These terms and conditions govern your use of the website alphaminr.com and its related services.
These Terms and Conditions (“Terms”) are a binding contract between you and Alphaminr, (“Alphaminr”, “we”, “us” and “service”). You must agree to and accept the Terms. These Terms include the provisions in this document as well as those in the Privacy Policy. These terms may be modified at any time.
Your subscription will be on a month to month basis and automatically renew every month. You may terminate your subscription at any time through your account.
We will provide you with advance notice of any change in fees.
You represent that you are of legal age to form a binding contract. You are responsible for any
activity associated with your account. The account can be logged in at only one computer at a
time.
The Services are intended for your own individual use. You shall only use the Services in a
manner that complies with all laws. You may not use any automated software, spider or system to
scrape data from Alphaminr.
Alphaminr is not a financial advisor and does not provide financial advice of any kind. The service is provided “As is”. The materials and information accessible through the Service are solely for informational purposes. While we strive to provide good information and data, we make no guarantee or warranty as to its accuracy.
TO THE EXTENT PERMITTED BY APPLICABLE LAW, UNDER NO CIRCUMSTANCES SHALL ALPHAMINR BE LIABLE TO YOU FOR DAMAGES OF ANY KIND, INCLUDING DAMAGES FOR INVESTMENT LOSSES, LOSS OF DATA, OR ACCURACY OF DATA, OR FOR ANY AMOUNT, IN THE AGGREGATE, IN EXCESS OF THE GREATER OF (1) FIFTY DOLLARS OR (2) THE AMOUNTS PAID BY YOU TO ALPHAMINR IN THE SIX MONTH PERIOD PRECEDING THIS APPLICABLE CLAIM. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL OR CERTAIN OTHER DAMAGES, SO THE ABOVE LIMITATION AND EXCLUSIONS MAY NOT APPLY TO YOU.
If any provision of these Terms is found to be invalid under any applicable law, such provision shall not affect the validity or enforceability of the remaining provisions herein.
This privacy policy describes how we (“Alphaminr”) collect, use, share and protect your personal information when we provide our service (“Service”). This Privacy Policy explains how information is collected about you either directly or indirectly. By using our service, you acknowledge the terms of this Privacy Notice. If you do not agree to the terms of this Privacy Policy, please do not use our Service. You should contact us if you have questions about it. We may modify this Privacy Policy periodically.
When you register for our Service, we collect information from you such as your name, email address and credit card information.
Like many other websites we use “cookies”, which are small text files that are stored on your computer or other device that record your preferences and actions, including how you use the website. You can set your browser or device to refuse all cookies or to alert you when a cookie is being sent. If you delete your cookies, if you opt-out from cookies, some Services may not function properly. We collect information when you use our Service. This includes which pages you visit.
We use Google Analytics and we use Stripe for payment processing. We will not share the information we collect with third parties for promotional purposes. We may share personal information with law enforcement as required or permitted by law.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2017
|
|
|
or
|
|
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
FOR THE TRANSITION PERIOD FROM
TO
|
|
|
Massachusetts
|
04-3039129
|
|
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
|
50 Northern Avenue, Boston, Massachusetts
|
02210
|
|
(Address of principal executive offices)
|
(Zip Code)
|
|
Large accelerated filer
x
|
Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller reporting company
o
|
|
|
|
|
|
|
Emerging growth company
o
|
(Do not check if a smaller reporting company)
|
||
|
Common Stock, par value $0.01 per share
|
249,068,782
|
|
Class
|
Outstanding at April 21, 2017
|
|
|
|
|
|
Page
|
|
|
||
|
|
||
|
|
Condensed Consolidated Statements of Operations - Three Months Ended March 31, 2017 and 2016
|
|
|
|
Condensed Consolidated Statements of Comprehensive Loss - Three Months Ended March 31, 2017 and 2016
|
|
|
|
Condensed Consolidated Balance Sheets - March 31, 2017 and December 31, 2016
|
|
|
|
Condensed Consolidated Statements of Shareholders' Equity and Noncontrolling Interest - Three Months Ended March 31, 2017 and 2016
|
|
|
|
Condensed Consolidated Statements of Cash Flows - Three Months Ended March 31, 2017 and 2016
|
|
|
|
||
|
|
||
|
|
||
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Revenues:
|
|
|
|
||||
|
Product revenues, net
|
$
|
480,622
|
|
|
$
|
394,410
|
|
|
Royalty revenues
|
1,551
|
|
|
3,596
|
|
||
|
Collaborative revenues
|
232,545
|
|
|
74
|
|
||
|
Total revenues
|
714,718
|
|
|
398,080
|
|
||
|
Costs and expenses:
|
|
|
|
||||
|
Cost of product revenues
|
46,242
|
|
|
49,789
|
|
||
|
Royalty expenses
|
746
|
|
|
860
|
|
||
|
Research and development expenses
|
273,563
|
|
|
255,860
|
|
||
|
Sales, general and administrative expenses
|
113,326
|
|
|
105,214
|
|
||
|
Restructuring expenses, net
|
9,999
|
|
|
687
|
|
||
|
Total costs and expenses
|
443,876
|
|
|
412,410
|
|
||
|
