Q1 2025 Co-Diagnostics Inc Earnings Call
Operator: Thank you for standing by.
Thank you for standing by my name is Cathy and I will be your conference operator today at this time I would like to welcome everyone to the code diagnostics first quarter 'twenty 25 earnings call.
Cath: My name is Cath, and I will be your conference operator today.
Operator: At this time, I would like to welcome everyone to the Co-Diagnostics First Quarter 2025 Earnings Call. All lines have been placed on mute to prevent any background noise.
All lines have been placed on mute to prevent any background noise.
Operator: After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, simply press star one again.
After the Speakers' remarks, there will be a question and answer session. If you would like to ask a question. During this time simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question.
Speaker Change: Press Star one again I would now like to turn the call over to Andrew Benson head of Investor Relations. Please go ahead.
Andrew Benson: I would now like to turn the call over to Andrew Benson, Head of Investor Relations. Please go ahead. Good afternoon, everyone. Thank you all for participating in today's conference call.
Speaker Change: 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 Co diagnostics released financial results from the first quarter ended March 31 2025.
Andrew Benson: On the line today from Co-Diagnostics, we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, Co-Diagnostics released financial results from the first quarter and in March 31st, 2025. A copy of the press release is available on the company's website.
Speaker Change: A copy of the press release is available on the Companys website, we will begin with managements 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 co diagnostics. During this call which are not historical facts are forward looking statements. This includes statements concerning the Companys Kodiak.
Andrew Benson: We will begin 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 Co-Diagnostics during this call, which are not historical facts, are forward-looking statements. This includes statements concerning the company's CODX PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale, in addition to diagnostic test developments and timing for commencement of clinical evaluations. 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: <unk> testing platform, which requires regulatory approval and marketing authorization for diagnostic use and is not currently for sale. In addition to diagnostic test development and timing for commencement of clinical evaluations.
Speaker Change: Actual outcomes and results may differ materially from what is expressed or implied in any statements 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 co diagnostics assumes no obligation and expressly disclaims any duty to update any forward looking statements.
Andrew Benson: 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.
Speaker Change: To reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events. 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. We refer you to the company's earnings release issued shortly.
Andrew Benson: 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. We refer you to the company's earnings release issued shortly before this call, which contains reconciliation to the non-GAAP financial measures presented to their most comparable GAAP results.
Speaker Change: Before this call, which contains a reconciliation to the non-GAAP financial measures presented to the most comparable GAAP results at this time I would like to turn the call over to Kodak <unk>, Chief Executive Officer, Dwight again right.
Dwight Egan: At this time, I would like to turn the call over to Co-Diagnostics' Chief Executive Officer, Dwight Egan. Thank you, Andrew. And good afternoon, everyone.
Speaker Change: Thank you Andrew and good afternoon, everyone. Thank you for joining co diagnostics first quarter 2025 earnings call.
Dwight Egan: Thank you for joining Co-Diagnostics first quarter 2025 earnings call. During the first quarter, we continued to advance our CODIX PCR platform and associated test pipeline towards initiating clinical evaluation. I am proud of the work our team has done as we seek to bring our low-cost, rapid, and easy-to-use platform to the point-of-care market. Our mission at Co-Diagnostics is to increase the accessibility of affordable, high-quality diagnostics in the United States, India, and around the world. And we are nearing several important development milestones in pursuit of that vision, including the commencement of clinical studies for critical indication. As discussed in previous calls, the test pipeline for the new platform includes our diagnostic tests for tuberculosis, or TB, COVID-19, 4-Plex respiratory panel, and 8-Plex HPV panel.
Speaker Change: During the first quarter, we continued to advance our Kodiak PCR platform and associated test pipeline towards initiating clinical evaluations I am proud of the work our team has done as we seek to bring our low cost rapid and easy to use platform to the point of care market.
Speaker Change: Our mission of code diagnostics is to increase the accessibility of affordable high quality diagnostics in the United States, India and around the World and we are nearing several important development milestones in pursuit of that vision, including the commencement of clinical studies for critical indications as.
Speaker Change: As discussed in previous calls.
Speaker Change: <unk> pipeline for the new platform includes our diagnostic tests for tuberculosis or TB COVID-19.
