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ONYX Pharmaceuticals, Inc. (ONXX)

February 26, 2013 1:30 pm ET

Executives

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

Julianna Wood - Vice President of Public Affairs

Presentation

Unknown Analyst

Our next presenter, which is Onyx Pharmaceuticals. And from Onyx, we have Matt Fust, who's the Executive Vice President and Chief Financial Officer. Matt?

Matthew K. Fust

Great. Thanks so much for the introduction and for the invitation to join you here at the conference today. I'm really pleased to have this opportunity to update you on Onyx and our continued evolving story as an emerging diversified biotechnology company. Let me also introduce my colleague, Julie Wood, our Vice President of Public affairs, who's here with me today.

As noted on this slide, my remarks today may include the usual forward-looking statements relating to Onyx's financial results, our business prospects, development plans for our pipeline candidates and so forth. I'll encourage you to review our SEC filings for the appropriate risk factors.

This past year has been one of tremendous transformation for Onyx. Just one year ago, Onyx had only a single-marketed therapy, Nexavar, in 2 indications, for the treatment of liver cancer and for kidney cancer. During 2012, 2 new products, Kyprolis and Stivarga, obtained marketing approvals and registration enabling data were obtained which may lead to additional indications for both Stivarga and Nexavar. Meaning, as we come to 2013, Onyx is a company with 3 approved therapies with marketing approvals and/or data in 6 different indications.

And importantly, this is just the beginning. This next chapter for Onyx includes expanding the global reach of the company to bring these therapies to patients around the world. This chapter starts with the foundation of Nexavar, already a blockbuster in oncology with more than $1 billion in sales in 2012 globally, and a product for which we recently announced continued growth expectation in 2013. The kinase inhibitor franchise is complemented by Stivarga, a Bayer product, which also has blockbuster potential. Both of these kinase inhibitors are covered under collaboration agreements with Bayer Corporation, Nexavar under a profit split in most countries and Stivarga, under a global royalty arrangement.

In 2012, we began commercializing Kyprolis, the first approved product in our proteasome inhibitor franchise. Kyprolis launched here in the U.S. in 2012, and we're pursuing plans to launch Kyprolis in other countries, which I'll discuss further in just a moment. Importantly, these multiple current and future revenue streams bring us significant value, diversification opportunity and optionality to this business.

The Onyx of today has been carefully crafted through the long history of the company. Therapies, including Nexavar, Stivarga and Pfizer's palbociclib, were developed through collaboration arrangements which provide this important foundation for our business. Over the course of the past 5 years, that foundation has been complemented with other transactions, including in licensing and 1 acquisition transaction that have fundamentally transformed Onyx's business. Today we are risk diversified with a much broader portfolio of opportunities, including an international expansion, which will be enabled by Kyprolis.

Let's start with a little bit deeper dive into the proteasome inhibitor franchise, where we're focusing initially on opportunities to treat multiple myeloma, a market which we expect could reach $10 billion by 2018 on a global basis, with compounded annual growth of 10% in the newly diagnosed, relapsed and later lines of therapy.

Here in the U.S., Kyprolis was approved in July of last year. Kyprolis has approved marketing indication for the treatment of patients with multiple myeloma, who received at least 2 prior therapies, including bortezomib and an IMiD, and who demonstrated disease progression on or within 60 days after completion of their last therapy. Kyprolis sales during approximately 5 months on the market in 2012 were $64 million, reflecting the orders that were placed and products received by clinics and hospitals, along with an approximately $10 million of deferred revenue as of the end of the year, a very strong start for the product and evidence to the significant unmet need among these late stage myeloma patients.

We estimate that there are probably 10,000 to 15,000 patients in the U.S. who are eligible each year under our label for Kyprolis. This number reflects the influx of newly eligible patients, as well as, unfortunately, the mortality rate for this deadly cancer. Last year, we deployed a multidisciplinary field team that focuses exclusively on Kyprolis, which is separate from our Nexavar and Stivarga field team. The Kyprolis team has deep expertise in oncology and a track record of success in communicating the clinical information, as well as experience working on injectable product.

Our commercial team is targeting approximately 2,000 physicians, offices and hospital infusion centers, where the vast majority of the patients eligible for Kyprolis therapy received their care and treatment. In the first 7 months after the launch, we've managed to establish a large base of Kyprolis prescribers, more than 75% of that 2,000 initial target have already ordered Kyprolis at least once, and more than 80% of those accounts report ordering more than once through December of 2012. We expect this year the new patient growth will come both from these established Kyprolis prescribers, as well as from newly adopting clinics and hospitals. And our market research continues to confirm that Kyprolis is predominantly being used for our indicated population and it's approved dosing regimen.

Kyprolis is now enabling an international expansion, a first in Onyx's history. Moving now beyond the capabilities of our U.S. commercial organization, we are preparing to bring Kyprolis to additional patients around the world. In Europe, we are in the initial stages preparing to commercialize Kyprolis in the key markets of Western Europe. Today, our modest European footprint includes the small core leadership team, who are preparing for potential launches in these markets, following approval by the European Medicines Agency, which may be available if we obtain positive results from either the ASPIRE or the FOCUS clinical trials for Kyprolis, which I'll talk about further in just a moment. Our early efforts in Europe this year are focused on activities such as preparing the reimbursement dossier, the advanced regulatory work and development of relationships with key myeloma thought leaders in Europe and elsewhere.

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