Q4 2024 Co-Diagnostics IncEarnings Call
Andrew Benson: Financial Officer. Earlier today, Co-Diagnostics released financial results from the fourth quarter and full year ended December 31st, 2024.
Earlier today <unk> diagnostics released financial results from the fourth quarter and full year ended December 31, 2020 for a copy of the press release is available on the company's website. We will begin the call with management's prepared remarks, and then open the call to analyst Q&A before we begin we would like to inform our listeners that certain statements made by co diagnostics during this.
Operator: A copy of the press release is available on the company's website. We will begin the call with management's prepared remarks, then open 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.
Call, which are not historical facts are forward looking statements include statements concerning the company's Kodiak PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use there's not currently for sale. In addition to testing diagnostic tests developments and timing for commencement.
Of clinical evaluations 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 code diagnostics filings with the SEC go diagnostics assumes no obligation and expressly.
Operator: 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 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.
<unk> disclaims any duty to update any forward looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events.
In addition, the company 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 a reconciliation to the non-GAAP financial measures presented to their most comparable.
Operator: 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.
GAAP results.
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. Thank you for joining Co-Diagnostics fourth quarter and full year 2024 earnings call. 2024 was an important year for co-diagnostics. We advanced the development of the CODX-PCR platform and associated test pipeline and added important manufacturing infrastructure as we strengthened the foundation for the platform's commercialization. During the course of the year, our team has worked hard to bring our low-cost, rapid, and easy-to-use platform closer to launch, and I'm excited to build upon our progress in 2025.
Dwight Egan: At this time I would like to turn the call over to co diagnostics, Chief Executive Officer, Dwight Egan right.
Okay.
Dwight Egan: Thank you Andrew and good afternoon, everyone.
Dwight Egan: Thank you for joining code diagnostics fourth quarter and full year 'twenty 'twenty four earnings call.
Dwight Egan: 'twenty 'twenty four was an important year for co diagnostics, we advanced the development of the Kodiak PCR platform and associated test pipeline and added important manufacturing infrastructure as we strengthened the foundation for the platforms commercialization.
Dwight Egan: During the course of the year. Our team has worked hard to bring our low cost rapid and easy to use platform closer to launch and I'm excited to build upon our progress in 2025.
Dwight Egan: I'd like to begin my remarks by discussing some recent developments within our test pipeline before discussing some of our key accomplishments in 2024 and our future development plan. Our main objective at Co-Diagnostics is to increase the accessibility of affordable, high-quality diagnostics in the United States and around the world. In June of 2024, we completed our first application to the U.S. FDA seeking 510K clearance for the CODIX-PCR-PRO instrument and the CODIX-PCR-COVID-19 test for over-the-counter use. The CODIACS team maintained active and collaborative dialogue with the FDA as they reviewed our submission and as we responded to requests for information, providing in additional context and support for our submission as needed.
Dwight Egan: I'd like to begin my remarks by discussing some recent developments within our test pipeline before discussing some of our key accomplishments in 'twenty 'twenty, four and our future development plans.
Dwight Egan: Our main objective that code agnostic as to increase the accessibility of affordable high quality diagnostics in the United States and around the World in June of 'twenty 'twenty four we completed our first application to the U S. F. D. A seeking 510 clearance five 10-K clearance for the Kodiak P C. Our pro <unk>.
Dwight Egan: Instrument and the Kodiak PCR COVID-19 test for over the counter use.
Dwight Egan: Kodiak team maintained active and collaborative dialogue with the F. D. A as they reviewed our submission and as we responded to requests for information, providing an additional context and support for our submission as needed.
Dwight Egan: As our conversations regarding the submission evolved, we received feedback from the FDA regarding the ability to monitor the shelf life stability of one of our COVID-19 test components. We explored several options to address this and concluded that replacing the component was the best course of action to help ensure the reliability and accuracy of the test for our customers and to be successful in our regulatory ambition. Any change to the design or composition of a medical device under review by the FDA requires the collection of new clinical data to evaluate the device's performance.
