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GBS Inc.

Q42021

8/11/2021

speaker
Operator
Conference Call Operator

Greetings and welcome to the GBS Incorporated fourth quarter 2021 earnings conference call. Currently, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Alex Arzeno, Investor Relations for GBS. Thank you. You may begin.

speaker
Alex Arzeno
Investor Relations

Thank you and good afternoon. Joining us today from the company are Harry Simonides, President and CEO, and Spiro Sekiris, Chief Financial Officer. A press release announcing the results and the update was issued this afternoon and is available now on the GBS website. I will now read the company's safe harbor statement. Some of the statements on this conference call are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E, of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act of 1995, which involves risk and uncertainties. Forward-looking statements on this call include, without limitation, GBS's Inc.' 's ability to develop and commercialize its diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although GBS believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, Expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. GBS has attempted to identify forward-looking statements by terminology including believes, estimates, anticipates, expects, plans, projects, intends, potential, may, could, might, will, should, approximately, or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions that involve known and unknown risks, uncertainties, and other factors, including the company's public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in the press release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or occur circumstances occurring after its date or to reflect the occurrence of unanticipated events. During this conference call, the company may refer to EBITDA, a non-GAAP measure. EBITDA is not and should not be considered an alternative to net income loss, income loss from operations, or any other measure for determining operating performance. EBITDA is normally calculated by adding back income tax, depreciation, amortization to net income loss. I would like to now turn the floor over to Harry, President and CEO of GABS. Harry, please go ahead.