Income (loss) from operations
|
270,842
|
|
|
(14,330
|
)
|
||
|
Interest expense, net
|
(16,765
|
)
|
|
(20,698
|
)
|
||
|
Other (expenses) income, net
|
(544
|
)
|
|
4,411
|
|
||
|
Income (loss) before provision for income taxes
|
253,533
|
|
|
(30,617
|
)
|
||
|
Provision for income taxes
|
3,985
|
|
|
5,485
|
|
||
|
Net income (loss)
|
249,548
|
|
|
(36,102
|
)
|
||
|
Income attributable to noncontrolling interest
|
(1,792
|
)
|
|
(5,529
|
)
|
||
|
Net income (loss) attributable to Vertex
|
$
|
247,756
|
|
|
$
|
(41,631
|
)
|
|
|
|
|
|
||||
|
Amounts per share attributable to Vertex common shareholders:
|
|
|
|
||||
|
Net income (loss):
|
|
|
|
||||
|
Basic
|
$
|
1.01
|
|
|
$
|
(0.17
|
)
|
|
Diluted
|
$
|
0.99
|
|
|
$
|
(0.17
|
)
|
|
Shares used in per share calculations:
|
|
|
|
||||
|
Basic
|
246,024
|
|
|
243,831
|
|
||
|
Diluted
|
248,700
|
|
|
243,831
|
|
||
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Net income (loss)
|
$
|
249,548
|
|
|
$
|
(36,102
|
)
|
|
Changes in other comprehensive income (loss):
|
|
|
|
||||
|
Unrealized holding gains on marketable securities, net of tax
|
3,534
|
|
|
229
|
|
||
|
Unrealized losses on foreign currency forward contracts, net of tax
|
(6,681
|
)
|
|
(5,212
|
)
|
||
|
Foreign currency translation adjustment
|
(2,001
|
)
|
|
(1,740
|
)
|
||
|
Total changes in other comprehensive income (loss)
|
(5,148
|
)
|
|
(6,723
|
)
|
||
|
Comprehensive income (loss)
|
244,400
|
|
|
(42,825
|
)
|
||
|
Comprehensive income attributable to noncontrolling interest
|
(1,792
|
)
|
|
(5,529
|
)
|
||
|
Comprehensive income (loss) attributable to Vertex
|
$
|
242,608
|
|
|
$
|
(48,354
|
)
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
|
Assets
|
|
|
|
||||
|
Current assets:
|
|
|
|
||||
|
Cash and cash equivalents
|
$
|
1,003,679
|
|
|
$
|
1,183,945
|
|
|
Marketable securities, available for sale
|
405,103
|
|
|
250,612
|
|
||
|
Restricted cash and cash equivalents (VIE)
|
44,564
|
|
|
47,762
|
|
||
|
Accounts receivable, net
|
207,955
|
|
|
201,083
|
|
||
|
Inventories
|
82,020
|
|
|
77,604
|
|
||
|
Prepaid expenses and other current assets
|
128,493
|
|
|
70,534
|
|
||
|
Total current assets
|
1,871,814
|
|
|
1,831,540
|
|
||
|
Property and equipment, net
|
708,395
|
|
|
698,362
|
|
||
|
Intangible assets
|
284,340
|
|
|
284,340
|
|
||
|
Goodwill
|
50,384
|
|
|
50,384
|
|
||
|
Cost method investments
|
20,276
|
|
|
20,276
|
|
||
|
Other assets
|
11,494
|
|
|
11,885
|
|
||
|
Total assets
|
$
|
2,946,703
|
|
|
$
|
2,896,787
|
|
|
Liabilities and Shareholders’ Equity
|
|
|
|
||||
|
Current liabilities:
|
|
|
|
||||
|
Accounts payable
|
$
|
63,145
|
|
|
$
|
61,451
|
|
|
Accrued expenses
|
277,962
|
|
|
315,249
|
|
||
|
Deferred revenues, current portion
|
6,057
|
|
|
6,005
|
|
||
|
Accrued restructuring expenses, current portion
|
7,634
|
|
|
6,047
|
|
||
|
Capital lease obligations, current portion
|
19,270
|
|
|
19,426
|
|
||
|
Customer deposits
|
104,774
|
|
|
73,416
|
|
||
|
Credit facility
|
—
|
|
|
300,000
|
|
||
|
Other liabilities, current portion
|
10,954
|
|
|
10,943
|
|
||
|
Total current liabilities
|
489,796
|
|
|
792,537
|
|
||
|
Deferred revenues, excluding current portion
|
5,742
|
|
|
6,632
|
|
||
|
Accrued restructuring expenses, excluding current portion
|
613
|
|
|
1,907
|
|
||
|
Capital lease obligations, excluding current portion
|
30,355
|
|
|
34,976
|
|
||
|
Deferred tax liability
|
135,402
|
|
|
134,063
|
|
||
|
Construction financing lease obligation, excluding current portion
|
498,775
|
|
|
486,359
|
|
||
|
Advance from collaborator
|
74,760
|
|
|
73,423
|
|
||
|
Other liabilities, excluding current portion
|
28,467
|
|
|
28,699
|
|
||
|
Total liabilities
|
1,263,910
|
|
|
1,558,596
|
|
||
|
Commitments and contingencies
|
|
|
|
|
|
||
|
Shareholders’ equity:
|
|
|
|
||||
|
Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding
|
—
|
|
|
—
|
|
||
|
Common stock, $0.01 par value; 500,000,000 shares authorized; 248,890,834 and 248,300,517 shares issued and outstanding at March 31, 2017 and December 31, 2016, respectively
|
2,459
|
|
|
2,450
|
|
||
|
Additional paid-in capital
|
6,616,975
|
|
|
6,506,795
|
|
||
|
Accumulated other comprehensive income
|
16,025
|
|
|
21,173
|
|
||
|
Accumulated deficit
|
(5,135,451
|
)
|
|
(5,373,836
|
)
|
||
|
Total Vertex shareholders’ equity
|
1,500,008
|
|
|
1,156,582
|
|
||
|
Noncontrolling interest
|
182,785
|
|
|
181,609
|
|
||
|
Total shareholders’ equity
|
1,682,793
|
|
|
1,338,191
|
|
||
|
Total liabilities and shareholders’ equity
|
$
|
2,946,703
|
|
|
$
|
2,896,787
|
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Other Comprehensive (Loss) Income |
|
Accumulated Deficit
|
|
Total Vertex
Shareholders’ Equity |
|
Noncontrolling
Interest |
|
Total
Shareholders’ Equity |
|||||||||||||||||
|
|
Shares
|
|
Amount
|
|
|
|
|
|
|
|||||||||||||||||||||
|
Balance at December 31, 2015
|
246,307
|
|
|
$
|
2,427
|
|
|
$
|
6,197,500
|
|
|
$
|
1,824
|
|
|
$
|
(5,261,784
|
)
|
|
$
|
939,967
|
|
|
$
|
153,661
|
|
|
$
|
1,093,628
|
|
|
Other comprehensive loss, net of tax
|
—
|
|
|
—
|
|
|
—
|
|
|
(6,723
|
)
|
|
—
|
|
|
(6,723
|
)
|
|
—
|
|
|
(6,723
|
)
|
|||||||
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(41,631
|
)
|
|
(41,631
|
)
|
|
5,529
|
|
|
(36,102
|
)
|
|||||||
|
Issuance of common stock under benefit plans
|
980
|
|
|
2
|
|
|
9,147
|
|
|
—
|
|
|
—
|
