Nasdaq: VRTX
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Press Release Details
Vertex Reports Full-Year and Fourth Quarter 2014 Financial Results and Provides Guidance for 2015
-Full-year 2014 total revenues of
-Cash, cash equivalents and marketable securities of approximately
-Company expects total 2015 KALYDECO net revenues of
Vertex reported total 2014 GAAP revenues of
Vertex reported total fourth quarter 2014 GAAP revenues of
"The potential approval and launch of the combination of lumacaftor and
ivacaftor and continued label and geographic expansion for KALYDECO are
expected to significantly increase both the number of people treated
with our medicines and our revenues to support the long-term growth of
our business," said
On
Oncology: Vertex is developing VX-970 and VX-803 as potential medicines for the treatment of a broad range of cancer tumor types. Both VX-970 and VX-803 were discovered by Vertex scientists and are designed to regulate the repair of damaged DNA within cancer cells through inhibition of a protein kinase known as ATR. Vertex is currently evaluating VX-970 and VX-803 in open-label Phase 1 clinical studies in people with advanced solid tumors.
Full-Year 2014 Non-GAAP Financial Results
The total 2014 non-GAAP financial results exclude stock-based
compensation expense, costs related to the relocation of the company's
corporate headquarters, hepatitis C-related revenues and costs and other
adjustments. The total 2013 non-GAAP financial results exclude
stock-based compensation expense, costs related to the relocation of the
company's corporate headquarters, certain hepatitis C-related revenues
and costs including expenses related to
Total Non-GAAP Revenues: Total 2014 non-GAAP revenues were
|
Twelve Months Ended |
||||||||||||||||
| (in millions) | ||||||||||||||||
| GAAP revenues |
HCV related |
Non-GAAP |
||||||||||||||
| Product revenues | ||||||||||||||||
| KALYDECO revenues, net | $ | 463.8 | $ | — | $ | 463.8 | ||||||||||
| INCIVEK revenues, net | 24.1 | (24.1 | ) | — | ||||||||||||
| Total product revenues, net | 487.8 | (24.1 | ) | 463.8 | ||||||||||||
| Royalty revenues | 40.9 | (13.5 | ) | 27.4 | ||||||||||||
| Collaborative revenues | 51.7 | (7.1 | ) | 44.6 | ||||||||||||
| Total revenues | $ | 580.4 | $ | (44.7 | ) | $ | 535.8 | |||||||||
-
Net Product Revenues from KALYDECO: Vertex's total 2014 net
product revenues from KALYDECO were
$463.8 million compared to$371.3 million for 2013. The increased KALYDECO net product revenues, compared to 2013, resulted primarily from the use of KALYDECO in the U.S. in people with the additional mutations approved by theFDA inFebruary 2014 and from increased revenues from markets outside of the U.S.
-
R&D Expenses: Non-GAAP R&D expenses were
$694.2 million for 2014, compared to$787.6 million in non-GAAP R&D expenses for 2013. -
SG&A Expenses: Non-GAAP SG&A expenses were
$225.6 million for 2014, compared to$309.1 million in non-GAAP SG&A expenses for 2013.
Non-GAAP Net Loss Attributable to Vertex: Vertex's total 2014
non-GAAP net loss was
Fourth Quarter 2014 Non-GAAP Financial Results
The fourth quarter 2014 non-GAAP financial results exclude stock-based
compensation expense, costs related to the relocation of the company's
corporate headquarters, hepatitis C-related revenues and costs and other
adjustments. The fourth quarter 2013 non-GAAP financial results exclude
stock-based compensation expense, costs related to the relocation of the
company's corporate headquarters, certain hepatitis C-related revenues
and costs including expenses related to
Total Non-GAAP Revenues: Total non-GAAP revenues for the fourth
quarter of 2014 were
|
Three Months Ended |
||||||||||||||||
| (in millions) | ||||||||||||||||
| GAAP revenues |
HCV related |
Non-GAAP |
||||||||||||||
| Product revenues | ||||||||||||||||
| KALYDECO revenues, net | $ | 124.4 | $ | — | $ | 124.4 | ||||||||||
| INCIVEK revenues, net | 0.6 | (0.6 | ) | — | ||||||||||||
| Total product revenues, net | 124.9 | (0.6 | ) | 124.4 | ||||||||||||
| Royalty revenues | 8.8 | (0.6 | ) | 8.2 | ||||||||||||
| Collaborative revenues | 10.8 | (2.8 | ) | 8.0 | ||||||||||||
| Total revenues | $ | 144.6 | $ | (4.0 | ) | $ | 140.6 | |||||||||
-
Net Product Revenues from KALYDECO: Vertex's fourth quarter
2014 net product revenues from KALYDECO were
$124.4 million compared to$109.4 million for the fourth quarter of 2013. The increased KALYDECO net product revenues, compared to the fourth quarter of 2013, resulted primarily from the use of KALYDECO in the U.S. in people with the additional mutations approved by theFDA inFebruary 2014 and from increased revenues from markets outside of the U.S.
