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Vertex Reports Full-Year and Fourth Quarter 2013 Financial Results and Provides Financial Guidance for 2014
-Full-year 2013 total revenues of
-Cash, cash equivalents and marketable securities of approximately
-Company expects total 2014 revenues of
Vertex reported total 2013 revenues of
Vertex reported total fourth quarter 2013 revenues of
"Data generated throughout the coming year will provide important
information to help define our future as we seek to create a sustainable
global company with multiple transformative medicines," commented
On
Cystic Fibrosis
-
VX-661 in Combination with Ivacaftor Granted Breakthrough Therapy
Designation: Vertex today announced that the
U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the combination of VX-661 and ivacaftor to treat people with cystic fibrosis (CF) who have two copies of the F508del mutation. According to theFDA , Breakthrough Therapy designation is based on preliminary clinical evidence and designed to expedite the development and review of medicines that are intended to treat a serious condition and may demonstrate substantial improvement over available therapy on one or more clinically significant endpoints. Vertex has submitted a protocol to theFDA for a 12-week Phase 2 study to evaluate the safety, efficacy and pharmacokinetics of VX-661 in combination with ivacaftor. The company is currently finalizing the design of this study and expects to begin the study in the first half of 2014. The study will enroll people with two copies of the F508del mutation.
Rheumatoid Arthritis
-
24-Week Results of Phase 2b Study of JAK3 Inhibitor VX-509:
Vertex today announced top-line 24-week results from a Phase 2b study
of the Janus kinase 3 (JAK3) inhibitor VX-509 in people with moderate
to severe rheumatoid arthritis (RA) who continued to receive stable
doses of methotrexate during the study. As previously announced, the
study met its 12-week primary endpoints of both the proportion of
people who achieved at least a 20 percent improvement in signs and
symptoms of RA, as measured by the ACR improvement criteria (ACR20),
and the change from baseline in Disease Activity Score for 28 joints
(DAS28). The top-line data announced today showed continued
improvements in the signs and symptoms of RA from week 12 to 24 as
measured by ACR20, ACR50 and ACR70. At week 24, all doses of VX-509
showed statistically significant ACR20, ACR50 and ACR70 responses
versus placebo. Across the four VX-509 dose groups, the ACR20, ACR50
and ACR70 responses were between 61 and 63 percent, 38 and 47 percent
and 15 and 25 percent, respectively, at 24 weeks of treatment. The
ACR20, ACR50 and ACR70 responses for patients who received placebo
were 17, 7 and 3 percent, respectively, at 24 weeks. Additional
details on the study design and 12-week results were provided is a
press release issued on
October 18, 2013 .
Safety results through 24 weeks of treatment were similar to results observed through 12 weeks. Through 24 weeks, the discontinuation rate due to adverse events was 9.1 percent for the pooled VX-509 treatment group and 8.5 percent for the placebo group. Overall, adverse event rates through 24 weeks were 59.9 percent in the pooled VX-509 treatment groups compared to 42.3 percent for those who received placebo. There were two deaths in the study, including one death in the VX-509 200 mg QD group in a patient with pneumonia and pancytopenia and a previously reported death in the VX-509 100 mg BID group in a patient who had cardiac failure.
In addition to the Phase 2b study in RA, Vertex has completed certain drug-drug interaction studies of VX-509 in healthy volunteers. These studies demonstrate that dosing with VX-509 inhibits CYP3A4 and indicate that dose modification with frequently prescribed medicines (e.g. atorvastatin, methylprednisone) or limited concomitant use of certain medications (e.g. oral midazolam) with VX-509 may be required.
Vertex is pursuing collaborative opportunities to support further global development of VX-509.
