-Second quarter 2012 total revenues of
-Cystic Fibrosis: Ongoing label-expansion studies for KALYDECO monotherapy and recent data from study of KALYDECO and VX-809 in combination support goal to help more people with cystic fibrosis; company recently announced European approval of KALYDECO-
-Hepatitis C: Positive seven-day viral kinetic data for nucleotide analogue ALS-2200 provide flexibility in the development of multiple all-oral approaches to treatment of hepatitis C, including Phase 2 all-oral studies planned for this year-
Vertex reported total revenues of approximately
"During the first half of the year, Vertex delivered several important
advancements across our broad pipeline. In cystic fibrosis, we obtained
U.S. and E.U. approval of KALYDECO earlier than anticipated, and we
announced promising data for a combination of VX-809 and KALYDECO that
accelerated our plans to begin a pivotal program early next year in
people with the most common type of cystic fibrosis. We also announced
today the first results for our nucleotide analogue ALS-2200, which
enhance our portfolio of potential hepatitis C medicines and provide
flexibility in the future development of multiple all-oral treatments
for this disease," said
Dr. Leiden concluded, "Our ability to consistently discover, develop and launch transformative medicines has created significant value for our shareholders. Vertex is positioned for continued leadership in the treatment of hepatitis C and cystic fibrosis, and our efforts to bring forward additional new medicines for other serious diseases are moving forward rapidly."
Cystic Fibrosis (CF)
Hepatitis C
Pipeline Programs
Second Quarter 2012 Financial Results
Total Revenues: Total revenues were
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 GAAP net
loss was
Non-GAAP Net Income (Loss) Attributable to Vertex: Vertex's
non-GAAP net income was
2012 Financial Guidance
This section contains forward-looking guidance about the financial
outlook for
Full-Year INCIVEK Revenues: Vertex today revised guidance for
full-year 2012 INCIVEK net revenues. The company expects full-year 2012
INCIVEK net revenues to be in the range of
Total Operating Expenses: Vertex today reiterated its guidance
for 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
Second Quarter and Six Month Results Consolidated Statements of Operations Data (in thousands, except per share amounts) (unaudited) |
||||||||||||||||
Three Months Ended
|
Six Months Ended
June 30, |
|||||||||||||||
2012 | 2011 | 2012 | 2011 | |||||||||||||
Revenues: | ||||||||||||||||
Product revenues, net | $ | 373,273 | $ | 74,535 | $ | 748,648 | $ | 74,535 | ||||||||
Royalty revenues | 33,480 | 10,010 | 72,461 | 16,071 | ||||||||||||
Collaborative revenues | 11,552 | 29,879 | 35,933 | 97,480 | ||||||||||||
Total revenues | 418,305 | 114,424 | 857,042 | 188,086 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenues | 104,549 | 5,404 | 130,467 | 5,404 | ||||||||||||
Royalty expenses | 9,874 | 3,902 | 23,167 | 6,568 | ||||||||||||
Research and development expenses (R&D) | 196,544 | 173,604 | 392,915 | 332,216 | ||||||||||||
Sales, general & administrative expenses (SG&A) | 117,514 | 96,663 | 228,660 | 168,186 | ||||||||||||
Restructuring expense | 594 | 741 | 954 | 1,501 | ||||||||||||
Total costs and expenses | 429,075 | 280,314 | 776,163 | 513,875 | ||||||||||||
Income (loss) from operations | (10,770 | ) | (165,890 | ) | 80,879 | (325,789 | ) | |||||||||
Net interest expense (Note 2) | (3,635 | ) | (6,760 | ) | (7,376 | ) | (17,359 | ) | ||||||||
Change in fair value of derivative instruments (Note 2) | — | (2,220 | ) | — | (7,818 | ) | ||||||||||
Income (loss) before provision for income taxes | (14,405 | ) | (174,870 | ) | 73,503 | (350,966 | ) | |||||||||
Provision for income taxes (Note 3) | 20,063 | 24,448 | 20,095 | 24,448 | ||||||||||||
Net income (loss) | (34,468 | ) | (199,318 | ) | 53,408 | (375,414 | ) | |||||||||
Net income (loss) attributable to noncontrolling interest (Note 1) | 30,463 | (25,249 | ) | 26,749 | (25,249 | ) | ||||||||||
Net income (loss) attributable to Vertex | $ | (64,931 | ) | $ | (174,069 | ) | $ | 26,659 | $ | (350,165 | ) | |||||
Net income (loss) per share attributable to Vertex common shareholders: | ||||||||||||||||
