Wow is all I can say ... the inclusion of IBD screening for CRC was announced. 50% of IBD patients die from CRC, did I hear that correctly? lots more info just starting the discussion ... God's speed to all those effected by the storm
Sentiment: Strong Buy
Here's my notes on a few points that haven't been discussed.
Good news: They have already made a pre-PMA submission and received comments from the FDA. They fully expect an expedited review. This is big news since this means that full FDA approval could occur in 2013. Full launch upon both FDA/CMS approvals.
50% of intended patients covered by medicare. Private payers follow inclusion of test on Medicare guidelines.
12000 patients in 28 sites – final number at 12500. 50 cancer pts enrolled and a few more are likely. Expect over 700 pre-cancerous polyp patients. Largest trial ever conducted for this type of screening. All samples will be assigned randomly to three sites and they will be processed starting in Dec. It will take 3 months to process all the samples. About a week to analyze and perform stats after unblinding. This will be a definitive study, and I'm glad they did it up-front. I'm also glad they are analyzing all the samples.
Manufacturing module submitted in Dec. Analytic Module in Feb. Top-line results to be announced in March. A little later for the top-line results than we expected but I like the fact that the submission starts this year.
Decided to focus at launch at 400 largest hospitals and systems. These make system-wide screening decisions. They also employ their own screening programs. They usually offer only 1 fecal non-invasive test. The FIT test has taken over from FOBT (65% sens for overall cancer detection). Has gone from 200K tests to 3.5 mm and growing. They will aggressively pursue replacement of FOBT and FIT.
Small MAYO test: 100% cancer and 80% pre-cancer detection in IBD with 89% specificity. Main method today is colo with multiple biopsies. Key opinion leaders have helped draft a protocol for enrolling 300 IBD patients 50 w/cancer or dysplasia and 250 w/o. 1.4 million pts currently with IBD. 30K new diagnosis each year. Peak onset 15-30 years old. They are typically screened for CRC starting 8 years after diagnosis. Note that the preliminary MAYO data is essentially as good as a colo where only 65-70% pre-cancerous lesions with high grade dysplasia are detected.
Lab Fee schedule – They think this will fall onto lab-fee and not physician-fee schedule since docs don’t make a read. Value of that is currently undergoing review and data will be provided to CMS and private payers. 3 of these tests over time (10 years?) is significantly lower cost than colonoscopy. CMS pays $2500/colo. They are not providing guidance on CMS reimbursement, but expect it will be in hundreds not thousands.
Any sense of what sales and marketing expenses might be in the ramp-up? Will talk about it on next CC. Huge R&D line will drop and will be replaced by S&M. Will not ramp up exponentially in 2013. They will make these decisions after top-line data is released. Increase will likely be in Q3, Q4 timeframe (2013). Overall operating burn will likely not increase too much since R&D replaced by S&M.
My key takeaways from the CC
1. IBD moving much faster than I expected. Clinical trial will be started and completed in 2013. Wow.
2. Deep-C delay is no biggie. I always suspected we wouldn't get top-line data until 1Q13 anyway. Getting CMS coverage, coding, and payment decisions within 3 months of FDA approval is awesome and more than makes up for it. Revenues can ramp much faster than I expected now.
3. KC opening and closing with offering to help Sandy victims, esp that being his sole closing comment, concerns me. Sounds like he's running for office. Long terms holders know why that is a concern with KC.
4. Their own lab. I guess that explains the recent facility expansion they did.
I hope the stock tanks tomorrow due to Deep-C data delay. Shares are already at a price where I want to add.
All just a bunch of rose colored glasses, pumptard #$%$ and blather. If you believe what you wrote may the good lord have mercy on your soul. NONE of today's news was good. Can you say "A DAY LATE AND A DOLLAR SHORT". This is just another delay. Please tell us genius, just how wide is our door open for the next PIPE DEAL? I would say, "just about wide enough to drive a tropical storm thru". DILUTION, Next Stop, DIlution!
Sentiment: Strong Sell
earwax, well done! I believe this is huge moving forward ... i can't imagine the physical act of scoping an IBD patient helps their situation ....
Note that the preliminary MAYO data is essentially as good as a colo where only 65-70% pre-cancerous lesions with high grade dysplasia are detected.
The parallel pilot program with CMS looks to be a HUGE factor!
The "expedited" review by CMS means that a National Coverage Determination - - - coverage, coding, and payment decision will occur within 3 months of FDA Approval!!!
Conroy stated that the Company has ALREADY made a pre-PMA submission with Agency comments. Looks like all of the parties involved really want to see Cologuard get on the market!
ACA mandates insurance coverage for screening tests rated either "A" or "B" by USPTF.
USPSTF evaluation is set to occur in 2013-2014.
CMS represents nearly 50% of the target patient population.
Thanks for the correction on IBD and CRC. I did go back and see that CRC is the LEADING cause of death in IBD suffers. Can you imagine have to endure 20+ colonoscopies/preps over the duration of your disease? The graphics suggested a fairly muddy picture of what the colonoscopist can view. A new paradigm of screening for these 1.4 mil is on the horizon. I would imagine Cologuard will be 'off-labeled' to these patients prior to clinical trial completion, approval, etc.?
Ranj, it sounded like he said that 50% of the IBD patients suffer from colonoscopy & or biopsy fatigue from the constant checks that are required for screening. It seems it is imperative for this patient population to be screened regularly, and to be screened in the matter of a colonoscopy on a continued and repeated basis, which I would assume is not very pleasant.
Sentiment: Strong Buy
exactly. And the point is that their colons are so messed up that colonoscopy is not very good at finding cancers. Thus, they must randomly biopsy the colons on a regular basis hoping they find any cancer if it is there. Cologuard represents a real breakthrough in detecting cancers in this patient population.
listened to it live Wish I had more cash to buy. This company, if not bought out, will have a market cap in the billions in the years to come. When does it start escalating? No one can know. But I'm all in here and content to wait for the financial world to give this the market cap it deserves.
KD, I agree ... I've been on board since '09 the execution of this team is superb! The analysts that were part of the Q&A spoke as a matter of when commercialization happens NOT if and will EXAS be prepared for the IMMEDIATE demand for Cologuard?The answer was yes because they will have their own lab and lab partners. Conroy said ' the attention level couldn't be higher' regarding the FDA/CMS. The delay to 11-15 in enrollment doesn't materially effect timing of commercialization. Everything that was communicated by Maneesh, Kevin and the analysts couldn't have had a more positive undercurrent to it. At the risk of sounding like a 'pumper' the explanation of the 83% detection of the high grade dysplasia and what that means was powerful.
8% of the large groups account for 60% of the FOBT/FIT volume ... appears they have targeted those as the initial target. I encourage all who own stock to listen to this CC you will sleep very well tonight if you are long of course :)
Sentiment: Strong Buy