-Successful launch of INCIVEK (telaprevir) for hepatitis C and recent approval of KALYDECO (ivacaftor) for cystic fibrosis position Vertex for continued growth, earnings and cashflow-
"The successful launch of INCIVEK in hepatitis C and rapid approval of
KALYDECO for people with a specific type of cystic fibrosis underscore
our ability to discover and develop breakthrough new medicines and to
bring them to patients," said
Development Program Updates
On
Fourth Quarter 2011 Financial Results
Total Revenues: Total revenues for the fourth quarter of
2011 were
Net Product Revenues from INCIVEK: Net product revenues for
INCIVEK for the fourth quarter of 2011 were
Research and Development (R&D) Expenses: R&D expenses for the
fourth quarter of 2011 were
Sales, general and administrative (SG&A) expenses: SG&A
expenses for the fourth quarter of 2011 were
GAAP Net Income (Loss) Attributable to Vertex: Vertex's GAAP net
income for the fourth quarter of 2011 was
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's
non-GAAP net income for the fourth quarter of 2011, was
Cash Position: At
Full-Year 2011 Financial Results
Total Revenues: Total revenues for 2011 were
Net Product Revenues from INCIVEK: Following the approval of
INCIVEK on
Research and Development (R&D) Expenses: R&D expenses for
2011 were
Sales, general and administrative (SG&A) expenses: SG&A
expenses for 2011 were
GAAP Net Income (Loss) Attributable to Vertex: Vertex's GAAP net
income for 2011 was
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's
non-GAAP net income for 2011 was
2012 Financial Guidance
"With the launch of INCIVEK and KALYDECO, Vertex is positioned to
deliver significant earnings while we continue to invest to support the
growth of our business," said
This section contains forward-looking guidance about the financial
outlook for
Full-Year INCIVEK Revenues: Vertex expects that full-year 2012
INCIVEK net revenues will be in the range of
Total Operating Expenses: Vertex expects 2012 total operating
expenses, excluding cost of revenues, stock-based compensation expense
and Alios expenses related to the accounting for the collaboration with
Vertex, to be in the range of
Non-GAAP Financial Measures
In this press release, Vertex's financial results and financial guidance
are provided both in accordance with accounting principles generally
accepted in
Fourth Quarter and
Twelve Months Results
Consolidated Statements of Operations
Data
(in thousands, except per share amounts)
(unaudited)
Three Months Ended |
Twelve Months Ended |
||||||||||||||||||||
2011 | 2010 | 2011 | 2010 | ||||||||||||||||||
Revenues: | |||||||||||||||||||||
Product revenues, net | $ | 456,759 | $ | --- | $ | 950,889 | $ | --- | |||||||||||||
Royalty revenues | 25,405 | 8,402 | 50,015 | 30,244 | |||||||||||||||||
Collaborative revenues | 81,176 | 57,122 | 409,722 | 113,126 | |||||||||||||||||
Total revenues | 563,340 | 65,524 | 1,410,626 | 143,370 | |||||||||||||||||
Costs and expenses: | |||||||||||||||||||||
Cost of product revenues | 22,936 | --- | 63,625 | --- | |||||||||||||||||
Royalty expenses | 7,191 | 3,049 | 16,880 | 12,730 | |||||||||||||||||
Research and development expenses (R&D) | 186,438 | 168,888 | 707,706 | 637,416 | |||||||||||||||||
Sales, general & administrative expenses (SG&A) | 121,881 | 62,478 | 400,721 | 187,800 | |||||||||||||||||
Restructuring expense (credit) | 992 | (2,257 | ) | 2,074 | 1,501 | ||||||||||||||||