Non-GAAP R&D and SG&A Expenses: Total combined non-GAAP
R&D and SG&A expenses for the fourth quarter of 2014 were
-
R&D Expenses: Non-GAAP R&D expenses were
$175.7 million for the fourth quarter of 2014, compared to$208.1 million in non-GAAP R&D expenses for the fourth quarter of 2013. The reduced R&D expenses reflect the prioritization of investment toward medicines for CF and the completion of the Phase 3 program for the combination of lumacaftor and ivacaftor in the first half of 2014, partially offset by costs related to the planned initiation of the pivotal Phase 3 program for VX-661 in combination with ivacaftor. -
SG&A Expenses: Non-GAAP SG&A expenses were
$60.4 million for the fourth quarter of 2014, compared to$65.4 million in non-GAAP SG&A expenses for the fourth quarter of 2013. This reduction is the result of prioritization of investment toward medicines for CF, partially offset by increased investment in global commercial support for KALYDECO and the potential launch of the combination of lumacaftor and ivacaftor.
Non-GAAP Net Loss Attributable to Vertex: Vertex's fourth quarter
2014 non-GAAP net loss was
Cash Position at
As of
2015 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for
-
KALYDECO Net Revenues: Vertex expects KALYDECO net revenues of
$560 to$580 million for 2015. Anticipated 2015 KALYDECO net revenues reflect:-
Use of KALYDECO by eligible patients in
Australia following the completion of reimbursement discussions in late 2014 -
Use of KALYDECO in some people in
the United States with the R117H mutation followingFDA approval in late 2014 - The completion of reimbursement discussions for gating mutations in certain European countries
-
Use of KALYDECO in children with CF ages 2 to 5 with the G551D or
other gating mutations in
the United States , based on potential approval inMarch 2015
-
Use of KALYDECO by eligible patients in
-
Non-GAAP R&D and SG&A Expenses: Vertex expects that its
combined non-GAAP R&D and SG&A expenses in 2015 will be in the range
of
$1.05 to$1.10 billion . The increase as compared to 2014 is primarily a result of launch preparation activities for lumacaftor in combination with ivacaftor and the planned pivotal Phase 3 development program for VX-661 in combination with ivacaftor.-
Non-GAAP R&D Expenses: Vertex expects that full-year
2015 non-GAAP R&D expenses will be in the range of
$770 to$800 million . The research component of 2015 non-GAAP R&D expenses is expected to remain consistent with 2014 at approximately$200 million . The development component of 2015 non-GAAP R&D expenses is expected to increase as compared to 2014 as a result of the planned pivotal Phase 3 program for VX-661 and investment in research and early-stage development programs. -
Non-GAAP SG&A Expenses: Vertex expects that full-year
2015 non-GAAP SG&A expenses will be in the range of
$280 to$300 million . The expected increase in SG&A is a result of planned investment in the company's commercial infrastructure to support the potential global launch of the combination of lumacaftor and ivacaftor.
-
Non-GAAP R&D Expenses: Vertex expects that full-year
2015 non-GAAP R&D expenses will be in the range of
Vertex's expected non-GAAP R&D and SG&A expenses exclude stock-based compensation expense and certain other expenses recorded in 2015.
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
Full-Year 2014 GAAP Financial Results
Total Revenues: Total 2014 revenues were
Operating Costs and Expenses: Total 2014 operating costs and
expenses were
-
R&D Expenses: 2014 R&D expenses were
$855.5 million , including,$161.3 million of certain charges, compared to$882.1 million for 2013, including$94.5 million of certain charges. -
SG&A Expenses: 2014 SG&A expenses were
$305.4 million , including$79.8 million of certain charges, compared to$356.2 million for 2013, including$47.1 million of certain charges.
Net Loss Attributable to Vertex: Vertex's 2014 net loss was
Fourth Quarter 2014 GAAP Financial Results
Total Revenues: Total revenues for the fourth quarter of 2014
were
Operating Costs and Expenses: Total operating costs and expenses
for the fourth quarter of 2014 were
-
R&D Expenses: R&D expenses were
$201.5 million for the fourth quarter of 2014, including$25.8 million of certain charges, compared to$238.5 million for the fourth quarter of 2013, including$30.3 million of certain charges. -
SG&A Expenses: SG&A expenses were
$78.5 million for the fourth quarter of 2014, including$18.2 million of certain charges, compared to$73.1 million for the fourth quarter of 2013, including$7.6 million of certain charges.
