Forum Topics AVH AVH CE Mark Approval

Pinned straw:

Added 3 months ago

ASX Announcement

At last!

Today’s CE Mark approval for RECELL GO unlocks AVITA Medical’s long-planned entry into Europe.

Rather than building its own salesforce, AVITA will commercialize the product through third-party distributors, a lower-cost strategy that leverages existing specialist networks. Distribution agreements are already in place across Germany, Austria, Switzerland (via PolyMedics), Benelux, the Nordics, the U.K. and Ireland, with Italy, Spain and Portugal close behind. This coverage secures AVITA a footprint across nearly all major Western European healthcare markets.

The maturity of the sales plans highlights the delay in getting the CE Mark, which CEO Jim Corbett repeatedly blamed in the past on "bureaucratic delays", but which I have previously cited as evidence that the company consistently sets expectations and targets that it then fails to deliver on - albeit several strictly being beyond its control.

The company’s marketing approach outside the US emphasizes ease of adoption. Unlike earlier RECELL versions, RECELL GO requires less training and case support, making it easier for European hospitals to integrate. AVITA expects its distributors to drive uptake through established hospital relationships, with reimbursement supported by national health systems. However, management has cautioned that international revenue contributions in 2025 will be modest, given reliance on distributor-led rollouts and the time needed for value analysis and reimbursement processes. In my view, it will likely be 2027 before revenue contributions outside the US are material.

With CE Mark approval, the company transitions from being a U.S.-centric player to one with a scalable global platform in acute wound care. While near-term sales will be limited, the groundwork is laid for Europe to become a significant revenue stream from 2026 (or 2027?) onward, particularly in high-volume trauma and burn markets.

Referring back to last week's post, this timing could not be better (accepting that it is delayed) given the recent presentation at the Europe Burns Conference on the reduced time in hospital for patients treated by Recell. This will both assist with reimbursement and be a boon to marketing efforts.

My Assessment

This is good news for the medium to longer term prospects for $AVH. In my view, the CE Mark decision was always a question of "when" and not "if".

Following the distributor model is the right thing. $AVH has to steward its cash carefully, and CEO Jim Corbett knows that getting to profitability and postive cashflow is key to creating some investor confidence around this company. He is wise to be focused on that.

While this good news might create some long-absent positive sentiment for this beaten up biotech, the major SP re-rate will await the 3Q result at the end of October, and any news of how sales in the US are progressing, and whether the CMS coding debacle has been resolved and to what extent hospitals are ordering again. For me, that is an vital test of management's credibility, given their detailed descriptions of what went wrong in Q1 and Q2. From my perspective, Q3 and Q4 have to deliver.

I still believe that $AVH's time will come, soon, so I am a HOLD for now.

Disc: Held in RL and SM

jcmleng
Added 3 months ago

Discl: Held IRL and in SM

Fully agree @mikebrisy, this is indeed a Praise-thy-Lord, long time coming, moment for sure! If its not too much to ask, a nice 3Q25 update would now be very nice ....!

AVH has guided to zero international revenue in FY2025, so this is really FY2026/FY2027 revenue. But it is just good to now have this part of my thesis materialise.

On expectations management on the CE Mark approval specifically (it was something that I tracked closely as it was one revenue driver in my thesis), I went back to my notes which only go back to April 2024 when I started following AVH closely, so I have very finite history. Commentary on CE Mark for RECELL GO came from slides, announcements or comments in meetings:

14 August 2024 

“Expect to receive the CE mark for RECELL GO in Q32024; fully prepared to meet supply demands upon approval”

13 Nov 2024

  • CE mark approval was expected in Sep 2024, now delayed to 1QFY2025 - this will enable expansion to Europe and Australia
  • In final stages of review, with a 1-2 month mostly admin process - impacted by current regulatory backlog
  • Impact is not significant as Profitability goals in FY25 are not dependent on overseas revenue
  • 3rd party distributors are looking forward to RGo as less training and startup is required which will help with faster customer adoption


9 May 2025

  • “Expect the notified body in the European Union to grant the CE mark for RECELL GO by mid-2025; fully prepared to meet supply demands upon approval”


8 August 2025

  • International CE Mark could move to Q4, delaying entry into EU & Australia - launch ready


14 August 2025

  • CE Mark - western Europe and Australia, expected Oct a year ago
  • Want to temper the international view, starting from zero, giving distributors training to develop market, slow and steady progress that is not going to impact profitability - laser focus on profitability


Fully agree that expectations and dates were set, but in Jim’s defence, I do not see this as something AVH failed to deliver on against expectations at all (at least from April 2024!).

