Q2 2024 Co-Diagnostics Inc Earnings Call

August 8, 2024

Operator: Good day and welcome to the COVID-19 Diagnostics Second Quarter 2024 Earnings Conference Call. Our participants will be in listen only mode. Should you need assistance, please let me know.

Speaker Change: Good day and welcome to the CODE Diagnostics Second Quarter 2024 Earnings Conference Call.

Speaker Change: All participants will be in listen-only mode.

Speaker Change: Should you need assistance, please signal a consultant 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 a touch-tone phone.

Speaker Change: To withdraw your question, please press star then 2. Please note that 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: Good afternoon everyone, thank you all for participating in today's conference call. On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, Codeagnostics released financial results for the 2nd quarter and a June 30th, 2024. A copy of the Fresh Release is available on the company's website.

Andrew Benson: Good afternoon everyone. Thank you all for participating in today's conference call. On the line today from Co-Diagnostics we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer.

Speaker Change: Earlier today, Co-Diagnostics released financial results from the second quarter and on June 30, 2024. A copy of the press release is available on the company's website.

Speaker Change: We will begin the call with management's prepared remarks and then open up the call to analyst Q&A. Before we begin, we would like to inform the listeners that certain statements made by Code Diagnostics during this call that are not historical facts are forward-looking statements.

Speaker Change: This includes statements concerning the company's forthcoming CODX PCR testing platform, which requires regulatory approval and marketing authorization for diagnostics use. It's currently being reviewed by the US FDA and is not currently for sale.

Speaker Change: Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in co-diagnostics filings with the SEC.

Speaker Change: 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.

Andrew Benson: 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 issued shortly before this call, which contains reconciliations 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. Thank you.

Speaker Change: In addition, the company may 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.

Speaker Change: We refer you to the company's earnings release issued shortly before this call, which contains reconciliation to the non-GAAP financial majors presented to their most comparable GAAP results.

Speaker Change: At this time, I would like to turn the call over to Co-Diagnostics Chief Executive Officer Dwight Egan.

Dwight Egan: Thank you, Andrew, and good afternoon, everyone. Thank you all for joining Co-Diagnostics' second quarter 2024 earnings call. I want to start by thanking everyone at Co-Diagnostics for all of their hard work, which led to a successful first half of the year on multiple fronts. Over the past several months, we have made significant progress towards bringing our low-cost, easy-to-use, and disruptive point-of-care platform to patients around the world. In June, we submitted our first 510k application to the FDA for our CODIX-PCR-PRO and CODIX-PCR-COVID-19 test kits for over-the-counter use. A pivotal milestone for our platform as we approach a commercial one.

Dwight Egan: Thank you, Andrew, and good afternoon, everyone. Thank you all for joining Co-Diagnostics' second quarter 2024 earnings call.

Dwight Egan: I want to start by thanking everyone at Co-Diagnostics for all of their hard work which has led to a successful first half of the year on multiple fronts.

Speaker Change: Over the past several months, we have made significant progress towards bringing our low-cost, easy-to-use, and disruptive point-of-care platform to patients around the world.

Dwight Egan: In June , we submitted our first 510k application to the FDA for our CODIACS PCR Pro and CODIACS PCR COVID-19 test kit for over-the-counter use.

Dwight Egan: a pivotal milestone for our platform as we approach a commercial launch.

Dwight Egan: During the quarter, we also continued to make progress in the development of our tuberculosis, respiratory multiplex, HPV, and strep tests and remain well-positioned to advance our development processes throughout the rest of the year. We focused our commercial efforts on two trade shows where we showcased our Codex PCR platform to market participants. Demonstrating the impact our technology can have on the broader health ecosystem. I'm very excited by the progress that we have made so far and believe that we can remain in a strong position to execute our goals for the remainder of 2024.

Dwight Egan: During the quarter, we also continued to make progress in the development of our tuberculosis, respiratory multiplex, HPV, and strep tests, and remain well-positioned to advance our development processes throughout the rest of the year.

Dwight Egan: We focused our commercial efforts on two trade shows where we showcased our CODIACS PCR platform to market participants.

Dwight Egan: demonstrating the impact our technology can have on the broader health ecosystem.