Speaker Change: <unk> respiratory panel and eight plex HPV panel over the past several years. These indications have developed into the most immediate opportunities for our unique technology and platform to impact the current standard of care and ultimately patient outcomes.
Dwight Egan: Over the past several years, these indications have developed into the most immediate opportunities for our unique technology and platform to impact the current standard of care and ultimately patient outcomes. Throughout our development efforts, we have been supported by several leading organizations who share in our passion for improving the global health infrastructure, including the Bill and Melinda Gates Foundation, Smart for TB, and the National Institute of Health's RADx Tech Program. We remain highly focused on bringing our CODIX PCR platform to market, including several advancements that have been developed by our scientific, engineering, and software development teams. These new platform developments will be incorporated into our instrument and test kits as part of upcoming regulatory submissions, which we anticipate will drive operating and manufacturing efficiencies down the line for our current and future tests.
Speaker Change: Throughout our development efforts, we have been supported by several leading organizations who share our passion for improving the global health infrastructure, including the Bill and Melinda Gates Foundation Smart for TB and the National Institute of Health right Ex Tech program.
Speaker Change: We remain highly focused on bringing our Kodiak PCR platform to market, including several advancements that have been developed by our scientific engineering and software development teams.
Speaker Change: These new platform developments will be incorporated into our instrument and test kits as part of upcoming regulatory submissions, which we anticipate will drive operating and manufacturing efficiencies down the line for our current and future tests.
Dwight Egan: The design for the Augmented CODX-PCR COVID-19 test has been completed and the test has undergone extensive verification testing and we have full confidence in the test's performance and stability. We plan to submit this updated version of our COVID-19 test to the FDA with a 510k application after updated clinical data has been collected. We are excited about the disruptive potential of our platform and will continue to work tirelessly to introduce this powerful new diagnostic solution to the market. We are pleased by the work that we have done on our TB test so far this year. As discussed last quarter, we have already completed several preliminary analytical studies, as well as testing on clinical samples to confirm performance.
Speaker Change: The design for the augmented codecs PCR COVID-19 test has been completed and the test has undergone extensive verification testing and we have full confidence in the test performance and stability.
Speaker Change: We plan to submit this updated version of our COVID-19 test to the FDA with a five 10-K application after updated clinical data has been collected.
Speaker Change: We are excited about the disruptive potential of our platform and will continue to work tirelessly to introduce this powerful new diagnostic solutions to the market.
Speaker Change: We are pleased by the work that we have done on our TB tests. So far this year as discussed last quarter. We have already completed several preliminary analytical studies as well as testing on clinical samples confirmed performance. Moreover, we have identified instruments for the TV sample prep, which.
Dwight Egan: Moreover, we have identified instruments for the TB sample prep, which takes place prior to samples being added to the CODIACS PCR-MTB Test Cup, enabling an efficient and affordable workflow process. This step is crucial to the commercial launch and success of the TB test and we believe we are in a great position as we prepare for upcoming clinical evaluations. We are very excited about the potential of this testing solution to provide low-cost, high-accuracy, real-time point-of-care diagnostics around the world to combat tuberculosis, which remains the leading global infectious disease killer. We see particular need for our TB tests in locations like India, our top priority market for TB testing, where we have significant experience, including regulatory, commercial, and manufacturing infrastructure through our joint venture, CoSera Diagnostics.
Speaker Change: <unk> placed prior to samples being added to the Kodiak PCR MTV test cup, enabling an efficient and affordable workflow process.
Speaker Change: This step is crucial to the commercial launch and success of the TV test and we believe we are in a great position as we prepare for upcoming clinical evaluations.
Speaker Change: We are very excited about the potential of this testing solutions to provide low cost high accuracy real time point of care diagnostics around the world to combat tuberculosis, which remains the leading global infectious disease killer.
Speaker Change: We see particular need for our TV test in locations like India, our top priority market for TB testing, where we have significant experience, including regulatory commercial and manufacturing infrastructure through our joint venture Costeira diagnostics.
Dwight Egan: We expect to begin clinical evaluations in India and South Africa in the back half of 2025, gathering data that will be utilized to support regulatory submissions to the Central Drug Standard Control Organization, or CDSCO, in India, and the South Africa Health Product Regulatory Agency, or SAFRA, in Africa. In our clinical evaluation preparations, we continue to engage with local health officials in those regions and potential customers to evaluate the most effective and efficient commercialization strategy. Elsewhere, our team continues to make significant progress on our 4PLEX respiratory panel, which has been developed with a grant support from the NIH's RADx Tech Initiative.