|
|
9,149
|
|
|
—
|
|
|
9,149
|
|
|||||||
|
Stock-based compensation expense
|
—
|
|
|
—
|
|
|
56,317
|
|
|
—
|
|
|
—
|
|
|
56,317
|
|
|
(71
|
)
|
|
56,246
|
|
|||||||
|
Balance at March 31, 2016
|
247,287
|
|
|
$
|
2,429
|
|
|
$
|
6,262,964
|
|
|
$
|
(4,899
|
)
|
|
$
|
(5,303,415
|
)
|
|
$
|
957,079
|
|
|
$
|
159,119
|
|
|
$
|
1,116,198
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
|
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
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(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
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
Cash flows from operating activities:
|
|
|
|
||||
|
Net income (loss)
|
$
|
249,548
|
|
|
$
|
(36,102
|
)
|
|
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
|
|
|
|
||||
|
Stock-based compensation expense
|
68,982
|
|
|
55,472
|
|
||
|
Depreciation and amortization expense
|
14,850
|
|
|
16,415
|
|
||
|
Deferred income taxes
|
1,212
|
|
|
2,060
|
|
||
|
Impairment of property and equipment
|
1,946
|
|
|
—
|
|
||
|
Other non-cash items, net
|
(5,152
|
)
|
|
(3,835
|
)
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Accounts receivable, net
|
(5,118
|
)
|
|
(2,512
|
)
|
||
|
Inventories
|
(3,650
|
)
|
|
(4,771
|
)
|
||
|
Prepaid expenses and other assets
|
(47,178
|
)
|
|
(7,325
|
)
|
||
|
Accounts payable
|
717
|
|
|
(343
|
)
|
||
|
Accrued expenses and other liabilities
|
(9,931
|
)
|
|
(29,922
|
)
|
||
|
Accrued restructuring expense
|
305
|
|
|
(1,459
|
)
|
||
|
Deferred revenues
|
(839
|
)
|
|
(2,815
|
)
|
||
|
Net cash provided by (used in) operating activities
|
265,692
|
|
|
(15,137
|
)
|
||
|
Cash flows from investing activities:
|
|
|
|
||||
|
Purchases of marketable securities
|
(248,273
|
)
|
|
(224,624
|
)
|
||
|
Maturities of marketable securities
|
98,393
|
|
|
131,173
|
|
||
|
Expenditures for property and equipment
|
(11,159
|
)
|
|
(11,974
|
)
|
||
|
Decrease in restricted cash and cash equivalents (VIE)
|
3,198
|
|
|
2,637
|
|
||
|
Decrease in other assets
|
60
|
|
|
80
|
|
||
|
Net cash used in investing activities
|
(157,781
|
)
|
|
(102,708
|
)
|
||
|
Cash flows from financing activities:
|
|
|
|
||||
|
Issuances of common stock under benefit plans
|
11,249
|
|
|
8,846
|
|
||
|
Payments on revolving credit facility
|
(300,000
|
)
|
|
—
|
|
||
|
Advance from collaborator
|
5,000
|
|
|
—
|
|
||
|
Payments on capital lease obligations
|
(4,703
|
)
|
|
(4,041
|
)
|
||
|
Payments on construction financing lease obligation
|
(117
|
)
|
|
(103
|
)
|
||
|
Repayments of advanced funding
|
(994
|
)
|
|
—
|
|
||
|
Net cash (used in) provided by financing activities
|
(289,565
|
)
|
|
4,702
|
|
||
|
Effect of changes in exchange rates on cash
|
1,388
|
|
|
2,620
|
|
||
|
Net decrease in cash and cash equivalents
|
(180,266
|
)
|
|
(110,523
|
)
|
||
|
Cash and cash equivalents—beginning of period
|
1,183,945
|
|
|
714,768
|
|
||
|
Cash and cash equivalents—end of period
|
$
|
1,003,679
|
|
|
$
|
604,245
|
|
|
|
|
|
|
||||
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
|
Cash paid for interest
|
$
|
17,527
|
|
|
$
|
20,603
|
|
|
Cash paid for income taxes
|
$
|
1,164
|
|
|
$
|
581
|
|
|
Capitalization of costs related to construction financing lease obligation
|
$
|
12,549
|
|
|
$
|
—
|
|
|
Issuances of common stock from employee benefit plans receivable
|
$
|
19,847
|
|
|
$
|
593
|
|
|
B.
|
Product Revenues, Net
|
|
|
Trade
Allowances |
|
Rebates,
Chargebacks and Discounts |
|
Product
Returns |
|
Other
Incentives |
|
Total
|
||||||||||
|
|
(in thousands)
|
||||||||||||||||||
|
Balance at December 31, 2016
|
$
|
2,568
|
|
|
$
|
81,927
|
|
|
$
|
3,492
|
|
|
$
|
1,214
|
|
|
$
|
89,201
|
|
|
Provision related to current period sales
|
5,638
|
|
|
28,567
|
|
|
370
|
|
|
6,093
|
|
|
40,668
|
|
|||||
|
Adjustments related to prior period sales
|
(169
|
)
|
|
(2,344
|
)
|
|
(48
|
)
|
|
(56
|
)
|
|
(2,617
|
)
|
|||||
|
Credits/payments made
|
(5,654
|
)
|
|
(27,916
|
)
|
|
(170
|
)
|
|
(4,428
|
)
|
|
(38,168
|
)
|
|||||
|
Balance at March 31, 2017
|
$
|
2,383
|
|
|
$
|
80,234
|
|
|
$
|
3,644
|
|
|
$
|
2,823
|
|
|
$
|
89,084
|
|
|
C.
|
Collaborative Arrangements and Pending Acquisition
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
|
Loss attributable to noncontrolling interest before provision for income taxes
|
$
|
1,547
|
|
|
$
|
839
|
|
|
Provision for income taxes
|
391
|
|
|
3,062
|
|
||
|
Increase in fair value of contingent payments
|
(3,730
|
)
|
|
(9,430
|
)
|
||
|
Net income attributable to noncontrolling interest
|
$
|
(1,792
|
)
|
|
$
|
(5,529
|
)
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
|
Parion
|
$
|
2,830
|
|
|
$
|
9,000
|
|
|
BioAxone
|
900
|
|
|
430
|
|
||
|
|
March 31, 2017
|
|
December 31, 2016
|
||||
|
|
(in thousands)
|
||||||
|
Restricted cash and cash equivalents (VIE)
|
$
|
44,564
|
|
|
$
|
47,762
|
|
|
Prepaid expenses and other current assets
|
5,957
|
|
|
6,812
|
|
||
|
Intangible assets
|
284,340
|
|
|
284,340
|
|
||
|
Goodwill
|
19,391
|
|
|
19,391
|
|
||
|
Other assets
|
687
|
|
|
399
|
|
||
|
Accounts payable
|
1,080
|
|
|
415
|
|
||
|
Taxes payable
|
1,159
|
|
|
1,330
|
|
||
|
Other current liabilities
|
1,998
|
|
|
2,137
|
|
||
|
Deferred tax liability, net
|
133,058
|
|
|
131,446
|
|
||
|
Other liabilities
|
300
|
|
|
300
|
|
||
|
Noncontrolling interest
|
182,785
|
|
|
181,609
|
|
||
|
D.