Dwight Egan: I'm very excited by the progress that we have made so far and believe that we can remain in a strong position to execute our goals for the remainder of 2024.

Dwight Egan: As I mentioned, in the second quarter, we submitted a 510k application to the US FDA for our CODIACS PCR platform for the CODIACS PCR Pro instrument and the CODIACS PCR COVID-19 test for over-the-counter or OTC use. We completed the submission through the FDA's Electronic Submissions Template and Resource for East. Our System is a comprehensive resource for medical device manufacturers that allowed us to standardize all information in preparation Our team conducted extensive preparation, research, and data to submit what we believe will become a gold-standard PCR diagnostics platform for its intended use. Clearance by the FDA would allow our platform to be utilized in settings such as the home and workplace. Medical devices cleared for use in OTC settings are automatically categorized as CLIA-WAVE.

Dwight Egan: Such clearance by the FDA will allow for the PCR-Pro instrument, software, and COVID-19 tests to be used by point-of-care or point-of-care users, which we believe will help further expand the addressable market and value proposition of our platform. In the meantime, we remain in communication with the FDA on our existing 510 case of mission and look forward to providing you with more updates as they become available. Upon the full commercialization of our platform for OTC settings, we plan to make it available to consumers in businesses or offices where multiple tests could be run each day, as well as for At Home You. For POC users, we plan to initially target high-volume care centers, including skilled nursing facilities, physicians' offices, clinics, and assisted living centers.

Dwight Egan: As I mentioned, in the second quarter we submitted a 510k application to the U.S. FDA for our CODIACS PCR platform for the CODIACS PCR Pro instrument.

Dwight Egan: and the CODAX PCR COVID-19 test for over-the-counter or OTC use.

Dwight Egan: We completed the submission through the FDA's Electronic Submissions Template and Resource, or eSTAR, system.

Dwight Egan: which is a comprehensive resource for medical device manufacturers that allowed us to standardize all information in preparation for our 510K.

Dwight Egan: Our team conducted extensive preparation, research, and data to submit what we believe will become a gold-standard PCR diagnostics platform for its intended use.

Dwight Egan: Clearance by the FDA would allow our platform to be utilized in settings such as the home and workplaces.

Speaker Change: Medical devices cleared for use in OTC settings are automatically categorized as clear-awayed.

Dwight Egan: Such clearance by the FDA will allow for the PCR-Pro instrument, software, and COVID-19 tests to be used by point-of-care or POC users, which we believe will help further expand the addressable market and value proposition of our platform.

Dwight Egan: In the meantime, we remain in communication with the FDA on our existing 510k submission and look forward to providing you with more updates as they become available.

Dwight Egan: Upon the full commercialization of our platform for OTC settings, we plan to make it available to consumers in businesses or offices where multiple tests could be run each day.

Dwight Egan: as well as for at-home use.

Dwight Egan: For POC users, we plan to initially target high-volume care centers, including skilled nursing facilities, physicians offices, clinics, and assisted living centers.

Dwight Egan: We see a large opportunity for high utilization of our device and associated COVID-19 test kits in skilled nursing facilities, where there remains an ongoing requirement and need to perform COVID testing due to the vulnerable populations that reside in them. Our regulatory strategy for this initial test on the CODIACS PCR Pro instrument will be crucial in establishing our commercial platform and paving the path for the utilization of additional tests in our pipeline in the future.

Dwight Egan: Our regulatory strategy for this initial test on the Codex PCR Pro instrument will be crucial in establishing our commercial platform and paving the path for utilization of additional tests in our pipeline in the future.

Dwight Egan: Shortly following our 510K submission and in preparation for commercial launch, we attended two highly-attended trade shows to showcase our Codex PCR platform, FYME and ADLM. In June, we attended the Florida International Medical Expo, or FIME, one of the leading medical trade expos for medical device and product purchase.

Charlie: Shortly following our 510k submission and in preparation for a commercial launch, we attended two highly attended trade shows to showcase our CODIACS PCR platform, FIME and ADLM.