Speaker Change: We expect to begin clinical evaluations in India, and South Africa in the back half of 2025 gathering data that will be utilized to support regulatory submissions to the central drug standard control organization or <unk> in India, and South Africa Health products regulatory agency.
Safra in Africa in our clinical evaluation preparations, we continue to engage with local health officials in those regions and potential customers to evaluate the most effective and efficient commercialization strategy.
Speaker Change: Elsewhere, our team continues to make significant progress on our four plex respiratory panel, which has been developed with a grant support from the NIH is radically Tech initiative.
Dwight Egan: The test has been designed to deliver simultaneous real-time PCR test results for flu A and B, COVID-19, and RSV. Market research has identified a considerable amount of interest in this panel, which we believe is warranted by the burden these diseases place on everyday life in the United States and around the world. Core to our value proposition is the capability to provide de-identified data to health departments at the local, regional, national, or international level to help track outbreaks of infectious diseases, thanks to the cloud-based analysis of tests performed on the CODIX-PCR-PRO. This situational awareness can provide health officials with key data and insights that could save lives and stop outbreaks.
Speaker Change: The test has been designed to deliver simultaneous real time PCR test results for flu, a and B COVID-19 and RSV.
Speaker Change: Market research has identified a considerable amount of interest in this panel, which we believe is warranted by the burden of these diseases place on everyday life in the United States and around the world.
Speaker Change: Core to our value proposition is the capability to provide de identified data to help departments at the local regional national or international level to help track outbreaks of infectious diseases. Thanks to the cloud based analysis of tests performed on the Kodiak PCR Pro.
Speaker Change: This situational awareness can provide health officials with key data and insights that can save lives and stop outbreaks.
Dwight Egan: In March, we completed a pre-submission to the FDA for the CODX-PCR-PRO respiratory multiplex panel test. We have been assigned a reviewer and plan to initiate clinical evaluations for this assay in the second half of this year. Rounding out our pipeline, we continue to make good progress in preparing the APLEX-HPV panel for upcoming clinical evaluation. This development has been supported by a grant from the Bill and Melinda Gates Foundation as there is a vast need for HPV testing around the world. HPV is one of the most widespread and common sexually transmitted infections worldwide. Several human papillomavirus subtypes are linked to cervical cancer, which causes hundreds of thousands of deaths annually.
In March we completed a pre submission to the FDA for the Kodiak PCR pro respiratory multiplex panel test kit.
Speaker Change: We have been assigned to a reviewer and plan to initiate clinical evaluations for this assay in the second half of this year.
Speaker Change: Rounding out our pipeline, we continue to make good progress in preparing the eight plex HPV panel for upcoming clinical evaluations.
Speaker Change: This development has been supported by a grant from the Bill and Melinda Gates Foundation as there is a vast need for HPV testing around the world.
Speaker Change: HBV is one of the most widespread and common sexually transmitted infections worldwide.
Speaker Change: Several human papilloma virus subtypes are linked to cervical cancer, which causes hundreds of thousands of deaths annually.
Dwight Egan: We believe the CODIAX PCR platform can have a significant impact on testing accessibility and efficiency. which remain key constraints to mitigating the impact of HPV on global health. Utilizing our co-primary technology, our HPV assay can simultaneously detect eight different high-risk HPV subtypes from a single cervical swab sample, providing an affordable and accessible tool for patients around the world. During the first quarter, our teams continued to generate performance data for our tests, which has met or exceeded internal expectations. With support from our funding partners and key stakeholders, we look forward to initiation of our clinical evaluations, our regulatory submissions, and platform commercialization.
Speaker Change: We believe the Kodiak PCR platform can have a significant impact on testing accessibility and efficiency, which remain key constraints to mitigating the impact of HBV on global health.
Speaker Change: Utilizing our co primary technology, our HPV assay can simultaneously detect eight different high risk HPV subtypes from a single cervical swab sample, providing an affordable and accessible tool for patients around the world.
Speaker Change: During the first quarter, our teams continued to generate performance data for our test, which has met or exceeded internal expectations.
