The trading update released by Diurnal this morning confirms the commercial progress of Alkindi and the initial roll-out of Efmody during the period to the end of June 2022.
Alkindi is a paediatric formulation of hydrocortisone for adrenal insufficiency (AI) and delivered revenues (including royalties) of £3.65m. Efmody, on the other hand, is still early in its European launch phase. Although approved for adolescent and adult congenital adrenal hyperplasia (CAH), sales are generated principally in Germany after the pricing agreement in September 2021. Efmody generated modest sales of £0.97m during the period. Our near-term revenue expectations were adjusted for Efmody after the Scottish Medicines Consortium's (SMC) decision not to recommend automatic reimbursement for Efmody. Cash at the end of June 2022 was £16.49m.
In the longer term we look to the results of the two trials involving Efmody to rejuvenate its fortunes. CONnECT is an ongoing Phase 3 registration trial which, if successful, should facilitate US approval in the key CAH indication. CHAMPAIN is a comparative European trial seeking to extend Efmody's use into the larger AI indication. Success in the future development of Efmody should hopefully permit Diurnal to readdress any perceived shortcomings which may have influenced the SMC decision.
We still believe that Efmody represents an important addition to the endocrinologists' medical armamentarium, given that it offers, for the first time, the prospect of a replacement therapy for CAH patients that best mimics the circadian production of cortisol. As a result, Efmody should facilitate better management of elevated overnight androgen levels at a lower dose than conventional glucocorticoid therapies. Indeed, we believe that Efmody possesses the attributes required by the CAH patient as they seek optimal treatment. Additionally, we suspect that the reimbursement issues in CAH may have unfairly cast a cloud over the prospects for Efmody in the more significant AI indication.
We look forward to the upcoming R&D day in September, which should allow Diurnal to provide a more detailed update on operational progress and remind investors of the prospects and opportunities for its pipeline of therapies targeting unmet needs in endocrinology.
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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.