"Turning to the PMA supplement for RECELL GO. In September, the FDA requested additional information on day 90 of the 180-day review cycle under the FDA's breakthrough device program. This request for additional information paused the clock on day 91. Upon receipt, we immediately began to prepare and submit a complete response to the FDA. Questions broadly fell into three categories:
The first category, representing a majority, consists of clarification questions that we were able to address within several days.
On the other hand, the second and third categories require additional in-house testing to fulfill the FDA's request. We've made incredible progress developing the data plan for the testing. In fact, all testing is already underway. Consequently, we now expect to complete the data set and submit our response to the FDA on February 28, 2024. Upon submission, the 180-day real time review resumes on March 1, 2024, positioning us for approval 90 days later on May 30, 2024 with an expected launch the following day (May 31, 2024).
The first area of testing focuses on human factor* testing associated with the use of RECELL GO at different sites of service. *Human Factors Considerations
The second area of testing in broad terms aims to establish the comparability of the autologous cell suspension between the current and the more controlled methodology of RECELL GO. Two examples here include:
the characterizing of the pressure used to disaggregate cells
the soak time needed in the process.
To date, over 17,000 cases have been performed under the current method of creating the autologous suspension. As one would expect, there is tension variability across the hundreds of surgeons who have implemented the current device using their individual hand pressure.
Second, the soak process is currently 15 to 30 minutes. But with RECELL GO, it will be 25 minutes each and every time.
RECELL GO aims to control the variability introduced from these steps.
We remain confident that the additional testing in progress will provide the FDA with sufficient responses to their questions."
Regarding the revenue guidance confusion, I think it's worth remembering that FY23 guidance midpoint was originally $50M from February, raised to $52M in August after the initial FTSD momentum that JC apparently saw: “August was double the cases of July, and RECELL was used to treat 7 different indications”,“80% of the new sales team passing 5 kits/month in August”, then lowered guidance back to $50M in November after the August momentum didn't continue during September-November.
The call in late February will set the scene for 2024 because we can expect "exciting guidance" and updates:
Q4 & FY23 results/annual report
Q1’24 revenue guidance
FY24 revenue guidance Average analyst consensus estimate is currently $75.85M (50% growth). I'm currently thinking $85M (70% growth) minimum. I don't think $100M+ is out of the question yet if VAC approvals flow in from Q1 and GO is rolled out from June.
Guidance on the quarter in 2025 in which they have positive cash flow and become profitable
Confirm timing of response to FDA’s questions & expected FDA approval date for RECELL GO
RECELL GO inventory production guidance? (assume April/May if still on track for May 31 launch)
Commercial sales force expansion details to support the FTSD market (when a territory reaches $2M in sales per year – thinking commence recruitment of 28 new reps for the original 16 out of the 40 territories from Q2’24?)
Update on TONE study timeline
VAC approval progress in the 100 initially targeted new high volume trauma accounts?
Complementary products update?
International expansion updates (Japan, EU/UK, AUS)? PolyMedics launch RECELL in Germany, Austria, Switzerland during Q1.
(20min delay)