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Just for completeness....
An ad-hoc House of Commons Committee briefly discussed these regulations earlier today. Only 20 or so minutes (audio only) of limited discussion. Confirmed that of 280 tests, only 50 found to be "reliable" in detecting Covid. Minister acknowledged frustration with the Porton Down validation process, but defended it against self-certification. No discussion of any individual tests, whether LFT or PCRs.
https://www.parliamentlive.tv/Event/Index/09c4fb83-c2b4-47e8-85d5-0b72dba71736
Short debate on these regulations yesterday in the House of Lords. Lots of criticism of certain Chinese tests. Only vaguely positive noises from the Government.
https://hansard.parliament.uk/lords/2021-07-12/debates/2A31C739-2678-474E-A02E-E78F33615C47/MedicalDevices(CoronavirusTestDeviceApprovals)(Amendment)Regulations2021
First post here, but thought some context of MCAP valuation might be helpful as we begin to rise and attract new PIs.
At an SP of 0.27p, Alba is valued at just under £17m.
If you think all our assets are undervalued (gold, graphite, ilmenite, iron ore etc in UK, Ireland and Greenland – see @Moodyboy posts on 7/7) and that we could have a MCAP of £50m, then the SP would be 0.8p (x3). If £100m, then the SP would be 1.6p (x6) or £200m, then 3.2p (x12).
Or if you prefer focusing on the SP, at 1p (£62m), 2p (£125m), 3p (£187m) or 4p (£250m). Or higher, but let’s cross that bridge if/when we come to it.
Pick your target(s) depending upon your circumstances and then be patient. DYOR.
For me, I’m genuinely confident we’ll be back up to last year’s SP levels shortly and pushing progressively through the levels above to multibag.
GLA
This Lord's Cttee report is now out and will be debated on Monday, as per previous post.
https://publications.parliament.uk/pa/ld5802/ldselect/ldsecleg/40/4003.htm
Looks like lots of interesting material for those of us (not me I'm afraid) who are well acquainted with the science and procedure:
12.Asked for further information about the new validation process and how it differs from the CE marking process, DHSC told us that:
“The CE marking process is far less rigorous than the CDTA desktop review. CE marking requirements do not specify sample size, sample type (clinical v contrived) or present the raw data from which an accurate assessment of the performance can be made. Many of the CE marked products that have been reviewed previously have insufficient and poor data sets that do not accurately reflect how a test product performs. This data and evidence does not facilitate accurate assessment of the product by the end-user and can be misleading. A common example is “front-loading” of data, whereby the CE marked instructions for use will provide performance data based on a selection of samples with a very high viral load thus the test appears to be highly sensitive but in fact may have a poor sensitivity. Other products have used clinical symptoms as the comparator method rather than a gold-standard PCR comparison. [ … ]
The desk top review is undertaken by an independent expert and ensures the validity and quality of the data used by the manufacturer for their CE mark self-certified claims. The pandemic has highlighted the inconsistency in the data behind such claims; for example using sets of samples that will make the performance of their test look better than if it was used on all samples, or not providing information on how their test works for all Variants of Concern. The data is then compared to defined performance thresholds for different testing technology types, as set within the legislation.”
These regulations are now due to be debated in the House of Lords next Monday (12 July). Peers that will be speaking in the debate will be listed by later today/tomorrow morning should anyone wish to contact them in advance. Lord Bethell is leading for the government.
https://whatson.parliament.uk/event/cal35487
Also, we can expect the Lords Committee (Secondary Legislation Scrutiny Committee) to publish their report sometime today. I'll post it when published.
Pains me to say it, but it looks as if the new NHS/home testing for kids test is the Chinese Orient Gene one. And after all that was said yesterday about supporting the UK diagnostics industry. The rest of the world is still a very big market.
https://www.gov.uk/government/publications/coronavirus-covid-19-rapid-lateral-flow-home-test-kit-instructions-for-nose-only-test
https://www.gov.uk/guidance/covid-19-self-test-help
Looks like a defence of Innova (and Orient Gene) on first reading....
Lateral flow device performance data
Analysis confirms lateral flow devices (LFDs) are successful at identifying infectious cases of coronavirus (COVID-19) and real-world data shows Innova LFDs are capable of detecting the Delta variant.
https://www.gov.uk/government/publications/lateral-flow-device-performance-data
And a couple more just published...
Dr James Davies (Conservative, Vale of Clwyd): To ask the Secretary of State for Health and Social Care, what recent assessment he has made of whether the Innova Lateral Flow Device Test is fit-for-purpose.
