top of page
Black Sky

Diurnal Group

Alkindi US Approval


Dr Brian White

Andrew Keith

Diurnal Group logo

30 September 2020

Alkindi US approval – another important milestone


Diurnal’s adrenal franchise has benefited significantly from a fast to market approach with its child-optimised preparation of hydrocortisone Alkindi. Sales in Europe are progressing well as new territories achieve reimbursement. The attraction of Eton Pharmaceuticals in the US provided external third-party validation with a highly appropriate partner. Securing US approval for Alkindi for the treatment of the orphan disorder, paediatric adrenal insufficiency, is an important milestone for both Alkindi and its licensor Eton Pharmaceuticals. US FDA approval provides an approved alternative to the unlicensed, and highly variable, compounded hydrocortisone preparations that have been used to date. Eton Pharmaceuticals has a focus on hospital-based products with a particular focus on paediatric rare diseases. Alkindi Sprinkle represents the lead paediatric drug for Eton Pharmaceuticals, and we note that previously it has suggested a peak sales potential of $100m. In addition to the upfront payments, Diurnal will receive an additional $2.5m on first commercial sales, which should be shortly after approval as well as double digit-high teens royalties on sales, and sales-based milestone payments of up to $45 million in total subject to sales thresholds.


All about the adrenal franchise for now


The approval of Alkindi Sprinkle in the US along with the European launches has allowed Diurnal to establish itself as a nascent player in the endocrinology field. This is a laudable achievement and provides the company with a solid foundation with several pipeline assets, which should further develop its adrenal franchise. While Alkindi has proven to be successful in providing a fast to market approach for Diurnal, we believe that significantly greater market potential lies with the adult hydrocortisone preparation Chronocort. Chronocort mimics the physiological release of cortisol in patients with low cortisol levels. The US Phase 3 CAH study is ready to go but requires the resource of an appropriate partner to risk share and provide funding. Sticking with the adrenal (low cortisol) franchise, the development of Chronocort for the larger adrenal insufficiency market looks like a relatively straightforward line extension. However, the US will inevitably be more involved and a partner will be key here.


Broader endocrinology pipeline emerging


Increasingly the pipeline is coming to the fore with positive data from the testosterone replacement therapy DITEST. This is a significant market opportunity with an unmet need for safer, more convenient alternatives with DITEST showing potential to provide a best in class addition. With a streamlined branded generic regulatory pathway on offer, we look forward to the attraction of a suitable partner to progress DITEST for classical male hypogonadism. Our Discounted Cash Flow valuation yields a fair value of 99p per share. Please see our initiation of coverage for more details on Diurnal Group.

Adrenal franchise sales (£m)

Source: Calvine Partners Research

Diurnal Group Income Statement (£m)

Source: Calvine Partners Research

Diurnal Group Cash Flow Statement (£m)

Source: Calvine Partners Research

Diurnal Group Balance Sheet (£m)

Source: Calvine Partners Research


Calvine Partners LLP is authorised and regulated by the Financial Conduct Authority for UK investment advisory and arranging activities.


This publication has been commissioned and paid for by Diurnal Group and, as defined by the FCA, is non-independent research. This report is considered to be a marketing communication under FCA Rules, and it has not been prepared under the laws and requirements established to promote the independence of investment research and it is not subject to any prohibition on dealing ahead of the dissemination of investment research. The information provided is widely available to the public.


This report in the United Kingdom is directed at investment professionals, certified high net worth individuals, high net worth entities, self-certified sophisticated investors, eligible counterparties as defined by Financial Services and Markets Act 2000 (Financial Promotion) Order 2000. The report may also be distributed and made available to persons to whom Calvine Partners is lawfully permitted. This publication is not intended for use by any individual or entity in any jurisdiction or country where that use would breach law or regulations, or which would subject Calvine Partners or its affiliates to any registration requirement within such jurisdiction or country.


Calvine Partners may provide, or seek to provide, services to other companies mentioned in this report. Partners, employees, or related parties thereof may hold positions in the companies mentioned in the report subject to Calvine Partners’ personal account dealing rules.


Calvine Partners has only used publicly available information believed to be reliable at the time of this publication and made best efforts to ensure that the facts and opinions stated are fair, accurate, timely and complete at the publication date. However, Calvine Partners provides no guarantee concerning the accuracy or completeness of the report or the information or opinions within. This publication is not intended to be an investment recommendation, personal or otherwise, and it is not intended to be advice and should not be treated in any way as such. Any valuation estimates, such as those derived from a discounted cash flow, price multiple, or peer group comparison, do not represent estimates or forecasts of a future company share price. In no circumstances should the report be relied on or acted upon by non-qualified individuals. Personal or otherwise, it is not intended to be advice and should not be relied on in any way as such. 


Forward-looking statements, information, estimates and assumptions contained in this report are not yet known, and uncertainties may cause the actual results, performance or achievements to be significantly different from expectations.


This report does not constitute an offer, invitation or inducement to engage in a purchase or sale of any securities in the companies mention. The information provided is for educational purposes only and this publication should not be relied upon when making any investment decision or entering any commercial contract. Past performance of any security mentioned is not a reliable indicator of future results and readers should seek appropriate, independent advice before acting on any of the information contained herein. This report should not be considered as investment advice, and Calvine Partners will not be liable for any losses, costs or damages arising from the use of this report. The information provided in this report should not be considered in any circumstances as personalised advice.


Calvine Partners LLP, its affiliates, officers or employees, do not accept any liability or responsibility with regard to the information in this publication. None of the information or opinions in this publication has been independently verified. Information and opinions are subject to change after the publication of this report, possibly rendering them inaccurate and/or incomplete.


Any unauthorised copying, alteration, distribution, transmission, performance, or display of this report, is prohibited.

bottom of page