Intelligent Bio Solutions Inc. (INBS) on Q2 2022 Results - Earnings Call Transcript
Operator Greetings, and welcome to the GBS Inc. Second Quarter 2022 Earnings Conference Call. Currently, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded.It is now my pleasure to introduce your host, Tim McCarthy of LifeSci Advisors, Investor Relations for GBS Inc. Thank you. You may begin.Tim McCarthy Thank you, operator, and good afternoon. Joining us today from the company are Dr. Steven Boyages, Interim CEO and Chairman of the Board; and Spiro Sakiris, Chief Financial Officer.A press release announcing the results and the update was issued this afternoon and is available now on the GBS website. If you haven’t received this news release or if you’d like to be added to the Company’s distribution list, please send an email to Investor.Relations@gbs.inc.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 of1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties.Forward-looking statements on this call include, without limitation, GBS 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 Inc. 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 Inc. has attempted to identify forward-looking statements by terminology, including believes, estimates, anticipates, expects, plans, projects, intents, 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 and involve known and unknown risks, uncertainties and other factors, included in the Company’s public filings, filed with the Securities and Exchange Commission.Any forward-looking statements contained in this 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 circumstances occurring after this 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 or loss from operations or any other measure in determining operating performance. EBITDA is normally calculated by adding back income tax, depreciation and amortization to net income loss.I would now like to turn the floor over to Dr. Steven Boyages, interim CEO of GBS, Inc. Steven, please go ahead.Steven Boyages Thank you, Tim. Good afternoon and thank you for joining us on our quarterly business and financial call today. We issued our second financial quarter 2022 preliminary financial and operating results, after the close of the market today. And I hope you have been able to look at them briefly.On today’s call, I would like to highlight the key developments that GBS team has made this quarter, highlighting specifically our clinical advancements, as well as development in the build-out of our high key manufacturing facility. I will then turn the call over to Spiro for a detail review of our financials, including our preliminary second quarter results and our forecasted cash burn.As GBS discussed in November, we prioritized the product development and manufacturing aspects growth. As we remain focused on advancing our diagnostics platform around the biosensor technology and grow our lead asset to saliva based glucose testing.Moving on to a quick business overview. GBS remains focused on developing and commercializing, innovating new biosensors, the point of care model and diagnostic tests. Our proprietary technologists incorporates saliva-based testing approaches with accuracy and ease of use not available on the market today.As we build our portfolio validated evidence, we intend to demonstrate accuracy similar to other food-based methods, such as serum, blood or urine. To simply put, we believe on offering patients an affordable, convenient and disposable testing option for people with diabetes, we can increased compliance and frequency of testing to drive better outcomes for our patients.We want to reiterate, we have prioritized the development of our flagship product, the saliva glucose biosensor, towards that commercialization goal, and are actively working with our licensor toward regulatory approval in both North America and Asia.Now let’s review this quarter’s key highlights, where we made significant advancements. Firstly, in December GBS announced that its licenseor, Lifescience Biosensor Diagnostics, LSBD had filed an application with the U.S. Food and Drug Administration, FDA for breakthrough device designation. Based on feedback from the FDA to LSBD further data generation would be advisable in order to advance this submission. The team is working towards this goal.Secondly, the team has submitted that clinical trial protocol or institutional review board approval to the Mills Peninsula Medical Center in California, which will be responsible for executing this initial clinical trial enrolling 40 subjects.The objectives of this key study are to explore the relationship between salivary glucose and plasma glucose, as well as the time course data between the two testing modalities, using sophisticated glucose times testing in 40 subjects.This will generate time course data to determine salivary glucose characteristics. This is expected to lead to the development of the algorithm between plasma and salivary glucose. It is anticipated that the first stage of this clinical plan to be completed by July 2022.Turning to our manufacturing advancements, following the recent grant of $4.7 million by the Australian Federal Government to fund the build-up of a high-tech biosensor manufacturing facility, GBS has begun sourcing required equipment.This sourcing has the dual purpose of immediately utilizing the equipment in the interest of efficiency to progress development at the biosensor and at the same time commissions equipment and preparation facility. Initial batch of equipment is expected to be ordered in April and finalized in June 2022.This non-dilutive capital is incredibly important for this next phase of manufacturing development in which DBS can accelerate product development through the purchase of several important technical machinery and equipment. Discussions are underway between the University of Newcastle and GBS Inc. for the location, build out and commissioning of the new high-tech manufacturing facility.To the Australian Government’s announcement of a medical research commercialization initiative, GBS is in the process of evaluating and preparing expressions of interest towards further Australian Government Funding as we believe the GBS firmly fits into the objectives of this initiative.The initiative will focus