Nice Release confirming RECELL results in 36% shorter hospital stays vs traditional skin grafting.

Won’t move the dial on the share price as the market is clearly in show-me-the-revenue mode, but this is pleasing as it makes the real-world evidence-based case to use RECELL that much more compelling for Burns hospitals, trauma centres and surgeons. 

The objective would surely be to get to the point where the AVH bods can say to the hospitals “Why on earth are you NOT yet using RECELL”?

• A greater proportion of RECELL-treated patients were discharged directly home, indicating improved recovery trajectories
• Analysis had:
• 741 adults from the Burn Care Quality platform registry
• 247 patients treated with RECELL experienced an average 5.6 day reduction in hospital LOS
• 36% decrease compared to those treated with split thickness skin graft, 494 patients
• Economically impactful:
• Based on an average daily inpatient bed cost of $7,554, use of RECELL is associated with potential per patient cost savings of $42,000, exclusive of procedure and rehabilitation costs
• Reduction in LOS may enable hospitals to treat 13 more patients per bed annually compared to treatment with STSG alone
• In 2023 alone, US burn cases consumed more than 110,000 ICU days, costing in excess of US$676m

Chart Review

The AVH price has drifted downwards as expected and seems to be forming a reasonable base around $1.32 to $1.33, a tad higher than my expected low of ~$1.28, which goes back to the last June 2022 low. Daily volume has stayed flattish, so its all been pretty orderly thus far.

I topped up last week at $1.355, probably a wee bit impatient, but I have one more top up ready to deploy if it gets below $1.30. 

Director Top Up

Sorry, forgot to add this.

The top up of 10k shares on market was 15% of his prior holdings of 63,291 ... not much, but this was in isolation, and with his own US$45k coin ... can't be bad!

Discl: Held IRL and in SM

Have not read @mikebrisy 's notes prior to posting this as I wanted to form an unbiased view. Would be very interesting to see the extent of agreement/disagreement after I post this!

When I read the announcement this morning, I was braced for this to be a shit show ala BOT’s “July PAHH Nightmare” and another 50% haircut. But after listening to the Webinar and digesting the news, while disappointed, I remain bullish and will likely top up.

The webinar is well worth a listen. I have, and continue to find, Jim and David’s communication style to be forthright, clear, logical and sensible. That was again on display today as Jim walked through the Reimbursement drama which hit RECELL sales badly this quarter.

Prior to listening to the preso and digesting the news, my mental checklist was:

• Are the products still performing, medically?
• Has the TAM changed?
• Is the Acute Wound Care Portfolio Strategy still valid?
• Is the headwind temporary or permanent?
• What could management have done to proactively mitigate the issue?
• Do I feel that management could have done more to fix the issue

The Bad News

• Revenue was flat QoQ at $18.5m - the market needed to see a rise in 2Q revenue, for that bloody FY25 US$100m revenue target (a cursed number in Pharma, it would seem!) to remain live. Did not happen.
• The FY25 revenue guidance was a whopping ($25m) to $78-$100m, 25% down
• We then had cashflow positive and GAAP Profitability pushed out another 6M and 9M respectively.
• There was a “capital raise” of 400k shares to OrbiMed to pay for the Credit Agreement amendments - at the US share price of ~US5.00 to US5.30, this was a $2.0m to $2.12m hit, not quite small coin
• AND, another FURTHER capital raise was flagged by David - with cash at $15.3m, $11.3m in Receivables vs operating cash burn of $26m per quarter, there does not seem a way to avoid this, as I don’t believe AVH can sell its way in 2HFY25 to avoid this - the ask is too big.
• And so, the shorts got what they expected, and thus should have done well with this outcome.

HOWEVER,

The Positive Takeaways

All the bad news that the shorts hoped for has now manifested, so the anxiety around will they/won’t they make it, raise/no raise, is now mostly resolved (no they won't make, yes they will need to capital raise!) - I see that as a good thing as it feels like it is harder to make big money from a short thesis from here, but would like to see the updated short numbers to validate this thinking

The Claims Processing issue looks to be mostly behind AVH - I found Jim’s explanation very clear. It was another example of US Medicare-related diabolicalness. July and Aug RECELL demand looked good, that is a good sign. Shit happens, nothing anyone could have done about that but react, which management did. This issue will pass, but by when, and the impact on the demand recovery is more uncertain.

The clinical evidence on RECELL from the British Burns Association preso and the cost savings to both hospital and patient, has become significantly more compelling - 36% reduction in length of stay, where 1 day of stay is ~$11k of cost to the patient. This is based on 6,300 real-world patients in real world hospitals, not in clinical trials - this is a huge tick.

I really like the Acute Wound Portfolio strategy with CoHealyx and PermeaDerm gaining traction and the contribution to revenue increasing. These Other Wound Care products contributed 7.39% of total revenue in 2QFY25, up from 0.03% in 1QFY25, providing a bit of a buffer to the drop in RECELL demand. The only direction from here is up, really.

I also like that Recell Go Mini is clearly opening up non-burns trauma and trauma hospitals sales for small wounds - this market wasn’t as clear without Recell Go Mini.

Operating expenses remain flat/falling and appears under control.

OrbiMed taking script instead of cash is a tick of their confidence

All said, yet another curveball has been thrown at AVH, and the impact did/does hurt. But it appears temporary. 

I have a much shorter exposure duration to AVH, starting with Jim/David. The rationale for headwinds and missed expectations since I followed AVH have been consistently clearly explained and make sense, so, while I have been disappointed, the explanations have all made sense to me. It is clear that bad things happen in US medical launches, it is far from a straight line, and that is just how it is. 

SUMMARY

And so, back to my initial questions to myself:

• Are the products still performing, medically? Hell yeah, and this looks like it is getting increasing attention
• Has the TAM changed? Nope, not at all 
• Is the Acute Wound Care Portfolio Strategy still valid? Absolutely - the impact on revenue is now starting to show and can only go upwards
• Is the headwind temporary or permanent? Temporary, mitigating actions have been taken, and we should see the back of it in the coming quarters
• What could management have done to proactively mitigate the issue? Not sure what they could have done differently really - this is not an AVH issue
• Do I feel that management could have done more to fix the issue? I don’t think so

A capital raise feels imminent. I still think it will be circa US30-40m to give AVH 2 full quarters of cash until full revenue kicks in. 

Looking at the volume and the “relatively muted” 13.62% drop, and the green candle, which I found totally surprising given the extent of the miss, I read 3 possible things into this:

1. the short thesis could have manifested, the short thesis from here is less compelling, so the shorts took their money;
2. some selling could have been deliberately absorbed to minimise the price drop in preparation for the imminent capital raise and/or;
3. the market consensus was a similar, “Yes, it was shit, but ....” view that I have.

And so, while the AVH price will go nowhere in the short/medium term, I think another peak pessimism level has emerged - hopefully, this is the "last" one.

I remain bullish and will remain very patient for the turnaround to gain momentum. All the ingredients are absolutely in place, particularly the medical evidence. Throughout the webinar, announcements and numbers, have not seen anything that makes me nervous. We just need a clear 3-6M runway of no further curve balls, for revenue traction to be regained!  

ACTION

From my current 2.45% allocation, I intend to top up when the price falls under to around $1.20-ish as I do expect it to drift lower further from here, up to my ideal allocation of ~3.0%. If there is a retail portion to the imminent capital raise, I do intend to participate.

Discl: Held IRL and in SM

Disc: Held IRL and in SM

SUMMARY

The Not So Good

Revenue looked to have impressively improved 67% vs pcp, but is actually the 2nd consecutive quarter of flat revenue.

If there is no improvement to the 1Q run rate of $18.5m, revenue will end up around $74-75m for FY25, well short of the revenue guidance of $100-106m - this is probably what spooked the market.

Operating Expenses remain high vs pcp and QoQ vs Q4 guidance which said expenses should stabilise around $26m - management attributed this to “typical higher 1Q expenses”, which does make sense, the question is whether expenses will remain elevated in the coming quarters as this will threaten the 4QFY25 GAAP profitability guidance.

Net Loss widened against both pcp and QoQ.

