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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
|
|
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2013
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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
|
04-3039129
|
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(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
|
130 Waverly Street, Cambridge, Massachusetts
|
02139-4242
|
|
(Address of principal executive offices)
|
(Zip Code)
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Large accelerated filer
x
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Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller reporting company
o
|
|
|
(Do not check if a smaller reporting company)
|
||
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Common Stock, par value $0.01 per share
|
233,756,871
|
|
Class
|
Outstanding at October 31, 2013
|
|
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Page
|
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||
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||
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||
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||
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||
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||
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||
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||
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||
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Three Months Ended September 30,
|
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Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Revenues:
|
|
|
|
|
|
|
|
||||||||
|
Product revenues, net
|
$
|
186,653
|
|
|
$
|
303,501
|
|
|
$
|
708,823
|
|
|
$
|
1,052,149
|
|
|
Royalty revenues
|
27,012
|
|
|
25,586
|
|
|
119,705
|
|
|
98,047
|
|
||||
|
Collaborative revenues
|
8,035
|
|
|
6,919
|
|
|
32,290
|
|
|
42,852
|
|
||||
|
Total revenues
|
221,700
|
|
|
336,006
|
|
|
860,818
|
|
|
1,193,048
|
|
||||
|
Costs and expenses:
|
|
|
|
|
|
|
|
||||||||
|
Cost of product revenues
|
20,048
|
|
|
30,680
|
|
|
75,698
|
|
|
161,147
|
|
||||
|
Royalty expenses
|
7,291
|
|
|
7,856
|
|
|
32,315
|
|
|
31,023
|
|
||||
|
Research and development expenses
|
228,624
|
|
|
200,161
|
|
|
669,174
|
|
|
593,076
|
|
||||
|
Sales, general and administrative expenses
|
87,754
|
|
|
97,684
|
|
|
287,154
|
|
|
326,344
|
|
||||
|
Restructuring expenses
|
12,048
|
|
|
696
|
|
|
12,863
|
|
|
1,650
|
|
||||
|
Intangible asset impairment charge
|
—
|
|
|
—
|
|
|
412,900
|
|
|
—
|
|
||||
|
Total costs and expenses
|
355,765
|
|
|
337,077
|
|
|
1,490,104
|
|
|
1,113,240
|
|
||||
|
Income (loss) from operations
|
(134,065
|
)
|
|
(1,071
|
)
|
|
(629,286
|
)
|
|
79,808
|
|
||||
|
Other income (expense), net
|
4,652
|
|
|
(4,041
|
)
|
|
(6,578
|
)
|
|
(11,417
|
)
|
||||
|
Income (loss) before provision for (benefit from) income taxes
|
(129,413
|
)
|
|
(5,112
|
)
|
|
(635,864
|
)
|
|
68,391
|
|
||||
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Provision for (benefit from) income taxes
|
(751
|
)
|
|
21,355
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|
|
(132,863
|
)
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|
41,450
|
|
||||
|
Net income (loss)
|
(128,662
|
)
|
|
(26,467
|
)
|
|
(503,001
|
)
|
|
26,941
|
|
||||
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
4,530
|
|
|
(31,076
|
)
|
|
13,688
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|
|
(57,825
|
)
|
||||
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Net loss attributable to Vertex
|
$
|
(124,132
|
)
|
|
$
|
(57,543
|
)
|
|
$
|
(489,313
|
)
|
|
$
|
(30,884
|
)
|
|
Net loss per share attributable to Vertex common shareholders:
|
|
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|
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|
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||||||||
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Basic
|
$
|
(0.54
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(2.20
|
)
|
|
$
|
(0.15
|
)
|
|
Diluted
|
$
|
(0.54
|
)
|
|
$
|
(0.27
|
)
|
|
$
|
(2.20
|
)
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|
$
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(0.15
|
)
|
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Shares used in per share calculations:
|
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||||||||
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Basic
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230,505
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213,767
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222,764
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|
|
211,053
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||||
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Diluted
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230,505
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|
213,767
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|
222,764
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|
|
211,053
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||||
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Three Months Ended September 30,
|
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Nine Months Ended September 30,
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||||||||||||
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2013
|
|
2012
|
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2013
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|
2012
|
||||||||
|
Net income (loss)
|
$
|
(128,662
|
)
|
|
$
|
(26,467
|
)
|
|
$
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(503,001
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)
|
|
$
|
26,941
