Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
reported consolidated financial results for the quarter ended
September 30, 2014. Vertex reported total third quarter 2014
GAAP revenues of $179 million, including revenues of $127 million
from KALYDECO® (ivacaftor). The GAAP net loss for the third quarter
of 2014 was $(170) million, or $(0.72) per share, which includes
net charges of $84 million. The non-GAAP net loss for the third
quarter of 2014 was $(86) million, or $(0.37) per share. The
company also today provided updated financial guidance for total
2014 non-GAAP revenues, 2014 KALYDECO revenues and non-GAAP
operating expenses. As of September 30, 2014, Vertex had $1.48
billion in cash, cash equivalents and marketable securities.
"With the recent progress across our research and development
programs in cystic fibrosis and the expansion of the number of
people being treated with KALYDECO, we have established a clear
path for the future of our company," said Jeffrey Leiden, M.D.,
Ph.D., Chairman, President and Chief Executive Officer of Vertex.
"We remain focused on investing in the discovery and development of
new medicines for CF and other serious and rare diseases while
increasing revenues to move us to profitability and drive earnings
growth."
Research and Development
Updates
In a press release issued on October 9, 2014, Vertex provided a
comprehensive update on its research and development programs aimed
at developing combinations of medicines to treat the underlying
cause of cystic fibrosis (CF) for the majority of people with the
disease. Vertex today provided the following updates:
KALYDECO® (ivacaftor)
Availability of KALYDECO in Australia: In Australia,
KALYDECO is expected to be listed on the Pharmaceutical Benefits
Scheme (PBS) as of December 1, which will provide reimbursement for
all eligible patients to begin and remain on treatment with
KALYDECO. There are approximately 250 people age 6 years and older
who are expected to be eligible for treatment with KALYDECO in
Australia.
R117H Mutation: Based on data from a Phase 3 study,
Vertex submitted a supplemental New Drug Application (sNDA) in the
U.S. in June and a Marketing Authorization Application (MAA)
variation in the E.U. in July for the approval of KALYDECO for use
in people who have the R117H mutation. On October 21, the U.S. Food
and Drug Administration's Pulmonary Allergy Drugs Advisory
Committee (PADAC) voted 13-2 to recommend approval of KALYDECO in
people with CF ages 6 and older who have the R117H mutation in the
cystic fibrosis transmembrane regulatory (CFTR) gene, which is the
indication being reviewed by the FDA. The FDA is not bound by the
committee's recommendation, but often follows its advice.
Third Quarter 2014 Non-GAAP Financial
Results
The third quarter 2014 non-GAAP financial results exclude
stock-based compensation expense, costs related to the relocation
of our corporate headquarters, hepatitis C revenues and costs and
other adjustments. The third quarter 2013 non-GAAP financial
results exclude stock-based compensation expense, expenses related
to Alios (HCV), hepatitis C-related costs and other
adjustments.
Total Non-GAAP Revenues: Total non-GAAP revenues for the
third quarter of 2014 were $165.0 million, including $126.8 million
in net product revenues from KALYDECO and $38.2 million from
royalties and collaborative revenues, which includes revenues from
a one-time payment of $30 million from Janssen related to the
out-licensing of VX-787 for the treatment of influenza. The
components of total non-GAAP revenues for the third quarter of 2014
were:
Three Months Ended September 30, 2014 (in millions) GAAP
revenues
HCV relatedrevenues
Non-GAAPrevenues
Product revenues KALYDECO revenues, net $ 126.8 $ — $ 126.8
INCIVEK revenues, net 10.3 (10.3 ) — Total product revenues,
net 137.1 (10.3 ) 126.8
Royalty revenues 8.4 (2.3 ) 6.1
Collaborative revenues 33.5 (1.4 ) 32.1
Total
revenues $ 179.0 $ (14.0 ) $ 165.0
- Net Product Revenues from
KALYDECO: Vertex's third quarter 2014 net product revenues from
KALYDECO were $126.8 million compared to $101.1 million for the
third quarter of 2013. The increased revenues, compared to the
third quarter of 2013, resulted primarily from the use of KALYDECO
in the U.S. in people with the additional mutations approved by the
FDA in February 2014 and from an increase of approximately $7
million that resulted from changes in Vertex's distribution
network.
