Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
I stared investing investing in mtph in 2015 and have averaged down since then (oh the pain) but holding at multiples over current SP. I've always viewed this a long term investment (but not maybe not as long as things have played out). Personally I'd like to see some concrete evidence on the 8th April date. I have seen multiple comments on other boards that "my broker told me that the books were closed until 8th April" etc. but no evidence to this as yet. I'd heed what Totalnew says, unless there is evidence (which I'm not ruling out) I'd strongly suspect that I might be being promised unicorns. Of course DYOR and here's an old but interesting article on ADR/home share price imbalance:
https://www.thestreet.com/story/1094904/1/the-truth-about-price-differences-between-adrs-and-their-home-shares.html
No need to panic. The FDA shutdown WILL NOT impact the Midatech regulatory response. The request was made in late October (RNS "Accordingly, in late October 2018 the Company provided a summary of the trial data to the FDA to seek confirmation on the FDA's original guidance for a single dose registration study in healthy volunteers" The FDA should respond in 75 calendar days, see Type C meetings, Page 9: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
FDA response is due inow, as already indicated by the company and FDA funding does not run out until a four more weeks (if no solution to the budget issue is found) https://www.cnbc.com/2019/01/22/shutdown-leaves-drugmakers-in-dark-on-fda-approval-of-new-treatments.html.
I'm a believer so I've topped up to average down, still averaging an uncomfortable ~40p though although this is less uncomfortable than my entry price. From the recent comms it seems like there is a good chance that the MTD201 clinical study can be completed in healthy volunteers, this was my initial thinking but I have been proven wrong on more than one occasion... In my view this is key for the short term survival of the company. I don't see why it took 2 full months for Midatech to provide the results to the FDA but we should have a response by mid Jan based on the FDA's published turnaround times. Funding options appear to be a clearly explained but uncertain area at the moment. There is a clear risk of dilutive funding but my fingers are crossed for some of the non-dilutive options to bear fruit to mitigate this somewhat. Dice are rolled, I hope that luck is on Midatech's side for once, they haven't been able to catch a break for a while.
I agree, I think we have hopefully found the bottom. There should be MTD201 news soon. We had the clinical RNS on Aug 31st and the longest lead time for an FDA meeting (depending on the type and I think they'll probably have a type C meeting) is 75 calendar days. In my opinion there are three potential outcomes here:
1) At the moment it's Midatech's opinion that they have a more effective drug. If the FDA don't agree then MTD201 is at least bioequivalent and Midatech will have to complete the clinical experiment they started and get to market relatively cheaply and quickly (but won't take as much of Novartis' business than if they had a more effective drug)
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2) If the FDA agree the profile looks better than Sandostatin LAR then Midatech will have to partner and go through a longer phase III development process (also more expensive and needs a partner but should provide a better return in the end).
3) FDA sits on the fence and it's up to Midatech to decide which way to go. I'm guessing Midatech will go for scenario 2 but there's a chance they may not want to take the risk without full FDA endorsement and go for scenario 1 instead.
Either way there is a development path here, which the SP does not reflect at the moment. To be honest right now I'd prefer scenario 1 but that's only from a selfish short term perspective. The long game obviously suits option 2 better.
Looks like something has gone Midatech's way for once. We're slowly creeping back towards my buy-in price. FYI - maybe excitement is a little tempered as these are just the preliminary Phase I results of the bioequiv. / therapeutic eqiv. study. The full pivotal trial needs to read out before it can be used for a 505(b)(2) NDA (which if accepted will be around 6 months faster that a normal NDA) - so on the market fast. Given that they are simply adding more subjects to a study where we now know the proof of principle works, I'm not worried. Midatech took a looooong time to consult with the FDA to design the study (causing much frustration at the time) so FDA will most likely accept if positive (silver lining). Looks promising. Even if Midatech takes a more realistic 100 Mn of the 2 Bn Sandostatin market then it's happy days given the market cap is only ~20 mil.That's without anything else from the pipeline contributing. This one is fairly low risk with good mid term return for me (unless there are any really stupid blunders) but as always DYOR.
I'll drink to that!
'George-Inn', I suppose shareholders (including myself) are a tough bunch to please. This said someone buying into a startup pharma like MTPH and expecting ALL experimenal programes to succeed then pulling out again at the first sniff of bad news perhaps doesn't fully appreciate the industry. MTPH (and a lot of other startups/mid caps) are always banging on about being the next Shire. If you look at Shire's beginnings above a wine shop in Overton (UK) to where they are now, the path is littered with failures and dead projects. All it took for Shire was the aquisition of a modified version of an old amphetamine drug to produce a blockbuster (Vyvanse) which provided the capital means to grow rapidly through further aquisitions. It seems that you already have the most sensible strategy, to sit tight to see what happens and don't follow the herd in the short term.