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|
|
Changes in other comprehensive income (loss):
|
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|
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|
|
|
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||||||||
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Unrealized holding gains on marketable securities, net of tax
|
166
|
|
|
69
|
|
|
7
|
|
|
324
|
|
||||
|
Foreign currency translation adjustment
|
514
|
|
|
188
|
|
|
(7
|
)
|
|
313
|
|
||||
|
Total changes in other comprehensive income (loss)
|
680
|
|
|
257
|
|
|
—
|
|
|
637
|
|
||||
|
Comprehensive income (loss)
|
(127,982
|
)
|
|
(26,210
|
)
|
|
(503,001
|
)
|
|
27,578
|
|
||||
|
Comprehensive loss (income) attributable to noncontrolling interest (Alios)
|
4,530
|
|
|
(31,076
|
)
|
|
13,688
|
|
|
(57,825
|
)
|
||||
|
Comprehensive loss attributable to Vertex
|
$
|
(123,452
|
)
|
|
$
|
(57,286
|
)
|
|
$
|
(489,313
|
)
|
|
$
|
(30,247
|
)
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2013(1)
|
|
2012(1)
|
||||
|
Assets
|
|
|
|
||||
|
Current assets:
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
583,181
|
|
|
$
|
489,407
|
|
|
Marketable securities, available for sale
|
839,469
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|
831,808
|
|
||
|
Restricted cash and cash equivalents (Alios)
|
51,059
|
|
|
69,983
|
|
||
|
Accounts receivable, net
|
120,281
|
|
|
143,250
|
|
||
|
Inventories
|
13,537
|
|
|
30,464
|
|
||
|
Prepaid expenses and other current assets
|
41,104
|
|
|
24,673
|
|
||
|
Total current assets
|
1,648,631
|
|
|
1,589,585
|
|
||
|
Restricted cash
|
127
|
|
|
31,934
|
|
||
|
Property and equipment, net
|
648,924
|
|
|
433,609
|
|
||
|
Intangible assets
|
250,600
|
|
|
663,500
|
|
||
|
Goodwill
|
30,992
|
|
|
30,992
|
|
||
|
Other assets
|
3,474
|
|
|
9,668
|
|
||
|
Total assets
|
$
|
2,582,748
|
|
|
$
|
2,759,288
|
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
||||
|
Current liabilities:
|
|
|
|
||||
|
Accounts payable
|
$
|
51,533
|
|
|
$
|
101,292
|
|
|
Accrued expenses
|
280,848
|
|
|
264,884
|
|
||
|
Deferred revenues, current portion
|
31,007
|
|
|
27,566
|
|
||
|
Accrued restructuring expenses, current portion
|
9,858
|
|
|
4,758
|
|
||
|
Capital lease obligations, current portion
|
14,429
|
|
|
13,707
|
|
||
|
Other liabilities, current portion
|
21,824
|
|
|
20,417
|
|
||
|
Total current liabilities
|
409,499
|
|
|
432,624
|
|
||
|
Deferred revenues, excluding current portion
|
77,354
|
|
|
96,242
|
|
||
|
Accrued restructuring expenses, excluding current portion
|
16,280
|
|
|
18,570
|
|
||
|
Capital lease obligations, excluding current portion
|
39,381
|
|
|
15,170
|
|
||
|
Convertible senior subordinated notes (due 2015)
|
—
|
|
|
400,000
|
|
||
|
Deferred tax liability
|
150,203
|
|
|
280,367
|
|
||
|
Construction financing lease obligation
|
392,569
|
|
|
268,031
|
|
||
|
Other liabilities, excluding current portion
|
10,782
|
|
|
13,902
|
|
||
|
Total liabilities
|
1,096,068
|
|
|
1,524,906
|
|
||
|
Commitments and contingencies
|
|
|
|
|
|
||
|
Redeemable noncontrolling interest (Alios)
|
39,624
|
|
|
38,530
|
|
||
|
Shareholders’ equity:
|
|
|
|
||||
|
Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding at September 30, 2013 and December 31, 2012
|
—
|
|
|
—
|
|
||
|
Common stock, $0.01 par value; 300,000,000 shares authorized at September 30, 2013 and December 31, 2012; 233,592,201 and 217,286,868 shares issued and outstanding at September 30, 2013 and December 31, 2012, respectively
|
2,311
|
|
|
2,149
|
|
||
|
Additional paid-in capital
|
5,274,307
|
|
|
4,519,448
|
|
||
|
Accumulated other comprehensive loss
|
(550
|
)
|
|
(550
|
)
|
||
|
Accumulated deficit
|
(4,011,180
|
)
|
|
(3,521,867
|
)
|
||
|
Total Vertex shareholders’ equity
|
1,264,888
|
|
|
999,180
|
|
||
|
Noncontrolling interest (Alios)
|
182,168
|
|
|
196,672
|
|
||
|
Total shareholders’ equity
|
1,447,056
|
|
|
1,195,852
|
|
||
|
Total liabilities and shareholders’ equity
|
$
|
2,582,748
|
|
|
$
|
2,759,288
|
|
|
(1)
|
Amounts include the assets and liabilities of Vertex’s variable interest entity (“VIE”), Alios BioPharma, Inc. (“Alios”). Vertex’s interests and obligations with respect to the VIE’s assets and liabilities are limited to those accorded to Vertex in its agreement with Alios. See
Note C, "Collaborative Arrangements,"
to these condensed consolidated financial statements for amounts.
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive Loss |
|
Accumulated Deficit
|
|
Total Vertex
Shareholders’ Equity |
|
Noncontrolling
Interest (Alios) |
|
Total
Shareholders’ Equity |
|
Redeemable
Noncontrolling Interest (Alios) |
|||||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
|
Balance, December 31, 2011
|
209,304
|
|
|
$
|
2,072
|
|
|
$
|
4,200,659
|
|
|
$
|
(1,053
|
)
|
|
$
|
(3,414,835
|
)
|
|
$
|
786,843
|
|
|
$
|
141,633
|
|
|
$
|
928,476
|
|
|
$
|
37,036
|
|
|
Unrealized holding gains on marketable securities, net of tax
|
|
|
|
|
|
|
324
|
|
|
|
|
324
|
|
|
|
|
324
|
|
|
|
||||||||||||||
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
313
|
|
|
|
|
313
|
|
|
|
|
313
|
|
|
|
||||||||||||||
|
Net income (loss)
|
|
|
|
|
|
|
|
|
(30,884
|
)
|
|
(30,884
|
)
|
|
57,825
|
|
|
26,941
|
|
|
|
|||||||||||||
|
Issuance of common stock under benefit plans
|
7,038
|
|
|
69
|
|
|
182,803
|
|
|
|
|
|
|
182,872
|
|
|
150
|
|
|
183,022
|
|
|
|
|||||||||||
|
Stock-based compensation expense
|
|
|
|
|
87,168
|
|
|
|
|
|
|
87,168
|
|
|
369
|
|
|
87,537
|
|
|
|
|||||||||||||
|
Tax benefit from equity compensation
|
|
|
|
|
1,097
|
|
|
|
|
|
|
1,097
|
|
|
|
|
|
1,097
|
|
|
|
|||||||||||||
|
Change in liquidation value of noncontrolling interest
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,263
|
)
|
|
(1,263
|
)
|
|
1,263
|
|
||||||||||||||
|
Balance, September 30, 2012
|
216,342
|
|
|