Intangible asset impairment charge (Note 3) | --- | --- | 105,800 | --- | |||||||||||||||||
Total costs and expenses | 339,438 | 232,158 | 1,296,806 | 839,447 | |||||||||||||||||
Income (loss) from operations | 223,902 | (166,634 | ) | 113,820 | (696,077 | ) | |||||||||||||||
Net interest expense (Note 2) | (12,233 | ) | (7,163 | ) | (36,574 | ) | (17,320 | ) | |||||||||||||
Change in fair value of derivative instruments (Note 2) | (868 | ) | (6,595 | ) | (16,801 | ) | (41,229 | ) | |||||||||||||
Income (loss) before provision for income taxes | 210,801 | (180,392 | ) | 60,445 | (754,626 | ) | |||||||||||||||
Provision for income taxes (Note 3) | 22,660 | --- | 19,266 | --- | |||||||||||||||||
Net income (loss) | 188,141 | (180,392 | ) | 41,179 | (754,626 | ) | |||||||||||||||
Net income attributable to noncontrolling interest (Note 1) | 29,512 | --- | 11,605 | --- | |||||||||||||||||
Net income (loss) attributable to Vertex | $ | 158,629 | $ | (180,392 | ) | $ | 29,574 | $ | (754,626 | ) | |||||||||||
Net income (loss) per share attributable to Vertex common shareholders: | |||||||||||||||||||||
Basic | $ | 0.76 | $ | (0.90 | ) | $ | 0.14 | $ | (3.77 | ) | |||||||||||
Diluted | $ | 0.74 | $ | (0.90 | ) | $ | 0.14 | $ | (3.77 | ) | |||||||||||
Shares used in per share calculations: | |||||||||||||||||||||
Basic | 206,758 | 201,355 | 204,891 | 200,402 | |||||||||||||||||
Diluted | 217,602 | 201,355 | 208,807 | 200,402 | |||||||||||||||||
Reconciliation of GAAP to
(in thousands, except per share amounts)
(unaudited)
Three Months Ended |
|||||||||||||||||||||||||||||||||||
|
Adjustments | ||||||||||||||||||||||||||||||||||
GAAP |
Alios |
Stock-based |
|
Mitsubishi Tanabe |
Restructuring |
Non-GAAP | |||||||||||||||||||||||||||||
Revenues | $ | 563,340 | $ | — | $ | — | $ | — | $ | (65,000 | ) | $ | — | $ | 498,340 | ||||||||||||||||||||
Operating costs and expenses | 339,438 | (3,119 | ) | (29,278 | ) | — | — | (992 | ) | 306,049 | |||||||||||||||||||||||||
Income from operations | 223,902 | 3,119 | 29,278 | — | (65,000 | ) | 992 | 192,291 | |||||||||||||||||||||||||||
Other income and expenses | (13,101 | ) | 358 | — | 8,798 | — | — | (3,945 | ) | ||||||||||||||||||||||||||
Income before provision for income taxes | 210,801 | 3,477 | 29,278 | 8,798 | (65,000 | ) | 992 | 188,346 | |||||||||||||||||||||||||||
Provision for income taxes | 22,660 | (19,511 | ) | — | — | — | — | 3,149 | |||||||||||||||||||||||||||
Net income | $ | 188,141 | $ | 22,988 | $ | 29,278 | $ | 8,798 | $ | (65,000 | ) | $ | 992 | $ | 185,197 | ||||||||||||||||||||
Net income attributable to noncontrolling interest (Alios) | 29,512 | (29,512 | ) | — | — | — | — | — | |||||||||||||||||||||||||||
Net income attributable to Vertex | $ | 158,629 | $ | 52,500 | $ | 29,278 | $ | 8,798 | $ | (65,000 | ) | $ | 992 | $ | 185,197 | ||||||||||||||||||||
Net income per share attributable to Vertex common shareholders: | |||||||||||||||||||||||||||||||||||
Basic | $ | 0.76 | $ | 0.89 | |||||||||||||||||||||||||||||||
Diluted | $ | 0.74 | $ | 0.86 | |||||||||||||||||||||||||||||||
Shares used in per share calculations: | |||||||||||||||||||||||||||||||||||
Basic | 206,758 | 206,758 | |||||||||||||||||||||||||||||||||
Diluted | 217,602 | 217,602 | |||||||||||||||||||||||||||||||||
Three Months Ended |
|||||||||||||||||||||||||||||||||||
|
Adjustments | ||||||||||||||||||||||||||||||||||
GAAP |
Alios |
Stock-based |
|
Mitsubishi Tanabe |
Restructuring |