Basic | $ | (0.31 | ) | $ | (0.85 | ) | $ | 0.13 | $ | (1.72 | ) | |||||
Diluted | $ | (0.31 | ) | $ | (0.85 | ) | $ | 0.12 | $ | (1.72 | ) | |||||
Shares used in per share calculations: | ||||||||||||||||
Basic | 211,344 | 204,413 | 209,681 | 203,377 | ||||||||||||
Diluted | 211,344 | 204,413 | 212,957 | 203,377 |
Reconciliation of GAAP to (in thousands, except per share amounts) (unaudited) |
|||||||||||||
Three Months Ended |
Adjustments |
||||||||||||
GAAP |
Alios |
Stock-based |
Inventory |
September |
Restructuring |
Non-GAAP | |||||||
Income (loss) from operations |
|
|
|
|
$— |
|
|
||||||
Other income and expenses | (3,635) | (179) | — | — | — | — | (3,814) | ||||||
Income (loss) before provision for income taxes |
(14,405) | 4,467 | 31,169 | 78,000 | — | 594 | 99,825 | ||||||
Provision for income taxes | 20,063 | (21,240) | — | 1,239 | — | — | 62 | ||||||
Net income (loss) | (34,468) | 25,707 | 31,169 | 76,761 | — | 594 | 99,763 | ||||||
Net income attributable to noncontrolling interest (Alios) | 30,463 | (30,463) | — | — | — | — | — | ||||||
Net income (loss) attributable to Vertex |
|
|
|
|
$— |
|
|
||||||
Net income (loss) per diluted share attributable to Vertex common shareholders (Note 4) |
|
|
|||||||||||
Three Months Ended |
Adjustments |
||||||||||||
GAAP |
Alios |
Stock-based |
Inventory |
September |
Restructuring |
Non-GAAP | |||||||
Loss from operations |
|
|
|
$— | $— |
|
|
||||||
Other income and expenses | (8,980) | — | — | — | 5,083 | — | (3,897) | ||||||
Loss before provision for income taxes | (174,870) | 801 | 31,879 | — | 5,083 | 741 | (136,366) | ||||||
Provision for income taxes | 24,448 | (24,448) | — | — | — | — | — | ||||||
Net loss | (199,318) | 25,249 | 31,879 | — | 5,083 | 741 | (136,366) | ||||||
Net loss attributable to noncontrolling interest (Alios) | (25,249) | 25,249 | — | — | — | — | |||||||
Net loss attributable to Vertex |
|
$— |
|
$— |
|
|
|
||||||
Net loss per diluted share attributable to Vertex common shareholders (Note 4) |
|
|
Reconciliation of GAAP to Non-GAAP Financial Information-Six Month (in thousands, except per share amounts) (unaudited) |
|||||||||||||
Six Months Ended |
Adjustments |
||||||||||||
GAAP |
Alios |
Stock-based |
Inventory |
September |
Restructuring |
Non-GAAP | |||||||
Income from operations |
|
|
|
|
$— |
|
|
||||||
Other income and expenses | (7,376) | (241) | — | — | — | — | (7,617) | ||||||
Income before provision for income taxes | 73,503 | 9,491 | 58,796 | 78,000 | — | 954 | 220,744 | ||||||
Provision for income taxes | 20,095 | (18,960) | — | 1,239 | — | — | 2,374 | ||||||
Net income | 53,408 | 28,451 | 58,796 | 76,761 | — | 954 | 218,370 | ||||||
Net income attributable to noncontrolling interest (Alios) | 26,749 | (26,749) | — | — | — | — | — | ||||||
Net income attributable to Vertex |
|
|
|
|
$— |
|
|
||||||
Net income per diluted share attributable to Vertex common shareholders (Note 4) |
|
|
|||||||||||
Six Months Ended |
Adjustments |
||||||||||||
GAAP |
Alios |
Stock-based |
Inventory |
September |
Restructuring |
Non-GAAP | |||||||
Loss from operations |
|
|
|
$ — |
|
|
|
||||||
Other income and expenses | (25,177) | — | — | — | 18,615 | — | (6,562) | ||||||
Loss before provision for income taxes | (350,966) | 801 | 59,758 | — | (31,385) | 1,501 | (320,291) | ||||||
Provision for income taxes | 24,448 | (24,448) | — | — | — | — | — | ||||||
Net loss | (375,414) | 25,249 | 59,758 | — | (31,385) | 1,501 | (320,291) | ||||||
Net loss attributable to noncontrolling interest (Alios) | (25,249) | 25,249 | — |
— |
— | — | — | ||||||
Net loss attributable to Vertex |
|
$— |
|
$— |
|
|
|
||||||
Net loss per diluted share attributable to Vertex common shareholders (Note 4) |
|
|
Condensed Consolidated Balance Sheets Data (in thousands) (unaudited) |
||||
June 30,
2012 |
December 31,
2011 |
|||
Assets |
|
|||
Cash, cash equivalents and marketable securities |
|
|
||
Restricted cash and cash equivalents (Alios) (Note 1) | 56,024 | 51,878 | ||
Accounts receivable, net | 185,618 | 183,135 | ||
Inventories | 87,805 | 112,430 | ||
Other current assets | 40,524 | 14,889 | ||
Property and equipment, net | 272,561 | 133,176 | ||
Restricted cash | 34,090 | 34,090 | ||
Intangible assets (Note 3) | 663,500 | 663,500 | ||
Goodwill (Note 3) | 30,992 | 30,992 | ||
Other non-current assets | 10,408 | 11,268 | ||