Dwight Egan: As our conversations regarding the submission evolved we received feedback from the FDA regarding the ability to monitor the shelf life stability of one of our COVID-19 tests components.
We are exploring several options to address this and concluded that we placed in the component was the best course of action to help ensure the reliability and accuracy of the test for our customers and to be successful in our regulatory ambitions.
Dwight Egan: Any change to the design or composition of a medical device under review by the FDA requires the collection of new clinical data to evaluate the device's performance.
Dwight Egan: Because this was not feasible to provide within FDA's review deadline for the original submission, management made the decision to withdraw our 510k submission application with the intention of submitting again with updated clinical data at a later date. We determined that a new submission with the updated chemistry and supporting clinical data represented the most efficient way to bring the new version of our test before the FDA, while simultaneously addressing the issues brought up by the FDA and improving the probability of a successful clearance. The FDA was extremely informative throughout our review process, and we believe we have a clear path forward based on their feedback.
Dwight Egan: Because this was not feasible to provide within Fda's review deadline for the original submission.
Speaker Change: Management made the decision to withdraw our five 10-K submission application with the intention of submitting again with updated clinical data at a later date.
Speaker Change: We determined that a new submission with the updated chemistry and supporting clinical data represented the most efficient way to bring the new version of our test before the F. D. A while simultaneously addressing the issues brought up by the F D a and improving the probability of a successful clearance.
Speaker Change: The FDA was extremely informative throughout our review process and we believe we have a clear path forward based on their feedback.
Dwight Egan: Since we believe our COVID-19 test represents the quickest path to regulatory clearance and commercialization, we have focused our efforts on completing the design updates for the test that will be used in the revised 510K application with the goal of accelerating our submission timeline. We have full confidence in the quality of the test performance and in our team to submit an enhanced COVID-19 test to the FDA with an application that is largely similar to that submitted in 2024. I'm pleased to report that the design for the new test has already been completed and undergone extensive verification testing.
Speaker Change: Since we believe our COVID-19 test represents the quickest path to regulatory clearance and commercialization. We have focused our efforts on completing the design updates for the test that will be used in the revised five 10-K application with the goal of accelerating our submission timeline.
Speaker Change: We have full confidence in the quality of the test performance and in our team to submit an enhanced COVID-19 tests to the F. D. A with an application that is largely similar to that submitted in 'twenty 'twenty four I am pleased to report that the design for the new test has already been completed and undergone X.
Speaker Change: Stenseth verification testing.
Speaker Change: Throughout the duration of the Fda's review process our work on the other tests in the pipeline was furthered by our R&D teams continued enhancements to the platform's capabilities, including aspects of the PCR instrument and test Cups.
Dwight Egan: Throughout the duration of the FDA's review process, our work on the other tests in the pipeline was furthered by our R&D team's continued enhancements to the platform's capabilities, including aspects of the PCR instrument and test cup. An important byproduct of the decision to complete a new 510k submission is that we can now also incorporate these new platform developments into the instrument and the test cups for the COVID-19 test in the new submission, which we anticipate will enhance operational and manufacturing efficiencies for future tests in our pipeline. At Co-Diagnostics, we pride ourselves on quality and reliability and continue to believe in the potential of our new platform to increase the accessibility of real-time PCR technology and play a transformative role in the domestic and global diagnostics landscape.
Speaker Change: An important byproduct of the decision to complete a new five 10-K submission is that we can now also incorporate these new platform developments into the instrument and the chest cups for the COVID-19 test in the new submission, which we anticipate will enhance operational and manufacturing efficiencies for future Tech.
Speaker Change: It's in our pipeline.
Speaker Change: At Ko diagnostics, we pride ourselves on quality and reliability and continued to believe in the potential of our new platform to increase the accessibility of a real time, PCR technology and play a transformative role in the domestic and global diagnostics landscapes.
