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https://twitter.com/DiurnalLtd/status/1398293941775183877
GLA
Good full page write-up in on-line shares magazine today.
GLA
I agree, there seems to be more trading activity of late, bigger volumes too. The SP is holding up very well after the placing, definitely a different feel to last time.
Lets hope DNL is a good winner too......
Appear to getting cleared now and the ii’s won’t be selling anytime soon. Very glad I didn’t take the placing and bought many more shares below 66p - News is only round the corner and I believe there a lot of people watching this from the sidelines and will be piling in soon
Thanks im happy i bought in under 70p we will see if its a good move to add more . Always said slow burner but so much going for it . Doubt it win share of the year however it might do in 3 years .LONGER term great here .Hope all is ok and well done on your winners .
So back in Jan i posted "Thanks scoredagainsteps ,always a pleasant discussion on this this thread , ATB and i hope you tell me in 6 months " i told you so " ... " well i think we can call it a draw ..price still in mid /high 60s ( although there was a spike that i missed ..hence the draw ) however good to see you still here and now im reinvest as DNL has come up on my alerts , still weary that they raised more more at 70p and shares fell but lets see...ATB
@ 66.83
Just bought another nice few at 68.83 put down as a sell . ALL my buys this week are marked as sells . THEY are offering 66.81 to sell as well . BE great to add another tick here to the jig saw .Good luck all
GREAT posts HunSen as usual . Just bough a nice few at 66.3 silly could of got them at 65.87 friday .Did not go all in as techs saying dead cross however techs can get it wrong . Just happy did not pay 7op as last time got caught out as DNLdrop to 48 .Good luck all
Second that Goosedeye. Always a pleasure to read Hunsen's posts. So informative.
Yes I agree, very kind of you to post all your research. It paints a very positive picture for the near and long term future
Thank you HunSen for all your effort here on DNL - it is appreciated.
Thanks HunSen, really appreciate that, lots of info from you. I will look out for the presentation once released looks like plenty in there.
I think takeover is the intended conclusion for DNL, hopefully with mature Alkindi sales, Efmody/Chronocort well established and Ditest further progressed as a minimum but you never know exactly how these things may play out.
If they take on a large partner for Ditest development that would probably indicate the most likely suitor further down the track.
Company: Neurocrine Biosciences
Market cap - $9.1b
Turnover - $1.05b
History of acquisitions – yes
Endocrinology – yes (including a cortisol drug)
Development partnerships – yes
From website
Neurocrine Biosciences completed a Phase II study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of crinecerfont in adult patients with classic congenital adrenal hyperplasia (CAH). The final results from this open-label, multiple-dose, dose-escalation study were reported in June 2020.
Comment: currently developing a competing product to Alkindi and Efmody which does not meet the same needs (from memory) this supresses androgens but does not replace cortisol.
Company: Ferring Pharma
Market cap - unknown
Turnover - €2.0b
History of acquisitions – yes (last in 2018)
Endocrinology – yes
Development partnerships – yes (last in 2018)
Limited information / time to research.
Company: Ipsen (SA)
Market cap €7.0b
Turnover €2.7b
History of acquisitions - yes
Endocrinology – yes
Development partnerships – yes
From website
“In April 2019, Ipsen acquired Clementia, a Canadian clinical stage biotech company focused on innovative new treatments for people with rare bone disorders and other diseases.
By bringing two passionate and patient-centric teams together, it significantly enhances our ability to treat rare disease in children and adults, specifically fibrodysplasia ossificans progressiva (FOP) – an ultra-rare, severely disabling disorder characterized by bone that forms outside the normal skeleton, in muscles, tendons or soft tissue as well as multiple osteochondromas (MO) – a rare, severely disabling, progressive, chronic disease in which multiple benign bone tumors develop on bones.”
Company: Endo Plc
Market cap $1.3b
Turnover $2.9b
History of acquisitions - yes
Endocrinology – yes
Development partnerships – yes
From annual report
License and Collaboration Agreements and Acquisitions
“We continue to seek to enhance our product line and develop a diversified portfolio of products through product acquisitions and in-licensing or acquiring licenses to products, compounds and technologies from third parties. The Group enters into strategic alliances and collaborative arrangements with third parties, which give the Group rights to develop, manufacture, market and/or sell pharmaceutical products, the rights to which are primarily owned by these third parties. These alliances and arrangements can take many forms, including licensing arrangements, co-development and co-marketing agreements, co-promotion arrangements, research collaborations and joint ventures. Such alliances and arrangements enable us to share the risk of incurring all R&D expenses that do not lead to turnover-generating products; however, because profits from alliance products are shared with the counter-parties to the collaborative arrangement, the gross margins on alliance products are generally lower, sometimes substantially so, than the gross margins that could be achieved had the Group not opted for a development partner.”