Speaker Change: With support from our funding partners and key stakeholders, we look forward to initiation of our clinical evaluations, our regulatory submissions and platform commercialization.
Dwight Egan: We plan to initially pursue regulatory clearance in India for this test before moving to South Africa and other regions. Leveraging our existing footprint in India through COSERA, we believe we are uniquely positioned to serve the Indian market.
Speaker Change: We plan to initially pursue regulatory clearance in India for this test before moving to South Africa, and other regions leveraging our existing footprint in India through Coursera. We believe we are uniquely positioned to serve the Indian market.
Dwight Egan: Before wrapping up, I would like to highlight events that Co-Diagnostics attended in the first quarter to build further awareness of the CODIACS PCR platform. Following the inauguration of the Oligonucleotide Synthesis Facility in December, in March we hosted an HPV and Cancer Symposium to honor International HPV Awareness Day 2025 in India. This was hosted in collaboration with COSERA, which helped to set the stage as we prepare for analytical and clinical studies for our HPV tests. We also hosted a booth at BioUtah's Life Sciences Day on the Hill at the Utah State Capitol Rotunda, which showcased our CODIX PCR platform for local health constituents and government officials.
Speaker Change: Before wrapping up I would like to highlight events. The co diagnostics attended in the first quarter to build further awareness of the Kodiak Pcr platform.
Speaker Change: Following the inauguration of the oligonucleotide synthesis facility in December and March we hosted an HBV in cancer Symposium to honor International HPV awareness day 2025 in India.
Speaker Change: This was hosted in collaboration with Coursera, which helped to set the stage as we prepare for analytical and clinical studies for our HPV test.
Speaker Change: We also hosted a booth at bio Utah's life Sciences day on the Hill at the Utah State capital will tender, which showcased our Kodiak PCR platform for local help constituents and government officials.
Dwight Egan: These events were well attended with a high level of engagement and interest in our platform. We welcome opportunities to engage with local and international potential customers and key stakeholders, which made these events a productive and collaborative experience for the company.
Speaker Change: These events were well attended with a high level of engagement and interest in our platform.
Speaker Change: We welcome opportunities to engage with local and international potential customers and key stakeholders, which made these events are productive and collaborative experience for the company.
Dwight Egan: To close out, I want to emphasize our commitment to achieving our regulatory objectives and to successfully launching the CODIACS PCR-PRO instrument and test kits to the world. Our team has been working diligently to advance our pipeline of diagnostic solutions, which has resulted in a successful first quarter. We are nearing several critical milestones, including clinical evaluations for all of the indications discussed here, and a new submission to the FDA for COVID-19. In India, we remain on track to complete the build-out of our manufacturing facility before the end of the year, which has already included an oligonucleotide synthesis facility inaugurated last December, giving us additional manufacturing capability in that region.
Speaker Change: To close out I want to emphasize our commitment to achieving our regulatory objectives and to successfully launching the Kodiak PCR pro instrument and test kits to the world.
Speaker Change: Our team has been working diligently to advance our pipeline of diagnostic solutions, which has resulted in a successful first quarter.
Speaker Change: We are nearing several critical milestones, including clinical evaluations for all of the indications discussed here and a new submission to the FDA for COVID-19.
Speaker Change: In India, we remain on track to complete the build out of our manufacturing facility before the end of the year, which is already included in all of the nucleotide synthesis facility inaugurated last December.
Speaker Change: US additional manufacturing capability in that region.
Dwight Egan: We believe the CODIAX PCR platform can revolutionize and set a new bar for the affordability, accessibility, and decentralization of infectious disease testing. I am very proud of the work of our team and look forward to another quarter of success.
Speaker Change: We believe the Kodiak PCR platform and revolutionize and set a new bar for the affordability accessibility and decentralisation of infectious disease testing.
Speaker Change: I am very proud of the work of our team and look forward to another quarter of success.
Brian Brown: With that, I will now turn the call over to Brian to discuss our financial results. Thanks, Dwight, and thanks to everyone who joined today's call. For the first quarter of 2025, total revenue decreased to $0.1 million, as compared to $0.5 million in the prior year's same period. All revenue recognition during the first quarter came from product revenue. Total operating expenses for the first quarter of 2025 decreased to $8.6 million from $10.5 million in the first quarter of 2024. Research and development expenses in the first quarter of 2025 were $4.9 million compared to $5.7 million during the first quarter of 2024.