Speaker Change: We continue to make great progress across our test development pipeline throughout 'twenty 'twenty, four and into 2025, which includes our diagnostic tests for tuberculosis or T. B.
Dwight Egan: We continue to make great progress across our test development pipeline throughout 2024 and into 2025, which includes our Diagnostic Test for Tuberculosis, or TB, Respiratory Multiplex, and HPV Multiplex. These indications reflect diseases where the CODIACS PCR platform has an opportunity to make a significant impact on the diagnostic standard of care and eventual patient outcomes. We have been supported in our development efforts by several leading organizations who share our values and our passion for improving the global health infrastructure, including the Bill and Melinda Gates Foundation, Smart for TV, and the National Institute of Health's RADx Tech Program.
Speaker Change: Respiratory multiplex and H P V multiplex these indications reflect diseases, where the Kodiak PCR platform has an opportunity to make a significant impact on the diagnostic standard of care and eventual patient outcomes.
Speaker Change: We have been supported in our development efforts by several leading organizations, who share our values and our passion for improving the global health infrastructure, including the Bill and Melinda Gates Foundation Smart for T V and the National Institute of Health radically Tech program.
Dwight Egan: Starting with our TB test, we are excited by our 2024 progress, which included the completion of several preliminary analytical studies. TB is a high priority in several countries and regions around the world, including India, where we have a strong presence through our joint venture, COSERA Diagnostics. A limiting factor for real-time PCR TB diagnostics at the point of care has historically been finding a way to prepare the patient's sample for the PCR process. in place of the sample extraction step performed in high-complexity clinical labs. Sample extraction is required to make the genetic material of the TB bacterium accessible to the primers used in the centralized lab's PCR tests, but incurs additional costs, adds to the overall PCR testing time, and must be performed in highly regulated, controlled conditions to limit contamination risk.
Speaker Change: Starting with our TV test we are excited by our 'twenty 'twenty four progress, which included the completion of several preliminary analytical studies T.
Speaker Change: <unk> is a high priority in several countries and regions around the world, including India, where we have a strong presence through our joint venture Coursera diagnostics.
Speaker Change: Limiting factor for real time, PCR D TB diagnostics at the point of care.
Speaker Change: Has historically been finding a way to prepare the patient sample for the PCR process.
Speaker Change: In place of the sample extraction step performed in high complexity clinical labs Sam.
Speaker Change: Sample extraction is required to make the genetic material of the TB bacterium accessible to the primers used in the centralized labs Pcr tests.
Speaker Change: But incurs additional costs adds to the overall PCR testing time and must be performed in highly regulated controlled conditions to limit contamination risk.
Dwight Egan: Developing a TB-PCR test used at the point of care has required re-envisioning how a patient's sample can be collected and prepared for the PCR analysis. Key to the operation of the TB test on the CODIX-PCR platform has been identifying a procedure that would simply and affordably prepare patient TB samples prior to being added to the CODIX-PCR TB test kit. After an exhaustive and global search, we have identified instruments that we believe allow us to achieve our performance and cost efficiency targets and to proceed with preparations for our clinical evaluation. We are on track to commence clinical evaluations in both South Africa and India in the second half of 2025 to support regulatory submissions in those countries.
Speaker Change: Developing a T V. PCR test used at the point of care has required re envisioning how a patient samples can be collected and prepared for the PCR analysis P.
Speaker Change: Key to the operation of the TB test on the Kodiak PCR platform has been identifying a procedure that would simply and affordably prepare patient TV samples prior to being added to the Kodiak P. C. R. T B test kit.
Speaker Change: After an exhaustive and global search we have identified instruments that we believe allow us to achieve our performance and cost efficiency targets and to proceed with preparations for our clinical evaluations.
Speaker Change: We are on track to commence clinical evaluations in both South Africa, and India in the second half of 2025 to support regulatory submissions in those countries in India. We plan to pursue a regulatory pathway through the central drug standard control organization or C. D. S. C. O initially targeting the point of.
