That will depend on whether they have patents in those other countries. I'm sure they don't have a global patent.
Essentially they will need to get around the negotiations table with illumia post appeal depending on that result. Maybe the judge was nibbled, illumia have the funds to do that ( only joking - don't want to be hauled up myself for slander )
I know outlook at moment is bleak but I really think this will fly in 2018.
But then I'm a gambler.
UK only it seems but a sad situation for women in the UK as the test will likely be withdrawn and they will have to hop on a plane to take it somewhere else. Obviously the Judge doesn't care about that it seems. Is the company in contempt of court if it still offers the test? Seems wrong that something so important in the public interest will be stopped.
It's been a long time coming but today it seems we are finally breaking out above that downward trendline with the price moving above the 50day EMA. Perhaps the judge and his family are buying before passing judgement..... or are Illumina taking a stake to offset their expected losses?
Based on these results, I am aghast as to why the share price is languishing still below the ten pence mark. It can only be the litigation that is suppressing this share unless other dark arts are at play. What do others think?
Full year results to 31 March 2017 and half-year trading update
Manchester, UK - 29 September 2017: Premaitha (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing ("NIPT"), announces its full year results for the twelve months ended 31 March 2017; and provides an update on trading performance in the current financial year to date.
· Revenues increased by 26% to £3.1m (2016: £2.5m), including one month contribution from Yourgene Bioscience ("Yourgene"), which was acquired in March 2017
- Revenues increased by 48% excluding a non-recurring 2016 equipment sale
· Gross profit increased by 83% to £1.3m (2016: £0.7m)
· Gross margin improved to 42% (2016: 29%) due to benefits of scale and reduced product costs
· General administrative expenses increased by 8% to £7.1m (2016: £6.6m), before separately disclosed exceptional items
· Operating loss reduced by 37% to £7.6m (2016: £12.0m)
· Cash of £1.3m at 31 March 2017 (31 March 2016: £5.3m)
- Additional US$5.0m loan funding secured from Thermo Fisher in July 2017
· Test volumes increased by 41% to over 24,000 (2016: over 17,000) in second full year since its commercialisation
· Completed the acquisition of Yourgene in March 2017, a significant provider of NIPT in Asia
- Post-period end, in June 2017, Premaitha launched SAGETM, an advanced NIPT analysis solution available through Yourgene, significantly expanding Premaitha's addressable market
· Successful expansion of geographic footprint, with Premaitha now commanding a significant distribution network across Europe, the Middle East, India and the Far East
· In July 2017, the legal proceedings in connection with the patent infringement suits filed by Illumina were heard in the English High Court - judgment expected in Q4 2017
· Genoma SA, Premaitha's Swiss customer, was placed into bankruptcy in May 2017 with an outstanding debt to Premaitha of £0.8m
Premaitha is actively pursuing options to recover the debt or equivalent assets
· Six month revenues to 30 September 2017 are expected to be up by approximately 75% to £2.6m (H1 2016: £1.5m)
· Test volumes for the first half are expected to be in excess of 22,000, demonstrating significant momentum (H1 2016: 11,000 tests; full year to March 2017: 24,000 tests)
- First half test volumes, excluding Yourgene, are up 140% to c.15,000 tests (H1 2016: 6,000 tests - excluding Genoma)
· Continued geographic diversification, significantly reducing the proportion of revenues from regions with intellectual property exposure
- Recently announced launch into South Africa and the award of Good Manufacturing Practice in Brazil
· Strong focus on achieving positive cashflows through sales ramp-up, implementing cost-per-test efficiencies and overhead cost control
Adam Reynolds, Non-executive Chairman of Premaitha Health, commented:
"I am delighted with the commercial progress made by Premaitha in the last financial year. This is reflected in both growing revenues and increasing test volumes.
"The Company is also making significant strides in its geographic and product diversification strategy which we believe will ensure that, whatever the outcome of the UK intellectual property disputes, Premaitha is developing a business that will succeed in what will inevitably become a huge global market for non-invasive prenatal testing.