Non-GAAP Operating Expenses: Total non-GAAP operating
expenses for the third quarter of 2014 were $212.4 million,
compared to $274.7 million for the third quarter of 2013. This
reduction was primarily the result of prioritization of investment
toward medicines for CF resulting in decreased R&D and SG&A
expenses as follows:
- Research and Development (R&D)
Expenses: Non-GAAP R&D expenses were $157.4 million for the
third quarter of 2014, compared to $200.3 million in non-GAAP
R&D expenses for the third quarter of 2013.
- Sales, General and Administrative
(SG&A) Expenses: Non-GAAP SG&A expenses were $55.1
million for the third quarter of 2014, compared to $74.4 million in
non-GAAP SG&A expenses for the third quarter of 2013.
Non-GAAP Net Income (Loss) Attributable to Vertex:
Vertex's third quarter 2014 non-GAAP net loss was $(86.2) million,
or $(0.37) per diluted share, compared to a non-GAAP net loss of
$(74.4) million, or $(0.32) per diluted share, for the third
quarter of 2013. The increased non-GAAP net loss for the third
quarter of 2014 was primarily the result of a reduction in INCIVEK
net product revenues, partially offset by increased KALYDECO
product revenues, decreased operating expenses and the revenues
from a one-time payment of $30 million from Janssen related to the
out-licensing of VX-787.
Cash Position at September 30,
2014
As of September 30, 2014, Vertex had $1.48 billion in cash,
cash equivalents and marketable securities compared to $1.47
billion in cash, cash equivalents and marketable securities as of
December 31, 2013. In July 2014, Vertex entered into a credit
agreement that provides for a secured loan of up to $500 million,
$300 million of which Vertex received in July 2014 and is
outstanding as of September 30, 2014.
2014 Financial Guidance
This section contains forward-looking guidance about the
financial outlook for Vertex Pharmaceuticals.
On May 1, 2014, Vertex provided guidance for 2014 total non-GAAP
revenues of $520 to $550 million, including total 2014 KALYDECO net
product revenues of $470 to $500 million. The company now expects
total non-GAAP revenues to be $525 to $535 million, with KALYDECO
net product revenues expected to be approximately $460 million. The
KALYDECO net product revenues range was based on assumptions of the
timing of label expansion and reimbursement approvals in certain
countries, and the company now expects KALYDECO revenues to be
below the range provided in May due primarily to the delay in the
reimbursement of KALYDECO in Australia.
Additionally, Vertex provided guidance for 2014 total non-GAAP
operating expenses of $890 to $930 million. 2014 total non-GAAP
operating expenses are now expected to be approximately $910 to
$920 million, which reflects ongoing activities to support the
accelerated advancement of VX-661 into a pivotal program in the
first half of 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 the United States (GAAP) and using certain
non-GAAP financial measures. In particular, non-GAAP financial
results exclude: (i) in 2014, stock-based compensation expense,
costs related to the relocation of the company's corporate
headquarters including a one-time cash payment received related to
a lease agreement, hepatitis C revenues and costs and other
adjustments and (ii) in 2013, stock-based compensation expense,
expenses related to Alios (HCV), the impairment of VX-222,
hepatitis C inventory charges and costs, certain interest expenses
related to the convertible notes due 2015 and other adjustments.
These results are provided as a complement to results provided in
accordance with GAAP because management believes these non-GAAP
financial measures help indicate underlying trends in the company's
business, are important in comparing current results with prior
period results and provide additional information regarding the
company's financial position. Management also uses these non-GAAP
financial measures to establish budgets and operational goals that
are communicated internally and externally and to manage the
company's business and to evaluate its performance. A
reconciliation of the GAAP financial results to non-GAAP financial
results is included in the attached financial information.