Management has made the call to stop focusing on the Vitiligo indication - too many uncertainties around insurance reimbursement as Recell is only currently reimbursible in a hospital vs Vitiligo which is treated at a Doctor’s clinic - revenue from this indication has not been baked into revenue forecasts, this feels like the right call given the huge opportunity on the burn wound products

Per Dow Newswires, the 1Q results fell short of expectations:

• Net loss ($0.45 per share) vs actual ($0.53 per share)
• Revenue $20.1m vs actual $18.5m, about ~8% below expectations

The Good

Products have not fully launched in 1Q - RecellGo Mini only launched on 1 Feb (announced as "during 1QFY25" in late Dec) and CoHealyx launched on 3 Apr (announced on 3 Apr) - against this backdrop, the market looks like it might have got ahead of itself.

Significant operational changes occurred in 1Q in what management terms a “Launch Readiness Phase” - (1) RecellGo Mini full launch (2) CoHealyx full launch post quarter-end (3) a comprehensive re-organisation of the Sales organisation to align to the product portfolio and expand sales coverage (explained at length during call) - made good management sense (4) PermeaDerm manufacturing integration into Ventura facility. These actions make good sense and are necessary, as management continues to operationally morph AVH from a single RecellGo product to a multi product portfolio.

Higher cash burn is being addressed by a $2.5m/quarter expense savings that have been found through the sales re-organisation - need to see this materialise next quarter.

Overall

It was not a great result vis-a-vis increased expectations arising from the increased FY25 revenue guidance, but once the operational context is baked in, seemed a fair outcome. RecellGo Mini only launched in Feb 2025 and CoHealyx only launched on 3 Apr, post the 1Q results, so revenue from these have not yet flowed in. 

I now see the $18.5m quarterly revenue as the “minimum” revenue base, based purely on RecellGo. Annualised, this is ~$74m of the $100m FY25 revenue. For AVH to meet the $100m revenue target, at least $26m needs to come from a combination of RecellGo + CoHealyx + PermeaDerm in the next 3 quarters - this translates to the following run rates:

• Roughly ~$9m per quarter contribution from these 3 products
• Assuming the minimum revenue per case for PermeaDerm $2,000 and Co-Healyx $20,000, the $9m additional quarterly revenue can be met by ~409 cases per quarter, or ~136 cases per month
• The annual FSTD caseload is ~270,000 cases
• This does not seem too onerous to achieve for the rest of FY2025

AVH’s operational readiness for that growth appears to also be in a significantly better place - the actions in 1Q were necessary and reflect an organisation that appears to learn and decisively action, the transition from a single product to multi product environment. 

There is nothing to suggest that the anticipated revenue growth will not kick in, in the coming quarters. The 20+% price drop feels overdone against a (8%) shortfall of revenue expectations and the remaining 9M runway ahead, with full launches having occurred. 

Thesis remains intact. Patience continues to be required as it is easy to forget that AVH is still morphing from a single product to a multi-product portfolio company - a massive change in strategic direction that needs time to work through/play out.

TREND CHARTS

• While 1Q25 revenue has been flat QoQ, it is clearly trending upwards, as is Gross Profit and Gross Profit Margin %
• Cost of Sales has also increased, as would be expected, but at a significantly slower rate of increase vs revenue.

• Total Operating Expenses continues to increase, driven primarily by increases in Sales & Marketing expense, but both have been trending downwards since 3Q24
• G&A and R&D have remained flat trend-wise, with G&A trending downwards

Amidst the market whiplash, this nothing-really-new announcement from AVH is a good reminder that while Trump goes about thrashing the US, one of the companies I own is still delivering against what it said it would do ...

Discl: Held IRL and in SM

AVH Entered into a new Contract Manufacturing Agreement for PermeaDerm® Biosynthetic Wound Matrix, along with an Amendment to its existing Exclusive Distribution Agreement with Stedical Scientific, Inc, effective 17 Mar 2025

Retain 60% of the average sales price from PermeaDerm sales while remitting 40% to Stedical after deducting manufacturing costs. Prior to the amendment, each party retained 50% of the average sales price from the sale of PermeaDerm.

------

Very positive move which makes a lot of sense:

• PermeaDerm has essentially morphed into a royalty-per-quantity-sold arrangement as AVH will now 100% control the end-to-end of PermeaDerm, from sales, distribution to the manufacturing supply chain - great move given how significantly PermeaDerm will increase AVH's TAM
• Optimises capacity at AVH’s manufacturing facilities - unclear of startup cost impact but as there was no mention, assuming that it is either immaterial or shared cost
• Manufacturing cost is 100% recovered from Stedical before remitting Stedical's share of revenue - may be some small accounting upside in the broader manufacturing cost recovery
• Increases revenue from 50% to 60% - that extra 10% revenue should drip straight to the bottomline as there is virtually no marginal cost for selling & distributing PermeaDerm

Remain very happy and bullish with how AVH management has continued to steadily and deliberately morph AVH from a single product to a multi-product company around a Recell Core, with a significantly expanded TAM.

Disc: Held IRL and in SM

AVH held the usual a-few-days-later Investor preso, this morning, following the results announcement. Picked up a few additional notes, mostly from the questions.

Discl: Held IRL and in SM

UPDATED TAM

I asked for, and got this updated TAM slide which provides a breakdown of the ~$2.0b additional TAM from FTSD indications.

• Excludes chronic wounds our of Indication - no intent to enter that market - do not believe that this is the best therapy for these wounds as have not studied it.
• Left with ~270k annual full-skin thickness traumatic and surgical wounds which (1) is a surgical wound (2) is an acute wound and (3) we can close it with combination of CoHealyx, RECELL and PermeaDerm
• Market is huge, in about 350-400 hospitals, adding $2b more of TAM to make combined TAM of Burns + FTSD wounds = $3.5b TAM
• Go from Burns Only TAM of ~$500m to Burns + Surgery + Trauma TAM of $3.5b
• Broader product line from the original single product RECELL to RECELL Go + RECELL Mini + CoHealyx + PermeaDerm
• Same wound, same patient, same doctor, same hospital - have seat at the sellig table, all the time

CURRENT MARKET SHARE

Currently, essentially selling to ALL 120k Burn Centres to some degree. Difficult to estimate market share as there is no direct competitor but suspect it is in the region of 20-25% - lots of upside ahead

In close to 200 new trauma hospital accounts, about 50% of trauma hospitals since the launch of the new FTSD indication - account size are not equal, some really big, some really small - depends on where located, the population around the hospital, type of wounds.

Big emphasis though, is to sell the portfolio of products - focus on product mix, deeper contributor to heal acute injuries

CASH SUFFICIENCY

Orbimed, debt provider, in for the long haul, complete supporter, sees the business growing.

Original 2023 revenue covenants were established with a very different AVH. FY2025 revenue guidance is below the trailing 12M revenue covenants with OrbiMed - mutually agreed to amend revenue covenants to that they are no longer a hindrance to the business and is aligned to the projected growth

No immediate risk of not meeting the revenue covenants and needing to repay back the debt, hence, see no reason to raise additional capital ahead of FCF in 2HFY25

COMPETITORS

PermeaDerm - many, but few have the features and benefits that PermeaDrm has - enough of these that being price competitive matters - happy to price appropriately to gain share as 50% revenue flows straight to the bottomline on any price, to demonstrate clinical advantages/increase adoption

CoHealyx - many, dermal matrices, ~20, key competitors include Integral Life Sciences, Caris, Polynovo (overlap on some cases) some more common than others, have same arrangement as PermaDerm, allows for same pricing flexibility BUT 5-year exclusivity term, and upon completion of CoHealyx1 study, share of revenue increases 10% to 60% or on 1 Jan 2026, not incentivised to get premium price, but to get adoption. Clinical data says Cohealyx is superior, hospitals put a lot into dermal matric inventory - win on clinical benefit, price, and on consignment model/working capital management.

FY2025 GUIDANCE

Based on current portfolio of products - does not bake in any new products in development.

My combo of notes and thoughts from the results presentation early morning Fri. Very happy shareholder!

Discl: Held IRL and in SM

SUMMARY

No surprises with Q4 results as the shortfall of $3-4m revenue and the pushing back of GAAP profitability by 1 quarter to 4QFY2025 had already been flagged to the market in early January.

Conversion to RECELL GO going well - 83% of total unit volume now converted.

Big jump in FY2025 revenue guidance of $100 to $106m, YoY growth of between 55% to 65% - the ability to achieve this will depend on the performance of CoHealyx and RECELL Go Mini - there is clearly a huge TAM opportunity, but will need to see actual revenue in 1QFY25 to understand the revenue momentum and trajectory.

