Only that the TAM given is deceptive (for BCRL anyway - very hard to estimate lymphedema related to other cancers)
The maximum revenue achievable from BCRL would likely be 50%(they are aiming for 30-50%) of the amount reimbursable from all the women diagnosed with BC , tested under the protocol of the Prevent Trial (five years , first at baseline, then four times the first year, by the fourth and fifth years once a year) × the average amount reimbursed (I have estimated US$190 - a rough average of the Medicare amount and the private payor amount) × 1.4(exchange rate 70¢). To achieve a TAM of USD1b per year would require nearly 900,000 new cases of BC per year - and the figure quoted by Impedimed is 300,000(though a figure I have seen online suggests that that may be an underestimate).
It doesn't matter how many extra sites of service there are - the total revenue achievable is still based on the total amount reimbursable, which ultimately depends on the number of new cases of BC per year
My last official maths was decades ago, so I would welcome any of you to check my figures. I know there are many on this forum who have backgrounds in finance .
It bothers me that the company quotes a TAM which is simply untrue - that is , it is not 'addressable' , or at least achievable. It makes me wonder whether there are other things where they are not being honest.
Also, not every woman will qualify for testing. Has anybody else closely examined the different policies issued thus far? Under the Priority Health and the Tennessee BCBS policies nearly every woman probably will. However, the Michigan BCBS policy is much more restrictive. For example, women who have axillary lymph node dissection or sentinel lymph node biopsy with six or more nodes biopsied are eligible to be tested. If the percentages of patients in the Prevent Trial are similar to the percentages of patients in the general community, that would result in 17.4% with ALND and about 80% with SLNB . However, only a tiny percentage of those who have SLNB have six or more nodes biopsied, so perhaps fewer than 20% of the total would qualify for testing on those grounds. And of the patients biopsied, my rough calculations give only about another 10% of the total who would qualify for testing because they have radiation, and perhaps another 20% who would qualify because they have taxane based chemotherapy. (Remember that there is an overlap in these fields).Hence, a woman who has a Tennessee BCSB would almost certainly be reimbursed, but a woman with a Michigan BCBS policy would only be 50-60% likely to be reimbursed. That is, if the percentages who have the various forms of surgery and therapy are the same as the percentages in the Prevent trial. We should be hoping that other private payors will follow Tennessee BCBS, not Michigan BCBS!
Again, I would welcome anyone to check my calculations.
My email to Tim asking for clarification on the TAM and other matters was sent on June 22. He didn't get around to it straight away, then he was away, then our IR lady contacted me a week ago to say that he was not prepared to answer any questions until after the financial results come out. (She thinks that the quarterly will be issued in the last week of July) I had decided not to post any more until then, but Maxkieh addressed me directly. This is the only HotCopper forum where I take an active role, as Impedimed is the only non-standard company in which we have a very significant holding .
To counteract the above negative comments -
1)The only study that I could find online that tackled ' lower extremity lymphedema' after gynaecological cancers had a figure much higher than the 20% for BCRL. Terrible for the patients, great for Impedimed's TAM.
2) The report from Wilson's (thank you very much Twodogs - that was extremely enlightening) suggests that the TAM can be increased by the addition of testing for thoracic lymphedema . Melanoma is mentioned, but, in fact, some breast cancer patients get lymphedema of the trunk also . Impedimed will need to do a study to prove to the FDA that SOZO should be cleared for testing for thoracic lymphedema, so revenues from that source could be at least a couple of years away.
3)Further looking into MoistureMeterD made me wonder why I ever thought it could be remotely considered a competitor. The Delfin website speaks of seventy clinical trials proving its efficacy, but the only ones I could find online were using MoistureMeterD to monitor already existing lymphedema , not to detect sub-clinical lymphedema.
In fact, the FDA has cleared it only for monitoring, not for detection, and it seems that my concern - that Delfin would be able to produce studies to ask the FDA to consider it for detection - was unfounded.
I rang Delfin's Australian distributor. It sells for $10,000 here, and I was told that they have good feedback. I suspect that it is probably bring used by physios who specialise in lymphedema, to monitor their patients. But that is worlds away from the revenue that SOZO in the US system should achieve.
Although I am at home as a carer, and therefore have a lot of time to look into this, today is a very busy day, and I hadn't really wanted to post all this. However, this forum is full of my bletherings, so I felt it was the honorable thing to do to answer Maxkieh.
My own final take is that the amount of revenue, and profitability, will depend on how generous the policies are. The revenue will be much less if they all end up as restrictive as Michigan BCBS. If I am allowed one question at the quarterly webinar, that will probably be it. However, when lower limb and thoracic lymphedemas are added, and , let us hope, renal and heart, the revenue should be very substantial. For a company in the growth phase, pumping money into sales staff , CSM's, and especially into refining the algorithms and conducting the studies to enable SOZO to be used for thoracic lymphedema, and renal and heart, profitability and dividends may be years away. (My emotional side has also been probably unduly affected by a certain distrust of a company that could dismiss someone of the quality of MB)
GLTAH
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