Dwight Egan: We are enthused by the turnout at FIME, with exhibitors from 116 countries and more than 15,000 professional attendees, which provided us with the opportunity to strengthen our relationships with key suppliers in the global medical device and equipment market, especially in Latin America. At the end of July, we attended the Association for Diagnostics and Laboratory Medicine, or ADLM, 2024 meeting in Chicago, formerly known as AACC. The focus of our presentation at ADLM was centered around the utility of our platform, the development of our tests, and the opportunity for PCR diagnostics to test for tuberculosis. Shows like FIME and ADLM play an important role in our initial pre-commercialization efforts and allow us to converse with key prospective customers and distributors on our accomplishments to date, along with our plans moving forward.

Dwight Egan: In June, we attended the Florida International Medical Expo, or FIME, one of the leading medical trade expos for medical device and product purchasers.

Dwight Egan: We are enthused by the turnout at FIME with exhibitors from 116 countries and more than 15,000 professional attendees.

Dwight Egan: which provided us with the opportunity to strengthen our relationships with key suppliers in the global medical device and equipment market, especially in Latin America.

Dwight Egan: At the end of July , we attended the Association for Diagnostics and Laboratory Medicine, or ADLM, 2024 meeting in Chicago, formerly known as AACC.

Dwight Egan: The focus of our presentation at ADLM was centered around the utility of our platform, the development of our tests and the opportunity for PCR diagnostics to test for tuberculosis.

Dwight Egan: shows like FIME and ADLM play an important role in our initial pre-commercialization efforts and allow us to converse with key perspective customers and distributors on our accomplishments to date, along with our plans moving forward.

Dwight Egan: Turning to our test pipeline, we are very excited by the development progress we have made so far this year. We remain highly focused on our test for tuberculosis, or TB, which remains the deadliest infectious disease in the world. Clinical samples from tuberculosis patients have already been run in TB test cups on the CODI-X PCR Pro instrument.

Speaker Change: Clinical Samples from tuberculosis patients have already been run in TB test cups on the Cody XPCR Pro instrument, and we plan to initiate clinical trials on our TB test before the end of the year in South Africa, as well as in India.

Dwight Egan: And we plan to initiate clinical trials on our TB tests before the end of the year in South Africa, as well as in India, one of our top priority markets for TB testing. We are working very closely with NGOs and other organizations and groups to ensure that our TB test meets the needs of our target market. These external groups are also helping to inform our TV commercial strategies surrounding markets to focus on, market opportunity, and total addressable market.

Speaker Change: One of our top priority markets for TB testing.

Dwight Egan: We are working very closely with NGOs and other organizations and groups to ensure that our TB test meets the needs of our target markets.

Dwight Egan: These external groups are also helping to inform our TV commercial strategies surrounding markets of focus, market opportunity and total addressable market.

Dwight Egan: We are iteratively refining our go-to-market strategy for TV so that our team is best prepared to address the locations of highest need. Following internal and external market research, we believe the global total addressable market for TB testing may reach over $3.6 billion within the next four years. This includes an estimated 17 million near-pointed care TB tests currently being performed in South and East Asia every year, and 10 million in Africa.

Dwight Egan: We are iteratively refining our go-to-market strategy for TVs so that our team is best prepared to address the locations of highest need.

Dwight Egan: Following internal and external market research, we believe the global total addressable market for TB testing may reach over 3.6 billion dollars within the next four years.

Dwight Egan: This includes an estimated 17 million near-pointed care TB tests currently being performed in South and East Asia every year and 10 million in Africa.

Dwight Egan: We are working closely with NGOs and other stakeholders in our target countries as we identify how much of the total global market will be serviceable by POC testing as infectious disease diagnostics continues its shift towards decentralization and how much we expect to be able to capture as our commercialization footprint grows. We are also encouraged by the progress we have made so far this year on our multiplex upper respiratory and HPV tests.

Dwight Egan: and how much we expect to be able to capture as our commercialization footprint grows.

Dwight Egan: We are also encouraged by the progress we have made so far this year on our multiplex upper respiratory and HPV test.

