Report
Peter Thilo Hasler
EUR 49.00 For Business Accounts Only

Strong growth in 2017/18 – more to come in 2018/19e

Clinuvel released an excellent set of figures for the FY 2017/18 (30/06) according to the preliminary final report. Revenues and EBIT were up 51.6% and 81.9%, respectively. Latest publications indicate that 1,200 implants were administered in just 57 days, indicating that Clinuvel is poised to further high (potential triple-digit) revenue and profit growth rates in the current fiscal year. Of only minor concern, in our view, is the fact that the FDA requested additional information regarding (1) the product manufacturing and (2) the European post-authorization use of Scenesse. Identifying deficiencies or concerns that appear to have been inadequately addressed in the NDA and requesting additional information in that stage of the application process is usual and should therefore be considered as another step in the review of the submission. In addition, filing review issues like these are certainly distinct from application deficiencies that serve as the basis for a Refusal-to-File (RTF). Following the strong outperform­ance of the shares since initiation of our research coverage (+66.4% vs. ASX +2.2%), we slightly raise our medium-term DCF entity-model based price target to AUD 32.70 from AUD 31.70 per share (base-case scenario) and confirm our buy rating. Our valuation is based solely on the treatment of EPP. Vitiligo as well as topical and neurodegenerative diseases should represent further substantial long-term upsides.

Underlying
Clinuvel Pharmaceuticals

Clinuvel Pharmaceuticals is a biopharmaceutical company engaged in the development of its drug candidate SCENESSE® (afamelanotide 16mg) for the treatment of a range of severe skin disorders. SCENESSE®, a drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the U.S. and Europe and has been approved by the European Commission for treating adults with EPP. Co.'s products aims at preventing the symptoms of skin diseases related to the exposure to harmful Ultraviolet radiation and at repigmentation of the skin due to a number of depigmentation disorders. Co. has operations in Europe, the U.S. and Singapore.

Provider
Sphene Capital GmbH
Sphene Capital GmbH

Founded in 2010, Sphene Capital is a German based pure-play research house offering state-of-the-art research and evaluation services to European small- and mid-caps by avoiding typical conflict of interests of traditional investment banks.

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Analysts
Peter Thilo Hasler

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