Full-Year 2013 Financial Results
Total Revenues: Total revenues for 2013 were
Twelve Months Ended |
|||||||
2013 | 2012 | ||||||
Product revenues, net | (in millions) | ||||||
INCIVEK revenues, net | $ | 466.3 | $ | 1,161.8 | |||
KALYDECO revenues, net | 371.3 | 171.6 | |||||
Total product revenues, net | $ | 837.6 | $ | 1,333.5 | |||
Royalty revenues | |||||||
Royalty revenues from INCIVO | 130.7 | 117.6 | |||||
Other royalty revenues | 25.9 | 23.9 | |||||
Total royalty revenues | $ | 156.6 | $ | 141.5 | |||
Collaborative revenues | $ | 217.7 | $ | 52.1 | |||
Total revenues | $ | 1,212.0 | $ | 1,527.0 |
A table of the components of total revenues on a quarterly basis for the last five quarters is provided following the Condensed Consolidated Statements of Operations Data.
-
Net Product Revenues from INCIVEK
Vertex's 2013 net product revenues from INCIVEK were$466.3 million , compared to$1.16 billion for 2012. The reduced revenues from INCIVEK were primarily due to fewer HCV patients receiving treatment with INCIVEK in 2013 compared to 2012. Vertex expects a continued decline in INCIVEK revenues as a result of increased competition.
-
Net Product Revenues from KALYDECO
Vertex's 2013 net product revenues from KALYDECO were$371.3 million , compared to$171.6 million for 2012. The increased revenues, compared to 2012, resulted primarily from the rapid uptake of KALYDECO by eligible patients inEurope in 2013. Nearly all eligible patients with the G551D mutation inthe United States andEurope have started treatment with KALYDECO. In 2014, further growth in KALYDECO revenues is dependent on completion of reimbursement discussions inAustralia andCanada for eligible patients with the G551D mutation and on the potential expansion of the KALYDECO label.
-
Royalty Revenues from INCIVO®
Vertex recognized$130.7 million in INCIVO royalty revenues in 2013 from the company's collaborator Janssen, compared to$117.6 million in INCIVO royalty revenues in 2012. InNovember 2013 , Vertex sold its rights to future royalties on INCIVO sales by Janssen for a$152.0 million cash payment. Beginning in the first quarter of 2014, Vertex will no longer receive INCIVO royalties.
Cost of Product Revenues: Cost of product revenues was
Research and Development (R&D) Expenses: R&D expenses were
Sales, General and Administrative (SG&A) Expenses: SG&A
expenses were
GAAP Net Loss Attributable to Vertex: Vertex's 2013 GAAP net loss
was
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's 2013
non-GAAP net loss was
Cash Position: As of December 31, 2013, Vertex had
Fourth Quarter 2013 Financial Results
Total Revenues: Total revenues for the fourth quarter of 2013
were
Three Months Ended |
|||||||
2013 | 2012 | ||||||
Product revenues, net | (in millions) | ||||||
INCIVEK revenues, net | $ | 19.3 | $ | 222.8 | |||
KALYDECO revenues, net | 109.5 | 58.5 | |||||
Total product revenues, net | $ | 128.8 | $ | 281.3 | |||
Royalty revenues | |||||||
Royalty revenues from INCIVO | 26.4 | 36.8 | |||||
Other royalty revenues | 10.5 | 6.7 | |||||
Total royalty revenues | $ | 36.9 | $ | 43.5 | |||
Collaborative revenues | $ | 185.4 | $ | 9.2 | |||
Total revenues | $ | 351.2 | $ | 334.0 |
-
Net Product Revenues from INCIVEK
Vertex's fourth quarter 2013 net product revenues from INCIVEK were$19.3 million , compared to$222.8 million for the fourth quarter of 2012. The reduced revenues from INCIVEK were due to fewer HCV patients receiving treatment with INCIVEK in the fourth quarter of 2013 compared to the fourth quarter of 2012 and a reduced realized price. Vertex expects a continued decline in INCIVEK revenues as a result of increased competition.
-
Net Product Revenues from KALYDECO
Vertex's fourth quarter 2013 net product revenues from KALYDECO were$109.5 million , compared to$58.5 million for the fourth quarter of 2012. The increased revenues, compared to the fourth quarter of 2012, resulted primarily from the rapid uptake of KALYDECO in eligible patients inEurope following the conclusion of reimbursement discussions. Nearly all eligible patients with the G551D mutation inthe United States andEurope have started treatment with KALYDECO. In 2014, further growth in KALYDECO revenues is dependent on completion of reimbursement discussions inAustralia andCanada for eligible patients with the G551D mutation and on the potential expansion of the KALYDECO label.
