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Onyx Pharmaceuticals, Inc. (ONXX)
Lazard Capital Markets Healthcare Conference
November 14, 2012 11:00 AM ET
Julie Wood – VP, Public Affairs
Barb Klencke – SVP, Clinical Development
Jason Kantor - Credit Suisse
Jason Kantor – Credit Suisse
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Good morning everyone. It’s a pleasure to be here today. It’s certainly been an exciting year for Onyx already and we have as you’ll see in this presentation much more to come in the months and years ahead, but let me begin by introducing my colleagues that are here. I am Julie Wood. I am the Vice President of Public Affairs. Dr. Barb Klencke is our Senior Vice President of Clinical Development at Onyx and next to her is Warren DeSouza. Warren is our Vice President of Finance at Onyx.
So with the introductions, we will do the presentation in this room and then I think we’re in Grand for the breakout session and we’ll do the Q&A in Grand. Of course we can't do a presentation without the forward-looking statement that you’re all aware of. We will be making forward-looking statements and we always direct you to the filings that we do with the SEC, the most recent being our third quarter Q, so for more detailed information on business risks please refer to our SEC documents.
So anyone that has been following Onyx for any period of time knows what an exciting year 2012 has been. We started in January with Nexavar. Already approved, Nexavar is a globally successful product approved in two indications, liver cancer and kidney cancer. As we move through the year, we’ve had a number of important achievements. We have the approval of Kyprolis for multiple myeloma and we’ve had the approval of Stivarga, a Bayer compound and I’ll talk about the economics of that medicine in a bit, so both were approved this year.
So that is really exciting time for us to be involved in different launches, but the good news doesn’t stop there. We have a number of clinical and regulatory milestones that are near-term that are going to keep momentum moving in the stock as we continue to move forward.
The way we like to look at the business is a way for you to analyze and think about both parts, is to think about our kinase inhibitor franchise and to think about our proteasome inhibitor franchise. If you think about the kinase inhibitors, as I said we have Nexavar. Nexavar is approved in over 100 countries for kidney cancer and liver cancer. For liver cancer, we maintain our leadership. As you know, there have been a number of other compounds that have tried to enter this marketplace but they’ve not been successful.
The important part for Nexavar is the continued growth in emerging markets, particularly Asia Pacific. And we’ll talk about additional clinical trials for Nexavar that are currently ongoing namely the Thyroid trial and the Breast Cancer trial which Barb will talk to you about in a minute. Stivarga as I mentioned was approved in September, a month ahead of its PDUFA date. It is approved for metastatic colorectal cancer and again Barb will go over some of the details of this trial that led to that registration.
There is a number of regulatory reviews ongoing both in Europe and Japan for colorectal cancer. There is also an SNDA that has been filed for a second potential indication GIST and subsequent to that approval, there will be again a global registration strategy. If you turn to the other side of the business, the proteasome inhibitors, Kyprolis is our wholly-owned product. It was approved on an accelerated basis in July and we are in the midst of launching that product now. We also have a number of additional clinical trials underway because we start with treating the sickest patients and move to those less sick patients. And we think that this is a medicine to decide daily suited to help these patients across the disease background.
We also have an oral proteasome inhibitor, Oprozomib that’s in clinical development and you’ll get a little bit more data on that particular compound at the upcoming ASH meeting. So let's talk for a minute about the proteasome inhibitor franchise. This is what Kyprolis looks like for those of you who haven't seen the bottle. As you know the indication is for patients who have received two prior therapies. They have had to have received Velcade and an IMiD and progressed on or within 60 days. This is an accelerated approval based on a single-arm trial where response rate was used as the mechanism for approval. We do have our confirmed tour study well underway, ASPIRE and again Barb will be talking to you about that in a moment.