Ann: SCENESSE Treatment in Europe-CUV.AX, page-2

Still we wait for EU sales. The Clinuvel update provided little in the way of new information except that subsidised product will no longer be supplied in Italy and Switzerland and also that each EPP centre’s ethics committee needs to approve the PASS. This last point is holding up administration in Germany, but should not be a major hurdle.

More significantly information that is not included in the announcement but is publicly available is the document from IQWIG which details the approved price of 22,000 Euros per implant. Also a Q and A with Wolgen and the German EPP patient group. This details that the number of implants is not restricted to 4, as recommended by the EMA and also for the first time an insight is given into the delay of the last 18 months. Wolgen describes the PRAC discussions as “futile and superfluous” and describes how the PRAC reviewers embarked on a mission outside their competence and mandate. The efficacy of the drug was questioned when the mandate was to assess the safety only. Difficult times for a CEO who had just endured the longest review process ever in the EMA. Wolgen also defends the price in the Q and A stating that Scenesse is priced at the low end for an ultra orphan indication. “SCENESSE® is one of the cheapest drugs made available for a rare, severe disorder. “ The price is fair at AUD 120,000 to 180,000 per year!

The published paper on long term use in 115 patients tells all that is needed and is unheralded prior to the commercial launch of a NME for an ultra rare disease. The patients do not drop out, they seek repeated use year after year because the drug changes their lives. Also the demand for the drug is known as patient groups are actively lobbying the EMA, their government agencies and Clinuvel. Just like investors they are tired of waiting.

Even with recent share price rises the market cap is 233 million. Income will be 100 million in the next 2 years (conservatively based on 1000 patients), costs will be low with distribution restricted to probably no more than 50-100 centres and performed in house. Sirtex have revenue of 176 million and net profit before tax of 52 million SRX market cap is 1.7 billion. I think Clinuvel will have a net profit of more than 50 million in 12-18 months with FDA approval to follow.(I expect PASS data to be included in the US dossier). A 1.7 billion market cap is totally comparable and realistic giving a share price of around $30!

This is about as close to a sure thing there is on the ASX casino. (just my thoughts)