Co-Diagnostics, Inc.

Q1 2021 Earnings Conference Call

5/13/2021

spk03: Good day and welcome to the Code Diagnostics first quarter 2021 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your phone. To withdraw the question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Andrew Benson, Head of Investor Relations. Please go ahead.
spk04: Thank you. I'm Andrew Benson, and joining me this afternoon are members of the Co-Diagnostics Management Team, including Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. We will begin the call with management's prepared remarks and then open up the call to questions from our analysts. Before we begin, we would like to inform the listeners that certain statements made by Co-Diagnostics during the course of this call are may constitute forward-looking statements. Any statement about company expectations, beliefs, plans, objectives, assumptions of future events or performance are forward-looking statements. For example, statements concerning 2021 financial and operational guidance, the development, regulatory clearance, commercialization and features of new products, plans and objectives of management and market trends are all forward-looking statements. The company believes these statements are based on reasonable assumptions. However, these statements are not guarantees of performance and involve known and unknown risks and uncertainties that may cause the actual results to be materially different from any future result expressed or implied by such statements. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in code agnostics filings with the SEC. Co-diagnostics assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events. In addition, the company will discuss certain non-GAAP financial measures during today's call. These non-GAAP financial measures should not be considered a replacement for and should be read together with GAAP results. We refer you to the company's earnings release out shortly before this call, which contains reconciliation to the non-GAAP financial measures presented to their most comparable GAAP results. At this time, I would like to turn the call over to Co-Diagnostics Chief Executive Officer Dwight Egan. Dwight?
spk01: Thank you, Andrew, and thank you all for joining us. On this call, we will provide an overview of our results for the quarter, updates on key financial performance metrics, and a discussion of progress and future strategy. Then we will take questions from our analysts. We are very enthused about the performance of Co-Diagnostics during the first quarter, the positive impact we've been able to have in various regions, and the value we've been able to provide to our shareholders. We would like to thank our employees for their dedication and actions that delivered outstanding results for the quarter. We are also excited about the continued progress the company has made so far in Q2. Sales of our tests continue to be strong in both domestic and international markets. And overall, sales momentum is continuing to be consistent with prior quarters since the pandemic began. As expected, demand for our logic smart COVID-19 test continued to drive sales, and we anticipate demand for our portfolio of products to continue as we remain well positioned to be a leading global molecular diagnostic company. As we forecast during our first quarter call, we expected the revenue mix to trend more toward the international markets as 2021 progressed. The Q1 domestic international revenue mix was essentially equivalent to prior quarters. And as we predicted in our last call, we are seeing some trending towards international sales in Q2. But as stated earlier, overall sales momentum has remained stable. The company's ability to maintain consistent sales, even as vaccination in the U.S. moves along, is the result of several factors, including our more durable business model, comprising a large number of distributors and customers in over 50 foreign markets and a broad-based network of CLIA lab customers in the U.S. The general sentiment in the U.S. is relief as vaccination rates rise. But meanwhile, the world as a whole is experiencing its highest level of infections since the pandemic began, seeing surges in cases and deaths in some countries. This means that new mutations, variants, and strains are evolving that may compromise the worldwide situation. Keep in mind that vaccination in the United States has just crossed through the one-third of the country being fully vaccinated. But on a worldwide basis, that equals less than one and a half percent of the Earth's population. Worldwide, only about 4% of the population is vaccinated. India is at 2 to 3%, and many countries have no material access to vaccines. That is why we have always agreed with Dr. Michael Osterholm, a member of the President's COVID-19 Task Force, who said, we're not going to be vaccinating our way out of this to 8 plus billion people in the world right now. According to the New York Times yesterday, in the U.S., more than 600 people die from COVID each day on average. India's death toll has been horrific. Cases have been rising in Cambodia, Malaysia, Thailand, and Brazil, and much of South America are struggling too. All of these serve as reminders that the world remains vulnerable to new waves. Suffice it to say that the worldwide incidence of COVID-19 infection is currently more prevalent than at any other time during the pandemic. In the United States, a great deal of political and media attention has been directed to the status of vaccinations in the country. But notwithstanding the great efforts to curtail COVID-19 through mass vaccination, the level of infection in the U.S. is still on par with what we were experiencing at the beginning of last summer, which as listeners may recall, was