Speaker Change: With that I will now turn the call over to Brian to discuss our financial results.
Brian Brown: Thanks, Duane and thanks to everyone, who joined today's call for the first quarter of 2025 total revenue decreased to <unk> 1 million as compared to zero point $5 million.
Speaker Change: In the prior year same period.
Speaker Change: All revenue recognition during the first quarter came from product revenue.
Speaker Change: Total operating expenses for the first quarter of 2025 decreased to $8 6 million.
Speaker Change: From $10 5 million in the first quarter of 2024.
Speaker Change: Research and development expenses in the first quarter of 2025 were $4 9 million.
Speaker Change: Compared to $5 $7 million during the first quarter of 2024.
Brian Brown: For the first quarter of 2025, income before taxes was a loss of $7.5 million as compared to a loss of $9.3 million reported in the prior year period. Net loss for the first quarter of 2025 was $7.5 million for a loss of $0.24 per fully diluted share compared to a net loss of $9.3 million for a loss of $0.31 per fully diluted share in the prior year period. Adjusted EBITDA was a loss of $7.4 million compared to an adjusted EBITDA loss of $8.4 million in the prior year period. We ended the quarter with $21.5 million in cash, cash equivalents, and marketable investment security.
Speaker Change: For the first quarter of 2025 income before taxes was a loss of $7 5 million as compared to a loss of $9 $3 million.
Speaker Change: <unk> in the prior year period.
Speaker Change: Net loss for the first quarter of 2025 was $7 5 million.
Speaker Change: For a loss of 24 per fully diluted share compared to a net loss of $9 3 million.
Speaker Change: Or a loss of 31 per fully diluted share in the prior year period.
Speaker Change: Adjusted EBITDA was a loss of $7 4 million compared.
Speaker Change: Compared to an adjusted EBITDA loss of $8 4 million.
Speaker Change: In the prior year period.
Speaker Change: We ended the quarter with $21 5 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 a future commercial launch. Throughout the year, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings. We plan to provide for the company's capital requirements through equity financing, seeking additional grant funding, and through operational efficiency. In the near term, we are focused on progressing our development pipeline towards regulatory submission and are managing our allocation of time and resources accordingly. We are very excited about our continued progress and remain optimistic about 2025 and future developments within our test pipeline.
Speaker Change: We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for a future commercial launch.
Throughout the year, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings.
Speaker Change: We plan to provide for the company's capital requirements through equity financing.
Speaker Change: Additional grant funding and through operational efficiencies.
Speaker Change: In the near term we are focused on progressing our development pipeline towards regulatory submission and are managing our allocation of time and resources Accordingly.
Speaker Change: We are very excited about our continued progress and we remain optimistic about 2025 and future developments within our test pipeline.
Brian Brown: I look forward to providing you with more updates on next quarter's call.
Speaker Change: I look forward to providing you with more updates on next quarters call.
Dwight Egan: With that, I will now turn the presentation back over to Dwight.
Dwayne: With that I will now turn the presentation back over to Dwayne.
Dwight Egan: Thank you Brian. To close, we want to extend our gratitude to Co-Diagnostic shareholders and our employees who work hard each day to progress our test pipeline and missions.
Speaker Change: Thank you Brian to close we want to extend our gratitude to co diagnostic shareholders and our employees, who work hard each day to progress our test pipeline admissions.
Operator: We will now take questions from our analysts, operator. Thank you. We will now begin the question and answer session. At this time, I would like to remind everyone, in order to ask a question, press star, then the number 1 on your telephone. We will pause for just a moment to compile the Q&A.
Dwayne: We will now take questions from our analysts operator.
Speaker Change: Yeah.
Speaker Change: Thank you we will now begin the question and answer session. At this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.
Speaker Change: We will pause for just a moment to compile the Q&A roster.
Eduardo: And your first question comes from the line of Yi Chen with HC Wainwright. Your line is open. Hi there, this is Eduardo on for you just had hoping to get a little bit more clarity on the timeline for for resubmission for that. You guys were planning on doing it. I understand for the covert test and state of that. And if there's anything else that would be required for that resubmission for the 5, 10 K. So thank you for the question. We have already completed the new design for our new version of the test and we have done extensive verification on the test.