Net (Loss) Income Attributable to Vertex: Vertex's fourth quarter
2014 net loss was
|
Fourth Quarter and Twelve Month Results Condensed Consolidated Statements of Operations Data (in thousands, except per share amounts) (unaudited) |
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|
Three Months Ended |
Twelve Months Ended |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||||||
| Revenues: | ||||||||||||||||||||
| Product revenues, net | $ | 124,942 | $ | 128,822 | $ | 487,821 | $ | 837,645 | ||||||||||||
| Royalty revenues | 8,785 | 36,887 | 40,919 | 156,592 | ||||||||||||||||
| Collaborative revenues (Note 2)(Note 4) | 10,829 | 185,448 | 51,675 | 217,738 | ||||||||||||||||
| Total revenues | 144,556 | 351,157 | 580,415 | 1,211,975 | ||||||||||||||||
| Costs and expenses: | ||||||||||||||||||||
| Cost of product revenues | 11,290 | 13,281 | 39,725 | 88,979 | ||||||||||||||||
| Royalty expenses | 2,737 | 8,983 | 21,262 | 41,298 | ||||||||||||||||
| Research and development expenses | 201,463 | 238,461 | 855,506 | 882,097 | ||||||||||||||||
| Sales, general and administrative expenses | 78,527 | 73,055 | 305,409 | 356,188 | ||||||||||||||||
| Restructuring expenses (Note 3)(Note 4) | 4,164 | 27,658 | 50,925 | 40,521 | ||||||||||||||||
| Intangible asset impairment charge (Note 4) | — | — | — | 412,900 | ||||||||||||||||
| Total costs and expenses | 298,181 | 361,438 | 1,272,827 | 1,821,983 | ||||||||||||||||
| Loss from operations | (153,625 | ) | (10,281 | ) | (692,412 | ) | (610,008 | ) | ||||||||||||
| Interest expense, net | (21,177 | ) | (12,626 | ) | (72,863 | ) | (22,926 | ) | ||||||||||||
| Other (expense) income, net (Note 3) | (3,792 | ) | 3,339 | 30,400 | 6,890 | |||||||||||||||
| Loss from continuing operations before provision for (benefit from) income taxes | (178,594 | ) | (19,568 | ) | (734,875 | ) | (626,044 | ) | ||||||||||||
| Provision for (benefit from) income taxes (Note 4) | 2,043 | 1,352 | 6,958 | (122,422 | ) | |||||||||||||||
| Loss from continuing operations | (180,637 | ) | (20,920 | ) | (741,833 | ) | (503,622 | ) | ||||||||||||
| Loss from discontinued operations, net of tax (Note 4) | (209 | ) | (163,629 | ) | (912 | ) | (183,928 | ) | ||||||||||||
| Net Loss | (180,846 | ) | (184,549 | ) | (742,745 | ) | (687,550 | ) | ||||||||||||
| Loss from discontinued operations attributable to noncontrolling interest (Note 4) | — | 228,834 | — | 242,522 | ||||||||||||||||
| Loss attributable to noncontrolling interest | 4,190 | — | 4,190 | — | ||||||||||||||||
| Net (loss) income attributable to Vertex | $ | (176,656 | ) | $ | 44,285 | $ | (738,555 | ) | $ | (445,028 | ) | |||||||||
| Amounts attributable to Vertex: | ||||||||||||||||||||
| Loss from continuing operations | $ | (176,447 | ) | $ | (20,920 | ) | $ | (737,643 | ) | $ | (503,622 | ) | ||||||||
| (Loss) income from discontinued operations (Note 4) | (209 | ) | 65,205 | (912 | ) | 58,594 | ||||||||||||||
| Net (loss) income attributable to Vertex | $ | (176,656 | ) | $ | 44,285 | $ | (738,555 | ) | $ | (445,028 | ) | |||||||||
| Amounts per share attributable to Vertex common shareholders: | ||||||||||||||||||||
| Net loss from continuing operations: | ||||||||||||||||||||
| Basic and diluted | $ | (0.74 | ) | $ | (0.09 | ) | $ |
(3.14 |
) | $ | (2.24 | ) | ||||||||
| Net (loss) income from discontinued operations: | ||||||||||||||||||||
| Basic and diluted | $ | — | $ | 0.28 | $ | — | $ | 0.26 | ||||||||||||
| Net (loss) income: | ||||||||||||||||||||
| Basic and diluted | $ | (0.74 | ) | $ | 0.19 | $ | (3.14 | ) | $ | (1.98 | ) | |||||||||
| Shares used in per share calculations: | ||||||||||||||||||||
| Basic and diluted | 238,272 | 231,264 | 235,307 | 224,906 | ||||||||||||||||
|
Reconciliation of GAAP to Non-GAAP Net Loss Fourth Quarter and Twelve Month Results (in thousands, except per share amounts) (unaudited) |
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|
Three Months Ended |