Very little is baked in for international sales but nothing will happen in this space until EU CE Certification is received, currently expected mid-2025 - appears to be minimal downside risk but good upside if the certification comes in earlier or “on time”.

Operating expenses have been guided to be fixed around ~$26m per quarter, based on 4QFY24 expenses, normalised after a 3Q spike in one-off expenses, and there being no planned increases of headcount or operating expenses - any incremental revenue from FY2024 will essentially drop straight to bottomline as the earning of this revenue requires no additional operating cost.

FY2024 was a good transformational year as AVH decisively executed the strategic an operational pivot from single to multi-products while continuing to achieve 29% YoY revenue growth and the various FDA approvals occurred as management guided.

Apart from the purchasing-related Q4 revenue shortfall which hurt the AVH share price, management continues to march forward as it said it would.

Do not see much risk of capital raising in FY2025 as AVH prefers debt, has long-term debt facilities lined up, expenses have flatlined, and is steadily generating more cash from operations as revenue expands and accelerates in FY2025

Management has a simple and clearly articulated strategy and game plan for FY2025 - FY2025 is shaping up to be the year where AVH performance really accelerates and achieves GAAP profitability, driven by RECELL GO Mini and CoHealyx product launches from a significantly more established RECELL GO platform.

There is clearly ongoing risk that GAAP profitability will not be achieved in FY2025. It is achievable given expected flat expenses (~$104m) and expected expansion of revenue (~$100-106m), but planets do need to align throughout the year. AVH will remain vulnerable to hiccups, any or all which could dent the share price again.However, any delays will likely only be a timing issue as the trajectory and plan to profitability is clear and imminent. 

Q4 RESULTS

Revenue $18.4m, $3-4m lower than forecast

• Key customers deferred buying to preserve cash - timing difference, not due to a lack of demand or other commercial operations issues
• Now have better understanding of customer end-of-year buying patterns
• January purchasing activities now back to normal

4Q Margins 87.7%, recovering from 83.7% in 3Q

Q4 operating expenses have stepped down $4.1m, from elevated levels in 3Q t0 $26.1m - No plans for headcount increases, other operating expenses in FY2025 and no planned expansion of commercial/sales organisation in the next 18-24M

Conversion to RCELL GO going well

All Burns accounts and 70% of trauma accounts have transitioned - 83% of total unit volume

FY24 RESULT

Revenue increased 30% YoY driven by:

• Accelerated transition to RECELL GO, 
• Deeper penetration within both existing customer accounts and new accounts targeting full-thickness skin defects in trauma centers

FY24 margin was 85.9%, at the higher end of the 85-86% gross margin guidance

Operating expenses increased from $86.5m to $111.8m, primarily due to costs from the expansion of the sales & marketing organisation

At 31 Dec 24, $35.9m in cash, cash equivalents and marketable securities - sufficient cash reserves to fund operations for the next 12 months.

FY25 GUIDANCE/EXPECTATIONS

Commercial revenue for the full-year 2025 is expected to be in the range of $100 to $106 million, reflecting growth of approximately 55% to 65% over the full-year 2024  

• RECELL GO Mini and CoHealyx will contribute substantially to this revenue growth following launches in Feb and Apr 2025, respectively
• Modest international revenue is baked into revenue guidance as timing of CE approval is uncertain - previous indication for approval was Oct 2024, there are no technical challenges, no revisions or materials that are pending, just dealing with an unpredictable process

$26.1m Q4 expenses is expected to be a consistent baseline for FY25 quarterly expenses

Expect to generate free cash flow in the second half of 2025 and reach GAAP profitability during Q4 2025

Expect use of cash to further decline over the next 3 quarters

Gross Margin for RECELL will stay in the 85-87% range, but margins overall will inevitably go down because of the distribution arrangements for CoHealyx and PermDerm (50-50 shared), as CoHealyx and PermDerm revenue becomes more significant, 

• Because of expected flatline operating expenses, all incremental Gross Margin essentially drops to the bottomline as no additional cost is expected to generate this revenue

Revenue Growth profile for FY2025, in response to an analyst question:

• Q1 - up sequentially, driven by RECELL GO Mini launch, PermaDerm gaining momentum
• Q2 - up sequentially
• Q3 and Q4 - CoHealyx impact will back end, plenty of gunpowder to keep revenue line growing, strong cadence during the year
• Burns - approximately 1,000 burn cases per month, these last 2 quarters

STRATEGY & TAM UPDATE

Since 2023, AVH have evolved from a single product company to a multi-product leader in therapeutic acute wound care

Focus on treating event-driven trauma and surgical wounds, full thickness skin defect (FTSD) indications - victims of severe and unpredictable events/trauma

FY24 was a transformative year in terms of expanding the TAM:

• 2 years ago, TAM for single-product RECELL was $500m per annum for burns wounds only
• 18M ago, FDA approval for FTSD indications expanded AVH’s market for RECELL to the trauma centre market - roughly 272,000 wound procedures annually could be eligible for RECELL Treatment, 122,000 traumatic wounds, 12,500 annual surgical wounds and 136,000 annual surgical resections and excisions for cancer
• Based on the increase in the potential revenue per patient from the addition of CoHealyx and PermDerm alongside RECELL, the TAM for AVH has now expanded to ~$3.5b per annum for therapeutic burns care across both burn and trauma centres, in the US alone - the numbers presented do not line up nicely with $3.5b - have asked for a slide to break this down for the Aussie presentation next week
• 120+ Burn Centres TAM = ~$1.5b
• RECELL: $500m
• PermaDerm: $100m
• CoHealyx: $1.0b
• Trauma Centres FTSD TAM = ~$2.9b
• CoHealyx: $1.35b
• PermaDerm: $135m
• RECELL: $1.5b

Strategy and focus for FY2025 is thus clear:

1. Expand RECELL GO adoption
2. Rollout RECELL GO Mini, focussing on trauma centres in 1QFY2025 (Feb 2025) - potential to expand the trauma centre market by 270,000 full thickness acute wounds annually
3. NOT targeting chronic wounds or chronic centres
4. Launch CoHealyx commercially in April 2025
5. Continue to rollout PermaDerm
6. Expect CE certification by mid-2025 which then opens up Europe and Australia markets

CoHealyx Plan Update

Embarking on a post market clinical study called “CoHealyx1” - ~40 patients enrolment, 26 weeks, 20 sites in real world settings

• A “OPC” objective criteria study design - objective is to benchmark Cohealyx performance against published data from alternative dermal matrices under controlled conditions
• Expect to demonstrate key outcomes (1) accelerated 7 days to graft readiness and (2) shorter overall time to wound closure vs alternative dermal matrices - 1st case in mid-Jan 2025, before the study commenced is already proving these outcomes - see slide in presentation pack.
• Study has 2 use cases (1) CoHealyx alone (2) CoHealyx with RECELL
• Expect study data to support 1 April launch of CoHealyx

1 April 2025 - full commercial launch for large wounds across 120 burn centres

• RFID tagging to simplify hospital adoption of consumption on a consignment model
• CoHealyx will be priced below current market leaders and will be positioned as a “value offering”
• CoHealyx can be used independent of RECELL

Expecting VAC approvals to be faster by ensuring:

• VAC sees pre-clinical data as it is published 
• VAC sees post-market case studies in real-time
• Price point is set where it saves hospitals $
• Hospitals do not hold inventory - consignment model will be much appreciated

OTHER POINTS

RECELL GO Mini addresses a key gap in RECELL GO which is intended for wounds up to 1920sq cm or 10% of Total Body Surface Area (TBSA) - most traumatic wounds are under 480sqcm’s or 2.5% of TBSA - this “wastage” of using full RECELL GO to treat smaller wounds was a key feedback item from customers

RECELL GO Mini uses the same equipment as the RECELL GO full, so transition to the Mini is seamless

Another yeah baby moment for AVH.

The approval was not unexpected at all, but it is still very nice when things actually happen when management say they expect it to happen.

Pieces have fallen nicely in place for revenue to flow in nicely for the rest of FY25 - may that now actually happen in reality!

Discl: Held IRL and in SM

Good to wake up to some positive company news instead of the doom & gloom around market crashes, Trump/Musk fights etc ...

Still some ways to go before revenue flows through, from around 2QFY2025, but its a good and required step forward.

No new news from today's webinar but management provided more detailed insights on various topics as management typically focuses on strategy evolution, operational insights etc, rather than the previously-released financials. This follow up webinar is always worth attending as I find I am able to better digest the commentary.

