I don't believe so. The international markets are targeted initially for the low cost so so they don't have to wait for these guidelines. The premise is that many international markets are primarily government pay markets and they can't afford the higher cost test. Therefore, Sequenom want's to offer a test that is lower cost so they can provide a "good enough" test for those markets at an approachable cost. In most markets that will likely focused upon their equivalent of high risk due to the existing guidelines that are relied upon by many countries. We haven't heard much about it, but they also are likely going to provide this test to "self pay" patients in the US as well. They likely won't market it, but if someone wants to pay for it themselves, it appears Sequenom will begin to provide it with the introduction of this test.
My guess is that they won't actively market this test in the US until guidelines/recommendations are out, insurance policy determinations are made that it is reimbursable for low risk, and they have reimbursement contracts in place at acceptable payment levels. That's why they have stated 2-3 years for this in US.
Test decline: Primary reason appears to be the shut off of govt nonpayers. That sequential decline was 3k. Commercial growth is clearly declining caused by competiton and penetration of around 40% in US high rigk.
Moving away from providing a goal for tests is likely driven by 2 separate agendas:
- A revised priority toward paid tests rather than unit market share.
- Slowing growth is clearly happening in US high risk. They are motivated to now focus on revenue growth which should be a more favorable metric with any improvement in reimbursement. My bet is this is a short term change. Once low risk is in play we will hear volume growth again.
I talked to Paul about it. Appears that until recently they had a very hard time with the defined price point requirement. He stated that there are a myriad of price points for agreements like BCBS based upon the different plans and affiliates under the umbrella. I thought they would get some as well by Y/E clearly it was again out of reach.
I have no idea what topic you are asking me to respond to. I've had you on ignore for a long time. Hard to evade (sic) something when I have no awareness of it. Let me know what it is specifically that you want to discuss.
Not all that surprising is it? The number of issues that have hammered the price action of this stock are still front of mind for many investors. Many of them are as yet unresolved
Not surprisingly you fail to point out anything inaccurate in the post nor do you provide any alternative analysis that runs contrary to the relevant company objective of achieving positive cash flows by Q4. I'm happy to have a civil debate about the potential catalysts and pitfalls looking forward. Hope you take the offer but I suspect you will chose to avoid providing original thought and continue to ridicule those that do.
Have to take your word for it. My ignore button has been put to full use on this board, despite my infrequent visits. Good catch on the potential for a patent news catalyst..
Hard to ignore some basic facts:
1) $71m of cash available vs 3 projected quarters of declining cash needs.
2) Company is hiring again despite priority of cash flow positive by y/e. Currently have about 20 more employees than after the RIF and have 20 open positions.
3) Q1 spending will likely be $1-2m lower than last quarter unless legal ramps up again.
4) Exec expenses run rate could drop by $500k per quarter with the departures of Hixon, Cantor, Lindsay and Maier even after promotion bumps and ongoing fees
5) International growth should be accelerating from the current 12.5% Q4 level with the Lab Cerba recent launch and the minimal penetration overseas.
6) With 21m covered government lives under contract and with CMS codes and negotiated rates, domestic revenues should re-accelerate.
7) Early stage market penetration usually has the highest price for tech companies. As markets mature and competition heats up, prices come down. Normal pricing arc. $1200 provides a good base to work from and the closer we get to competition, the more the quality difference will influence choice.
8) Commercial covered lives has finally reached critical mass. Now has reached the level where those not under contract will be more frequently compared with those that have coverage by consumers.
9) Sequenom spent around $12m in licensing fees last year (14% diag COGS) and around $20m in IP legal fees to contest infringement. This redundancy will eventually sort itself out. Likely not this CY and they are STILL projecting cash flow positive.
10) Bioscience operating income was dramatically better in C13 than C12 after absorbing cost of FDA filing and new RUO panels. That won't be ignored by anyone reviewing results.
These are Real operating trends that are all positive. None of them rely on the random possible catalysts that could include:
a) FDA approval
b) Bioscience sale/partnership
c) low cost launch pr
d) accrual basis conversion upside at some point
e) old reimbursements, some of which will be upside eventually
And going back to the amount of the receivables that earn on our balance sheet that we showed the $46 million to $51 million, we were conservative and didn’t include any Medicaid in our assumption for that number. So, there is quite a bit of outside there.
Rob, any way you can help us with the contribution you expect from the Verinata collaboration for the year?