-
Royalty Revenues from INCIVO®
Vertex recognized$26.4 million in INCIVO royalty revenues for the fourth quarter of 2013 from the company's collaborator Janssen, compared to$36.8 million in INCIVO royalty revenues for the fourth quarter of 2012. InNovember 2013 , Vertex sold its rights to future royalties on INCIVO sales by Janssen for a$152.0 million cash payment. Beginning in the first quarter of 2014, Vertex will no longer receive INCIVO royalties.
Cost of Product Revenues: Cost of product revenues was
Research and Development (R&D) Expenses: R&D expenses were
Sales, General and Administrative (SG&A) Expenses: SG&A
expenses were
GAAP Net Income (Loss) Attributable to Vertex: Vertex's fourth
quarter 2013 GAAP net income was
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's
fourth quarter 2013 non-GAAP net loss was
2014 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for
-
Total Revenues: Vertex expects total 2014 net revenues of
$570 to$600 million . Total revenues include net product revenues for KALYDECO and INCIVEK, as well as royalty and collaborative revenues.-
KALYDECO Net Revenues: Vertex expects KALYDECO net revenues
of
$470 to$500 million for 2014.
-
KALYDECO Net Revenues: Vertex expects KALYDECO net revenues
of
-
Non-GAAP Operating Expenses: Vertex expects that its 2014
non-GAAP operating expenses will be in the range of
$900 to$950 million . The company's planned 2014 investment includes approximately$40 to$50 million of expense related to development of an all-oral treatment regimen for hepatitis C.-
Research and Development Expenses: Vertex expects that
full-year 2014 non-GAAP R&D expenses will be in the range of
$665 to$695 million . The research component of 2014 non-GAAP R&D expenses is expected to remain consistent with 2013 at approximately$200 million . -
Sales, General and Administrative Expenses: Vertex expects
that full-year 2014 non-GAAP SG&A expenses will be in the range of
$235 to$255 million .
-
Research and Development Expenses: Vertex expects that
full-year 2014 non-GAAP R&D expenses will be in the range of
Vertex's expected non-GAAP operating expense excludes cost of revenues, stock-based compensation expense, restructuring charges, transition costs related to the relocation of our corporate headquarters, post-restructuring HCV collaborative revenues and development costs, and any similar expenses incurred in 2014.
Non-GAAP Financial Measures
In this press release, Vertex's financial results and financial guidance
are provided in accordance with accounting principles generally accepted
in
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Fourth Quarter and Twelve Month Results |
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Condensed Consolidated Statements of Operations Data |
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(in thousands, except per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
Three Months Ended |
Twelve Months Ended |
|||||||||||||||
2013 | 2012 | 2013 | 2012 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenues, net | $ | 128,822 | $ | 281,309 | $ | 837,645 | $ | 1,333,458 | ||||||||
Royalty revenues | 36,887 | 43,451 | 156,592 | 141,498 | ||||||||||||
Collaborative revenues (Note 1) | 185,448 | 9,234 | 217,738 | 52,086 | ||||||||||||
Total revenues | 351,157 | 333,994 | 1,211,975 | 1,527,042 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenues (Note 2) | 13,281 | 75,595 | 88,979 | 236,742 | ||||||||||||
Royalty expenses | 8,983 | 12,120 | 41,298 | 43,143 | ||||||||||||
Research and development expenses (R&D) | 249,609 | 213,109 | 918,783 | 806,185 | ||||||||||||
Sales, general and administrative expenses (SG&A) | 75,188 | 110,452 | 362,342 | 436,796 | ||||||||||||