Speaker Change: And your first question comes from the line of <unk> Chen with <unk>.
Speaker Change: H C. Wainwright your line is open.
Eduardo: Hi, there this is eduardo on for UV.
Speaker Change: Just hoping to get a little bit more clarity on the timeline for for Resubmission for.
Speaker Change: You guys were planning on doing it as I understand with the Covid tests and state of that and if there's anything else that.
Speaker Change: Would be required for that Resubmission for the five 10-K application.
Speaker Change: So thank you for the question.
Speaker Change: We have already.
Speaker Change: Completed the new design for our new version of the test and we have done extensive verification on the test.
Dwight Egan: The feedback we had originally received from the FDA on our previous submissions surrounding the ability to monitor the shelf stability of one of our test components. has been solved and we are just getting ready to enter our clinical evaluation. In this process, we have continued to enhance our platform's capabilities and we're now able to incorporate new developments onto the instrument and test cups. for the new COVID-19 test for our new submission, along with other tests in our pipeline. So we're confident that in these enhancements, which we believe unlocks greater manufacturing and operational efficiencies for our new platform and the tests, we're now focused on assembling and preparing for this new submission, which will be substantially similar to our earlier submission, enhanced by the new data that will come from our clinical trial upcoming.
Speaker Change: The feedback we had originally received from the FDA on our previous submission surrounding the ability.
Speaker Change: To monitor the shelf stability one of our team.
Speaker Change:
Speaker Change: Has been solved.
Speaker Change: And we.
Speaker Change: We are just getting ready to enter our clinical evaluations.
Speaker Change: In this process, we have continued to enhance our platforms capabilities and we're now able to incorporate new developments onto the instrument and test cups for.
Speaker Change: For the new COVID-19 tests or our new submission along with other tests in our pipeline.
Speaker Change: So we're confident that these enhancements, which we believe unlocks greater manufacturing and operational efficiencies for our new platform and the tests.
Speaker Change: We're now focused on assembling and preparing for this new submission, which will be substantially similar to our earlier submission.
Speaker Change: <unk> by the new data that will come from our clinical trial upcoming.
Eduardo: So we remain very positive on the functionality and quality of the test. We believe that the revised 510 application will increase the probability of a successful clearance. And so we're very far along in this process and don't anticipate that it will be a long time coming before we will commence our clinical trial. Got it.
Speaker Change: So we remain very positive on the functionality and quality of the test we believe that the revised but an application will increase the probability of a successful clearance and so we're we're very far along in this process and don't anticipate that it will be.
Speaker Change: Long time coming before we will commence.
Speaker Change: Commence our clinical trials.
Dwight Egan: And do you have any specific date by which you expect to submit? Sort of the governor of that is what the prevalence of COVID is in the world, in the United States in particular. So, for instance, if we ended up. you know, being ready to go to clinical trials, but we weren't seeing a prevalence of COVID-19 at our test sites, we would hold on until we saw the amount of COVID infection that would be required to conduct an effective and efficient test. So it's a It's a little bit of a waiting game for when does COVID emerge.
Speaker Change: Got it.
Speaker Change: And do you have any specific date by which you expect to submit.
Speaker Change: Sort of the governor of that is what the prevalence of Covid is.
Speaker Change: In the world in the United States in particular.
Speaker Change: So for instance, if we ended up.
Speaker Change: You know being ready to go to clinical trials, but we werent seeing.
Speaker Change: A prevalence of COVID-19.
At our test sites.
Speaker Change: We would hold on until we saw.
Speaker Change: Out of Covid infection that would be required to conduct an effective and efficient test. So it's it's a.
Speaker Change: It's a little bit of a waiting game for when does Covid emerge. It is you know the history of Covid. It tends to have outbreaks that may for instance be caused by.
Eduardo: As you know, the history of COVID, it tends to have outbreaks that may, for instance, be caused by activities that get group settings together, Thanksgiving, holidays. Ballgames, those sorts of things. So, we don't know exactly what the timing is because there are some exogenous. events and characteristics. that we have to pay attention to. Got it. That's helpful.
Speaker Change: Activities that get group settings, together Thanksgiving holidays.
Speaker Change: All games those sorts of things. So we don't know exactly what the timing is because there are some.