Dwight Egan: In India, we plan to pursue a regulatory pathway through the Central Drug Standard Control Organization, or CDSCO, initially targeting the point of care, remote settings, and local health care centers. We believe that our tests on the new platform can be a critical asset to the country's goal of eradicating TB. As we continue to prepare for clinical studies, our team has been collaborating with local health officials, potential customers, and other organizations to map our optimal go-to-market strategy. In 2024, we evaluated higher throughput smear microscopy centers, where target customers and experts agree that a point-of-care diagnostic solution could improve upon and help close the accessibility gaps left by outdated testing methods.
Speaker Change: Tear remote settings, and local health care centers, we believe that our test on the new platform can be a critical asset to the country's goal of eradicating TB.
Speaker Change: As we continue to prepare for clinical studies, our team has been collaborating with local health officials potential customers and other organizations to map our optimal go to market strategy in 2024, we evaluated higher throughput smear microscopy centers, where target customers and experts agree that a point of care.
Speaker Change: <unk> diagnostic solution could improve upon and help close the accessibility gaps left by outdated testing methods.
Dwight Egan: Our regulatory and commercial pathway also includes the pursuit of clearance in South Africa through the South Africa Health Products Regulatory Agency, or SAFRA, which we believe could facilitate registering and marketing our tuberculosis test and the PCR Pro instrument throughout several jurisdictions in Africa as an in vitro diagnostic solution.
Speaker Change: Our regulatory and commercial pathway also includes the pursuit of clearance in South Africa through the South Africa health products regulatory agency or Safra.
Speaker Change: Which we believe could facilitate registering and marketing our tuberculosis test and the PCR pro instrument throughout several jurisdictions in Africa as an in vitro diagnostic solution.
Speaker Change: The respiratory multiplex test developed in part with financial support from the NIH is radical Tech initiative has been designed to deliver real time PCR test results for flu, a and B COVID-19 in RSV.
Dwight Egan: The Respiratory Multiplex Test, developed in part with financial support from the NIH's Radix Tech Initiative, has been designed to deliver real-time PCR test results for flu A and B, COVID-19, and RSV. CODIACS completed the pre-submission to the FDA earlier this month and we have been assigned a reviewer. Our development team continues to work hard on preparing the assay for clinical evaluations, which are expected to begin in the second half of this year. The burden that respiratory illnesses place on the healthcare system, businesses, families, and patients has always been high. We continue to see a considerable degree of interest in this multiplex test and believe interest will remain high as we look forward to completing the steps that will allow us to put it into commercialization.
Speaker Change: <unk> completed the pre submission to the FDA earlier this month and we have been assigned a reviewer.
Speaker Change: Our development team continues to work hard on preparing the assay for clinical evaluations, which are expected to begin in the second half of this year.
Speaker Change: The burden that respiratory illnesses place on the health care system businesses families and patients has always been high we continue to see a considerable degree of interest in this multiplex test and believe interest will remain high as we look forward to completing the steps that will allow us to put it into commercialization.
Speaker Change: One of the key differentiating features of the platform is its operability via a smartphone with cloud based analysis that can all allow D identified data to be provided to help departments at the local regional national or international level to help track track outbreaks of infectious.
Dwight Egan: One of the key differentiating features of the platform is its operability via a smartphone with cloud-based analysis that can allow de-identified data to be provided to health departments at the local, regional, national, or international level to help track outbreaks of infectious diseases. We anticipate use cases for this situational awareness feature to benefit areas as small as an assisted living center, potentially being afflicted by an outbreak of RSV within a community, or a region in India covering several hundred square miles, enabling public health officials to target their efforts to deliver TB therapeutics to patients whose need is most urgent, thanks to the early warning system that this awareness could provide.