Twelve Months Ended |
|||||||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||||||
| GAAP net (loss) income attributable to Vertex | $ | (176,656 | ) | $ | 44,285 | $ | (738,555 | ) | $ | (445,028 | ) | |||||||||
| Stock-based compensation expense | 42,381 | 23,240 | 177,542 | 126,853 | ||||||||||||||||
| Real estate restructuring costs (Note 3) | 3,660 | 19,164 | 40,963 | 20,583 | ||||||||||||||||
| HCV related revenues and costs (Note 4) | (1,920 | ) | (215,135 | ) | 2,245 | 90,382 | ||||||||||||||
| Other adjustments (Note 5) | 703 | — | 6,587 | 3,908 | ||||||||||||||||
| Non-GAAP net loss attributable to Vertex | $ | (131,832 | ) | $ | (128,446 | ) | $ | (511,218 | ) | $ | (203,302 | ) | ||||||||
| Amounts per share attributable to Vertex common shareholders - diluted: | ||||||||||||||||||||
| GAAP | $ | (0.74 | ) | $ | 0.19 | $ | (3.14 | ) | $ | (1.98 | ) | |||||||||
| Non-GAAP | $ | (0.55 | ) | $ | (0.56 | ) | $ | (2.17 | ) | $ | (0.90 | ) | ||||||||
| Shares used in diluted per share calculations: | ||||||||||||||||||||
| GAAP | 238,272 | 231,264 | 235,307 | 224,906 | ||||||||||||||||
| Non-GAAP | 238,272 | 231,264 | 235,307 | 224,906 | ||||||||||||||||
|
Reconciliation of GAAP to Non-GAAP Revenues and Expenses Fourth Quarter and Twelve Month Results (in thousands) (unaudited) |
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|
Three Months Ended |
Twelve Months Ended |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||||||
| GAAP total revenues | $ | 144,556 | $ | 351,157 | $ | 580,415 | $ | 1,211,975 | ||||||||||||
| HCV related revenues and costs (Note 4) | (3,968 | ) | (182,396 | ) | (44,626 | ) | (182,396 | ) | ||||||||||||
| Non-GAAP total revenues | $ | 140,588 | $ | 168,761 | $ | 535,789 | $ | 1,029,579 | ||||||||||||
|
Three Months Ended |
Twelve Months Ended |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||||||
| GAAP cost of product revenues and royalty expenses | $ | 14,027 | $ | 22,264 | $ | 60,987 | $ | 130,277 | ||||||||||||
| HCV related revenues and costs (Note 4) | (801 | ) | — | (16,036 | ) | (10,358 | ) | |||||||||||||
| Non-GAAP cost of product revenues and royalty expenses | $ | 13,226 | $ | 22,264 | $ | 44,951 | $ | 119,919 | ||||||||||||
| GAAP research and development expenses | $ | 201,463 | $ | 238,461 | $ | 855,506 | $ | 882,097 | ||||||||||||
| Stock-based compensation expense | (25,714 | ) | (17,075 | ) | (116,998 | ) | (81,204 | ) | ||||||||||||
| Real estate restructuring costs (Note 3) | — | (5,288 | ) | (25,094 | ) | (5,288 | ) | |||||||||||||
| HCV related revenues and costs (Note 4) | (159 | ) | (7,966 | ) | (14,993 | ) | (7,966 | ) | ||||||||||||
| Other adjustments (Note 5) | 87 | — | (4,242 | ) | — | |||||||||||||||
| Non-GAAP research and development expenses | $ | 175,677 | $ | 208,132 | $ | 694,179 | $ | 787,639 | ||||||||||||
| GAAP sales, general and administrative expenses | $ | 78,527 | $ | 73,055 | $ | 305,409 | $ | 356,188 | ||||||||||||
| Stock-based compensation expense | (16,667 | ) | (6,165 | ) | (60,544 | ) | (45,649 | ) | ||||||||||||
| Real estate restructuring costs (Note 3) | (122 | ) | (1,442 | ) | (4,645 | ) | (1,442 | ) | ||||||||||||
| HCV related revenues and costs (Note 4) | (879 | ) | — | (14,095 | ) | — | ||||||||||||||
| Other adjustments (Note 5) | (491 | ) | — | (491 | ) | — | ||||||||||||||
| Non-GAAP sales, general and administrative expenses | $ | 60,368 | $ | 65,448 | $ | 225,634 | $ | 309,097 | ||||||||||||
| Combined Non-GAAP R&D and SG&A expenses | $ | 236,045 | $ | 273,580 | $ | 919,813 | $ | 1,096,736 | ||||||||||||
|
Three Months Ended |
Twelve Months Ended |
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| 2014 | 2013 | 2014 | 2013 | |||||||||||||||||
| GAAP interest expense, net and other income (expense), net | $ | (24,969 | ) | $ | (9,287 | ) | $ | (42,463 | ) | $ | (16,036 | ) | ||||||||
| Real estate restructuring costs (Note 3) | — | 12,283 | (36,685 | ) | 12,283 | |||||||||||||||