$
|
2,141
|
|
|
$
|
4,471,727
|
|
|
$
|
(416
|
)
|
|
$
|
(3,445,719
|
)
|
|
$
|
1,027,733
|
|
|
$
|
198,714
|
|
|
$
|
1,226,447
|
|
|
$
|
38,299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
|
Balance, December 31, 2012
|
217,287
|
|
|
$
|
2,149
|
|
|
$
|
4,519,448
|
|
|
$
|
(550
|
)
|
|
$
|
(3,521,867
|
)
|
|
$
|
999,180
|
|
|
$
|
196,672
|
|
|
$
|
1,195,852
|
|
|
$
|
38,530
|
|
|
Unrealized holding gains on marketable securities, net of tax
|
|
|
|
|
|
|
7
|
|
|
|
|
7
|
|
|
|
|
7
|
|
|
|
||||||||||||||
|
Foreign currency translation adjustment
|
|
|
|
|
|
|
(7
|
)
|
|
|
|
(7
|
)
|
|
|
|
(7
|
)
|
|
|
||||||||||||||
|
Net loss
|
|
|
|
|
|
|
|
|
(489,313
|
)
|
|
(489,313
|
)
|
|
(13,688
|
)
|
|
(503,001
|
)
|
|
|
|||||||||||||
|
Issuance of common stock under benefit plans
|
8,029
|
|
|
79
|
|
|
248,207
|
|
|
|
|
|
|
248,286
|
|
|
(70
|
)
|
|
248,216
|
|
|
|
|||||||||||
|
Convertible senior subordinated notes (due 2015) conversion
|
8,276
|
|
|
83
|
|
|
402,182
|
|
|
|
|
|
|
402,265
|
|
|
|
|
|
402,265
|
|
|
|
|||||||||||
|
Stock-based compensation expense
|
|
|
|
|
104,470
|
|
|
|
|
|
|
104,470
|
|
|
348
|
|
|
104,818
|
|
|
|
|||||||||||||
|
Change in liquidation value of noncontrolling interest
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,094
|
)
|
|
(1,094
|
)
|
|
1,094
|
|
||||||||||||||
|
Balance, September 30, 2013
|
233,592
|
|
|
$
|
2,311
|
|
|
$
|
5,274,307
|
|
|
$
|
(550
|
)
|
|
$
|
(4,011,180
|
)
|
|
$
|
1,264,888
|
|
|
$
|
182,168
|
|
|
$
|
1,447,056
|
|
|
$
|
39,624
|
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2013
|
|
2012
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net income (loss)
|
$
|
(503,001
|
)
|
|
$
|
26,941
|
|
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
||||
|
Depreciation and amortization expense
|
30,734
|
|
|
25,818
|
|
||
|
Stock-based compensation expense
|
103,933
|
|
|
86,649
|
|
||
|
Other non-cash based compensation expense
|
5,856
|
|
|
8,070
|
|
||
|
Intangible asset impairment charge
|
412,900
|
|
|
—
|
|
||
|
Deferred income taxes
|
(130,164
|
)
|
|
35,759
|
|
||
|
Impairment of property and equipment
|
6,650
|
|
|
—
|
|
||
|
Write-down of inventories to net realizable value
|
10,358
|
|
|
78,000
|
|
||
|
Other non-cash items, net
|
(1,393
|
)
|
|
(304
|
)
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable, net
|
20,737
|
|
|
43,538
|
|
||
|
Inventories
|
5,212
|
|
|
(32,419
|
)
|
||
|
Prepaid expenses and other current assets
|
(16,477
|
)
|
|
(22,698
|
)
|
||
|
Accounts payable
|
(46,005
|
)
|
|
1,359
|
|
||
|
Accrued expenses and other liabilities
|
32,872
|
|
|
12,027
|
|
||
|
Excess tax benefit from share-based payment arrangements
|
—
|
|
|
(1,097
|
)
|
||
|
Accrued restructuring expense
|
2,810
|
|
|
(2,158
|
)
|
||
|
Deferred revenues
|
(15,447
|
)
|
|
(32,203
|
)
|
||
|
Net cash provided by (used in) operating activities
|
(80,425
|
)
|
|
227,282
|
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of marketable securities
|
(1,850,015
|
)
|
|
(1,309,044
|
)
|
||
|
Sales and maturities of marketable securities
|
1,842,361
|
|
|
941,314
|
|
||
|
Expenditures for property and equipment
|
(36,922
|
)
|
|
(43,094
|
)
|
||
|
Decrease in restricted cash and cash equivalents
|
31,807
|
|
|
1,923
|
|
||
|
Decrease (increase) in restricted cash and cash equivalents (Alios)
|
18,924
|
|
|
(23,075
|
)
|
||
|
Decrease (increase) in other assets
|
1,094
|
|
|
(997
|
)
|
||
|
Net cash provided by (used in) investing activities
|
7,249
|
|
|
(432,973
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Excess tax benefit from share-based payment arrangements
|
—
|
|
|
1,097
|
|
||
|
Issuances of common stock from employee benefit plans
|
242,360
|
|
|
174,950
|
|
||
|
Payments to redeem secured notes (due 2015)
|
(158
|
)
|
|
—
|
|
||
|
Payments on capital lease obligations
|
(14,601
|
)
|
|
(2,408
|
)
|
||
|
Payments on construction financing lease obligation
|
(63,242
|
)
|
|
(6,272
|
)
|
||
|
Net cash provided by financing activities
|
164,359
|
|
|
167,367
|
|
||
|
Effect of changes in exchange rates on cash
|
2,591
|
|
|
(110
|
)
|
||
|
Net increase (decrease) in cash and cash equivalents
|
93,774
|
|
|
(38,434
|
)
|
||
|
Cash and cash equivalents—beginning of period
|
489,407
|
|
|
475,320
|
|
||
|
Cash and cash equivalents—end of period
|
$
|
583,181
|
|
|
$
|
436,886
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
|
Cash paid for interest
|
$
|
6,700
|
|
|
$
|
6,700
|
|
|
Conversion of convertible senior subordinated notes (due 2015) for common stock
|
399,842
|
|
|
—
|
|
||
|
Interest on converted convertible senior subordinated notes (due 2015) offset to additional paid-in capital
|
6,700
|
|
|
—
|
|
||
|
Unamortized debt issuance costs of converted convertible subordinated notes (due 2015) offset to additional paid-in capital
|
4,230
|
|
|
—
|
|
||
|
Capitalization of construction in-process related to construction financing lease obligation
|
176,484
|
|
|
167,996
|
|
||
|
Assets acquired under capital lease
|
38,520
|
|
|
27,552
|
|
||
|
A.
|
Basis of Presentation and Accounting Policies
|
|
B.
|
Product Revenues, Net
|
|
|
Trade
Allowances |
|
Rebates,
Chargebacks and Discounts |
|
Product
Returns |
|
Other
Incentives |
|
Total
|
||||||||||
|
|
(in thousands)
|
||||||||||||||||||
|
Balance at December 31, 2012
|
$
|
5,416
|
|
|
$
|
63,560
|
|
|
$
|
2,852
|
|
|
$
|
3,565
|
|
|
$
|
75,393
|
|
|
Provision related to current period sales
|
26,584
|
|
|
155,269
|
|
|
3,687
|
|
|
8,161
|
|
|
193,701
|
|
|||||
|
Adjustments related to prior period sales
|
348
|
|
|
4,433
|
|
|
11,125
|
|
|
(228
|
)
|
|
15,678
|
|
|||||
|
Credits/payments made
|
(29,960
|
)
|
|
(153,035
|
)
|
|
(3,649
|
)
|
|
(9,641
|
)
|
|
(196,285
|
)
|
|||||
|
Balance at September 30, 2013
|
$
|
2,388
|
|
|
$
|
70,227
|
|
|
$
|
14,015
|
|
|
$
|
1,857
|
|
|
$
|
88,487
|
|
|
C.