The insulin results are disappointing but also a little perplexing. The first clinical trail (run in healthy volunteers some time ago) showed positive results vs. the standard of care (insulin injection) so I take from this that the technology worked in this study.The difference in the most recent study is that it has been performed in patients. Low bioavailability i.e. how much of the unchanged drug got to the systemic circulation is a little surprising as I would have thought that the absorption of drug from a diabetic's cheek was much the same as a healthy person's but what do I know... On AIM I don't suppose it really matters why, negative results = lower share price. Fortunately in the words of the CEO 'there are multiple shots on goal' and only one or two need to find the back of the net to drive a very decent return. This is normal pharma strategy and in practice not everything will work out (actually very little from a drug pipeline will actually get to market). In my opinion MTPH is a medium risk high return opportunity. The reason I view this as medium and not high risk are two-fold 1) There are multiple assets - as previously mentioned 2) The trials being conducted are mainly using drugs that have already have PROVEN CLINICAL EFFICACY but MTPH is helping them get to places in th body they haven't been able to reach before. This removes the addtional hurdle of having to worry if the drug actually does what it is supposed to. This is a ~5 year investment for me.
Delboy, really, up you say?
A little good news: The FDA has approved the use of Breo for asthma in adults. http://uk.reuters.com/article/2015/04/30/us-glaxosmithkline-asthma-idUKKBN0NL2PN20150430 A little positive news may stem the EXPAREL related SP bleeding.
The SP knock today is to do with Pacira's 1Q15 financial report. There are good sales figure for EXPAREL (up 63% over prior year) but 1Q15 growth is sluggish (blamed on the weather??) Unfortunately due to the investigation by the US DoJ into alleged 'unsubstantiated efficacy claims' Pacira has suspended its EPAREL sales guidance for 2015 'Given the current lack of visibility on EXPAREL sales resulting from the combined impact of recent regulatory developments and the government investigation, Pacira is suspending full year 2015 guidance for EXPAREL revenues and non-GAAP product gross margins'. http://www.marketwatch.com/story/pacira-pharmaceuticals-inc-reports-first-quarter-exparel-revenues-of-560-million-and-first-quarter-2015-financial-results-2015-04-30 The DoJ investigation isn't good but would only result in a fine (for Pacira) and shouldn't impact SKP. With $56m of registered sales for EXPAREL already this year, we should still exceed the $250m limit for the royalty pay out .
Oldabutnowisa, personally I'd like to see SKP to pursue Flutiform in the US. A win here and the right partnering deal would increase revenue significantly. I'm also interested in seeing more info on SKP-2075 development as this could also be a good cash generator once marketed. We'll see how long term growth might be achieved soon but for all the speculators out there, the rumour mill is turning again: http://www.fool.co.uk/investing/2015/02/27/glaxosmithkline-plc-and-skyepharma-plc-a-match-made-in-heaven/ Some good points and there are some obvious synergies between SKP and GSK........
If you haven't seen....Pacira released some year end financials yesterday that contain some encouraging news for SKP. The 2015 Exparel financial projections suggest that revenue will reach $310-$330 million with 10% coming from the new nerve block indication (PDUFA decision for nerve block to be announced on the 5th March). If this is correct the major milestone payment will be triggered ($32 million) for passing the $200 million mark. In 2015 at the Exparel projected $310 million figure, total payments to SKP would be $41.3 million. http://investor.pacira.com/phoenix.zhtml?c=220759&p=irol-newsArticle&ID=2019287 I'm looking forward to the 5th of March for the marketing approval and finding out how R&D investment is going to drive further growth for the company at the end of March.
I think that today's RNS proves that the SKP BoD are committed to getting the best out of any penny that is generated. "We are pleased to announce the early repayment of the remainder of the CRC Finance facility, which has been possible due to the Group's strong cash generation over the last 12 months. The repayment of the U.S. Dollar CRC Finance facility, combined with the early repayment last year of the Euro CRC Finance facility, delivers £2.7 million in total cost savings and will remove the associated security obligations and restrictions. With the 2014 repayment of the bond debt and the Paul Capital Note, the repayment of the CRC Finance facility means that Skyepharma is no longer encumbered by expensive debt." I'm sure that this frugalness will play out when it comes to us understanding the R&D investments that have been promised.
Hi Mac19, I've been holding SKP for a while now but not as long as you. I used to work for GSK (for my sins) but bought into SKP after I had left (as not to get into any potential insider trading entanglements) as I saw what a great company it was and what value it added. It's really positive that SKP are investing more into R&D as this is what will drive further growth over the longer term and make this a better investment.
I don't want to talk too soon but the charts seem to suggest that we are just seeing the start of some positive momentum and a reversal of the bearish trend.
I can't see this lull in SP lasting for long. The negative shareholder reaction to the fact that SKP want to sustain their continuing growth by investing in R&D and the future is one of a fundamental lack of knowledge of the pharma industry. It seems that the wheat has now been separated from the chaff and the SP has stabilised. There may also be a slight dent in SP caused by the delay in payments from GSK due to poor sales of Breo / Anoro but this is just a delay not a cancellation / reduction. GSK's new sales rep incentives have been blamed for this problem but I can't see (nor can analysts) GSK letting this slide. I see the SKP share price returning at least to where it was by financial year end on announcement of results if it isn't bought out in the mean time for being undervalued.