Mamma Mia! Here We (ReCell)-Go Again
I came to this morning’s 2Q FY2025 earnings call for dermal repair company Avita Medical ($AVH on the ASX; $RCEL on the NASDAQ) with low expectations, and some trepidation. I wasn’t disappointed.
I’ve followed this company for nearly six years. And among all the players in the dermal repair space, $AVH wins my special award for most consistently setting high expectations, missing them, and then confidently explaining why it was either outside management’s control..
So why am I still here? Why (knowing what I know) did I choose in May to allocate precious capital to this serial underperformer? I’ll get to the answer. But first, the results.
$AVH’s “Highlights”
Financial Results
- Commercial Revenue: $18.4 million — up 21% YoY
- Net Loss: $9.9 million (–$0.38/share), improved from a $15.4 million loss (–$0.60/share) YoY
- Operating Expenses: $26.1 million, down from $28.7 million in Q2 2024
Business Update
- Significant revenue headwinds from a temporary reimbursement gap caused by delays in Medicare Administrative Contractor (MAC) payments for the ReCell® System. Multiple MACs began resolving these issues in July, with full resolution expected in Q3.
- Amended credit terms with OrbiMed: lowered revenue covenants and issued common stock in lieu of a cash payment.
- Appointed Michael Tarnoff, MD, FACS (former CEO of Tufts Medical Center and Medtronic/Covidien executive) to the Board.
Clinical Highlights
- Real-world burn registry analysis shows RECELL reduces hospital stays by 36%.
- CMS approves NTAP (New Technology Add-on Payment) for RECELL in trauma wound care.
- Early clinical results for Cohealyx™ show autograft readiness in as little as five days.
- PermeaDerm® featured in 10 U.S. burn conferences, including in a multi-center RCT.
My Analysis: The Heart of the Problem – Revenue
The market reaction (–15% at time of writing) was all about one issue: revenue.
This was a massive miss. Management attributed it to a major disruption in reimbursement stemming from new CMS CPT codes that took effect in January. According to CEO Jim Corbett, implementation by MACs (contractors to CMS) lagged, causing widespread delays in hospital reimbursements, and a cascade effect on ordering behavior.
“This is not a product issue,” Jim said. “It’s a claims processing issue, specifically around how the ReCell procedure is valued and reimbursed.”
Translation: hospitals ordered enthusiastically early in the year, but when reimbursement stopped flowing, reorders dried up. Jim estimates a six-month backlog and a $10 million hit to revenue, more than half of the total $18.4 million reported for the quarter.
More Detail on the MAC Issue
CMS changed the reimbursement model: instead of assigning fixed prices, it delegated pricing decisions to MACs under a “Contractor Pricing” model. This created widespread confusion and an adjudication backlog—not denials, just… silence. Hospitals didn’t get paid. So they stopped ordering.
Jim claims SAVH only realised the extent of the issue in Q2. But while ReCell demand from surgeons remained strong, provider uncertainty “dampened utilisation.” AVH now estimates a $10 million revenue impact in H1, with $5 million lost from just their top 10 accounts.
Efforts to resolve the problem are underway across the industry. Multiple MACs recently announced intentions to resume adjudication. Jim expects a resolution in Q3 and a rebound in demand through Q4.
But This "Bump" Has Material Consequences
- Revenue guidance for FY2025 slashed from $100–106 million to $76–81 million — a ~$25m downgrade.
- Implied revenue growth falls from 55–65% to just 19–27%.
- Loan covenant waiver required from lender OrbiMed, in exchange for 400,000 $AVH shares.
- Cash burn remains an issue: cash and equivalents fell from $25.8m (Q1) to $15.7m at 30 June.
- Breakeven pushed out: previously H2 2025, now Q2 2026.
$AVH must maintain at least $10m cash under its OrbiMed covenant. They can raise ~$5.7m via a 3.8 million share issuance under their current mandate. If revenue rebounds strongly, that may suffice—but further dilution is likely.
Track Record: A History of Overpromising
Throughout my time following $AVH, this has been a company that routinely misses its own targets: product approvals, breakeven timelines, revenue forecasts, loan covenants, you name it. This pattern has continued under Jim Corbett’s leadership since September 2022.
There seems to be a systematic failure to factor in real-world risks, or to differentiate between internal stretch targets and externally-guided expectations. Or maybe they’ve just been extremely unlucky. The CMS-MAC issue is genuinely unusual, but not without precedent.
