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Vertex Pharmaceuticals Incorporated (VRTX)
Q1 2013 Earnings Call
April 30, 2013 5:00 pm ET
Michael Partridge - Senior Director of Strategic Communications
Jeffrey M. Leiden - Chairman, Chief Executive Officer and President
Stuart A. Arbuckle - Chief Commercial Officer and Executive Vice President
Ian F. Smith - Chief Financial Officer and Executive Vice President
Peter R. Mueller - Chief Scientific Officer, Executive Vice President of Global Research & Development and Member of The Scientific Advisory Board
Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division
Geoffrey C. Meacham - JP Morgan Chase & Co, Research Division
Michael J. Yee - RBC Capital Markets, LLC, Research Division
Rachel L. McMinn - BofA Merrill Lynch, Research Division
Mark J. Schoenebaum - ISI Group Inc., Research Division
Yaron Werber - Citigroup Inc, Research Division
Liisa A. Bayko - JMP Securities LLC, Research Division
Brian Corey Abrahams - Wells Fargo Securities, LLC, Research Division
Robyn Karnauskas - Deutsche Bank AG, Research Division
Matthew Roden - UBS Investment Bank, Research Division
Ying Huang - Barclays Capital, Research Division
Howard Liang - Leerink Swann LLC, Research Division
Philip Nadeau - Cowen and Company, LLC, Research Division
Y. Katherine Xu - William Blair & Company L.L.C., Research Division
Salveen J. Richter - Canaccord Genuity, Research Division
Previous Statements by VRTX
» Vertex Pharmaceuticals' CEO Hosts Phase II Results for VX-661 Conference (Transcript)
» Vertex Pharmaceuticals' Management Presents at Barclays Global Healthcare Conference (Transcript)
» Vertex Pharmaceuticals Incorporated - Special Call
Thank you, operator, and good evening to everyone. Joining me on tonight's call are Dr. Jeff Leiden, Vertex's Chairman and CEO; Stuart Arbuckle, Chief Commercial Officer; and Ian Smith, Chief Financial Officer. Jeff will begin with a review of our progress this year in executing against our long-term strategy of creating innovative medicines with a focus on specialty diseases. Then, Stuart will comment on market trends for our key medicines, KALYDECO for people with cystic fibrosis, who have the G551D mutation and INCIVEK for hepatitis C. And to close, we will review the first quarter financial results and update our 2013 guidance for KALYDECO net revenues. After prepared remarks, Bob Kauffman, Chief Medical officer; and Peter Mueller, Chief Scientific Officer, will join us for a question-and-answer period. And after the call, we will be available in our offices for follow-up.
Before we begin, I will note that information discussed on this conference call includes forward-looking statements, which are subject to the risks and uncertainties discussed in detail in our 10-K reports, which have been filed with the Securities and Exchange Commission and also in the press release announcing our financial results tonight.
These statements, including, without limitation, those regarding the commercial performance of INCIVEK and KALYDECO, our development plans and expectations and our guidance are based on management's current assumptions and are subject to the risks and uncertainties that could cause actual outcomes and events to differ materially.
GAAP and non-GAAP financial measures will be discussed on this call. The information regarding our use of these measures and a reconciliation of GAAP to non-GAAP is available in our first quarter 2013 financial press release, which is on our website. And I would also refer you to the information on Slide 4 of tonight's webcast.
I'll now turn it over to Jeff.
Jeffrey M. Leiden
Thanks, Michael. Good afternoon, everyone. I'm pleased to discuss with you the progress that Vertex has made in 2013. Earlier this year, we identified key priorities that will enable you to measure the progress of our business. In January, at the JPMorgan conference, I outlined 3 strategic imperatives for our business that would position us for long-term growth: first, prioritizing our development investments to advance our late-stage medicines. We have important late-stage medicines in development for cystic fibrosis, hepatitis C and autoimmune diseases, and our goal is to provide these therapies to patients, their families and healthcare providers as soon as possible. Second, focus on continuing to create innovative medicines for serious diseases out of our R&D efforts. Making ground-breaking new medicines is the reason Vertex was founded. It continues to define who we are today. And third, maintaining our financial strength. We recognize that we're in an important period of investment to realize sustained growth opportunities in the near future and the funding of this investment while maintaining our balance sheet's strength is an important priority.
So far in 2013, we have accomplished a great deal to advance our late-stage medicines and show the potential to bring further ground-breaking therapies to patients. We also continue to maintain our financial strength with a good financial performance for the first quarter.
In cystic fibrosis, we received breakthrough designation from the U.S. FDA for ivacaftor as monotherapy. We have multiple studies underway that could potentially expand the KALYDECO label. We are on track to have the first clinical data for ivacaftor monotherapy outside of G551D in the second half of 2013.
We also received breakthrough designation for the combination of ivacaftor with our lead corrector molecule, VX-809. With the VX-809 plus ivacaftor combination, we reached agreement with the regulatory authorities and have now begun a Phase III program that will evaluate 6 months of treatment in 1,000 patients homozygous for the Delta 508 mutation. We anticipate that we will receive Phase III data and submit an NDA for this combination in 2014.
We also reported Phase II data earlier this month with another corrector, VX-661, that has further validated the strategy of combining a corrector and a potentiator to treat CF patients with 2 copies of the Delta 508 mutation. Also, we announced that we continue to advance an additional corrector, VX-983, and we expect to start a combination study with this compound in people with 2 copies of the Delta 508 mutation in the second half of this year.