deemed to be a very serious situation in every region of the country. Moreover, as previously mentioned, worldwide we are experiencing more COVID infections than we have ever had before. In other words, the political and media focus on vaccination progress in the United States is masking the true prevalence of COVID-19 cases around the world and to some extent in the United States as well. So, to be clear, let me reiterate, sales remain strong and our domestic and international distribution model is proving to be a durable and diverse business model. These conditions are providing the cash flow for co-diagnostics to increase the number of markets we serve and to more fully develop the capabilities of our powerful and unique intellectual property, which we are about to leverage in significant and far-reaching ways over the next several quarters and in the years to come. Turning to normalization of society, we believe that many organizations will develop testing protocols to promote the safety of their employees and customers as normalization is attempted in countries where vaccination is more prevalent. Restaurants, for example, will want to inform patrons that the staff is tested on a regular basis so the transmission resulting from close contact with a server and diner is minimized. In a recent survey, two-thirds of participants said they would rather quit than return to the workplace, with more than half citing COVID as the primary reason. Businesses want to provide a COVID-safe work environment for employees and also desire to avoid potential legal liability for negligence claims that may obtain If prudent, regular testing protocols are ignored and employees, customers, or their families get sick and possibly die from COVID exposure while at work. Obviously, airlines, cruise ships, theme parks, and entertainment venues are also concerned about ensuring COVID-safe conditions for their employees and customers. Over the last 16 months since we first engineered a COVID-19 test, doing our part to supply test kits around the world has been our primary concern. we have contributed in important ways to the ongoing development of several new innovations for mass scale testing, as well as point of care and at-home applications that are in wide use around the world. For example, in conjunction with some of our capable partners, such as Clinical Reference Laboratory, one of the largest privately held clinical testing laboratories in the U.S., new PCR science and technology pioneered by the company and CRL, is enabling and expanding the applications and accessibility of PCR tests, including non-invasive and highly accurate saliva PCR tests for at-home collection. In November, CRL announced that it is selling its CRL rapid response saliva-based COVID-19 RT-PCR test directly to consumers. And in February of this year, CRL and Walgreens announced that the FDA-authorized CRL rapid response COVID-19 saliva test based on CoDiagnostics CoPrimer technology, is now available through Walgreens FindCare, a digital health platform available on the Walgreens app and Walgreens.com, offering consumers the convenience of self-collecting the test right in their own homes without supervision. The CRL announcement states that the test uses CoPrimer probes and primers developed by CoDiagnostics with high degrees of sensitivity and specificity, and a simple saliva collection device that can be administered in virtually any setting with results in typically 24 hours that are delivered via a secure online computer or mobile device platform. While we observe the daily infection and death counts around the world, we are also, of course, able to monitor the daily influx of demand for our tests, which now includes several different variations of our COVID assays and several different modes of sample collection and instrumentation. The strong level of orders has not abated, and we believe the expected shift of geographic emphasis trending towards our international clients reflects the lack of vaccination combined with mutations and more pernicious variants or other causes which has resulted in infection and death that is off the rails in some countries such as India and Brazil. Just how long the virus continues to run somewhat unchecked in certain areas of the globe, we cannot say. But if our order flow for tests is any indication of the world's predicament, we potentially have a long way to go before the world is COVID safe. In addition, much attention is being placed on normalization in the developed world, including the United States. To be sure, this is still in its infancy, and a significant amount of ongoing and regular testing is likely to be needed in order to create COVID safe work environments, safe schools, safe restaurants, and safe travel and sports venues. Since cold and flu symptoms mirror COVID-19 in the beginning stages, people potentially infected with COVID will need differentiation tests. Our ABC test, for example, has traversed from comprising 1% of fourth quarter testing orders to 5% in Q1 and 14% so far in Q2. We will continue to supply the United States with critical PCR tests as normalization is attempted. And we will also continue to supply a significant number of tests to international customers who are comparatively a long way from COVID safety and far behind the US with respect to vaccinations. India is only at 2% to 3% vaccination levels, and Africa is only at approximately 1%. That's how we see the current environment. I will now turn to a discussion of the ICON testing platform, which we regard as the most important of all our inventions and technologies, and represents the culmination of a Herculean effort on the part of the company as well as other world-renowned experts who are involved in its development. The ICON