Onyx Pharmaceuticals Inc. (ONXX)
Q1 2009 Earnings Call
May 6, 2009; 5:00 pm ET
Dr. Tony Coles - President & Chief Executive Officer
Laura Brege - Chief Operating Officer
Matt Fust - Chief Financial Officer
Todd Yancey - Vice President of Clinical Development
Julie Wood - Vice President, Investor Relations and Corporate Communications
Mona Ashiya - JP Morgan
Jim Birchenough - Barclays Capital
Jessica Li - Goldman Sachs
Howard Liang - Leerink Swann
Jason Zhang - BMO Capital Markets
Stephen Willey - Thomas Weisel Partners
David Moskowitz - Caris & Company
Philip Nadeau - Cowen and Company
Previous Statements by ONXX
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I’ll now turn the call over to Onyx Pharmaceutical. Onyx Pharmaceuticals 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 first 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 first 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 corresponding GAAP measures, please see today’s press release which is posted on our website at www.onyx-pharm.com.
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
Dr. Tony Coles
Thanks Julie. There is little doubt that we are living in interesting times and that the rules as we knew them are changing. This is even apparent in our industry, once thought of as recession proof, where we are now seeing the impact of the global economic recession even a month that will weather companies. We’d like to offer that there are some things that will continue to be indicators of success, despite the current economic situation.
Onyx continues to generate revenue from Nexavar, as it expands the large untapped market in liver cancer and drives positive cash flow. We are also increasing our development opportunities, maintaining our profitability and growing already strong cash reserves. These are positive and fundamental indicators of our current and expected success. Our goal, short and long term, is to continually strengthen top line performance and manage Nexavar as a business. So, let’s get started.
We are pleased to report our progress for the first quarter of 2009. Global net sales of Nexavar grew 17% in the first quarter, compared to the same period last year. This growth was driven largely by a string of successful liver cancer launches and the first stages of a focused market expansion for liver cancer.
While the current economic conditions caused some headwinds for Nexavar in the first quarter, we believe this effect will be temporary and that product and reimbursement approvals throughout the year will complement our ongoing market development efforts to achieve strong growth for the brand in 2009. With our clinical program for Nexavar and our recently expanded product portfolio, we remain positioned for continued success. With this in mind I want to take a few minutes to highlight the strengths that differentiate the company today.
First, in kidney cancer, Nexavar remains an important therapy for treatment. With more physicians using targeted therapies sequentially to extend patient lives, we expect Nexavar will remain an important choice for our physicians.
In liver cancer, which is the third leading cause of cancer related deaths, Nexavar is the only approved oral targeted therapy. We don’t expect any competition for sometime, giving us a leadership advantage in this market. We’ve continued unmet medical need in these two tumors around the world. We believe we are a long way from realizing the full value of Nexavar.
Second, it’s our expectation that Nexavar will have broad application across a number of other tumors. Nexavar’s dual mechanism of action, proven efficacy and too tough to treat diseases and established safety profile in tens of thousands of patients worldwide, has spurred tremendous interest from clinicians wanting to explore its use across a range of cancers.
In collaboration with these investigators, as well as through Onyx and Bayer responsive trials, there are literally hundreds of ongoing studies evaluating Nexavar in a variety of treatment settings. Chief among these are several Phase III company sponsored studies that are either ongoing or planned. As a result we are positioning Nexavar in the years to come with an ongoing stream of new data from these potential registrational trials and several more Phase II signal generating studies.