Another RNS ;)30 Jul 2020 08:13
Financial highlights:
· Alkindi® revenues for the year ended 30 June 2020 were £2.39m (year ended 30 June 2019: £1.04m), representing year-on-year growth of 130%. This strong performance was driven by new country launches and increased market penetration in the UK and Germany. Moreover, it was achieved despite challenges in access to hospital-based prescribing physicians due to Covid-19 restrictions, particularly in Italy where Alkindi® was launched in February 2020.
· Cash balance of £15.4m, reflecting the successful placing in March 2020 which resulted in gross proceeds of approximately £11.2m, and the upfront payment of $3.5m from Eton Pharmaceuticals received in April 2020.
Operational highlights:
· Alkindi® now fully launched in UK, Germany, Italy, Austria, Sweden, Norway, Denmark and Iceland.
· New Drug Application (NDA) for Alkindi® Sprinkle accepted for review by the US Food and Drug Administration (FDA). The PDUFA date set by the FDA, which would be the earliest date at which approval could occur, is 29 September 2020
· US licensing agreement signed with Eton Pharmaceuticals for Alkindi® Sprinkle, with upfront payment of $5.0m and an additional $2.5m cash milestone payment upon first commercial sale following regulatory approval and grant of Orphan Drug Status. Confirmation of Orphan Drug Status is anticipated concurrently with NDA approval.
· Validation of Marketing Authorisation Application (MAA) for Chronocort® to the European Medicines Agency (EMA) in April 2020 following submission in December 2019. Diurnal is anticipating recommendation for approval of Chronocort® by the EMA in Q1 2021.
· The Company remains vigilant to risks posed by the current Covid-19 situation. There have been no significant changes to the impacts on its business operations since the previous update in April 2020 and the Board remains confident that Diurnal is well-positioned to continue to minimise the impact of Covid-19 on the Company's business.
Martin Whitaker, CEO of Diurnal, commented:
"Over the past year we have made significant progress as a business, financially and operationally. We have increased our commercial footprint in key markets whilst advancing both Alkindi® Sprinkle in the US and Chronocort® in Europe along their respective regulatory pathways. During the remainder of 2020, we expect FDA approval for Alkindi® in the US and further approvals for Alkindi® in Australia and Israel, in addition to continuing to progress our next product, DITEST™, following confirmation of the regulatory path with the FDA, as announced today. Our successful fundraise in March 2020 allows us to progress our vision of becoming a world-leading specialty pharma company in endocrinology and is expected to take our cortisol deficiency business, represented by Alkindi® and Chronocort®, through to profitability."
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