And so, while I do believe the reimbursement problem will be resolved, I don’t believe the timeline. I’m not confident it’ll be fixed this quarter, or even next. And that uncertainty means more dilution. Fortunately, OrbiMed seems supportive, for now and at a price.
Product Progress: A Glimmer of Hope
However, today’s presentation contained some very encouraging clinical news that could reshape $AVH’s market standing over time, both for ReCell and the newly launched Cohealyx.
ReCell
A new, large-scale real-world study of ReCell shows a 36% reduction in length of stay for burn patients. Based on burn size (TBSA), median LOS savings equated to nearly 6 days, or ~$48,000 in hospital cost savings for a $10–20k treatment.
ReCell is already widely adopted in U.S. burn centers. These new outcomes data are likely to accelerate adoption. $PNV's David Williams has said on mulitple occasions that ReCell complements Novosorb BTM, indicating synergy with dermal substitutes.
Cohealyx
Launched in April, Cohealyx (licensed from Regenity Biosciences) achieved autograft readiness in just 5–7 days in early studies, compared to 2–4 weeks for competitors like Integra’s DRT and Kerecis GraftGuide.
A 40-patient post-market clinical trial (Cohealyx1) is underway, with results expected in 2026.
But the market doesn't appear to be waiting for these results. Early signals are promising, with 25% of U.S. burn centers submitting Cohealyx to their Value Analysis Committees (VACs). July saw $300k in orders from the largest account.
If this trend continues, I expect positive updates in Q3 and meaningful revenue contribution in Q4.
Final Thoughts
Taken at face value, today’s revenue result was dreadful, flat QoQ revenue and declining gross margins due to product mix. Under normal circumstances, management would deserve criticism and $AVH would fail the "moment of truth" I declared when I initiated by position in May of this year.
But this time is different. $AVH had no control - and likely no visibility - over the CMS implementation delays. Still, the consequences were real and severe, and shareholders will bear the cost through dilution and delayed breakeven.
That said, I found Jim’s explanation credible. The reimbursement issue is temporary. What isn’t temporary is the mounting clinical evidence and competitive momentum behind ReCell and Cohealyx.
I remain deeply sceptical of management’s timelines. But I also see a company with a growing product portfolio, US$75m annual run-rate revenue, and a differentiated strategy built around full-spectrum treatment for burns and trauma.
Execution remains the Achilles’ heel. But if reimbursement recovers and Cohealyx gains traction, $AVH may finally begin to fulfil its promise.
Valuation
Today, I ran a quick turn of the handle on my model.
I’ve assumed:
- A further 20% dilution over time.
- That 2025 revenue guidance is missed, albeit narrowly.
- However, I’ve also factored in strong revenue growth from 2026 through 2028, and I acknowledge that management has exercised commendable cost control over the past year.
With these inputs, and applying a 10% discount rate, my model yields 2028 valuations of:
- $4.49 / $5.24 / $5.98 at P/E multiples of 30 / 35 / 40, respectively.
By 2028, I expect today’s reimbursement issues will be firmly in the rear-view mirror—and EPS growth should be significant.
However, given the continued execution risk and repeated underperformance, I’m applying an additional margin of safety - and unusually for me - using a 20% discount rate. That’s the minimum return I want for taking on this risk.
On that basis, my valuation range compresses to:
- $1.88 / $2.19 / $2.50 at the same P/E multiples.
Conclusion and Investment Decision
I’ve always believed that in business, it's often darkest before the dawn. I thought the darkest hour came in May, when I initiated my position in $AVH at a 2.5% portfolio allocation in my RL ASX portfolio.
At that point, I said Q2 would be “make or break” for the company. And based solely on the headline earnings result, I should have exited today.
But I didn't.
And that’s because I believe the only factor driving today’s miss is external, uncontrollable, and temporary. The market understandably focused on the revenue shortfall—but overlooked what I see as compelling new data that positions $AVH to become one of the long-term winners in dermal repair… assuming it doesn’t get acquired first, which I now see as the biggest near-term risk.
Today, I added a further 30% to my RL position. Yes, my total holding is now down 23% on it's cost basis. But my conviction is growing - not shrinking - that this company has a real shot at success.
I just wish management would stop giving forward guidance.
Disc: Held in RL and SM (will top up SM on Monday)