Forum Topics PNV PNV FY24 Results

Pinned straw:

Added 3 months ago

I'm limbering up for the DW Show at 2pm this afternoon with a quick review of the $PNV results. The financials have been well-telegraphed in advance, and I've gone through the Accounts and it's all remarkably close to my forecasts.

FY24 Results and Financial Statements

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Their Highlights

  • Total revenue including BARDA of A$104.8m, up 57.5% on STLY of A$66.5m
  • Strong growth in U.S. achieving record sales of A$68.7m up 49.0% on STLY of A$46.1m.
  • ROW sales of A$23.4m up by 73.3% on STLY of A$13.5m.
  • Positive cash flow from operations of A$3.7m up 155.7% on STLY (A$6.6m)
  • Net profit after tax of A$5.3m (FY23: A$4.9m loss)
  • At year end the business had A$45.9m cash and cash equivalents


During the Period, the Company’s other key initiatives and achievements include:

  • Record monthly sales in April of A$9.2m (monthly revenue: A$10.5m) and May of A$9.8m (monthly revenue: A$11.3m).
  • Initiated a full market launch campaign in the U.S. for NovoSorb MTX in June 2024.
  • Strengthened the U.S. team from 93 to 107 (June 2024)
  • Increased U.S. customer accounts by 197 from 299 to 496 (June 2024)
  • Increased global employee headcount from 218 to 254
  • New C-suite roles - Chief Medical Officer, Chief People Officer, General Counsel and President, Asia Pacific.
  • Supplied into certain war zones for humanitarian needs.
  • Obtained registrations for Bolivia, Ecuador, Thailand, and Sri Lanka.
  • Enrolled 120 patients into the U.S. BARDA pivotal trial for full thickness burns.
  • Finalised design and selected a builder of the third manufacturing facility to service up to $500m in additional revenue.
  • Awarded Victorian Government grant of A$2 million for R&D facilities expansion, subject to customary conditions. 


My Analysis

The key for today is that $PNV delivered on their commitment at the capital raise to be profiable in FY24.

EBITDA, EBIT, NPAT, and FCF all positive. The first year we've had this.

Gross Margin % of 94.8%

In the US, with modest sales team growth, new accounts and revenue grew strongly, reflecting the lag effect of 1-2 years between adding headcount and driving revenue per account. A key question is where is the US trajectory from here?

2024 has been a foundational year: 1) broading market approvals across the global where Novosorb can be sold 2) progressing the design of the major manufacturing capacity expansion, 3) re-igniting R&D to build out further products to exploit the platform technology (R&D expense in FY24 up to $11m from $7,4m, but still only a CSL-esque 10% of revenue), and 4) building out the management team. These are all important steps in building a business from this start-up with a genuous product.

In the Chairman and CEO remarks, there were further details on revenue progression in key markets:

  • UKI up 81.5%
  • EU/Germany distributor markets up 81.2%
  • Australia up 38.7%


I take the UKI as a good indicator of what the EU can ultimately do, and it looks like the distributor is kicking into gear. UK/EU growth will be important in maintaining the group trajectory as the US inevitably matures.

The addition of licensing in SUPRATHEL means it looks like $PNV are taking a leaf out of the $AVH book. Once you have the sales foot print, who need to give them more things to help drive contribution margin per account. So, good.

What's not mentioned - India. There is a lack of granularity there. So hopefully the analysts will try to tease out some more on that on the call. After all, we've had 20+ people now working that market for over a year, and there have been some qualitative stories of progress. India does not need to be a "today thing", however, over the longer term the potential for the product to get traction at a reasonable contribution margin in middle income/developing markets helps the long-term growth thesis. (And after all, it's why - or one reason why - Swami joined the company!)

My Key Take Aways

Report entirely as expected. No surprises. So the question is what else can we learn on the call at 2pm.

Lunch now, and then I'll be sure to get my ringside seat for the DW show!