Robert F. Friel - Chairman, Chief Executive Officer, President and Member of Finance Committee
Well, I would say, we -- as I said in the comments, we're -- I would say long-term we feel good about NIPT, right? And you can see the ramp-up in the coverage has been very good. The real question is how quickly the payers and the payment occurs. And one of the things that -- we look back even at our NTD business and the biochemical screening, and it does take a couple of years for that test to ramp up and to beget a sustainable reimbursement rate. So I think that's the question for us. It's being adopted. Its being sort of picked up by contract. But I still think it's going to take a little while before you'll see consistent, repeatable reimbursement.
LOL very true but note his statements in the documentary.
Today they ship to US and have NO insurance coverage.
In the future he sees 3 inevitable changes....
1) Cost has to decline to be economically viable to reimburse for all.
2) At that point the government insurance will reimburse for test.
3) Samples will need to be processed locally.
Course seems pretty clear. Let's get the low cost NIPT out on an alternative platform and get to work on 2-3.
Victorian Clinical Genetic Services uses the Panorama prenatal test, offered by the US biotech company Natera
David Amor is the director of Victorian Clinical Genetic Services "It's a certainty that eventually there will be government funding for this type of testing..... It's inevitable that this test will need to be done in Australia. We can't go on forever shipping samples around the world. " Victorian Clinical Genetic Services uses the Panorama prenatal test, offered by the US biotech company Natera
PM - Documentary special - prenatal screening 10/01/2014 - ABC
I'm sure most are, but i'm not smart enough to be able to tell the difference. When I got burned by fraudulent bank confirmations that were sent to auditors by bank employees, I finally realized how unreliable the control functions are with China companies. Companies and banks float cash to prop up balance sheets as "proof" of sales. WHen the SEC tried to get documents from auditors, the govt of China steps in and stops it claiming state secrecy laws (advertising?) Good luck with AMCN
Looks like it. Might have been a budgeting exercise where they put jobs in system as a placeholder for some RFP and then removed them.
Hi Max-I sold most of my TCS some time ago. I took a quick look at Airmedia and I'll pass. I was burned by another China advertising company. Amazing coordination of management fraud and forged bank confirmations from bank officials. I'll never invest in another China company directly.
Company generated $150m of cash from the IPO of Fox. That has yet to be redeployed so naturally estimates are down. They now only own 54% of Fox so their earnings from Fox will be down 46%.
They addressed the dividend Q after the Q3 results as follows:
While we expect our cash flow per share to be reduced to a level below our current distribution per share as a result of Fox's IPO, our board made the decision to maintain CODI's current level of cash distribution given the significant proceeds generated from this transaction.
Since our own IPO, we have realized gains of more than $270 million from the monetization of our interest in CODI subsidiaries, including Fox, which are not included in our calculation of CAD.
I haven't spent any time on this board for a couple months because of the business trend. Yet you and band of cronies/aliases continue to remember me. Honored!
So what is it you think I have or should have learned? This should be interesting and I'll promise to take notes if you want to educate.
I looked all over and couldn't find any news. Suspect that the run up was on hope they would increase the divi after the IPO and when they didn't the stock sold back off. Just a guess though
I haven't talked to Bill for several months. I call Paul periodically to clarify what presentation statements or press releases. Sorry for slow response. I don't look here often for obvious reasons. If you want to chat, it's probably best to go to SA and comment. They send me an email alert every time a comment is posted on an article. GL
The IP clarity and ILMN agreements are not important to the 2-3 timeline referenced. My understanding is the 2-3 years is based upon the following:
- More clinical trials are needed beyond the one done for T21 by Seq
- Results from these future trials need to be published.
- After published, organizations like ACOG and CTAF will need to assess and eventually recommend the test for low risk populations.
- Once these recommendations exist, then policy determinations will be done by coverage providers.
- After policy determinations are made, then out of network reimbursement could occur and negotiations on contracts can be completed.
What is interesting however, is that it appears they will make this test available to low-risk self-pay patients in the US. First time I have heard them consider this option. I think the IP ruling has them ticked off and willing to go after this portion of the market to aggressively compete with Harmony
Illumina announced that they are going to submit their 2500 HiSeq with Verifi technology to FDA for IVD approval. This doesn't sound like low risk or some test other than MPSS to me. Could be that this will change in the coming months but it seems more likely that they want to stop their own lab processing of tests and would like to outsource the high risk to other labs which would then buy the sequencers. Once the setup for low risk market exists, I suspect the approval process to extend to low risk would be pretty streamlined.
I don't see Sequenom submitting to FDA for IVD status on any Illumina sequencing equipment. As you say, the FDA reviews the entire submission and with the platform and reagents outside the control of Sequenom, they would have a very tough approval process.