Speaker Change: <unk> you.
Speaker Change: Vance and characteristics that we have to pay attention to.
Speaker Change: Got it got it that's helpful and.
Dwight Egan: And regarding the other products that you are planning to launch in India and South Africa, do you have a timeline for that? I don't know what the regulatory process or timeline for that is as well. So the best guidance I can give you on the other three tests, that would be our multiplex ABCR test, as we refer to it internally, COVID, or it includes COVID-19, it includes RSV, it includes flu A and flu B. That is also governed by the same kind of constraints that I mentioned with respect to COVID. And then there's the HPV test and the TB test we expect.
Speaker Change: Regarding the other products that you are planning to launch in India, and South Africa do you have a timeline for that.
Speaker Change: I don't know what the regulatory process or timeline for that is as well.
Speaker Change: So the best guidance I can give you on the other three tests that would be our multiplex.
Speaker Change: Our task as we referred to it internally COVID-19.
Speaker Change: Sure.
Speaker Change: COVID-19 includes RSV it includes flu a flu b.
Speaker Change: That is also governed by the same kind of constraints that I mentioned with respect to Covid.
Speaker Change: And then Theres the HPV test in the TB test we expect.
Dwight Egan: all of those tests to be into clinical trials during the remainder of this year. They will commence clinical trials during the remaining part of 2025. As you can appreciate, in places like India, we don't have any problem getting samples. So there's not a constraint with respect to the presence of HPV. HPV India comprises roughly 25% of all HPV cases in the world. So we don't have an anticipation that we're going to have any trouble getting samples there. And of course, in tuberculosis. It is the number one infectious disease killer on the planet, and India is certainly one of the epicenters of that.
Speaker Change: All of those SaaS to be into clinical trials during the remainder of this year they will commence clinical trials.
Speaker Change: During the remaining part of 2025.
Speaker Change: As you can appreciate in places like India, We don't have any problem getting samples so theres not a constraint with respect to the <unk>.
Speaker Change: Presence of HPV.
Speaker Change: HPV, India comprises roughly 25% of all HPV cases in the world. So we don't have an anticipation that we're going to have any trouble getting samples there and of course in tuberculosis.
Speaker Change: It is the number one infectious disease killer on the planet and India is certainly one of the Epicenters of that so we don't anticipate having any trouble getting those samples so but other than that from a data standpoint, they will all be entering.
Dwight Egan: So we don't anticipate having any trouble getting those samples. So, but other than that, from a date standpoint, they will all be entering the clinical trial phase. during the rest of this calendar year. Got it, got it. That's really helpful. So, broadly speaking, it's probable that the HPV and tuberculosis tests or trials might run a little bit quicker, leading to maybe an earlier launch. Is that a fair characterization? It is a that is certainly a possibility. The, largely that stems from the ability to get. samples at will, basically. So keep in mind that all of these indications are you know, currently undergoing important testing.
Speaker Change: The clinical trial phase.
Speaker Change: During the rest of this calendar year.
Speaker Change: Got it got it that's really helpful. So broadly speaking it's.
Speaker Change: Probable that the HBV and tuberculosis tests or trials might run a little bit quicker.
Speaker Change: So maybe an earlier launch that fair characterization.
Speaker Change: It is a that is certainly a possibility.
Speaker Change: The.
Speaker Change: Largely that stems from.
Speaker Change: The ability to get.
Speaker Change: Samples at will basically.
Speaker Change: So keep in mind that all of these indications.
Speaker Change: Yeah.
Speaker Change: Are.
Speaker Change: Currently undergoing important testing we have manufactured hundreds of thousands of test cups in our <unk>.
Dwight Egan: We have manufactured hundreds of thousands of test cups in our facility, our manufacturing facility, so there's been a ton of work done getting ready for these clinical trials. I would add, I think, that our original submission with respect to COVID-19, the FDA did not have a problem with our instrument. They didn't have a problem with And, you know, the clinical trial that was performed, which involved well over 800 different patients, we just wanted to fix the one internal positive control and makes it so that that was not something we had to really ever worry about again.
Speaker Change: In our.
Facility, our manufacturing facility.
Speaker Change: So there's been a ton of work done getting ready for these clinical trials.
Speaker Change: I would add I think that our original submission with respect to COVID-19.