|
Earnings Per Share
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands, except per share amounts)
|
||||||
|
Basic net income (loss) attributable to Vertex per common share calculation:
|
|
|
|
||||
|
Net income (loss) attributable to Vertex common shareholders
|
$
|
247,756
|
|
|
$
|
(41,631
|
)
|
|
Less: Undistributed earnings allocated to participating securities
|
(406
|
)
|
|
—
|
|
||
|
Net income (loss) attributable to Vertex common shareholders—basic
|
$
|
247,350
|
|
|
$
|
(41,631
|
)
|
|
|
|
|
|
||||
|
Basic weighted-average common shares outstanding
|
246,024
|
|
|
243,831
|
|
||
|
Basic net income (loss) attributable to Vertex per common share
|
$
|
1.01
|
|
|
$
|
(0.17
|
)
|
|
|
|
|
|
||||
|
Diluted net income (loss) attributable to Vertex per common share calculation:
|
|
|
|
||||
|
Net income (loss) attributable to Vertex common shareholders
|
$
|
247,756
|
|
|
$
|
(41,631
|
)
|
|
Less: Undistributed earnings allocated to participating securities
|
(401
|
)
|
|
—
|
|
||
|
Net income (loss) attributable to Vertex common shareholders—diluted
|
$
|
247,355
|
|
|
$
|
(41,631
|
)
|
|
|
|
|
|
||||
|
Weighted-average shares used to compute basic net income (loss) per common share
|
246,024
|
|
|
243,831
|
|
||
|
Effect of potentially dilutive securities:
|
|
|
|
||||
|
Stock options
|
2,037
|
|
|
—
|
|
||
|
Restricted stock and restricted stock units
|
627
|
|
|
—
|
|
||
|
Other
|
12
|
|
|
—
|
|
||
|
Weighted-average shares used to compute diluted net income (loss) per common share
|
248,700
|
|
|
243,831
|
|
||
|
Diluted net income (loss) attributable to Vertex per common share
|
$
|
0.99
|
|
|
$
|
(0.17
|
)
|
|
|
Three Months Ended March 31,
|
||||
|
|
2017
|
|
2016
|
||
|
|
(in thousands)
|
||||
|
Stock options
|
8,303
|
|
|
12,619
|
|
|
Unvested restricted stock and restricted stock units
|
807
|
|
|
3,565
|
|
|
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, 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
|
$
|
313,629
|
|
|
$
|
313,629
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Corporate debt securities
|
11,027
|
|
|
11,027
|
|
|
—
|
|
|
—
|
|
||||
|
Commercial paper
|
6,834
|
|
|
6,834
|
|
|
—
|
|
|
—
|
|
||||
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Corporate equity securities
|
69,372
|
|
|
69,372
|
|
|
—
|
|
|
—
|
|
||||
|
Corporate debt securities
|
203,181
|
|
|
—
|
|
|
203,181
|
|
|
—
|
|
||||
|
Commercial paper
|
132,550
|
|
|
—
|
|
|
132,550
|
|
|
—
|
|
||||
|
Prepaid and other current assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
8,318
|
|
|
—
|
|
|
8,318
|
|
|
—
|
|
||||
|
Other assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
249
|
|
|
—
|
|
|
249
|
|
|
—
|
|
||||
|
Total financial assets
|
$
|
745,160
|
|
|
$
|
400,862
|
|
|
$
|
344,298
|
|
|
$
|
—
|
|
|
Financial instruments carried at fair value (liability position):
|
|
|
|
|
|
|
|
||||||||
|
Other liabilities, current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
$
|
(613
|
)
|
|
$
|
—
|
|
|
$
|
(613
|
)
|
|
$
|
—
|
|
|
Other liabilities, excluding current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
(86
|
)
|
|
—
|
|
|
(86
|
)
|
|
—
|
|
||||
|
Total financial liabilities
|
$
|
(699
|
)
|
|
$
|
—
|
|
|
$
|
(699
|
)
|
|
$
|
—
|
|
|
|
Fair Value Measurements as
of December 31, 2016 |
||||||||||||||
|
|
|
|
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
|
$
|
280,560
|
|
|
$
|
280,560
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Government-sponsored enterprise securities
|
15,508
|
|
|
15,508
|
|
|
—
|
|
|
—
|
|
||||
|
Corporate equity securities
|
64,560
|
|
|
64,560
|
|
|
—
|
|
|
—
|
|
||||
|
Commercial paper
|
59,404
|
|
|
—
|
|
|
59,404
|
|
|
—
|
|
||||
|
Corporate debt securities
|
111,140
|
|
|
—
|
|
|
111,140
|
|
|
—
|
|
||||
|
Prepaid and other current assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
14,407
|
|
|
—
|
|
|
14,407
|
|
|
—
|
|
||||
|
Other assets:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
1,186
|
|
|
$
|
—
|
|
|
1,186
|
|
|
$
|
—
|
|
||
|
Total financial assets
|
$
|
546,765
|
|
|
$
|
360,628
|
|
|
$
|
186,137
|
|
|
$
|
—
|
|
|
Financial instruments carried at fair value (liability position):
|
|
|
|
|
|
|
|
||||||||
|
Other liabilities, current portion:
|
|
|
|
|
|
|
|
||||||||
|
Foreign currency forward contracts
|
$
|
(144
|
)
|
|
$
|
—
|
|
|
$
|
(144
|
)
|
|
$
|
—
|
|
|
Total financial liabilities
|
$
|
(144
|
)
|
|
$
|
—
|
|
|
$
|
(144
|
)
|
|
$
|
—
|
|
|
F.