Third Quarter 2014 GAAP Financial
Results
Total Revenues: Total revenues for the third quarter of
2014 were $179.0 million compared with $221.7 million in total
revenues for the third quarter of 2013. Third quarter 2014 revenues
are comprised primarily of $126.8 million in KALYDECO net revenues
and an aggregate of $52.2 million in net product revenues from
INCIVEK, royalty revenues and collaborative revenues, which
includes revenues from a one-time payment of $30.0 million from
Janssen related to the out-licensing of VX-787 for the treatment of
influenza. For the third quarter of 2013, Vertex reported $101.1
million in net product revenues from KALYDECO and $120.6 million in
net product revenues from INCIVEK, royalty revenues and
collaborative revenues.
Operating Costs and Expenses: Total operating costs and
expenses for the third quarter of 2014 were $321.2 million,
including certain charges of $108.8 million, compared to $345.3
million for the third quarter of 2013, including certain charges of
$70.6 million. GAAP operating costs and expenses include:
- R&D Expenses: R&D
expenses were $190.9 million for the third quarter of 2014,
including $33.6 million of certain charges, compared to $219.4
million for the third quarter of 2013, including $19.2 million of
certain charges.
- Sales, General and Administrative
(SG&A) Expenses: SG&A expenses were $75.2 million for
the third quarter of 2014, including $20.2 million of certain
charges, compared to $86.4 million for the third quarter of 2013,
including $12.0 million of certain charges.
Net Loss Attributable to Vertex: Vertex's third quarter
2014 net loss was $(170.1) million, or $(0.72) per share, and
includes net charges of $83.8 million. Vertex's third quarter 2013
net loss was $(124.1) million, or $(0.54) per share, including net
charges of $49.7 million.
Vertex Pharmaceuticals
Incorporated
Third Quarter and Nine Month
Results
Condensed Consolidated Statements of
Operations Data
(in thousands, except per share
amounts)
(unaudited)
Three Months EndedSeptember 30,
Nine Months EndedSeptember 30, 2014
2013 2014 2013
Revenues: Product revenues, net $ 137,099 $ 186,653 $
362,879 $ 708,823 Royalty revenues 8,386 27,012 32,134 119,705
Collaborative revenues 33,502 8,035 40,846
32,290 Total revenues 178,987 221,700 435,859
860,818 Costs and expenses: Cost of product revenues
10,208 20,048 28,435 75,698 Royalty expenses 3,976 7,291 18,525
32,315 Research and development expenses (R&D) 190,939 219,442
654,043 643,636 Sales, general and administrative expenses
(SG&A) 75,224 86,427 226,882 283,133 Restructuring expenses
40,843 12,048 46,761 12,863 Intangible asset impairment charge
(Note 1) — — — 412,900 Total costs and
expenses 321,190 345,256 974,646 1,460,545
Loss from operations (142,203 ) (123,556 ) (538,787 )
(599,727 ) Interest expense, net (20,384 ) (95 ) (51,686 ) (10,109
) Other income (expense), net (Note 2) (3,990 ) 4,751 34,192
3,360 Loss from continuing operations before
provision for (benefit from) income taxes (166,577 ) (118,900 )
(556,281 ) (606,476 ) Provision for (benefit from) income taxes
(Note 1) 3,419 2,555 4,915 (123,774 ) Loss
from continuing operations (169,996 ) (121,455 ) (561,196 )
(482,702 ) Loss from discontinued operations, net of tax (Note 3)
(64 ) (7,207 ) (703 ) (20,299 ) Loss from discontinued operations