Restructuring expense (Note 3) | 27,658 | 194 | 40,521 | 1,844 | ||||||||||||
Intangible asset impairment charges (Note 4) (Note 6) | 250,600 | — | 663,500 | — | ||||||||||||
Total costs and expenses | 625,319 | 411,470 | 2,115,423 | 1,524,710 | ||||||||||||
Income (loss) from operations | (274,162 | ) | (77,476 | ) | (903,448 | ) | 2,332 | |||||||||
Other expense, net (Note 5)(Note 6) | (66,091 | ) | (3,296 | ) | (72,669 | ) | (14,713 | ) | ||||||||
Income (loss) before provision for (benefit from) income taxes | (340,253 | ) | (80,772 | ) | (976,117 | ) | (12,381 | ) | ||||||||
Provision for (benefit from) income taxes (Note 4) | (155,704 | ) | (2,696 | ) | (288,567 | ) | 38,754 | |||||||||
Net loss | (184,549 | ) | (78,076 | ) | (687,550 | ) | (51,135 | ) | ||||||||
Net loss (income) attributable to noncontrolling interest | 228,834 | 1,928 | 242,522 | (55,897 | ) | |||||||||||
Net income (loss) attributable to Vertex | $ | 44,285 | $ | (76,148 | ) | $ | (445,028 | ) | $ | (107,032 | ) | |||||
Net income (loss) per share attributable to Vertex common shareholders: | ||||||||||||||||
Basic | $ | 0.19 | $ | (0.35 | ) | $ | (1.98 | ) | $ | (0.50 | ) | |||||
Diluted | $ | 0.19 | $ | (0.35 | ) | $ | (1.98 | ) | $ | (0.50 | ) | |||||
Shares used in per share calculations: | ||||||||||||||||
Basic | 231,264 | 214,607 | 224,906 | 211,946 | ||||||||||||
Diluted | 235,717 | 214,607 | 224,906 | 211,946 | ||||||||||||
Consolidated Revenues |
|||||||||||||||||||
(in millions) |
|||||||||||||||||||
(unaudited) |
|||||||||||||||||||
Three Months Ended | |||||||||||||||||||
|
|
2013 |
|
|
|||||||||||||||
Product revenues, net | |||||||||||||||||||
INCIVEK revenues, net | $ | 19.3 | $ | 85.6 | $ | 155.8 | $ | 205.6 | $ | 222.8 | |||||||||
KALYDECO revenues, net | 109.5 | 101.1 | 99.0 | 61.8 | 58.5 | ||||||||||||||
Total product revenues, net | 128.8 | 186.7 | 254.8 | 267.4 | 281.3 | ||||||||||||||
Royalty revenues | |||||||||||||||||||
Royalty revenues from INCIVO | 26.4 | 21.0 | 44.1 | 39.0 | 36.8 | ||||||||||||||
Other royalty revenues | 10.5 | 6.0 | 5.0 | 4.5 | 6.7 | ||||||||||||||
Total royalty revenues | 36.9 | 27.0 | 49.1 | 43.6 | 43.5 | ||||||||||||||
Collaborative revenues | 185.4 | 8.0 | 6.8 | 17.4 | 9.2 | ||||||||||||||
Total revenues | $ | 351.2 | $ | 221.7 | $ | 310.8 | $ | 328.4 | $ | 334.0 | |||||||||
Reconciliation of GAAP to |
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(in thousands, except per share amounts) |
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(unaudited) |
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Three Months Ended |
|||||||||||||||||||
Adjustments | |||||||||||||||||||
GAAP |
Alios Transaction (Note 6) |
Stock-based Compensation |
Other Adjustments (Note 8) |
Non-GAAP | |||||||||||||||
Income (loss) from operations | $ | (274,162 | ) | $ | 262,475 | $ | 23,240 | $ | (140,042 | ) | $ | (128,489 | ) | ||||||
Other income (expense), net | (66,091 | ) | 55,204 | — | 12,283 | 1,396 | |||||||||||||
Income (loss) before provision for (benefit from) income taxes | (340,253 | ) | 317,679 | 23,240 | (127,759 | ) | (127,093 | ) | |||||||||||
Provision for (benefit from) income taxes | (155,704 | ) | 157,056 | — | — | 1,352 | |||||||||||||
Net income (loss) | (184,549 | ) | 160,623 | 23,240 | (127,759 | ) | (128,445 | ) | |||||||||||
Net loss (income) attributable to noncontrolling interest ( |
228,834 | (228,834 | ) | — | — | — | |||||||||||||
Net income (loss) attributable to Vertex | $ | 44,285 | $ | (68,211 | ) | $ | 23,240 | $ | (127,759 | ) | $ | (128,445 | ) | ||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 7) | $ | 0.19 | $ | (0.56 | ) | ||||||||||||||
Three Months Ended |
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Adjustments | |||||||||||||||||||
