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Genomic Health, Inc. (GHDX)

Review of Positive Clinical Validation and Development of the Oncotype DX Prostate Cancer Test Conference

May 08, 2013 4:00 pm ET


Kimberly J. Popovits - Chairman, Chief Executive Officer, President and Member of Non-Management Stock Option Committee

Steven Shak - Chief Medical Officer and Executive Vice President of Research & Development

G. Bradley Cole - Chief Operating Officer and Member of Non-Management Stock Option Committee

Emily Faucette

Mark Lee


Rafael Tejada - BofA Merrill Lynch, Research Division

Kevin DeGeeter - Ladenburg Thalmann & Co. Inc., Research Division

David C. Clair - Piper Jaffray Companies, Research Division

Isaac Ro - Goldman Sachs Group Inc., Research Division

Vamil Divan - Crédit Suisse AG, Research Division

Doug Schenkel - Cowen and Company, LLC, Research Division

Daniel L. Leonard - Leerink Swann LLC, Research Division

George B. Zavoico - MLV & Co LLC, Research Division

Tycho W. Peterson - JP Morgan Chase & Co, Research Division



Good afternoon. My name is Roya, and I'll be your conference operator today. At this time, I would like to welcome everyone to Genomic Health Investor Conference Call from AUA. [Operator Instructions] I would now like to turn the call over to Kim Popovits, President and CEO of Genomic Health. You may begin your conference.

Kimberly J. Popovits

Good afternoon, everyone, and welcome. I know we have a good crowd here in the room. So thanks for the opportunity to again share some exciting data. This has, of course, been a milestone week for Genomic Health, for our collaborators and most importantly, for prostate cancer patients. So we're delighted to be able to have this extra time with all of you to go through the data again to answer questions.

I will mention upfront here with our Safe Harbor statements that we may be making some forward-looking statements here today. So keep that in mind and refer to our SEC filings for -- especially in regards to our risk factors around our business.

So let's get right into this. We have been joined today by various esteemed panel of guests, starting with Dr. Caroll who will be joining us on the phone to walk through some slides here followed by Dr. Cooperberg who spoke this morning. I hope many of you saw that and took copious notes and got every bit of the detail down in those 5.5 minutes, whatever they were. So you'll get an opportunity again to talk to Dr. Cooperberg and get some questions answered there. And then very importantly, Dr. Klein is joining us to talk about the development work that we did leading into this very important study. So I think you'll find that very interesting.

We will start though with the conclusions upfront since we know that we want to get the punchline out there really quickly for you, and Steve's going to walk through the patient report and just the positioning and some of our plans around launch. And I will just end my comments by saying we were delighted this morning around 8:00 to see the first sample be ordered online and to Genomic Health, quite a celebratory moment there as a company and look forward to helping many more patients in the coming weeks.

So with that, I'll turn the call over to the folks at UCSF, and we can get going. Thanks.

Peter Carroll

Well, thank you very much. If we can go to my next slide. So prostate cancer in 2013 is at a real crossroads. We have about 260,000 deaths worldwide. It's the sixth leading cause of cancer death in the world, actually the second-leading cause of cancer death in the U.S. Interestingly, over the last 2 decades, we've seen death rates decline in high-income North America, but increase in all other regions. Actually, it's increased over 41% worldwide.

What accounts for this is that in developed countries, with the introduction of PSA, this a simple blood test. And it's clear that screening of healthy, young, well-informed men with this blood test reduces significantly the risk of dying of prostate cancer, somewhere between 21% and 44%. And actually here in the U.S., we've seen a 39% reduction in mortality, and many people don't realize that this accounts for 20% of the overall reduction in cancer mortality in men.

If I could have my next slide. And this is a very good example. You can see cancer death rates in the U.S. lung and bronchial cancer declining as a result of smoking cessation. And you see these other remarkable declines in prostate cancer death rates starting in the early to mid-'90s at the time we reduced PSA. This is clearly due to early detection and improved treatment methods. But it's been a profound reduction, and that reduction continues.

Next slide. You go can go ahead and advance that. So further facts. The lifetime risk for U.S. men, men born in the U.S. each year, their lifetime risk of prostate cancer is 1 in 6. About 240,000 cases are diagnosed each year. It is the most common cancer. 31% will die each year, again, the second most common cause of cancer death. But if you look at the ratio between the number who die and the number of diagnosed, most men who get prostate cancer will not die of it. So despite the fact that it's a deadly disease for some, many more men will live with the disease than die of it. And the reason for this is using current method of diagnosis, again, PSA testing, we diagnosed many men with very small slow-growing cancers, which would never present a risk to them if left undiagnosed or untreated. This is a phenomenon called over-detection. It's not unique to prostate cancer, but it's probably most apparent in prostate cancer compared to some other malignancies.

Next slide. So the problem we are trying to solve is this one. Detection and treatment phenomenon called over-treatment are currently too tightly linked in the U.S. So in this country, if you get diagnosed with prostate cancer whatever risk you most uniformly treated. That is not the case in Europe where they do something called active surveillance, a little bit more common than here. So clearly, too many men undergo treatment for a disease, which would never become apparent if left untreated, again not unique to prostate cancer. Now there may be many reasons for this, but one, I think, very prominent reason is the worry about patients and their physicians that they harbor higher risk disease. By that I mean that they, in the biopsy, the PSA shows what appears to be lower risk disease, but they're fearful that they're harboring higher risk disease, which was not adequately diagnosed, kind of a tip of the iceberg phenomenon. And I think this is has been a major barrier, at least one of the barriers to active surveillance.

Next slide. So I think this is a good example here. Each one of those gray dots represents 1,000 men -- 1,000 U.S. men. The red dots hollow and filled in the lower-left corner represent the number of men who would die of prostate cancer if we didn't have screening. The hollow dots represent the number saved with screening. So, again, PSA reduces death rates. The problem is you diagnose many men with the disease. So in that large rectangle there, currently we'll diagnose about 90 to 120 men with PSA testing, and yet not all of those you can see here are at risk of dying of disease. And we would estimate probably that there's some controversy about this, but at least 20% to 40% of these patients, again diagnosed each year, would be diagnosed with what we call low-risk disease. Low grade, not very aggressive-looking, low volume confined to the prostate likely with a very low growth rate. So again we're diagnosing a lot patients to save lives, and this is a big problem in the United States.

Next slide. So this study was designed to address this issue, which is a really significant issue in my opinion in men's health. So the problem to solve was patients with low-risk prostate cancer concerned that they may have more advanced disease, which, if not treated immediately, would compromise their outcomes. Again, this fear that they harbor something more significant than what's been identified using current technology. So the solution, the hypothesis here and why we did this study was to answer the question, "Can gene expression analysis of the biopsy, which was done for diagnosis -- again, this is being done on the same biopsy we've done for diagnosis, can it predict the risk of more advanced disease better than current methods? Now the consequences if this is true is that more men would choose active surveillance in lieu of immediate treatment.

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