|
Collaborative Arrangements
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||
|
Royalty revenues (INCIVO)
|
$
|
20,994
|
|
|
$
|
19,957
|
|
|
$
|
104,108
|
|
|
$
|
80,811
|
|
|
Collaborative revenues:
|
|
|
|
|
|
|
|
||||||||
|
Amortized portion of up-front payment
|
$
|
3,107
|
|
|
$
|
3,107
|
|
|
$
|
9,321
|
|
|
$
|
9,321
|
|
|
Net reimbursement (payment) for telaprevir development costs
|
1,413
|
|
|
(503
|
)
|
|
1,422
|
|
|
(2,569
|
)
|
||||
|
Reimbursement for manufacturing services
|
—
|
|
|
—
|
|
|
10,299
|
|
|
4,449
|
|
||||
|
Total collaborative revenues attributable to the Janssen collaboration
|
$
|
4,520
|
|
|
$
|
2,604
|
|
|
$
|
21,042
|
|
|
$
|
11,201
|
|
|
Total revenues attributable to the Janssen collaboration
|
$
|
25,514
|
|
|
$
|
22,561
|
|
|
$
|
125,150
|
|
|
$
|
92,012
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||
|
Collaborative revenues attributable to the CFFT collaboration
|
$
|
3,515
|
|
|
$
|
4,315
|
|
|
$
|
11,318
|
|
|
$
|
12,772
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||
|
Loss before provision for (benefit from) income taxes
|
$
|
9,056
|
|
|
$
|
5,090
|
|
|
$
|
21,177
|
|
|
$
|
14,581
|
|
|
Decrease (increase) in fair value of contingent milestone and royalty payments
|
(1,220
|
)
|
|
(57,560
|
)
|
|
1,600
|
|
|
(112,760
|
)
|
||||
|
Provision for (benefit from) income taxes
|
(3,306
|
)
|
|
21,394
|
|
|
(9,089
|
)
|
|
40,354
|
|
||||
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
$
|
4,530
|
|
|
$
|
(31,076
|
)
|
|
$
|
13,688
|
|
|
$
|
(57,825
|
)
|
|
|
As of
September 30, 2013 |
|
As of
December 31, 2012 |
||||
|
|
(in thousands)
|
||||||
|
Restricted cash and cash equivalents (Alios)
|
$
|
51,059
|
|
|
$
|
69,983
|
|
|
Prepaid expenses and other current assets
|
8,821
|
|
|
672
|
|
||
|
Property and equipment, net
|
1,374
|
|
|
1,728
|
|
||
|
Intangible assets
|
250,600
|
|
|
250,600
|
|
||
|
Goodwill
|
4,890
|
|
|
4,890
|
|
||
|
Other assets
|
153
|
|
|
861
|
|
||
|
Accounts payable
|
1,251
|
|
|
1,054
|
|
||
|
Accrued expenses
|
6,689
|
|
|
6,099
|
|
||
|
Deferred tax liability
|
150,203
|
|
|
152,781
|
|
||
|
Other liabilities, excluding current portion
|
873
|
|
|
1,625
|
|
||
|
Redeemable noncontrolling interest (Alios)
|
39,624
|
|
|
38,530
|
|
||
|
Noncontrolling interest (Alios)
|
182,168
|
|
|
196,672
|
|
||
|
D.
|
Net Loss Per Share Attributable to Vertex Common Shareholders
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||
|
Stock options
|
16,807
|
|
|
20,226
|
|
|
16,807
|
|
|
20,226
|
|
|
Convertible senior subordinated notes
|
—
|
|
|
8,192
|
|
|
—
|
|
|
8,192
|
|
|
Unvested restricted stock and restricted stock units
|
2,838
|
|
|
2,222
|
|
|
2,838
|
|
|
2,222
|
|
|
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 September 30, 2013 |
||||||||||||||
|
|
|
|
Fair Value Hierarchy
|
||||||||||||
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Financial assets carried at fair value:
|
|
|
|
|
|
|
|
||||||||
|
Cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Money market funds
|
$
|
308,981
|
|
|
$
|
308,981
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Government-sponsored enterprise securities
|
2,895
|
|
|
2,895
|
|
|
—
|
|
|
—
|
|
||||
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Government-sponsored enterprise securities
|
555,527
|
|
|
555,527
|
|
|
—
|
|
|
—
|
|
||||
|
Commercial paper
|
125,264
|
|
|
—
|
|
|
125,264
|
|
|
—
|
|
||||
|
Corporate debt securities
|
158,678
|
|
|
—
|
|
|
158,678
|
|
|
—
|
|
||||
|
Total
|
$
|
1,151,345
|
|
|
$
|
867,403
|
|
|
$
|
283,942
|
|
|
$
|
—
|
|
|
F.
|
Marketable Securities
|
|
|
Amortized Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
As of September 30, 2013
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Cash and money market funds
|
$
|
580,286
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
580,286
|
|
|
Government-sponsored enterprise securities
|
2,895
|
|
|
—
|
|
|
—
|
|
|
2,895
|
|
||||
|
Total cash and cash equivalents
|
$
|
583,181
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
583,181
|
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
U.S. Treasury securities (due within 1 year)
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Government-sponsored enterprise securities (due within 1 year)
|
555,502
|
|
|
35
|
|
|
(10
|
)
|
|
555,527
|
|
||||
|
Commercial paper (due within 1 year)
|
125,073
|
|
|
191
|
|
|
—
|
|
|
125,264
|
|
||||
|
Corporate debt securities (due within 1 year)
|
148,672
|
|
|
21
|
|
|
(38
|
)
|
|
148,655
|
|
||||
|
Corporate debt securities (due after 1 year through 5 years)
|
10,019
|
|
|
5
|
|
|
(1
|
)
|
|
10,023
|
|
||||
|
Total marketable securities
|
$
|
839,266
|
|
|
$
|
252
|
|
|
$
|
(49
|
)
|
|
$
|
839,469
|
|
|
Total cash, cash equivalents and marketable securities
|
$
|
1,422,447
|
|
|
$
|
252
|
|
|
$
|
(49
|
)
|
|
$
|
1,422,650
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
As of December 31, 2012
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Cash and money market funds
|
$
|
489,407
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
489,407
|
|
|
Government-sponsored enterprise securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
|
Total cash and cash equivalents
|
$
|
489,407
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
489,407
|
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
U.S. Treasury securities (due within 1 year)
|
$
|
111,350
|
|
|
$
|
2
|
|
|
$
|
(2
|
)
|
|
$
|
111,350
|
|
|
Government-sponsored enterprise securities (due within 1 year)
|
440,181
|
|
|
49
|
|
|
(5
|
)
|
|
440,225
|
|
||||
|
Commercial paper (due within 1 year)
|
225,294
|
|
|
155
|
|
|
—
|
|
|
225,449
|
|
||||
|
Corporate debt securities (due within 1 year)
|
15,429
|
|
|
1
|
|
|
(1
|
)
|
|
15,429
|
|
||||
|
Corporate debt securities (due after 1 year through 5 years)
|
39,358
|
|
|
10
|
|
|
(13
|
)
|
|
39,355
|
|
||||
|
Total marketable securities
|
$
|
831,612
|
|
|
$
|
217
|
|
|
$
|
(21
|
)
|
|
$
|
831,808
|
|
|
Total cash, cash equivalents and marketable securities
|
$
|
1,321,019
|
|
|
$
|
217
|
|
|
$
|
(21
|
)
|
|
$
|
1,321,215
|
|
|
G.