Disc: Held in RL and SM

SudMav
Added 3 months ago

Thanks @mikebrisy@Parko5@Dominator - some great insight and information here :)

I have been following PNV for a while as a former shareholder I am glad to see this company finally turning a profit.

My only concern with the growth figures they provided this year is that 67% of the NPAT comes from Tax Benefit (losses from prior years) making the forward PE on this one quite high if you normalise this figure. They still have quite a bit in prior losses that can be recognised in future years to keep beefing up the growth numbers as the company scales.

That said, they are still a ripper of a company with a $6m increase in NPAT year on year (excluding tax benefit) and huge future growth potential and a clear market advantage/moat being developed.

Personally I am not yet certain about what growth multiplier to use on this one, so will probably excitedly wait until the next the next half year reporting before I can make a call.


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mikebrisy
Added 3 months ago

@SudMav for a company that is just at the inflection point of profitablity like $PNV, focusing on NPAT is almost meaningless.

From my perspective, I did care about it this year because it demonstrated the delivery of a commitment the company made at the capital raising at the end of 2022. (We need growing companies to exercise capital and cost discipline.) However, this is a company with a leading product that needs to invest heavily in the global rollout. The business in the USA has demonstrated it is highly profitable.

Furthermore, they need to step-up the investment in R&D to exploit the platform and develop new products. Their 10% of revenue-going to-R&D is a BARE MINIMUM. At this stage in their evolution I wouldn't mind if it was 15-20%. However, they are demonstrating discipline so far in capital allocation, so I'm OK with that.

NPAT will have its day, But today is not the day. So, frankly, I don't care how much of the NPAT that I am not yet focused on came from where.

The measures I am tracking are:

  1. % annual revenue growth (How long does it stay >50% p,a,? The market thinks next year is 28% - they might be very wrong indeed!)
  2. % gross margin
  3. Sales & marketing / Revenue (they don't report it, so I need to model it from their headcount)
  4. Overhead/Revenue


For this company, 1. is the focus, 2. appears to be a given (93%-95%!), and 3. & 4. are to be monitored closely. As it's very capital light, I keep half an eye on capex too. For example, $26m capex is going to buy them $500m pa additional revenue capacity. I'll take that any day.

It is so important to focus on the right things at the right time.

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SudMav
Added 3 months ago

Totally Fair - I appreciate the different perspective and in no way doubt the massive growth opportunities they have going forwards.

I agree that all 4 of the points you are tracking are definitely a great gauge at determining where the company will be heading in the future.

I was more suggesting that from my perspective (probably from some of the bad experiences in the past) I find it hard to work out what a fair multiple/market price to attribute to emerging businesses. I have always tended to focus on NPAT/EPS and have never been a good gauge of what is right in the small cap space.

Insights like yours and posts/research from all Strawman members have been a great help me since becoming a member a few weeks ago, as they are helping to bridge the knowledge gap and understand what to focus on in these emerging companies.

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mikebrisy
Added 3 months ago

I'll finish a busy week by jotting down a few points from the $PNV call.

Overall Key message:

There were no specific, material disclosures beyond what you can read in DW's and SR's statements in the Financial Report or in the slides. The overall performance was more buttoned down and disciplined, with the team working really well together. Minimal SP response today due to no surprises compared with the pre-release on 23 July.


Details

Having said that, DW promised a short call ... but it ran for 1.5 hours. And, as ever I personally got a lot of value from it.

In the points below, I pull out a bit of the color around the formal content. So, I'm not going to repeat any of the core materials from the slides, but just focus on the extra insights.

I've grouped all the key points I wrote down in my notebook, under topic headings, not the order of delivery on the call which was a bit more "organic" shall we say.