Jo Churchill (Parliamentary Under-Secretary of State, DHSC): Evaluation from Public Health England and the University of Oxford have shown that Innova lateral flow tests were shown to detect over 95% of individuals with high viral load or the most infectious cases. Results of the Innova evaluation in 2020 showed that the tests were effective in picking up viral antigens in both symptomatic and asymptomatic individuals. The Department continues to monitor the performance of the Innova lateral flow test.
https://questions-statements.parliament.uk/written-questions/detail/2021-06-29/24270
Dr James Davies (Conservative, Vale of Clwyd): To ask the Secretary of State for Health and Social Care, what assessment he has made of the performance of lateral flow devices available in the UK; and what comparative assessment he has made of the performance of those devices that are available in the UK and overseas.
Jo Churchill (Parliamentary Under-Secretary of State, DHSC): Since August 2020, Public Health England has evaluated over 150 lateral flow antigen devices (LFDs) produced by United Kingdom and international manufacturers. To date, 31 of these have displayed performance characteristics desirable for mass testing, with a very high specificity and sensitivity against viral loads associated with infectiousness. Devices are also tested for robustness, usability and evidence of cross-reactivity with seasonal coronaviruses.
The Department monitors the evaluation of LFDs that are performed in other countries to shortlist LFDs for validation that meet criteria designed to identify the most likely future requirements and use cases in the United Kingdom.
https://questions-statements.parliament.uk/written-questions/detail/2021-06-29/24269
Justin Madders (Labour, Ellesmere Port and Neston): To ask the Secretary of State for Health and Social Care, for what reason Innova lateral flow tests had their authorisation extended by the Medicines & Healthcare products Regulatory Agency only until 28 August 2021.
Jo Churchill (Parliamentary Under-Secretary of State, DHSC): An Exceptional Use Authorisation (EUA) is only needed if the lateral flow test is not UKCA, CE, or CE UKNI marked.?The Medicines and Healthcare products Regulatory Agency (MHRA) provides EUAs where there are no UKCA, CE, UKNI products available and where there is a clinical and/or public health need. The MHRA has determined this is the case for the re-purposed Innova lateral flow tests.?The duration of an EUA can differ for a number of reasons and a shorter extension was considered appropriate for the re-purposed Innova tests. This does not preclude further extensions if requested by NHS Test and Trace.
https://questions-statements.parliament.uk/written-questions/detail/2021-06-24/21930
@Scardey and anyone else interested,
The "draft" legislation press released by DHSC were published on 17 June (sorry, I missed it!) as a Statutory Instrument (secondary legislation) under the Medicines and Medical Devices Act 2021. They set out the new approval and performance requirements (sensitivity and specificity) for Covid antigen (LFT), direct molecular tests and extracted molecular tests (PCR, LAMP, CRISPR). It also has an exclusion paragraph - which is obviously of concern.
The actual SI (The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021) can be found here:
https://www.legislation.gov.uk/ukdsi/2021/9780348224795/pdfs/ukdsi_9780348224795_en.pdf
The process for SIs is very obscure and involves various Committees in both the Commons and Lords.
Of immediate interest is the House of Lords' Secondary Legislation Scrutiny Committee which will be considering the draft regulations ****next Tuesday (6 July)****. It considered the SI at its meeting this Tuesday (29 June) but had a number of issues/concerns (!!!) and went back to the Department of Health for their response.
The Committee can be directly contacted via the contact details (at the bottom of this link) but any correspondence needs to be sent asap to enable them to consider it and raise any questions with DHSC. Correspondence sent to the general email address is circulated to the members:
https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/
On 22 June, this same Committee expressed its concerns about ISO certification of private test providers, which may be of interest:
https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/news/156043/lords-echo-concerns-about-private-providers-of-coronavirus-tests-on-the-governments-webpage/
It will also be considered by a House of Commons but I'm still trying to find out when - but SI's are normally a tick-box exercise in the Commons, whilst the Lords tend to do things more thoroughly.
GLA
@scardey The DHSC press release of 17 June clearly stated that it was to be "draft" legislation - which would ordinarily be considered in a Committee before general consideration by either the Commons or Lords - but no sign of it yet. Still nothing that I can see, either as published primary legislation, a draft Bill or secondary legislation (regulations). I'm still watching.
Thanks @Scardey. With Parliament breaking for their Summer Recess on 22 July and the new regulatory framework needing to be in place by 1 September, they'll have to get a move on to get it through before parliamentarians dig out their buckets and spades. It hasn't been published yet, but I'll try and look out for it.
Been watching TGP for a few weeks now, but yet to invest. This looks like an impressive list of new contract wins since the results to September 2020, but are there any LTHs with a view about whether this is standard for the time period or an uptick? Any opinions about potential value on top of the two that were RNSd (£8.5m)? Thanks in advance for any replies.