|
Marketable Securities
|
|
|
Amortized Cost
|
|
Gross
Unrealized Gains |
|
Gross
Unrealized Losses |
|
Fair Value
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
As of March 31, 2017
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Cash and money market funds
|
$
|
985,818
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
985,818
|
|
|
Commercial paper
|
6,834
|
|
|
—
|
|
|
—
|
|
|
6,834
|
|
||||
|
Corporate debt securities
|
11,027
|
|
|
—
|
|
|
—
|
|
|
11,027
|
|
||||
|
Total cash and cash equivalents
|
$
|
1,003,679
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,003,679
|
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Corporate equity securities
|
43,213
|
|
|
26,159
|
|
|
—
|
|
|
69,372
|
|
||||
|
Commercial paper (matures within 1 year)
|
132,640
|
|
|
1
|
|
|
(91
|
)
|
|
132,550
|
|
||||
|
Corporate debt securities (matures within 1 year)
|
180,465
|
|
|
3
|
|
|
(143
|
)
|
|
180,325
|
|
||||
|
Corporate debt securities (matures after 1 year)
|
$
|
22,882
|
|
|
$
|
—
|
|
|
$
|
(26
|
)
|
|
$
|
22,856
|
|
|
Total marketable securities
|
$
|
379,200
|
|
|
$
|
26,163
|
|
|
$
|
(260
|
)
|
|
$
|
405,103
|
|
|
Total cash, cash equivalents and marketable securities
|
$
|
1,382,879
|
|
|
$
|
26,163
|
|
|
$
|
(260
|
)
|
|
$
|
1,408,782
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
As of December 31, 2016
|
|
|
|
|
|
|
|
||||||||
|
Cash and cash equivalents:
|
|
|
|
|
|
|
|
||||||||
|
Cash and money market funds
|
$
|
1,183,945
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,183,945
|
|
|
Total cash and cash equivalents
|
$
|
1,183,945
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,183,945
|
|
|
Marketable securities:
|
|
|
|
|
|
|
|
||||||||
|
Government-sponsored enterprise securities (matures within 1 year)
|
$
|
15,506
|
|
|
$
|
2
|
|
|
$
|
—
|
|
|
$
|
15,508
|
|
|
Corporate equity securities
|
43,213
|
|
|
21,347
|
|
|
—
|
|
|
64,560
|
|
||||
|
Commercial paper (matures within 1 year)
|
59,331
|
|
|
73
|
|
|
—
|
|
|
59,404
|
|
||||
|
Corporate debt securities (matures within 1 year)
|
111,225
|
|
|
—
|
|
|
(85
|
)
|
|
111,140
|
|
||||
|
Total marketable securities
|
$
|
229,275
|
|
|
$
|
21,422
|
|
|
$
|
(85
|
)
|
|
$
|
250,612
|
|
|
Total cash, cash equivalents and marketable securities
|
$
|
1,413,220
|
|
|
$
|
21,422
|
|
|
$
|
(85
|
)
|
|
$
|
1,434,557
|
|
|
G.
|
Accumulated Other Comprehensive Income (loss)
|
|
|
Foreign Currency Translation Adjustment
|
|
Unrealized Holding Gains on Marketable Securities, net of tax
|
|
Unrealized Gains (Losses) on Foreign Currency Forward Contracts, net of tax
|
|
Total
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Balance at December 31, 2016
|
$
|
(7,862
|
)
|
|
$
|
17,521
|
|
|
$
|
11,514
|
|
|
$
|
21,173
|
|
|
Other comprehensive (loss) income before reclassifications
|
(2,001
|
)
|
|
3,534
|
|
|
(2,802
|
)
|
|
(1,269
|
)
|
||||
|
Amounts reclassified from accumulated other comprehensive loss
|
—
|
|
|
—
|
|
|
(3,879
|
)
|
|
(3,879
|
)
|
||||
|
Net current period other comprehensive (loss) income
|
$
|
(2,001
|
)
|
|
$
|
3,534
|
|
|
$
|
(6,681
|
)
|
|
$
|
(5,148
|
)
|
|
Balance at March 31, 2017
|
$
|
(9,863
|
)
|
|
$
|
21,055
|
|
|
$
|
4,833
|
|
|
$
|
16,025
|
|
|
|
Foreign Currency Translation Adjustment
|
|
Unrealized Holding Gains on Marketable Securities
|
|
Unrealized Gains (Losses) on Foreign Currency Forward Contracts, net of tax
|
|
Total
|
||||||||
|
|
(in thousands)
|
||||||||||||||
|
Balance at December 31, 2015
|
$
|
(2,080
|
)
|
|
$
|
126
|
|
|
$
|
3,778
|
|
|
$
|
1,824
|
|
|
Other comprehensive (loss) income before reclassifications
|
(1,740
|
)
|
|
229
|
|
|
(3,827
|
)
|
|
(5,338
|
)
|
||||
|
Amounts reclassified from accumulated other comprehensive loss
|
—
|
|
|
—
|
|
|
(1,385
|
)
|
|
(1,385
|
)
|
||||
|
Net current period other comprehensive (loss) income
|
$
|
(1,740
|
)
|
|
$
|
229
|
|
|
$
|
(5,212
|
)
|
|
$
|
(6,723
|
)
|
|
Balance at March 31, 2016
|
$
|
(3,820
|
)
|
|
$
|
355
|
|
|
$
|
(1,434
|
)
|
|
$
|
(4,899
|
)
|
|
H.