I like that everything that has happened, and is happening, with AVH, makes simple and sound sense. Planets are really aligning very, very, nicely with lots of milestones to look forward in the coming quarters to as AVH continues commercial expansion, which looks set to accelerate from hereon.

Discl: Held IRL and in SM

Vision and Mission

Been a while since I last reviewed this, but it is clear now that AVH has fully transformed from a single product RECELL company to become the “leading global regenerative tissue company by addressing a broad continuum of clinical needs”

IP and Regulatory moat for Recell is a minimum 3-5 years - caused thinking on what doctors and patients need around Recell for the same wound.

“Same Doctor, same Patient, same Wound” is a really good encapsulation of AVH’s strategy pivot - AVH is no longer a single product company

Defining the Standard in Wound Care & Skin Regeneration, PermeaDerm Impact

Have not seen this slide before which reinforces the point that PermeaDerm is actually potentially used 2x in a burn treatment - temporarily, then to cover the wound

VAC Approvals for PermeaDerm - Jim made the point that VAC approvals for PermeaDerm are significantly easier than for RecellGo - it is a dressing, which the VAC sees a lot of, and is significantly less complex than RecellGo, and so, is not a big obstacle at all

TAM Expanded to ~US$2b

Potential Revenue expansion per Patient with AVH’s Burn Continuum strategy - the slide documents the excitement verbalised during the previous investor call.

TAM is calculated from the number of Recell-eligible burns treatment per year, which AVH estimates is ~35,000

• Recell-only TAM was ~US$455m ($13,000 x 35,000 cases)
• Recell + PermeaDerm + Cohealyx TAM rises to ~US$1.925m ($55,000 x 35,000 cases)
• This is a significant TAM expansion, once Cohealyx comes onboard

Current ~20% penetration in the market - can see a clear pathway to 40-50% in the next 1-2 years based on increase usage at top burn centres, but how long it will take to get to this will become clearer in the next 1- 2 quarters

Recell Platform

Good summary slide which differentiates RecellGo and RecellMini - the move away from “old Recell” into this single RecellGo platform makes it significantly easier to understand the product differentiation, and the components of the Platform

The Processing devices can be used 200x vs the single use Preparation Kits

Expecting to fully complete the conversion of existing customers to Recell Go by end Q32024 - priority was given to the bigger burn and trauma centres as they wanted to get onboard early, have bigger consumption etc.

Essentially, a biopsy of skin approximately the size of a credit card is the input to develop spray on skin that can potentially cover 2,200sqcm, a 80:1 ratio - that puts the benefit of Recell in good perspective.

International Expansion

Overall approach is to ensure international expansion is “contribution positive” - hence the approach to not invest heavily but instead to use 3rd party distributors

Will take time to develop, but confident it WILL develop

Japan

• Distributor has only pursued burns indication - AVH is working on an alternative strategy for FSTD indications.
• 1st year has been focused on inventory build out and to establish the distribution framework
• Utilisation from here will reflect actual case utilisation.
• Does not sound like management expects too much from Japan at this stage

Europe

• CE Mark still has 2 more hoops to cross - (1) technical review, expected this month (2) 1-2 month Admin process that flows. Approval is expected 1QFY2025 but it all depends on the Regulatory body which does not have a statutory requirement on review timeframes
• Already ready to ship inventory today, startup is expected to be a swift 1 week from when approval is obtained
• Will be for Burns and FSTD indications
• Contribution from Europe will be much more valuable than Japan given bigger population and more countries

Australia: Announcement today of appointment of the Australian distributor

Manufacturing Facility Update

Completed transformation of the 1960’s Ventura manufacturing facility to a modern one, which expands capacity 10x, from the current 8,000 units to 80,000 units per annum.Do not expect any need for capacity increases for the next 3-5 years

Other change is that AVH is no longer required to hold stock for Barda which frees up inventory

Built a service centre to address repairs, re-qualification of kits etc

FINANCIALS

Operating Cost Outlook

Very few headcount increases are planned for FY2025, no further increase in Sales Team in the next 18-24M.

G&A 3Q24 contained one-off expenses (recruitment, severance costs etc), Q2FY24 G&A is more representative of the cost going forward.

R&D expenses expected to be flat for the next 12M - makes sense as AVH operationally digests the current suite of products.

Revenue Covenants

31 Mar 2025 - trailing 12M revenue of $75m - only need to generate US$17m of revenue in 1QFY25 to meet this, not an issue

30 Jun 2025 - US$99m, easier to meet with current significant Q-on-Q revenue growth trajectory

Cash Reserves

Clear management view that the $4m cash reserves will be sufficient to take AVH to cash flow positive by 3QFY2025

Cash use in Q3 was lowest during this commercialisation phase, expecting cash use to be at similar levels in Q4FY2024 - revenue expansion will then generate sufficient cash

My notes and views from today's Results call. I always get a lot out of the AVH calls as management does a really good job at providing the operational context, observations and detailed explanations, which makes it easy to follow the narrative.

SUMMARY

Overall

Very comfortable with the results - 3Q was a big quarter of not only revenue, but also good, sensible sales-related positioning

Pivot to convert existing install base to RecellGo vs previous focus on getting through VACs made good management sense.

Very excited at the addition of Cohealyx to the continuum and how that could potentially drive a big uptick in revenue - continues AVH’s morphing from a single product company to a “burns solution” company, all centred around and further embedding Recell - this strategy really optimises the use of the Sales organisation to chase incremental, almost no-effort, revenue.

Next 6M and FY25 overall will be full of milestones and activity as revenue momentum accelerates with new approvals imminent and products coming on stream.

Positives

• Continued strong revenue growth from Q2 - 29+ consecutive quarters of growth
• Deliberate pivot in the Quarter to focus on, and accelerate, the conversion to the RecellGo conversion so that the benefits of RecellGo can be reaped by both patient and clinicians
• Entered into multi-year development & distribution agreement for exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical branded collagen-based dermal matrix - this fills up the Dermal Replacement/Matrices gap in the AVH Burns & FSTD Wound Care Continuum
• The introduction of Cohealyx into the AVH product mix appears significant as it is looking to drive ~3x more spend in the burns per-treatment spend from the current RecellGo + PermeaDerm offering of between US$8.5k to US$17.5k to between US$28k to US$55k - multiplying this increased spend to the 35k annual AVH-eligible burns case sees an additional ~US$1.5b potentially added to the TAM in the US alone
• Good/on track progress on (1) Recell Mini FDA approval (2) publishing of Vitiligo study findings (3) overseas market startup (4) expansion of manufacturing facilities
• FY2025 is looking very exciting with (1) Recell Go Mini startup (2) PermeaDerm expansion (3) Cohealyx approval and startup (4) CE Mark Approval to drive overseas expansion
• No change to management guidance of GAAP profitability and Cash flow Positive by 3QFY2025

Not So Good/Watch Areas

• Pivot on RecellGo conversion impacted progress on the VAC approvals - 23 accounts approved vs planned 40-50 this Quarter - management said this was a deliberate choice in the use of Sales time
• Delays encountered in (1) CE mark approval from Sep 24 to 1QFY25, delaying entry to Europe and Australia, minimal impact to FY25 profitability targets
• Rise in expenses - was a bit concerned with the trajectory of this in FY24 at first glance, but expect this to level off from here based on management comments plus expected significant boost in revenue once the FY25 drivers kick in progressively during FY25

Position Size

Now a 4.17% position, which is where I wanted it to be.

No further action other than to remain vigilant for buying opportunities if prices dip below $3.00 on market weakness.

Chart Review

Price has run up strongly in the past 2 weeks from ~$3.00 to peak at $3.80, breather is thus expected.

Has broken past resistance level ~$3.23 and the significant 200 SMA, both of which have held despite today’s pullback - expect this to provide some degree of support in the near-term.

OPERATIONAL HIGHLIGHTS

Deliberate Pivot to RecellGo Platform (RGo) Conversion.

Made deliberate decision to accelerate the conversion of existing customers on to RGo to enable revenue growth and set foundation for long-term scalability.

Accelerate benefits of (1) Significant workflow efficiencies (2) Shortens anaesthesia time (3) Reduce operating theatre time (4) Accelerates patient healing.

Transitioned ~75% of installed base to RGo within 4M of FDA approval, indicating operational agility.