Non-GAAP | |||||||||||||||||||||||||||||
Revenues | $ | 65,524 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 65,524 | |||||||||||||||||||||
Operating costs and expenses | 232,158 | — | (23,574 | ) | — | — | 2,257 | 210,841 | |||||||||||||||||||||||||||
Loss from operations | (166,634 | ) | — | 23,574 | — | — | (2,257 | ) | (145,317 | ) | |||||||||||||||||||||||||
Other income and expenses | (13,758 | ) | — | — | 10,551 | — | — | (3,207 | ) | ||||||||||||||||||||||||||
Net loss attributable to Vertex | $ | (180,392 | ) | $ | — | $ | 23,574 | $ | 10,551 | $ | — | $ | (2,257 | ) | $ | (148,524 | ) | ||||||||||||||||||
Net loss per share attributable to Vertex common shareholders: | |||||||||||||||||||||||||||||||||||
Basic | $ | (0.90 | ) | $ | (0.74 | ) | |||||||||||||||||||||||||||||
Diluted | $ | (0.90 | ) | $ | (0.74 | ) | |||||||||||||||||||||||||||||
Shares used in per share calculations: | |||||||||||||||||||||||||||||||||||
Basic | 201,355 | 201,355 | |||||||||||||||||||||||||||||||||
Diluted | 201,355 | 201,355 | |||||||||||||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Information-Twelve Months
(in
thousands, except per share amounts)
(unaudited)
Twelve Months Ended |
Adjustments | |||||||||||||||||||||||||||||||||||||||
GAAP |
Alios |
Stock-based |
|
Mitsubishi Tanabe |
Intangible Asset |
Restructuring |
Non-GAAP | |||||||||||||||||||||||||||||||||
Revenues | $ | 1,410,626 | $ | — | $ | — | $ | (250,000 | ) | $ | (65,000 | ) | $ | — | $ | — | $ | 1,095,626 | ||||||||||||||||||||||
Operating costs and expenses | 1,296,806 | (9,178 | ) | (117,922 | ) | — | — | (105,800 | ) | (2,074 | ) | 1,061,832 | ||||||||||||||||||||||||||||
Income from operations | 113,820 | 9,178 | 117,922 | (250,000 | ) | (65,000 | ) | 105,800 | 2,074 | 33,794 | ||||||||||||||||||||||||||||||
Other income and expenses | (53,375 | ) | 358 | — | 38,488 | — | — | — | (14,529 | ) | ||||||||||||||||||||||||||||||
Income before provision for income taxes | 60,445 | 9,536 | 117,922 | (211,512 | ) | (65,000 | ) | 105,800 | 2,074 | 19,265 | ||||||||||||||||||||||||||||||
Provision for income taxes | 19,266 | (48,809 | ) | — | — | — | 32,692 | — | 3,149 | |||||||||||||||||||||||||||||||
Net income | $ | 41,179 | $ | 58,345 | $ | 117,922 | $ | (211,512 | ) | $ | (65,000 | ) | $ | 73,108 | $ | 2,074 | $ | 16,116 | ||||||||||||||||||||||
Net income attributable to noncontrolling interest (Alios) | 11,605 | (11,605 | ) | — | — | — | — | — | — | |||||||||||||||||||||||||||||||
Net income attributable to Vertex | $ | 29,574 | $ | 69,950 | $ | 117,922 | $ | (211,512 | ) | $ | (65,000 | ) | $ | 73,108 | $ | 2,074 | $ | 16,116 | ||||||||||||||||||||||
Net income per share attributable to Vertex common shareholders: | ||||||||||||||||||||||||||||||||||||||||
Basic | $ | 0.14 | $ | 0.08 | ||||||||||||||||||||||||||||||||||||
Diluted | $ | 0.14 | $ | 0.08 | ||||||||||||||||||||||||||||||||||||
Shares used in per share calculations: | ||||||||||||||||||||||||||||||||||||||||
Basic | 204,891 | 204,891 | ||||||||||||||||||||||||||||||||||||||
Diluted | 208,807 | 208,807 | ||||||||||||||||||||||||||||||||||||||
Twelve Months Ended |
Adjustments |
|||||||||||||||||||||||||||||||||||||||
GAAP |
Alios |
Stock-based |
|
Mitsubishi Tanabe |
Intangible Asset |
Restructuring |
Non-GAAP | |||||||||||||||||||||||||||||||||
Revenues | $ | 143,370 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 143,370 | ||||||||||||||||||||||||