|
Hedging
|
|
|
As of March 31, 2017
|
|
As of December 31, 2016
|
||||
|
Foreign Currency
|
(in thousands)
|
||||||
|
Euro
|
$
|
187,375
|
|
|
$
|
164,368
|
|
|
British pound sterling
|
66,133
|
|
|
65,237
|
|
||
|
Australian dollar
|
28,645
|
|
|
23,776
|
|
||
|
Total foreign currency forward contracts
|
$
|
282,153
|
|
|
$
|
253,381
|
|
|
As of March 31, 2017
|
||||||||||
|
Assets
|
|
Liabilities
|
||||||||
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
|
(in thousands)
|
||||||||||
|
Prepaid and other current assets
|
|
$
|
8,318
|
|
|
Other liabilities, current portion
|
|
$
|
(613
|
)
|
|
Other assets
|
|
249
|
|
|
Other liabilities, excluding current portion
|
|
(86
|
)
|
||
|
Total assets
|
|
$
|
8,567
|
|
|
Total liabilities
|
|
$
|
(699
|
)
|
|
As of December 31, 2016
|
||||||||||
|
Assets
|
|
Liabilities
|
||||||||
|
Classification
|
|
Fair Value
|
|
Classification
|
|
Fair Value
|
||||
|
(in thousands)
|
||||||||||
|
Prepaid and other current assets
|
|
$
|
14,407
|
|
|
Other liabilities, current portion
|
|
$
|
(144
|
)
|
|
Other assets
|
|
1,186
|
|
|
Other liabilities, excluding current portion
|
|
—
|
|
||
|
Total assets
|
|
$
|
15,593
|
|
|
Total liabilities
|
|
$
|
(144
|
)
|
|
|
As of March 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
|
$
|
8,567
|
|
|
$
|
—
|
|
|
$
|
8,567
|
|
|
$
|
(699
|
)
|
|
$
|
7,868
|
|
|
Total liabilities
|
$
|
(699
|
)
|
|
$
|
—
|
|
|
$
|
(699
|
)
|
|
$
|
699
|
|
|
$
|
—
|
|
|
|
As of December 31, 2016
|
||||||||||||||||||
|
|
Gross Amounts Recognized
|
|
Gross Amounts Offset
|
|
Gross Amounts Presented
|
|
Gross Amounts Not Offset
|
|
Legal Offset
|
||||||||||
|
Foreign currency forward contracts
|
(in thousands)
|
||||||||||||||||||
|
Total assets
|
$
|
15,593
|
|
|
$
|
—
|
|
|
$
|
15,593
|
|
|
$
|
(144
|
)
|
|
$
|
15,449
|
|
|
Total liabilities
|
$
|
(144
|
)
|
|
$
|
—
|
|
|
$
|
(144
|
)
|
|
$
|
144
|
|
|
$
|
—
|
|
|
|
As of March 31, 2017
|
|
As of December 31, 2016
|
||||
|
|
(in thousands)
|
||||||
|
Raw materials
|
$
|
9,172
|
|
|
$
|
6,348
|
|
|
Work-in-process
|
60,921
|
|
|
56,672
|
|
||
|
Finished goods
|
11,927
|
|
|
14,584
|
|
||
|
Total
|
$
|
82,020
|
|
|
$
|
77,604
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
|
Stock-based compensation expense by type of award:
|
|
|
|
||||
|
Stock options
|
$
|
26,981
|
|
|
$
|
26,260
|
|
|
Restricted stock and restricted stock units
|
40,745
|
|
|
27,533
|
|
||
|
ESPP share issuances
|
2,064
|
|
|
2,524
|
|
||
|
Less stock-based compensation expense capitalized to inventories
|
(808
|
)
|
|
(845
|
)
|
||
|
Total stock-based compensation included in costs and expenses
|
$
|
68,982
|
|
|
$
|
55,472
|
|
|
|
|
|
|
||||
|
Stock-based compensation expense by line item:
|
|
|
|
||||
|
Research and development expenses
|
$
|
44,837
|
|
|
$
|
34,448
|
|
|
Sales, general and administrative expenses
|
24,145
|
|
|
21,024
|
|
||
|
Total stock-based compensation included in costs and expenses
|
$
|
68,982
|
|
|
$
|
55,472
|
|
|
|
As of March 31, 2017
|
||||
|
|
Unrecognized Expense
|
|
Weighted-average
Recognition Period |
||
|
|
(in thousands)
|
|
(in years)
|
||
|
Type of award:
|
|
|
|
||
|
Stock options
|
$
|
200,906
|
|
|
2.65
|
|
Restricted stock and restricted stock units
|
$
|
291,088
|
|
|
2.57
|
|
ESPP share issuances
|
$
|
2,016
|
|
|
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)
|
||||||
|
$18.93–$20.00
|
|
134
|
|
|
0.85
|
|
$
|
18.93
|
|
|
134
|
|
|
$
|
18.93
|
|
|
$20.01–$40.00
|
|
1,576
|
|
|
2.95
|
|
$
|
33.77
|
|
|
1,576
|
|
|
$
|
33.77
|
|
|
$40.01–$60.00
|
|
1,678
|
|
|
5.34
|
|
$
|
48.36
|
|
|
1,678
|
|
|
$
|
48.36
|
|
|
$60.01–$80.00
|
|
1,279
|
|
|
6.88
|
|
$
|
75.86
|
|
|
924
|
|
|
$
|
75.61
|
|
|
$80.01–$100.00
|
|
5,932
|
|
|
8.65
|
|
$
|
89.51
|
|
|
1,757
|
|
|
$
|
89.81
|
|
|
$100.01–$120.00
|
|
1,572
|
|
|
7.79
|
|
$
|
109.33
|
|
|
799
|
|
|
$
|
109.30
|
|
|
$120.01–$134.69
|
|
1,427
|
|
|
8.22
|
|
$
|
130.53
|
|
|
668
|
|
|
$
|
130.27
|
|
|
Total
|
|
13,598
|
|
|
7.19
|
|
$
|
82.60
|
|
|
7,536
|
|
|
$
|
71.52
|
|
|
|
Three Months Ended March 31,
|
||
|
|
2017
|
||
|
|
(in thousands)
|
||
|
Liability, beginning of the period
|
$
|
—
|
|
|
Restructuring expense
|
9,218
|
|
|
|
Cash payments
|
(3,258
|
)
|
|
|
Asset impairments and other non-cash expense
|
(2,233
|
)
|
|
|
Liability, end of the period
|
$
|
3,727
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
|
Liability, beginning of the period
|
$
|
4,328
|
|
|
$
|
7,944
|
|
|
Restructuring expense
|
485
|
|
|
203
|
|
||
|
Cash payments
|
(5,264
|
)
|
|
(3,931
|
)
|
||
|
Cash received from subleases
|
2,976
|
|
|
3,008
|
|
||
|
Liability, end of the period
|
$
|
2,525
|
|
|
$
|
7,224
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
|
Liability, beginning of the period
|
$
|
3,626
|
|
|
$
|
5,964
|
|
|
Restructuring expense
|
296
|
|
|
233
|
|
||
|
Cash payments
|
(4,405
|
)
|
|
(3,156
|
)
|
||
|
Cash received from subleases
|
2,478
|
|
|
2,408
|
|
||
|
Liability, end of the period
|
$
|
1,995
|
|
|
$
|
5,449
|
|
|
|
Three Months Ended March 31,
|
||
|
|
2016
|
||
|
|
(in thousands)
|
||
|
Liability, beginning of the period
|
$
|
1,450
|
|
|
Restructuring expense
|
251
|
|
|
|
Cash payments
|
(439
|
)
|
|
|
Liability, end of the period
|
$
|
1,262
|
|
|
•
|
Tezacaftor is a corrector compound that we are evaluating in a Phase 3 development program in combination with ivacaftor in multiple CF patient populations who have at least one copy of the F508del mutation in their
CFTR
gene.