Total assets |
|
|
||
Liabilities and Shareholders' Equity | ||||
Other liabilities |
|
|
||
Accrued restructuring expense | 24,830 | 26,313 | ||
Deferred tax liability (Note 3) | 263,017 | 243,707 | ||
Deferred revenues | 137,368 | 163,132 | ||
Convertible notes (due 2015) | 400,000 | 400,000 | ||
Noncontrolling interest (Alios) (Note 1) | 205,834 | 178,669 | ||
Shareholders' equity (Vertex) | 1,037,773 | 786,843 | ||
Total liabilities and shareholders' equity |
|
|
||
Common shares outstanding | 215,435 | 209,304 |
Note 1: The company has consolidated the financial statements of
its collaborator Alios BioPharma, Inc., as of June 30, 2012 and
December 31, 2011, for the three and six months ended
Note 2: In the first half of 2011, 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 relate to two financial transactions that
the company entered into in September 2009 relating to milestone
payments under the company's collaboration agreement with
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
Note 4: Shares used in Non-GAAP net income (loss) per diluted
share attributable to Vertex common shareholders were 224,124,000 and
204,413,000 for the three months ended
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 (ivacaftor) is indicated for the treatment of cystic fibrosis (CF) in patients age 6 and older who have a G551D mutation in the CFTR gene.
KALYDECO is not effective in patients with CF who are homozygous for the F508del mutation in the CFTR gene. KALYDECO has not been studied in other populations of patients with CF.
Therefore, use of KALYDECO in these patients is not recommended.
KALYDECO is contraindicated in any patient with hypersensitivity to the active substance or to any of the excipients.
Moderate elevations in liver function tests (transaminases) are common in subjects with CF. Overall, the incidence and clinical features of transaminase elevations in clinical trials was similar between subjects in the ivacaftor and placebo treatment groups. In the subset of patients with a medical history of elevated transaminases, increases have been reported more frequently in patients receiving KALYDECO compared to placebo. Therefore, liver function tests are recommended prior to initiating KALYDECO, every 3 months during the first year of treatment, and annually thereafter. Patients who develop unexplained increased transaminase levels during treatment should be closely monitored until the abnormalities resolve and consideration should be given to the continuation of treatment after assessment of the individual benefits and risks.
Ivacaftor is a substrate of CYP3A4 and CYP3A5 isoenzymes. Medicinal products that inhibit or induce CYP3A activity, may impact the pharmacokinetics of ivacaftor. Ivacaftor is a weak CYP3A inhibitor and may modify the pharmacokinetics of medicinal products metabolized through the CYP3A system. In vitro studies indicated that ivacaftor has the potential to inhibit P-glycoprotein (P-gp) and CYP2C9. The dose of KALYDECO must be adjusted when concomitantly used with potent and moderate CYP3A inhibitors. Exposure to ivacaftor is reduced by the concomitant use of CYP3A inducers, therefore potentially resulting in loss of efficacy of KALYDECO.
The most common adverse reactions in patients treated with KALYDECO were abdominal pain (stomach ache), diarrhea, dizziness, rash, upper respiratory tract reactions (including common cold, nasal congestion, redness of the throat, sore throat, runny nose, sinus congestion, and nose and throat inflammation), headache and bacteria in sputum. Two patients reported a serious adverse reaction of abdominal pain.
Please see full U.S. Prescribing Information for KALYDECO at www.KALYDECO.com.
INDICATON AND IMPORTANT SAFETY INFORMATION FOR INCIVEK
Indication
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 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, without
limitation, Dr. Leiden's statements in the second and third paragraphs
of the press release, the information provided in the two paragraphs
following the statement "This section contains forward-looking guidance
about the financial outlook for
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 10939223.
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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