VAC Approvals Impacted

This pivot has come at expense of slower Value Add Community (VAC) approvals - 23 new accounts vs planned 40-50 this Quarter - less VAC’s was a deliberate choice in the use of Sales time.

Now ~300 accounts for Full Skin Thickness Defect (FTSD) accounts, more than double from a year ago.

RGo is expected to make closing new accounts easier.

Q4, 60 accounts in VAC process, expect 30-40 to close in Q4.

VACs are wanting to see evaluation cases as part of the approval process - have not proactively prepared for this request.

As an indicator of adoption, only 1 hospital required VAC approval specifically for RGo.

Addition of Dermal Matrix Product, Cohealyx to Burn Wound Management Continuum

On July 31, 2024, entered into a multi-year development and distribution agreement with Regenity Biosciences that provides AVITA Medical with the exclusive rights to market, sell, and distribute Cohealyx™, an AVITA Medical branded collagen-based dermal matrix.

Submitted FDA approval end-Sept, expecting FDA clearance by end-Dec 2024.

Cohealyx promotes generation of vascularised tissue, takes 5-15 days, and prepares the wound for grafting - this looks like a direct competitor to PNV’s Novosorb BTM.

Cohealyx will be used as a combination of RGo + PermeaDerm (PD) and Cohealyx as a comprehensive solution for FSTD wounds - improve patient experience and streamline clinician workflow in a 2-step treatment process:

• Step 1 - Apply Cohealyx to promote vascularisation of tissue
• Step 2 - meshed split thickness skin graft is used to prepare spray-on skin using RG, which is then sprayed on top of meshed skin graft
• Uses significantly less skin than traditional skin graft and enables more definitive skin closure
• PermeaDerm, a transparent dressing, is then applied over the Recell skin graft to optimise wound protection and moisture management

Cohealyx Changes Business Model and Expands AVH Market Potential

For 10-20% of burns patients, treatment is expected to utilise (1) 1-2 RGo kits (2) 1 application of PD and (3) 1 application of Cohealyx.

Current per-treatment spend for RGo + PD between $8.5k to $17.5k - this increases to between $28k to $55k for RGo + PD + Cohealyx.

CoHealyx increases the pre-treatment spend by 3-fold, applying the increase spend to the ~35k Recell-eligible burns cases per annum, TAM is US$1.5b in the US alone - will meaningfully enhance market penetration and strengthen market position in FSTD and Burns markets.

Plans for a post approval, post clinical study using the combined 3 solutions vs other Dermal Matrix-solutions - enrolment in 1QFY25, expense will be required for the study in 1HFY25. Intent is to prove the time-to-graft benefit from 3 elements:

• Cohealyx gets to ready-for-graft without infection, more rapidly, in days
• This speeds up the faster-to-close process
• This then speeds up the out-of-hospital days

RGo Mini Update

Fills the smaller wound gap with the offering, expands AVH reach as it addresses the up-to-480sqcm wound vs RGo’s scope of up to 1920 sqcm wounds.

Use the same multi-use RCGo device but with smaller disposal cartridge.

On track for approval by year end, launch in 1QFY2025, rollout plan:

• Training 1st half of 1QFY25
• Rollout during 1QFY25 - practical customer utilisation will be 2nd half of 1QFY25
• Targeted at Trauma Centres which is where FSTD cases are - would have added well over 200 accounts since FSTD approval in 2023

In terms of expectations for adoption, in the study for FDA approval, there were zero study cases which were over 500sqcm - RGoMini was developed to better fit patient needs.Market is the same, but expect adoption will be quicker as it is the same RGo use on a smaller sized wound.

International Expansion, CE Mark Approval Delayed

• 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 are 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.

Vitiligo Study

• Studies have been submitted to major medical medical publications, expect to be published late 2024/early 2025
• Foundational to get commercial insurers onboard - this is expected in 2HFY25
• Not guiding to a a significant vitiligo contribution in FY2025 as this is looking to be a FY2026 impact instead

Manufacturing Capacity to Meet FY2025 Demand

• Completed Project early in the Quarter to revamp Ventura manufacturing facility - this has expanded capacity by 10x
• Included the creation of a service centre for durables
• No supply shortages encountered during period of fast revenue expansion

3QFY2025 FINANCIAL RESULTS

Commercial revenue of $19.5 million, an increase of approximately 44% compared to the same period in 2023.

Gross profit margin of 83.7% - this was expected due to ongoing RGo engineering and validation of the RGo durable and disposal cartridges - temporary, expecting GM to be between 85-86% for FY24.

Operating expenses US$30.2m.

• Sales & Marketing expenses up US$4.4m - employee-related costs following Sales Org expansion in 2QFY23 and 1QFY24
• G&A increased US$3.5m, mostly due to employee-benefits
• R&D costs increase US$1.0m, employee costs of medical liaison team

US$44.4m cash & cash equivalent vs US$89.1m as at 31 Dec 2023 - Q3 was the lowest use of cash in this phase of commercial expansion - current low rate of cash utilisation expected to continue in 4Q.

On November 7, 2024, amended the credit agreement with OrbiMed in a mutually beneficial arrangement, forgoing access to an additional $50 million in funding in exchange for removal of the 12-month trailing revenue covenant for the period ending December 31, 2024 - reiterated comment that there was no previous intention to draw down the $50m funding.

Built on success of strong 2Q - outpaced performance by 29% , 44% YoY.

OUTLOOK

4QFY2024

US22.3m to $24.3m - a QoQ improvement of between 14-25%, a YoY improvement of 58-72% - aligns to full year FY24 guidance.

FY2025 Guidance

No change to guidance of GAAP Profitability and CashFlow +ve by 3QFY2025 - huge focus on crossover to profitability.

Expecting to add very little durable operational cost from hereon - no significant org growth for the next 18-24M.

Positive revenue trajectory to continue into FY2025 with FY2025 Growth Drivers:

• RGo - increase usage of Recell in accounts
• RGoMini from Jan 2025
• PermeaDerm - collecting clinical evidence, accelerate use in FY2025
• Cohealyx - limited launch in 1QFY25, gather clinical data collection, full launch in 2QFY25

Recell drives the majority of revenue today - Cohealyx and PD will become substantial revenue contributors over coming Quarters.

Going forward GM mix change:

• Gross profit of a combination of RGo, PD and Cohealyx will be less than RGo alone
• Not adding to operating expense
• Cohealyx addition to operating margin will be substantial 

Notes on today's AVH 2QFY24 Investor Webinar, and then I think I am done with AVH for this Q!

TLDR SUMMARY

Nothing new as most of the content was released as part of the 2QFY24 results last week

What was very useful, however, was the detailed insights and colour to (1) the step change introduced by the RecellGo devices and the impact of this (2) the position behind the New Account numbers - a bigger than run-rate jump is expected in Q3 (3) approach to the globalisation strategy (4) positioning of Regnity in the Continuum of Wound Care strategy and the product selection process and (5) update on how profitability will play out.

Clear reiteration that with the current growth trajectory with RecellGo, there is sufficient cash to get to profitability without having to draw down on $25m of upcoming debt tranches.

Even if AVH meets the lower end of revenue growth guidance it still expects to reach the break-even goals as AVH is now setup for sequential QoQ growth.

Very apparent that Jeff and David are still very sore with the drop in the 1QFY24 results and the impact this will have on FY2024 - declaring that it really was “self-inflicted” and they have owned that. But AVH is now poised for growth and “is in a good place to make this happen”.

My thesis is absolutely playing out and am very bullish as the various pieces for sustainable growth previously discussed are now in place. It is now all about delivering against the playing field that AVH has created in the coming quarters ....

Discl: Topped up this morning in both SM (assuming closed) and IRL (to 3%) to move AVH into a medium conviction holding in my portfolio. Intend to top up another 1 to 1.5% if the price weakens from here.

THE SIGNIFICANT IMPROVEMENT OF RECELLGO

I think I finally grasped the step change that RecellGO brings over Recell v1.0. This table is my layman's summary based on the pictures above:

NEW ACCOUNTS UPDATE

Q2 internal target was 46 units to new accounts which includes orders - landed short at 31 New Accounts + 6 VAC approved but no orders yet

Expect further improvement in Q3 as AVH has fine-tuned the new account process - 89 is in the pipeline vs 50-70 if maintained current run rate

Sales organisation is full staffed now, from 30 previously to 100 today

One of the early challenges was that some of the new accounts were seeing RecellGo for the first time and being positioned as the 1st in class in trauma centres causing process bottlenecks as most wanted to see trials being conducted first etc - have modified approach to overcome this.