|
Accumulated Other Comprehensive Loss
|
|
|
Foreign Currency Translation Adjustment
|
|
Unrealized Holding Gains on Marketable Securities, Net of Tax
|
|
Total
|
||||||
|
|
(in thousands)
|
||||||||||
|
Balance at December 31, 2012
|
$
|
(746
|
)
|
|
$
|
196
|
|
|
$
|
(550
|
)
|
|
Other comprehensive income (loss) before reclassifications
|
(7
|
)
|
|
7
|
|
|
—
|
|
|||
|
Amounts reclassified from accumulated other comprehensive loss
|
—
|
|
|
—
|
|
|
—
|
|
|||
|
Net current period other comprehensive income (loss)
|
(7
|
)
|
|
7
|
|
|
—
|
|
|||
|
Balance at September 30, 2013
|
$
|
(753
|
)
|
|
$
|
203
|
|
|
$
|
(550
|
)
|
|
H.
|
Inventories
|
|
|
As of
September 30, 2013 |
|
As of
December 31, 2012 |
||||
|
|
(in thousands)
|
||||||
|
Raw materials
|
$
|
232
|
|
|
$
|
3,754
|
|
|
Work-in-process
|
7,980
|
|
|
11,317
|
|
||
|
Finished goods
|
5,325
|
|
|
15,393
|
|
||
|
Total
|
$
|
13,537
|
|
|
$
|
30,464
|
|
|
I.
|
Intangible Assets and Goodwill
|
|
J.
|
Convertible Senior Subordinated Notes
|
|
K.
|
Long-term Obligations
|
|
Year
|
|
(in thousands)
|
||
|
2013
|
|
$
|
1,883
|
|
|
2014
|
|
18,077
|
|
|
|
2015
|
|
15,608
|
|
|
|
2016
|
|
8,924
|
|
|
|
2017
|
|
8,481
|
|
|
|
2018
|
|
7,877
|
|
|
|
2019
|
|
409
|
|
|
|
Total payments
|
|
61,259
|
|
|
|
Less: amount representing interest
|
|
(7,449
|
)
|
|
|
Present value of payments
|
|
$
|
53,810
|
|
|
L.
|
Stock-based Compensation Expense
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||
|
Stock-based compensation expense by type of award:
|
|
|
|
|
|
|
|
||||||||
|
Stock options
|
$
|
19,010
|
|
|
$
|
18,869
|
|
|
$
|
68,633
|
|
|
$
|
59,774
|
|
|
Restricted stock and restricted stock units
|
10,998
|
|
|
7,104
|
|
|
30,108
|
|
|
21,643
|
|
||||
|
ESPP share issuances
|
1,504
|
|
|
1,948
|
|
|
6,077
|
|
|
6,120
|
|
||||
|
Less stock-based compensation expense capitalized to inventories
|
(204
|
)
|
|
(339
|
)
|
|
(885
|
)
|
|
(888
|
)
|
||||
|
Total stock-based compensation expense included in costs and expenses
|
$
|
31,308
|
|
|
$
|
27,582
|
|
|
$
|
103,933
|
|
|
$
|
86,649
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
Stock-based compensation expense by line item:
|
|
|
|
|
|
|
|
||||||||
|
Research and development expenses
|
$
|
19,223
|
|
|
$
|
17,444
|
|
|
$
|
64,312
|
|
|
$
|
54,425
|
|
|
Sales, general and administrative expenses
|
12,085
|
|
|
10,138
|
|
|
39,621
|
|
|
32,224
|
|
||||
|
Total stock-based compensation expense included in costs and expenses
|
$
|
31,308
|
|
|
$
|
27,582
|
|
|
$
|
103,933
|
|
|
$
|
86,649
|
|
|
|
As of September 30, 2013
|
||||
|
|
Unrecognized Expense,
Net of Estimated Forfeitures |
|
Weighted-average
Recognition Period |
||
|
|
(in thousands)
|
|
(in years)
|
||
|
Type of award:
|
|
|
|
||
|
Stock options
|
$
|
184,969
|
|
|
2.74
|
|
Restricted stock and restricted stock units
|
103,454
|
|
|
2.61
|
|
|
ESPP share issuances
|
830
|
|
|
0.31
|
|
|
|
|
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)
|
|
$ 9.07–$20.00
|
|
462
|
2.64
|
$15.27
|
|
462
|
$15.27
|
|
$20.01–$30.00
|
|
1,076
|
5.98
|
$29.37
|
|
801
|
$29.19
|
|
$30.01–$40.00
|
|
7,253
|
5.59
|
$36.58
|
|
4,525
|
$35.93
|
|
$40.01–$50.00
|
|
4,552
|
9.10
|
$46.33
|
|
570
|
$46.73
|
|
$50.01–$60.00
|
|
1,840
|
7.61
|
$53.72
|
|
805
|
$54.49
|
|
$60.01–$70.00
|
|
44
|
8.64
|
$63.23
|
|
11
|
$63.19
|
|
$70.01-$80.00
|
|
85
|
9.67
|
$77.73
|
|
4
|
$77.73
|
|
$80.01-$88.18
|
|
1,495
|
9.81
|
$83.13
|
|
166
|
$81.54
|
|
Total
|
|
16,807
|
7.09
|
$44.47
|
|
7,344
|
$37.87
|
|
M.