"While the UK litigation remains a distraction, Premaitha's strong technology, growing international commercial footprint, support from Thermo Fisher and dedicated global team, place us extremely well for continued growth. In the current financial year the Company has already delivered some record sales months a
almost a month since my last garbled message and still no news, well apart from South Africa. Does anyone else get a good feeling that soon this is going to rocket when the legal shenanigans are put to bed and illumia and sequenaom are left licking their wounds and wondering if they should adopt a new strategy of buying Premaithia and taking it off the market, thus sending the sp northwards?
Manchester, UK - 19 September 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing, announces that it has signed an agreement with Ampath group, practising as Drs Du Buisson, Kramer, Swart, Bouwer Inc. ("Ampath") to offer the Company's IONA® test in South Africa, where the Company has appointed Barker Medical Pty Ltd ("Barker") as its distributor.
Ampath will install a dedicated non-invasive prenatal testing ("NIPT") centre at its national reference laboratory in Gauteng province, servicing major cities, including Johannesburg. Premaitha believes Ampath will be among the first laboratories in South Africa to offer a CE-IVD accredited NIPT system and will act as a hub, extending services to its national network of clinics and hospitals across the country.
Premaitha's IONA® test estimates the risk of a fetus being affected with Down's syndrome or other genetic conditions. The test is performed on a maternal blood sample, containing traces of fetal DNA, which is then analysed using next generation DNA sequencing technology. The test is highly accurate and significantly reduces the number of women who are unnecessarily subjected to risky, invasive follow up procedures to diagnose Down's syndrome and other genetic conditions.
Dr Stephen Little, CEO of Premaitha Health, commented: "We are delighted to announce that the IONA® test will be made available to women in South Africa, expanding Premaitha's footprint to another continent. South Africa is another strategically important region as we build our global footprint and further de-risk our business."
It's quite interesting to me that illumine and sequanom or whatever they are called should file a new claim. I seem to remember in a previous RNS that they were all advised to bring all claims together in one law/file suit so as not to waste or big down the courts time. Does anyone else remember this?
Consequently I have come to the conclusions that a new foreign language is being used here. Because of my sneaky suspicious mind think this new claims actually a flag or marker to institutions or brokers that the file and law suit is about to be announced and has failed, so it is time to fill your boots. The new action designed to shake free shares from Pi's.
Let's see how many buys and sells happen now.
Well spotted nahkit!
And the RNS continues with '...after which both Premaitha and the Claimants may be entitled to appeal'.
This could go on and on...!
By the time all my shares come good DPRK will have figured out how to really annoy Mr Trump and my shares will become worthless in the midst of WW3...
Get this litigation out of the way and it will be clear blue skies..
Eventually Premaitha will become a takeover tarhet, and it will be at many many times current sp.
Premaitha Health PLC
Investment Agreement Extension with Thermo Fisher
RNS Number : 7829K
Premaitha Health PLC
12 July 2017
Premaitha Health Plc
("Premaitha", the "Company" or the "Group")
Investment Agreement Extension with Thermo Fisher Scientific
Manchester, UK - 12 July 2017 - Premaitha Health Plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing, is pleased to announce that it has entered into a further extension of the investment agreement with Thermo Fisher Scientific ("Thermo Fisher") announced on 14 December 2015 and extended as announced on 23 September 2016, further developing this important relationship.
Thermo Fisher is the world leader in serving science, with revenues of over $18 billion and more than 55,000 employees in 50 countries. Premaitha's IONA® and SAGE prenatal screening tests run on Thermo Fisher's DNA sequencing instruments and the additional investment signifies a deepening of this relationship, as well as a move to scale up the Group's commercial activities. This includes continuing our geographic diversification strategy and further broadening the Company's product and service offering; as well as, in turn, accelerating pull-through of Thermo Fisher's reagents and instruments.
Under the terms of the agreement, Thermo Fisher will make available to Premaitha an additional secured loan facility of $5.0m (the "Loan"), of which $4.0m will be drawn down immediately for the purposes of working capital to support commercial growth strategies. The remaining loan ("Second Tranche") will be drawn down against performance milestones to be reviewed quarterly. The new loan facility follows on from the existing facility, announced on 14 December 2015 and extended as announced on 23 September 2016, on similar terms. Specifically, interest on amounts drawn on the Loan will accrue at a rate of 6 per cent per annum payable quarterly in arrears or will be capable of conversion to loan principal. The Loan is repayable on 14 December 2023, with the option to repay sooner.
