Good afternoon, ladies and gentlemen, and welcome to the Chembio Diagnostics third quarter 2022 earnings conference call and webcast. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions after the presentation. It is now my pleasure to turn the floor over to your host, Philip Taylor. Sir, the floor is yours. Thank you, operator. Before we begin, let me remind you that the company's remarks made during this conference call today, November 3rd, 2022, may include predictions, estimates, or other information that might be considered forward-looking. These forward-looking statements represent Chembio's current judgment for the future. They are, however, subject to numerous assumptions, risks, and uncertainties, many of which are beyond Chembio's control, including risks and uncertainties described from time to time in Chembio's SEC filings, including those under Risk Factors in its annual report on Form 10-K for the full-year 2021, in its quarterly reports on Form 10-Q for the first quarter and second quarter of 2022, and in subsequent SEC filings. Chembio's results may differ materially from those projected. Chembio undertakes no obligation to publicly revise or update any forward-looking statement made today. I encourage you to review all the company's filings with the SEC concerning these and other matters. With that, I would like to turn the call over to Richard Eberly, President and Chief Executive Officer. Good afternoon, and thank you all for joining us. On today's call, we will review our strategy and our progress scaling growth, improving operational efficiency, and further developing our test portfolio. Larry will then cover the third quarter financial results and provide a detailed update on our Global Competitiveness Program. I will then conclude and open the call for questions. First, I want to provide a brief description on the current priorities that have guided Chembio's strategic pivot over the year. Across the business, profitable growth remains the top objective. In prior quarters, we've announced several initiatives to pursue higher margin business and reduce operating expenses. Not all of these changes are reflected immediately in our financial results, but we expect their impact to be significant in the coming quarters and for the company long term. This year, we've renewed our focus on commercial efforts with our core business in higher value markets. We are now more focused on markets like the U.S. and Europe with higher average selling prices for advanced technologies. These markets also represent healthcare systems that support recurring opportunities versus large one-time government tenders. Additionally, we have expanded our attention toward OTC markets, which provide similar structural benefits. We believe winning business with a regular cadence of frequent smaller orders should allow us to be more efficient with resource planning, supply chain management, and product manufacturing. To further improve our operating efficiency, we have advanced our manufacturing capabilities by leveraging both expanded automation and contract manufacturing in Malaysia. Both solutions, combined with tighter cost controls, are expected to improve our cost of product revenue. Over the medium term, we plan to develop products to broaden our portfolio with differentiated tests that command premium value. Now I will outline our third quarter performance and growth drivers. In the third quarter, we generated total revenue of $11.2 million, including product revenue of $10.8 million. Product revenue grew 16% compared to the prior year period. Product revenue in the third quarter was primarily driven by $4.8 million of sales in the United States. Growth here of 361% compared to the prior year period resulted mainly from increased SCoV-2 Ag Detect Rapid Tests. The self-test version of this test received an EUA, and we have initiated a direct-to-consumer launch to service the OTC market through an e-commerce platform. One of our featured core products, the DPP HIV-Syphilis System, also contributed to sales in the United States. We continue to believe this differentiated test will be a meaningful growth driver upon receipt of a CLIA waiver. Third quarter Latin America sales were $2.3 million. Sales in the region transitioned back to core product sales from COVID sales, as in the prior year period, sales in the region were predominantly for DPP SARS-CoV-2 tests under the large Bio-Manguinhos order. Approximately $2 million of DPP HIV tests were shipped to Bio-Manguinhos in the quarter. In Brazil, we are now focused on marketing our SURE CHECK and HIV self-testing. We continue to believe that is the most promising commercial opportunity supported by our current product portfolio in the region. The healthcare system in Brazil is currently promoting self-testing through the Ministry of Health and awareness campaigns. As a reminder, our product resides on the shelf in three out of the five largest pharmacy chains in Brazil, and we have just launched our e-commerce sales channel. In EMEA and Asia, product revenues in the third quarter grew 43% compared to the prior year to $3.8 million. In Europe, like Brazil, we've heightened distribution efforts of the SURE CHECK HIV Self-Test. We continue to