Biomonster
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Diurnal Group has a very low valuation of only £31 Million and attractive drugs in late stage development .This undiscovered stock has significant upside potential , the fair value should be north 100p right now and more on approval of Alkindi in USA and Chronocort in Europe both expected next year .Diurnal is definitely one if not the cheapest pharma stock in UK . Lots of news expected during second half 2019 .GL
Alkindi for the treatment of paediatric adrenal insufficiency is approved in Europe (launched in UK & Germany other EU countries will follow shortly) , US-NDA submission expected in Q4 .
Chronocort for the treament of congenital adrenal hyperplasia (CAH) MAA submission to EMA for European approval in Q4 and Start of US-Phase 3 also expected in 2H 2019
Management already in discussion to partner the Drugs in USA and RoW .
Diurnal Group (DNL)
Market Cap: £31Million
Cash: £11 Million
Price: 36p
Shares Out: 84.6 million
interim-results-presentation
https://www.diurnal.co.uk/media/36769/interim-results-presentation-march-2019-pp.pdf
https://www.diurnal.co.uk/non-healt...ing-open-offer-and-notice-of-general-meeting/
Filing a Market Authorisation Application (MAA) for Chronocort® in Europe by end 2019;
Filing a New Drug Application (NDA) for Alkindi® in the US by end 2019;
Continuing the development of the European commercial organisation and roll-out of Alkindi® in Europe to maximise revenues; and
Progressing licensing discussions for Alkindi® and Chronocort® in the US and the rest of the world
Clarity for Chronocort regulatory pathwayDiurnal (DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term ‘Adrenal Franchise’. The first product, Alkindi®, is being launched in key EU markets, and this was expected to be followed by the adult version, Chronocort®. After unexpected Phase III results, positive feedback from the EMA has cleared the path for regulatory submission of Chronocort for adult CAH in Europe before the end of 2019, and allowed DNL to revise the primary endpoint in theprotocol for the US Phase III trial.
Based on our clearly stated assumptions, the net present value of the cashflows that could be generated from DNL’s first two products alone equates to £248m. Riskadjustment to take account of their different stages of development in different territories reduces this to £139m, or 225p per share.
“Diurnal also expects additional progress for Alkindi®, with further country launches scheduled during 2019 to accelerate growth of revenues,along with a planned NDA submission in the US during Q4 2019.Diurnal has received strong interest in Alkindi® and Chronocort® for the US and will continue to progress licensing discussions, including the potential for co-development of Chronocort® in the US, both in CAH and AI. The US remains an important market for Diurnal’s late-stage pipeline focused on cortisol deficiency, with a combined market size for the treatment of CAH and paediatric AI estimated at $132m, and a future expansion opportunity in adult AI, which represents a $0.9bn market opportunity in the US.”
Largest Shareholder:
IP Group Plc /Venture Capital/....34,410,147
Finance Wales Investments Ltd.....11,534,888
Polar Capital LLP....6,622,631
Oceanwood Capital Management LLP....3,115,166
Richard Griffiths and controlled undertakings....4,999,615
Richard John Martin Ross, MD....1,554,925
Rowan Dartington & Co. Ltd. (Broker)....1,245,000
Rathbone Investment Management Ltd.....354,000
Hargreaves Lansdown Stockbrokers Ltd.....216,000
Octopus Investments Ltd.....181,818
Alkindi for the treatment of paediatric adrenal insufficiency is approved in Europe (launched in UK & Germany other EU countries will follow shortly) , US-NDA submission expected in Q4 .
Chronocort for the treament of congenital adrenal hyperplasia (CAH) MAA submission to EMA for European approval in Q4 and Start of US-Phase 3 also expected in 2H 2019
Management already in discussion to partner the Drugs in USA and RoW .
Diurnal Group (DNL)
Market Cap: £31Million
Cash: £11 Million
Price: 36p
Shares Out: 84.6 million
interim-results-presentation
https://www.diurnal.co.uk/media/36769/interim-results-presentation-march-2019-pp.pdf
https://www.diurnal.co.uk/non-healt...ing-open-offer-and-notice-of-general-meeting/
Filing a Market Authorisation Application (MAA) for Chronocort® in Europe by end 2019;
Filing a New Drug Application (NDA) for Alkindi® in the US by end 2019;
Continuing the development of the European commercial organisation and roll-out of Alkindi® in Europe to maximise revenues; and
Progressing licensing discussions for Alkindi® and Chronocort® in the US and the rest of the world
Clarity for Chronocort regulatory pathwayDiurnal (DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term ‘Adrenal Franchise’. The first product, Alkindi®, is being launched in key EU markets, and this was expected to be followed by the adult version, Chronocort®. After unexpected Phase III results, positive feedback from the EMA has cleared the path for regulatory submission of Chronocort for adult CAH in Europe before the end of 2019, and allowed DNL to revise the primary endpoint in theprotocol for the US Phase III trial.
Based on our clearly stated assumptions, the net present value of the cashflows that could be generated from DNL’s first two products alone equates to £248m. Riskadjustment to take account of their different stages of development in different territories reduces this to £139m, or 225p per share.
“Diurnal also expects additional progress for Alkindi®, with further country launches scheduled during 2019 to accelerate growth of revenues,along with a planned NDA submission in the US during Q4 2019.Diurnal has received strong interest in Alkindi® and Chronocort® for the US and will continue to progress licensing discussions, including the potential for co-development of Chronocort® in the US, both in CAH and AI. The US remains an important market for Diurnal’s late-stage pipeline focused on cortisol deficiency, with a combined market size for the treatment of CAH and paediatric AI estimated at $132m, and a future expansion opportunity in adult AI, which represents a $0.9bn market opportunity in the US.”
Largest Shareholder:
IP Group Plc /Venture Capital/....34,410,147
Finance Wales Investments Ltd.....11,534,888
Polar Capital LLP....6,622,631
Oceanwood Capital Management LLP....3,115,166
Richard Griffiths and controlled undertakings....4,999,615
Richard John Martin Ross, MD....1,554,925
Rowan Dartington & Co. Ltd. (Broker)....1,245,000
Rathbone Investment Management Ltd.....354,000
Hargreaves Lansdown Stockbrokers Ltd.....216,000
Octopus Investments Ltd.....181,818
.