on early stage translation and commercialization support, which funds support for early stage medical research and innovation projects with commercial potential. This Medical Research Future Fund will have available to it approximately US$225 million of project funding over the next 10-years for companies that meet the outlined criteria.Now before turning over the quarter, our CFO Spiro Sakiris will discuss the financial second year financial quarter results. I feel it is important to briefly mention the GBS by the small and micro capital sector overall that are experiences volatile equity markets of life. And while investors recite valuations and they needed for capital on an ongoing basis, we remain engaged and committed to driving returns for our stakeholders.Finally, we would like to thank you for your support and look forward to sharing our successes as we see. With that I would like now turn the call over to our CFO, Spiro Sakiris for more detail review of our second quarter financials. Spiro.Spiro Sakiris Thanks, Steven. I will provide a brief overview of GBS’ second quarter financial results. For the quarter ended December 31, 2021, the Company had a preliminary net loss of 3.46 million or $0.23 per share, compared with a net loss of 1.9 million or again $0.23 per share in the same period last year. This is predominantly due to the acceleration of development and commercialization expenditures, which includes the expensing of 2.6 million of prepaid R&D contributions, which had been funded in the previous year.Government support income was 177,791 to the three-months ended December 31, 2021, a decrease of 55,427 for the same period ending 2020. The nature of government support income is in the form of research and development tax offset payment and Australian Government MMI grants for the 4.7 million. The revenue for these grants is recognized as qualifying expenditure as the expenditure is incurred.As at December 31, 2021, the Company’s cash, cash equivalents and marketable securities totaled approximately 11.19 million, compared to approximately 12.57 million on June 30, 2021. As of December 31, 2021, the company had 14.88 million shares outstanding.Despite equity capital market conditions of light, the company continues to be favorably positioned financially and has multiple funding resources and strategies with over 10 million in the bank. Management continued fiscal responsibility and control cash burn provides a calculated runway for the Company and we are confident that the markets will recognize this value.GBS is of the view that based on the current operating plan and financial resources, its cash, cash equivalents and marketable securities as of December 31, 2021, will be sufficient to cover expenses and capital requirements into the first half of 2023.With that overview of our financials, I will now turn the call back to the operator to open the line for questions. Operator, please open the floor to questions.Question-and-Answer Session Operator Thank you. Ladies and gentlemen at this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from John Vandermosten with Zacks Small Capital Research. Please proceed.John Vandermosten Thank you and good morning Steve and Sapiro. Thanks for the quick rundown on progress on all the fronts and a few other items I wanted to follow-up on are just the partner identification for the Chinese markets, I know that you are making progress there and wondered if you have seen any other progress since our last update.Steven Boyages Yes, I will start up and then hand across to. Spiro you can answer that too.Spiro Sakiris So basically the list as we have identified before, there is a short list discussions, commencing as we identified before that we are not reposition at the report and conclusive as stages are.John Vandermosten Okay, very good. And then on the COVID side, I know you are working with Wyss Institute and we are progressing some validation efforts there. Any update on how that is coming along?Spiro Sakiris No updates yet. John, we understand that the progress is excellent as we announced previously to the market. We are expecting further announcements within the next quarter, but at this stage, No.John Vandermosten Okay, very good. And you did give us an update on the next step for the glucose sensor the trial, 40% trial. I guess is that what - after you complete that, I think you provided a date of July 2022. I guess that is when the study will end and then results will come out shortly after that. And then after you have results, I guess, will you go into submitting a package to the FDA or what should we expect following the completion of that?Steven Boyages Yes John and that is our expectation. We are very excited about those studies. They are quite detailed studies and they are about setting up a gold standard for saliva glucose. And we have been talking with our research partners in the U.S. and in both on the east side and the west side, West Coast.And we are looking at what we call glucose tolerance testing, that is where we of the glucose loads of individuals. And we measure, both in plasma, capillary blood, venous blood and in saliva, the glucose parameters.So, we can set up an effective gold standard and we are using mass spectromety to actually be able to validate those measurements at this point in time. So, as you indicated, we are expecting results by July, 2022 and then you are absolutely correct.Then we will be looking at further submissions. This is the first stage of about a three part clinical validation. So, there are some ongoing studies beyond that, but they will lay support to our future submissions.John Vandermosten Okay. Very good. And then, looking at the study, what is the magnitude of difference that would be acceptable to the FDA between the saliva and plasma glucose? What would they be looking for in terms of numbers there?Steven Boyages Look, it is not going to be a magnitude of difference. It is really going to be on that coefficient variation. The gold standard for the market is, we wanted to have plus or minus 15%. So, when we measure - whatever we measure in any body fluid, we want to be confident that that measurement is reproducible.So, we know that saliva the glucose measurement will be a couple of log orders lower, but