Onyx Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript

Onyx Pharmaceuticals (ONXX)

Q2 2012 Earnings Call

August 01, 2012 5:00 pm ET

Executives

Amy Figueroa

N. Anthony Coles - Chief Executive Officer, President and Director

Helen Torley - Chief Commercial officer and Executive Vice President

Matthew K. Fust - Chief Financial Officer, Principal Accounting Officer and Executive Vice President

Barbara Klencke

Analysts

Michael G. King - Rodman & Renshaw, LLC, Research Division

Cory William Kasimov - JP Morgan Chase & Co, Research Division

Terence C. Flynn - Goldman Sachs Group Inc., Research Division

Rachel L. McMinn - BofA Merrill Lynch, Research Division

Howard Liang - Leerink Swann LLC, Research Division

Biren Amin - Jefferies & Company, Inc., Research Division

Matthew R. Wooten - Robert W. Baird & Co. Incorporated, Research Division

Navdeep Singh - Deutsche Bank AG, Research Division

Geoffrey C. Porges - Sanford C. Bernstein & Co., LLC., Research Division

Ling Wang - Summer Street Research Partners

Echo Yinghui He - Maxim Group LLC, Research Division

Ryan Martins - Lazard Capital Markets LLC, Research Division

Nicholas Bishop - Cowen and Company, LLC, Research Division

Ying Huang - Barclays Capital, Research Division

Marshall Urist - Morgan Stanley, Research Division

Jim Birchenough - BMO Capital Markets U.S.

Presentation

Operator

Welcome to the Onyx Pharmaceuticals Conference Call. My name is Trish, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded.

I would now like to turn the call over to Onyx Pharmaceuticals.

Amy Figueroa

Thanks, Trish. Good afternoon. I'm Amy Figueroa, Senior Director of Investor Relations at Onyx Pharmaceuticals. Thank you for participating on our second quarter 2012 financial results conference call.

Leading the call today is Dr. Tony Coles, President and Chief Executive Officer. After Tony's introductory comments, Dr. Helen Torley, Executive Vice President and Chief Commercial Officer, will discuss the progress in our franchises. Next, we will have Matt Fust, Executive Vice President and Chief Financial Officer, review our financial results for the second quarter of 2012 and provide an update on financial guidance. Then, Dr. Barb Klencke, Senior Vice President of Clinical Development, will discuss our ongoing clinical program. After that, we will open the call to your questions.

Please note that we will be making forward-looking statements during this conference call that could include financial, clinical, regulatory 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, 2011, as well as to our other filings. We expect to file our 10-Q for the second quarter ended June 30, 2012 early next week.

For a full prescribing information on Kyprolis, we refer you to the package insert posted at www.kyprolis.com. Kyprolis carfilzomib for injection has been approved for the treatment of patients with multiple myeloma who have received at least 2 prior therapies, including bortezomib and an immunomodulatory agent or -- and have demonstrated disease progression on or within 60 days of completion of the last therapy. The indication for Kyprolis is based on response rates. Currently, no data are available for Kyprolis that demonstrates an improvement in progression-free survival or overall survival.

On today's call, we will be presenting and discussing non-GAAP financial measures. For a reconciliation of these non-GAAP financial measures to the corresponding GAAP measures, please see today's press release, which is posted on the Onyx website at www.onyx.com within the News & Media section.

A slide presentation that supplements the information on this conference call is also available on the Onyx website. The presentation is located on the Financial Information page of the Investors section.

I would now like to turn the call over to Tony.

N. Anthony Coles

Thanks, Amy. Good afternoon, and thanks for joining us today.

Over the past 3 years, we've executed on our strategy to build a leading oncology company with 2 franchises and multiple therapies to treat increasing numbers of patients with cancer. With the recent accelerated approval of Kyprolis, the transformation of Onyx has accelerated and our growth strategy has being realized.

We're on track to reach our goal of taking Onyx from a company with 1 therapy to a company with as many as 3 therapies with the recent approval of Kyprolis and with regorafenib regulatory action on the horizon for later this year. We're proud of these achievements, and we expect the significant momentum in our business to continue in the second half of this year and into 2013 as we build Onyx for future success.

For the proteasome inhibitor franchise, in the United States, we are launching our first wholly-owned product, Kyprolis. This important milestone provides us with the opportunity to serve more patients and expands our footprint in oncology. While we are very early in the launch, literally days, it's gratifying to see the execution of our commercial plan going well with the experienced team that Helen has assembled.

To further unlock the value of this franchise, we are also executing a broad, global development program across additional lines of therapy in myeloma. Additionally, we are advancing oprozomib, our oral proteasome inhibitor in the clinic.

Before turning the call over to Helen, I'd like to spend a moment on our kinase inhibitor business where we have also made good progress. Nexavar is the foundation of this successful global business, and Bayer's regorafenib, now under priority review by the FDA, represents a second asset in this franchise. With Nexavar's increasing cash flow generation and continued leadership in liver cancer and with regorafenib as a potential near-term revenue driver in colorectal cancer, we're well-positioned to invest in the future growth of Onyx.

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