expand shipments to pharmacies across Europe and are now on the shelf in approximately 35,000 pharmacies through the excellent work of our distribution partner in France. Within the U.K., we have launched our direct-to-consumer channel through Amazon and are also in pharmacies in the region. We continue to seek opportunities for expansion of our HIV self-test across applicable markets in Europe. Turning to Africa, this quarter, Chembio completed its tender with Ethiopia for shipments of the HIV 1/2 STAT-PAK Assay. This tender had generated margins below our expectations, and now we are actively pursuing opportunities in markets seeking higher-margin premium solutions. Shifting now to our product and regulatory development pipeline. On the DPP HIV-Syphilis System, we continue our work to address the FDA's request for additional data to achieve a CLIA waiver. Our EUA submission for the DPP SARS-CoV-2 Antigen test continues to be under active review by the FDA, and we are encouraged by the progress made over the past quarters. Late in the third quarter, we announced the company was awarded a $3.2 million contract from the Centers for Disease Control for the development and clinical validation of a rapid point-of-care diagnostic test for syphilis. We are actively developing a syphilis treponemal, nontreponemal that we're branding TnT, leveraging our Dual Path Platform or DPP technology and proprietary DPP Micro Reader II. We expect that the assay will be able to simultaneously and separately detect treponemal and nontreponemal IgM and IgG antibodies. We anticipate that grant revenue will begin in the fourth quarter and will be milestone-based through the regulatory submission. We are excited to expand our portfolio as we endeavor to develop a highly sensitive and specific test where we can anticipate a large need for physicians to quickly and accurately confirm active or prior syphilis infections. We also announced in the third quarter development of a rapid point-of-care diagnostic test for Lyme disease. Lyme disease, caused by the bacterium Borrelia burgdorferi, is transmitted to humans via infected tick bites. Recently, the CDC has updated its guidelines for Lyme test, Lyme disease diagnosis with a new algorithm termed MTTT for modified two-tier testing. These two steps are methods that are labor-intensive, take a long time to run, and require trained professional laboratory personnel. The DPP Lyme IgM/IgG test is designed to be a rapid, multiplex point-of-care test and combine the two-tier testing algorithm into one DPP test cassette utilizing our DPP MicroReader Two for objective test results. We are currently collecting preclinical data for our DPP Lyme test in development. We are hopeful this data will underpin a productive pre-submission meeting with the FDA. Our intention is to complete the pre-submission meetings for both the DPP TnT and the Lyme test to discuss guidance on the structure and requirements for potential pivotal clinical trials. I will now hand the call over to Larry to detail the third quarter financials and provide more details on our operational improvements under the Global Competitiveness Program. Thank you, Rick. For the three months ended September 30, 2022, total revenue was $11.2 million, representing a decline of 7% compared to the prior year period. Product revenue for the third quarter of 2022 was $10.8 million, an increase of 16% compared to the prior year period. Government grant income, license and royalty revenues, and R&D revenues combined for the three months ended September 30, 2022, were $0.4 million compared to $2.7 million the prior year period. The decrease was due to the expiration of previous partner development agreements. Our revenues were in compliance with the quarterly twelve-month rolling minimum total revenue covenant in our credit agreement. Gross product margins during the three months ended September 30, 2022, decreased to $1.2 million compared to $1.5 million in the prior year period. Gross product margin percent was 11% in the quarter, compared to 16% in the third quarter of 2021, impacted by inventory reserves taken in the third quarter of this year. R&D costs decreased by $1.6 million compared to the prior year period to $1.9 million in the third quarter of 2022. Primarily associated with completion of development work from prior partnership development agreements. Selling, general, and administrative expenses decreased by $0.4 million compared to the prior period to $5.6 million in the third quarter of 2022. Net loss in the three months ended September 30, 2022 was $6.7 million or a loss of $0.21 per diluted share compared to a net loss of $6.4 million or a loss of $0.24 per diluted share in the prior year period. On the balance sheet, cash and cash equivalents as of September 30, 2022 totaled $21.1 million. In the third quarter of 2022, the company received net proceeds of approximately $4 million from sales of its common stock as part of its ongoing ATM offering. Net working capital as of September 30, 2022 was $8.7 million. Looking forward, given the substantial nature of the COVID revenues over the past three quarters, as expected, revenue for the year will be first half weighted, and we anticipate challenging sales growth