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Trading update

Trading update

Manchester, UK – 19 June 2015 – Premaitha Health plc ("Premaitha” or “the Company”, AIM: NIPT) announces the following trading update in respect of the financial year ended 31 March 2015.


Highlights

  • Reverse takeover and AIM admission of Premaitha Health plc in July 2014
  • Launch of first and only CE-marked in-vitro diagnostic non-invasive prenatal test (NIPT) in February 2015 positioning Premaitha at the forefront of the emerging NIPT sector in Europe
  • Multiple NIPT contracts won across Europe providing pregnant women with access to the IONA® test both privately and, in the UK, on the National Health Service (NHS)
  • Established a new enabling and clinical lab with plans to further increase capacity  to meet significant and ongoing demand
  • Substantial new international client enquiries
  • Patent infringement suit lodged by Illumina, Inc. in March 2015 (the “Claim”) followed by a robust defence and counterclaim filed by Premaitha in the High Court of Justice, Chancery Division, Patents Court in May 2015
  • Operating loss for the year in the range of £4.9 million - £5.3 million, reflecting additional development activities of £1.0 million - £1.2 million and a provision for litigation costs of £0.5 millio
  • Cash balance at the year-end was £2.6 million (30 September 2014: £5.2 million)


David Evans, Chairman of Premaitha, commented: “Premaitha has hit its key milestones as promised at the time of the reverse. We have delivered the world’s first CE-marked diagnostic product, signed contracts across Europe, including launching the first NHS test in the UK, and achieved recognition amongst our peers and key opinion leaders. This has all been achieved in a short period of time and is despite wholly opportunistic legal obstacles placed in our path.“

Premaitha is at the forefront of a revolution in prenatal screening which will benefit pregnant women and healthcare professionals. Our intention is to accelerate the roll–out of the IONA® test by working closely with our partners, customers and respective Health Authorities to make it as widely available to pregnant women as possible.

“We are bringing leading scientists to Manchester and creating high quality jobs in the north of England. We look forward to actively engaging with the Northern Powerhouse initiative to ensure indigenous world-class companies such as ours thrive.”


Update on the IONA® test
Contracts won during the period include collaborations with Esperite NV in Switzerland, Centrum Badan DNA in Poland and St George’s University Hospitals NHS Foundation Trust. The first two contracts provide access to the IONA® test to private customers throughout Europe. Notably, the St George’s contract enables high risk pregnant women in the UK to access the IONA® test on the NHS for the first time.

Premaitha’s marketing and sales teams have been working across multiple business areas to raise awareness of the IONA® test, attract new partners, thereby driving sales and levels of testing. There is increasing public awareness of NIPT, such as the recent extensive BBC and national newspaper coverage, supported by Premaitha’s own newsflow. Within the healthcare community in the UK and Europe, the IONA® test is attracting good key opinion leader support. The Company is also engaged in discussions with a number of its strategic partners to seek ways in which to advance the roll out of the IONA® test.

Combining all of these factors with the quality of the IONA® test, the Directors are already seeing increased demand for local (European-based) NIPT testing and further contract wins are anticipated by the Board in the months ahead.

Illumina Claim
In March 2015, Illumina, Inc. lodged a patent infringement suit in the High Court of Justice, Chancery Division, Patents Court in the UK. Premaitha filed a robust defence and counterclaim in May 2015. Since the filings, there have been no significant developments in the legal process for the Claim. The Directors, having received legal advice, believe they will successfully resist the Claim.

The Board will create a provision of £0.5 million in the March 2015 accounts to cover the expected costs necessary to fully defend the Claim. The Board anticipates that the majority of these costs will be recovered in the event that the Claim is ultimately denied.

Financial performance
For the financial year ended 31 March 2015, the Company is expected to report an operating loss for the year in the range of £4.9 million to £5.3 million (before the accounting treatment and costs associated with the reverse takeover and readmission to AIM). These costs include additional development activity in connection with the launch of the IONA® test of approximately £1.0 million to £1.2 million, and a provision for litigation costs of £0.5 million. Cash at the year-end was £2.6 million (30 September 2014: £5.2 million).

Going forward, the Directors believe that the development of the IONA® test and associated software is critical to maintaining its advantage in a competitive market. Near-term timing of customer take-up is difficult to predict, given both the complex purchasing decisions and associated initial investment required. To counter this, Premaitha is offering its own in-house service and strengthening relationships with supply chain partners. In addition, the average unit price is lower than originally assumed due to the weaker Euro and to the actions of non-CE-marked competitors. However, this is being offset by increased levels of testing and the better margins of its own in-house service, which is growing significantly.

The final results are expected to be announced in mid-September 2015.

The Board remains confident that Premaitha will achieve a sizeable share of the NIPT market in the medium-term.

About Premaitha Health
Premaitha Health (AIM: NIPT) is an innovative molecular diagnostics company employing the latest advances in DNA analysis technology to develop tests for non-invasive prenatal screening (NIPT) and other applications. Premaitha’s flagship product, the IONA® test is the first non-invasive in vitro diagnostic CE marked product for prenatal screening enabling clinical laboratories to offer a regulated NIPT in-house.

The IONA® test estimates the risk of a fetus having Down’s syndrome or other serious genetic diseases. The IONA® test has a higher detection rate and lower false positive rate than existing screening tests, giving pregnant women, their families and their doctors greater confidence in the result and reducing the need for unnecessary invasive follow-up tests and the associated anxiety and stress.

The IONA® test is a complete diagnostic system that is simple and standardised, enabling Premaitha’s clinical laboratory customers to perform the test in their own facilities. This supports Premaitha’s strategy of accelerating the broad dissemination of NIPT tests to ensure that their benefits are available to pregnant women everywhere.

Premaitha Health plc is listed on the AIM market of the London Stock Exchange. Premaitha is ISO 13485 certified and its R&D, manufacturing and commercial operation is located at Manchester Science Park, UK.

For further information please visit www.premaitha.com  or email iona@premaitha.com.
 

Issued for and on behalf of Premaitha Health by Instinctif Partners.

For more information please contact premaitha@instinctif.com.

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Melanie Toyne-SewellManaging Partner