Over the last seven years, Clinuvel Pharmaceuticals (CUV: $14.95) has generated around $330 million in sales from its pharmaceutical product Scenesse for the treatment of EPP. The compound annual growth rate in sales over the last six years has been 42% and the company has been profitable for the last seven years.

Lachlan Hay, Director of Global Operations at Clinuvel, said at this year's Summit that Clinuvel's approach has been initially to remain a focused company, commercialising Scenesse first before diversifying, which is occurring now.

In developing a treatment for an ultra-orphan indication (with 5,000 - 10,000 patients worldwide), it was important to start communicating with the patients early on. Clinuvel used social media as early as 2006, and could see patients communicating with each other via social media networks. This also attracted a number of investors from Silicon Valley said Hay.

From 2016 - 2024, the focus was on how to build on this foundation that had been created over the previous decade. The company established a prescriber network with specialty treatment centres and elected to progress the business independently. By conducting its activities in-house, Hay highlighted that the company has a greater control over its costs and its systems. This includes pharmaco-vigilance, clinical data, interactions and ultimately over the net margin. The company's model has been to vertically integrate its activities as much as possible.

The trade-off is it takes longer to build the business and there is more key-person risk within the company, said Hay. 

Clinuvel has now reached the next stage of its commercial life which is about building a global brand. The company currently has around 80 treatment centres that control the prescription and administration of Scenesse in the US. This will expand to around 120, and importantly, will also service the next indication for Scenesse, that being the treatment of Vitiligo, which is a market considerably larger than EPP, estimated at US$4.5 billion in the US.

Enrolment into the first Phase III study, in 200 patients, is expected to be completed this year. The second study is expected to start this year, with an NDA anticipated in 2026.

Clinuvel's approach has been to work in areas that have strong unmet medical need where there is no or little competition. In Vitiligo, the company is seeking to turbocharge the existing process (narrowband UVB) that provides mediocre results even after many, many treatment sessions. With Scenesse, the re-pigmentation is not only quicker, but there is deeper and wider pigmentation of the skin according to Hay.

Hay said that the FDA has now accepted Vitiligo as a medical condition that requires treatment, with the first therapy approved, that being a topical cream for less than 10% of the body. That product, Opzelura from Incyte (a topical JAK inhibitor) was approved in 2022. Hay said that sometimes it's good to be first and sometimes it's not, with Incyte having paved the regulatory path for the pharmaceutical treatment and reimbursement for this condition.

The FDA has also now accepted combination therapies for the treatment of Vitiligo. (Clinuvel's study combines Scenesse with narrowband UVB, even though the latter is used off-label for this treatment. Getting approval of the combination study from the FDA has delayed the program moving into registration studies.)

Another expansion for the company is translating its learnings in melanocortins and skin health and protection into a range of photocosmetics using high profile ambassadors to help build awareness and the global Clinuvel brand.

Clinuvel is capitalized at $749 million.

 

Bioshares recommendation: Buy

 

 

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