Doesn't know the commercial status of prostate test nearly a year after launch. Indicates that the breast market is nearly tapped out? neglects developments in Europe with NICE.
A total waste of time.
Was on CNBC this AM and said he thought that the price of nat gas would remain around $5 mbbu through this summer. He indicated that the inventory rebuild will not occur very rapidly since many of the land based rigs have converted to oil exploration.
Boone is not always right but he does have a pretty good pulse of the petroleum E&P Business.
Up until fairly recently the BB BCRX holdings have not performed all that well. Don't get me wrong the BB are one of things that drew me to GHDX, however it is important not to believe that anyone is infallible.
My position is based on my belief that genomic testing will bring patient benefits (better selection of treatment options) and will help society better spend its health care dollars at a time when the aging of the baby boom generation is poised to break the bank.
The investor should realize that there are powerful forces allied against the type of cost savings that GHDX represents. Think about how many proton beam radiation treatment units or robotic surgery units could lose business if the prostate test delivers on half of its promise. These are big money makers for some hospitals. The key is whether the affordable Health Care Act is successful in shifting the payment model from treatment based to outcome based. If the US proceeds down a path half as stringent as Great Britain (think NICE) then GHDX should be well positioned for the next decade.
Unfortunately Yahoo no longer allows the link to be posted.
Note that the biopsy samples in this study were all from radical prostatectomies. This may underscore the GHDX test being sensitive to sample volume and heterogeneity effects.
Myriad Genetics Publishes Prolaris(R) Data in the Journal of Urology
Tue February 18, 2014 7:05 AM|GlobeNewswire | About: MYGN
SALT LAKE CITY, Feb. 18, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) today announced it has published data in the Journal of Urology demonstrating that its Prolaris test accurately predicted, based on biopsy specimens, which men would develop biochemical recurrence (BCR) or metastatic disease following radical prostate surgery. Prolaris is a 46-gene molecular diagnostic test that has been evaluated in more than 5,000 patients across 11 clinical studies.
The study evaluated biopsy specimens in 582 men who were treated by radical prostatectomy. In the study, biopsy samples were evaluated from three cohorts of contemporary patients in the United States and Germany. The clinical endpoints were metastatic disease and BCR. In all cohorts, the Prolaris test was a statistically significant predictor of BCR and was the single strongest predictor of metastatic disease when compared to Gleason Score or PSA. In the pooled analysis, each one-unit increase in the Prolaris score translated into a fivefold increased risk of metastases and a 1.6-times increased risk of BCR.
I don't think anyone really knows exactly how OncoType DX prostate test stacks up against the Prolaris test from MYGN. I listened to both conference calls and it is apparent that GHDX sounds very optimistic about there test whereas MYGN was somewhat subdued. This is probably because they have a lot more irons in the fire and are not as dependent on Prolaris for growth. I would not place much emphasis on the 19 vs 48 genes. Until there are definitive head to head comparisons there is probably a lot of room for both to do very well. That is why GHDX has to ramp their sales force now or concede market share. It is aparent that Prolaris has first mover advantage and Medicare coverage would be a huge benefit to their sales team. This is why part of GHDX's 2014 expenditures are for additional validation studies. They also need to secure coverage ASAP.
It seems like a head to head study could be completed pretty quickly. The samples of biopsies exist go back and look at the Prolaris score vs the Oncotype DX score and then evaluate the scores against the course the disease took. The call indicated a high ONco Type DX reorder rate by Urologists and they did not give any indication that they thought competition would constrain sales. I guess if there is room in the market for both companies neither will conduct the head to head comparison unless you know you will prevail. I think "prevail" means which test has a lower false negative and false positive rate. I think a company would have to run this type of study and know the outcome before they take a chance in publishing anything.
I agree with most of what you wrote hobo. However, I still think think my strategy of selling upside calls when the price goes up and buying new shares on these dips makes sense given the volatility. At least until the trend really changes. I plan to keep my core position but sell calls on about 25% of my holdings. I think this strategy is good for the next 6 months but will reevaluate after the mid year. I may lock up the trading shares if progress starts improving (i.e., more prostate validation studies and visibility on medicare reimbursement for prostate)
It is unlikely that the BB will acquire a substantial number of additional shares unless they want to file GHDX with the SEC as a wholly owned subsidiary.
I believe that biogenerics are the strongest engine for growth going forward. 8 Phase III studies are underway for some of the biggest blockbusters in medicine including Humira, Enbrel and Rituxan. These products will drive long term growth and will face less competition than typical drugs. Competitors like Teva have dropped there program for Rituxan. Biogenerics are positioning Sandoz to become the largest generics company in the world.