Market Overall

  • 50,000 patients treated to date since inception. Swami still eyeing a global market of "millions"
  • Now selling into 29 countries
  • Building to 41 countries: +12 accessing actively now by working trials/evaluations, engaging KOLs, developing training and professional education
  • Countries requesting $PNV to enter ... usually via an influential surgeon ,,, they can't alway say yes, as need not to overwhelm the team. (Cited one call of a surgeon in tears begging them to come.) DW explained that you can't just send product. You have to ensure registration and training for proper use to get the right outcomes.
  • As market mix diversifies SR sees "50% annual revenue growth, but 80% annual volume growth" (This was an illustrative remark to discuss the effect of adding lower price markets to the mix ... but again, is he indicating that directionally he sees continued 50% reevnue growth in prosect. If he is right, then this has huge implications for valuation, as consensus is assuming revenue growth falls to c.30% in FY25. 1H FY25 will be a key proof point.)
  • Focussed on pushing from burns to trauma and complex trauma.
  • DW gave example from Auckland, NZ lead BTM surgeon who was discussing an amputation a colleague wanted to perform for a patient with a venous leg ulcer. BTM superuser said, throw some BTM on it ... leg is saved. It worked. Now "10 more surgeons" are using BTM to avoid amputations.


US Market

  • BTM is now the market leader in US for burns and soft issue trauma (not sure I got the indication quite right)
  • Wilson's analyst was cited as believing Integra could be out of the market until 2026 with one product, following the recall
  • DW said, once BTM takes share, hard to get back
  • Accounts expanded from 299 adding 197 to 496 accounts: have all the major burns sites covered and moving to extend further into trauma
  • c. 20% of US sales came from account acquired within the year - the balance is growth of existing accounts
  • DFU going on the back burner - hard to control product use to get a differentiated outcome. Harder to control in outpatient setting. The focus is trauma.
  • SR believes the US is a "5-10 year growth story"


BARDA Trial

  • Enrolment now complete - India really helped accelerate competion
  • Have the package to submit to FDA - need BARDA signoff
  • Applied for "sprint conversation" with FDA
  • BARDA advocating with FDA on behalf of $PNV
  • Plan is Nov-24 formal submission; hope for FDA decision by Nov-25
  • FDA indication on full thickness burns will be important: some US physician already using it; but will help wider adoption; will help reimbursement
  • Swami: "The data is superb,... we are confident, but we need to convince them"
  • DW expecting an imminent announcement
  • This can be big for other markets. Many markets don't have regulatory capacity and will look to an FDA approval as part of granting indication for FTB to BTM.
  • Overall I believe an eventual FDA approval for FTB will give revenue growth a further incremental push.


UKI ( Direct) and Germany/EU (Distributor) markets

  • Prices lower but overall doing more here in volume than the US (I need to check the transcript, as it doesn’t seem right!)
  • PMI distribtor in Germany/EU - SUPRATHEL deal for $PNV to distribute in UKI and ANZ - more product to sell
  • Doing comparison with SUPRATHEL and BTM - secondary wound applications. Much higher volume than BTM


Japan

  • Starting product registration discussions in September
  • Market entry expected during CY2025


India

  • In country for >12 months now
  • Federal Government eProcurement approval accesses 600 hospitals. Focus is the Top 25 burns units.
  • Bureaucratic process post-approval. Multiple procedures for hospitals, and registering with distributors - all very bureacratic and takes a long time
  • Next, they have to go through it all again with each State system, to access the State government health systems.
  • High volume: FY24 US 1,100 burns cases. FY24 India 365 burns cases - all private sector
  • SR expects volumes in India to "shoot up" in FY25 ("shoot up" ... but they already did 1/3rd of the burns volume of the US in FY24!)
  • SR gave example of the BARDA registration for India. It took from June-23 to Apr-24 to get it approved, but one approved, they got 20 patients onboard very quickly
  • SR: in India hospital infection is a big issue for burns. BTM is proving robust. Experience indicates that this is going to be important for all developing markets.
  • SR sees India as "proof of concept for developing markets" - which he thinks will be a big volulme driver.
  • What's the pricing? They won't disclose, but this is the second time that DW has done one of his "nudge nudge wink wink" comments: "What if the price is 50% of the US. Still a big margin." (My notes: So I think maybe he's telling us to assume 50% selling price? However, I believe the discount could be significantly more. Will run scenarios for developing markets at 20% and 50% of US price; sales force is a lot cheaper <20>

