Skip to main content
EquitiesIndustrials

Clinuvel Pharmaceuticals (CUV): Looking to Vitiligo

Reviewing vitiligo expectations, Phase 3 readout CY25

CUV are conducting two Phase 3 trials to expand the label of Scenesse to include patients with vitiligo. Following recent company announcements, we have revisited vitiligo development expectations and market forecasts. The first Phase 3 trial primary readout is expected in 2H CY25 and represents one of the next major catalysts for the company excluding financial results. Assuming the Phase 3 trials proceed smoothly, we expect submission to the FDA in late CY26 for potential approval by end-CY27.

With ~1% of the US population affected by vitiligo, the market size is far greater than the single rare disease for which Scenesse is currently approved. We estimate a directly addressable vitiligo market in the US of ~65-70k patients (vs. ~2k patients for EPP). This translates into legitimate potential for Scenesse to increase its annual sales several fold if the Phase 3 trials succeed and regulatory approval is granted.

Generic drug for ACTH also progressing

Beyond vitiligo, CUV are pursuing Scenesse label expansion in other rare diseases (e.g. xeroderma pigmentosum and variegate porphyria) with smaller market opportunities. We also have a positive view on CUV’s development of an ACTH generic, a peptide closely related to Scenesse and expected to be submitted to the FDA in CY26. Only two ACTH products are on the market currently with combined annual sales of ~US$600m.

Investment view: Maintain BUY and $22.25 PT

Our near-term forecasts remain unchanged and are based on ongoing sales in EPP, where CUV is expected to maintain a commercial monopoly for at least another 3-4 years. There is no change to our BUY recommendation and $22.25 PT. Our valuation is based on a DCF (10.0% WACC, 2.0% TGR) and EV/EBITDA multiple (17.5x). We view the first vitiligo Phase 3 readout in CY25 as a significant catalyst for the company and see the current CUV price as a good entry point for those willing to take on clinical risk with downside mitigated to a degree by the existing, profitable EPP franchise.

To read the full report click the button below.

View Detailed Report
Authored by Thomas Wakim – Analyst – at Bell Potter Securities, 17 June 2024
Important Disclaimer—This may affect your legal rights: Because this document has been prepared without consideration of any specific client’s financial situation, particular needs and investment objectives, a Bell Potter Securities Limited investment adviser (or the financial services licensee, or the proper authority of such licensee, who has provided you with this report by arrangement with Bell Potter Securities Limited) should be consulted before any investment decision is made. While this document is based on the information from sources which are considered reliable, Bell Potter Securities Limited, its directors, employees and consultants do not represent, warrant or guarantee, expressly or impliedly, that the information contained in this document is complete or accurate. Nor does Bell Potter Securities Limited accept any responsibility to inform you of any matter that subsequently comes to its notice, which may affect any of the information contained in this document. This document is a private communication to clients and is not intended for public circulation or for the use of any third party, without the prior approval of Bell Potter Securities Limited. In the USA and the UK this research is only for institutional investors. It is not for release, publication or distribution in whole or in part to any persons in the two specified countries. This is general investment advice only and does not constitute advice to any person.
Disclosure of Interest: Bell Potter Securities Limited receives commission from dealing in securities and its authorised representatives, or introducers of business, may directly share in this commission. Bell Potter Securities and its associates may hold shares in the companies recommended.