GLOBAL COMMERCIALISATION STRATEGY

Countries on AVH’s radar met 3 internal criteria (1) Health Care systems must be able to leverage the Recell technology (2) have the ability to pay (3) has sufficient population size

Current new-country approach of expanding via local 3rd parties is to leverage off the partner’s knowledge of the local healthcare system

At the last step for CE mark certification in 3Q FY2024.

WOUND CARE STRATEGY

Reiterated that Recell has no competitor - if AVH gave away the IP to someone, it would take 2 PMA cycles over 4-5 years to get the requisite approvals from scratch - this is the lead time runway that AVH has to embed Recell as the standard of care for burns and FSTD indications.

Reiterated that the AVH strategy is to define and sell the suite of products across the full Continuum of Wound Care around the Recell spray-on.

There are many products in the Dermal Matrix space, but AVH had 3 specific criteria, which Regenity met the best:

• Needs to help speed up the process of getting the graft ready - Regenity is 40% faster, leading to rapid closure of the wound - this will the subject of the 1st planned clinical study
• Need to help speed up graft uptake to begin the healing process
• Enable rapid closure of the wound

Deal ensures that AVH gets more rights and improved margins as each clinical study gets approved - this is good skin in the game without having to develop a product from scratch

AVH is very excited at the prospect of a Regenity-Recell combination enabling AVH to define a 1-step standard of care/procedure vs the current 2-step approach of stabilising the wound in the Dermal Matrix followed by the Skin Graft procedure - this will be the focus in the planned clinical trials after PMA approval for Reginity has been obtained

FINANCIALS

Enough cash to get to profitability given current revenue growth trajectory.

AVH will not be eligible to draw down $25m tranche of debt which will become available as will not meet FY24 revenue threshold of $75m, this also means the 2nd tranche of $25m in FY25 will lapse - not an issue as AVH never expected to have to draw down these 2 tranches anyway - these is sufficient cash

Comments around profitability:

• Sales Org structure is now fully in place and no change is expected to be required for the next 2 years
• R&D expenses are expected to be stable
• G&A expenses have fallen and continued to fall as process for AVH to scale are in place and AVH has capacity to increase production by 10x. Insourcing of RecellGO manufacturing has allowed better quality control etc
• AVH expects profitability to rise as revenue rises and expenses remain stable/flatten

This confirms my commentary in the 2Q results that operational leverage could already be in play

David explained the rationale for the downward guidance in FY24 revenue - need to re-listen the webinar recording to capture the detail of this comment

David also said that even if AVH meets the lower end of revenue growth guidance, it still expects to reach the break-even goals as AVH is now setup for sequential QoQ growth

Very apparent that Jeff and David are still very sore with the drop in the 1QFY24 results and the impact this will have on FY2024 - declaring that it really was “self-inflicted” and they have owned that. But AVH is now poised for growth and “is in a good place to make this happen”

Super pleased that in the just concluded AVH Q2 Investor Webinar, my question on how AVH views PNV's NovoSorb, whether it was a direct or indirect competitor and if a competitor, how was it addressing that competition, was the first question, was read in full and I think, answered in full ... it was about 42 mins in.

This was my first crack at asking management a direct question as a super-small-fry retail investor outside of SM management sessions, so am still digesting the fact that I CAN ask questions and get answers ....!

I need to re-listen the recording as Jeff went into some medical explanation which I could not comprehend quicky enough but immediate points I picked up:

1. NovoSorb is a very good product (with no hesitation)
2. Does not do what Recell does, sounds like it is more in the space of what the new product Regenity does, at the Dermal Matrix level per diagram below
3. It is used in indications which do not use collagen matrix as part of the treatment vs Reginitywhich is a collagen-based dermal matrix
4. It is "more synergistic and addresses different indications" - Jeff talked about a Venn diagram which overlaps to a small extent where it does "compete", then there is a much wider area of the diagram where it treats different indications.

For me, this means that I can look at PNV as a standalone and different product to Recell, but operating in the same burns/trauma centre space, same customers etc.

Discl: AVH held IRL and in SM, evaluating PNV as a side-by-side addition

Worked through AVH's announcement last Thurs on the new addition to its wound care portfolio, Regenity. The more I understand this, the more AVH's strategy makes sense. Have re-organised the points in the press release to make better sense of the deal. Have to say that my enthusiasm and conviction in AVH might just have gone up another notch.

Discl: Held IRL and in SM

THOUGHTS

This is another way for AVH to win, targeted for 2025

End game objective is to define a new standard of care for FSTD wounds by using both Regenity and Recell in a single procedure, from the current 2-step procedure.

Each one of these adjacent bolt-on products not only expands AVH revenue opportunities, but it also changes the scope of, and tightens AVH’s moat around (1) RECELL and (2) AVH’s customers in the Burns Treatment world as it strives to define the new standard of care for burns wounds using a multi-product approach strategy

I am thus thinking that AVH's moat is rapidly morphing into (1) Defining the new standard of care using a suite of wound-care products across the full skin thickness (2) establishing the synergies and benefits of using the products in conjunction with other other, rather than a single product (3) monopolising the rights to market, sell and distribute the wound care products suite. which make up the new standard of care.

This is a significantly more robust go-to-market strategy vs a single Recell product approach, which only solves one of the many problems in a burns wound.

Overview of the Regenity Deal

• Exclusive multi-year development and distribution agreement with Regenity Biosciences (“Regenity”), a leading regenerative medical product developer and manufacturer of bioresorbable technologies. 
• As part of the exclusive development and distribution agreement, Regenity expects to secure 510(k) clearance for a collagen-based dermal matrix developed in collaboration with AVITA Medical in the fourth quarter of 2024. 
• Following 510(k) by the FDA, AVITA Medical will hold the exclusive marketing, sales and distribution rights to a unique collagen-based dermal matrix, which will be manufactured by Regenity.
• Once 510(k) clearance is obtained, Regenity will manufacture and supply this product to AVITA Medical. 
• AVITA Medical will then hold its exclusive rights to market, sell, and distribute the product, including any future enhancements or modifications, under the AVITA Medical brand name within the U.S., and potentially in countries in the European Union, as well as in Australia and Japan. 

Defining the New Standard of Care Using Regenity and RECEL in a Single Procedure Instead of The Current 2-Step Procedure

• Alongside the use of RECELL for the treatment of thermal burn wounds and full-thickness skin defects, our new product will generate a dermal-like tissue in full-thickness wounds through rapid cell repopulation and revascularization of the dermal collagen matrix. “We believe we also have the potential to establish a new standard of care with a one-stage closure, thereby improving patient outcomes.” 
• Immediately following 510(k) clearance and commercialization, AVITA Medical plans to initiate multiple clinical studies to establish the unique synergies between the new dermal matrix and RECELL. 
• These studies will include the evaluation of the new dermal matrix and other commercially available dermal matrices in full-thickness wounds, followed by delayed treatment with a split-thickness skin graft plus RECELL in a two-stage procedure (the current standard of care), to demonstrate improved time to grafting and wound closure. 
• Additional clinical studies will evaluate the use of the new dermal matrix in full-thickness wounds with immediate grafting together with RECELL in a single procedure, aiming to establish a new standard of care. 
• AVITA Medical anticipates completing these studies in 2025 

Commercial Terms

• The initial term of the exclusive development and distribution agreement is five years, with an automatic extension of an additional five years, contingent upon meeting certain criteria. 
• AVITA Medical will make a $2.0 million payment upon receipt of 510(k) clearance by Regenity. 
• AVITA Medical has a further obligation to make up to an additional $3.0 million payment on or before January 4, 2026, to support manufacturing capacity, contingent on the positive results of the clinical studies related to the new dermal matrix. 
• The first two years of revenue sharing from sales of the product is expected to be equal to 50% of its average sales price. 
• In subsequent years, AVITA Medical’s share of revenue will increase to 60% of the product’s average sales price. 

Did a more detailed review of the AVH Q2 results. The AVH price in the US spiked 20% on Fri, which has not happened for quite some time. Looking forward to Monday for a change!

Discl: Held IRL and in SM

TLDR SUMMARY

Very pleasing result - very encouraging signs that short term challenges of slow increase in new accounts is being overcome with a tangible increase in New Accounts (31) and VAC Approved accounts (6).