Dwight Egan: As we discussed on our most recent call, the upper respiratory multiplex test has the potential to provide low-cost and easily accessible diagnosis for some of the most pernicious respiratory infections in at-home and point-of-care settings. Run on our new CODIACS PCR Pro instrument, this test is strengthened by a low unit cost and could unlock significant clinical and economic efficiencies enabled by the ability to detect COVID, Flu A, Flu B, and RSV infections all at once. We continue to expect clinical evaluations to commence during the upcoming North American flu season.

Dwight Egan: As we discussed on our most recent call, the upper respiratory multiplex test has the potential to provide low cost and easily accessible diagnosis for some of the most pernicious respiratory infections in at home and point of care settings.

Dwight Egan: Run on our new Codex PCR Pro instrument, this test is strengthened by a low-unit cost and could unlock significant clinical and economic efficiencies enabled by the ability to detect COVID, flew away, flew B and RSV infections all at once.

Dwight Egan: We continue to expect clinical evaluations to commence during the upcoming North American flu season.

Dwight Egan: The development of this specific test has also driven even more innovations on the platform, including enhancements to the instrument and to the software, which we believe will provide local, national, and international organizations the ability to monitor and react to disease outbreaks. These continued iterative upgrades are the result of input from prospective markets and customers, which underscores our commitment to a design and development process focused on producing results that directly address existing shortcomings in health care, all with the aim of producing diagnostics that could easily be adopted by users searching for better solutions.

Dwight Egan: These continued iterative upgrades are the result of input from prospective markets and customers.

Dwight Egan: which underscores our commitment to a design and development process focused on producing results that directly address existing shortcomings in healthcare. All with the aim of producing diagnostics that could easily be adopted by user searching for better solutions.

Dwight Egan: And while we remain highly focused on taking the platform to market with the pipeline of tests we have already shared, ongoing R&D is also continually expanding the boundaries of this innovative new platform's capabilities, providing new opportunities for the future that we believe have the potential to dramatically increase its impact well beyond our original vision.

Dwight Egan: And while we remain highly focused...

Dwight Egan: On taking the platform to market with the pipeline of tests we have already shared, ongoing R&D is also continually expanding the boundaries of this innovative new platforms capabilities, providing new opportunities for the future that we believe have the potential to dramatically increase its impact well beyond our original vision.

Dwight Egan: Our team is committed to developing more than just respiratory infection diagnostics, as we believe our device can also make other diagnostic processes, such as STI testing, more efficient. For HPV, Co-Diagnostics has continued to work closely with our Indian Joint Venture, CoSERA Diagnostics, where research shows there exists a significant need for HPV testing and test accessibility. Our HBV test efforts are supported by the Bill and Melinda Gates Foundation grant that we received last year, which speaks to the importance of the work that we continue to do.

Dwight Egan: On HPV, Co-Diagnostics has continued to work closely with our Indian Joint Venture, COSERA Diagnostics, where research shows there exists a significant need for HPV testing and test accessibility.

Dwight Egan: Our HPV test efforts are supported by the Bill and Melinda Gates Foundation grant that we received last year, which speaks to the importance of the work that we continue to do.

Dwight Egan: Additionally, while our STREP-A test is the most recent test to be added to our pipeline, we are excited by our development strategy and the opportunity to help diagnose patients in pediatric centers and clinics around the country.

Dwight Egan: Before closing, I would like to briefly discuss the progress of our vector control business.

Dwight Egan: We are pleased that the CODIACS Vector Control Footprint continued to grow in the U.S. this quarter with expansion into Nevada, the 15th U.S. state we have reached with this technology.

Dwight Egan: Our vector control suite of product offerings includes vector smart PCR tests that can be utilized for mosquito-borne illness surveillance and which deliver same-day results of mosquito pool testing to more quickly mitigate transmission of disease to humans and animals.

Dwight Egan: This comes at a time when nearly 200 people have been infected with dengue virus in New York and New Jersey, according to the CDC, and a public health emergency for the mosquito-borne illness has been declared in the U.S. territory of Puerto Rico.

Dwight Egan: As mentioned on our prior call, while our vector smart testing products primarily include those for mosquito abatement, our flu A, B, and COVID-19 or ABC logic smart test has shown capabilities to detect the H5N1 virus or avian flu. Co-Diagnostics has initiated work to explore ways in which our company can be beneficial in the detection of the H5N1 virus, which has included initial design work for a more specific co-pro We look forward to the opportunity to develop an effective and efficient detection solution for the H5N1 virus should the need for the product arise.