GAAP |
Alios Transaction |
Stock-based Compensation |
Other Adjustments |
Non-GAAP | |||||||||||||||
Income (loss) from operations | $ | (77,476 | ) | $ | 5,706 | $ | 27,524 | $ | 55,383 | $ | 11,137 | ||||||||
Other income (expense), net | (3,296 | ) | (243 | ) | — | — | (3,539 | ) | |||||||||||
Income (loss) before provision for (benefit from) income taxes | (80,772 | ) | 5,463 | 27,524 | 55,383 | 7,598 | |||||||||||||
Provision for (benefit from) income taxes | (2,696 | ) | 1,325 | — | — | (1,371 | ) | ||||||||||||
Net income (loss) | (78,076 | ) | 4,138 | 27,524 | 55,383 | 8,969 | |||||||||||||
Net loss (income) attributable to noncontrolling interest ( |
1,928 | (1,928 | ) | — | — | — | |||||||||||||
Net income (loss) attributable to Vertex | $ | (76,148 | ) | $ | 2,210 | $ | 27,524 | $ | 55,383 | $ | 8,969 | ||||||||
Net loss per diluted share attributable to Vertex common shareholders (Note 7) | $ | (0.35 | ) | $ | 0.04 |
Reconciliation of GAAP to |
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(in thousands) |
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(unaudited) |
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Three Months Ended |
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2013 | 2012 | |||||||
GAAP total costs and expenses | $ | 625,319 | $ | 411,470 | ||||
Adjustments: | ||||||||
Cost of product revenues (Note 2) and royalty expenses | (22,264 | ) | (87,715 | ) | ||||
Stock-based compensation expense | (23,240 | ) | (27,524 | ) | ||||
|
(262,475 | ) | (5,706 | ) | ||||
Other Adjustments (Note 8) | (42,354 | ) | (194 | ) | ||||
Non-GAAP total costs and expenses | $ | 274,986 | $ | 290,331 | ||||
GAAP research and development expenses | $ | 249,609 | $ | 213,109 | ||||
Adjustments: | ||||||||
Stock-based compensation expense | (17,075 | ) | (17,019 | ) | ||||
|
(9,749 | ) | (4,784 | ) | ||||
Other Adjustments (Note 8) | (13,254 | ) | — | |||||
Non-GAAP research and development expenses | $ | 209,531 | $ | 191,306 | ||||
GAAP sales, general and administrative expenses | $ | 75,188 | $ | 110,452 | ||||
Adjustments: | ||||||||
Stock-based compensation expense | (6,165 | ) | (10,505 | ) | ||||
|
(2,126 | ) | (922 | ) | ||||
Other Adjustments (Note 8) | (1,442 | ) | — | |||||
Non-GAAP sales, general and administrative expenses | $ | 65,455 | $ | 99,025 | ||||
Reconciliation of GAAP to Non-GAAP Financial Information-Twelve Months |
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(in thousands, except per share amounts) |
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(unaudited) |
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Twelve Months Ended |
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Adjustments | ||||||||||||||||||||||
GAAP |
|
Stock-based |
Debt Conversion |
Other |
Non-GAAP | |||||||||||||||||
Income (loss) from operations | $ | (903,448 | ) | $ | 283,823 | $ | 126,853 | $ | — | $ | 296,079 | $ | (196,693 | ) | ||||||||
Other income (expense), net | (72,669 | ) | 55,033 | — | 3,908 | 12,283 | (1,445 | ) | ||||||||||||||
Income (loss) before provision for (benefit from) income taxes | (976,117 | ) | 338,856 | 126,853 | 3,908 | 308,362 | (198,138 | ) | ||||||||||||||
Provision for (benefit from) income taxes | (288,567 | ) | 166,145 | — | — | 127,586 | 5,164 | |||||||||||||||
Net income (loss) | (687,550 | ) | 172,711 | 126,853 | 3,908 | 180,776 | (203,302 | ) | ||||||||||||||
Net loss (income) attributable to noncontrolling interest ( |
242,522 | (242,522 | ) | — | — | — | — | |||||||||||||||
Net income (loss) attributable to Vertex | $ | (445,028 | ) | $ | (69,811 | ) | $ | 126,853 | $ | 3,908 | $ | 180,776 | $ | (203,302 | ) | |||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 7) | $ | (1.98 | ) | $ | (0.90 | ) | ||||||||||||||||
