
|
|
||||||||||||||
|
|
Foreign Currency Translation Adjustment
|
|
On Available-For-Sale Debt Securities
|
|
On Equity Securities
|
|
On Foreign Currency Forward Contracts
|
|
Total
|
||||||||||
|
|
(in thousands)
|
||||||||||||||||||
|
Balance at December 31, 2017
|
$
|
(21,031
|
)
|
|
$
|
(594
|
)
|
|
25,069
|
|
|
$
|
(15,016
|
)
|
|
$
|
(11,572
|
)
|
|
|
Other comprehensive loss before reclassifications
|
(2,729
|
)
|
|
(460
|
)
|
|
—
|
|
|
(7,639
|
)
|
|
(10,828
|
)
|
|||||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
—
|
|
|
—
|
|
|
6,777
|
|
|
6,777
|
|
|||||
|
Net current period other comprehensive (loss) income
|
$
|
(2,729
|
)
|
|
$
|
(460
|
)
|
|
$
|
—
|
|
|
$
|
(862
|
)
|
|
$
|
(4,051
|
)
|
|
Amounts reclassified to accumulated deficit pursuant to adoption of new accounting standard
|
949
|
|
|
—
|
|
|
(25,069
|
)
|
|
—
|
|
|
(24,120
|
)
|
|||||
|
Balance at March 31, 2018
|
$
|
(22,811
|
)
|
|
$
|
(1,054
|
)
|
|
$
|
—
|
|
|
$
|
(15,878
|
)
|
|
$
|
(39,743
|
)
|
|
|
|
|
Unrealized Holding Gains (Losses), Net of Tax
|
|
|
||||||||||||||
|
|
Foreign Currency Translation Adjustment
|
|
On Available-For-Sale Debt Securities
|
|
On Equity Securities
|
|
On Foreign Currency Forward Contracts
|
|
Total
|
||||||||||
|
|
(in thousands)
|
||||||||||||||||||
|
Balance at December 31, 2016
|
$
|
(7,862
|
)
|
|
$
|
(10
|
)
|
|
17,531
|
|
|
$
|
11,514
|
|
|
$
|
21,173
|
|
|
|
Other comprehensive (loss) income before reclassifications
|
(2,001
|
)
|
|
(251
|
)
|
|
3,785
|
|
|
(2,802
|
)
|
|
(1,269
|
)
|
|||||
|
Amounts reclassified from accumulated other comprehensive income (loss)
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,879
|
)
|
|
(3,879
|
)
|
|||||
|
Net current period other comprehensive (loss) income
|
$
|
(2,001
|
)
|
|
$
|
(251
|
)
|
|
$
|
3,785
|
|
|
$
|
(6,681
|
)
|
|
$
|
(5,148
|
)
|
|
Balance at March 31, 2017
|
$
|
(9,863
|
)
|
|
$
|
(261
|
)
|
|
$
|
21,316
|
|
|
$
|
4,833
|
|
|
$
|
16,025
|
|
|
H.
|
Hedging
|
|
|
As of March 31, 2018
|
|
As of December 31, 2017
|
||||
|
Foreign Currency
|
(in thousands)
|
||||||
|
Euro
|
$
|
326,024
|
|
|
$
|
257,230
|
|
|
British pound sterling
|
78,066
|
|
|
77,481
|
|
||
|
Australian dollar
|
33,134
|
|
|
30,501
|
|
||
|
Canadian dollar
|
21,104
|
|
|
—
|
|
||
|
Total foreign currency forward contracts
|
$
|
458,328
|
|
|
$
|
365,212
|
|
|
As of March 31, 2018
|
||||||||||
|
Assets
|
|
Liabilities
|
||||||||
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
|
(in thousands)
|
||||||||||
|
Prepaid and other current assets
|
|
$
|
540
|
|
|
Other liabilities, current portion
|
|
$
|
(15,370
|
)
|
|
Other assets
|
|
31
|
|
|
Other liabilities, excluding current portion
|
|
(850
|
)
|
||
|
Total assets
|
|
$
|
571
|
|
|
Total liabilities
|
|
$
|
(16,220
|
)
|
|
As of December 31, 2017
|
||||||||||
|
Assets
|
|
Liabilities
|
||||||||
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
|
(in thousands)
|
||||||||||
|
Prepaid expenses and other current assets
|
|
$
|
13
|
|
|
Other liabilities, current portion
|
|
$
|
(13,642
|
)
|
|
Other assets
|
|
—
|
|
|
Other liabilities, excluding current portion