Operating costs and expenses | 839,447 | — | (91,124 | ) | — | — | — | (1,501 | ) | 746,822 | ||||||||||||||||||||||||||||||
Loss from operations | (696,077 | ) | — | 91,124 | — | — | — | 1,501 | (603,452 | ) | ||||||||||||||||||||||||||||||
Other income and expenses | (58,549 | ) | — | — | 56,297 | — | — | — | (2,252 | ) | ||||||||||||||||||||||||||||||
Net loss attributable to Vertex | $ | (754,626 | ) | $ | — | $ | 91,124 | $ | 56,297 | $ | — | $ | — | $ | 1,501 | $ | (605,704 | ) | ||||||||||||||||||||||
Net loss per share attributable to Vertex common shareholders: | ||||||||||||||||||||||||||||||||||||||||
Basic | $ | (3.77 | ) | $ | (3.02 | ) | ||||||||||||||||||||||||||||||||||
Diluted | $ | (3.77 | ) | $ | (3.02 | ) | ||||||||||||||||||||||||||||||||||
Shares used in per share calculations: | ||||||||||||||||||||||||||||||||||||||||
Basic | 200,402 | 200,402 | ||||||||||||||||||||||||||||||||||||||
Diluted | 200,402 | 200,402 | ||||||||||||||||||||||||||||||||||||||
Condensed Consolidated Balance Sheets Data | ||||||||||
(in thousands) | ||||||||||
(unaudited) | ||||||||||
December 31, |
December 31, |
|||||||||
Assets |
|
|||||||||
Cash, cash equivalents and marketable securities | $ | 968,922 | $ | 1,031,411 | ||||||
Restricted cash and cash equivalents (Alios) (Note 1) | 51,878 | --- | ||||||||
Accounts receivable, net | 183,135 | 12,529 | ||||||||
Inventories | 112,430 | --- | ||||||||
Other current assets | 14,889 | 13,099 | ||||||||
Property and equipment, net | 133,176 | 72,333 | ||||||||
Restricted cash | 34,090 | 34,090 | ||||||||
Intangible assets (Note 3) | 663,500 | 518,700 | ||||||||
Goodwill (Note 3) | 30,992 | 26,102 | ||||||||
Other non-current assets | 11,268 | 17,182 | ||||||||
Total assets | $ | 2,204,280 | $ | 1,725,446 | ||||||
Liabilities and Shareholders' Equity | ||||||||||
Other liabilities | $ | 405,616 | $ | 182,142 | ||||||
Accrued restructuring expense | 26,313 | 29,595 | ||||||||
Deferred tax liability (Note 3) | 243,707 | 160,278 | ||||||||
Deferred revenues | 163,132 | 234,668 | ||||||||
Convertible notes (due 2015) | 400,000 | 400,000 | ||||||||
Liabilities related to milestone
transactions (Note 2) |
--- | 214,790 | ||||||||
Noncontrolling interest (Alios) (Note 1) | 178,669 | --- | ||||||||
Shareholders' equity (Vertex) | 786,843 | 503,973 | ||||||||
Total liabilities and shareholders' equity | $ | 2,204,280 | $ | 1,725,446 | ||||||
Common shares outstanding | 209,304 | 203,523 |
Note 1: The company has consolidated the financial statements of
its collaborator
Note 2: A portion of the collaborative revenues, the change in
fair value of derivative instruments and a portion of the net interest
expense reflected in the Consolidated Statements of Operations Data, and
the liabilities related to milestone transactions reflected in the
Condensed Consolidated Balance Sheets Data as of
Note 3: The intangible assets, the goodwill and the deferred tax
liability reflected in the Condensed Consolidated Balance Sheets Data
relate to the company's acquisition of
In the third quarter of 2011 the company determined that the value of
VX-759, which was a back-up to VX-222, had become impaired and that the
fair value of VX-759 was zero as of
About Vertex
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies 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 hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
Vertex's press releases are available at www.vrtx.com.