Speaker Change: The FDA did not have a problem with our instrument.
Speaker Change: They didn't have a problem with it.
Speaker Change: The clinical trial that was performed which evolved well over 800 different patients.
Speaker Change: We just wanted to fix the one internal positive control.
Speaker Change: And it makes it so that that was not something we had to really ever worry about again in the same.
Dwight Egan: And the same positive control that's RNA-based is also incorporated into the ABCR test. So, we are on the lip of the cup of being ready to go into clinical trials and look forward to that very important step for us during the remainder of this year. And then it's on to regulatory submission and our initial commercialization.
Speaker Change: Positive control. This RNA base is also incorporated into the ABC or test.
Speaker Change: So we are on the lipid the cut of being ready to go into clinical trials.
Speaker Change: And look forward to that very important step for us.
Speaker Change: During the remainder of this year and then it's onto regulatory submission and our mission our initial commercialization launch.
Speaker Change: Understood and then just one final one I guess.
Speaker Change: If I could be obviously, if you have any idea for pricing in the gross margins for the device and the test cups.
Dwight Egan: Do you have any idea for pricing and the gross margins for the device and the test cups? I imagine it would vary from geography, but if you could give maybe ballpark estimates if they're available. Yeah, I think we have long talked about the cost of our instrument initially being in the $300 to $500 range, kind of depends on how many people buy. And at scale, you know, we know where our target is at the lower end of that number, and we may begin our deployment at a little bit higher number as we scale up. But that's the sort of working number that we're looking for.
Speaker Change: I imagine it would vary from geography, but if you could give maybe a ballpark estimates if they're available.
Speaker Change: Yeah, I think we have long.
Talked about the costs of our instrument and initially being in the three to $500 range kind of depends on how many people buy.
Speaker Change: At scale, we know where our target is at the lower end of that number and we may begin our deployment a little bit higher number as we scale up.
Speaker Change: But that's the sort of working a number that we're looking for it's not a guaranteed number but that's what our target is and with respect to the test cartridges as you have mentioned.
Dwight Egan: It's not a guaranteed number, but that's what our target is. And with respect to the test cartridges, as you have mentioned, you're right. It kind of depends on the geography. Low and middle income countries will have a lower price test, generally speaking, than in the developing, developed world. So we've typically used the $15 to $20 per cup price in the developed world and for diseases such as tuberculosis. We've used. Pricing that is lower than our primary competitors in places like India. That's as much guidance, I think, as I can give you on that right now.
Speaker Change: Youre right it kind of depends on the geography.
Speaker Change: Low and middle income countries will have a lower price test generally speaking than in the.
Speaker Change: Developing the developed world.
Speaker Change: So we've typically used the 15% to $20.
Speaker Change: Per Cup.
Speaker Change: Price in the developed world.
Speaker Change: For diseases, such as tuberculosis.
Speaker Change: We'd be used.
Speaker Change: Pricing that is lower than our primary competitors in places like India. That's as much guidance have been because I can give you on that right now and in human Papilloma virus is probably not as sensitive as television and Eduardo. This is Bryan just to add one little piece of information to that.
Dwight Egan: And the human papillomavirus is probably not as sensitive as TB.
Brian Brown: And Eduardo, this is Brian. Just to add one little piece of information to that, we would expect in terms of margins that our margins on the device would be similar to the equipment that we sold in the past. And we'd expect that the tests are similar, the margins are going to be similar to the margins we've experienced when we've sold the lab-based tests in the past. Got it.
Speaker Change: We would expect in terms of margins that our margins on the device would be similar to the equipment that we sold in the past and we'd expect that the tests are similar the margins are going to be similar to the margins. We've experienced when we sold the lab based test in the past.
Eduardo: So using, are these past references for those? Alright, really appreciate the answers and thanks for taking the question. Thanks Eduardo. Thank you.
Speaker Change: Got it so using these past references for those.
Speaker Change: Alright really appreciate it.
Speaker Change: The answers.
Speaker Change: Thanks for taking the questions.
Speaker Change: Thanks Alvaro.
Speaker Change: Okay.
Operator: I'm not showing any further questions in the queue.
Speaker Change: Thank you I'm not showing any further questions in the queue, ladies and gentlemen that concludes today's call. Thank you all for joining you may now disconnect.
Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining.
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