Twelve Months Ended |
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Adjustments | |||||||||||||||||||
GAAP |
Alios Transaction |
Stock-based Compensation |
Other Adjustments
|
Non-GAAP | |||||||||||||||
Income (loss) from operations | $ | 2,332 | $ | 20,062 | $ | 113,804 | $ | 135,033 | $ | 271,231 | |||||||||
Other income (expense), net | (14,713 | ) | (18 | ) | — | — | (14,731 | ) | |||||||||||
Income (loss) before provision for (benefit from) income taxes | (12,381 | ) | 20,044 | 113,804 | 135,033 | 256,500 | |||||||||||||
Provision for (benefit from) income taxes | 38,754 | (39,029 | ) | — | 1,239 | 964 | |||||||||||||
Net income (loss) | (51,135 | ) | 59,073 | 113,804 | 133,794 | 255,536 | |||||||||||||
Net loss (income) attributable to noncontrolling interest ( |
(55,897 | ) | 55,897 | — | — | — | |||||||||||||
Net income (loss) attributable to Vertex | $ | (107,032 | ) | $ | 114,970 | $ | 113,804 | $ | 133,794 | $ | 255,536 | ||||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 7) | $ | (0.50 | ) | $ | 1.18 | ||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information-Twelve Months |
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(in thousands) |
||||||||
(unaudited) |
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Twelve Months Ended |
||||||||
2013 | 2012 | |||||||
GAAP total costs and expenses | $ | 2,115,423 | $ | 1,524,710 | ||||
Adjustments: | ||||||||
Cost of product revenues (Note 2) and royalty expenses | (130,277 | ) | (279,885 | ) | ||||
Stock-based compensation expense | (126,853 | ) | (113,804 | ) | ||||
|
(283,823 | ) | (20,062 | ) | ||||
Other Adjustments (Note 8) | (468,117 | ) | (1,844 | ) | ||||
Non-GAAP total costs and expenses | $ | 1,106,353 | $ | 1,109,115 | ||||
GAAP research and development expenses | $ | 918,783 | $ | 806,185 | ||||
Adjustments: | ||||||||
Stock-based compensation expense | (81,204 | ) | (71,242 | ) | ||||
|
(27,088 | ) | (16,264 | ) | ||||
Other Adjustments (Note 8) | (13,254 | ) | — | |||||
Non-GAAP research and development expenses | $ | 797,237 | $ | 718,679 | ||||
GAAP sales, general and administrative expenses | $ | 362,342 | $ | 436,796 | ||||
Adjustments: | ||||||||
Stock-based compensation expense | (45,649 | ) | (42,562 | ) | ||||
|
(6,135 | ) | (3,798 | ) | ||||
Other Adjustments (Note 8) | (1,442 | ) | — | |||||
Non-GAAP sales, general and administrative expenses | $ | 309,116 | $ | 390,436 | ||||
Condensed Consolidated Balance Sheets Data |
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(in thousands) |
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(unaudited) |
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|
|
||||||
Assets | |||||||
Cash, cash equivalents and marketable securities | $ | 1,465,076 | $ | 1,321,215 | |||
Restricted cash and cash equivalents ( |
— | 69,983 | |||||
Accounts receivable, net | 85,517 | 143,250 | |||||
Inventories (Note 2) | 14,147 | 30,464 | |||||
Other current assets | 23,836 | 24,673 | |||||
Restricted cash | 130 | 31,934 | |||||
Property and equipment, net | 696,911 | 433,609 | |||||
Intangible assets (Note 4) | — | 663,500 | |||||
Goodwill | 30,992 | 30,992 | |||||
Other non-current assets | 2,432 | 9,668 | |||||
Total assets | $ | 2,319,041 | $ | 2,759,288 | |||
Liabilities and Shareholders' Equity | |||||||
Other liabilities | $ | 422,377 | $ | 429,372 | |||
Accrued restructuring expense | 28,353 | 23,328 | |||||
Deferred tax liability (Note 4) | — | 280,367 | |||||
Deferred revenues | 70,969 | 123,808 | |||||
Construction financing lease obligation | 440,937 | 268,031 | |||||
Convertible notes (due 2015) (Note 5) | — | 400,000 | |||||