Speaker Change: Texas diseases, we anticipate use cases for this situational awareness feature to benefit areas as small as an assisted living center potentially being afflicted by an outbreak of ours be within a community or a region in India covering several hundred square miles, enabling public health officials to target their efforts to <unk>.
Speaker Change: Deliberate TV therapeutics to patients who need is most urgent thanks to the early warning system that this awareness could provide.
Dwight Egan: The development of the HPV multiplex test, which was supported by a grant from the Bill and Melinda Gates Foundation, experienced substantial positive movement during 2024. High-risk human papillomavirus subtypes can lead to cervical cancer, which caused an estimated 350,000 deaths in 2022. And HPV remains a disease for which there is a vast international need for testing, as testing accessibility and efficiency remains a key constraint to combating the impact of HPV on global health. Like the other tests on the new platform, the CODIX HPV Multiplex test utilizes the multiplexing advantages of CODIX CoPrimers technology and is designed to use the unique architecture of the CODIX PCR Pro instrument to detect eight high-risk HPV subtypes from cervical swab samples and the goal of providing an affordable, accessible HPV screen tool for patients around the world, especially in low- and middle-income countries.
Speaker Change: The development of the H D D multiplex test, which was supported by a grant from the Bill and Melinda Gates Foundation experienced substantial positive movement during 'twenty 'twenty four high risk human papilloma virus subtypes can lead to cervical cancer, which caused an estimated 350000 deaths in 2022 and H.
Speaker Change: <unk> remains a disease for which there is a vast international need for testing as testing accessibility and efficiency remains a key constraint to combating the impact of HBV on global health.
Speaker Change: Like the other tests on the new platform the codex HBV multiplex test utilizes the multiplexing advantages of Cody ex co primaries technology and is designed to use the unique architecture of the kony ex PCR pro instrument to detect eight high risk HPV subtypes from cervical swab.
Speaker Change: <unk> samples.
Speaker Change: And the goal of providing an affordable accessible HPV screening tool for patients around the world.
Speaker Change: Especially in low and middle income countries.
Dwight Egan: The chemistry optimization is complete, and we are pleased with the preliminary performance data. We are working with funding partners and other collaborative stakeholders in the project to determine the most appropriate and expeditious pathway towards initiating clinical studies with the CODIACS HPV multiplex test with the goal of pursuing regulatory clearance in India and expanding clearance into other regions. Similar to TB, we believe the combination of our joint venture, COSERA, and the fully differentiated nature of our platform leave us well-positioned to address another unmet diagnostic need in the Indian market.
Speaker Change: The chemistry optimization is complete and we are pleased with the preliminary performance data.
We are working with funding partners and other collaborative stakeholders in the project to determine the most appropriate and expeditious pathway towards initiating clinical studies with the Kodiak HPV multiplex tests with the goal of pursuing regulatory clearance in India and expanding clearance into other regions.
Speaker Change: Similar to T V. We believe the combination of our joint venture co Sarah and the fully differentiated nature of our platform leave us well positioned to address another unmet diagnostic need in the Indian market.
Speaker Change: In addition to new test development. We also accomplished several goals in 2024 that have been positioned co diagnostics for the successful commercialization of the codex PCR platform in April we inaugurated a new manufacturing facility in South Salt Lake, Utah, which has been designed to manufacture the kodiak.
Dwight Egan: In addition to new test development, we also accomplished several goals in 2024 that have been positioned Co-Diagnostics for the successful commercialization of the CODX-PCR platform. In April, we inaugurated a new manufacturing facility in South Salt Lake, Utah, which has been designed to manufacture the CODX-PCR Pro Instrument Test Cups and our Co-Primers technology. This facility will play a key role in supporting our commercialization efforts and will be instrumental in helping us to meet the anticipated demand for our platform upon our initial launch. Later in the year, we inaugurated a second facility in India to support cost-effective manufacturing of our co-primers, oligonucleotides.
Speaker Change: PCR Pro instrument test Cups, and our co primary technology.
