Quarterly Business Update -- December 2022; Sixth Consecutive Quarter of Growth

MELBOURNE, Australia, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE," Company", "GTG"), a global leader in guidance-driven genomics-based tests in health, wellness and serious diseases releases its Quarterly business update for the quarter ended 31 December 2022 (Q2 FY23).

Highlights:

 
 
 --    Qtr 2 Receipts from customers were A$2.4 million, up 
       15% compared to prior quarter and up 32% compared to 
       prior year 
 
 --    YTD Receipts from customers total A$4.45 million up 
       67% on prior year 
 
 --    Revenue of A$2.2 million for the quarter, underpinned 
       by the introduction of new distribution channels in 
       the U.S. 
 
 --    6 consecutive quarters of revenue growth on the prior 
       year for EasyDNA & AffinityDNA 
 
 --    R&D Tax Incentive of A$1.96 million expected Q3 2023 
 
 --    Ten active engagements with U.S. payer groups, with a 
       combined coverage of 42 million lives, including 
       insurers, payers, and Key Opinion Leaders ('KOL's) 
 
 --    Invited to India as guests of MedAchievers to explore 
       GeneType MultiTest launch strategy 
 
 --    Advancing Innovation; Epigenetics and precision 
       oncology collaboration with the University of 
       Melbourne on track 
 

Commenting on the Company's quarterly cash performance, Chief Executive Officer Simon Morriss said:

"The continued momentum in our business is exciting with 6 consecutive quarters of growth where today we have presence in more than 40 countries with more than 50 tests on offer via our global network of partner laboratories.

Looking ahead we remain focussed on securing further growth and revenue uplift for our core brands, GeneType, EasyDNA and AffinityDNA. We see the combination of KOL support, the progress with commercialization plans in Australia and success with our engagement with the key payer groups in the U.S. as important underpinning revenue drivers. We are building a strong presence and support with KOL's as we push to develop our new channels to market. Further, we continue to meet important milestones both from a scientific point of view, but importantly from a commercial perspective.

Importantly, we are continuing to challenge our go to market strategies for all our brands, to continue our revenue growth and improve profitability."

Growing EasyDNA & AffinityDNA

EasyDNA & AffinityDNA's revenue base continues to grow, achieving a sixth consecutive quarter of prior year revenue growth to record A$2.2 million in Q2 FY23, an increase of 15% on the previous quarter. This result reflects the early success of commercial initiatives during the past year, but importantly the growing market presence in the U.S.

Further, EasyDNA has focused on expanding the Direct-to-Consumer channel, with our new EasyDNA website and eCommerece platform the targeted to launch in February 2023. The relaunch of EasyDNA's website will streamline the purchasing process, improve overall customer experience, increase brand awareness, and boost online sales revenue.

GeneType commercial progress

GTG has a core focus on initiatives that will be key to growing the adoption of the company's GeneType platform and securing commercial success for GTG's Business to Business (B2B) strategy. The GeneType platform is underpinned by 27 patents, 18 of which are granted patents, ensuring maximum protection of GeneType sales in key markets.

We have actively engaged with U.S. payer groups to gain reimbursement, this is key to obtaining wider adoption in the U.S. market and accelerating a step change in GTG's revenue growth of GeneType's risk assessment test. The Company is leveraging its' Budget Impact Model $(BIM.AU)$, which demonstrates substantial health economic benefits from the implementation of GeneType, as a core initiative underpinning this B2B strategy. Currently, GTG has more than ten active engagements underway with U.S. payers. These payers have total coverage of 42 million people. GTG is also targeting smaller niche payers such as employer groups, with the goal of developing commercial pilot studies with one or more of these groups during the second half of FY 2023. These commercial pilot studies have the goal of highlighting the benefits of adopting the GeneType test. Executing one or more commercial pilot programs will be a significant milestone and will represent an important value inflection point for the Company.

Critical to the clinical implementation has been the deliberate focus of engaging with Key Opinion Leaders $(KOL)$ in the U.S., who are leaders in their relative field and actively supporting the implementation of risk assessment tests. GTG believes their support will help build partnerships with new medical practices, accessing a wider group of patients. These KOL's include:

   -- Dr Joel Evans - MD, a board certified obstetrician- gynaecologist 
      ('OB/GYN') and international lecturer, is the director of The Center for 
      Functional Medicine in Stamford, CT. He has a special interest in breast 
      cancer, and, is the medical director of the "Keep A Breast Foundation" 
      which brings the latest information on cancer risk assessment and 
      prevention to his patients. 
 