Noncontrolling interest ( |
— | 235,202 | |||||
Shareholders' equity (Vertex) | 1,356,405 | 999,180 | |||||
Total liabilities and shareholders' equity | $ | 2,319,041 | $ | 2,759,288 | |||
Common shares outstanding | 233,789 | 217,287 | |||||
Note 1: During the fourth quarter of 2013, the company sold its
product royalty rights relating to INCIVO (telaprevir) to Janssen
Pharmaceutica NV. Under this amendment to the company's collaboration
agreement with Janssen, Janssen made a
Note 2: In the twelve months ended December 31, 2013, the company
recorded within cost of product revenues reserves for excess and
obsolete inventories of
Note 3: The Company recorded
Note 4: As of December 31, 2013, there were no intangible assets or deferred tax liability reflected in the condensed consolidated balance sheet.
In the first quarter of 2013, the company determined that the value of
VX-222 had become impaired and that the fair value of VX-222 was zero as
of
In the fourth quarter of 2013, the company determined that the value of
the HCV nucleotide analogue program related to the company's
collaboration agreement with
Note 5: In the second quarter of 2013, the company elected to
redeem
Note 6: The company has consolidated the financial statements of
its collaborator
The net effect of the impairment charge, the tax benefit, and the
related deconsolidation was a gain of approximately
Note 7: Shares used in non-GAAP net income (loss) per diluted share attributable to Vertex common shareholders were 231,264,000 and 217,291,000 for the three months ended December 31, 2013 and 2012, respectively, and 224,906,000 and 215,263,000 for the twelve months ended December 31, 2013 and 2012, respectively.
Note 8: In the three and twelve months ended
In the three and twelve months ended
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO™ (ivacaftor)
Ivacaftor (150mg tablets) is indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
Ivacaftor is not for use in people with CF due to other mutations in the CFTR gene. It is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CFTR gene. The efficacy and safety of ivacaftor in children younger than 6 years of age have not been evaluated.
Elevated liver enzymes (transaminases; ALT and AST) have been reported in patients receiving ivacaftor. It is recommended that ALT and AST be assessed prior to initiating ivacaftor, every 3 months during the first year of treatment, and annually thereafter. Patients who develop increased transaminase levels should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal. Following resolution of transaminase elevations, consider the benefits and risks of resuming ivacaftor dosing.
Use of ivacaftor with medicines that are strong CYP3A inducers, such as the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's Wort, substantially decreases exposure of ivacaftor which may diminish effectiveness. Therefore, co-administration is not recommended.
The dose of ivacaftor must be adjusted when used concomitantly with potent and moderate CYP3A inhibitors. The dose of ivacaftor must be adjusted when used in patients with moderate or severe hepatic disease.
Ivacaftor can cause serious adverse reactions including abdominal pain and high liver enzymes in the blood. The most common side effects associated with ivacaftor include headache; upper respiratory tract infection (the common cold), including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; and dizziness. These are not all the possible side effects of ivacaftor. A list of the adverse reactions can be found in the product labeling for each country where ivacaftor is approved. Patients should tell their healthcare providers about any side effect that bothers them or does not go away.