as long as we can differentiate between low, normal or high then the absolute magnitude of difference between blood and saliva won’t be an issue. It is really that coefficient variation.John Vandermosten Exactly. Right. Thank you for correcting me on that. Okay, great. And then, we have seen the COVID test number spike with the recent Omicron and then they are kind of rolling over. Do you think we are going to continue to see a lot of variation in the number of tests out there? Any thoughts on kind of how that trend might continue for?Steven Boyages Look, I think as much as of us are suffering from fatigue from COVID, I don’t think it is going to go away rapidly. And I think as we get better understanding of the illness characteristics and the need for understanding, who is immune and who is not immune, who is infected, there is going to be a great need for laboratory testing for both COVID antigen and COVID antibodies. So, we see strong both in this market.John Vandermosten Okay great. I will hop back into and see if there is anyone else who wants to ask question. Thank you.Steven Boyages Thanks John.Operator Our next question comes from Ted Yu with Zach Small Cap Research. Please proceed.Ted Yu Hey, Steven and Spiro, thanks for taking our questions. Just to piggyback off of John’s questions there. You had submitted a pre-submission package in October last year. Wondered, if there is any update on that and whether you received feedback from the FDA.Steven Boyages Spiro, do you want to answer that one?Spiro Sakiris Yeah. So basically it is the pre-submission the waiting for response back from FDA, in relation to their work or their work was quite - quite busy in relation to the COVID so there’s no further progress on that yet.Ted Yu Okay, excellent, thank you. Regarding the manufacturing facility, and we are excited to hear updates on that. It appears from your release that this is maybe going to be working a little closer with University of Newcastle than maybe I had anticipated. Could you give a little color on maybe the extent of this partnership or how - what the role and relationship with University of Newcastle is going to look like with GBS funded a facility on University of Newcastle property?Steven Boyages Spiro you can answer that when you have been laid on that project.Spiro Sakiris Yes, so basically, what we are doing, the first step is, in relation to that, as we mentioned in the announcement, we are looking at getting the first stretch of equipment across which the objective is that we will install that on Newcastle University’s premises. Now, the objective of that will be to expediate the progress of the commercialization and then at the same time, the commissioning that property, the equipment.Now, what happens is once we did that commissioned and that by doing that, we are not delaying time in relation to ultimately getting the factory up and going. So whilst we are sourcing the site, finalizing the site, we are getting that work done on that equipment and getting the tutor unparalleled so we operating it as efficiently as possible. And that is where the University of Newcastle with ongoing development that is utilizing that equipment.Steven Boyages Just add to that, I mean, that is just in case people aren’t aware the innovation and the founders are actually at the University of Newcastle. So co-locating the facility with them will trade a lot of efficiencies and increase the rate of development.Ted Yu Yes, and also I appreciate the additional color into the existing facilities. It sounds like they will run in parallel. And I think that is it for me and I will hop back in queue. Thank you, guys.Steven Boyages Thank you.Spiro Sakiris Thank you.Operator Our next question comes again from the line of John Vandermosten with Zacks Small Cap Research.John Vandermosten Thank you. Next question was just on the income statement. I noticed that the development and regulatory expenses were a little bit below trend in the first quarter, it seemed to be above trend in the second quarter, just want to see if those were timing issues that led to that. And looking forward, we should just maybe average those two amounts for the second half of the year?Steven Boyages Yes, John that is a very good question. The nature of the expenditure is not even if it is very concrete, depending on milestones that have been delivered by the research partners. So let’s talk specifically about the one we have now.So we have included in that, which I referred to in the announcements and was talking, that we do have an expensive list and prepaid R&D of about 2.6 million that R&D was funded in the previous year. We treat it as a pre payment and then as once deriving the benefits to the R&D, put that in the profit and loss.So I would say, look it is difficult to say to average to project forward, because you have already isolating it to six months, and very, very clumpy in nature. I have used that as a staff, but then just to keep an eye on our reporting and possibly update that as we have got updates on the R&D expenditure.John Vandermosten Okay. Because my forecast actually, kind of average the first six months and uses up the same amount in the second half of the year. So it sounds like I should just keep that based on what you are seeing at this point.Steven Boyages Yes. Keep that on for the time being and then like I said, it gets updated as we get further releases. Then you will see with mall centers have been delivered that averages at the [R&D] (Ph) expenditure.John Vandermosten Great, all right thank you Sapiro, take care and thank you Steven for your answers as well.Steven Boyages Thank you.Operator [Operator Instructions] At this time, there are no further questions. I would like to turn the floor back over to Dr. Boyages for closing remarks.Steven Boyages Thank you, operator. As I mentioned in my opening remarks. We are extremely pleased with our performance this quarter. As we build momentum for a new testing platform. We look forward to seeing everyone at our Annual Shareholder Meeting in the coming months. In closing, I want to thank everybody for joining us tonight and have a great evening. Thank you.Operator This concludes today’s conference. You may disconnect your lines at this time. Thank you for your participation.