Under the terms of the Loan, Premaitha will issue Thermo Fisher warrants over 28,938,797 new ordinary shares in the Company exercisable at 10.725 pence ("New 2017 Warrants"), being a premium of 10% over the closing share price on 10 July 2017 (the last business day prior to issue of the New 2017 Warrants). A second tranche of warrants will be issued on 1 March 2018, or earlier if loan drawdowns commence on the Second Tranche, over new ordinary shares in the Company at a premium of 10% over the closing share price on the last business day prior to the date of issue.
Dr Stephen Little, CEO, commented: "I am delighted that an organisation of Thermo Fisher's scale and reputation has chosen to back Premaitha's next phase of expansion and deepen its relationship with our group. It is further validation of our non-invasive prenatal testing technologies and of their global potential. This additional funding, combined with our existing liquid resources, will enable Premaitha to accelerate the scale-up of the business and meet its goal of becoming operating cashflow self-sufficient by the end of the current financial year."
I know that Premaitha are intending to cite the recent German instances as set precendences within the defence of the Illuminia patent infringment claims.
What with the sp be if the company come out the other side the victors?
Difficult one... 40p? 50p?
I have seen figures touted around these levels.
The progress made by NIPT since the claims were made have been very impressive, but none have been given any credibility in the form of sp increases.
They are expanding across Asia at a decent rate. Under normal terms announcements of this kind of magnitude would all be met with decent % increases to the sp.
As it is, each time good news is announced it has zero effect on the sp.
The recent acquisition and protection afforded by being outside of patent infringment claims across Asia, would IMO justify a MC of double todays price.
Well done NIPT.
Great to see the continued diversification across Asia, which as we all know is outside the remit of the patent infringment claims. :-)
Premaitha Health PLC
Premaitha announces two laboratory hub contracts
RNS Number : 5206K
Premaitha Health PLC
10 July 2017
Premaitha Health plc
("Premaitha" or the "Company" or the "Group")
Premaitha announces two laboratory hub contracts in South East Asia
Manchester, UK - 10 July 2017: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing ("NIPT"), announces that it has signed contracts with two significant laboratories in South East Asia through its Taiwanese subsidiary, Yourgene Bioscience ("Yourgene").
The agreements have been signed with two partners for laboratories which are in different countries in South East Asia and will act be established as regional hubs for NIPT. Both partners are already established providers of NIPT in their domestic markets with ambitions to further expand across the region. One partner is also amongst the largest listed genomic testing companies in Asia and will market the test under its own brand.
Dr Stephen Little, CEO, commented: "South East Asia is a very important region for Premaitha as the NIPT market is well-established and growing apace. These newly secured market leading partners will increase Premaitha's presence in the region, whilst further expanding our routes to market.
"We continue to work with our partners globally to increase awareness of the benefits of NIPT as we seek to further strengthen our footprint."
The trial will commence in the Patents Court, one of the specialist courts of the High Court of Justice of England and Wales (the "Court") on 4 July 2017 and is expected to last approximately three weeks. The trial will focus on a complex variety of interconnected patent claims and will involve testimony from a series of renowned experts in their respective fields. As part of its defence, Premaitha is seeking declarations from the Court that certain new processes which Premaitha is developing would not infringe the patents in suit. The first-instance judgment is expected to be handed down in the autumn, after which both Premaitha and the Claimants may be entitled to appeal.
Dr Stephen Little, CEO of Premaitha, commented:
"The matters which are the subject of the trial commencing this week have been a distraction to Premaitha and to its customers. I am therefore pleased that proceedings will shortly be underway. Despite the actions taken by Illumina in bringing these claims, Premaitha has continued to provide a high-quality service to an ever increasing and geographically diverse global customer base. We are determined that women should not be denied choice and access to high quality localised screening, which Premaitha's products provide. We are confident of our position and in the meantime we continue our strategy of geographic and product diversification to mitigate the risks of the UK actions."
