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Onyx Pharmaceuticals, Inc. (ONXX)

Credit Suisse 2012 Healthcare Conference Call

November 14, 2012 11:00 am ET


Matthew K. Fust – Executive Vice President and Chief Financial Officer


Ryan Martins – Lazard Capital Markets

Ryan Martins, biotech analyst here at Lazard. Next presenting company is Onyx Pharmaceuticals. Onyx has had a pretty exciting year with the approval of KYPROLIS and the recent launch which is gone pretty well. They’ve also had approval of STIVARGA for colorectal cancer. So it’s been a pretty exciting transformational year for the company and now to give you some more details around what the company has been up to, I’d like to invite Matt Fust, the CFO of the company.

Matthew K. Fust

Good morning. Ryan, thank you so much for the invitation to join the conference and thanks for all of you as well for joining us to hear an update on the evolving Onyx story as Ryan said. Let me also introduce my colleague Amy Figueroa, our Senior Director of Investor Relations. She is here at the conference with me today.

I remind as usual that my remarks today may include forward-looking statements relating to Onyx’s financial results, business prospects, and the development and commercialization of our products and encourage you to reference our recent SEC 10-Q and 10-K for more information in particular on the risk factors.

So during the last several years, Onyx has made significant progress and is trying to build a leading oncology company. If you look back just half a dozen years, the first generation of Onyx’s growth with the initial approval of NEXAVAR in advanced kidney cancer and subsequently in liver cancer which really forms the foundation for Onyx’s growth today.

In our current inclination ONYX 2.0, we continue to see strong growth in NEXAVAR sales notably in liver cancer and especially in the Asia Pacific region where NEXAVAR sales globally last year exceeded $1 billion for the first time and have grown 4% on a year-to-date basis through 2012 again with strong growth in the liver cancer arena in particular.

New to the story in ONYX 2.0 is our franchise strategy with the addition of STIVARGA or regorafenib in the kinase inhibitor franchise, and the recent U.S. launch of KYPROLIS or carfilzomib as the anchor for our proteasome inhibitor franchise. These two platforms for growth are enabling ONYX 3.0, three approved products, NEXAVAR, KYPROLIS and STIVARGA with two of those products currently in launch with here in the U.S.

In addition to potential regulatory approvals for STIVARGA, we expect over the next year to bring additional clinical results both for NEXAVAR and for KYPROLIS, which we give us data or marketing approvals and up to six different indications across those three products, which I think gives us very important optionally for driving the business and of course in helping patients.

Let's dig just a little bit deeper into each of the franchises, which enable ONYX 3.0. Those of you followed the company for sometime clearly familiar with NEXAVAR with approvals beginning in 2005 for kidney cancer and in 2007 for liver cancer. NEXAVAR, however, also has an ongoing development program which I will talk about more momentarily including important Phase 3 trials in both thyroid cancer and in breast cancer.

New to the kinase inhibitor franchise is STIVARGA, STIVARGA is a multi-kinase inhibitor, which recently completed clinical trials, recent U.S. regulatory approval for metastatic colorectal cancer, and a number of regulatory submissions in place both for metastatic colorectal cancer and for gastrointestinal stromal tumors or GIST along with an ongoing clinical program seeking to develop new indications for STIVARGA.

Both of these kinase inhibitors are covered under a global collaboration agreement with Bayer Corporation, NEXAVAR under a global profit split in most countries of the world except Japan, and STIVARGA under a global royalty agreement. The proteasome inhibitor franchise on the other side of the slide includes KYPROLIS which was recently launched in United States for multiple myeloma and oprozomib, an oral proteasome inhibitor which may have a role in various settings both for multiple myeloma as well as potentially in other indications.

Beginning with the proteasome inhibitor franchise, I’d like to focus on the opportunities for KYPROLIS and oprozomib in treating multiple myeloma and market which we expect could reach $9 billion in global sales by 2016.

Here in the United States, KYPROLIS was approved on July 20 by the FDA under an accelerated approval process. KYPROLIS’ approved marketing indication as you see here is for the treatment of patients with multiple myeloma who received at least two prior therapies including treatment with bortezomib and an IMiD and we demonstrated disease progression within 60 days after completion of the their last therapy. KYPROLIS is an injectable agent and its dosed on two consecutive days over a three-week period followed by 12 day rest period.

I'll point out that full data from the clinical study on which KYPORILS was approved was recently published in Blood, the pre-review Journal of the American Society of Hematology, which is a great overview of the details of that clinical trial.

Let me pause here to provide you with some perspectives on the KYPORILS U.S. launch which has been a source of great focus obviously for the company as well as the investment community over the past several months.

We announced on our earnings call last week that, net sales for the approximately two months that KYPORILS was on the market during the third quarter were $18.6 million reflecting orders, which have been placed and received by clinics, hospitals and infusion centers which administer KYPORILS.

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