   -- Dr Carolyn Young is an OB/GYN in Rockville, Maryland and is affiliated 
      with multiple hospitals in the area, including Johns Hopkins 
      Medicine-Suburban Hospital and Adventist Healthcare Shady Grove Medical 
      Center. 
 
   -- Dr Lisa Larkin is a board-certified internist practicing internal 
      medicine and women's health since 1991. She is the Founder and CEO of Ms. 
      Medicine, LLC, a national membership organization for women's health 
      clinicians and a concierge women's health primary care network. 

Through increasing sales efforts and general practitioner $(GP)$ partnerships in Australia, with the sales efforts of GTG's Virtual Sales Rep $(VSR)$ and face-to-face engagements, via the MedLab Medical Science Liaison personnel, GTG has established over 90 medical practices in Australia who are actively evaluating the GeneType platform with their patients. Some of these medical practices have initiated the referral of patients on a commercial basis, with the Company expecting revenue growth from these initiatives to continue as more of these practices move to routine implementation of GeneType tests.

In addition, GTG is also continuing to build partnerships with other key users including:

   -- Dr Nicole Yap at the The Australian Breast Care Centre 
 
   -- A/Prof Charles Siles, providing immediate access to more than 1,000 
      referring primary care physicians 
 
   -- Prof Bruce Mann at Royal Women's Hospital for the Melbourne Launch of 
      screening for breast cancer risk 

GTG showcasing the clinical validity and clinical utility of GeneType risk assessment tests

In the past quarter, the Company has published three separate peer-reviewed papers in scientific journals and presented at prestigious medical conferences. These events increase the awareness among medical physicians, validate the benefits of the GeneType tests, and ultimately support the adoption of the GeneType platform.

GTG's Director of Clinical and Scientific Affairs, Dr Erika Spaeth, presented at the prestigious American Society of Clinical Oncology Gastroenterology Cancer Symposium (ASCOGI) in January 2023. Her presentation demonstrated significant improvement in identifying patients at risk of colorectal cancer by expanding the number of Single Nucleotide Polymorphisms (SNPs) genetic markers, a key component in GeneType risk assessment tests for colorectal cancer.

In addition, GTG released several publications showing GeneType as an enabling predictor of breast cancer, ovarian cancer, cardiovascular disease $(CVD)$ and type 2 diabetes.

These publications were:

   -- "Polygenic risk scores for cardiovascular diseases and type 2 diabetes" 
      published in PLOS ONE1 
 
   -- "A combined clinical and genetic model for predicting risk of ovarian 
      cancer" published in the European Journal of Cancer Prevention2 
 
   -- "Integrating Personalized Medicine into Preventative Care through Risk 
      Stratification" published in the Journal of Precision Medicine 3 

Building our GeneType Brand

A number recent of media events have been undertaken to continue to build the brand awareness of geneType. These included a segment on channel 7 News http://youtu.be/21SoDP8PTxg, a Webinar in which GTG's Director of Medical Affairs, Dr Erika Spaeth, interviewed Associate Professor Charles Siles on the utility of geneType Breast Cancer Risk Assessment Test https://www.youtube.com/watch?v=Xmwn-WYFIeE, and an interview with GTG's CEO, Simon Morriss, that aired on Bloomberg US https://youtu.be/YPBOPf8tPDE.

Financial and cashflow overview

At the end of December 2022, GTG had A$5.0 million in cash and cash equivalents. Cash outflows used in operating activities were A$2.8 million. Cash receipts from customers for the quarter were A$2.4 million, primarily driven by EasyDNA and AffinityDNA product sales. At the end of December 2022, GTG had 1.86 quarters of cash. The December cash balance does not include receipt of the R&D Tax Incentive for the 2022 financial year which is expected to result in a refund of A$1.96 million. Adding this to the December cash balance, the company's cash runway extends to 2.5 quarters.

Payments to related parties of the entity and their associates for the quarter were $68k as disclosed in Item 6.1 of the Appendix 4C.

To support the Company's continued investment in its core brands, GeneType, EasyDNA and AffinityDNA, and to secure further revenue growth, the Company expects to raise further equity. The Board are currently in discussions with equity advisors and will provide a further update to the market as appropriate.

Authorized for release by the Board of Genetic Technologies Limited

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