QoQ Revenue up 36.8%, direct costs up 39.5% but Gross Profit was an impressive 36.4% - encouraging signs of operational leverage perhaps.

Flagged increase in Sales cost has kicked in with a 29% increase, but impact was softened by falls in G&A and R&D, leading to a 7.1% overall cost increase.

FY24 Revenue guidance has been reduced from between $78.8m to $84.5m to between $68.0m to $70m - not great, but this will mostly be from the poor 1Q result. Happy to let this go if positive Q2 momentum is sustained throughout 2HFY24.

Have increasing confidence in management credibility as things have panned out as they have explained and guided in this result - continued confidence will need to be continually earned!

Other pipeline projects - RecellGo Mini FDA certification, Vitiligo studies progressing as planned.

Key for Q3 is continued evidence of sustained momentum in (1) New Accounts (2) Revenue, including expansion of non-US revenue (3) overall operating cost containment to absorb higher S&M expenses.

THOUGHT PROCESS

I am focused almost exclusively on understanding QoQ changes.

PcP changes are good to know, but significantly less important, as my view is that AVH has made step changes in the last 6M due to (1) RecellGo FDA certification (2) made clear moves in its transformation into a broad-based wound care company (distribution of Perma Derm, Regenity products alongside RecellGo) (3) upcoming RecellGO Mini FDA certification etc, which makes it a very different organisation than what it was in FY2023.

I am now thinking of AVH as not a single product, RecellGO-driven company, but as a broad-based wound care Company, which focuses on addressing all wound treatment issue around a central burn wound which is primarily treated by RecellGO - this pivot in thinking has been important to make sense of all the recent AVH moves and what is ahead.

I am desperately wanting to have clarity on where PNV’s NovoSorb sits in both this Continuum of Wound Care and Product Compatibility diagrams to understand how much of a competitor it is to AVH’s market position and strategy and/or whether it makes sense to open a position in PNV to ride on the NovSorb opportunity ahead - have asked the question for the AVH Investor Seminar next week.

Updated Continuum to Include Regenity

THE GOOD IN Q2

Tangible increase in New Accounts for RecellGo Full Thickness Skin Defects - the lack of progress in securing VAC approval for new accounts caused the 1QFY24 results to dive, expectations were reset, and there is now a tangible uptick in New Accounts and VAC approval. Q3 looks promising in terms of extending this new account momentum.

Revenue rose 36.8% QoQ to US$15.1m, at the top end of Q2 guidance of “between $14.3m to $15.3m”.

While from a very low base, good to see revenue increases in non-US markets as AVH focuses on expanding its RecellGo global footprint.

Cost of sales corresponding rose 39.5%, but Gross Profit rose 36.4%, which hints at improving operational leverage as the revenue increase was almost fully sustained through to gross profit margins. Need more evidence that this is sustainable but this is a really encouraging sign. It also lends credence to management’s explanation that the slowdown in 1Q revenue was primarily due to the challenges of navigating the VAC process in hospitals, which AVH had to learn from and fine-tune its approach to expedite the process.

Operating Expenses rose 7.1% QoQ, despite a clearly prior-flagged increase in Sales & Marketing expense of 29% as G&A and R&D expenses fell 16.1% and 5.9% respectively, to compensate for the increased sales cost. This is also encouraging as AVH appears to containing overall cost increase despite the sharp increase in Sales & Marketing expenses.

Cash balance increased $0.5m, or 3% and appears that operations now has a good cash-flow cadence. This augurs well for (1) the AVH objective of being cash flow positive no later than 3QFY25 (2) is likely to further improve as revenue momentum increases in the coming quarters and (3) keeps the risk of a operations-driven cash raise risk, low.

Other projects appear to be going well and on track (1) RecellGO Mini FDA approval (2) Vitiligo study.

THE NOT GREAT in Q2

Full Year revenue guidance has now dropped to between $68.0 and $70.0m from the initial FY24 guidance of $78.5m to $84.5m, but still a very respectable YoY growth of 37% to 41% over FY23 - much of this will be due to the poor 1Q result. 

This is not great, but I am happy to let this go IF there is continued 2HFY24 momentum in (1) New Accounts (2) QoQ revenue and (3) improving non-US revenue contribution, as this blip will likely only be temporary. All bets will be off if 2HFY24 momentum falters!

EXPECTATIONS FOR Q3

• Meet or achieve New Accounts and VAC Approved Accounts - I view this to be more important than meeting revenue guidance as this is the driver of future revenue growth
• Management guidance is for Q3 revenue to be in the range of $19.0 to $20.0m
• Continued step increases in non-US revenue, particularly the EU where AVH is focused on growing its presence
• Sustaining of margins as sales of other wound-care products increasingly contribute to revenue
• Modest rise in Operating Expenses to demonstrate continued containment of costs
• Sustained Cash balance

THESIS UPDATE

• Thesis remains very much intact - the operational outlook of this thesis has improved with this result.
• Moving AVH to a medium-conviction holding in my portfolio.
• Will progressively top up if price weakens again to the ~$2.35 to ~$2.50 range to move the current 2.2% holding to between 3.0% and 3.5% over the coming weeks.

Am working through the AVH's 2QFY24 results, which at first glance, looks good. The market certainly liked it!

It is a much-welcomed change from the recent bash-almost-everything-I-am-also-hurting mood across the market which I am desperately trying to tune out of ...

The AVH 2Q pcp improvement looks good, but what I am more focused on is tangible QoQ improvement to gauge sales momentum ...

In signing up for the Investor Webinar next week, I have asked the following question:

Could you please provide insights on how AVH view's PolyNovo's NovoSorb product. Where does NovoSorb sit in the AVH Wound Care Continuum? Does it compete with RecellGo, directly or indirectly, and if so, how is this competition being addressed? 

Hoping AVH will pick up the question and provide some insights, that I will share.

Discl: Held IRL and in SM

Very impressed with the planning and prep, deployment and execution of the RECELL GO. FDA approval was received on Thu 30 May 24, so 1st use was the day after.

The Joseph M. Still Burn Center at Doctors Hospital of Augusta is the first U.S. burn center to treat a patient using its RECELL GO™ System

• RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin™Cells. 
• This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme™ incubation time to ensure optimal cell yield and viability. 
• These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients. 

A much-expected-but-good-to-finally-see-it FDA approval for RECELL GO was received by AVH overnight. AVH has been all set to launch to market the day it got FDA approval. This could well be the turning point for the rough past 6M.

• U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO™ System, its next-generation autologous cell harvesting device that harnesses the regenerative properties of a patient’s own skin to treat thermal burn wounds and full-thickness skin defects. 
• RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin™ Cells. This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme™ incubation time to ensure optimal cell yield and viability. These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients. 
• "FDA approval of RECELL GO marks a paradigm shift in the treatment of partial-thickness and full-thickness wounds,” said Jim Corbett, Chief Executive Officer of AVITA Medical. “By streamlining processes and enhancing operational efficiency with the use of RECELL GO, clinicians can now treat a greater number of patients and more broadly experience the proven benefits of RECELL technology. We believe that this transformative shift will empower more clinicians to achieve optimal outcomes for their patients, driving greater adoption, and fundamentally redefining wound care management. It's GO time for a new era in wound care." 

In the United States, the Company will launch RECELL GO in its top burn treatment centers in June, and other existing accounts will be converted to RECELL GO throughout the year. New accounts will receive RECELL GO with their first order, eliminating the need for conversion. 

My notes on AVH's 1QFY24 earnings and earnings call.

