29 December 2017 – Half Year Results

Premaitha Health PLC
(“Premaitha”, the “Company” or the “Group”)

Half year results

Manchester, UK – 29 December 2017: Premaitha Health PLC (AIM: NIPT), a leading molecular diagnostics group with a primary focus on the commercialisation of its non-invasive prenatal testing (“NIPT”) technology, announces half year results for the six months ended 30 September 2017.

Financial highlights
•    Revenues increased by 87% to £2.7m (H1 2016/17: £1.5m)
•    Test volumes doubled to over 22,000 (H1 2016/17: 11,000)
•    Gross profit up 120% to £1.3m, 48% of revenues (H1 2016/17: £0.6m, 41%)
•    Operating loss increased to £4.7m (H1 2016/17:  £3.5m) due to £1.3m charge to increase litigation provision
•    Recovery efforts continuing for debts owed by Swiss customer, Genoma SA (“Genoma”), including successful application to place Genoma in bankruptcy in May 2017
•    Further $5.0m investment by Thermo Fisher in July 2017 in form of loan facility extension and associated warrants
•    Cash and cash equivalents at 30 September 2017 of £1.6m (not including R&D tax credits of £0.6m) (30 September 2016: £2.7m)
•    Continued focus on achieving positive pre-litigation cashflows by year-end March 2018
•    Litigation funding scenarios under review in light of adverse judgment in November 2017 and potential developments in Q1 2018

Operational highlights
•    Integration of Yourgene Bioscience (“Yourgene”) acquisition completed successfully and synergies already being realised
•    Significant commercial progress:
    o Expansion of customer base and increased market penetration in existing territories including: India; South East Asia; Middle East and Europe
    o Entry into new markets with customers secured in East Asia and South Africa
    o IONA^® test approved for Brazilian Good Manufacturing Practice
• Product development roadmap delivering enhancements and range expansion:
    o IONA^® test validated on Thermo Fisher’s Ion S5 range of instruments
    o Launched Sage™ remote analysis prenatal screening solution
• Patent litigation continues to create significant headwinds:
    o Further UK patent infringement claim filed by Illumina in September 2017, counter-application by Premaitha for abuse of legal process to be heard in March 2018
    o Post period-end received adverse UK first instance judgment in relation to ongoing dispute with Illumina, appeal in preparation
    o Active engagement continues with EU Competition Commission for anti-trust defence

Dr Stephen Little, CEO of Premaitha, said: “We continue to make excellent commercial progress, with revenues up 87% and test volumes doubling. In the last 6 months, the Group has made significant strides in expanding the business and de-risking its intellectual property position through international expansion. Today, less than 20% of the Group’s revenues are impacted by the UK judgment.  Recent laboratory installations and public policy implementations will drive further growth in 2018 and will further reduce the percentage of our revenues from the UK as our share of the very substantial global NIPT market continues to grow – a market which is forecast to exceed $1 billion by 2021.

“We were very disappointed by the first instance judgment in the UK in relation to the Illumina NIPT patent claims, for which we are preparing a robust appeal ahead of the next hearing in late January 2018.  The potential scenarios remain complex and we are reviewing how best to achieve a de-risked IP landscape for investors and customers, with appropriate working capital in place to realise the significant global potential for the Group in 2018 and beyond.

“The Group remains focused on product development and international expansion. We have built a very strong network of distributors and customers in the NIPT space from which we expect to see substantial growth as awareness of the benefits of NIPT continues to grow. In addition, we are accelerating efforts to leverage Premaitha’s scientific expertise into other applications of our molecular diagnostics technology and look forward to announcing exciting developments in due course.”
 
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

For more information, please contact:   
 
Premaitha Health PLC
Dr Stephen Little, Chief Executive Officer
Barry Hextall, Chief Financial Officer
Joanne Cross, Head of Marketing
investors@premaitha.com
Tel: +44 (0)161 667 105
 
Cairn Financial Advisers LLP (NOMAD)
Liam Murray / James Caithie   
Tel: +44 (0)20 7213 0880

finnCap (Broker)
Adrian Hargrave / Scott Mathieson (Corporate Finance)
Andrew Burdis / Abigail Wayne (Corporate Broking)   
Tel: +44 (0)20 7220 0500

Vigo Communications
Ben Simons / Fiona Henson / Antonia Pollock
premaitha@vigocomms.com
Tel: +44 (0)20 7830 9700
 
About Premaitha

Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests. The Group’s primary focus is on non-invasive prenatal tests (NIPT) for pregnant women – an emerging, multi-billion dollar global market.

Premaitha’s IONA^® test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in-house. The IONA^® test is performed on a maternal blood sample – which contains traces of fetal DNA – and estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA^® test can significantly reduce the number of women subjected to unnecessary invasive follow up diagnostic procedures, such as amniocentesis, which are costly, resource intensive and carry a risk of miscarriage.

In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening test that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha’s IONA^® test. Yourgene brings significant benefits to the Group through expanded market access in Asia – the world’s fastest growing NIPT market – as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.

Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. Its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information, please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.

