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Onyx Pharmaceuticals Inc. (ONXX)
Q2 2009 Earnings Call Transcript
August 4, 2009 5:00 pm ET
Julie Wood – VP, IR and Corporate Communications
Tony Coles – President and CEO
Laura Brege – EVP and COO
Matt Fust – EVP and CFO
Todd Yancey – VP, Clinical Development
Jim Birchenough – Barclays Capital
Jessica Li – Goldman Sachs
Howard Liang – Leerink Swann
Jason Zhang – BMO Capital Markets
David Moskowitz – Caris & Company
Blake Arnold – Robert W. Baird & Co.
Derek Jellinek – Boenning & Scattergood
Phil Nadeau – Cowen and Company
Previous Statements by ONXX
» Onyx Pharmaceuticals Inc. Q1 2009 Earnings Call Transcript
» Onyx Pharmaceuticals, Inc., Q4 2008 Earnings Call Transcript
» ONYX Pharmaceuticals, Inc. Q3 2008 Earnings Call Transcript
I’ll now turn the call over to Onyx Pharmaceuticals Inc. You may begin.
Thank you. Hello and welcome. I’m Julie Wood, Vice President of Investor Relations and Corporate Communications at Onyx Pharmaceuticals. We thank you for joining us today for our second quarter 2009 financial results conference call.
Leading our call is Onyx President and Chief Executive Officer, Dr. Tony Coles. Also providing updates on the teleconference are Laura Brege, our Chief Operating Officer; and Matt Fust, our Chief Financial Officer. Joining us during the Q-and-A period will be Dr. Todd Yancey, Vice President of Clinical Development
Please note that we will be making forward-looking statements during this teleconference that could include financial, clinical or commercial projections. Statements that are not historical facts are forward-looking. References to what we expect, believe, intend to do, plan, estimate or other statements referring to future events or results are intended to identify these statements as forward-looking.
Forward-looking statements are inherently subject to risks and uncertainties. For a discussion of these risks and uncertainties, we refer you to our 10-K for the year ended December 31, 2008, as well as to our 10-Q for the second quarter of 2009.
In addition, we will be presenting and discussing non-GAAP financial measures in this presentation. For reconciliation of these non-GAAP financial measures to the corresponding GAAP measures, please see today’s press release which is posted on our website.
I would now like to turn the call over to Tony Coles, who will begin the discussion with an overview of our business. After Tony’s remarks, the management team will review commercial, clinical and financial highlights before we open the call for questions-and-answers. Tony?
Thanks, Julie, and good afternoon. Let me start the call by saying how we pleased we are that our strategy to grow Nexavar as a brand and Onyx as a company continues to yield significant results. The quarterly results we have announced today indicate continued strong growth for Nexavar and strong underlying fundamentals for our business. Onyx remains firmly on course to realize its vision of becoming a leading bio-pharmaceutical company. And given Nexavar’s continued sales growth, encouraging new clinical data, and or expanding pipeline, we are continuing to build a strong foundation for the company.
First, I would like to highlight the promising breast cancer results we’ve recently announced. As you know, we have a diverse clinical program evaluating Nexavar in a wide range of malignancies beyond its approved use in liver and kidney cancer, including our program in breast cancer, one of our most valuable potential opportunities. Despite treatment advances, breast cancer remains a devastating disease with 1.3 million cases worldwide each year.
In our large randomized Phase II trial, investigators looked at Nexavar in combination with the oral chemotherapeutic, capecitabine, in patients with advanced and metastatic breast cancer. We were pleased to report that trial met its primary endpoint of extending progression free survival in patients treated with the Nexavar, capecitabine combination compared to patients receiving capecitabine and placebo. These results were highly statistically significant and based on these encouraging data; we are evaluating various strategies to determine the most expeditious regulatory path forward.
We expect to present the full dataset at an upcoming medical meeting this year and or thrilled with these results, particularly with what an all-oral combination regimen could mean as a new treatment option for these patients. At the same time, we continue to leverage our demonstrated success with Nexavar to maximize its potential in liver and kidney cancer. For the first time ever, Nexavar sales surpassed the $200 million threshold this quarter, demonstrating continued strong performance in key markets worldwide.
There remains tremendous opportunity for market expansion and are currently approved indications and key drivers to additional sales growth include increasing penetration in existing markets, expanding Nexavar’s use earlier in the treatment continuum for HCC patients, maximizing duration of therapy and importantly, broadening and deepening access within various geographies through additional marketing and reimbursement approvals.
In the second quarter, we continue to see the success of our efforts in driving faster penetration of Nexavar in existing liver cancer market and in expanding our reach to additional geographies through approvals and reimbursements with 19%growth in global net sales of Nexavar compared to the same period last year. In May, we delivered on a key corporate milestone when Nexavar was approved in Japan, where liver cancer incident is amongst the highest in the world. This is an important step forward for these patients and a great development for the brand.
With free randomized trials in liver cancer stopped early for efficacy, we are pleased with the clinical data we have amassed to date and look forward to additional opportunities to venture patients with these diseases. To further expand our leadership position in liver cancer, we are conducting a broad clinical program aimed at reaching even more patients at different stages of the disease. This program is generating data across the treatment continuum with a goal of identifying all patients who benefit from Nexavar in doing so earlier in the course of their disease.