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Vertex Reports Second Quarter 2011 Financial Results and Provides Updates on Launch of INCIVEKTM (telaprevir) and Development Programs
-Quarter highlighted by approval and launch of INCIVEKTM for hepatitis C and completion of VX-770 Phase 3 program in cystic fibrosis-
-Continued progress in advancing new combinations of medicines for the future treatment of hepatitis C and cystic fibrosis-
The company reported approximately
"The second quarter of 2011 was marked by several defining events for
our company, including the approval and launch of INCIVEK for the
treatment of hepatitis C and the completion of the Phase 3 program for
VX-770 in cystic fibrosis," said
"Upon approval in May, Vertex was prepared to immediately make INCIVEK available to people with hepatitis C, and the first person was able to begin treatment just three days after approval. We are very pleased with the launch of this important new medicine."
Recent Clinical Development Progress
Positive Opinion Issued by
Vertex's collaborator, Tibotec Virco-Virology BVBA, one of the
Janssen Pharmaceuticalcompanies of Johnson & Johnson, announced last week that the CHMP adopted a positive opinion to recommend the approval of telaprevir in Europe. The positive opinion will be considered by the European Commission, which has authority to approve new medicines for use throughout the European Union. Vertex expects that Tibotec will receive a response from the European Commissionon their application for approval in the third quarter of 2011. Following marketing authorization approvals, telaprevir will be marketed in the European Unionand certain other global territories under the brand name INCIVOTM by the Janssencompanies.
Enrollment Complete in Phase 3b Study of Twice-daily Dosing of INCIVEK
- Patient enrollment is complete in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (750 mg; q8h) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) for people with chronic genotype 1 hepatitis C. Sustained viral response (SVR, or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily dosing of INCIVEK by the end of 2012.
Interim Results from Phase 2 Combination Study of INCIVEK and VX-222
- In a separate press release issued earlier this week, Vertex announced results from an interim analysis of the two, four-drug (quad) arms of an ongoing Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of Vertex's lead investigational hepatitis C virus polymerase inhibitor, VX-222, dosed in combination with INCIVEK. The study currently includes four treatment arms. Two of the arms are fully enrolled and are evaluating four-drug combinations of VX-222 (400 mg or 100 mg; BID), INCIVEK (1,125 mg; BID), pegylated-interferon and ribavirin. The third and fourth arms are three-drug treatment arms that are evaluating a twice-daily, all-oral, interferon-free regimen of INCIVEK (1,125 mg), VX-222 (400 mg) and ribavirin in people with genotype 1a or 1b chronic hepatitis C. Vertex expects to complete enrollment in the all-oral arms in the third quarter of 2011.
- Data from this study will be submitted for presentation at a medical meeting later this year.
Phase 2 Study of INCIVEK Combination Treatment Evaluating 12-week Regimens on Track to Begin in the Third Quarter
- Vertex plans to begin a Phase 2 trial in the third quarter that will evaluate a treatment regimen of INCIVEK dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene. All people in the study will receive 12 total weeks of treatment. The trial is expected to include approximately 400 people with genotype 1 chronic hepatitis C who have not previously been treated. Data from this trial are expected in 2012.
Additional information on INCIVEK, including important safety information, appears at the end of this release.
Cystic Fibrosis (CF):
Submission of VX-770 NDA and MAA on Track for
The Phase 3 program for VX-770, Vertex's cystic fibrosis transmembrane
conductance regulator protein (CFTR) potentiator, is now complete. In
October, Vertex plans to submit both its VX-770 NDA to the
U.S. Food and Drug Administration(FDA) and its VX-770 MAA to the European Medicines Agency(EMA). Additional regulatory submissions are planned for Canadaand other countries following the submissions of the NDA and MAA. Vertex is seeking approval of VX-770 in people six years of age and older who have at least one copy of the G551D mutation in the CFTR gene.
