YGEN.L Regulatory News (YGEN)

Yourgene Health plc

("Yourgene" or the "Company")

AGM statement

Manchester, UK - 22 September 2020: Yourgene (AIM: YGEN), the international molecular diagnostics group, will be holding its Annual General Meeting (AGM) at 4:00pm today.

At the meeting, Adam Reynolds, Non-executive Chairman, will make the following statement:

I am delighted to welcome longstanding and recent shareholders to our AGM. Whilst the pandemic has presented serious challenges to individuals, communities and businesses worldwide, these are nevertheless encouraging times for Yourgene investors given the exciting opportunities we are cultivating for delivering continued growth, not only through the recently enlarged core business but also through deploying our capabilities to the global fight against COVID-19.

Our full year results for the year ended 31 March 2020 demonstrated strong organic growth across the Group and underlined the benefits of two strategic acquisitions in the UK and France. Notably, the Group also recorded its first profits at an adjusted EBITDA level. The new financial year started with much of the world in lockdown, however our core business has proved resilient and, along with the launch of our Clarigene® SARS CoV-2 test and with the recent acquisition of Coastal Genomics, we have created a stronger foundation for the business in the coming years.

Following the CE mark and subsequent launch earlier this month of IONA® Nx NIPT workflow, our new NIPT format developed for the Illumina platform, we are very pleased with the early progress made to transition key customer accounts to IONA® Nx with everything proceeding to plan. Our French subsidiary, AGX-DPNI S.A.S. (acquired in March 2020) is on track to hit its first performance milestone and has already transitioned two key customers labs to IONA® Nx. The remaining target customers are all scheduled for transition over the coming weeks. Additionally, the targeted roll-out of IONA® Nx in new territories is progressing with regulatory submissions underway and negotiations with new customers advancing in the EU, Japan and Australia.

This time last year we announced the establishment of our US-based operations and our first customer revenues. Despite the impact of COVID-19 on UK-US trading, we have not stood still and we have a number of initiatives which are now starting to bear fruit. Yesterday we announced a new US distributor agreement with Immuno-Biological Laboratories Inc, which covers several of our PCR tests, but particularly our DPYD assay for Research Use Only at first, a product which is already selling well in Europe and has been approved in Australia. Pleasingly, we already have a healthy pipeline of material opportunities based around the Yourgene Flex™ software platform and the recently acquired Coastal Genomics business: we will update shareholders as these opportunities crystallise and which we expect to contribute revenue from the second half of the current financial year onwards.

Last month we announced that our Clarigene® SARS-CoV-2 in vitro diagnostic kit received CE-IVD marking and we are close to submitting the assay to regulatory authorities in a number of other regions. We have also expanded our testing capacity for our own high throughput COVID-19 service lab in Manchester which utilises Clarigene®. The expansion and custom refit of our Manchester laboratories will see us routinely processing c10,000 tests per month from early October and we are utilising some of the recent fundraising proceeds to further materially expand capacity in the coming quarter. As well as existing arrangements already announced, we are in advanced stages of negotiations with a number of public and private partners who are seeking a dependable UK testing provider to offer a quick and reliable confirmation of COVID-19 infection. We therefore believe our growing pipeline will deliver significant capacity utilisation between now and March 2021.

Alongside the above initiatives, we are progressing our strategy to become a full lifecycle partner in the molecular diagnostics industry and we are expanding our genomic research services offering to pharmaceutical and other research organisations from our Manchester and Taipei laboratories, with further international coverage under review.

Overall, we have a strong pipeline of opportunities and remain confident about our prospects for future growth in our core business whilst also benefitting from near-term accretive revenues from our COVID-19 solutions.

The Company's CEO, Lyn Rees, will provide shareholders with a short presentation via the Investor Meet Company platform after the formal business of the AGM concludes and there will be an opportunity for investors to ask questions. Investors can sign up to Investor Meet Company for free and register for the Yourgene Health meeting via: https://www.investormeetcompany.com/yourgene-health-plc/register-investor

The presentation recording and responses to investor questions will be made available on the Investor Meet Company platform at the earliest opportunity.

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

About Yourgene Health plc

Yourgene is an international molecular diagnostics group which develops and commercialises genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science. 

Yourgene develops and commercialises simple and accurate molecular diagnostic solutions, for reproductive health and molecular genetics. The Group's products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, male infertility tests and genetic disease tests. Yourgene's commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia.

Our product development, research service and commercial capabilities extend across the lifecycle of genetic test development including regulatory submissions. Through our technical expertise and partnerships, Yourgene is also extending its genetic testing offering into oncology.

Yourgene is headquartered in Manchester, UK with offices in Taipei, Singapore, the US and Canada and is listed on the London Stock Exchange's AIM market under the ticker "YGEN". For more information, visit www.yourgene-health.com and follow us on twitter @Yourgene_Health.

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.