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Onyx Pharmaceuticals (ONXX)

Q4 2012 Earnings Call

February 21, 2013 5:00 pm ET

Executives

Amy Figueroa - Senior Director of Investor Relations

N. Anthony Coles - Chairman and Chief Executive Officer

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

Gene Mack - Brean Capital LLC, Research Division

Jim Birchenough - BMO Capital Markets U.S.

Michael G. King - JMP Securities LLC, Research Division

Rachel L. McMinn - BofA Merrill Lynch, Research Division

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

Howard Liang - Leerink Swann LLC, Research Division

Alethia Young - Deutsche Bank AG, Research Division

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

Philip Nadeau - Cowen and Company, LLC, Research Division

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

Ryan Martins - Lazard Capital Markets LLC, Research Division

Andrew Bell - Canaccord Genuity, Research Division

Marshall Urist - Morgan Stanley, Research Division

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

Christina Zhang - Barclays Capital, Research Division

Matthew Roden - UBS Investment Bank, Research Division

Presentation

Operator

Welcome to the Onyx Pharmaceuticals conference call. My name is Ellen, and I will be your operator for today's call. [Operator Instructions] Please note that this conference is being recorded. I will now turn the call over to Onyx Pharmaceuticals Inc. You may begin.

Amy Figueroa

Thanks, Ellen. Good afternoon. I'm Amy Figueroa, Senior Director of Investor Relations at Onyx Pharmaceuticals. Thank you for participating on our year-end and fourth quarter 2012 financial results conference call.

Leading the call today is Dr. Tony Coles, Onyx's Chairman and Chief Executive Officer. After Tony's introductory comments, Dr. Helen Torley, Executive Vice President and Chief Commercial Officer, will discuss the commercial progress in our proteasome inhibitor and kinase inhibitor franchises, focusing specifically on the recent launches of both Kyprolis and Stivarga in the United States.

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 2012 and provide 2013 corporate financial guidance. We will then open the call to 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 the perspective supplement we filed with the SEC on January 17, and our 10-K for the year ended December 31, 2012, which we expect to file next week, as well as to our other filings.

During today's call, we will be discussing Kyprolis, carfilzomib, for injection. For full prescribing information on Kyprolis, we refer you to the package insert posted at www.kyprolis.com. We will also discuss Bayer's Stivarga, regorafenib tablet, which are approved for the treatment of patients with metastatic colorectal cancer who have been previously treated with currently available therapies. For the full prescribing information on Bayer's 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 and slide presentation, which are posted on the Onyx website at www.onyx.com. I will now turn the call over to Tony.

N. Anthony Coles

Thanks, Amy. Good afternoon and thanks for joining us today. One year ago, we made the bold assertion that we had the potential to transform Onyx from a company with 1 therapy in 2 indications to 1 with 3 approved therapies. In 2012, we did just that, with the approvals of Kyprolis and Stivarga, offering new alternatives for cancer patients who previously had limited treatment options. Over the last 12 months, across the Onyx portfolio, we've made great progress both meeting and exceeding important clinical, regulatory and commercial milestones, making this vision a reality. We enter 2013 with Nexavar, Kyprolis and Stivarga all now approved across 4 indications, with positive Phase III data in 2 additional types of cancer, creating the architecture for near-term momentum and a foundation for growth. The next chapter of our story begins now, with Onyx positioned for a sustained growth. This success, the result of several years of hard work by our team, brings us several steps closer to realizing our vision of becoming a global oncology leader.

Let's briefly review our 2012 accomplishments and then I'd like to share our perspective on the year ahead. Approved in July of 2012 as Onyx's first wholly-owned product, Kyprolis, serves as the foundation for our proprietary proteasome inhibitor franchise. We've executed a successful launch in the United States, helping patients who had limited treatment options before this approval and creating significant value for stockholders with a new revenue stream opportunity. But this is just the beginning. As we are committed to investing strategically and prudently in a comprehensive Phase III development program across all lines of therapy in myeloma to support additional approvals and expand the indication set for Kyprolis, enabling us to reach more patients globally.

The second launch last year was Stivarga, a Bayer therapy that we believe has potential to become another global blockbuster. Last September, Stivarga was approved in the United States for the treatment of metastatic colorectal cancer and is now undergoing priority review in GIST. While Stivarga has only been available commercially in the United States for less than 6 months, we're pleased with the strong early physician interest and the important royalty revenue it will generate for Onyx. In addition, we expect regulatory actions in Europe and Japan this year, opening both of these important markets. Building on this momentum, Bayer is now executing a broad clinical development program with additional Phase III trials planned.

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