Forum Topics CUV CUV FY25 1H Results

Pinned straw:

Last edited 3 months ago

Clinuvel Pharmaceuticals (CUV) reported last week. From their presentation:

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I thought this was a pretty good result as seasonally 1H is the weaker half of the year. On a operational level, Revenues increased by 10% compared to the pcp with interest income also boosting revenues due to the large cash balance.

In November 2024, the business decided to refocus into 3 core clinical programs: Porphyria (EPP & VP), Vitiligo and ACTH. With a 4th additional focus into photocosmetics.

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To date, only Porphyria is revenue generating with the hope that the other segments will become revenue generating in due course pending results.

Surprisingly, the report did not touch upon anything from the photocosmetics side of the business although they did mention briefly that they are due to release new products in 2026 which contain melanocortins ("M line" products).

Listening into the investor briefing, there seems to be a sense that the business is in some what of a transition phase away from the current Managing Director (Phillipe Wolgen) who was announced to be stepping down but was then extended till June 2026. Normally Phillipe would lead the results but this was instead lead by the CFO and the lead of the clinical programs instead. There was mention that they are not sure how the new CEO/MD will decide to take the business going forward and perhaps this is why the share price has been depressed.

CUV screams cheap on all valuation methods, with a strong balance sheet and no debt, it seems the market is waiting for some certainty as to the future leadership of the business. I will admit that there have always been rumblings of issues behind the scenes and perhaps their inability to find a new MD/CEO may hint at these issues.

Given that operationally the results are still strong, I will continue to hold as I believe the risk/reward proposition still exists. But definitely not as high conviction as I was previously.

Disc: Held IRL and on Strawman.

Travisty
Added 3 months ago

@BoredSaint I can't agree more! I've been a shareholder for the past 4 years and have watched (squirmed) as the market has given this company no love, all the while shorters have been putting pressure on the SP with no real attempt from the company to progress with their buyback at these depressed (undervalued) prices. I speculate that a company with only $50m shares on issue and avg trading volume of just over $1m a day may see the SP suddenly move with any decent BuyBack activity by the company, along with a resulting short squeeze would end up in a trading halt and a please explain from the ASX.

The value proposition for me is that this is a company that in 2019 made $18.1m in PBT (I didn't use NPAT as they had years of accumulated losses built up in prior years to use as offset on their tax payable) and had a market valuation of $1.5b, to now being a company projected to make $55-$60m in PBT in 2025, have over $200m in Cash and No Debt, but has a market cap that's 66.6% less than in 2019!! It makes me scratch my head as to why that's the case!? What am I missing? As you said some of the issues with the lack of market confidence in the company may be around the uncertainty of the replacement for Dr. Wolgen as CEO/Managing Director. It was interesting to see Lachlan Hay, the COO take the lead on the HY results with the absence of Phillipe. Could he be at the head of the line to take over? I've heard him speak many times in the past and while I'm not a huge fan of his tone when speaking, he does seem very knowledgeable and understands the company very well as it's COO.

Other possible issues?... The slow progression of their Vitiligo clinical trials and if they will ever get it to the point of commercialisation is worrying. However, they are making decent strides and have provided interesting real life evidence that the treatment is effective. If they do get to commercialisation and can penetrate the market as they project, they would be looking at the below added value to the company. Instantly tripling their revenue! For a business that averages 37% Profit Margins, you just need to do a basic, back of the envelope calculation with a very conservative PE and it's amazing value at this point in time. Was far better value last month when it traded under $11 though!

It reminds me a little of Nueren in that you almost get a 2 for 1 in the company at current prices. EPP is priced in, but you get all the upside of Vitiligo, ACTH and Photo Cosmetics (to a smaller extent) pretty much for FREE.

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ADDITIONALLY - They have also experienced headwinds in expansion of Scenesse into the European market due some pretty shady reviews by the EMA, however they seem to be ticking off all the extra boxes and hoops they have to jump through that the EMA are (I believe unfairly) demanding to advance treatment for EPP patients in Europe as well as extending treatment to adolescents who are need of something to help treat their horrible EPP affliction.

Anyway, I decided to do a little DCF which I'll add to my own valuation soon, but below is a simple chart outlining the movement in Revenue (broken in to Commercial Sales & Other income as they make a decent amount in interest on their cash) v Expenses v NPAT. Over the past 6 years you can see their growth isn't stalling (it may be slowing slightly), but they continue to grow patient intake and commercial sales. All the while accumulating a HUGE war chest of cash, which is just under a 3rd of their total Market Cap at this current time, to which provides the ability to make strategic M&A decisions to either build their competitive advantage in their Melanocortins market, or provide significant return to shareholders via a special dividend or more aggressive BuyBack, which I hope they recommence at these prices.

**Note on the chart. FY22 was the point at which the company had used all of their prior years tax losses and had to start paying tax on their earnings. Hence the slight dip.

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DISC Held in RL & on SM.

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BoredSaint
Added 3 months ago

@Travisty I agree with your thoughts that the business seems to growing still but the share price has been the reverse.

I would say the lack of transparency in the business doesn't help the share price. The lack of buyback activity was mentioned at the last meeting as well and they said that it was due to ASX rules that they weren't able to continue. But they also haven't done any buybacks since (when "allowed") either even though the share price has been depressed.


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Travisty
Added 3 months ago

@BoredSaint Yes, I recall Phillipe stating that the buyback couldn't continue if the company were in possession of news that would be considered material or price sensitive. However surely that isn't the case now that they've released everything to market for the HY results and more recently their "unveiling" of their Vitiligo Program at the AAD conference to be held in Orlando this month. With the Share BB program due to end soon, they have a lot of making up to do to get to the 1.5m shares they initially intended to buy back.