Additional Studies of VX-770 Planned for 2012
- Pediatric Study: The Phase 3 program for VX-770 was focused on people ages 6 and older with the G551D mutation. In the first half of 2012, Vertex plans to begin the first study of VX-770 in children younger than 6 years of age. The study is expected to enroll children ages 2 through 5 and will evaluate the safety, tolerability, and effect on sweat chloride and other measures of clinical efficacy using a pediatric formulation of VX-770.
- Studies of VX-770 in People with other CFTR Mutations: The G551D mutation is the most common gating mutation, present in approximately 4 percent of all people with CF. In the first half of 2012, Vertex plans to begin two clinical studies of VX-770 in people with CF who have other CFTR mutations where, based on in vitro data, VX-770 may help improve the function of CFTR proteins at the cell surface. These additional studies are expected to enroll people with CF who have certain other gating mutations that result in the CFTR protein functioning abnormally at the cell surface, as well as people with other mutations that result in some residual CFTR function. A goal of the trials will be to generate data to support the evaluation of the use of sweat chloride measurements as a marker for clinical benefit in people with CF.
- Additional information on these studies will be provided upon completion of discussions with regulatory agencies in the U.S. and E.U.
Phase 2 Trials Combining Two CFTR Modulators for the Treatment of People with the Most Common Mutation of CF
Vertex is conducting an exploratory Phase 2 clinical trial to evaluate
combination regimens of VX-770 and VX-809, a CFTR corrector, in people
with the most common mutation in CF, known as F508del. Vertex recently
completed the first part of the trial and is on track to initiate the
second part of the trial in
September 2011. Part Two of this trial will include dosing of VX-809 alone for at least four weeks followed by dosing of VX-770 and VX-809 in combination for at least four weeks. Similar to Part One, the primary goals of the second part of the trial will be to evaluate the safety and tolerability and the effect of the combination of VX-770 and VX-809 on CFTR function as measured by sweat chloride. Lung function will be measured as a secondary endpoint. The trial is expected to evaluate higher doses of VX-809 than the 200 mg dose studied in the first part of the trial and to enroll people with CF who have one copy or two copies of the F508del mutation.
- Vertex also plans to initiate a Phase 2a clinical trial to evaluate combination regimens of VX-770 and VX-661, another CFTR corrector, by the end of 2011. This trial will evaluate people with two copies of the F508del mutation.
Data from Phase 2 Study of JAK3 Inhibitor VX-509 Expected in September
Vertex is conducting a Phase 2 proof-of-concept clinical trial of the
JAK3 inhibitor VX-509 in people with moderate to severe rheumatoid
arthritis. All patients in the study have completed dosing of VX-509,
and analyses of all data from the trial are ongoing. Vertex expects to
announce clinical results from this trial in September, including
safety and tolerability data and measurements of clinical efficacy
American College of Rheumatology (ACR) and Disease Activity Score(DAS) response criteria.
VX-787 to Enter Phase 1 Clinical Development in September
Vertex recently completed a successful pre-Investigational New Drug
(pre-IND) meeting with the
FDAfor VX-787, a medicine in development designed to treat influenza A, including recent H1 (pandemic) and H5 (avian) influenza strains. VX-787 is the first of a new class of molecules that aims to treat influenza in a way that is distinct from neuraminidase inhibitors, the current standard of care for the treatment of influenza, and from other previous approaches to the treatment of influenza. Vertex plans to begin Phase 1 development of VX-787 in healthy volunteers in September. Pending results from Phase 1 studies, VX-787 could begin to be evaluated in influenza in the first half of 2012.
Second Quarter Results
INCIVEK Revenues: For the quarter ended
Total Revenues: Total revenues for the quarter ended
Cost of Product Revenues: Cost of product revenues for the
Research and Development (R&D) Expense: R&D expense
for the quarter ended
Sales, General and Administrative (SG&A) Expense: SG&A
expense for the quarter ended
GAAP and Non-GAAP Loss Attributable to Vertex: For the
The non-GAAP loss attributable to Vertex for the quarter ended
Cash Position: At
This section contains forward-looking guidance about the financial
Vertex is today revising its guidance for 2011 total operating expenses.