|
Sale of HIV Protease Inhibitor Royalty Stream
|
|
N.
|
Income Taxes
|
|
O.
|
Restructuring Liabilities
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Liability, beginning of the period
|
$
|
22,051
|
|
|
$
|
24,830
|
|
|
$
|
23,328
|
|
|
$
|
26,313
|
|
|
Cash payments
|
(3,901
|
)
|
|
(3,726
|
)
|
|
(11,323
|
)
|
|
(11,137
|
)
|
||||
|
Cash received from subleases
|
2,670
|
|
|
2,355
|
|
|
8,000
|
|
|
7,329
|
|
||||
|
Restructuring expense
|
524
|
|
|
696
|
|
|
1,339
|
|
|
1,650
|
|
||||
|
Liability, end of the period
|
$
|
21,344
|
|
|
$
|
24,155
|
|
|
$
|
21,344
|
|
|
$
|
24,155
|
|
|
|
Restructuring Expense
|
|
Cash
Payments |
|
Non-cash Expense
|
|
Restructuring Liability at September 30, 2013
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Employee severance, benefits and related costs
|
$
|
409
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
409
|
|
|
Asset impairments
|
6,650
|
|
|
—
|
|
|
(6,650
|
)
|
|
—
|
|
||||
|
Contract termination and other associated costs
|
4,385
|
|
|
—
|
|
|
—
|
|
|
4,385
|
|
||||
|
Liability, end of the period
|
$
|
11,444
|
|
|
$
|
—
|
|
|
$
|
(6,650
|
)
|
|
$
|
4,794
|
|
|
P.
|
Legal Proceedings
|
|
Q.
|
Contingencies
|
|
R.
|
Guarantees
|
|
•
|
We are evaluating ivacaftor in patients six years of age and older with CF with gating mutations other than the G551D mutation in a Phase 3 clinical trial. In July 2013, we reported that patients in this clinical trial had statistically significant improvements in their lung function (FEV
1
) and other measures of disease. The safety and tolerability results from this clinical trial were consistent with those observed in prior Phase 3 clinical trials of ivacaftor monotherapy in patients with CF who have the G551D mutation. We submitted an sNDA to the FDA in September 2013 and an MAA variation in the European Union in October 2013 for the use of ivacaftor monotherapy in patients with CF six years of age and older who have gating mutations other than the G551D mutation. We estimate that in North America, Europe and Australia approximately 400 patients with CF six years of age and older have at least one non-G551D gating mutation.
|
|
•
|
We are conducting a fully-enrolled Phase 3 clinical trial evaluating ivacaftor in patients six years of age and older with CF who have the R117H mutation in the
CFTR
gene on at least one allele. We expect data from this clinical trial to be available at the end of 2013. If this clinical trial is successful, we plan to submit an sNDA to the FDA in early 2014 and an MAA variation in the European Union in the second quarter of 2014 for the use of ivacaftor monotherapy in patients with CF who are six years of age and older who have the R117H mutation in the
CFTR
gene on at least one allele. We estimate that in North America, Europe and Australia approximately 1,100 patients with CF six years of age and older have at least one copy of the R177H mutation in their
CFTR
gene. Patients diagnosed with CF who have the R117H mutation exhibit a range of severity and signs and symptoms of the disease, with an average life expectancy in the 50s.
|
|
•
|
We are conducting a fully-enrolled Phase 3 clinical trial in which we are evaluating a pediatric formulation of ivacaftor as a treatment for children with CF two to five years of age with gating mutations in the
CFTR
gene, including the G551D mutation. We expect data from this clinical trial in the second quarter of 2014. If this clinical trial is successful, we plan to submit an sNDA in the second half of 2014. We estimate that in North America, Europe and Australia approximately 300 patients with CF two to five years of age have a gating mutation.
|
|
•
|
We are conducting a fully-enrolled proof-of-concept Phase 2 clinical trial in which we are evaluating ivacaftor in patients with CF who have clinical evidence of residual CFTR function. We expect data from this clinical trial in the second quarter of 2014. We estimate that in North America, Europe and Australia more than 3,000 patients with CF six years of age and older have non-R117H CFTR mutations that result in residual function.
|
|
•
|
We recently completed dosing of 100 mg and 200 mg of VX-135 in combination with RBV as part of a 12-week Phase 2 clinical trial in Europe. This clinical trial enrolled 10 patients with genotype 1 HCV infection in each 100 mg and 200 mg dose group, and all 20 patients completed 12 weeks of treatment. Both the 100 mg and 200 mg doses were well tolerated, no serious adverse events were reported and no liver or cardiac safety issues were identified. 70 percent and 80 percent of patients in the 100 mg and 200 mg dosing arms, respectively, had undetectable HCV RNA
|
|
•
|
We have completed dosing of 100 mg of VX-135 in combination with RBV as part of a 12-week Phase 2 clinical trial in the United States. The 100 mg dose group enrolled 10 patients with genotype 1 HCV infection. All 10 patients completed 12 weeks of treatment. The 100 mg dose was well tolerated, no serious adverse events were reported and no liver or cardiac safety issues were identified. All patients achieved undetectable HCV RNA levels during the 12-week dosing period, and 60 percent of patients had undetectable HCV RNA levels within four weeks of initiating treatment. The sustained viral response rate four weeks after completion of treatment was 10 percent.