comparisons in the fourth quarter of 2022. Line of sight on orders is a major priority for the final quarter of the year, especially with regards to our large customers and markets. I will now provide an overview of the progress we are making on our Global Competitiveness Program, which we launched in the first quarter of 2022. We continue to prioritize higher margin options within key markets that the organization has identified as prime growth opportunities. We are focusing on both our core products and non-core products that have potential to be profitable. We've identified a global opportunity for a SURE CHECK HIV Self-Test and have allocated resources to support its adoption and distribution. Additionally, we're actively lowering our manufacturing costs through increased adoption of automated manufacturing. We believe automation and labor reductions are required to improve product gross margins and scale unit volumes to support new initiatives. We have executed on a previously communicated strategy to have all our product platforms on an automated line by end of Q3. Bolstering these efforts is our contract with Reszon Diagnostics International to oversee the manufacturing efforts of our HIV 1/2 STAT-PAK Assay at our Chembio Diagnostics Malaysia facility. They are now up and running, and we have initiated production in the facility. In an effort to reduce infrastructure expenses, we conducted an internal audit of our business and external spending to reduce costs. We reduced our organizational headcount from 290 to 211 employees as of September 30th. We expect to continue to increase our automation capabilities and further reduce our headcount and dependency on manual labor. Our path to profitability is clear. As we realign our organization to reduce costs and prioritize efficiency, we believe the company is well-positioned for long-term growth. Keeping our customers at the forefront of our vision, we believe our organization can deliver the initiatives necessary to achieve expansion both domestically and internationally. We look forward to providing more updates and are excited for the future of Chembio. I'll now turn the call back to Rick for concluding remarks. Thank you, Larry. We are pleased with our results from the third quarter of 2022. Over the course of this year, we have improved efficiency, identified and initiated commercialization of promising market opportunities, and reduced our operating infrastructure. We improved visibility on our top line and sales efforts have been refocused on our core products in key growth markets. With advancements in our pipeline supported by a new contract with the CDC, we are excited by the opportunities that lie ahead to propel Chembio to long-term profitable growth. With that, operator, please open up the call for questions. Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Thank you. We have a question from Per Ostlund with Craig-Hallum. Please go ahead. Thank you. Good afternoon, guys. Hey, Per. I'm gonna start out with the Q3 revenue number. Candidly, I was pleasantly surprised here. I had been sort of, you know, while not officially having an estimate, we have talked and you've talked about the second half being lighter than the first half. I kind of assumed that with a couple of contracts being fulfilled earlier in the year that we would see a sequential step down. I was happy to see that number be so strong here in the quarter. Was there anything unusual as far as, you know, a bolus of orders, stocking orders somewhere, that wouldn't have otherwise recur? Or was this simply a function of the growing depth of product and geography that you have at your disposal. Yeah, Per. Thank you for that question, and I'm glad you were happily surprised. You know, as we've talked over the last several quarters, our strategy has really been to diversify the business by region and by product, and become less dependent on large government tenders or large government orders, whether they come from Brazil, as we've experienced over the last year, or global fund countries in Africa. You know, this quarter I think was a good indication that we're getting good, balanced revenue from tremendous growth in the United States from our sales team and the investment we've made in the US. South America, same thing. Our balanced attack in Brazil now is beyond COVID. We're focused on our core products in Brazil. You know, our strategy in Brazil is multifaceted, not dependent upon the government or Ministry of Health or Bio-Manguinhos. We now have a retail strategy where our pharmacy partners are now selling our SURE CHECK HIV Self-Test online on their websites, as well as an e-commerce platform we've set up. That's a retail strategy. Our other strategy in Brazil is now going out to the states and local areas like Rio and São Paulo to work with the state and city governments, where they're putting together programs as well for rapid testing. We're going into the traditional markets in Brazil as well through our distribution partner in Brazil, who calls on hospitals and clinics and so forth throughout the country. I would say it's a balanced approach. Strategically, we continue to maintain excellent relationships with the Ministry of Health, as well as Bio-Manguinhos, in