Premaitha Health PLC

(“Premaitha”, the “Company” or the “Group”)

Half year results

Manchester, UK – 29 December 2017: Premaitha Health PLC (AIM: NIPT), a leading molecular diagnostics group with a primary focus on the commercialisation of its non-invasive prenatal testing (“NIPT”) technology, announces half year results for the six months ended 30 September 2017.

Financial highlights

·       Revenues increased by 87% to £2.7m (H1 2016/17: £1.5m)

·       Test volumes doubled to over 22,000 (H1 2016/17: 11,000)

·       Gross profit up 120% to £1.3m, 48% of revenues (H1 2016/17: £0.6m, 41%)

·       Operating loss increased to £4.7m (H1 2016/17: £3.5m) due to £1.3m charge to increase litigation provision

·       Recovery efforts continuing for debts owed by Swiss customer, Genoma SA (“Genoma”), including successful application to place Genoma in bankruptcy in May 2017

·       Further $5.0m investment by Thermo Fisher in July 2017 in form of loan facility extension and associated warrants

·       Cash and cash equivalents at 30 September 2017 of £1.6m (not including R&D tax credits of £0.6m) (30 September 2016: £2.7m)

·       Continued focus on achieving positive pre-litigation cashflows by year-end March 2018

·       Litigation funding scenarios under review in light of adverse judgment in November 2017 and potential developments in Q1 2018

Operational highlights

·       Integration of Yourgene Bioscience (“Yourgene”) acquisition completed successfully and synergies already being realised

·       Significant commercial progress:

o   Expansion of customer base and increased market penetration in existing territories including: India; South East Asia; Middle East and Europe

o   Entry into new markets with customers secured in East Asia and South Africa

o   IONA^® test approved for Brazilian Good Manufacturing Practice

·       Product development roadmap delivering enhancements and range expansion:

o   IONA® test validated on Thermo Fisher’s Ion S5 range of instruments

o   Launched Sage™ remote analysis prenatal screening solution

·       Patent litigation continues to create significant headwinds:

o   Further UK patent infringement claim filed by Illumina in September 2017, counter-application by Premaitha for abuse of legal process to be heard in March 2018

o   Post period-end received adverse UK first instance judgment in relation to ongoing dispute with Illumina, appeal in preparation

o   Active engagement continues with EU Competition Commission for anti-trust defence

Dr Stephen Little, CEO of Premaitha, said: “We continue to make excellent commercial progress, with revenues up 87% and test volumes doubling. In the last 6 months, the Group has made significant strides in expanding the business and de-risking its intellectual property position through international expansion. Today, less than 20% of the Group’s revenues are impacted by the UK judgment.  Recent laboratory installations and public policy implementations will drive further growth in 2018 and will further reduce the percentage of our revenues from the UK as our share of the very substantial global NIPT market continues to grow – a market which is forecast to exceed $1 billion by 2021.

“We were very disappointed by the first instance judgment in the UK in relation to the Illumina NIPT patent claims, for which we are preparing a robust appeal ahead of the next hearing in late January 2018.  The potential scenarios remain complex and we are reviewing how best to achieve a de-risked IP landscape for investors and customers, with appropriate working capital in place to realise the significant global potential for the Group in 2018 and beyond.

“The Group remains focused on product development and international expansion. We have built a very strong network of distributors and customers in the NIPT space from which we expect to see substantial growth as awareness of the benefits of NIPT continues to grow. In addition, we are accelerating efforts to leverage Premaitha’s scientific expertise into other applications of our molecular diagnostics technology and look forward to announcing exciting developments in due course.”

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

About Premaitha

Premaitha is an international molecular diagnostics group which uses the latest advances in DNA analysis technology to develop safer, faster and regulatory approved genetic screening tests. The Group’s primary focus is on non–invasive prenatal tests (NIPT) for pregnant women – an emerging, multi–billion dollar global market.

Premaitha’s IONA® test was launched in 2015 as the first CE-IVD NIPT test in Europe. It enables laboratories and healthcare practitioners to offer a complete CE-marked NIPT system in–house. The IONA® test is performed on a maternal blood sample – which contains traces of fetal DNA – and estimates the risk of a fetus being affected with Down’s syndrome or other genetic conditions.

Unlike existing prenatal screening methods, due to its high level of accuracy, the IONA® test can significantly reduce the number of women subjected to unnecessary invasive follow up diagnostic procedures, such as amniocentesis, which are costly, resource intensive and carry a risk of miscarriage.

In March 2017, Premaitha acquired Yourgene Bioscience, a specialist next generation sequencing and bioinformatics company based in Taiwan, with its own NIPT screening test that operates on the same Thermo Fisher next-generation sequencing platform as Premaitha’s IONA® test. Yourgene brings significant benefits to the Group through expanded market access in Asia – the world’s fastest growing NIPT market – as well as opportunities for cross-selling and the ability to jointly develop expanded test content both within NIPT and beyond.

Premaitha is headquartered in Manchester, England, with Yourgene offices in Taipei and Singapore. Its shares trade on the AIM market of the London Stock Exchange (AIM: NIPT). For further information, please visit www.premaitha.com. Follow us on twitter @PremaithaHealth.

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