platform includes several breakthrough technological advancements. The unique chemistry includes co-diagnostics flagship patented co-primer molecules in a lyophilized or freeze-dried reagent that is activated with the company's direct saliva extraction free protocol. Co-primers virtually eliminate cross-reactivity, which enables multiplexed assays with a high level of accuracy. The device is being developed by trailblazing real-time PCR scientists who are renowned for previous PCR-based inventions currently in widespread use around the world by prominent entities, including Roche, BMRU, and the U.S. government. The ICON device is designed to deliver accurate COVID-19 PCR results in less than 30 minutes from patient-direct saliva samples, which do not require extraction. A simple saliva sample is placed into a disposable receptacle, which is then inserted into the compact platform, and a command from a smartphone app starts the test. The smartphone app displays the progress of the test, concluding with a result in about 30 minutes. Additional cloud-based data applications facilitate multiple paths for data distribution to appropriate parties. There are several global trends that motivated CoDiagnostics to create the new platform. First and foremost is a long-term need for molecular testing that is inexpensive, providing fast results in at-home, point-of-care, and remote locations, and just as important, providing results that are accurate. We believe CoDiagnostics ICON platform will meet the critical imperative for at-home and point-of-care locations that need to be addressed during the pandemic. But the ICON aspirations go far beyond COVID. Indeed, It is designed to cover any RNA or DNA pathogen for which the company develops an extraction-free test. As the unstoppable trend in healthcare moves rapidly towards decentralized healthcare locations, including telemedicine, patients will want faster diagnoses than ever before. But the results have to be reliable, and test costs need to be cheap, among other considerations. Taking all of this into account, including the evaluation of early entries hoping to fill this need, CoDiagnostics embarked on the most significant development project in its history to create what we believe will be one of the most significant diagnostic inventions ever engineered for worldwide healthcare. We believe the ramifications of this development will be widespread and pervasive. The company has been vigorously pursuing the ICON development, And we are very aware of competitive offerings seeking to attract the same vast market that we envision. But it is one thing to be first and another thing to be right. CoDiagnostics believes it will be the first company to get it right as we move forward in introducing this brilliant new diagnostic platform. By getting it right, we mean that the ICOM platform will be a very low cost, fully integrated sample to result molecular diagnostic platform designed to meet all three criteria of cheap, fast, and accurate testing, positioning the company to revolutionize molecular testing in a way that could drive co-diagnostic results for many years to come. Traditionally, molecular testing has been a complicated process that involves numerous steps. These steps include extraction, amplification, detection, interpretation, and reporting results. Because of the complexity of the process, sophisticated, often centralized labs with trained personnel using expensive equipment were required to process the test. In contrast, the ICON platform, through a combination of unique and powerful technologies and innovations, will be able to complete all necessary steps in a sample to result mode with almost no human interaction besides spitting into a small container, placing the container into the compact device, and activating the test through a smartphone app. The user can then walk away while the system provides rapid results through the smartphone app. The progress that has been made on the device in a relatively short amount of time is truly staggering, and we anticipate being able to provide updates on the validation and timeline for an application with the FDA for emergency use for the device and the initial test by the next earnings call, as well as our more long-term expectations for additional regulatory clearance and updates on the planned menu for the platform. The key to getting it right is not just for the short term. It is, rather, a long-term strategy that can replace antigen testing because it has all of the primary benefits of an antigen test, low cost, rapid testing, at home, and point of care locations, while also delivering gold standard PCR accuracy as opposed to less accurate antigen testing. Over the next several years, the company expects to conduct sales campaigns to a vast number of potential clients, which include doctors and dentist offices, schools and college campuses, theme parks, airlines, cruise ships, sports venues, restaurants, and others. We believe the overall value proposition of this product has the potential to leapfrog over diagnostic systems currently in place, as well as open up the at-home and point-of-care markets in ways not previously addressed by other less nimble technologies. From the creation of the CoPrimer technology to the engineering of this device, To the human factor studies and focus groups, to the regulatory team, this product development represents a high level of innovation, expertise, and skill sets, which together portend a successful future for the product and the company as a whole. Let me now turn things over to Brian Brown, our CFO, for a review of the key financial metrics and numbers, after which I will conclude with a discussion of future plans outside of what has already been discussed here. Brian? Thanks, Dwight.