Speaker Change: As mentioned on our prior call, while our vector smart testing products primarily include those from mosquito abatement, our flu AV and COVID-19 or ABC logic smart test has shown capabilities to detect the H5N1 virus or AVN flu.

Dwight Egan: Co-Diagnostics has initiated work to explore ways in which our company can be beneficial in H5N1 detection, which has included initial design work for a more specific Co-Primers H5N1 test.

Dwight Egan: We look forward to the opportunity to develop an effective and efficient detection solution for the H5N1 virus should the need for the product arise.

Dwight Egan: And close, I would like to express my confidence in the value proposition that Code Iagnostics will bring to the global molecular diagnostics market, especially at the point of care. We have strategically positioned ourselves to transform the way that providers test for infectious diseases. Our patented co-primer technology significantly reduces the number of false positives, leading to results that healthcare providers can trust and with enhanced multiplexing capabilities, which are then delivered to the TOTIX mobile app in approximately 30 minutes through our cloud-based HIPAA compliant technology.

Dwight Egan: To close, I would like to express my confidence in the value proposition that co-diagnostics will bring to the global molecular diagnostics market, especially at the point of care.

Dwight Egan: We have strategically positioned ourselves to transform the way that providers test for infectious diseases.

Dwight Egan: Our patented co-primers technology significantly reduces the number of false positives leading to results that health care providers can trust and with enhanced multiplexing capabilities which are then delivered to the CODIX mobile app in approximately 30 minutes through our platform's cloud-based

Dwight Egan: The size of our instrument, our in-house manufacturing and scale capabilities, efficient management of our balance sheet, and the grant support we have received provides code diagnostics with the ability to support a commercial launch that enables platform delivery to populations all around the world. We are excited by the potential the Codex PCR platform has to increase the availability and accessibility of the highest quality of diagnostics and improve the quality of global health care.

Dwight Egan: HIPAA compliant technology.

Dwight Egan: We are excited by the potential that the CODIACS PCR platform has to increase availability and accessibility of the highest quality of diagnostics and to improve the quality of global health care.

Dwight Egan: I'm proud of our Co-Diagnostics team and the immense effort that they have dedicated to improving the quality of healthcare through best-in-class diagnostics. I look forward to providing you with more updates as we progress throughout the remainder of 2024. With that, I will now turn the call over to Brian to discuss our second quarter financial results.

Dwight Egan: I'm proud of our co-diagnostic team and the immense effort that they have dedicated to improving the quality of healthcare through best-in-class diagnostics.

Dwight Egan: I look forward to providing you with more updates as we progress throughout the remainder of 2024. With that, I will now turn the call over to Brian to discuss our second quarter financial results.

Brian Brown: The decrease from the prior year is primarily due to higher expenses in 2023 related to stock-based compensation, bad debt, and expenses related to clinical trials for CODIAC's PCR platform. Research and development expenses in the second quarter were $5.6 million compared to $6.0 million in the comparable prior year period. For the second quarter, income before taxes was a loss of $7.7 million, as compared to a loss of $11.2 million reported in the prior year.

Brian Brown: Thanks for everyone who joined today's call.

Brian Brown: For the second quarter of 2024, total revenue increased to $2.7 million as compared to $0.2 million in the prior year's same period.

Brian Brown: Grant revenue in the second quarter of 2024 was $2.5 million, and product revenue was $0.2 million.

Brian Brown: Gross profit for the quarter increased to 2.4 million dollars compared to negative 0.3 million dollars in the prior year comparable period.

Brian Brown: Total operating expenses for the quarter ended June 30, 2024, decreased to $10.1 million from $11.7 million in the second quarter of 2023.

Brian Brown: Research and development expenses in the second quarter were $5.6 million, compared to $6.0 million in the comparable prior year period.

Brian Brown: For the second quarter, income before taxes was a loss of $7.7 million, as compared to a loss of $11.2 million, reported in the prior year.