Comment: one route for DITEST could be a development partnership as described above.
I have been briefly researching the 4 companies listed on the DNL presentation on a scale of Large Pharma (the likes of Pfizer) > Large Speciality Pharma (the group researched here) > Small Niche Endocrinology (where DNL sits).
A very short brief on each company follows;
Continuing from the presentation notes, here are some further thoughts.
I noticed the CEO mention that the CFO had experience "exiting companies" and I didn't recall hearing that before, but after checking previous presentations, it has been said before.
On further research, the CFO was involved in the 2004 sale of Celltech to UCB for £1.5b.
My subsequent understanding of the history of smaller biotech is that once revenue generating they are acquired by larger organisations to fill their pipeline. I will look into the "Large speciality pharma" companies listed on the DNL presentation which list 4 companies in the endocrinology market.
In my opinion, the company has been kept very lean, has no debt and has a very loyal institutional following - a takeover would be a logical conclusion (as would continued growth into profitability).
Good questions were asked during the presentation, including which countries are showing the fastest growth for Alkindi - the answer UK and Germany. While these launched first, it is also encouraging that these "risk adverse" countries are taking up Alkindi quickly.
Related to covid delays, the process for prescribing in the UK is through "specialist clinics" which I believe are associated with certain hospitals throughout the UK. Patients are referred direct to these clinics, so this delay will now be reduced.
In terms of news flow, plenty of strong news due for the remainder of the year.
ALB
Sorry, hit the wrong key; timeline continued...
News flow outlook;
Q2 2021 - conclude SPA plan for Efmody in USA
Q2 2021- submission of DITEST IND in US
Q3 2021 - start DITES MAD study
Q3 2021 - first launch of Efmody in Europe
H2 2021 - start Efmody P3 study in USA.
These are the points I listed from the presentation, the video should be available online shortly and is well worth watching.
ALB
Hi Albino,
yes, I thought it was an interesting presentation. My notes include the following (in slide order);
- good number of large investors
- experienced board, including CFO with "experience exiting companies"
- Efmody expected to launch Q3
- DITEST route to US approval agreed
- DNL (niche), large speciality companies Endo, Ipsen, Ferring, Neurocrine (could these target DNL for acquisition)?
- Alkindi launched in UK, Germany, Austria, Sweden, Denmark, Norway, Iceland, Italy. Price agreed in Netherlands.
- Plans in place for remaining EU launches, the same commercial infrastructure will be used for future launches.
- Other distribution agreements reached.
- Alkindi (US) orphan status expected to be confirmed Q2 (any time) - launched to patients in Nov 2020
- Alkindi approved in Australia (for all ages), Israel, China and Turkey - Japan pending.
- Efmody launch due Q3 in Europe, commercial infrastructure already in place.
- UK approval expected after a similar timeframe to EU process (meaning unclear on slides - 180 days?).
- ROW agreements will use data from the EU trials.
- US FDA Special Protocol Assessment agreement due Q2, expected to be a 12 month trial (the shortest available I believe) with a patient recruitment phase beforehand. Endpoints close to agreement.
- EU extension for Efmody estimated end 2023 / start 2024 raising EU addressable market to $2.1b combined
- US extension depends on initial approval, estimated Q2 2025
- Competition close to P3 approval?? Crinecerfont recruiting for P3 trial BUT don't provide all the benefits of Efmody.
- P1 DITEST complete (proof of concept, 24 patients), primary endpoint met testosterone levels of a healthy young male.
- Next DITEST phase due to start H2 2021
- Pipeline is $9.6b addressable market
News flow outlook;
Q2 2021 - conclude SPA plan for Efmody in USA
Q2 2021- submission of DITEST IND in US
Q3 2021 - start DITES MAD study
Q3 2021 -
Anything interesting? Tried to register but seems to take a few days for them to confirm (sharesoc).
Looking forward to the 5pm webinar today.
GLA
Last chance to register for our webinar with Diurnal tomorrow at 5pm! Martin Whitaker – CEO will be presenting to ShareSoc.
https://www.sharesoc.org/events/sharesoc-webinar-with-diurnal-dnl-19-may-2021/