Manufacturing Capacity

  • Using 60% of current capacity (running 2 shifts, can add a third)
  • Six months inventory in place in markets; 8m in US. So coverage for any demand surge (or product slippage)
  • New facility to add $500m sales volume design complete
  • Updated cost of $26m - total project (pretty close to capital raise estimate)
  • DW wisely managing risk of overrun by say "it might be $30-$40m all in" - smart, but it means they put good contingency in the original estimate, as prices should have escalated.
  • Construction mostly through FY25; onstream by Dec 2025. (Expect most of the spend in FY25)
  • Next plant after this - maybe overseas - maybe in Australia (DW: "some governments would pay us to build this capability in their country." Capital light/sovereign capability)


Product Development

MTX

  • So far, limited release only
  • MTX $700,000 sales
  • They've been working with selected surgeons to develop the product range and supporting protocol and training material.
  • Developing MTX range 2mm, 4mm, 6mm, and granules so as to be able to fill any wound (My observation: this will result in them stealing market from $ARX and other biologics already in this space! Yay!)
  • They've taken their time to work with surgeons so they get the right product range before wide launch
  • Full roll-out in FY25.


Product Development - need to show the slide

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  • SR asked about more specific timelines
  • Wants to keep wide window 15 - 36 months
  • They have a range of products, driven by surgeon requests
  • Moving to testing in animals - compare with standard of care
  • Then into humans
  • The don't want to engage regulators and register products until they know they have products that will work for the surgeons
  • My comment: This is the first year for several years that we've had visibility of a product development portfolio. Its not coming in 2025, but my sense is that we will start hearing more tangible newsflow as a matter of course. SR being careful not to set expectations that will be missed. This is starting to feel real again.
  • Quite a bit more to write here - but will keep for another time. A "lot" of product development ideas - many surgeon-driven.


Margin Evolution (Jan-CFO)

  • FY23 to FY24 you can see the operating leverage
  • Have to continue to invest to grow
  • Profit is important, but so is R&D
  • "Normal" price increases to push through in FY25 (note: BTM much cheaper than biologics)
  • Expect to see continued operating leverage
  • % GMs will trend down as we 1) move beyond burns and 2) increase volume outside US
  • India a fraction of the price ("half?") but still high margin


M&A

  • Potential - not imperative
  • Option 1: a salesforce with relevant skills / geogrpahy and market access we want
  • Option 2: a complementary technology that enhances our product
  • Option 3: other products that leverage the sales force (e.g. Suprathel ... but not Suprathel ... or is it .... the DW Dance of the Seven Veils)


Leadership

  • SR wants to drive growth but recognises important not to overstretch the team
  • Need to make sure we get it right and don't make mistakes
  • Need to work with surgeons and iterate produdct developments to meet their needs
  • Need to roll out products with proven procedures, evidence, training and professional development
  • Sense of urgency but take time to do it properly to make sure product achieves differentiated outcomes


Reporting

  • DW: now we've passed $10m monthly sales, the Board is thinking of stopping "record month" reporting - I hope so, then we can have a gentler ride!


------------------

OK - I've timed out. Friday cocktail hour beckons. T

That's all the key points and it gives me what I need to do my major update on my model. I'm simplifying the model from my current complex one. Still a DCF, but key assumptions will be:

  • 10 yr DCF; uplift continuing value to reflect greater confidence in development product portfolio
  • US revenue growth over time
  • Developed market growth over time & margins
  • Developing market growth over time and margins
  • Capex - understood
  • R&D - a few assumptions 10% revenue; 12%+ revenue but then declining over time
  • Expenses evolution - good handle on this
  • Exclude M&A options
  • New products - just treat as revenue growth in out-years at reduced margin


Still a lot of uncertainty - particularly the rate at which US matures. Still very exciting.

My sense is that upper limit of valuation will increase significantly, and lower bound will nudge up. But still a lot of unknowns. Net net,...will just need to continue to hold on for the ride.