spk05: For the quarter, revenue increased to $20.0 million from $1.5 million from the prior year first quarter, primarily due to continued sales of the Logic Smart COVID-19 test. Gross profit increased from $1.1 million in the first quarter of 2020 to $16.8 million in the first quarter of 2021, representing 83.7% of consolidated revenue due to improved product mix as compared to the prior year period. Total operating expenses for the quarter, inclusive of corporate general and administrative, sales and marketing, research and development, and depreciation and amortization, increased $4.3 million from $2.1 million in the first quarter of 2020 to $6.4 million in the first quarter of 2021, primarily driven by overall business activities resulting from our increase in revenue and investment in people, processes, and research and development. Income from operations for the first quarter improved to $10.3 million versus an operating loss in the prior year quarter due to continued strong revenue and gross profit. We achieved income before taxes of $9.9 million compared to a loss of $1.1 million in the prior year comparative quarter. As it relates to income taxes, for the three months ended March 31st, 2021, we recorded income tax expense of $2.0 million, representing a corporate effective tax rate of 20.1%. We achieved net income for the first quarter of $7.9 million, or 26 cents per fully diluted share, compared to a net loss of $1.1 million in the prior year first quarter. which was primarily the result of sales of our logic smart COVID-19 test and resulting margins from those sales offset by increased operating expenses and corporate income taxes. Turning now to our balance sheet and liquidity. Our balance sheet remains strong, allowing us to invest in additional growth opportunities. As of March 31st, 2021, cash, cash equivalents, and marketable securities totaled $60.1 million, an increase of $12.8 million from December 31, 2020. We continue to remain well capitalized with no debt and a strong cash position that has afforded us financial flexibility as we execute our strategic growth plan, which includes investment in our people, processes, and research and development. While we anticipate increased expenses in the second quarter of 2021, we expect our cash balance to continue to grow with no debt. We ended the quarter generating $12.3 million in cash from operations, which represents an improvement of $13.6 million over the prior year quarter's use of operating cash of $1.3 million. This significant increase in cash flow from operations is a testament to the hard work of our people and continued improvement of our processes. Now turning to our guidance for the second quarter of 2021. We anticipate revenue for the quarter totaling between $20.0 million and $22.0 million due to continued strong demand for our products, including expected R&D spending on our new diagnostics platforms, We anticipate diluted earnings per share between 19 and 23 cents based on 30 million shares outstanding and a corporate effective income tax rate of approximately 21.0%. As noted previously, we remain confident in our ongoing profitability and will continue to invest in our growth. We are expanding our international footprint as sales continue to increase abroad. We are building upon our solid business foundation and are in a strong position to continue progressing the company forward. We continue to innovate and leverage our technologies in order to scale and develop other necessary testing, which will allow us to more quickly enter markets while staying focused on our long-term growth strategy. Let me now turn things back over to Dwight.