Discl: Held IRL and in SM

KEY TAKEAWAYS

• Not a great quarter at all
• AVH continues to battle the complex Value Analysis Committee (VAC) approval process at trauma centres - a key insight learnt was this is the first period that AVH has had to front the VAC process, so they are very much learning on their feet in terms of how best to successfully navigate this process
• With Q2 revenue being guided to US14.3m to US$15.3m, essentially 4QFY23 revenue, the back-ending of revenue to meet the lower end of revenue guidance of between US$78.5m and $84.5m, particularly in 3Q and 4Q, is very steep 
• The ingredients to achieving revenue momentum are very much in place, it is now a matter of executing the delivery - (1) RECELL GO FDA approval end-May (2) significant leanings applied into the VAC process to increase velocity and success rate (3) increased sales force is in place (4) PermeaDerm contribution to start flowing through (5) RECELL Mini approval end-2024 (6) ongoing hunt for synergistic burns wound products to complement RECELL treatment (7) overseas approvals and expansion.
• Management appears to be actively managing the issues, have appeared transparent in their communication of the challenges and resolution steps, and appear to have well managed all things within their control (Recell Go inventory, increasing sales force, applying VAC leanings, looking for synergistic products etc)
• Strategic Transition to the Continuum of Burns Wound Care in and around the RECELL technology makes good sense - management has thus far appear disciplined in how they are working against this strategy
• Will need patience for the full effects of all of these to kick in before any meaningful re-rating occurs - likely to only be late CY2024/early CY2025, price will be choppy and event-driven in the meantime

Risks

• Bog down in VAC process continues deep into FY2024 - Medium
• Slower uptake of PermaDerm will dent revenue - Medium
• FY2024 revenue guidance not met as planets do not align - Medium/High
• Overseas expansion and then ramp up does not occur as quickly as planned for there to be meaningful revenue contribution - Medium

Outlook

• Much of the risks are timing rather than permanent issues - the need for burns wound care is an ongoing, critical need and the cost benefits from RECELL are significant
• Once ironed out, growth momentum will take off as AVH has many ways to win, on an ongoing basis

Action

• Continue to hold 
• Add to current position up to max of 2%, only on price weakness
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NOTES FROM EARNINGS CALL

• Disappointing quarter - short of expectations and 1st quarter since Jim arrived that sequential quarterly growth was not achieved
• Burns core business was slower than normal:
• Burns cases are predictable and typically flat
• Jan 2024 saw an abnormal 20% reduction in burns admissions from the last 3 January’s
• Feb and Mar 2024 and current admissions appear flat vs prior years, back to normal
• Pipeline of VAC approvals remain strong - 46 are due for approval in 2QFY24 - there are precise dates for these in Q2, not expecting any rejections
• AVH has not had to go through the VAC process prior to the approval for the expanded scope of Full Thickness Skin Defect (FTSD) indications, and the approval process is complex - feeling much better on this front as significant leanings have occurred, and AVH’s approach to the VAC process has been fine-tuned
• Strategy now in place for sales team to spend 60% of their time on site to educate, train and sell
• RECELL GO inventory is already on hand and AVH is ready to go as soon as FDA approval is received end-May 2024
• On the 8 rejections in the VAC approval process, no clear pattern for these rejections and has occurred randomly - rejections are not expected to have a material impact on guidance
• Tone study for Vitiligo indications will commence in June, ending in July 2024, preliminary insights will be provided in the August 2024 call
• Overseas expansion - good progress
• Submitted technical documentation to EU for CE certification, confirmation that documents provided is OK
• European launch is expected to be post northern summer to coincide with RECELL GO approval and EU certification, expected in Sep 2024

Financials

• Gross Profit improved to 86.4% vs FY23 FY23’s 84.5% - expecting margin dilution rest of FY2024 as lower margin (50%) PermeaDerm revenue increasingly kicks in 
• $4.0m of expenses are not recurring - purchase of PermeaDerm inventory, other Stedical-related costs, as startup costs for PermeaDerm - of this, $3.1m is product inventory
• Increase of Sales & Marketing cost is due to the expansion of the Sales Team, the ramp up occurred in 1QFY24 - will continue to rise in the next Quarter as the full quarter impact is felt from the staff uplift
• G&A and R&D costs vs pcp and prior Quarters were mostly due to increased employee costs - G&A expected to be stable to lower and R&D costs expected to be stable going forward
• BARDA income has stopped as the BARDA Agreement has expired - AVH is only obligated to provide BARDA with 1st priority to purchase a max of 1,000 units, which AVH owns in the event of a national disaster
• Increased cash use this Quarter is not a concern and does not impact the goal to achieve cash flow break even and GAAP profitability no later than 3QFY2025
• Impact of expanding Sales & Marketing force has not had a significant impact on sales:
• changeover of reps has occurred across accounts but evidence suggests that accounts with changed Sales reps has performed slightly better than accounts with unchanged reps
• the sales force expansion is not a cause of the current challenges
• Post VAC approval, the 1st customer order is typically placed quickly, then time is required to train, educate and assist the trauma centre in the use of RECELL - AVH medical scientist staff are key to this diagnose and how-to-treat phase

Guidance for 2QFY24

• Revenue 2QFY24 to be between $14.3m to $15.3m
• Reiterate FY24 guidance to be at the lower end of $78.5m to $84.5m, including PermeaDerm revenue - acknowledged that the backend ramp in 3Q and 4Q revenues is very steep
• Expecting 2Q to recapture sales momentum as AVH overcomes the VAC approval process challenges
• PermeaDerm will start to meaningfully contribute - extent and timing is uncertain at this stage, but will become clearer in 2QFY24 - no significant additional expense required to sell PermeaDerm as it complements the Recell treatment
• Significant boost expected from RECELL GO approval
• New Accounts do not seem to be waiting for RECELL GO approval before committing
• Great sense of anticipation from existing, bigger customers on RECEL GO - AVH is expecting a significant boost in uptake from RECELL GO as there are significant benefits in terms of (1) reduction of 1 person currently required to prepare/treat burns (2) reduces operating theatre time and expense, for FTSD indications, as it is a step improvement in terms of being easier to learn and use
• As AVH is confident with the steep ramp up, if the lower end of guidance is met, AVH will burn less cash and will be very close to cash flow break even 

Have started building a small position in AVH.

PROBLEM THAT AVH IS TRYING TO SOLVE

• Split-Thickness Skin Grafts (STSG), where donor skin is harvested from a healthy area of a patient’s skin, has been the standard treatment for more than 50 years - associated with significant pain, itching, infection, dyschromia, dyspigmentation, delayed healing, and hypertrophic scarring of the donor site.
• Lack of healthy donor skin in patients prevents immediate and complete treatment of the entire burn injury - must wait for the donor sites have healed to enable re-harvest - delays in treatment, requiring multiple procedures and extending hospital stay
• Overall cost of STSG treatment is expensive - eg. 40% mixed-depth burn could cost $579k and 59.4 days in hospital

INVESTMENT CASE

• Essentially a monopoly for burns wound management via the RECELL Platform
• No known competitor in this space
• Barriers to entry is high - FDA approvals required etc
• Challenges in penetrating hospitals once approvals are obtained
• Multiple ways to win with RECELL Platform:
• Core Usage:
• Core business of burns wound management - ~35,000 procedures per year - are not elective surgeries, they arise from significant skin defects or burns - recession should not impact AVH significantly 
• Full Skin Thickness Skin Defects - adds 10x eligible procedures over and above, a further ~400,000 annual eligible FTSD procedures
• Vitiligo - further expansion of use of RECELL in FY2025
• Definitive steps to expand footprint into Europe FY2024 via distributorships
• Platform:
• RECELL GO - May 2024, improved process/procedure, higher % that are viable and ready to cling on to the wound
• RECELL MINI - Dec 2024, for skin treatments up to 500 sq cm vs 1,920 sq cm for the primary device
• Adjacent Distributorships
• PermeaDerm, a biosynthetic wound dressing, same sales force, pure revenue upside in FY2024
• Financials
• On clear path to cash flow breakeven and GAPP profitability no later than 3QFY2025
• Gross profit margins ~84.5%
• Use of debt funding starting to slow
• Ingredients are in place to penetrate, expand and grow
• Share price has fallen significantly from its Feb 2020 peak of $17.20, to a low of $2.60, despite there being now significantly more clarity on the path and opportunity forward

RISKS

• Medium: Slower than anticipated penetration into Trauma Centres and Hospitals - FTSD FDA Approval unexpectedly increased the scope of the initial approval request, resulting in expanded scope of required physician specialist approvals prior to Value Analysis Committee (VAC) approvals being obtained. This is the current key obstacle to expanding the hospital footprint where RECELL can be used. This will impact revenue in the short term, but expect AVH sales to get smarter in how it works through the approval process
• Medium: Studies in Vitiligo do not show enough non-medical benefit for treatments using Vitiligo to be insurance-reimbursible, impacting the expansion of RECELL usage to treat Vitiligo. Still early days in the ongoing studies. Need to monitor
• Low: Delays in FDA Approval for RECELL GO device - but things appear to be on track for approvals

WHEN TO EXIT

• Clear signs that there is no traction in penetration of hospitals and trauma centres
• Vitiligo studies do not pan out as expected
• Series of negative patient impact incidents with use of RECELL

POSITION SIZE

• 2%

Discl: Held IRL and in SM