| Other adjustments (Note 5) | (13 | ) | — | (13 | ) | 3,908 | ||||||||||||||
| Non-GAAP interest expense, net and other income (expense), net | $ | (24,982 | ) | $ | 2,996 | $ | (79,161 | ) | $ | 155 | ||||||||||
| GAAP provision for (benefit from) income taxes | $ | 2,043 | $ | 1,352 | $ | 6,958 | $ | (122,422 | ) | |||||||||||
| HCV related revenues and costs (Note 4) | — | — | — | 127,586 | ||||||||||||||||
| Other adjustments (Note 5) | (3,876 | ) | — | (3,876 | ) | — | ||||||||||||||
| Non-GAAP (benefit from) provision for income taxes | $ | (1,833 | ) | $ | 1,352 | $ | 3,082 | $ | 5,164 | |||||||||||
|
Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) |
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|
|
|
||||||||||
| Assets | |||||||||||
| Cash, cash equivalents and marketable securities | $ | 1,387,106 | $ | 1,465,076 | |||||||
| Accounts receivable, net | 72,994 | 85,517 | |||||||||
| Inventories | 30,848 | 14,147 | |||||||||
| Other current assets | 57,193 | 23,836 | |||||||||
| Property and equipment, net | 715,812 | 696,911 | |||||||||
| Intangible assets | 29,000 | — | |||||||||
| Goodwill | 39,915 | 30,992 | |||||||||
| Other non-current assets | 3,441 | 2,562 | |||||||||
| Total assets | $ | 2,336,309 | $ | 2,319,041 | |||||||
| Liabilities and Shareholders' Equity | |||||||||||
| Other liabilities | $ | 323,697 | $ | 356,730 | |||||||
| Accrued restructuring expense | 45,855 | 28,353 | |||||||||
| Deferred revenues | 45,276 | 70,969 | |||||||||
| Capital leases | 57,099 | 65,647 | |||||||||
| Construction financing lease obligation | 473,424 | 440,937 | |||||||||
| Senior secured term loan | 294,775 | — | |||||||||
| Shareholders' equity | 1,096,183 | 1,356,405 | |||||||||
| Total liabilities and shareholders' equity | $ | 2,336,309 | $ | 2,319,041 | |||||||
| Common shares outstanding | 241,764 | 233,789 | |||||||||
Note 1: In addition to amounts specifically reconciled in this press release, the company excludes from its non-GAAP income (loss) attributable to Vertex all restructuring expenses, intangible asset impairment charges and discontinued operations.
Note 2: 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
Note 3: In the three and twelve months ended
Note 4: In the three and twelve months ended
The company consolidated the financial statements of
Note 5: In the three and twelve months ended
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO® (ivacaftor)
Ivacaftor (150 mg tablets) is a cystic fibrosis transmembrane conductance regulatory (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR gene.
In the
Ivacaftor is not effective in patients with CF with 2 copies of the F508del mutation (F508del/F508del) in the CFTR gene. The safety and efficacy of ivacaftor in children with CF younger than 6 years of age have not been established.
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 and may diminish effectiveness. Therefore, co-administration is not recommended. The dose of ivacaftor must be adjusted when used concomitantly with strong and moderate CYP3A inhibitors or when used in patients with moderate or severe hepatic disease.
Cases of non-congenital lens opacities/cataracts have been reported in pediatric patients up to 12 years of age treated with ivacaftor. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating ivacaftor treatment.
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 KALYDECO (ivacaftor) U.S. Prescribing Information, EU Summary of Product Characteristics, Canadian Product Monograph, Australian Consumer Medicine Information and Product Information, Swiss Prescribing Information and Patient Information, and the New Zealand Datasheet and Consumer Medicine Information.
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. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research 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,
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