|
|
◦
|
In the first quarter of 2017, we obtained positive results from two Phase 3 clinical trials that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in patients with CF 12 years of age and older who have certain mutations in their CFTR gene. The 24-week EVOLVE clinical trial evaluated tezacaftor in combination with ivacaftor in patients with CF who are homozygous for the F508del mutation in their CFTR gene. This clinical trial met its primary endpoint with a mean absolute improvement in ppFEV1 through 24 weeks of 4.0 percentage points from baseline compared to placebo (p < 0.0001). The second clinical trial, EXPAND, was an 8-week crossover clinical trial that evaluated the combination treatment in patients with CF who have one mutation that results in residual CFTR function and one F508del
mutation. This clinical trial met the primary endpoints of absolute change in ppFEV1 from baseline to the average of the Week 4 and Week 8 measurements, with the tezacaftor/ivacaftor combination treatment demonstrating a mean absolute improvement of 6.8 percentage points compared to placebo (p < 0.0001) and the ivacaftor monotherapy group demonstrating a mean absolute improvement of 4.7 percentage points compared to placebo (p < 0.0001). Across both clinical trials, the tezacaftor/ivacaftor combination treatment was generally well tolerated. Based on these results, we plan to submit a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA and a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, in the third quarter of 2017.
|
|
◦
|
We expect to complete enrollment in a third Phase 3 clinical trial in the first half of 2017 evaluating tezacaftor in combination with ivacaftor in patients 12 years of age or older who have one copy of the F508del mutation and a second mutation that results in a gating mutation in the CFTR gene that has been shown to be responsive to ivacaftor alone.
|
|
◦
|
We are conducting a Phase 3 clinical trial of the tezacaftor/ivacaftor combination in patients with CF six to eleven years of age in the U.S. The clinical trial is evaluating the safety and tolerability of the tezacaftor/ivacaftor combination in children who are homozygous for the F508del mutation and in
children who have one copy of the F508del mutation and a gating or residual function mutation.
|
|
•
|
VX-152, VX-440, VX-659 and VX-445 are next-generation CFTR corrector compounds that we are evaluating as part of triple combination treatment regimens. We are conducting Phase 2 clinical trials of VX-152 and VX-440 in patients with CF and Phase 1 clinical trials of VX-659 and VX-445 in healthy volunteers and patients with CF. We expect data for three of these triple combinations in patients with CF in the second half of 2017 and for the fourth triple combination that includes VX-445 in patients with CF in early 2018. We recently amended the Phase 2 clinical
|
|
•
|
VX-371, an investigational epithelial sodium channel, or ENaC, inhibitor, is being evaluated in a Phase 2 development program and which we exclusively licensed from Parion Sciences, Inc., or Parion, in 2015.
|
|
•
|
CRISPR Therapeutics AG, or 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;
|
|
•
|
Parion, pursuant to which we are developing epithelial sodium channel, or ENaC, inhibitors for the treatment of pulmonary diseases;
|
|
•
|
Moderna Therapeutics, Inc., or Moderna, pursuant to which we are seeking to identify and develop mRNA therapeutics for the treatment of CF; and
|
|
•
|
BioAxone Biosciences, Inc., or BioAxone, pursuant to which we are evaluating VX-210 as a potential treatment for patients who have spinal cord injuries.
|
|
•
|
Merck KGaA, which is advancing four oncology research and development programs; and
|
|
•
|
Janssen Pharmaceuticals, Inc. which is developing JNJ-3872 (formerly VX-787) for the treatment of influenza.
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Revenues
|
$
|
714,718
|
|
|
$
|
398,080
|
|
|
$
|
316,638
|
|
|
80
|
%
|
|
Operating costs and expenses
|
443,876
|
|
|
412,410
|
|
|
31,466
|
|
|
8
|
%
|
|||
|
Other items, net
|
(23,086
|
)
|
|
(27,301
|
)
|
|
4,215
|
|
|
15
|
%
|
|||
|
Net income (loss) attributable to Vertex
|
$
|
247,756
|
|
|
$
|
(41,631
|
)
|
|
$
|
289,387
|
|
|
n/a
|
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Product revenues, net
|
$
|
480,622
|
|
|
$
|
394,410
|
|
|
$
|
86,212
|
|
|
22
|
%
|
|
Royalty revenues
|
1,551
|
|
|
3,596
|
|
|
(2,045
|
)
|
|
(57
|
)%
|
|||
|
Collaborative revenues
|
232,545
|
|
|
74
|
|
|
232,471
|
|
|
n/a
|
|
|||
|
Total revenues
|
$
|
714,718
|
|
|
$
|
398,080
|
|
|
$
|
316,638
|
|
|
80
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
ORKAMBI
|
$
|
294,861
|
|
|
$
|
223,128
|
|
|
$
|
71,733
|
|
|
32
|
%
|
|
KALYDECO
|
185,715
|
|
|
170,509
|
|
|
15,206
|
|
|
9
|
%
|
|||
|
INCIVEK
|
46
|
|
|
773
|
|
|
(727
|
)
|
|
(94
|
)%
|
|||
|
Total product revenues, net
|
$
|
480,622
|
|
|
$
|
394,410
|
|
|
$
|
86,212
|
|
|
22
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Cost of product revenues
|
$
|
46,242
|
|
|
$
|
49,789
|
|
|
$
|
(3,547
|
)
|
|
(7
|
)%
|
|
Royalty expenses
|
746
|
|
|
860
|
|
|
(114
|
)
|
|
(13
|
)%
|
|||
|
Research and development expenses
|
273,563
|
|
|
255,860
|
|
|
17,703
|
|
|
7
|
%
|
|||
|
Sales, general and administrative expenses
|
113,326
|
|
|
105,214
|
|
|
8,112
|
|
|
8
|
%
|
|||
|
Restructuring expenses, net
|
9,999
|
|
|
687
|
|
|
9,312
|
|
|
1,355
|
%
|
|||
|
Total costs and expenses
|
$
|
443,876
|
|
|
$
|
412,410
|
|
|
$
|
31,466
|
|
|
8
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Research expenses
|
$
|
73,056
|
|
|
$
|
63,010
|
|
|
$
|
10,046
|
|
|
16
|
%
|
|
Development expenses
|
200,507
|
|
|
192,850
|
|
|
7,657
|
|
|
4
|
%
|
|||
|
Total research and development expenses
|
$
|
273,563
|
|
|
$
|
255,860
|
|
|
$
|
17,703
|
|
|
7
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Research Expenses:
|
|
|
|
|
|
|
|
|||||||
|
Salary and benefits
|
$
|
21,533
|
|
|
$
|
20,710
|
|
|
$
|
823
|
|
|
4
|
%
|
|
Stock-based compensation expense
|
13,691
|
|
|
10,656
|
|
|
3,035
|
|
|
28
|
%
|
|||
|
Laboratory supplies and other direct expenses
|
11,365
|
|
|
9,874
|
|
|
1,491
|
|
|
15
|
%
|
|||
|
Outsourced services