Speaker Change: This facility will play a key role in supporting our commercialization efforts and will be instrumental in helping us to meet the anticipated demand for our platform upon our initial launch.
Speaker Change: Later in the year, we inaugurated a second facility in India to support cost effective manufacturing of our co primers oligonucleotides.
Dwight Egan: The facility also has space for future production capacity for our instrument and kits, which will allow in-country manufacturing of our platform and tests that we plan to commercialize in the Indian market. Earlier this month, COSERA received what is known as a test license on Form MD-13 from the CDSEO in India, which licenses COSERA to manufacture limited predetermined quantities of CODAX PCR Pro instruments, CODAX PCR MTB test cups, and CODAX PCR HPV test cups in its facilities. for the purpose of gathering data from evaluations and clinical studies. The data gathered in these studies will be used in submissions to the CDSCO for IBD clearance.
Speaker Change: Facility also has space for future production capacity for our instruments and kits.
Speaker Change: It will allow in country manufacturing of our platform and tests that we plan to commercialize in the Indian market.
Speaker Change: Earlier this month <unk> received what is known as a test license on form M. D 13 from the C. D. S. T O in India, which licenses co Sarah to manufacturer limited predetermined quantities of Kodiak PCR Pro instruments, Kodiak, PCR MTB test cups, and Kodiak specie or HPV test cups in its.
Speaker Change: <unk>.
Speaker Change: For the purpose of gathering data from evaluations and clinical studies.
Speaker Change: The data gathered in these studies will be used in submissions to the C. D. A C O for IBD clearance.
Dwight Egan: While it's important to point out that it does not authorize COSERA to manufacture these items for commercial use or sale, receiving this test license from the CDSCO is a vital step towards regulatory submission and IVD clearance, as well as for qualifying for the Make in India initiative. Manufacturing instruments and test kits in-house is required to qualify under this initiative, which will allow the CODIX PCR platform to benefit from the cost-saving advantages over importing complete instruments and tests into India, and is expected to help overcome other hurdles confronting foreign companies doing business in India. In addition to building new manufacturing capacity overseas and in Utah, we also spent time in discussions with potential commercial partners at industry conferences and trade shows around the world.
Speaker Change: While it's important to point out that it does not authorized coursera to manufacture these items for commercial use or sale receiving this test license from the C. D. S. T. O is a vital step towards regulatory submission in IBD clearance as well as for qualifying for the make in India initiative.
Manufacturing instruments and test kits in the house is required to qualify under this initiative, which will allow the codex PCR platform to benefit from the cost saving advantages over importing complete instruments and test into India and is expected to help overcome other hurdles confronting foreign companies doing business in India.
Speaker Change: In addition to building new manufacturing capacity overseas and in Utah, we.
Speaker Change: We also spent time in discussions with potential commercial partners at industry conferences and trade shows around the world. We are receiving encouraging feedback on the platform and maintaining a regular dialogue with the valuable contacts made through these efforts.
Dwight Egan: We are receiving encouraging feedback on the platform and maintaining a regular dialogue with the valuable contacts made through these efforts. I am pleased with both the quantity and quality of our commercial discussions and look forward to building upon our relationships in 2025.
Speaker Change: I am pleased with both the quantity and quality of our commercial discussions and look forward to building upon our relationships in 2025.
Speaker Change: I am proud of our 2020 for progress and I'm eager to tackle the opportunities before co diagnostics in 2025.
Dwight Egan: I am proud of our 2024 progress, and I'm eager to tackle the opportunities before co-diagnostics in 2025. In addition to working diligently to complete a new 510k submission for this COVID-19 test and the CODX PCR Pro instrument during 2025, we also are planning to initiate clinical evaluations for all the other tests in our pipeline discussed today on the new platform. I am confident we are taking the right steps to advance the commercial and technical aspects of the CODX PCR platform, which has the potential to revolutionize diagnostic testing around the world. With all the work we have done in 2024, including building manufacturing capacity, advancing discussions with potential customers and commercial partners, and further advancing our test pipeline, I am excited to build upon our progress to drive a successful 2025.
