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Onyx Pharmaceuticals (ONXX)

Q3 2012 Earnings Call

November 01, 2012 4:30 pm ET

Executives

Amy Figueroa

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

Helen I. Torley - Chief Commercial officer and Executive Vice President

Barbara Klencke

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

Analysts

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

Rachel L. McMinn - BofA Merrill Lynch, Research Division

Jim Birchenough - BMO Capital Markets U.S.

Gene Mack - Brean Murray, Carret & Co., LLC, Research Division

Rene Shen

Laura K. Chico - Robert W. Baird & Co. Incorporated, Research Division

Robyn Karnauskas - Deutsche Bank AG, Research Division

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

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

Ryan Martins - Lazard Capital Markets LLC, Research Division

Ling Wang - Summer Street Research Partners

Stephen Willey - Stifel, Nicolaus & Co., Inc., Research Division

Salveen J. Richter - Canaccord Genuity, Research Division

Marshall Urist - Morgan Stanley, Research Division

Arlinda Lee - Barclays Capital, Research Division

Philip Nadeau - Cowen and Company, LLC, Research Division

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

Presentation

Operator

Welcome to the Onyx Pharmaceuticals Third Quarter 2012 Financial Results Conference Call. My name is Anthony, and I will be your operator for today's call. [Operator Instructions] Later, we will conduct a question-and-answer session. Please note that this conference is being recorded.

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

Amy Figueroa

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

Leading the call today is Dr. Tony Coles, Onyx' 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 and specifically, the U.S. launches of both Kyprolis and Stivarga. Next, Dr. Barb Klencke, Senior Vice President of Clinical Development, will provide an update on our global clinical programs. Finally, Matt Fust, Executive Vice President and Chief Financial Officer, will review our financial results for the third quarter of 2012. We will then open the call to questions.

Please note that we are issuing a correction to our press release as one of the supplemental tables reconciling GAAP and non-GAAP diluted EPS was missing a bracket around some of the numbers for the 3 months ending September 30, 2012 period. Please note also 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 third quarter ended September 30, 2012 tomorrow.

During today's call, we will be discussing 2 recently approved therapies: Kyprolis, carfilzomib for injection; and Bayer Stivarga, regorafenib tablets. For full prescribing information on Kyprolis, we refer you to the package insert posted at www.kyprolis.com. For full prescribing information on Bayer Stivarga, we refer you to the package insert posted at www.stivarga-us.com. These links are also included in today's press release.

In addition, 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 being posted on the Onyx' website. The presentation will be located on the Financial Information page of the Investors section.

I will now turn the call over to Tony.

N. Anthony Coles

Thanks, Amy. Good afternoon, and thanks for joining us today. As we begin our call, let me first say that our thoughts are with the many impacted by Hurricane Sandy, with the hope that all those affected will be able to quickly begin the recovery process. We're very mindful, especially of the Onyx' employees affected, and wish them the very best in the days ahead.

We started this year with one globally successful product, Nexavar, approved for the treatment of 2 types of cancer and a bold vision for building a leading oncology company with multiple therapies to help even more patients with cancer.

Specifically, our objective was to have, by the end of this year, 2 newly approved oncology therapies, bringing the total number of medicines in the Onyx portfolio to 3 across an array of solid and liquid tumors. We knew this would be an ambitious goal, but I'm very pleased and very proud to say that we have achieved this important milestone. And with this achievement, Onyx has truly been transformed, both as a company and as a business. We're focused on growing our top line and continuing our evolution as a leading biopharmaceutical company.

In a single quarter, both Kyprolis and Stivarga received FDA approval. And today, both these new products are available to patients in disease settings where treatment options have been extremely limited or nonexistent. These approvals would not have been possible without the patients, their caregivers and the physicians who participated in multiple clinical trials. And for this, we thank them. At Onyx, we're dedicated to innovation in the service of patients with unmet needs, and launching these 2 new therapies is our way of demonstrating this ongoing commitment.

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