Please see full U.S. Prescribing Information for KALYDECO at www.KALYDECO.com, the EU Summary of Product Characteristics for KALYDECO at http://goo.gl/N3Tz4, the Canadian Product Monograph for KALYDECO at www.vrtx.ca and the Australian Consumer Medical Information and Product Information for KALYDECO (ivacaftor) at http://bit.ly/18wlMld.
Indication and Important Safety Information for INCIVEK (telaprevir)
INCIVEK® (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment. It is not known if INCIVEK is safe and effective in children under 18 years of age.
Important Safety Information
INCIVEK® (telaprevir) should always be used in combination with peginterferon alfa and ribavirin. INCIVEK combination treatment may cause serious side effects including skin rash and serious skin reactions, anemia (low red blood cell count) that can be severe, and birth defects or death of an unborn baby.
Skin rashes are common with INCIVEK combination treatment. Sometimes these skin rashes and other skin reactions can become serious, require treatment in a hospital, and may lead to death. Patients should call their healthcare provider right away if they develop any skin changes or itching during treatment with INCIVEK. Their healthcare provider will decide if they need treatment or if they need to stop INCIVEK or any of their other medicines. Patients should not stop taking INCIVEK combination treatment without talking with their healthcare provider first.
Patients' healthcare providers will do blood tests regularly to check for anemia. If anemia is severe, the healthcare providers may tell them to stop taking INCIVEK.
INCIVEK combined with peginterferon alfa and ribavirin may cause birth defects or death of an unborn baby. Therefore, a patient should not take INCIVEK combination treatment if she is pregnant or may become pregnant, or if he is a man with a sexual partner who is pregnant. Females who can become pregnant and females whose male partner takes these medicines must have a negative pregnancy test before starting treatment, every month during treatment, and for 6 months after treatment ends. Patients must use two forms of effective birth control during treatment and for 6 months after all treatment has ended. These two forms of birth control should not contain hormones, as these may not work during treatment with INCIVEK.
INCIVEK and other medicines can affect each other and can also cause side effects that can be serious or life-threatening. There are certain medicines patients cannot take with INCIVEK combination treatment. Patients should tell their healthcare providers about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of INCIVEK combination treatment include itching, nausea, diarrhea, vomiting, anal or rectal problems (including hemorrhoids, discomfort, burning or itching around or near the anus), taste changes and tiredness. There are other possible side effects of INCIVEK, and side effects associated with peginterferon alfa and ribavirin also apply to INCIVEK combination treatment. Patients should tell their healthcare provider about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information including Boxed Warning, and the Medication Guide for INCIVEK available at www.INCIVEK.com.
About Vertex
Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of cystic fibrosis, hepatitis C, rheumatoid arthritis and other life-threatening diseases. In addition to our clinical development programs, Vertex has more than a dozen ongoing preclinical programs aimed at other serious and life-threatening diseases.
Founded in 1989 in
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, including, without
limitation, Dr. Leiden's statements in the fourth paragraph of the press
release, the information provided in the section captioned "2014
Financial Guidance," and the information provided regarding (i) Vertex's
plans regarding the design and initiation of a Phase 2 study of VX-661
in combination with ivacaftor; (ii) the suggestion that use of VX-509
with certain other medicines may require dose modification or limited
concomitant use; (iii) Vertex pursuing collaborative opportunities to
support further global development of VX-509; and (iv) Vertex's
expectations regarding 2014 revenues, including KALYDECO and INCIVEK
revenues. While Vertex believes the forward-looking statements contained
in this press release are accurate, these forward-looking statements
represent the company's beliefs only as of the date of this press
release and there are a number of factors that could cause actual events
or results to differ materially from those indicated by such
forward-looking statements. Those risks and uncertainties include, among
other things, that the company's expectations regarding its 2014
revenues and financial results and its 2014 non-GAAP operating expenses
may be incorrect (including because one or more of the company's
assumptions underlying its revenue or expense expectations may not be
realized), that data from the company's development programs may not
support registration or further development of its compounds due to
safety, efficacy or other reasons, and other risks listed under Risk
Factors in Vertex's annual report and quarterly reports filed with the
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