speaker
Harry Simonides
President and CEO

Thank you, Alex. Good afternoon, and thank you for joining us on our quarterly business and financial update call today. We issued our fourth quarter and full year 2021 financial and operating results after the close of market today. And I hope you've been able to review them. GBS is focused on developing and commercializing innovative biosensor for point of care monitoring and diagnostic tests. We leverage proprietary technologies which allow saliva-based testing approaches to be as accurate as other fluid-based methods such as serum, blood, or urine. We believe offering patients a convenient, low-cost, and disposable test strip as small as a piece of gum will allow compliance and frequency of testing to reach new levels in developed economies. GBS's goal is to have our technology readily available to both patients and physicians at an affordable price. that will be comparable to what is on the market today. We have identified 130 additional diagnostic tests. In due time, we anticipate our technology will have broad applications across different diagnostic modalities, enabling diagnostic tests such as clinical chemistry, immunology, tumor markers, allergens, and endocrinology. The BISENSA technology was developed at the University of Newcastle, Australia and was acquired by Life Sciences BISENSA Diagnostic Proprietary Limited. The technology was then licensed to GBS for the Asia Pacific region and has been under continuous development with GBS over the last seven years. The biosensor is a platform technology which uses proprietary organic thin film transistor technology, which is patent protected till the year 2033. Currently, we are advancing two lead product candidates towards commercialization. First, our flagship product candidate is a novel saliva glucose biosensor. and convenient point-of-care tests expected to substitute the invasive finger-pricking blood glucose monitoring for patients living with diabetes. And second, a saliva SARS-CoV-2 antibody test candidate, which will provide real-time quantitative detection for SARS-CoV-2 virus antibodies. With respect to our glucose biosensor technology for patients living with diabetes, we believe our tests will have the ability to make blood-based fingerprint testing obsolete. When you look at patients' preference, as we have done extensively throughout our patient survey, a saliva-based glucose biosensor that is pain-free, non-invasive, simple to use, and convenient is the preferred method when compared to the current blood testing mechanisms available today. Unfortunately, there have been little to no recent advancement around testing for people living with diabetes, and this is where we see the very attractive opportunity. Diabetes is a global epidemic, and the disease is growing rapidly, with markets estimated to exceed 465 million people, and we expect to grow to $700 million by the year 2045. Our commercial license applies to the world's largest diabetes population, the Asia-Pacific region. This is the market that GBS will be addressing to bring an affordable, non-invasive, real-time, point-of-care diagnostic test to people living with diabetes. Rapidly rising rates of diabetes have been seen in the APAC region And according to the latest data, more than 170 million people living with diabetes representing over 36% of the world's total population of people living with diabetes. Given what we believe of the superior analytical characteristics of the biosensor technology and the current development stage, it was important that GBS, with its global license agreement, joined the international effort to combat the COVID-19 pandemic with its first-class technology. In 2020, as the emergence of COVID-19 infections began to skyrocket exponentially, GBS decided to expedite a collaboration with the Wyss Institute of Biologically Inspired Engineering at Harvard University. in order to develop a more accurate and real-time SARS COVID antibody testing to support both the international vaccination efforts and testing. This past quarter, and indeed the year, has been one of both challenges and opportunities, as COVID-19 has become a focal point across the global healthcare industry. and a good part of our daily lives. Today, as we learn more about the Delta variant, we must all recognize that COVID-19 is not going to be eradicated as easily and we must remain vigilant. Recent reports from the World Health Organization and CDC indicate this new strain is more contagious and can allow people already vaccinated to transmit the virus. While these developments are unfortunate on so many levels, it is important that we as a society now understand the importance of COVID testing and how we can implement these tools in our lives so we can better prepare for any future pandemics that arise. At GBS, we are proud to be joining the efforts to enhance healthcare diagnostics by providing convenient and accurate antibody testing as a long-term efficacy of approved vaccinations have yet to be demonstrated clinically. Turning to GBS's fourth quarter and full-year financial results, which our CFO Spiros Sekiris will discuss in greater detail shortly, represented another solid period for our NASDAQ-listed companies, creating awareness across the medical and investment communities. Briefly, I'd just like to highlight a couple of financial points to start. In December 2020, we went public by an initial public offering and raised $21.6 million in gross proceedings and listed on the NASDAQ global stock markets. Proceeds from this financing were to be utilized to obtain regulatory approvals, pipeline advancements, marketing, and establishing a distribution network in addition to working capital. And most recently, GBS was awarded a grant of $4.7 million from the Australian federal government to fund the build-out of a high-tech biocenter manufacturing facility. This recognition goes beyond just the value of the grant. As biosensor platform technology was identified by the Australian government as one of only six national manufacturing priorities under its modern manufacturing strategy, the facility will be solely focused on advancing GBS's products. We continue to be physically responsible and have multiple tools and strategies to extend our cash runway through sub-licensing and collaborations which have been provided as a diverse set of financial opportunities to the company. Now let's review some of our recent key highlights. Our core focus remains on the product development on both our saliva glucose and saliva SARS COVID-2 antibody tests. In February this year, we announced the execution of a sponsored research agreement with John Hopkins Bloomberg School of Public Health to accelerate the development of the saliva collection protocols for the saliva-based diagnostic tests. This collaboration pulls together resources from John Hopkins Environmental Health and Engineering, as well as its School of Public Health, and the lab's saliva biomarkers and infectious disease programs. In February, GBS also announced its collaboration with the Weiss Institute of Biologically Inspired Engineering at Harvard University to develop a COVID-19 antibody test. Subsequently, to integrate the Weiss Institute rapid eat technology with GBS's proprietary transistor sensor technology. Later in the spring, we received approval from Harvard Longwood Campus Institute Review Board to commence the validation study to test clinical samples from the COVID-19 repository. In order to advance these assets into commercialization phase as effectively as possible, Management has preemptively executed certain priorities to ready the company post an approval. In June, GBS completed a global voice of customer survey of people living with diabetes to verify the desirability, discuss the applications in the daily life, and review the product features of Xylodoglucose Biosensor. Key findings were In all markets, 9 out of 10 patients responded positively to our BioSensor platform. 7 out of 10 patients were seriously interested in purchasing the product when it is released. And 3 out of 10 wanted to be placed on a pre-order waiting list ahead of the product release. Finally, while patients in the U.S. indicated the price of a pain-free alternative to current glucose monitoring will pay a role in determining their decision to purchase a new device, patients in China indicated price was not an issue, as long as the product was accurate and reliable. Most recently, we engaged with L.E.K. Consulting, to deliver a short list of suitable commercial partners for distribution in China as we prepare for the initial discussion with potential collaborators in this region. On behalf of GBS's senior management team, I want to express our gratitude to all our employees for their perseverance and dedication to the company in these challenging times. Our continued grit and perseverance can bring a shift to the point-of-care diagnostic industry as affordable saliva-based testing will one day deliver a more accurate and convenient way to conduct accurate testing. GBS's goal is to align our tests to our patients' needs by providing an affordable, non-invasive test at point-of-care in an easy and administrative test strip. we can empower patients to test easily and safely for multiple indications. We have made important advances across the organization in 2021, and we are confident in both our development and commercial approach, as well as our ability to execute on each year ahead. With these insights, I would like to now turn and call over our CFO, Spiro Sekiris, for a more detailed review of the 2021 financials. Spiro?

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