Brian Brown: Net loss for the second quarter of 2024 was $7.6 million, or a loss of $0.25 per fully diluted share, compared to a net loss of $8.9 million, or a loss of $0.31 per fully diluted share, in the prior year. Adjusted EBITDA was a loss of $5.9 million compared to an adjusted EBITDA loss of $9.6 million in the prior year. We ended the quarter with $44.9 million in cash, cash equivalents, and marketable investment securities.

Brian Brown: adjusted EBITDA was a loss of $5.9 million compared to an adjusted EBITDA loss of $9.6 million in the prior year.

Brian Brown: We ended the quarter with $44.9 million in cash, cash equivalents, and marketable investment securities.

Brian Brown: We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for long-term growth. Co-Diagnostics remains focused on maintaining our cash position through appropriate and diligent management. Position the company for success upon a future commercial launch of our platform. We believe that we are operating from a strong cash position, and we'll continue to focus on driving operational efficiency. We remain excited about our 2024 plan and are very optimistic about our test pipeline and the CODX-PCR platform. I look forward to updating you on our next earnings call. With that, I will now turn the presentation back over to Dwight. Thank you, Brian.

Brian Brown: We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for long-term growth.

Brian Brown: Co-Diagnostics remains focused on maintaining our cash position through appropriate and diligent management.

Brian Brown: to position the company for success upon a future commercial launch of our platform.

Brian Brown: We believe that we are operating from a strong cash position and will continue to focus on driving operational efficiencies.

Brian Brown: We remain excited about our 2024 plan and are very optimistic about our test pipeline and the CODX-PCR platform. I look forward to updating you on our next earnings call.

Dwight Egan: Thank you, Brian. Before opening for Q&A, I want to take this time to extend a thank you to our Cody XSharehold. In addition to our employees and distributors who work hard each and every day to progress our platform and the mission of Co-Diagnostics. We will now take questions from our analysts, operator.

Brian Brown: With that, I will now turn the presentation back over to Dwight.

Dwight Egan: Thank you, Brian . Before opening for Q&A, I want to take this time to extend a thank you to our CODIEX shareholders, in addition to our employees and distributors who work hard each and every day to progress our platform and the mission of co-diagnostics.

Speaker Change: We will now take questions from our analysts, operator.

Operator: Thank you. We will now begin the question and answer session. If you want to ask a question, you may press star and then one on your touchstone phone. If you're using a speaker phone, please pick up your handset before pressing the key. If at any time your question has been answered and you would like to withdraw your question, please withdraw it and too. At this time, we will pause momentarily to assemble our roster. The first question comes from Jade Montgomery with HC Wainwright. Please go ahead.

Speaker Change: Thank you. We will now begin the question and answer session. Do ask a question, you may press star, then one on your touchtone phone. If you're using a speaker phone, please pick up your handset before pressing the keys.

Speaker Change: If at any time your question has been answered and you would like to withdraw your question, please press star then 2.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Speaker Change: [inaudible]

Speaker Change: The first question comes from Jade Montgomery with HC Wainwright. Please go ahead.

Jade Montgomery: Hey, thanks. I'm for Yi Chen at AC Mayor Edgerton. So my first question, I mean, I know you just submitted it, but have you heard back at all from the FDA yet on the 510k? Any feedback yet?

Speaker Change: Hello, I'm Andrew Benson, and I'm from Newtown, and I see where I'm just from.

Speaker Change: I don't know.

Jade Montgomery: So, my first question, I mean, I know you just submitted it, but have you heard back

Dwight Egan: for your question. We have had regular contact with the FTA since we submitted our request.

Speaker Change: Thank you for your question. We have regular contact with the FTA since we have submitted.

Jade Montgomery: [inaudible]

Speaker Change: Any particular guidance you'd share with us or do you know when potentially you could expect that 5-10 clearance?

Dwight Egan: We really can't comment on regulatory decisions by the FDA. We are in regular contact with them, and we are pleased with their response so far.

Speaker Change: We really can't comment on regulatory decisions by the FDA. We're in regular contact with them. We are pleased with their response so far.

Jade Montgomery: and I thank you so much. And just, I mean, outside of that with those two trade shows, have there been any potential customers that have really indicated their strong interest to place purchase orders when you get that catching game out there?

