Glad to hear that @Goldfish, and you raise good points about the risks.

Perhaps I have a warped perspective on the risks for Anteris these days — my baseline was from when it was a barely solvent penny-dreadful on the ASX. It’s a much larger part of my portfolio now and yet this position causes me much, much less of the anxiety of those earlier years.

My opinion is that the market is mis-pricing both of those risks — clinical and financial.

Clinically I think the size of the sample to date is significant. The pivotal trial may only involve several more hundred DurAVR implantations. The head-to-head is against the standard of care (Sapien and Evolut) — and really the data for those products is a pretty known quantity. I get the impression that the FDA has already responded with some follow-up request(s) post IDE submission — and also, that with some exceptional uses cases still occurring in North America, this is much less of a hurdle for Anteris than the EFS was.

Anteris is not completely without diversity. It still owns the ADAPT tissue as a platform. Also, there is perhaps room for it on the market even if it is only clinically superior to Sapien but not Evolut (due to DurAVR being also balloon expandable like Sapien). Anteris also has the patent for a single piece valve — which both Edwards or Medtronic would want regardless of outcome of the trial. This — plus with the valuation already so low — could provide a buffer between your investment and zero even in the worst case.

Financially, I share the view of at least one Cap raise in Q3 or Q4 (US FY/2025). Beyond that I’m less concerned. I see the start of the pivotal trial (as in the first op performed under it) as a major inflection point. I think it will put a few million options in the money by the end of the year. I also think revenue from the trial won’t be negligible. I think first M&A offers will come from third parties (not Edwards & Medtronic) by that same time — which hopefully at least raises the share price to make raising capital less dilutive. Pending good trial outcomes I anticipate offers from the incumbents themselves.

Bumpy ride. Confirmed, couldn’t agree more. We are strapped into the Volatility Vomitron together on this for sure. But highly risky? I’m more sceptical on that.

Thanks for the reply

Having given this some more thought overnight, I am now more concerned about the amount of capital required vs AVRs current share price.

There are currently 36.81 million shares outstanding, with a share price of AU$6.85. This gives a market cap of AU$252 million (some sites are reporting this incorrectly, I am not sure why).

The last cap raise was in April 2024 at AU$23 per share. One million shares were issued, raising AU$23 million.

The IPO on the NASDAQ was at US$6 per share (around AU$9.3) in December 2024. 14.8 million shares were issued, raising US$89 million.

Current cash burn is over US$20 million per quarter

At the current share price (US4.15), assuming a small discount, the company would need to issue a further 5 million shares every quarter just to fund it's operations. For the next 12 quarters. At least

The NASDAQ appears to be a little more generous than the ASX, in that it allows a cap raise of up to 20% before shareholder approval is required. But 20%, at the current share price, would only raise enough cash to fund operations for around 1.5 quarters (7.3 million shares at US$4 each = US$29.2 million)

Interested in your comment on this. It seems to me that at the current share price, raising enough capital is going to be a big problem. Even if FDA approval comes through and there is a 50% share price bump, the situation would still be challenging.

My other thought is that, rather than selling 75% of the company at a discount (in order to fund it for the next 3 years), why not sell 100% of the company for a premium? Could make sense for one of the big companies to buy AVR for say US$300 million and spend another $300 million to fund it (probably less without the corporate costs). US$600 million all up for a product that could be worth several billion.

It’s definitely something worth thinking about @Goldfish, and I’m not trying to trivialise the capital issue.

Just so it’s clear but, the capital raise (and options exercises) I’m anticipating are in the order of a 300-400% increase in share price in July to August 2025. I think if the prevailing share price conditions were somehow continuing by then the company would give preference to debt finance.

I think it’s the thought that you express in your last paragraph that touches on my confidence with this. Why would Anteris sell its equity at a discount for consecutive quarters when it is worth more? It won’t, I think is the answer. And I think table stakes for this type of acquisition starts at the USD billion mark.

NASDAQ is the absolute game changer here. One of the reasons for incorrect market cap you may be seeing is due the sites (even my broker NABtrade) using only the 15 million ASX CDIs to calculate market cap. The true market cap for Anteris is the 21 million NASDAQ common stock + the 15 million CDIs. Yet NABtrade records the correct market cap on my AVR.NAS shares. Just one small example of where I think it pays now to focus on how this looks in the US. Daily volume for AVR on NASDAQ is about 400,000. I also think there are hedge funds with short interest that are focused barely beyond Q2 2025. My horizon is much longer. The only reason I even have NAS.AVR was for times I thought the prices couldn’t even stay as low as they are until the start of the Aussie trading session. I was wrong of course, but I don’t know for how much longer I will be. I definitely have no expectation that prices get much cheaper than this.

I’m committed of course, but not as much as others. Wayne Paterson for example fought to retain his options upon IPO. When he eventually uses those it could be to great affect to the market as a signal.

He’s just one of many with too much at stake to let this fail on quarterly fiscal concerns.

@PabloEskyBruh Thank you for the reply

I don't understand this sentence:

Just so it’s clear but, the capital raise (and options exercises) I’m anticipating are in the order of a 300-400% increase in share price in July to August 2025

Do you mean that you are expecting a 300-400% rise in the share price prior to the capital raise occuring?

Yes. That sounds big @Goldfish, but on the lower end that is only $12.45 USD. And not much above 100% of the December IPO of $6.00 USD. I think if they don’t get something approaching that the company will favour short-term debt mechanisms as opposed to diluting at levels below or so close to the IPO. There is a lot happening this year.