Vertex now expects 2011 total operating expenses, excluding cost of
revenues and stock-based compensation expense, 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
Vertex Pharmaceuticals Incorporated
2011 Second Quarter and Six Month Results
Consolidated Statements of Operations Data
(in thousands, except per share amounts)
Three Months Ended
Six Months Ended
|Product revenues, net||$74,535||$ ---||$74,535||$ ---|
|Costs and expenses:|
|Cost of product revenues||5,404||---||5,404||---|
Research and development expenses
Sales, general & administrative expenses
|Total costs and expenses||280,314||201,195||513,875||383,906|
|Loss from operations||(165,890||)||(169,573||)||(325,789||)||(329,855||)|
|Net interest expense (Note 2)||(6,760||)||(3,199||)||(17,359||)||(6,699||)|
Change in fair value of derivative
Adjusted for: Net loss attributable to
|Net loss attributable to Vertex||$(174,069||)||$(200,006||)||$(350,165||)||$(365,277||)|
Basic and diluted net loss per common share
Basic and diluted weighted-average number of
Non-GAAP Loss and Loss per
Three Months Ended
Six Months Ended
|GAAP Net Loss Attributable to Vertex||$(174,069||)||$(200,006||)||$(350,165||)||$(365,277||)|
|Pro Forma Adjustments:|
Milestone revenues related to
Stock-based compensation expense
Stock-based compensation expense
|Total stock-based compensation expense||$31,879||$24,449||$59,758||$43,782|
Expenses related to September 2009
|Non-GAAP Loss Attributable to Vertex||$(136,366||)||$(142,509||)||$ (320,291||)||$ (282,595||)|
Basic and diluted non-GAAP loss per
Note 1: The Company has consolidated the financial statements of
Note 2: A portion of the collaborative revenues for the first
half of 2011, 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, relate to two financial transactions that the company entered into
in September 2009 relating to future 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
Condensed Consolidated Balance Sheets Data
|Cash, cash equivalents and marketable securities||$593,491||$1,031,411|
|Restricted cash and cash equivalents (Alios) (Note 1)||63,098||---|
|Accounts receivable, net||96,016||12,529|
|Other current assets||21,897||13,099|
|Property and equipment, net||84,203||72,333|
|Intangible assets (Note 3)||769,300||518,700|
|Goodwill (Note 3)||33,501||26,102|
|Other non-current assets||14,858||17,182|
|Liabilities and Shareholders' Equity|
|Accrued restructuring expense||28,205||29,595|
|Deferred tax liability (Note 3)||160,372||160,278|
|Convertible notes (due 2015)||400,000||400,000|
Liabilities related to milestone
transactions (Note 2)
|Noncontrolling interest (Alios) (Note 1)||256,919||---|
|Shareholders' equity (Vertex)||307,549||503,973|
|Total liabilities and shareholders' equity||$1,763,100||$1,725,446|
|Common shares outstanding||207,473||203,523|
Indication and Important Safety Information
INCIVEK™ (telaprevir) tablets 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, you should not take INCIVEK combination treatment if you are pregnant or may become pregnant, or if you are a man with a sexual partner who is pregnant.
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 you cannot take with INCIVEK combination treatment. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
INCIVEK can cause serious side effects including rash and anemia. 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. Tell your healthcare provider about any side effect that bothers you or doesn't go away.
Please see full Prescribing Information for INCIVEK, including the Medication Guide, available at www.INCIVEK.com.
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, epilepsy and other life-threatening diseases.
Founded more than 20 years ago in
Vertex's press releases are available at www.vrtx.com.
INCIVEKTM is a trademark of
PEGASYS® and COPEGUS® are registered trademarks of Hoffmann-La Roche.
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 statements
regarding (i) continued progress in advancing new combinations of
medicines for the future treatment of hepatitis C and cystic fibrosis,
(ii) the expectation that Vertex will become a cash flow and earnings
positive company for 2012, (iii) the plan to submit an NDA in
Conference Call Information
Vertex will host a conference call and webcast today,
To listen to the live call on the telephone, dial 1-866-501-1537 (
The conference ID number for the live call and replay is 80694276.
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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