Indication and Important Safety Information for KALYDECO
KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have a certain mutation in their CF gene called the G551D mutation.
KALYDECO is not for use in people with CF due to other mutations in the CF gene. It is not effective in CF patients with two copies of the F508del mutation (F508del/F508del) in the CF gene.
It is not known if KALYDECO is safe and effective in children under 6 years of age.
KALYDECO should not be used with certain medicines, including the antibiotics rifampin and rifabutin; seizure medications (phenobarbital, carbamazepine, or phenytoin); and the herbal supplement St. John's Wort.
KALYDECO can cause serious side effects. High liver enzymes in the blood have occurred in patients taking KALYDECO. Regular assessment is recommended.
The most common side effects associated with KALYDECO include headache; upper respiratory tract infection (common cold) including sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.
These are not all the possible side effects of KALYDECO. Patients should tell their healthcare providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for KALYDECO at www.KALYDECO.com.
Indication and Important Safety Information for INCIVEK
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.
INCIVEK should always be taken in combination with peginterferon alfa and ribavirin. 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. Patients must use two forms of effective birth control during treatment and for the 6 months after treatment with these medicines. Hormonal forms of birth control, including birth control pills, vaginal rings, implants or injections, 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 non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including skin reactions, rash and anemia that can be severe. The most common side effects of INCIVEK include itching, nausea, diarrhea, vomiting, anal or rectal problems, 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 providers about any side effect that bothers them or doesn't go away.
Please see full Prescribing Information for INCIVEK including the Medication Guide, available at www.INCIVEK.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 Dr. Leiden's
statements in the second paragraph of the press release, Mr. Smith's
statements in the paragraph following the caption "2012 Financial
Guidance," the information provided in the four paragraphs following the
statement "This section contains forward-looking guidance about the
financial outlook for Vertex Pharmaceuticals" and statements regarding
(i) Vertex being positioned for growth, earnings and cashflow; (ii) the
expected timing of data from (A) studies of VX-809 and VX-661, in each
case dosed in combination with KALYDECO, (B) studies of ALS-2200 and
ALS-2158 and (C) the ZENITH study; and (iii) the plans to conduct
additional studies of KALYDECO, Phase 2 studies of ALS-2200 or ALS-2158
with VX-222 or INCIVEK, a global Phase 2b study of VX-509 and a Phase 2a
study of VX-787. While Vertex believes the forward-looking statements
contained in this press release are accurate, 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 outcomes for each of
Vertex's ongoing and planned clinical trials and studies may not be
favorable, that the company's expectations regarding its 2012 INCIVEK
revenues and/or 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) and other risks listed under
Risk Factors in Vertex's annual report and quarterly reports filed with
the
Conference Call Information
Vertex will host a conference call and webcast today,
To listen to the live call on the telephone, dial 1-877-250-8889 (
The conference ID number for the live call and replay is 40883608.
The call will be available for replay via telephone commencing
Following the live webcast, an archived version will be available on
Vertex's website until
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