attributable to noncontrolling interest (Alios) (Note 3) —
4,530 — 13,688 Net loss from discontinued
operations attributable to Vertex (Note 3) (64 ) (2,677 ) (703 )
(6,611 ) Net loss attributable to Vertex $ (170,060 ) $ (124,132 )
$ (561,899 ) $ (489,313 ) Net loss per share from continuing
operations: Basic $ (0.72 ) $ (0.53 ) $ (2.40 ) $ (2.17 ) Diluted $
(0.72 ) $ (0.53 ) $ (2.40 ) $ (2.17 ) Net loss from
discontinued operations per share attributable to Vertex common
shareholders: Basic $ — $ (0.01 ) $ — $ (0.03 ) Diluted $ — $ (0.01
) $ — $ (0.03 ) Net loss per share attributable to Vertex
common shareholders: Basic $ (0.72 ) $ (0.54 ) $ (2.40 ) $ (2.20 )
Diluted $ (0.72 ) $ (0.54 ) $ (2.40 ) $ (2.20 ) Shares used
in per share calculations: Basic 236,137 230,505 234,195 222,764
Diluted 236,137 230,505 234,195 222,764
Consolidated Revenues
(in millions)
(unaudited)
Three Months Ended September
30,2014 June 30,2014
March 31,2014 December 31,2013
September 30,2013 Product revenues KALYDECO
revenues, net $ 126.8 $ 113.1 $ 99.5 $ 109.5 $ 101.1 INCIVEK
revenues, net 10.3 9.3 3.9 19.3 85.6
Total product revenues, net 137.1 122.4 103.5 128.8 186.7 Royalty
revenues 8.4 13.0 10.7 36.9 27.0 Collaborative revenues 33.5
3.0 4.3 185.4 8.0 Total revenues $ 179.0
$ 138.4 $ 118.5 $ 351.2 $ 221.7
Reconciliation of GAAP to Non-GAAP
Financial Information-Third Quarter
(in thousands, except per share
amounts)
(unaudited)
Three Months Ended September 30, 2014
Adjustments GAAP Stock-basedcompensationexpense
Corporateheadquartersrelocation(Note 4) HCV
relatedcosts(Note 5) Otheradjustments(Note 6) Non-GAAP
Income (loss) from operations $ (142,203 ) $ 46,136 $ 43,896
$ (4,621 ) $ (1,648 ) $ (58,440 ) Other income
(expense), net (24,374 ) — — —
(24,374 ) Income (loss) from continuing operations before
provision for (benefit from) income taxes (166,577 ) 46,136 43,896
(4,621 ) (1,648 ) (82,814 ) Provision for (benefit from) income
taxes 3,419 — — — — 3,419
Net income (loss) from continuing operations (169,996 )
46,136 43,896 (4,621 ) (1,648 ) (86,233 ) Net income (loss) from
discontinued operations attributable to Vertex (Note 3) (64 ) —
— 64 — — Net income
(loss) attributable to Vertex $ (170,060 ) $ 46,136 $ 43,896
$ (4,557 ) $ (1,648 ) $ (86,233 ) Net income (loss)
per diluted share attributable to Vertex common shareholders (Note
7) $ (0.72 ) $ (0.37 )
Three Months Ended September 30,
2013 Adjustments GAAP Stock-basedcompensationexpense
Aliostransaction(Note 3) HCV relatedcosts(Note 5)
Otheradjustments(Note 6) Non-GAAP Income (loss) from operations $
(123,556 ) $ 31,197 $ — $ 16,800 $ 524 $ (75,035 ) Other income
(expense), net 4,656 — — —
4,656 Income (loss) from continuing operations
before provision for (benefit from) income taxes (118,900 ) 31,197
— 16,800 524 (70,379 ) Provision for (benefit from) income taxes
2,555 — — — — 2,555
Net income (loss) from continuing operations (121,455 )
31,197 — 16,800 524 (72,934 ) Net income (loss) from discontinued
operations attributable to Vertex (Note 3) (2,677 ) — 1,220
— — (1,457 ) Net income (loss)
attributable to Vertex $ (124,132 ) $ 31,197 $ 1,220
$ 16,800 $ 524 $ (74,391 ) Net income (loss)
per diluted share attributable to Vertex common shareholders (Note
7) $ (0.54 ) $ (0.32 )
Reconciliation of GAAP to Non-GAAP
Financial Information-Third Quarter
(in thousands)
(unaudited)
Three Months Ended September 30, 2014
2013 GAAP total costs and expenses $
321,190 $ 345,256 Adjustments: Cost of product revenues and royalty
expenses (14,184 ) (27,339 ) Stock-based compensation expense
(46,136 ) (31,197 ) Corporate headquarters relocation (Note 4)
(43,896 ) — HCV related costs (Note 5) (6,185 ) (11,524 ) Other
adjustments (Note 6) 1,648 (524 )
Non-GAAP operating
costs and expenses $ 212,437 $ 274,672 GAAP research and
development expenses $ 190,939 $ 219,442 Adjustments: Stock-based
compensation expense (31,131 ) (19,155 ) Corporate headquarters
relocation (Note 4) (3,511 ) — HCV related costs (Note 5) (1,494 )
— Other adjustments (Note 6) 2,580 —
Non-GAAP
research and development expenses $ 157,383 $ 200,287
GAAP sales, general and administrative expenses $ 75,224 $ 86,427
Adjustments: Stock-based compensation expense (15,005 ) (12,042 )
Corporate headquarters relocation (Note 4) (633 ) — HCV related
costs (Note 5) (4,532 ) —
Non-GAAP sales, general and
administrative expenses $ 55,054 $ 74,385
Reconciliation of GAAP to Non-GAAP
Financial Information-Nine Month
(in thousands, except per share
amounts)
(unaudited)
Nine Months Ended September 30, 2014
Adjustments GAAP Stock-basedcompensationexpense
Corporateheadquartersrelocation(Note 4) HCV
relatedcosts(Note 5) Otheradjustments(Note 6) Non-GAAP
Income (loss) from operations $ (538,787 ) $ 135,160 $
76,206 $ 3,650 $ 3,526 $ (320,245 ) Other income
(expense), net (17,494 ) — (36,685 ) — —
(54,179 ) Income (loss) from continuing operations before
provision for (benefit from) income taxes (556,281 ) 135,160 39,521
3,650 3,526 (374,424 ) Provision for (benefit from) income taxes
4,915 — — — — 4,915
Net income (loss) from continuing operations (561,196 )
135,160 39,521 3,650 3,526 (379,339 ) Net income (loss) from
discontinued operations attributable to Vertex (Note 3) (703 ) —
— 703 — — Net income
(loss) attributable to Vertex $ (561,899 ) $ 135,160 $
39,521 $ 4,353 $ 3,526 $ (379,339 ) Net
income (loss) per diluted share attributable to Vertex common
shareholders (Note 7) $ (2.40 ) $ (1.62 )
Nine Months
Ended September 30, 2013 Adjustments GAAP
Stock-basedcompensationexpense Aliostransaction(Note 3)
HCV relatedcosts(Note 5) Otheradjustments(Note 6)
Non-GAAP Income (loss) from operations $ (599,727 ) $ 103,585 $ — $
434,782 $ 1,339 $ (60,021 ) Other income (expense), net (6,749 ) —
— 3,908 (2,841 ) Income
(loss) from continuing operations before provision for (benefit
from) income taxes (606,476 ) 103,585 — 434,782 5,247 (62,862 )
Provision for (benefit from) income taxes (123,774 ) —
127,586 — 3,812 Net
income (loss) from continuing operations (482,702 ) 103,585 —
307,196 5,247 (66,674 ) Net income (loss) from discontinued
operations attributable to Vertex (Note 3) (6,611 ) — (1,600
) — — (8,211 ) Net income (loss) attributable
to Vertex $ (489,313 ) $ 103,585 $ (1,600 ) $ 307,196
$ 5,247 $ (74,885 ) Net income (loss) per diluted
share attributable to Vertex common shareholders (Note 7) $ (2.20 )
$ (0.34 )
Reconciliation of GAAP to Non-GAAP
Financial Information-Nine Month
(in thousands)
(unaudited)
Nine Months Ended September 30, 2014
2013 GAAP total costs and expenses $ 974,646 $
1,460,545 Adjustments: Cost of product revenues and royalty
expenses (46,960 ) (108,013 ) Stock-based compensation expense
(135,160 ) (103,585 ) Corporate headquarters relocation (Note 4)
(76,206 ) — HCV related costs (Note 5) (29,026 ) (424,424 ) Other
adjustments (Note 6) (3,526 ) (1,339 )
Non-GAAP operating costs
and expenses $ 683,768 $ 823,184 GAAP research and
development expenses 654,043 643,636 Adjustments: Stock-based
compensation expense (91,284 ) (64,100 ) Corporate headquarters
relocation (Note 4) (25,094 ) — HCV related costs (Note 5) (14,834
) — Other adjustments (Note 6) (4,329 ) —
Non-GAAP
research and development expenses $ 518,502 $ 579,536
GAAP sales, general and administrative expenses $ 226,882 $ 283,133
Adjustments: Stock-based compensation expense (43,876 ) (39,485 )
Corporate headquarters relocation (Note 4) (4,524 ) — HCV related
costs (Note 5) (13,216 ) —
Non-GAAP sales, general and
administrative expenses $ 165,266 $ 243,648
Condensed Consolidated Balance Sheets
Data
(in thousands)
(unaudited)
September 30, 2014 December 31,
2013 Assets Cash, cash equivalents and marketable
securities $ 1,477,737 $ 1,465,076 Accounts receivable, net 114,308
85,517 Inventories 16,753 14,147 Other current assets 41,298 23,836
Restricted cash 121 130 Property and equipment, net 720,878 696,911
Goodwill 30,992 30,992 Other non-current assets 3,999 2,432
Total assets $ 2,406,086 $ 2,319,041
Liabilities and Shareholders' Equity Other liabilities $
370,734 $ 422,377 Accrued restructuring expense 55,602 28,353
Deferred revenues 55,933 70,969 Construction financing lease
obligation 473,172 440,937 Senior secured term loan 294,740 —
Shareholders' equity 1,155,905 1,356,405
Total
liabilities and shareholders' equity $ 2,406,086 $
2,319,041 Common shares outstanding 240,238 233,789
Note 1: The company determined that the value of VX-222
had become impaired and that the fair value of VX-222 was zero as
of March 31, 2013. This resulted in a $412.9 million impairment
charge in the nine months ended September 30, 2013. In connection
with this impairment charge, the company recorded a credit of
$127.6 million in its provision for income taxes.
Note 2: The company recorded the effect of a one-time
cash payment received related to a lease agreement in Other income
(expense), net during the nine months ended September 30, 2014.
Note 3: The company reflects the effect of its
relationship with its collaborator Alios in its condensed
consolidated statement of operations as a loss from discontinued
operations. The company consolidated the financial statements of
Alios from June 13, 2011 through December 31, 2013. The
company presents the effect of its relationship with Alios as
discontinued operations attributable to noncontrolling interest
(Alios) and discontinued operations attributable to Vertex in its
condensed consolidated statements of operations.
Note 4: In the three and nine months ended September 30,
2014, "Corporate headquarters relocation" primarily consists of (i)
$4.1 million and $29.6 million in transition costs related to the
company's relocation, respectively, (ii) $39.8 million and $46.6
million in restructuring charges related to this relocation,
respectively, and (iii) $0.0 million and $36.7 million of credits
to record the effect of the one-time cash payment discussed in Note
2 above, respectively.