Brazil. We're working on with them on a well-detailed forecast for 2023. Then over to Europe, you know, I think we're beginning to see the fruits of a strong investment in our distribution partner in France, who now is in almost every Western European country, in 35,000 pharmacies with our HIV SURE CHECK product. They're launching into new Eastern European countries. We're talking about a Middle East strategy as well for that product. We're getting good contribution from Europe. In the U.K., we've invested time and energy with our distribution partner in the U.K. to get Amazon up and running, as well as the Boots Pharmacy. It's now on the shelf in the U.K. through our pharmacy partner in the U.K. I think, you know, it's a long-winded answer, Per, but I think we're beginning to see a really good distribution of product revenue in our core products, as well as by regions around the world where, you know, in the history of Chembio, they were largely focused on Africa and Southeast Asia, where there's tremendous pricing pressure, tremendous competition from the South Asian manufacturers of rapid tests. That's where we're at. I can perfectly accept a long-winded answer when some of these other regions are starting to contribute. Thank you for going into that detail. As we look at one of those higher value markets that I think is foundational to what you're trying to accomplish, going forward, the US, that was a nice number here in the quarter. Rick, I think you called out the Detect COVID test as well as HIV syphilis as being the key drivers there. Two questions related to the US. One, I would hazard it's safe to say, but I'll let you say it, is it safe to say that even with the HIV syphilis contribution that you've seen already, you are, you know, barely scratching the surface of the opportunity given that the CLIA waiver is still in front of you? Then, number two on that, as you talk about some of the OTC, DTC type opportunities globally, it stands to reason that there's a logic for you to have a retail opportunity here domestically as well, whether it's the Walgreens or, you know, MinuteClinic and that sort of thing, here. Is that something that you're pursuing, and what are the gating factors to penetrating that opportunity? Yeah. Per, we do have a strategy for the US. You know, our HIV syphilis test, we've talked a lot about, you know, we're at the end stages with the FDA in terms of getting the CLIA waiver. We're hopeful that, you know, is in Q4 or early Q1. We talked about the market in the US. Most of the HIV syphilis combination testing in the US is point-of-care. It's in a physician office, it's in OB-GYN office, where they wanna get a quick result for both HIV and syphilis. Treatment can be, you know, immediately implemented upon testing. The CLIA labs in the United States, we just did some analysis on how many CLIA labs now exist in the United States post-COVID and it's 250,000 CLIA waived labs, which are mostly urgent care centers, physician offices and so forth. We are really optimistic that once we get CLIA waiver, that we'll see tremendous growth in the United States. The other thing I would say about HIV syphilis is in this sexually transmitted disease community, one of the reasons the CDC is concerned is they're seeing a growth in co-infections. If you're infected with syphilis, the risk of your partner being infected with HIV, if that patient's HIV positive, is five time to six times the risk. The CDC is pushing for additional syphilis testing. Syphilis is growing exponentially in the United States, and the CDC is tracking that. The CDC, you know, part of the $3.2 million grant to Chembio was because they saw the value of our multiplex DPP product, allowing a physician to diagnose and treat immediately in one visit before the patient leaves the office and maybe is not back for a second or third visit, especially during pregnancy. That's very, very important. You know, we're very, very delighted that the CDC has committed to us that kind of funding to take this product, the syphilis screen and confirm TnT product, through full development and clinical trials, which will be happening in 2023. Regarding OTC in the United States for our HIV home test, or self-test, we're seeing, again, tremendous interest from the CDC. They just announced, I wanna say three weeks ago, a $42 million program to make tests available for people to test at home discreetly. It's what we're seeing the CDC's interest is that, a lot of times people are reluctant to get tested in a physician's office or urgent care center because it's not discreet. The home test, the self-test, will allow discreet testing for an individual, you know, in the privacy of their home. The CDC is also very interested in supporting us, because we have a very proven SURE CHECK product because it's been on the market since 2018 in Europe, and it's WHO certified or approved, CE marked, Anvisa approved in Brazil. We've got a really good performance track record, and that's what they're seeing with our SURE CHECK product, is that they're seeing the performance is extremely good compared to the competition. It's extremely easy to use. It has the world's smallest full blood finger stick sample, which is basically 2.5 microliters, which