|
|
(866
|
)
|
||
|
Total assets
|
|
$
|
13
|
|
|
Total liabilities
|
|
$
|
(14,508
|
)
|
|
|
As of March 31, 2018
|
||||||||||||||||||
|
|
Gross Amounts Recognized
|
|
Gross Amounts Offset
|
|
Gross Amounts Presented
|
|
Gross Amounts Not Offset
|
|
Legal Offset
|
||||||||||
|
Foreign currency forward contracts
|
(in thousands)
|
||||||||||||||||||
|
Total assets
|
$
|
571
|
|
|
$
|
—
|
|
|
$
|
571
|
|
|
$
|
(571
|
)
|
|
$
|
—
|
|
|
Total liabilities
|
$
|
(16,220
|
)
|
|
$
|
—
|
|
|
$
|
(16,220
|
)
|
|
$
|
571
|
|
|
$
|
(15,649
|
)
|
|
|
As of December 31, 2017
|
||||||||||||||||||
|
|
Gross Amounts Recognized
|
|
Gross Amounts Offset
|
|
Gross Amounts Presented
|
|
Gross Amounts Not Offset
|
|
Legal Offset
|
||||||||||
|
Foreign currency forward contracts
|
(in thousands)
|
||||||||||||||||||
|
Total assets
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
13
|
|
|
$
|
(13
|
)
|
|
$
|
—
|
|
|
Total liabilities
|
$
|
(14,508
|
)
|
|
$
|
—
|
|
|
$
|
(14,508
|
)
|
|
$
|
13
|
|
|
$
|
(14,495
|
)
|
|
|
As of March 31, 2018
|
|
As of December 31, 2017
|
||||
|
|
(in thousands)
|
||||||
|
Prepaid expenses and other current assets
|
$
|
115
|
|
|
$
|
—
|
|
|
Other liabilities, current portion
|
$
|
—
|
|
|
$
|
(684
|
)
|
|
|
As of March 31, 2018
|
|
As of December 31, 2017
|
||||
|
|
(in thousands)
|
||||||
|
Raw materials
|
$
|
17,587
|
|
|
$
|
20,924
|
|
|
Work-in-process
|
78,232
|
|
|
74,237
|
|
||
|
Finished goods
|
21,527
|
|
|
16,669
|
|
||
|
Total
|
$
|
117,346
|
|
|
$
|
111,830
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
(in thousands)
|
||||||
|
Stock-based compensation expense by type of award:
|
|
|
|
||||
|
Stock options
|
$
|
26,055
|
|
|
$
|
26,981
|
|
|
Restricted stock and restricted stock units (including PSUs)
|
50,418
|
|
|
40,745
|
|
||
|
ESPP share issuances
|
2,128
|
|
|
2,064
|
|
||
|
Stock-based compensation expense related to inventories
|
(465
|
)
|
|
(351
|
)
|
||
|
Total stock-based compensation included in costs and expenses
|
$
|
78,136
|
|
|
$
|
69,439
|
|
|
|
|
|
|
|
|||
|
Stock-based compensation expense by line item:
|
|
|
|
||||
|
Cost of sales
|
$
|
813
|
|
|
$
|
457
|
|
|
Research and development expenses
|
48,488
|
|
|
44,837
|
|
||
|
Sales, general and administrative expenses
|
28,835
|
|
|
24,145
|
|
||
|
Total stock-based compensation included in costs and expenses
|
$
|
78,136
|
|
|
$
|
69,439
|
|
|
|
As of March 31, 2018
|
||||
|
|
Unrecognized Expense
|
|
Weighted-average
Recognition Period |
||
|
|
(in thousands)
|
|
(in years)
|
||
|
Type of award:
|
|
|
|
||
|
Stock options
|
$
|
203,271
|
|
|
2.79
|
|
Restricted stock and restricted stock units (including PSUs)
|
$
|
386,253
|
|
|
2.76
|
|
ESPP share issuances
|
$
|
2,117
|
|
|
0.43
|
|
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
|
Range of Exercise Prices
|
|
Number
Outstanding |
|
Weighted-average
Remaining Contractual Life |
|
Weighted-average
Exercise Price |
|
Number
Exercisable |
|
Weighted-average
Exercise Price |
||||||
|
|
|
(in thousands)
|
|
(in years)
|
|
(per share)
|
|
(in thousands)
|
|
(per share)
|
||||||
|
$26.73–$40.00
|
|
726
|
|
|
1.63
|
|
$
|
34.46
|
|
|
726
|
|
|
$
|
34.46
|
|
|
$40.01–$60.00
|
|
588
|
|
|
4.24
|
|
$
|
49.43
|
|
|
588
|
|
|
$
|
49.43
|
|
|
$60.01–$80.00
|
|
644
|
|
|
5.96
|
|
$
|
75.25
|
|
|
627
|
|
|
$
|
75.28
|
|
|
$80.01–$100.00
|
|
3,791
|
|
|
7.85
|
|
$
|
89.21
|
|
|
1,357
|
|
|
$
|
89.45
|
|
|
$100.01–$120.00
|
|
972
|
|
|
6.80
|
|
$
|
109.28
|
|
|
622
|
|
|
$
|
109.15
|
|
|
$120.01–$140.00
|
|
1,138
|
|
|
7.35
|
|
$
|
130.20
|
|
|
732
|
|
|
$
|
129.98
|
|
|
$140.01–$160.00
|
|
1,496
|
|
|
9.86
|
|
$
|
155.57
|
|
|
10
|
|
|
$
|
155.57
|
|
|
$160.01–$163.74
|
|
600
|
|
|
9.25
|
|
$
|
162.94
|
|
|
76
|
|
|
$
|
162.94
|
|
|
Total
|
|
9,955
|
|
|
7.30
|
|
$
|
103.03
|
|
|
4,738
|
|
|
$
|
84.36
|
|
|
•
|
We have submitted a supplemental new drug application, or sNDA, to the FDA and an MAA line extension to the EMA for ivacaftor in patients with CF 12 months to two years of age. The target date for the FDA to complete its review of the sNDA under the Prescription Drug User Fee Act, or PDUFA, is August 15, 2018. We expect the EMA to complete its review in the first half of 2019.
|
|
•
|
We have submitted a new drug application, or NDA, to the FDA and an MAA line extension to the EMA for lumacaftor in combination with ivacaftor in patients with CF two to five years of age. The target date for the FDA to complete its review of the NDA under PDUFA is August 7, 2018. We expect the EMA to complete its review in the first half of 2019.
|
|
•
|
We have completed enrollment in a Phase 3 clinical trial evaluating tezacaftor in combination with ivacaftor in patients with CF six to eleven years of age who are F508del homozygous or who have at least one mutation in their
CFTR
gene that is responsive to tezacaftor/ivacaftor. We expect to receive data from this clinical trial in the second half of 2018.
|
|
•
|
We are evaluating ivacaftor in a Phase 3 clinical trial in patients with CF less than 12 months of age.
|
|
•
|
We expect to commence a Phase 3 clinical trial evaluating lumacaftor in combination with ivacaftor in patients with CF 12 months to two years of age in the second half of 2018.
|
|
•
|
CRISPR, pursuant to which we are collaborating on the discovery and development of potential new treatments aimed at the underlying genetic causes of human diseases using CRISPR-Cas9 gene editing technology;
|
|
•
|
Moderna Therapeutics, Inc., or Moderna, pursuant to which we are seeking to identify and develop messenger ribonucleic acid, or mRNA therapeutics for the treatment of CF;
|
|
•
|
BioAxone Biosciences, Inc., or BioAxone, pursuant to which we are evaluating VX-210 as a potential treatment for patients who have spinal cord injuries; and
|
|
•
|
Parion Sciences, Inc., or Parion, pursuant to which we are developing epithelial sodium channel, or ENaC, inhibitors for the treatment of pulmonary diseases.
|
|
•
|
Janssen Pharmaceuticals, Inc., which is developing pimodivir (formerly VX-787) for the treatment of influenza; and
|
|
•
|
Merck KGaA, which licensed four oncology research and development programs from us in early 2017.
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Revenues
|
$
|
640,799
|
|
|
$
|
714,718
|
|
|
$
|
(73,919
|
)
|
|
(10
|
)%
|
|
Operating costs and expenses
|
511,898
|
|
|
443,876
|
|
|
68,022
|
|
|
15
|
%
|
|||
|
Other items, net
|
81,362
|
|
|
(23,086
|
)
|
|
104,448
|
|
|
n/a
|
|
|||
|
Net income attributable to Vertex
|
$
|
210,263
|
|
|
$
|
247,756
|
|
|
$
|
(37,493
|
)
|
|
(15
|
)%
|
|
|
|
|
|
|
|
|
|
|||||||
|
Net income per diluted share attributable to Vertex common shareholders
|
$
|
0.81
|
|
|
$
|
0.99
|
|
|
|
|
|
|||
|
Diluted shares used in per share calculations
|
258,526
|
|
|
248,700
|
|
|
|
|
|
|||||
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Product revenues, net
|
$
|
637,729
|
|
|
$
|
480,622
|
|
|
$
|
157,107
|
|
|
33
|
%
|
|
Royalty revenues
|
1,356
|
|
|
1,551
|
|
|
(195
|
)
|
|
(13
|
)%
|
|||
|
Collaborative revenues
|
1,714
|
|
|
232,545
|
|
|
(230,831
|
)
|
|
(99
|
)%
|
|||
|
Total revenues
|
$
|
640,799
|
|
|
$
|
714,718
|
|
|
$
|
(73,919
|
)
|
|
(10
|
)%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
KALYDECO
|
$
|
249,539
|
|
|
$
|
185,715
|
|
|
$
|
63,824
|
|
|
34
|
%
|
|
ORKAMBI
|
354,066
|
|
|
294,861
|
|
|
59,205
|
|
|
20
|
%
|
|||
|
SYMDEKO
|
34,124
|
|
|
—
|
|
|
34,124
|
|
|
n/a
|
|
|||
|
Total CF product revenues, net
|
$
|
637,729
|
|
|
$
|
480,576
|
|
|
$
|
157,153
|
|
|
33
|
%
|
|
`
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Cost of sales
|
$
|
71,613
|
|
|
$
|
46,988
|
|
|
$
|
24,625
|
|
|
52
|
%
|
|
Research and development expenses
|
310,553
|
|
|
273,563
|
|
|
36,990
|
|
|
14
|
%
|
|||
|
Sales, general and administrative expenses
|
129,808
|
|
|
113,326
|
|
|
16,482
|
|
|
15
|
%
|
|||
|
Restructuring (income) expenses
|
(76
|
)
|
|
9,999
|
|
|
(10,075
|
)
|
|
n/a
|
|
|||
|
Total costs and expenses
|
$
|
511,898
|
|
|
$
|
443,876
|
|
|
$
|
68,022
|
|
|
15
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Research expenses
|
$
|
77,942
|
|
|
$
|
73,056
|
|
|
$
|
4,886
|
|
|
7
|
%
|
|
Development expenses
|
232,611
|
|
|
200,507
|
|
|
32,104
|
|
|
16
|
%
|
|||
|
Total research and development expenses
|
$
|
310,553
|
|
|
$
|
273,563
|
|
|
$
|
36,990
|
|
|
14
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Research Expenses:
|
|
|
|
|
|
|
|
|||||||
|
Salary and benefits
|
$
|
24,088
|
|
|
$
|
21,533
|
|
|
$
|
2,555
|
|
|
12
|
%
|
|
Stock-based compensation expense
|
14,760
|
|
|
13,691
|
|
|
1,069
|
|
|
8
|
%
|
|||
|
Laboratory supplies and other direct expenses
|
10,916
|
|
|
11,365
|
|
|
(449
|
)
|
|
(4
|
)%
|
|||
|
Outsourced services
|
7,897
|
|
|
7,337
|
|
|
560
|
|
|
8
|
%
|
|||
|
Collaboration and asset acquisition payments
|
308
|
|
|
—
|
|
|
308
|
|
|
n/a
|
|
|||
|
Infrastructure costs
|
19,973
|
|
|
19,130
|
|
|
843
|
|
|
4
|
%
|
|||
|
Total research expenses
|
$
|
77,942
|
|
|
$
|
73,056
|
|
|
$
|
4,886
|
|
|
7
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Development Expenses:
|
|
|
|
|
|
|
|
|||||||
|
Salary and benefits
|
$
|
57,002
|
|
|
$
|
48,971
|
|
|
$
|
8,031
|
|
|
16
|
%
|
|
Stock-based compensation expense
|
33,728
|
|
|
31,146
|
|
|
2,582
|
|
|
8
|
%
|
|||
|
Laboratory supplies and other direct expenses
|
14,473
|
|
|
14,013
|
|
|
460
|
|
|
3
|
%
|
|||
|
Outsourced services
|
84,719
|
|
|
73,185
|
|
|
11,534
|
|
|
16
|
%
|
|||
|
Collaboration and asset acquisition payments
|
250
|
|
|
250
|
|
|
—
|
|
|
—
|
%
|
|||
|
Drug supply costs
|
8,421
|
|
|
1,949
|
|
|
6,472
|
|
|
332
|
%
|
|||
|
Infrastructure costs
|
34,018
|
|
|
30,993
|
|
|
3,025
|
|
|
10
|
%
|
|||
|
Total development expenses
|
$
|
232,611
|
|
|
$
|
200,507
|
|
|
$
|
32,104
|
|
|
16
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Sales, general and administrative expenses
|
$
|
129,808
|
|
|
$
|
113,326
|
|
|
$
|
16,482
|
|
|
15
|
%
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
|
|
|
|
|
||||
|
Loss attributable to noncontrolling interest before provision for income taxes and changes in fair value of contingent payments
|
$
|
557
|
|
|
$
|
1,547
|
|
|
Provision for income taxes
|