NVS has too many moving parts to look for one major catalyst. Your better going to small biotechs if that is what you are looking for. NVS is more like a well diversified Health care mutual fund.
This announcement shocked me. I'm surprised NVS would make any investment in India after the disregard they have shown for the Glivec intellectual property.
I listened to the MYGN call last night. A couple interesting points were made but the real interesting thing was the lack of any specifics on prolaris. Other than they hope to have medicare coding approval by end of the year there was not too much information.
They definitely have the first mover advantage over the OncoType DX prostate test (sales force has been in existance longer, may have medicare approval sooner).The Prolaris test is based on the expression of 46 genes, and focuses on risk stratification. However, I suspect that Prolaris is vulnerable to sample size and sample hetrogeneity issues since GHDX seems to drive this point home in every call.
Part of the MYGN call focused on Medicare pulling the payor approval coding for one of their Breast cancer tests. I believe they saw a drop in sales of this product of 15% in the quarter. Anyone know whether that loss of medicare approval corresponds to OncoType DX's Breast test approval?
How likely is Medicare to look at any type of head to head data on the prostate test before granting approval to Prolaris. If non exists, how likely are they to put off a decision until a more definative head to head evaluation exists.
I had pretty much the same take away. I thought the spending ramp for prostate was a positive since it is in response to stronger than expected demand. They are definitely under promising hopefully to set up an over delivery in a few quarters. The lack of catalysts you cite can change quickly. I would not be surprised if the NICE OncoTypeDX Breast endorsement opens several doors in western Europe. Most of Europe is looking for ways to cut healthcare costs and trimming unnecessary chemotherapy can be a strong incentive. I can see that it might take several months to negotiate with payers so announcements of new payment agreements could hit at any time.
I think that GHDX is very conservative and has only built projection of current growth rates into their guidance. They will have to reach the tipping point (sales staff learning curve etc.) before the growth rate can ramp.
I'm long and have no reason to panic anyone out of GHDX. I admire the Baker Bros investing acumen. However, the fact remains that when more than 50% of the shares are held by just 2 institutions it devalues any say that the minority shareholders might have. Right now I have no reason to suspect that the Baker Bros interests are not aligned with the minority shareholders.
With regard to the earthquake prone issue, GHDX does not think this is a minor issue and they list it in their annual report as a concern. I would not be surprised if sales volumes take off in Western Europe, if we see another lab facility being launched overseas in the next couple of years.
Just because someone looks objectively at both positives and negatives does not mean that they are a shill. This investment will play out over many years so I do not feel compelled to have to hype it up.
Looks like a washout. Added a little more in the $26's. Its funny that a company like Amazon can forstall profitability for years while they build their competitive advantage but there is zero tolerance for the same type of a build out to occur at GHDX.
Its interesting to note that MYGN was charting similarly to GHDX but broke out this morning on better than expected earnings.
Guidance has a lot of moving parts, but I think you are right that things do not really pick up until after the 4th qtr or in 2015 after prostate validation tests are published and the sales staff ramp (urology and western Europe) stabilizes.
Interesting part of the call is that competition really isn't a concern. Prostate test method has been patented. The prostate test is meeting an unmet need and has encouraged them to ramp up the sales staff faster than had initially been anticipated. Wall Street wants immediate profits, however, I'd rather see GHDX establish a moat by getting the sales force in place, getting validation studies supporting the prostate test and getting payer approval coding in place. Once these things are in place anyone could sell the product.
I think you are right there will be a buy opportunity do to lack of patience.
There is not that much float so it is a good chance to snag shares at a discount. When the pieces are in place this thing will move.
I also think that GHDX's only lab facility is built on an earthquake prone fault to be a negative. However, based on my DD the positives outweigh the negatives so I'm long. Good luck with your strategy of making decisions off of one piece of data.
I do not consider the fact that more than 50% is in such few hands a positive. Too much potential to push an initiate which benefits them at the expense of small shareholders,
I see tomorrows report as providing another data point. Likely to see continued strong rev growth but earnings will be depressed and reflect the costs of launching the prostate test. Real growth in earnings will be apparent when the Urology sales force is fully staffed and the payer codes (medicare etc.) are in place for the prostate test. That could be a year away.
I was hoping that the short term chart would provide another chance to fill out my position in the 20's. It did. I expect that the short term pattern may soon be eclipsed by the longer term upward chart pattern. Hopefully tomorrows cc provides the impetus for this move.
I started listing out the growth drivers for GHDX and got to 10 and decided it was a screaming buy.
My father died more than a decade ago from prostate cancer, and I believe that that the OncoType DX test has the potential to be a real game changer in men's health.