Speaker Change: Okay, thank you so much. And just, I mean, you know, outside of that has with those two trade shows, has there been any potential customers that have really indicated their strong interest to place purchase orders once you get that 510k? Or...

Dwight Egan: We attended a lot of shows last year; we attended about 30 different shows. So we're always talking to potential customers about the benefits and progress that we're making. Until we have clearance from the FDA, we're not permitted to sell the product. But we have a lot of constructive conversations about what we're doing and the state of our technology, and we're very enthused by the response that we received from the market.

Speaker Change: We have attended a lot of shows. Last year, we attended about 30 different shows.

Jade Montgomery: and by that I mean that the potential market is both domestic and international, or mostly domestic.

Speaker Change: So we're always talking to potential customers about the benefits, progress that we're making.

Speaker Change: Until we have clearance from the FDA, we're not permitted to sell the product. So we have a lot of constructive conversations about what we're doing and the state of our technology and we're very enthused by the response that we received from the market.

Speaker Change: and I mean that potential market is both domestic and international or mostly domestic.

Dwight Egan: It's both domestic and international. During the last several years, we have sold our product in over 50 different countries around the world. So we have a lot of distributors across the world. And the interest in our product spans the globe.

Speaker Change: It's both domestic and international during the last several years we have sold our product in over 50 different countries around the world so we have a lot of distributors across the world so the interest in our product spans the globe.

Jade Montgomery: Alright, thank you so much. That's all I had for today.

Speaker Change: Alright, thank you so much. That's all I had for today.

Operator: This concludes our question and answer session and today's conference call. Thank you for attending this presentation. You may now disconnect.

Speaker Change: Good morning.

Speaker Change: This concludes our question and answer session and today's conference call.

Speaker Change: Thank you for attending today's presentation. You may now disconnect.

Speaker Change: ??? ??? ??? ???

Brian Brown: Thanks, Dwight, and thanks to everyone who joined today's call. For the second quarter of 2024, total revenue increased to $2.7 million, as compared to $0.2 million in the prior year's same period. Grant revenue in the second quarter of 2024 was $2.5 million, and product revenue was $0.2 million. Gross profit for the quarter increased to $2.4 million compared to negative $0.3 million in the prior year comparable period. Total operating expenses for the quarter and for June 30th, 2024, decreased to $10.1 million from $11.7 million in the second quarter of 2023.

Jade Montgomery: Any particular guidance you can share with us, or do you know when you could potentially expect that 5-10 clearance?

Operator: Please signal the content specialists 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 a catch-to-turn phone, to submit your question, please press star, then one. Please note that this event is being recorded. Now, I would like to turn the conference over to Andrew Benson, head up in last relation. So, you go

Dwight Egan: We have reached with this technology. Our vector control suite of product offerings includes vector smart PCR tests that can be utilized for mosquito-borne illness surveillance and which deliver same-day results of mosquito pool testing to more quickly mitigate the transmission of disease to humans and animals. This comes at a time when nearly 200 people have been infected with the dengue virus in New York and New Jersey, according to the CDC, and a public health emergency for the mosquito-borne illness has been declared in the U.S. territory of Puerto Rico.

Andrew Benson: We will begin the call with management's prepared remarks and then open up the call to analyst Q&A. Before we begin, we would like to inform the listeners that certain statements made by Codeagnostics during this call that are not historical facts are forward-looking statements. This includes statements concerning the company's forthcoming CODX PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use. It is currently being reviewed by the US FDA and is not currently for sale.

Dwight Egan: Additionally, while our stress test is the most recent test to be added to our pipeline, we are excited by our development strategy and the opportunity to help diagnose patients in pediatric centers and clinics around the country. Before closing, I would like to briefly discuss the progress of our vector control business. We are pleased that the Codex vector control footprint continued to grow in the U.S. this quarter with expansion into Nevada, the 15th U.S. state.

Andrew Benson: Actual outcomes and results may differ materially from what is expressed or implied in any statement. Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in Codeignostics' filings with the SEC. Codeignostics 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 unintestated events. In addition, the company may discuss certain non-GAAP financial measures during today's call.

Q2 2024 Co-Diagnostics Inc Earnings Call

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