I have always taken Jim’s updates on CE Mark approval as nothing more than basic management commentary as to (1) when they expect approval and (2) how ready they are against that expected date. I expected nothing less really. I also took significant comfort that management was already putting plans in place in anticipation of the imminent CE Mark approval and accepted that it really was “que sera sera” as to when the Europeans got their act together and approve.

The alternative update approach of stating no-expected date and “we just don’t know” or “we will get it when we do” would have not sat well with me as it would have been a sign of management laziness .... There was no way the analysts would have allowed Jim to get away with not providing an indicative date either - I think he was merely proactively pre-empting the inevitable “when” question, which is always sensible to do.

Chart Review

The market seems to have appreciated the update .... The price has also behaved quite nicely prior to that. It did drift to ~1.27, but I did not back myself with that view and topped up a wee bit too early at 1.355 prior. 

Sentiment is still with the dogs ... the 3Q results release should see some movement, hopefully north!

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mikebrisy
Added 3 months ago

@jcmleng Yes, you are right about management communications. My remarks on this theme with $AVH are ever so slightly tongue-in-cheek. I honestly consider Jim to be an open and candid communicator.

I just think that the reality of delivering in the healthcare space (and probably more generally) requires more care on setting expectations. Personally, I think a lot of unproductive effort and share price volatility could be avoid if management (not just $AVH) focused their communications on what HAS happened, rather than what and when they think things will happen. It is particuarly the case in the healthcare system where so many factors are outside management control, or where wildcards can be delivered from one of any of a number of sources.

As a holder, I believe there is a big opportunity here. However, even though it is in my "buy" zone, I consider my 3.5% position sufficient for now.

16

jcmleng
Added 3 months ago

Discl: Held IRL and in SM

Never a dull moment with AVH/RCEL!

  • Was totally gobsmacked watching last night’s RCEL 48.25% pop on news of AVH receiving CE mark approval for Recell Go Mini, and then waking up this morning to see it actually hold. 
  • While I understand the market’s relief at another box being ticked, as posted yesterday, I did not share the same exuberance - its great, but that's for later. What is more pressing is evidence that the Medicare reimbursement drama’s have subsided and sales are back on track.
  • What was a bigger positive shocker was the overnight RCEL volume of 19.6m shares that accompanied the pop. Last night’s single day volume was about 75% greater than the previous AVH pop days (up and down), going back to 2018. The volume prior to 2018 was even lower.
  • Feels like a tightly wound negative coil just snapped and rapidly unwound - while that many shares were sold by those taking advantage to get out, that many shares were bought, presumably these must be the believers waiting for some signal to back the truck and load up


We’ve been here before - a nice pre-results pop, then the results come in flat because of some drama or the other, show is over and the price falls back into depression again, so I’ll take today’s pop and be happy for today. But the real test is the 3QFY25 results, due in a months time .... if that is positive, then ....

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AVH’s ASX movement was "relatively" more muted as it had popped 10+% yesterday already.

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mikebrisy
Added 3 months ago

@jcmleng at one level the result is surprising, and at another level it is obvious.

Surprising: If you believe the market is valuing $AVH fairly, and you look across the industry and estimate how much margin comes from North America vs. RoW, and then consider the time delay to RoW, then the pop on the NASDAQ and following today on ASX, makes no sense whatsoever.

Obvious: However, if you believe that $AVH is on track to becoming a sustainable business over the next year or two, then with reasonable FCF growth from there, well, then pretty much any valuation of it says the SP is completely beaten up, for reasons we've discussed. If on top of that you add RoW sales enabled by the CE Mark, and take notice of the recent clinical data, the of course it is reasonable that some volumes will return to the stock, recognising that there is a recovery in making here.

Of course, short term price action is really all about changes in daily buying and selling flows and nothing to do with performance.

Q3, and then Q4 sales are still King, in terms of SP over the next 6-12 months.

As you say, we've been here before, but still it doesn't dull the enjoyment on the day. Enjoy!

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