14-Apr CPS for a further offshore wind farm in China
12-Mar Pipeshield 1,200 drop bags for a subsea project in Trinidad and Tobago
11-Mar Complex tooling to support operational offshore wind farm
17-Feb CPS for two offshore wind farm projects in China (Guangdong)
09-Feb CPS for the Kaskasi Offshore wind farm in Germany
04-Feb TekDuct impact and abrasion protection system for Indonesia
01-Feb CPS for Saint-Nazaire Offshore wind farm
28-Jan CPS for the Neart na Gaoithe offshore wind farm in the UK
20-Jan Major operational offshore wind farm project- RNS £4.5m
08-Jan Major quay development project - RNS over £4m
18-Dec Two new contracts to supply VBR strings for subsea projects in India and Australia
02-Dec Impact protection system for project in Baltic Sea
25-Nov Further contracts in the Middle East
02-Oct Multiple contract for offshore wind farm projects in China
01-Oct TekDuct contract for telecoms in the Middle East
? Supply to offshore energy project in the Norwegian North Sea
? TekDuct in Indonesia
Not sure, but a bit disappointing for sure. I suspect it's this delay below, which will have an impact on the anticipated volume of tests from December until February/March next year. Still, great figures to begin building up an M&A warchest for the future.
"The DHSC contract is expected to be extended through Public Health England's ("PHE") National Microbiology Framework Lot 4 - Clinical Laboratory Diagnostic Testing Services ("Lot4"), however this framework is now not expected to be awarded until February 2021, although this may be subject to further change, having originally been expected to be awarded in November 2020. This delay is expected to impact testing volumes into Q1 2021 but the Board remains confident in its financial outlook for FY21 as a whole."
I'm working on the assumption that it will be in late Jan or early Feb, but hoping for a first update before Christmas to build interest and momentum.
Thanks GW, much appreciated - mine is [LSE username]@gmail.com
Welcome to the board KHDJ - and thanks for pointing out the Vox podcast with Harwoods.
GW2014, I think you've said you have the Liberum research note. Wouldn't mind seeing it myself.
Sorry about late night scrambled previous post:
GW2014, ShaunP - Been reworking possible Covid-testing predictions after presentation on Thursday. The one hard figure was that an average of 5,150 tests/day carried out in September, for income of £6.9m. Suggests average revenue per test of about £44.50 - think it was said that average is about £40 but with some customers paying substantially more. The below uses the £44.50 as a guide and the given income figures for May (the beginning of testing) to September and the target of 10,500 by the end of year/beginning 2021.
May 2020, 750 tests/day, £1m
June, 900 tests/day, £1.189m
July, 2100 tests/day, £2.8m
Aug, 2400 tests/day, £3.2m
Sept, 5150 tests/day, £6.9m
Oct, 7200 tests/day, £9.6m
Nov, 8500 tests/day, £11.35m
Dec, 9500 tests/day, £12.7m
Total testing income, May-Dec 2020, circa £48.7m.
This could be conservative, if the ave cost has been higher in some months and if the 10,500 tests/day target is met in December.
Looking ahead to 2021, SBI says that the “IPO funds and Covid-19 testing cash generation to allow faster ramp-up of Covid-19 testing” and also “IPO proceeds to further accelerate capacity expansion”. Could the 10,500/day be exceeded? The co talked about expansion into a new lab in August on an upper floor, but I’m not clear whether the ground floor lab is still operational, which was capable of 2k tests. So, I’ve put the upper limit at 12500, which may be generous. SBI have also said that they believe testing will begin to slowly fall away from the middle of 2021. As I’ve already posted, think this may be cautious, but they know the situation better than me, so gone with a steady decline from possible peak in June 2021.
Jan 2021 , 10500 tests/day, £14m
Feb, 12500 tests/day, £16.7m
Mar, 12500 tests/day, £16.7m
Apr, 12500 tests/day, £16.7m
May, 12500 tests/day, £16.7m
June, 12500 tests/day, £16.7m
July, 12000 tests/day, £16m
Aug, 11500 tests/day, £15.3m
Sept, 11000 tests/day, £14.7m
Oct, 10500 tests/day, £14m
Nov, 10000 tests/day, £13.3
Dec, 9500 tests/day, £12.7m
Total testing income, 2021, circa £183.5m.
Alternatively could be a low of £140m on the basis of a peak of 10.5k tests/per day and a progressive reduction of 1k tests/per day every month after June.
H1 core business revenue (Healthcare diagnostics, genomics and stability storage) was £10.186m in H1. On the basis of improved figures for H2 2020, suggest circa £21m in 2020, up from £19.75m in 2019. With improved conditions, suggest 2021 revenue from core businesses could be a low of £23m and a high of £29m.
Healthcare diagnostics, £7.293m in 2019, £7m in 2020
Genomics, £4.523 in 2019, £5m in 2020
Stability storage, £7.934m in 2019, £9m in 2020
Which could mean:
Total revenue 2020, circa £70m
Total revenue 2021, low £163m and a high of £212m.
Would welcome any thoughts/corrections/additions.
Will have a go at EBITDA in a future post, but can’t promise to compete with ShaunP (