Clinuvel Pharmaceuticals (CUV: $8.24) is looking to make the US more of a focus, with its first Phase III study in Vitiligo to read out later this year. One of the company's priorities is to build out its US presence with its operational headquarters to be based in the US, along with internal manufacturing.
Alongside these events, the company is currently considering a listing on the Nasdaq market, and to delist from the ASX. Underperformance of the company's share price over the last five years, falling from an all-time high of $44 in 2021, is a likely driving factor in light of the strong business performance over this period. Over that time, product revenue has doubled from $48 million to $94 million in 2026, and net profit before tax has increased by 86% to $47.7 million.
The company has been investing in two other key programs over this period, Vitiligo and Neuracthel, a potentially high-margin, generic ACTH product. The company's cash balance has increased by 200% from $82.7 million to $252 million at June 30 this year.
A re-rating of the stock from a US listing is an unknown outcome, with the company's shares currently trading on the Nasdaq as Level II ADS. Just one third of the stock is held by Australian investors, with the balance predominantly in the US and Europe.
2026 Financial Results
For FY2026, revenue from product sales was down 1% to $94 million from the PCP, with net profit after tax down 6% to $33.9 million. The US market was down due to competing drugs in development for the treatment of EPP being made available to patients with EPP for no charge. European sales volumes increased by 13% over the year.
One drug candidate, bitopertin from Disc Medicine has been made available to patients with EPP under an Expanded Access Program. This drug candidate was originally trialed in schizophrenia by Roche. Clinuvel CEO Philippe Wolgen remains skeptical about this therapy in EPP.
Another drug in development is dersimelagon, which was licensed to Leo Pharma last month by Tanabe Pharma for US$425 million in upfront and short term milestones, plus longer term milestone payments and royalties. The drug candidate was submitted for FDA approval in June. The compound’s side effects are mild-to-moderate, including nausea and the development of freckles.
Chronic use of the therapy will be a consideration. By comparison, Clinuvel's Scenesse therapy has been delivered over 21,500 times over 16 years with a very favourable and well established safety profit. A long-term Phase III safety and tolerability study in 301 subjects across 45 sites is continuing with dersimelagon. Dersimelagon is an orally delivered melanocortin-1 receptor agonist.
Wolgen indicated that he is not overly concerned with the current competitors. "We are pretty calm."
Peptide Delivery Technology Advances
Clinuvel's drug Scenesse is a peptide that is delivered as a depot injection that lasts for two months. Over several years the company has been developing a controlled-release, liquid injectable technology to allow more flexible dosing. The company has passed the proof-of-concept stage following positive results in a preclinical model.
Clinuvel is looking at a range of melanocortin peptides. Wolgen said that outside of Vitiligo, this is the most exciting development within the company, with very little competition.
The company is doubling the footprint of its Singapore R&D facility, where the peptide delivery development work is undertaken.
Vitiligo
Results from the first Phase III study in 200 patients with Vitiligo are due to be released in December, with a second Phase III study to begin in November this year. Pricing of Scenesse in Vilitigo is expected to be similar to the current price for EPP treatment. Patients are receiving seven injections over 20 weeks with narrowband UVB treatment (twice weekly), with the potential in the future for one to two maintenance injections each year.
Neuracthel
Neuracthel, a generic version of ACTH, is due to be filed with the European regulator this year. Whilst it may take 12-16 months to gain approval, Wolgen expects rapid penetration into the market, which will be sold directly to hospitals. There are between two to four competitors in various markets around the world.
Clinuvel is capitalized at $413 million.
Bioshares recommendation: Buy
(Note the shares may stop trading on the ASX and list on the Nasdaq market.)
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