Speaker Change: In addition to working diligently to complete our new five 10-K submission for this COVID-19 test and the Kodiak PCR Pro instrument. During 2025, we also are planning to initiate clinical evaluations for all the other tests in our pipeline discussed today on the new platform.
I am confident we are taking the right steps to advance the commercial and technical aspects of the Kodiak PCR platform, which has the potential to revolutionize diagnostic testing around the world.
Speaker Change: With all the work we have done in 'twenty to 'twenty, four including building manufacturing capacity advancing discussions with potential customers and commercial partners and further advancing our test pipeline I'm excited to build upon our progress to drive a successful 2025.
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 fiscal year 2024, total revenue decreased to $3.9 million as compared to $6.8 million in the prior year's same period. Grant revenue in 2024 was $3.1 million, and product revenue was $0.8 million. Gross profit for the full year, 2024, increased to $2.9 million, compared to $2.6 million in the prior year. Total operating expenses for the year ended December 31, 2024, decreased to $43.0 million from $45.3 million in 2023. The decrease from the prior year is primarily due to higher expenses in 2023 from platform development and regulatory submission preparation.
Brian: With that I will now turn the call over to Brian to discuss our financial results.
Brian: Thanks, Dwight and thanks to everyone who joined today's call.
Brian: For fiscal year, 2024, total revenue decreased to $3 $9 million as compared to $6 8 million in the prior year same period.
Brian: Grant revenue in 2024 was $3 $1 million and product revenue was zero point $8 million.
Brian: Gross profit for the full year 2024 increased to $2 9 million.
Brian: Compared to $2 $6 million in the prior year.
Brian: Total operating expenses for the year ended December 31, 2024 decreased to 43.0 million from $45 $3 million in 2023.
Brian: The decrease from the prior year is primarily due to higher expenses in 2023 from platform development and regulatory submission preparation.
Brian: Research and development expenses in 2024 or $21.0 million compared to 23 points here $1 million in 2023.
Brian Brown: Research and Development Expenses in 2024 were $21.0 million compared to $23.0 million in 2023. Legal expenses for the year ended December 31, 2024, increased to $7.0 million from $1.7 million in 2023. The significant increase in legal expenses is due to funding the defense of two securities class action lawsuits and related derivative suits.
Brian: Legal expenses for the year ended December 31 2024.
Brian: Increased to $7.0 million from $1 $7 million in 2023.
Brian: The significant increase in legal expenses is due to funding the defense of two securities class action lawsuits and related derivative suits.
Brian: As announced on March six 2025, the securities in governance litigation team at Baker Hostettler, the legal firm retained to represent the company when complete dismissal on summary judgment of one of the Securities class action suits that had been pending against the company in the United States District Court for the district of Utah.
Brian Brown: As announced on March 6, 2025, the Securities and Governance Litigation Team at Baker Hostetler, the legal firm retained to represent the company, won complete dismissal on summary judgment of one of the securities class action suits that had been pending against the company in the United States District Court for the District of Utah. For 2024, income before taxes was a loss of $37.6 million, as compared to a loss of $38.1 million reported in the prior year. Net loss for 2024 was $37.6 million, or a loss of $1.24 per fully diluted share, compared to a net loss of $35.3 million, or a loss of $1.20 per fully diluted share in the prior year.
Our 2020 for income before taxes was a loss of $37 6 million as compared to a loss of $38 $1 million reported in the prior year.
Brian: Net loss for 2024 was $37 6 million or a loss of $1 24 per fully diluted share compared to a net loss of $35 $3 million or a loss of $1 20 per fully diluted share in the prior year.
Brian: Adjusted EBITDA was a loss of $33 $5 million compared to an adjusted EBITDA loss of $33.0 million in the prior year.
