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Vertex Pharmaceuticals Incorporated Message Board

  • bluecheese4u bluecheese4u Jan 29, 2013 5:06 PM Flag

    Vertex Reports Full-Year and Fourth Quarter 2012 Financial Results and Provides Updates on Key Development Programs

    Vertex Reports Full-Year and Fourth Quarter 2012 Financial Results and Provides Updates on Key Development Programs

    -2013 investment focused on key development programs in cystic fibrosis, hepatitis C and autoimmune diseases-

    -Full-year 2012 revenues of $1.53 billion, including net product revenues of $1.16 billion for INCIVEK in hepatitis C and $171.6 million for KALYDECO in cystic fibrosis-

    -Company ends 2012 with $1.32 billion in cash, cash equivalents and marketable securities-

    January 29, 2013
    CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated financial results for the full year and fourth quarter ended December 31, 2012. The company also today provided financial guidance for 2013.

    Vertex reported total 2012 revenues of $1.53 billion, including net product revenues of $1.16 billion from INCIVEK® (telaprevir) and $171.6 million from KALYDECOTM (ivacaftor). The GAAP net loss attributable to Vertex was $(107.0) million, or $(0.50) per share, for 2012. 2012 non-GAAP net income attributable to Vertex was $255.5 million, or $1.18 per diluted share, excluding certain charges of $362.6 million. The company reported $1.32 billion in cash, cash equivalents and marketable securities as of December 31, 2012.

    For the fourth quarter of 2012, Vertex reported $334.0 million in total revenues, including $222.8 million from INCIVEK and $58.5 million from KALYDECO. In the fourth quarter of 2012, the GAAP net loss attributable to Vertex was $(76.1) million, or $(0.35) per share. Non-GAAP net income attributable to Vertex was $9.0 million, or $0.04 per diluted share, excluding certain charges of $85.1 million, for the fourth quarter of 2012.

    "Entering 2013, we are committed to advancing key development programs and to maintaining financial strength to position the company for sustainable long-term growth," said Jeffrey Leiden, M.D., Ph.D., Chair, President and Chief Executive Officer of Vertex. "Over the coming year, we expect to generate a significant amount of data from our key development programs in cystic fibrosis, hepatitis C and autoimmune diseases and to initiate important studies designed to bring additional transformative medicines to people with serious diseases, with a focus on specialty markets."

    Development Program Updates

    On January 6, 2013, Vertex provided a comprehensive update on the status of its development programs. The company today provided the following additional updates to its programs for cystic fibrosis, hepatitis C and autoimmune diseases:

    Cystic Fibrosis

    Combination of VX-809 and ivacaftor for People with Two Copies of the F508del Mutation

    In early January, Vertex announced that the combination of VX-809 and ivacaftor for the treatment of people with CF who have two copies of the F508del mutation received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). Vertex completed an end-of-Phase 2 meeting with the FDA and has submitted a proposed design for a pivotal Phase 3 program for the combination to the FDA. While the specific implications of the Breakthrough Therapy Designation cannot be determined at this time, Vertex is in discussions with the FDA regarding the final design of this program and expects to begin pivotal Phase 3 development in the first quarter of 2013, pending regulatory approval.
    Hepatitis C

    Telaprevir Twice-daily Dosing

    Vertex recently submitted a supplemental New Drug Application (sNDA) for a twice-daily dosing regimen of telaprevir to the FDA. Also in January, the company submitted a supplemental New Drug Submission (sNDS) in Canada for a twice-daily dosing regimen of telaprevir.
    Pipeline Programs

    Ongoing Evaluation of VX-509 in Rheumatoid Arthritis

    As part of its Phase 2 evaluation of VX-509 in rheumatoid arthritis (RA), Vertex recently initiated a 40-patient Phase 2 study in people with RA to evaluate the potential for VX-509 to improve structural joint changes as measured by Magnetic Resonance Imaging (MRI) and markers of inflammation and joint damage measured in joint fluid. The study will also examine a broad range of doses of VX-509 to provide information for future studies.
    Full-Year 2012 Financial Results

    Total Revenues: Total revenues for 2012 were $1.53 billion, compared with $1.41 billion in total revenues for 2011. The components of total revenues for 2012 and

    investorsDOTvrtxDOTcom/releasedetailDOTcfm?ReleaseID=736569

 
VRTX
97.74+1.43(+1.48%)Jul 22 3:59 PMEDT

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