Diurnal Group this morning announced the formal launch of Efmody in Germany and Austria. Efmody, for Congenital Adrenal Hyperplasia (CAH), is Diurnal’s most important product to date.
Notably, the release highlights that reference pricing is in line with management (and our) expectations. Diurnal didn’t obtain orphan status for Efmody in Europe, and there had been some concern that this might impact pricing. Management’s ability to agree on an acceptable price in Germany, Europe’s key market, provides considerable support for revenue forecasts and the investment case.
Europe represents a $250m market opportunity for Efmody in CAH. Through Alkindi’s launch in 2018, Diurnal has built a commercial infrastructure that it can now use to expedite the roll-out of Efmody.
We think that Diurnal’s current valuation fails to reflect the prospects for Efmody in Europe. Successful commercialisation in Europe alone would justify our 241p per share valuation. On top of this, there is a $1.8bn European market opportunity for Efmody in adrenal insufficiency (AI). With Efmody now approved for CAH, the regulatory pathway should be straightforward, with Diurnal set to conduct a comparator study with incumbent Plenadren for optimal commercial positioning. We expect Efmody AI approval in Europe towards the end of 2023.
Please see our recent note on the outlook for Efmody here.
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Diurnal Group is a client of Calvine Partners, and as such, this publication is not independent and should be considered a marketing communication under FCA Rules. None of the information contained in this publication should be considered as any form of advice.