6,405
|
|
|
391
|
|
||
|
Increase in fair value of contingent payments
|
(24,000
|
)
|
|
(3,730
|
)
|
||
|
Net income attributable to noncontrolling interest
|
$
|
(17,038
|
)
|
|
$
|
(1,792
|
)
|
|
|
March 31,
|
|
December 31,
|
|
Increase/(Decrease)
|
|||||||||
|
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Cash, cash equivalents and marketable securities
|
$
|
2,477,017
|
|
|
$
|
2,088,666
|
|
|
$
|
388,351
|
|
|
19
|
%
|
|
Working Capital
|
|
|
|
|
|
|
|
|||||||
|
Total current assets
|
3,041,116
|
|
|
2,648,963
|
|
|
392,153
|
|
|
15
|
%
|
|||
|
Total current liabilities
|
827,312
|
|
|
807,260
|
|
|
20,052
|
|
|
2
|
%
|
|||
|
Total working capital
|
$
|
2,213,804
|
|
|
$
|
1,841,703
|
|
|
$
|
372,101
|
|
|
20
|
%
|
|
•
|
our expectations regarding the amount of, timing of and trends with respect to our revenues, costs and expenses and other gains and losses, including those related to CF net product revenues;
|
|
•
|
our expectations regarding clinical trials, development timelines, timing of our receipt of data from our ongoing and planned clinical trials and regulatory authority filings and submissions for ivacaftor, lumacaftor, tezacaftor, VX-659, VX-445, VX-561, VX-150, VX-128 and VX-210 and the MAA for tezacaftor in combination with ivacaftor;
|
|
•
|
our ability to obtain reimbursement for ORKAMBI in ex-U.S. markets and our ability to otherwise successfully market KALYDECO, ORKAMBI and SYMDEKO or any of our other drug candidates for which we obtain regulatory approval;
|
|
•
|
our expectations regarding the timing and structure of clinical trials of our drugs and drug candidates, including ivacaftor, lumacaftor, tezacaftor, VX-659, VX-445, VX-561, VX-150, VX-128 and VX-210, and the expected timing of our receipt of data from our ongoing and planned clinical trials;
|
|
•
|
the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance compounds, continue development or support regulatory filings;
|
|
•
|
our beliefs regarding the support provided by clinical trials and preclinical and nonclinical studies of our drug candidates for further investigation, clinical trials or potential use as a treatment;
|
|
•
|
our plan to continue investing in our research and development programs and our strategy to develop our drug candidates, alone or with third party-collaborators;
|
|
•
|
the establishment, development and maintenance of collaborative relationships;
|
|
•
|
potential business development activities;
|
|
•
|
our post-closing integration of the assets acquired from Concert;
|
|
•
|
potential fluctuations in foreign currency exchange rates;
|
|
•
|
our ability to use our research programs to identify and develop new drug candidates to address serious diseases and significant unmet medical needs; and
|
|
•
|
our liquidity and our expectations regarding the possibility of raising additional capital.
|
|
Period
|
|
Total Number
of Shares Purchased (1) |
Average Price
Paid per Share |
Total Number of Shares
Purchased as Part of Publicly Announced Plans or Programs (2) |
Approximate Dollar Value of Shares that May Yet be Purchased Under the Plans or Programs (2)
|
|
January 1, 2018 to January 31, 2018
|
4,445
|
$0.01
|
—
|
500,000,000
|
|
|
February 1, 2018 to February 28, 2018
|
22,043
|
$85.06
|
11,164
|
498,125,176
|
|
|
March 1, 2018 to March 31, 2018
|
63,886
|
$146.73
|
55,920
|
488,751,049
|
|
|
Total
|
90,374
|
$124.47
|
67,084
|
488,751,049
|
|
|
Exhibit Number
|
Exhibit Description
|
|
31.1
|
|
|
31.2
|
|
|
32.1
|
|
|
101.INS
|
XBRL Instance
|
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation
|
|
101.LAB
|
XBRL Taxonomy Extension Labels
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation
|
|
101.DEF
|
XBRL Taxonomy Extension Definition
|
|
|
Vertex Pharmaceuticals Incorporated
|
|
|
|
|
|
|
April 27, 2018
|
By:
|
/s/ Thomas Graney
|
|
|
|
Thomas Graney
|
|
|
|
Senior Vice President and Chief Financial Officer
(principal financial officer and duly authorized officer) |
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|