Wont hear anything until post end of ofJuly ... the EU commissioners are looking at stuff in tandem with this ... anti-competition stuff. Coukd easily drag on. Hoping for an early solution but not holding my breath.
Premaitha launches Sage prenatal screening solution in Hong Kong
Manchester, UK - 16 June 2017: Premaitha Health PLC (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing ("NIPT"), announces the launch of Sage, an NIPT solution incorporating additional prenatal screening analysis tools.
Sage is an advanced NIPT analysis solution, available through Yourgene Bioscience Singapore ("Yourgene"), which was acquired by Premaitha in March 2017. It uses the latest technology to detect placental DNA in a maternal blood sample, enabling pregnant women to get fast, safe and reliable test results whilst reducing the number of women required to undergo invasive follow up tests with the associated risks.
Sage offers customers a cost-effective, high-quality and flexible prenatal screening test that can be tailored to provide a full clinical service for hospitals or to local laboratory set-ups, all with a fast workflow of just three days. Utilising cloud-based bioinformatics analysis, Sage allows laboratories to upload sequencing data files to the cloud for remote analysis via Yourgene's bespoke portal analysis package.
This solution will significantly expand Premaitha's addressable market, giving access not only to new customers, but also offering additional analysis tools for existing IONA® customers. Sage is a complementary solution to IONA® as Premaitha's CE-marked IONA® test detects trisomies 21, 18 and 13, whereas Sage offers an extended test panel, including full chromosome analysis, thereby enabling customers to maintain a competitive edge in the growing number of laboratories offering NIPT.
Health authorities implementing public health screening policies often mandate the use of a CE-marked test, such as IONA® test, or equivalent. The launch of Sage will enable Premaitha to capitalise on the growing awareness and demand for NIPT in countries that have not yet seen the implementation of standard regulation and for the private payer market in cases where public provision is not available.
The Sage analysis solution has been developed utilising the sequencing and bioinformatics expertise of Yourgene, alongside Premaitha's clinical understanding, IVD and quality standards. Sage is being launched at the Asian and Oceanic Obstetric Congress of Obstetrics and Gynaecology in Hong Kong, where the Company will be exhibiting and showcasing both the Sage solution and the IONA® test.
Dr Stephen Little, CEO of Premaitha Health, commented: "To be able to launch the Sage test, a valuable addition to the Premaitha portfolio, having only completed the acquisition of Yourgene three months ago, is a real testament to the capabilities and expertise across our technical, clinical and commercial teams.
"The launch of Sage presents a significant opportunity to extend Premaitha's footprint and market penetration across Asia Pacific and other regions. Yourgene already has a strong, established network of customers across APAC and we are now in a position to offer a complete NIPT solution to address the needs of any laboratory, with our IONA® test continuing to service demand for premium CE-IVD testing.
"Our team will work with local customers across the APAC region to increase understanding of the benefits of NIPT and raise awareness in and amongst clinicians. Premaitha is also very keen to support healthcare professionals offering Sage and IONA® with comprehensive clinical and technical training to ensure they are well equipped to counsel pregnant women on their NIPT options."
Manchester, UK - 5 June 2017: Premaitha Health plc (AIM: NIPT), a leading international molecular diagnostics group focused on non-invasive prenatal testing, is pleased to provide an update on commercial progress in India.
Yourgene Bioscience ("Yourgene"), acquired by Premaitha in March 2017, is now firmly established as one of India's leading providers in the emerging non-invasive prenatal testing ("NIPT") market, with representation in 9 of the 15 most populous states and several of the largest nationwide pathology laboratory groups running Yourgene's NIPT workflow in-house. There are five laboratories with installed NIPT solutions, and an additional two laboratories are expected to become active later this year. These laboratories have an extensive network of hospitals feeding samples into them across all the regions of the country. In addition, there are currently thirteen Indian laboratory customers sending samples to Yourgene's laboratory in Taiwan for processing and analysis and the expectation is that some of these laboratories in time will establish their NIPT solution in house.