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Parko5
Added 3 months ago

Great set of meeting notes @mikebrisy

I would just add the following from my notes:

  • Pricing - there was talk with Jan (CFO) that they have been putting up prices in USA in line with inflation, but there could be scope for additional price rises. But not in FY25.
  • "New Stuff" - David Williams said he wanted to share a bunch of new things...but couldn't yet. But hopes to soon. Any guesses on what this would be? New countries or partnerships?
  • Swami said that they have developed their products to not need cold storage from FY25 onwards. This will obvioulsy reduce the cost to the hospitals but also costs in transport around the world and help margins.
  • I loved Swami's comments about how we are not 'Next Generation wound care' we are now 'New Standard of Care'.


I would also say that Swami is now working at the peak of his abilities (which are very high). He was across everything and gave very precise answers but also giving his team room for delays etc., and not setting unrealistic expectations in the market. I feel it has taken him some time to get all the current and future R&D projects under control and set in the right direction. But as @mikebrisy said...i feel these products are def on the way in the next 2 years.

I would also like to contrast that meeting with the IIQ meeting. David Williams Chairs both companies. The PNV team really make the difference. I know they are further down the commercial pipeline.....but I think the Directors of IIQ should be looking at how PNV runs it's team.



@mikebrisy my previous post in PNV i asked if anyone had some thoughts on how MTX will add to revenue. How are you dealing with it in your model. Actually...how are you dealing with all the current and future products?

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Dominator
Added 3 months ago

@mikebrisy Potentially just a change in timing issue but was there any mention of higher staff costs in the call? Using a very basic measure of average employee expense per employee figure has increased quite a bit. Employee related expenses up 51% while number of employees up 17%.

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mikebrisy
Added 3 months ago

@Parko5 … good adds.

The pricing lever is important. $PNV is a lot cheaper per sq cm compared with biologics. Once the healthcare economics studies are published, highlight value of treatment (total cost, patient outcomes) this might create pressure by payors on HCPs and Hospitals in US to use Novosorb. (At present there is published evidence that hospitals are incentivised to use higher cost solutions because they can extract a higher profit!)

I also think $PNV are being smart on pricing: capture the market, prove the outcomes, redefine the standard of care, then price is a later lever.

On modelling of products, I am taking a simple approach.

First, treat MTX within BTM. Over time, as mix shift moves from burns to trauma, I am slowly eroding %GM, e.g., from 95% down a few percentage points over my 9-year horizon.

I’m not modelling new products. This is for two reasons. First, I think it will still take 3 years to commercialise them. Then once commercialised, there are existing standards of care to be displaced. Even in the success case, I’m not convinced these are high revenue applications. (For example, I’ve done some research into hernia mesh, and I think the revenues available to Syntrel aren’t that high.)

Therefore, Ive decided to model the scenario wherein $PNV is successful in developing a broader range of products off the Novosorb platform simply as a higher continuing value in the terminal year of my 9 year DCF. e.g., 4.5% vs 3.5%, for example.

I've thought about alternatives, but concluded it would create false precision.

Any yes, I still think material new product revenues, are a way off.

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mikebrisy
Added 3 months ago

@Dominator - yes, it was discussed, but only at the headline level. And the analysts didn't particularly dig into it.

I see the underlying employee cost growth trend is lower because:

  • Large HC increase in FY23 (+43%) now flows through to full year FY24 cost impact, as the sales and marketing build out made a step change in FY23
  • This effect should be smaller from FY24 to FY25, as the FY24 HC increase is only 17% as you've shown
  • Several new FY24 senior hires skew the numbers a little: CHRO, General Counsel, Head of APAC
  • Building up R&D, will be above average $/FTE
  • They will have paid high levels of incentives in sales in the US (commissions; bonuses)


More generally, there will have been a strong payout on performance-based compensation across the board. Looking at the odd 2022 number - its skewed by the reversal of CEO incentives that were booked in 2021 for SR's predecessor.