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease)
|
|
Increase/
(Decrease)
|
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease)
|
|
Increase/
(Decrease)
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Revenues
|
$
|
221,700
|
|
|
$
|
336,006
|
|
|
$
|
(114,306
|
)
|
|
(34
|
)%
|
|
$
|
860,818
|
|
|
$
|
1,193,048
|
|
|
$
|
(332,230
|
)
|
|
(28
|
)%
|
|
Operating costs and expenses
|
355,765
|
|
|
337,077
|
|
|
18,688
|
|
|
6
|
%
|
|
1,490,104
|
|
|
1,113,240
|
|
|
376,864
|
|
|
34
|
%
|
||||||
|
Other items, net
|
5,403
|
|
|
(25,396
|
)
|
|
n/a
|
|
|
n/a
|
|
|
126,285
|
|
|
(52,867
|
)
|
|
n/a
|
|
|
n/a
|
|
||||||
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
4,530
|
|
|
(31,076
|
)
|
|
n/a
|
|
|
n/a
|
|
|
13,688
|
|
|
(57,825
|
)
|
|
n/a
|
|
|
n/a
|
|
||||||
|
Net loss attributable to Vertex
|
$
|
(124,132
|
)
|
|
$
|
(57,543
|
)
|
|
$
|
66,589
|
|
|
116
|
%
|
|
$
|
(489,313
|
)
|
|
$
|
(30,884
|
)
|
|
$
|
458,429
|
|
|
1,484
|
%
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Product revenues, net
|
$
|
186,653
|
|
|
$
|
303,501
|
|
|
$
|
(116,848
|
)
|
|
(39
|
)%
|
|
$
|
708,823
|
|
|
$
|
1,052,149
|
|
|
$
|
(343,326
|
)
|
|
(33
|
)%
|
|
Royalty revenues
|
27,012
|
|
|
25,586
|
|
|
1,426
|
|
|
6
|
%
|
|
119,705
|
|
|
98,047
|
|
|
21,658
|
|
|
22
|
%
|
||||||
|
Collaborative revenues
|
8,035
|
|
|
6,919
|
|
|
1,116
|
|
|
16
|
%
|
|
32,290
|
|
|
42,852
|
|
|
(10,562
|
)
|
|
(25
|
)%
|
||||||
|
Total revenues
|
$
|
221,700
|
|
|
$
|
336,006
|
|
|
$
|
(114,306
|
)
|
|
(34
|
)%
|
|
$
|
860,818
|
|
|
$
|
1,193,048
|
|
|
$
|
(332,230
|
)
|
|
(28
|
)%
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
INCIVEK
|
$
|
85,592
|
|
|
$
|
254,340
|
|
|
$
|
(168,748
|
)
|
|
(66
|
)%
|
|
$
|
446,962
|
|
|
$
|
939,006
|
|
|
$
|
(492,044
|
)
|
|
(52
|
)%
|
|
KALYDECO
|
101,061
|
|
|
49,161
|
|
|
51,900
|
|
|
106
|
%
|
|
261,861
|
|
|
113,143
|
|
|
148,718
|
|
|
131
|
%
|
||||||
|
Total product revenues, net
|
$
|
186,653
|
|
|
$
|
303,501
|
|
|
$
|
(116,848
|
)
|
|
(39
|
)%
|
|
$
|
708,823
|
|
|
$
|
1,052,149
|
|
|
$
|
(343,326
|
)
|
|
(33
|
)%
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||
|
Janssen
|
$
|
4,520
|
|
|
$
|
2,604
|
|
|
$
|
21,042
|
|
|
$
|
11,201
|
|
|
Mitsubishi Tanabe
|
—
|
|
|
—
|
|
|
—
|
|
|
18,879
|
|
||||
|
CFFT and other
|
3,515
|
|
|
4,315
|
|
|
11,248
|
|
|
12,772
|
|
||||
|
Total collaborative revenues
|
$
|
8,035
|
|
|
$
|
6,919
|
|
|
$
|
32,290
|
|
|
$
|
42,852
|
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Cost of product revenues
|
$
|
20,048
|
|
|
$
|
30,680
|
|
|
$
|
(10,632
|
)
|
|
(35
|
)%
|
|
$
|
75,698
|
|
|
$
|
161,147
|
|
|
$
|
(85,449
|
)
|
|
(53
|
)%
|
|
Royalty expenses
|
7,291
|
|
|
7,856
|
|
|
(565
|
)
|
|
(7
|
)%
|
|
32,315
|
|
|
31,023
|
|
|
1,292
|
|
|
4
|
%
|
||||||
|
Research and development expenses
|
228,624
|
|
|
200,161
|
|
|
28,463
|
|
|
14
|
%
|
|
669,174
|
|
|
593,076
|
|
|
76,098
|
|
|
13
|
%
|
||||||
|
Sales, general and administrative expenses
|
87,754
|
|
|
97,684
|
|
|
(9,930
|
)
|
|
(10
|
)%
|
|
287,154
|
|
|
326,344
|
|
|
(39,190
|
)
|
|
(12
|
)%
|
||||||
|
Restructuring expense
|
12,048
|
|
|
696
|
|
|
11,352
|
|
|
1,631
|
%
|
|
12,863
|
|
|
1,650
|
|
|
11,213
|
|
|
680
|
%
|
||||||
|
Intangible asset impairment charge
|
—
|
|
|
—
|
|
|
—
|
|
|
n/a
|
|
|
412,900
|
|
|
—
|
|
|
412,900
|
|
|
n/a
|
|
||||||
|
Total costs and expenses
|
$
|
355,765
|
|
|
$
|
337,077
|
|
|
$
|
18,688
|
|
|
6
|
%
|
|
$
|
1,490,104
|
|
|
$
|
1,113,240
|
|
|
$
|
376,864
|
|
|
34
|
%
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease)
|
|
Increase/
(Decrease)
|
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease)
|
|
Increase/
(Decrease)
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Research expenses
|
$
|
60,246
|
|
|
$
|
56,400
|
|
|
$
|
3,846
|
|
|
7
|
%
|
|
$
|
186,329
|
|
|
$
|
175,888
|
|
|
$
|
10,441
|
|
|
6
|
%
|
|
Development expenses
|
168,378
|
|
|
143,761
|
|
|
24,617
|
|
|
17
|
%
|
|
482,845
|
|
|
417,188
|
|
|
65,657
|
|
|
16
|
%
|
||||||
|
Total research and development expenses
|
$
|
228,624
|
|
|
$
|
200,161
|
|
|
$
|
28,463
|
|
|
14
|
%
|
|
$
|
669,174
|
|
|
$
|
593,076
|
|
|
$
|
76,098
|
|
|
13
|
%
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Research Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Salary and benefits
|
$
|
20,692
|
|
|
$
|
18,714
|
|
|
$
|
1,978
|
|
|
11
|
%
|
|
$
|
65,287
|
|
|
$
|
57,536
|
|
|
$
|
7,751
|
|
|
13
|
%
|
|
Stock-based compensation expense
|
6,577
|
|
|
6,268
|
|
|
309
|
|
|
5
|
%
|
|
21,252
|
|
|
19,218
|
|
|
2,034
|
|
|
11
|
%
|
||||||
|
Laboratory supplies and other direct expenses
|
11,174
|
|
|
8,730
|
|
|
2,444
|
|
|
28
|
%
|
|
33,249
|
|
|
30,943
|
|
|
2,306
|
|
|
7
|
%
|
||||||
|
Contractual services
|
5,500
|
|
|
5,304
|
|
|
196
|
|
|
4
|
%
|
|
16,756
|
|
|
15,983
|
|
|
773
|
|
|
5
|
%
|
||||||
|
Infrastructure costs
|
16,303
|
|
|
17,384
|
|
|
(1,081
|
)
|
|
(6
|
)%
|
|
49,785
|
|
|
52,208
|
|
|
(2,423
|
)
|
|
(5
|
)%
|
||||||
|
Total research expenses
|
$
|
60,246
|
|
|
$
|
56,400
|
|
|
$
|
3,846