NIPT in India is still in an early phase of development and Yourgene's test volumes are growing at a rate of 100% per annum with coverage across all key metropolitan areas including Mumbai, New Delhi, Bangalore, Hyderabad and Chennai. India has the highest birth rate in the world with over 26 million births per annum, and access to prenatal screening is spreading to the expanding middle class populations living in the cities and regions where screening is available. Yourgene's menu-based test offering allows for testing to be tailored to local ethical and clinical requirements.
Dr Stephen Little, CEO, commented: "With its extremely high birth rate and growing middle class population we expect India, in time, to become a very large market for NIPT and we are well positioned to be one of the principal suppliers to the market in the years to come.
"Premaitha and Yourgene are working closely together to deliver a complementary test offering to suit all sizes of hospital and laboratory customer. We already have a leading presence with growing test volumes from an expanding customer base. I believe our combined product strategy positions us strongly to win significant market share in this country and others with similar health service characteristics."
Appear on face value to be overly pessimistic.
An understanding of the company far eraching scope and margins suggest an sp many times that of broker forecasts of 20p. :-)
But considering that 20p is 100% increase from where we are now does nothoing to me other than highlight what an opportunity to acquire this stock there is.
With court case looming large now, I am extremelly hopeful (Confident) that the shackles that have hedl NIPT back will be released.
About time to i say.
International molecular diagnostics group Premaitha Health announced on Friday that the IONA test, the company's CE-IVD non-invasive prenatal test, had been validated for use on Thermo Fisher Scientific's Ion S5 range of instruments.
The AIM-traded firm said the validation of the IONA test on the Ion S5 platform, performed in partnership with Thermo Fisher Scientific, would broaden Premaitha's potential laboratory customer base.
It said the Ion S5 instrument was now being widely adopted by laboratories carrying out next-generation DNA sequencing around the world.
The IONA test was therefore now a possible NIPT solution for the growing network of laboratories, Premaithas board claimed.
Additionally, as the Ion S5 could be used for wider applications, including oncology, the platform allowed Premaitha to work with lower volume laboratories that were keen to offer NIPT as part of a wider choice of genetic tests for their patient populations.
The IONA test was already validated on Thermo Fisher Scientific's Ion Proton and Ion Chef sequencing instruments, which are part of the same Ion Torrent platform.
Validation on the Ion S5 is another important technological milestone which achieves a simpler IONA® test workflow, enabling less 'hands-on' time, and provides access to an even greater pool of international laboratory customers that are installing the new platform or who are not solely focused on NIPT, said CEO Stephen Little.
We already have several S5 laboratories ready to roll out the IONA® test, and are in discussions with more, Dr Little added.
Premaitha completes IONA test validation on Thermo Fisher's Ion S5 instrument
Manchester, UK - 26 May 2017: Premaitha Health plc (AIM: NIPT, "Premaitha" or the "Company"), a leading international molecular diagnostics group focused on prenatal testing, announces that the IONA® test, the Company's CE-IVD non-invasive prenatal test ("NIPT"), has been validated for use on Thermo Fisher Scientific's Ion S5 range of instruments.
The validation of the IONA® test on the Ion S5 platform, performed in partnership with Thermo Fisher Scientific, will broaden Premaitha's potential laboratory customer base. The Ion S5 instrument is now being widely adopted by laboratories carrying out next generation DNA sequencing around the world. The IONA® test is therefore now a possible NIPT solution for this growing network of laboratories. Additionally, as the Ion S5 can be used for wider applications, including oncology, the platform allows Premaitha to work with lower volume laboratories that are keen to offer NIPT as part of a wider choice of genetic tests for their patient populations.
The IONA® test is already validated on Thermo Fisher Scientific's Ion Proton and Ion Chef sequencing instruments (part of the same Ion Torrent platform).
Dr Stephen Little, CEO, commented: "Validation on the Ion S5 is another important technological milestone which achieves a simpler IONA® test workflow, enabling less 'hands-on' time, and provides access to an even greater pool of international laboratory customers that are installing the new platform or who are not solely focused on NIPT. We already have several S5 laboratories ready to roll out the IONA® test, and are in discussions with more."
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