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Dominator
Added 3 months ago

I've had Clinuvel on my watchlist for a while. Looked at results and thought maybe this is their good half and shocked to see that it is their lower profit half. Cant work out as a casual observer what I am missing... Maybe thats why it cant catch a break.

For those in the know are there patents running out or issues of that kind that explain the low EV/NPAT? I was trying to find out more, looks like some in the next few years lapsing potentially? Could generic products cut the future profit margins?

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edgescape
Added 3 months ago

Definitely something to do with vision and leadership here holding back cuv. Possibly more independent board of directors too would help.

I think in their earnings calls they are reluctant to take questions as well.

16

Mujo
Added 3 months ago

The financials look great but yes I think it's governance concerns that are keeping people away.

They don't take questions, non-mainstream auditor, railing against hedge funds - just a lot of red flags.

Also the expansion into cosmetics.

Could all be nothing - but uncertainty means a luck lustre market valuation.

15

Scoonie
Added 3 months ago

The following column from the Financial Review was written by Joe Aston back in August 2020, a while ago I agree.

In the latest annual report Clinuvel CEO Phillippe Wolgen took home $3.7m at a company that has a market cap of $550m.

As a general rule if a publicly listed company comes to the attention of the likes of Joe Aston, I will not invest in it. This is because what they are telling you in print is likely just the tip of the iceberg of information insiders have dropped to them.

I do not follow Clinuvel and am not sure what Mr Wolgen has done for Clinuvel however he seems to have been pretty handy at buttering his own bread.  

Clinuvel board praises "unusual, amazing" CEO Philippe Wolgen

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Travisty
Added 3 months ago

Hi @Dominator The large variance in revenue between halves is due the 2nd half year leads into the northern hemisphere summer so EPP patients get more Scenesse treatment during this period to protect against the greater sun exposure. In terms of patient intake and slowing of revenue, CUV have only really penetrated the US market for EPP, with more market to be captured. The issue they have is they need to to have more clinics and specialists come onboard to prescribe the treatment to patients. Doctors & specialists might suffer from Status Quo Bias and therefore are reluctant to try something new.

CUV do have other markets they're aiming to build into, including Canada & Europe which they can currently only treat patients through a Special Patient Access Scheme. Below is a snippet from their FY24 report explaining more about their expansion of Scenesse....

We are committed to ensuring the ongoing supply of SCENESSE® and increased treatment centres and reimbursement arrangements to support expected growth in patient demand. The demand of EPP patients for SCENESSE® was robust in FY2024 and is expected to continue over the next three years. Step-up growth may come from access to new countries, including Latin America through our partnership with Valentech, and regulatory approval, following the completion of CUV052 and re-submission to the EMA, to treat adolescent patients.

 In the USA we have expanded our independent network of Specialty Centers to 85 and are well on track to reach 120 centres by the end of 2025. This network will be capable of treating both EPP and other patients, with an initial focus on vitiligo. Source: FY24 Annual report

I consulted my PA (aka ChatGPT) to list the patents that Clinuvel have and their expiry dates. Here is what it listed for me:

Clinuvel Pharmaceuticals holds a range of patents protecting its technologies and products, particularly SCENESSE® (afamelanotide 16mg). The expiry dates of these patents range from 2026 to 2033. Source: Clinuvel.com

In July 2023, Clinuvel secured additional intellectual property rights for melanocortin-based molecules as treatments for central nervous system disorders. The patents and applications assigned to Clinuvel include:

  • European patent application EP3030256A1
  • Australian patent AU2014304566B2
  • US patent US10610573B2
  • US patent application US2020360484A1

Source: Clinuvel.com

For instance, US patent US10610573B2, titled "Use of Melanocortin Receptor Agonists for the Treatment of Neurodegenerative and Neuroinflammatory Disorders," was granted on April 7, 2020, and is set to expire on August 20, 2027. Source: Patents.google.com

Additionally, SCENESSE® holds exclusivity rights, including Orphan Drug Exclusivity, which is set to expire on October 8, 2026. Source: pharsight.greyb.com

Please note that patent expiration dates can vary based on factors such as patent term adjustments and extensions. For the most accurate and up-to-date information, it's advisable to consult official patent databases or Clinuvel's official communications.

I do agree with the observation by @Scoonie that Phillipe has been remunerated handsomely by a company that's only at a market cap of ~$550m, with a good chunk coming from STI cash-based rewards. The companies KMP remuneration structure does factor more around robustness of the company (cash), retention of talent and risk management (of drug development and clinical study success) rather than purely shareholder value accretion. They have certainly built a robust company for a bio-tech. They have said numerous times over the past couple of years, that they want to self fund all of their clinical trials as well as control product manufacturing and distribution as they can circumvent a lot of the intermediaries that take their slice of the pie during the process of getting the drug to the patient.

How this Company robustness (cashed up), talent retention and risk management plays out, only time will tell. As the great Howard Marks says "being early is indistinguishable from being wrong".

9

Dominator
Added 3 months ago

Thanks @Travisty. As an investor that isn't in the medical space or knows much about biomed companies I would say those short-dated patents are of concern because I don't understand how this could play out. How will the company continue to grow? If the profit margins are attractive enough what is stopping a generic product being brought to market and undercutting Clinuvel?

11

BoredSaint
Added 3 months ago

I think the moat for Clinuvel is in the way the drug is administered. It is given as a subcutaneous implant through their Specialty Centres with doctors trained by CUV. Even if the molecule (afamelonotide) patent expires, it is hard for another company to establish such an extensive network of centres in order to administer the drug for EPP patients. MD Phillipe Wolgen spoke briefly on this at the Strawman meeting we held in Aug 2022.

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