Pelikapuntzak schreef op 7 oktober 2014 13:25:
Enkele interessante vraagstellingen vanuit Biostoxx. Ze zijn trouwens laaiend enthousiast.
On 6 October SNJ-Biostoxx requested some clarifications from MDXHealth on Medicare reimbursements. We will post the reply to the letter below when we get it.
Dear Dr Groen,
Please be informed that SNJ-Biostoxx starts following MDXHealth with an initial 2015 share price target of EUR 7,80 (+96%). (http://snj-biostoxx.eu/mdx-health). We are excited about the company's clinical and commercial developments and consider that this will be reflected in the share price in due course.
We would be grateful if you could clarify some questions that would help us to further enhance our coverage of MDXHealth.
We have carefully analysed MDXHealth press releases and quarterly reports. We have some unanswered questions on issues related to revenue recognition for Medicare patients. Our questions relate in particular to the possible cash flow and revenue impact of the 23 September LCD decision for ConfirmMDX.
In the 2013 annual report, you state that ConfirmMDX tests were performed for 7000 patients in 2013 representing a value of $ 9,2 million, of which $ 3,8 Million is recognized and $ 5,4 Million is not. These unrecognized sales are attributed for $ 2,8 Million to Medicare and $ 2,6 Million to private insurers. Medicare thus apparently covered more than 30% of total patients tested and potential sales. In H1 2014, a total of 5500 patients were tested with ConfirmMDX.
Based on the revenue reported on 21 August at the presentation of the 2014H1 results, the performed tests to date for which no revenues have been recognized amount to a value of around $ 10 million by end-June 2014, of which according to our assessment of the income statements and revenue recognition half could be attributed to Medicare.
In the MDXHealth press release of 23 September 2014 on the LCD for ConfirmMDX, the company indicated that “MDxHealth's ConfirmMDx for Prostate Cancer Test Qualifies for Medicare Coverage Effective November 3, 2014”
To SNJ-Biostoxx it is not clear what this decision means for reimbursement of Medicare patient tests to date.
- Can Medicare now reimburse - a share of, or all - test performed to date? Or just the new tests performed under the PASCUAL programme? If not, by when can Medicare reimburse the tests performed to date?
- Does the LCD decision imply that MDXHealth may - or will need to - recognize (part of) this revenue in the 2014 Q3 or Q4 financial reporting?
- We would also be interested whether there Is any decision published on CMS/Medicare pricing of ConfirmMDX for Medicare.
On behalf of SNJ-Biostoxx,