|
|
|
7
|
%
|
|
$
|
186,329
|
|
|
$
|
175,888
|
|
|
$
|
10,441
|
|
|
6
|
%
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease) |
|
Increase/
(Decrease) |
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Development Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||
|
Salary and benefits
|
$
|
41,984
|
|
|
$
|
37,555
|
|
|
$
|
4,429
|
|
|
12
|
%
|
|
$
|
130,379
|
|
|
$
|
106,700
|
|
|
$
|
23,679
|
|
|
22
|
%
|
|
Stock-based compensation expense
|
12,646
|
|
|
11,176
|
|
|
1,470
|
|
|
13
|
%
|
|
43,060
|
|
|
35,207
|
|
|
7,853
|
|
|
22
|
%
|
||||||
|
Laboratory supplies and other direct expenses
|
11,639
|
|
|
7,953
|
|
|
3,686
|
|
|
46
|
%
|
|
33,166
|
|
|
27,482
|
|
|
5,684
|
|
|
21
|
%
|
||||||
|
Contractual services
|
66,386
|
|
|
58,500
|
|
|
7,886
|
|
|
13
|
%
|
|
170,224
|
|
|
157,763
|
|
|
12,461
|
|
|
8
|
%
|
||||||
|
Drug supply costs
|
9,773
|
|
|
1,705
|
|
|
8,068
|
|
|
473
|
%
|
|
25,873
|
|
|
10,681
|
|
|
15,192
|
|
|
142
|
%
|
||||||
|
Infrastructure costs
|
25,950
|
|
|
26,872
|
|
|
(922
|
)
|
|
(3
|
)%
|
|
80,143
|
|
|
79,355
|
|
|
788
|
|
|
1
|
%
|
||||||
|
Total development expenses
|
$
|
168,378
|
|
|
$
|
143,761
|
|
|
$
|
24,617
|
|
|
17
|
%
|
|
$
|
482,845
|
|
|
$
|
417,188
|
|
|
$
|
65,657
|
|
|
16
|
%
|
|
|
Three Months Ended September 30,
|
|
Increase/
(Decrease)
|
|
Increase/
(Decrease)
|
|
Nine Months Ended September 30,
|
|
Increase/
(Decrease)
|
|
Increase/
(Decrease)
|
||||||||||||||||||
|
|
2013
|
|
2012
|
|
$
|
|
%
|
|
2013
|
|
2012
|
|
$
|
|
%
|
||||||||||||||
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
|
Sales, general and administrative expenses
|
$
|
87,754
|
|
|
$
|
97,684
|
|
|
$
|
(9,930
|
)
|
|
(10
|
)%
|
|
$
|
287,154
|
|
|
$
|
326,344
|
|
|
$
|
(39,190
|
)
|
|
(12
|
)%
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
(in thousands)
|
||||||||||||
|
Loss before provision for (benefit from) income taxes
|
$
|
9,056
|
|
|
$
|
5,090
|
|
|
$
|
21,177
|
|
|
$
|
14,581
|
|
|
Decrease (increase) in fair value of contingent milestone and royalty payments
|
(1,220
|
)
|
|
(57,560
|
)
|
|
1,600
|
|
|
(112,760
|
)
|
||||
|
Provision for (benefit from) income taxes
|
(3,306
|
)
|
|
21,394
|
|
|
(9,089
|
)
|
|
40,354
|
|
||||
|
Net loss (income) attributable to noncontrolling interest (Alios)
|
$
|
4,530
|
|
|
$
|
(31,076
|
)
|
|
$
|
13,688
|
|
|
$
|
(57,825
|
)
|
|
•
|
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 net product revenues from sales of INCIVEK and KALYDECO and royalty revenues from net sales of INCIVO and to the intangible assets associated with the Alios collaboration;
|
|
•
|
our expectations regarding clinical trials, development timelines and regulatory authority filings and submissions for ivacaftor, lumacaftor, VX-135, VX-509 and VX-661;
|
|
•
|
our expectations regarding the timing of data from our clinical trials of ivacaftor monotherapy and lumacaftor in combination with ivacaftor, the possibility of using that data to support regulatory submissions and the timing of those potential submissions;
|
|
•
|
our ability to successfully market INCIVEK and/or KALYDECO 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, VX-135, VX-509 and VX-661, and the expected timing of our receipt of data from our ongoing and planned clinical trials;
|
|
•
|
our intent to provide further data to the FDA, including sustained viral response data from our ongoing clinical trials of VX-135 and RBV and VX-135 and daclatasvir, through the first half of 2014;
|
|
•
|
the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance molecules, 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;
|
|
•
|
the focus of our drug development efforts and our financial and management resources and 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 estimates regarding the charges associated with the October 2013 workforce reduction and restructuring activities;
|
|
•
|
our ability to use our research programs to identify and develop new drug candidates to address serious diseases and significant unmet medical needs;
|
|
•
|
our estimates regarding obligations associated with a lease of a facility in Kendall Square, Cambridge, Massachusetts; and
|
|
•
|
our liquidity and our expectations regarding the possibility of raising additional capital.
|
|
Period
|
|
Total Number
of Shares Purchased |
Average Price
Paid per Share |
Total Number of Shares
Purchased as Part of Publicly Announced Plans or Programs |
Maximum Number of
Shares that May Yet be Purchased Under the Plans or Programs |
|||
|
July 1, 2013 to July 31, 2013
|
19,506
|
|
$
|
0.01
|
|
—
|
—
|
|
|
August 1, 2013 to August 31, 2013
|
38,061
|
|
$
|
0.01
|
|
—
|
—
|
|
|
September 1, 2013 to September 30, 2013
|
29,099
|
|
$
|
0.01
|
|
—
|
—
|
|
|
Exhibit Number
|
Exhibit Description
|
|
31.1
|
Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
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
|
|
|
|
|
|
|
November 7, 2013
|
By:
|
/s/ Ian F. Smith
|
|
|
|
Ian F. Smith
|
|
|
|
Executive 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 |
|---|