@PabloEskyBruh Well if you are right, I should definitely buy now at $6 then :-)

Seriously, I think that is highly optimistic

I also doubt the ability to raise debt. I am no expert, but who is going to lend US$20 million a quarter to a company that is at least 3 years away from maybe making some profits? The debt would have to be structured in a way that gives away a lot of the upside.

The more I think about it, the more I believe that the market is basically forcing a sale. Either the share price doubles in the next few months, before the cash runs out, or capital raises are not going to be sufficient to fund the pivotal trial. I don't believe that debt is an option either. That leaves a takeover as the only way out.

I have no idea what price a takeover would come in at. But I suspect that a company that is nearly out of cash and has run out of options to raise capital would struggle to achieve a generous price.

The underlying product seems good, so hopefully that would act as a floor. If several companies were interested, maybe they could at least achieve a decent premium to todays depressed share price.

It would be good to hear other's thoughts on this. Am I wrong? Am I missing something?

That’s definitely a valid point of view @Goldfish, and at the moment the market appears to agree with you.

I also agree I’m optimistic, but my comments above are far from the most outrageous I’ve made on Strawman.

A capital raise in the $10 - $15 USD range represents over a 100% discount to my present valuation, which I still consider to be conservative one.

$44 AUD is not a future price target, it’s the price at which today I am tempted to sell — or (were it not for capital allocation considerations) the price at which I stop buying.

I don’t think you are wrong. I don’t think you are missing anything. You just have your own perspective and I have mine.

I have the only advantage that a retail investor ever has and that is the lack of scarcity on time horizon. I’ve seen what existential financial dire straits look like for Anteris and I’m convinced that these aren’t them. Big possibility I’m wrong.

Had another look at this today. Interested in your thoughts @PabloEskyBruh

Couple of things:

1. What is happening with the IDE? It was submitted before the end of Q1 and the FDA supposedly has 30 days to respond. My assumption is that the FDA wasn't completely satisfied with the original submission and that there has been some negotiation happening. But so far nothing has been disclosed.
2. I had a look at the Boston Acurate valve. Their ACURATE-IDE trial enrolled 1500 patients and was very similar to what is proposed for AVR - a non-inferiority trial vs Edwards and Medtronic. It took them nearly 4 years to enrol all of the patients (to be fair, it was impacted by COVID), and then another year and a half to report that it missed its primary endpoint.

Basically the combination of these 2 things, in my mind makes it even more challenging for AVR to fund itself. There is clearly going to be a further delay to starting the IDE trial. July is not going to happen. Maybe September at best, if FDA approval happens soon. Wayne (the CEO) has suggested: "We're looking around about Q4 2026 to be fully enrolled. So we’ll come out the other side in Q4 2027, and pop outside of that with an approval early 2028. Now, Europe could be up to a year earlier than that, we don't really know". This also looks highly optimistic. Reality is probably more like 2029, or even 2030 if there are problems.

They need at least $300 million USD to fund all of this through to clinical approval. That is nearly double the current market cap. I don't see how they can get there with cap raises or debt. Only option is a takeover or some kind of partnership agreement.

It does seem like AVR would be a good fit for Boston Scientific, given the failure of their own product. Even if they paid a 50% premium to the current SP, it would be a relative bargain for them. Lets see

[disclosure: I am now a holder IRL. Very small amount. Good product, but high risk]

Congrats on taking the plunge @Goldfish! I hope there will be no regrets for you — or only that you didn’t buy more.

I’m more bullish on Anteris’ prospects, as you have gathered.

In response to your valid points here are my takes on the situation:

1. I’m less concerned on the IDE announcement. I’m now seeing it as also essentially being the approval for the parameters of the PARADIGM study itself. I haven’t taken the lack of FDA or Anteris announcement to be anything fatal to the application or substantially disruptive to Paterson’s timeframes. I think the blow FDA has taken to its capacity is real. I think Anteris already knows the centre that will do the Q3 implantations — so even FDA delays won’t have a huge impact in that.
2. I don’t think it will be as many as 1500 patients in this study. I think it will be between 750 and 1000. Half with DurAVR and half with Sapien and Evolut in accordance with market proportion. That would favour Anteris anyway as it’s already known that Sapien is easier to beat clinically so to have more of them in the trial helps Anteris. Anteris already knows the centres it is using. It’s chosen them for volume and Paterson has been consistent in suggesting 18 months is enough time for the amount of operations required. I think the centres are closely aligned with various members of the scientific advisory board.

To my mind Anteris has long been a takeover/partnership play — but with each successful milestone that becomes less essential and the value Anteris commands is higher.

I agree that a further $300 million USD probably gets Anteris to an FDA approved TAVR product. I also think — at that point — we are looking at Anteris as being conservatively a $10 billion USD company. If only because that’s about the TAM for TAVR by 2030, and a clinically superior DurAVR would command significant market share and have a long growth runway as it took more share each year.

I think big buyers — including incumbents — won’t wait until that point to put in offers Anteris no longer needs.

Having said that, Anteris doesn’t need the full $300 million USD by the end of the year. It just needs enough to get to the next milestone at each point. There are plenty of potential exit ramps along the way. At the moment the next point is announcement of commencement of the pivotal trial /and the first patient of that trial. I can now see a re-rate at that point — because the market appears to be pricing this as it not actually going to occur by end of Q3 — whereas I think it is going to happen.

I’m interested in any surprise la about Europe or ViV. I’m not sure that Anteris has entirely abandoned a notion of perhaps getting a Humanitarian Device Exemption for ViV (or some sub-set of patients requiring ViV). That would be icing on the cake — but I’m not banking on it at all.