spk01: Thank you, Brian. Our international footprint continues to grow as sales increase. And we believe that this fact sets co-diagnostics apart for many other participants in the COVID-19 testing space. Our distribution model is diverse with multiple distributors and covering over 50 countries. This means we are not limited to the traffic generated to a few CLIA labs by limited numbers of mass testing sites. Our customer base is worldwide. which as mentioned is currently experiencing high levels of infection along with low levels of vaccination. Also, our PCR test, in contrast to antigen tests, is even more important as the overall value proposition of less sensitive technologies diminishes. We are confident in co-diagnostic growing portfolio of molecular diagnostics products, and we will continue to leverage our co-primer technology platform as we scale up that menu. allowing us to provide more products to more markets even faster. Key among these anticipated products are those within our liquid biopsy vertical, which we anticipate playing a significant role in as part of our growth strategy. We believe that liquid biopsy testing for cancer and cancer treatment monitoring is the future of cancer detection, and the global market as a whole is expected to grow from a little over 1 billion in 2019 to over 5 billion in 2027, as more hospitals, labs, and physicians adopt liquid biopsy as the standard for cancer detection and monitoring. The company is pleased with the results that we have been seeing during the development process for liquid biopsy products built on the CoPrimer platform, and we anticipate being able to provide technology and development updates for this vertical soon. The company regards its expanded international presence to also be a considerable asset, not only for our existing COVID-19 suite of diagnostics, including our ABC and direct saliva tests, which continue to see increasing sales, but for the other products planned and in development. Among these products include diagnostics for hepatitis B and hepatitis C, the combined global market size for which is estimated to grow to nearly 7 billion by 2025. Nearly every single international customer or distributor, along with several domestic customers, have expressed interest in these tests once developed and brought to market. This is similarly true for human papillomavirus and HIV diagnostics with respective global market sizes of over a billion expected in 2025 and 4.9 billion expected in 2023. With growing global markets and ready-made customers for these diagnostics, the value of our growing network of distributors and customers becomes apparent. Other tests currently in development include those for RSV. A malaria test that uses our novel co-primer technology to differentiate between species of the parasite that might be resistant to certain treatments. An STI panel for gonorrhea and chlamydia and more. Aside from these products, our vector control vertical is also showing growth this year with some of our largest orders of tests received to date. There are relatively few diagnostics companies developing and marketing tests to this largely unaddressed customer base. Our revenue from the segment is entirely domestic, and since our VectorSmart products are not used for human diagnosis, we are able to offer these tests throughout the country without an EUA, 510 clearance, or other premarket authorization from the FDA. Additionally, we continue to develop our agricultural vertical, which is supported by strong partnerships and customer relationships with companies like LGC BioSearch and Bayer. With regards to India, we believe that the country's approach to testing in the latter part of 2020 and the first quarter of 2021 failed to reflect the seriousness and danger of COVID-19. As a result, Coursera experienced a monetary loss in both of the last two quarters. The current surge of cases and death that is plaguing the country has brought with it a renewed focus on the importance of accurate, reliable, affordable, high throughput PCR testing exactly the kind of support that Coursera has been well-positioned to provide. As a result, so far this quarter, the joint venture is experiencing a dramatic uptick in the number of tests sold. Even before the pandemic began, India has been poised to become the largest healthcare market on the planet, and its high infectious disease burden has made the country an area of focus for co-diagnostics since even before we established the Coursera Diagnostics Joint Venture. These factors, along with the quality of our joint venture partners and state-of-the-art manufacturing facility, have contributed to making India a critical component of the company's long-term strategy, especially in that region of the world. Keep in mind that it has never been more important to ensure that we are having maximum positive impact in a region where we are able to help as many people as possible, which includes pricing our products at prices that can be supported by the market. Each new customer and distributor with whom we forge a solid relationship during the pandemic enlarges our footprint and will afford even more future opportunities related to the health care market for other eventual products. The joint venture's dedication to the Indian people in providing quality real-time PCR tests has expanded territory to about 160 current customers, which includes equipment installation in 73 laboratories, over 40 of which did not have access to PCR technology prior to becoming COSERA customers. The joint venture is already awaiting the export quota to be assigned for additional tests for the surrounding Asia Pacific, African, and Middle East territories, and is in the process of applying for CE IVD clearance for several of its products. 2020 was truly an inflection point for CoDiagnostics, illustrating our ability to successfully and profitably develop, and bring high-quality diagnostic products to the market. And our upcoming menu that I described previously illustrates that our near and long-term growth plans will allow us to continue to operate profitably in the future, independent of revenue derived from our primary COVID test. We are already seeing our CE marked ABC test for influenza and COVID-19 begin to replace orders for the standalone COVID-19 test, a fact which we believe is indicative of the direction COVID testing is going as the disease becomes endemic in many parts of the world and bodes well for our continued foothold in the respiratory diagnostic space. But it is important not to lose sight of the fact that the need for COVID-19 diagnostics remains strong at the present time and demand for our menu of COVID tests seems to indicate the need for continued testing domestically and especially internationally despite widespread vaccination in the U.S. and certain other more developed countries. That concludes our prepared remarks. Operator, we are ready to begin the question and answer portion of the call.
spk03: We will now begin the question and answer session. To ask a question, you may press star then one on your touch-tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Yi Chen with HC Wainwright. Please go ahead.
spk02: Thank you for taking my questions and congratulations for a solid quarter. My first question is, is COSERA's operation in any way negatively impacted by the pandemic in India?
spk01: Yi, thank you for that question with respect to COSERA. COSERA is, was the, our laboratory in COSERA in India, in Ranoli, India, was the very first laboratory in the country that received permission to make a COVID-19 test. And as you know, during 2020, we experienced a robust testing sales environment throughout India. As I mentioned in my prepared remarks, during the last couple of quarters when India basically dropped the ball on testing, which has resulted in a just devastating environment in that country,
spk02: I'm not actually asking for the output. I'm asking for whether the operation itself, whether the personnel are affected by the COVID-19.
spk01: Okay, good question. The operation is operating just fine. There were periods of time when they had lockdowns that it affected people's ability to come into the lab, but I wouldn't say that Those types of things have hampered the ability of the company or joint venture to meet its demand for tests. Got it, got it.
spk02: And the second question is, do you expect to maintain the gross margin demonstrated in the first quarter going forward?
spk05: Yeah, this is Brian. Yes, we are able to do that. There will be, you know, we do expect some pricing pressures as we move forward a bit in some countries. but we expect to be able to maintain a similar gross margin going forward.
spk02: Got it. Thank you.
spk03: Our next question comes from Jason McCarthy with Maxim Group. Please go ahead.
spk06: Everyone, thanks for taking my question. It's Dave on the line for Jason. So as COVID continues to be a problem in other parts of the world outside of the U.S., like you mentioned in your prepared remarks, do you foresee the export of COVID tests to ex-U.S. territories? Do you foresee that being a major revenue driver in 2021? And my second question is, it's kind of in a similar vein. Are you considering any other potential partnership opportunities outside the U.S. similar to the Coursera joint venture?
spk01: Thank you for the question, Jason. Our international business is very strong, and we anticipate it to continue to grow. As we mentioned on our call last quarter, where we had about a 60-40 U.S. international mix in revenues, we expected that to kind of flip over during 2021 into a 40% domestic, 60% international. And I think it's safe to say we are seeing gradually a move in that direction. The first quarter didn't really show that. It was pretty much as we had expected and experienced in the past. But as we are into the second quarter, we are seeing heavy movement into the international markets along the way of, I think, that 40-60 move that we would be expecting. And I'm You know, very enthused about how we have established a presence in 50 countries with some terrific distributors and the need for our tests, not just our initial COVID test, but our COVID version two that has, you know, more than one target in the genome and also our ABC test and our saliva test. These are all things that are helping to increase our market share overseas. With respect to your second question as it relates to partnerships outside of the country, currently we don't have any relationships outside of the country that we're exploring with respect to a joint venture of the nature that we have with Coursera. We did the Coursera joint venture several years ago because we identified India as being a in our minds, potentially the largest healthcare market in the world, which I think it will become and is becoming. And so that was the reason we established the presence there. You know that a number of other companies, large companies, have also moved into India with manufacturing facilities for all types of pharmaceutical needs. So we believe that there's a very prudent and good move that we made in India. As I mentioned, we've got a pretty strong customer base there now with about 160 customers and about 73 different labs that are now using our products. And now we're ready to give them a much broader menu and to continue to expand that. I think you'll see and what we're looking forward to is more and more laboratories that are taking our tests as time goes forward. And let me just touch on one other thing, Jason. You know, we're talking about, you know, what we are providing in things like COVID testing and Hep B and Hep C and such within the regular you know, complex laboratory setting of conducting PCR. And Jason, I know you're an expert in that field, and you know how that testing is done. And you also know about our co-primers and what is so unique about that technology. But it's important to realize that with our new forthcoming ICON platform, which is going to be a very low-cost device with low-cost tests that do PCR, real-time PCR, in less than 30 minutes, it is a very unique product. Nothing like it in the world today as far as we know. And that is the product that will, in our view, explode from a market standpoint in places like India, where you have as many as 100,000 labs, but many of them we would not call labs from our perspective. But with the availability of something like the ICON product, the amount of labs that can all of a sudden get into the molecular diagnostics business making it so that somebody in a more rural area of India doesn't have to travel to New Delhi or Ahmedabad or Bangalore or someplace to get a test, where they don't have the ability to afford the travel or the cost of the test. I think that's the kind of thing you have to look forward to in terms of how far-reaching and revolutionary our new ICON platform is going to be.
spk06: Great. Thanks for the additional color. Appreciate it.
spk03: Our next question comes from Theodore O'Neill with Litchfield Hills Research. Please go ahead.
spk07: Thank you, and congratulations on the good quarter. Dwight, I was wondering, so this icon testing platform, is this basically a lab in a box that I'm going to have at home?
spk01: I think that's not a bad way to characterize it. It's a very small device. Think of it as being about – four and a half, five and a half inches square. This was featured not too long ago on NBC television on the Today Show where they were showing what kind of things are likely to happen as people go back to work in the United States and what workers could expect to see. And they highlighted our icon device and showed us a quick demonstration of how it would be used and how simple it is to use. So mean the important thing about it is it is a direct saliva or nasal swab sample from the patient which is self-administered and it just goes right into the little box you close the box and then you use a cell phone app to activate the test and start it you can then walk away go back to work go back to your desk go back to whatever you were doing in your home and and let the result come to you in less than 30 minutes. And then, of course, because of the Bluetooth connectivity and connectivity into the cloud, all the other data distribution points into the cloud for public health and other reasons will also be able to be accommodated. What makes this device really unique are a few things, but one of them is the fact that it doesn't require extraction to get to the pathogen. And that's one of the main things that has made it so this has not happened before in our world of molecular diagnostics and why it has required very sophisticated labs to do the process. So when we talk about being able to take it out of that environment because we've gotten rid of extraction, which is very unique and very important, along with lyophilizing our product and then along with developing a device with world-renowned experts who are really trailblazers and and known internationally for their ability to do rapid PCR which as I mentioned they've done for other companies that gives you an idea you know why this is in fact as you characterize a lab in a box but it's a very unique lab in a box I don't think it should be viewed as just another iteration of what's been coming down the pike and of course the fact that it's PCR you know gold standard diagnostics at the end of the day also sets it apart from many of the offerings that are currently out there. And this box will last for many years in the hands of a school or a business or a home, wherever it's placed. This is not a throwaway device. The very inexpensive consumable is used once to put the saliva into, puts in the box, and then you discard that. But the box itself has a long-term utility for the purchaser of it.
spk07: You've got a lot of cash on the balance sheet now. Is there any thought about, given where the stock is, about buying shares back?
spk01: We don't have any thoughts about that right now. We have a lot of cash. We have been able to finance our operation and our R&D, which is significant, especially with respect to the ICON product. You know, we're all about creating value for our shareholder base, and, you know, Anything that we think would enhance that are things that we will consider and take under advisement. But for right now, I think the best way for us to proceed is to keep our heads down and execute on the delivery of this ICON product with associated test menu. And we think that's going to catapult us into a very important place in the universal or international molecular diagnostics territory. This is a, in our minds, truly a revolutionary product. And we're very excited about taking it out. We believe that we have to have cash reserves on hand so that we have all the flexibility we need to launch this worldwide marketing. We have a lot of good distributors, but it's going to be a big task to take it out to the world, both domestically and internationally. So right now, we're accumulating cash. plan on continuing to accumulate cash and get this product ready to go.
spk07: Okay, thanks very much.
spk03: This concludes the question and answer session. I would like to turn the conference back over to Dwight Egan for any closing remarks.
spk01: Thank you. Since the beginning of the pandemic, it's been difficult to accurately predict exactly how much impact COVID-19 has will have on co-diagnostics in the long term. For us, the disease provided a gateway to introduce our co-primer technology platform and suite of high quality PCR products to a far wider audience and to do so substantially faster than would have been imaginable before 2020. And what I hope I've been able to illustrate today is that while we do believe sales directly related to COVID are expected to remain strong in the short and medium term, Our long-term prospects are even more exciting than anything we have experienced to date. This performance will be driven by a substantially increased suite of molecular diagnostics for established customers and distributors in growing domestic and international markets, becoming a key player in the cancer detection space, and most importantly, our entrance into the molecular diagnostics device market with the ICON platform. Thanks to all of you for your interest in our company. our analysts, our shareholders. Thanks for joining us today on our first quarter call. We look forward to talking with you again after the second quarter.
spk03: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-