Co-Diagnostics, Inc. (CODX) on Q1 2021 Results - Earnings Call Transcript
Operator: Good day, and welcome to the Co-Diagnostics First Quarter 2021 Earnings Call. All participants will be in listen-only mode. After today’s presentation, there will be an opportunity to ask questions. 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.
Andrew Benson: 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 to call with management's prepared remarks and then open up the call to questions to 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 may constitute forward-looking statements. Any statement about company expectations, beliefs, plans, objectives, assumptions of future events or performance are forward-looking statements.
Dwight Egan: Thank you, Andrew, and thank you all for joining us. On this call, we will provide an overview of our results for the quarter and updates on key financial performance metrics and the 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. Cells of our tests continued 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 Logix Smart COVID-19 tests 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.
Brian Brown: Thanks, Dwight. 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 Logix 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 improve 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 dollars 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 31, 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 $0.26 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 Logix 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 31, 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 platform. We anticipate diluted earnings per share between $0.19 and $0.23 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.
Dwight Egan: 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-Diagnostics growing portfolio of molecular diagnostics products and we will continue to leverage our CoPrimer 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 and 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 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 build on the CoPrimer platform, and we anticipate being able to provide technology and development updates for this vertical soon. The companies regard this 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 test, which continued 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 $1 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, our malaria test that uses our novel CoPrimer technology to differentiate between species of the parasite that might be resistant to certain treatments, and STI panel for gonorrhoea and chlamydia and more. Aside from these products, our vector control verticals 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 test to this largely unaddressed customer base. Our revenue from the segment is entirely domestic. And since our Vector Smart products are not used for human diagnosis, we are able to offer these tests throughout the country without and EUA 510(k) 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 in the first quarter of 2021 failed to reflect the seriousness and danger of COVID-19. As a result, CoSara 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 CoSara 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 CoSara 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. However, 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 healthcare market for other eventual products. The joint ventures dedication to the Indian people in providing quality real time PCR tests has expanded territory to about 160 current customers, which includes equipment installation and 73 laboratories, over 40 of which did not have access to PCR technology prior to become CoSara 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 Co-Diagnostics, 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 mark 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 remained 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.
Operator: Our first question comes from Yi Chen with H.C. Wainwright. Please go ahead.
Yi Chen: Thank you for taking my questions and congratulations for a solid quarter. My first question is, is CoSara operation in anyway negatively impacted by the pandemic in India?
Dwight Egan: Yes, Yi thank you for that question with respect to CoSara. CoSara is was - our laboratory in CoSara an Indian and only India was the very first laboratory in the countries 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 the…
Yi Chen: I'm actually asking what - I'm not actually asking for the output, I'm asking for whether the operation itself, whether the personnel’s are affected by the COVID-19?
Dwight Egan: Okay, good question. The operation is operating just fine. Yi, 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.
Yi Chen: And the second question is, do you expect to maintain the gross margin demonstrated in the first quarter going forward?
Brian Brown: Yes Yi, 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.
Operator: Our next question comes from Jason McCarthy with Maxim Group. Please go ahead.
Unidentified Analyst: 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 of the U.S. similar to the CoSara joint venture?
Dwight Egan: Thank you for the question, Jason. Our international business is very strong. And we anticipated to you know, 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 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 moves 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 reg, initial COVID test, but our COVID Version 2 that has 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 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 CoSara. We did the CoSara joint ventures several years ago, because we identified India as being 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 of the things Jason, we're talking about, what we are providing, and things like COVID testing, and hep B and hep C and such within the regular complex laboratory setting and 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 CoPrimers and what is so unique about that technology. But it's important to realize that with our new forthcoming Eikon 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 Eikon 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, 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 Eikon platform is going to be.
Operator: Our next question comes from Theodore O'Neill with Litchfield Hills Research. Please go ahead.
Theodore O'Neill: Thank you, and congratulations on the good quarter. Dwight, I was wondering so this Eikon testing platform is this basically a lab in a box that I'm going to have at home?
Dwight Egan: I think that's not a bad way to characterize it. It's a it's a very small device, you know, think of it as being about 4.5, 5.5 inch square. This was featured not too long ago on NBC television on today's 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 Eikon device and showed us a quick demonstration of how it would be used and how simple it is to use. So I mean, the important thing about 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 let the results 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 known internationally for their ability to do rapid PCR, which as I mentioned, they've done for other companies. That gives you an idea - 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 pipe. 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.
Theodore O'Neill: You've got a lot of cash on the balance sheet now, is there any thought about giving away the stock is about buying shares back?
Dwight Egan: 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 Eikon product. We're all about creating value for our shareholder base, and 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 Eikon product with associated test menu. And we think that's going to catapult us into an 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, and but it's going to be a big test to take it out to the world, both domestically and internationally. So right now, we're accumulating cash. We plan on continuing to accumulate cash and get this product ready to go.
Operator: This concludes the question and answer session. I would like to turn the conference back over to Dwight Egan for any closing remarks.
Dwight Egan: Thank you. Since the beginning of the pandemic, it's been difficult to accurately predict exactly how much impact COVID-19 will have on Co-Diagnostics in the long-term. For us, the disease provided a gateway to introduce our CoPrimer 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 Eikon platform. Thank 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.
Operator: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