So, overall, it was in-line with my model, and I'm reasonably conformfortable.

Another way to get comfortable is that Rev/Employee grew by 35%, while wages/employee grew by 29%. This is very encouraging because the company is still rapidly expanding its global footprint, so there is a general lag effect. I think that as the rate of employee additions moderates, that difference will continue to increase, as the sales and marketing team gains traction in their territories. (It takes around 2-3 years for a new sales rep. to become fully effective, and that is in addition to the growing adoption of the product by clinicians, and relates more to them building all the relationships within their accounts)

Does that make sense?


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Dominator
Added 3 months ago

@mikebrisy thanks for the deeper insights.

On the topic of future HC growth. David has previously talked about the need to grow the sales team to grow revenues, was a surprise to me they only added 36 HC this FY, was expecting more around the 60 number. Do you think they can continue revenue growth of 50-60% without adding significant (50+) sales staff a year? Or in your view are we starting to see the effectiveness of sales staff hired years ago come through?

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mikebrisy
Added 3 months ago

@Dominator that's a question I am mulling over deeply at the moment, as I finalise my model update!

I did expect FY24 to be a period of consolidation on sales and marketing growth headcount. Why?

Well, after the cap raise at end-2022 the lid came off hiring and they added a lot in the US, but also built out in UKI and ANZ. And for good measure they threw in a starter pack of 20 in India with $0 sales! (Note: UKI has only 9 for sales in FY24 of what I estimate to be c. $6m, or $3.5m when they went from 6 to 9!)

So, after that FY22-to-FY23 burst, we saw FY24 back off relatively, speaking.

But, as you say, we are yet to see the full impetus of the FY23/24 cohort play through. And those new account adds in the US ... wow! Now before we get too excited, a lot of those new accounts will be smaller revenue accounts.

The second factor, is that I think we saw a little cost discipline in FY24, because DW and Co. knew they were on a promise to deliver a profit in FY24. SR also spooke about not pushing the organisation too hard. At this scale, hypergrowth can have unintended consequences. They have to hire good people, onboard them, and drive the right culture. SR understands this, and I think over the two years he's been at $PNV, he's releasised that he's not at J&J and is leading a relatively immature operation.

In answer to your question, I think 50-60% revenue growth in FY25 is unlikely, unless they win a whole bunch of tenders in India and that market really takes off (unlikely) and if they add a bunch of HMOs in the US (possible, as that is where SR will be pushing them.)

Also, don't forget about BARDA, In the push to finish enrolling the 120 patients, BARDA revenues grew from $5.663m in FY23 to a massive $11.150m in FY24. I'm now kicking myself that I didn't ask a forward looking question about BARDA. Potentially, being now in the evaluation phase, there could be very limited BARDA revenues in FY25. While there is ample money in the contract (recently expanded to a total value of $US25m, I just don't know what they are going to spend it on as far as $PNV is concerned.)

I'm in the process of finalising my growth scenarios, but if sales to customers grows 50% and BARDA falls back to $2m, for example, then the growth trajectory FY24 to FY25 looks like:

FY25 (1.5 x $92.042 + $2.0) / FY24 ($92.042 + $11.150) = 37.4%

and if we see commercial sales grow at 55% then it looks like:

FY25 (1.55 x $92.042 + $2.0) / FY24 ($92.042 + $11.150) = 40.2%

I expect the analysts (especially, Macquarie) will talk about BARDA in their follow-up discussions with DW, so I'll be looking to see if they call it out when they do their next detailed research note.

At the moment, consensus revenue (based just on the quick updates) has FY25/FY24 at only +28%, which I think is way off the mark, but it indicates to me that the analysts have cottoned onto the end of the BARDA pivotal trial. So the "BARDA effect" is a potential one-off wild-card in the FY25. But it is a one-off, so it might spook the horses who act on the headline, but for those who understand the business, it shouldn't matter much. Sounds like a bit of juicy short-term volatility potential to me!!

Hope that makes sense.

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