is a drop of blood. We are in the early stages of discussions with the FDA and the CDC on how we can accelerate an abbreviated clinical trial in 2023 to get that OTC product for HIV onto the market in the U.S. We are going after the higher value markets. The other thing I would add, Per, that we haven't really talked a lot about is that we are now selling a flu product and a respiratory antigen product in the United States. We brand it by the name of Status. If we do have a flu season, and we're beginning to see an uptick in flu incidents in the United States, coming up from the south, and moving north. If we do have a pretty difficult flu season, we're in a position, a great position, with a flu product, standalone flu product, as well as a respiratory antigen product that detects COVID, flu A and flu B. That's where we're moving, higher value markets, higher average selling prices and, hopefully that's another long answer to your question, but it's imperative to our strategy, as we move into 2023. No, that makes sense. I ask long questions, so long answers are perfectly logical. This is gonna sound odd going back away from higher margin and higher value testing. As you have the Malaysian agreement in place, you have automation, you know, more or less fully in place on Long Island, you know, the company is, I think you've characterized it as in the past kind of chasing revenue for revenue's sake. Are you in a position? Do you have any desire to chase any of that business now that you actually could probably make a little more money on it than the company historically has? Yeah, Per, we are not focused on the high volume, low margin business. Meaning, we're already in certain algorithms in seven countries in Africa. There's always changes to algorithms. You know, it changes from year to year. For example, the Ethiopia algorithm, that was a three-year contract that started at the end of 2018. It was gross margins below our expectations. You know, we've said, Larry and I both said we wanna get into the 40%-60% range for gross margins. Although that high volume business can have a contribution margin to product margins, you know, it takes resources to go after that business. You know, we are in a position now though, with Malaysia, and our Malaysian partner that, you know, if there's opportunities that come around for STAT-PAK in Southeast Asia, like Indonesia, Malaysia, Thailand, Vietnam, you know, our cost of production is in a position where we can compete, but it's not our focus. You know, the commercial organization, as I said, is extremely focused on higher margin products. We're viewing that business as opportunistic. If we can win some business and some of the algorithms in Africa, you know, we'll pursue it. But we're not gonna compete on price with manufacturers from Korea and China, where we're seeing price erosion be incredible. So again, STAT-PAK has a great track record, a great performance, among the WHO and global funded countries. It's been out there for many, many years, proven. You know, we also raised our price recently. You know, again, it's an opportunistic view on that business at this point. Okay, good. I like that answer. And it dovetails into my last one. I promise I won't hog the call further. The elephant, I guess, in the room is, you know, the debt and the revenue covenants, and as Larry noted, you're in full compliance with the trailing twelve months, and I think back of the envelope would lead me to believe, you know, it won't take you a herculean effort to get there here in Q4. When Q1 of 2022 rolls off, that's a fairly big number that goes away. I think while we all appreciate not chasing revenue for revenue's sake, the covenant I suspect ends up or could end up being an issue, you know, maybe in Q1 or Q2 of 2023. Is that, you know, short of paying off some or all of that debt, are there discussions in place to try to reconfigure that situation or relationship so that, you know, maybe you're not feeling like you're forced to go and chase bad business just to make a number? Per, it's Larry. I'll answer that. Yeah, we are proactively searching all options. We do have an S-1 filing out there. So that is certainly an option. You know, we wanna address this year, you know, in the next quarter as we look out. We wanna be able to, you know, start to minimize our cash burn and then address our capital structure 'cause we feel it is a major overhang to our company and valuation. So as we'll get through the next months, we would, you know, look to update everyone on where we are, either with the capital raise or other options and certainly speaking to, you know, our lender. So more to come. Absolutely, a major priority for us as a company to get through that debt agreement. Fantastic. Thanks for the color, all of it. Thank you. Yep. Thank you, Per. Gentlemen, as there appear to be no further questions in the queue, I will hand it back to Rick for any closing comments he has to finish with. I wanna thank you for your time today. Really appreciate, you know, the questions from Per. Again, thanks for your time and have a good evening. Thank you, ladies and gentlemen, and this does conclude today's conference call. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation.