Issued on behalf of Premaitha Health plc
Manchester, UK: Monday, 14 December 2015
Results for the half year ended 30 September 2015
Manchester, UK – 14 December 2015: Premaitha Health PLC (AIM: NIPT, “Premaitha” or the “Company”) announces its results for the half year ended 30 September 2015.
Financial position
• Revenues of £0.6m (H1 2014: £0.1m) generated from early sales of the IONA® test.
• Loss before one-off and non-cash items of £2.7m (H1 2014: £2.3m) reflecting recruitment of staff, product development and commercialisation activities.
• July 2015, oversubscribed placing raised £8.0m at 20p per share.
• Cash balance at the period end was £6.6m (H1 2014: £5.2m).
• Provision for anticipated litigation costs increased to £1.9m (FY 2015: £0.5m) to enable strong defence against Illumina patent infringement claims.
• £5.0m investment by Thermo Fisher announced today in the form of secured loans and warrants (see separate announcement).
Operational highlights
• IONA®, the CE-marked non-invasive prenatal test (NIPT), installed in four laboratories in the UK, Switzerland and Poland, now generating revenues and organically growing with Premaitha’s support.
• First French customer announced and now in set-up phase.
• NIPT clinical testing service launched from Manchester and Care Quality Commission registration received. Now migrated to dedicated facility with first customers in UK and Chile.
• Two independent clinical performance studies of the IONA® test showed 100% accuracy with 0% false positives.
• European reimbursement policies starting to emerge, firstly in Switzerland, to complement private sector early movers. Other countries expected to follow suit in the near future.
• Management changes – appointment of Barry Hextall as CFO and Dr William Denman as CMO.
Dr Stephen Little, CEO of Premaitha, said:
“The first half of our financial year has seen our first four customers go live in three different countries and start to generate revenues with the IONA® test. We also saw the publication of excellent clinical results and are participating in the world’s first reflex DNA screening project with the prestigious Wolfson Institute. These achievements demonstrate the high quality and clinical relevance we have built into the IONA® test, the first CE-marked NIPT product which we launched in February 2015.
“We continue to enhance the test for laboratory efficiency and include clinically-relevant features such as the recently added fetal sex determination option. We remain on course for our target of 10 contract wins this financial year, despite the unpredictable timing inherent in such a complex sales process and the distraction of a non-CE marked competitor’s litigation.
“Today’s announcement of a partnership with Thermo Fisher also represents a significant opportunity for Premaitha.”
A group analyst briefing will be held at 9.30am on Monday 14 December 2015 at Instinctif Partners’ offices at 65 Gresham Street, London EC2V 7NQ.
Analysts who wish to participate should contact Instinctif Partners on +44 (0)20 7457 2020 or email premaitha@instinctif.com to register.
For more information, please contact:
Premaitha Health PLC
Dr Stephen Little, Chief Executive Officer
Barry Hextall, Chief Financial Officer
Joanne Cross, Head of Marketing
Tel: +44 (0) 161 667 1053
investors@premaitha.com
Cairn Financial Advisers LLP (NOMAD)
Liam Murray / Avi Robinson
Tel: +44 (0) 20 7148 7900
Panmure Gordon (UK) Limited (Broker)
Robert Naylor (Corporate Finance)
Tel: +44 (0) 20 7886 2714
Maisie Atkinson (Corporate Broking)
Tel: +44 (0) 20 7886 2699
Instinctif Partners
Melanie Toyne Sewell / Jayne Crook / Emma Barlow
Tel: +44 (0) 207 457 2020
premaitha@instinctif.com
Notes to Editors
About Premaitha Health
Premaitha 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 a non-invasive in vitro diagnostic product for prenatal screening, enabling clinical laboratories to offer CE-marked NIPT in-house for the first time.
The IONA® test estimates the risk of a fetus having Down’s syndrome or other serious genetic diseases. It 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. The Company also has a registered clinical laboratory in Manchester providing an NIPT screening service directly to healthcare professionals and to support their laboratory customers. Premaitha’s strategy is to accelerate the broad dissemination of NIPT tests to ensure that their benefits are available to pregnant women everywhere.
Premaitha is listed on the London Stock Exchange (AIM: NIPT) and is ISO 13485:2003 certified. 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
Please click here to view the full Interim Financial Report http://www.premaitha.com/investors/key-documents/financial-reports