|
7,337
|
|
|
4,161
|
|
|
3,176
|
|
|
76
|
%
|
|||
|
Infrastructure costs
|
19,130
|
|
|
17,609
|
|
|
1,521
|
|
|
9
|
%
|
|||
|
Total research expenses
|
$
|
73,056
|
|
|
$
|
63,010
|
|
|
$
|
10,046
|
|
|
16
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Development Expenses:
|
|
|
|
|
|
|
|
|||||||
|
Salary and benefits
|
$
|
51,954
|
|
|
$
|
44,351
|
|
|
$
|
7,603
|
|
|
17
|
%
|
|
Stock-based compensation expense
|
31,146
|
|
|
23,792
|
|
|
7,354
|
|
|
31
|
%
|
|||
|
Laboratory supplies and other direct expenses
|
11,030
|
|
|
8,250
|
|
|
2,780
|
|
|
34
|
%
|
|||
|
Outsourced services
|
73,435
|
|
|
84,488
|
|
|
(11,053
|
)
|
|
(13
|
)%
|
|||
|
Drug supply costs
|
1,949
|
|
|
2,653
|
|
|
(704
|
)
|
|
(27
|
)%
|
|||
|
Infrastructure costs
|
30,993
|
|
|
29,316
|
|
|
1,677
|
|
|
6
|
%
|
|||
|
Total development expenses
|
$
|
200,507
|
|
|
$
|
192,850
|
|
|
$
|
7,657
|
|
|
4
|
%
|
|
|
Three Months Ended March 31,
|
|
Increase/(Decrease)
|
|||||||||||
|
|
2017
|
|
2016
|
|
$
|
|
%
|
|||||||
|
|
(in thousands)
|
|
|
|||||||||||
|
Sales, general and administrative expenses
|
$
|
113,326
|
|
|
$
|
105,214
|
|
|
$
|
8,112
|
|
|
8
|
%
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2017
|
|
2016
|
||||
|
|
(in thousands)
|
||||||
|
Loss attributable to noncontrolling interest before provision for income taxes
|
$
|
1,547
|
|
|
$
|
839
|
|
|
Provision for income taxes
|
391
|
|
|
3,062
|
|
||
|
Increase in fair value of contingent payments
|
(3,730
|
)
|
|
(9,430
|
)
|
||
|
Net income attributable to noncontrolling interest
|
$
|
(1,792
|
)
|
|
$
|
(5,529
|
)
|
|
•
|
In February 2017, we repaid the outstanding $300 million balance of our revolving credit facility.
|
|
•
|
In March 2017, we entered into an asset purchase agreement with Concert to acquire certain assets including CTP-656 from Concert. Upon closing, we will be required to pay Concert $160 million in cash for all worldwide development and commercialization rights to CTP-656.
|
|
•
|
whether or not the FDA and European regulatory authorities determine that the evidence gathered in well-controlled clinical trials, other clinical trials and nonclinical studies demonstrates that tezacaftor in combination with ivacaftor is safe and effective as a treatment for patients for whom marketing approval is sought;
|
|
•
|
whether or not the FDA and European regulatory authorities are satisfied that the manufacturing facilities, processes and controls for the combination of tezacaftor and ivacaftor are adequate, that the labeling is satisfactory and that plans for post-marketing studies, safety monitoring and risk evaluation and mitigation are sufficient; and
|
|
•
|
the timing and nature of the FDA and European Medicines Agency, or EMA's, comments and questions regarding the NDA and MAA for the combination of lumacaftor and ivacaftor, the scheduling and recommendations of any advisory committee meeting to consider the combination of tezacaftor and ivacaftor, the time required to respond to the FDA or EMA’s comments and questions and to obtain the final labeling for the combination of tezacaftor and ivacaftor and any other delays that may be associated with the NDA and MAA review process.
|
|
•
|
that we fail to successfully develop and/or integrate CTP-656 into our pipeline in order to achieve our strategic objectives;
|
|
•
|
that we receive inadequate or unfavorable data from clinical trials evaluating the CTP-656 in combination with other CFTR modulators; and
|
|
•
|
the potential failure of the due diligence processes to identify significant problems, liabilities or other shortcomings or challenges of CTP-656 or any of the other assets acquired from Concert, including but not limited to, problems, liabilities or other shortcomings or challenges with respect to intellectual property, product quality, safety, and other known and unknown liabilities.
|
|
•
|
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 net product revenues from KALYDECO and ORKAMBI;
|
|
•
|
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 our products and drug candidates, including the planned NDA and MAA submissions for tezacaftor in combination with ivacaftor and the ongoing and planned clinical trials to evaluate our next-generation correctors;
|
|
•
|
our ability to successfully market KALYDECO and ORKAMBI or any of our other drug candidates for which we obtain regulatory approval;
|
|
•
|
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;
|
|
•
|
the potential closing of the Concert transaction;
|
|
•
|
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 |
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 |
|
January 1, 2017 to January 31, 2017
|
26,293
|
$0.01
|
—
|
—
|
|
|
February 1, 2017 to February 28, 2017
|
11,980
|
$0.01
|
—
|
—
|
|
|
March 1, 2017 to March 31, 2017
|
44,802
|
$0.01
|
—
|
—
|
|
|
Exhibit Number
|
Exhibit Description
|
|
10.1
|
Strategic Collaboration and License Agreement, between Vertex Pharmaceuticals Incorporated and Merck KGaA, Darmstadt, Germany, dated January 10, 2017 †
|
|
10.2
|
Asset Purchase Agreement, dated March 3, 2017, by and among Vertex Pharmaceuticals (Europe) Ltd., as Buyer, Vertex Pharmaceuticals Inc., as Guarantor, and Concert Pharmaceuticals, Inc.
|
|
10.3
|
First Amendment to Lease, effective March 1, 2017, between ARE-SD Region No. 23, LLC and Vertex Pharmaceuticals Incorporated.
|
|
31.1
|
Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
31.2
|
Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.
|
|
32.1
|
Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS
|
XBRL Instance
|
|
101.SCH
|
XBRL Taxonomy Extension Schema
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation
|
|
101.LAB
|
XBRL Taxonomy Extension Labels
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation
|
|
101.DEF
|
XBRL Taxonomy Extension Definition
|
|
|
Vertex Pharmaceuticals Incorporated
|
|
|
|
|
|
|
April 28, 2017
|
By:
|
/s/ Ian F. Smith
|
|
|
|
Ian F. Smith
|
|
|
|
Executive Vice President, Chief Operating Officer and Chief Financial Officer
(principal financial officer and duly authorized officer) |
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | 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 |
|---|