Note 5: In the three and nine months ended September 30,
2014, "HCV related costs" primarily consists of (i) $10.3 million
and $23.5 million net product revenues related to INCIVEK,
respectively, (ii) $2.3 million and $12.9 million royalty revenues
related to INCIVO, respectively, and a corresponding amount of
royalty expenses, (iii) $0.2 million and $11.3 million net charges
related to post-restructuring HCV collaborative revenues and
development costs, respectively, and (iv) $4.5 million and $13.2
million related to the 2014 pharma fee and commercial costs related
to INCIVEK, respectively. In the three and nine months ended
September 30, 2013, HCV related costs consisted of (1) inventory
write-offs related to INCIVEK of $5.3 million and $10.4 million,
respectively, (2) $11.4 million in restructuring expense related to
the October 2013 strategic restructuring and (3) the first quarter
of 2013 VX-222 impairment charge, net of tax discussed in Note 1
above.
Note 6: In the three and nine months ended September 30,
2014, "Other adjustments" consists of (i) credits for development
cost and net charges associated with VX-509 of $2.6 million and
$4.3 million, respectively, (ii) restructuring credits related to a
lease obligation of $0.5 million and $2.2 million, respectively and
(iii) miscellaneous restructuring charges of $1.4 million recorded
in the third quarter of 2014. In the three and nine months ended
September 30, 2013, "Other adjustments" consists of (1) $3.9
million of interest expense related to the 2015 Notes that were
converted in the second quarter of 2013 and (2) restructuring
charges related to a lease obligation of $0.5 million and $1.3
million, respectively.
Note 7: Shares used in non-GAAP net income (loss) per
diluted share attributable to Vertex common shareholders were
236,137,173 and 230,504,963 for the three months ended September
30, 2014 and 2013, respectively, and 234,195,172 and 222,763,995
for the nine months ended September 30, 2014 and 2013,
respectively.
INDICATION AND IMPORTANT SAFETY
INFORMATION FOR KALYDECO (ivacaftor)
Ivacaftor (150 mg 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.
In the United States, ivacaftor is also indicated for the
treatment of CF in patients age 6 and older who have one of the
following mutations in the CFTR gene: G1244E, G1349D, G178R, G551S,
S1251N, S1255P, S549N, or S549R. In Canada, ivacaftor is indicated
for these same mutations and additionally for G970R.
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.
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 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 Cambridge, Mass., Vertex today has research
and development sites and commercial offices in the United States,
Europe, Canada and Australia. For five years in a row, Science
magazine has named Vertex one of its Top Employers in the life
sciences. For additional information and the latest updates from
the company, please visit www.vrtx.com.
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
second paragraph of the press release, the information provided in
the section captioned "2014 Financial Guidance," and the
information provided regarding Vertex's sNDA in the U.S. and an MAA
variation in Europe for people with CF who have the R117H mutation.
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, that Vertex could experience
unforeseen delays in submitting regulatory filings, that regulatory
authorities may not approve, or approve on a timely basis,
lumacaftor in combination with ivacaftor or ivacaftor for
additional indications 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 Securities and Exchange
Commission and available through the company's website at
www.vrtx.com. Vertex disclaims any obligation to update the
information contained in this press release as new information
becomes available.
Conference Call and Webcast
The company will host a conference call and webcast today at
5:00 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.)
or +1 (720) 545-0001 (International). The conference call will be
webcast live and a link to the webcast can be accessed through
Vertex's website at www.vrtx.com in the "Investors" section under
"Events and Presentations.” To ensure a timely connection, it is
recommended that users register at least 15 minutes prior to the
scheduled webcast. An archived webcast will be available on the
company's website.
(VRTX-GEN)
Vertex Pharmaceuticals IncorporatedInvestors:Michael
Partridge, 617-341-6108orKelly Lewis,
617-961-7530orMedia:Zach Barber,
617-341-6992mediainfo@vrtx.com
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