Brian Brown: Adjusted EBITDA was a loss of $33.5 million compared to an adjusted EBITDA loss of $33.0 million in the prior year. We ended the quarter with $29.7 million in cash, cash equivalents, and marketable investment securities. We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for a future commercial launch. In 2025, 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.
Brian: We ended the quarter with $29 $7 million in cash cash equivalents and marketable investment securities.
Brian: We continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for future commercial launch.
Brian: In 2025, we will continue to make improvements to our operating footprint that will drive efficiency gains and cost savings.
Brian: We plan to provide for the company's capital requirements through equity financing seeking additional grant funding and through operational efficiencies.
Brian: 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.
Brian: We're very excited about our continued progress and remain optimistic about 2025 and future developments within our test pipeline.
Brian Brown: We are very excited about our continued progress and 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.
Brian: 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. Thank you, Brian.
Speaker Change: With that I will now turn the presentation back over to <unk>.
Brian: Thank you Brian.
Dwight Egan: To close, we want to extend our gratitude to Co-Diagnostics shareholders and our employees who work hard each day to progress our test pipeline and mission.
Speaker Change: 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.
Operator: We will now take questions from our analysts. Operator? We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touch-tone phone. If you are using a speakerphone, please pick up your handset before pressing the key. If at any time your question has been addressed, and you would like to withdraw your question, please press star and then 2.
Speaker Change: We will now take questions from our analysts operator.
Speaker Change: Thank you.
Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone.
Speaker Change: If you are using a speakerphone please pick up your handset before pressing the keys.
Speaker Change: At any time. Your question has been addressed and you would like to withdraw your question. Please press Star and then two.
Operator: At this time, we will pause momentarily to assemble our roster.
Speaker Change: At this time, we will pause momentarily to assemble our roster.
Speaker Change: And your first question today will come from E. Chen with H C. Wainwright. Please go ahead.
Operator: And your first question today will come from Yi Chen with HC Wainwright. Please go ahead. Good afternoon. This is Eduardo on for ye.
Speaker Change: Good afternoon. This is Eduardo on for you I had a quick question, whether or not you all would be interested or open to the possibility of dropping an avian flu test.
Dwight Egan: I had a quick question, whether or not you all would be interested or open to the possibility of developing an avian flu test, either for birds or humans. This is Dwight. Thank you for your questions. We have developed a H5N1 test. And we are. you know, very prepared to make additions to that type of test should the need arise.
Speaker Change: Either for birds to humans.
Dwight Egan: This is dwight.
Speaker Change: Thank you for your question.
Speaker Change: We have developed a H five N one test.
Speaker Change: And we are.
Speaker Change: Very prepared to.
That make additions to that type of test should the need arise.
Speaker Change: Okay and is it being used actively.
Dwight Egan: Okay, and is it being used actively? Is it the ambition that it be used for, obviously, human testing rather than bird testing? Our ambition would be that it would have use both for humans and for livestock and birds. You know, it may have some optimizations for the different types of. people or animals as it's used for, but we jumped on that opportunity when the H5N1 first became an item of interest and we're prepared, as I said, to respond if need be. Okay, that's helpful.
Speaker Change: Is it is there an ambition that it would be used for obviously human testing rather than.
Speaker Change: Bird testing.
Speaker Change: Our ambition would be that it would have used both for humans.
Speaker Change: And for livestock and birds.
Speaker Change: You know it may have some.
Speaker Change: Optimizations for the different types.
Speaker Change: Types of.
Speaker Change: Yes.
Speaker Change: People or animals are accused four.
Speaker Change: We jumped on that opportunity when the H five N. One first became.
Speaker Change: And item of interest and we're prepared as I said to respond if need be.
Speaker Change: Okay.
Speaker Change: That's helpful.
Speaker Change: Yeah.
Speaker Change: This will conclude our question and answer session as well as conference call. Thank you for attending today's presentation. You may now disconnect your lines and have a great day.
Operator: This will conclude our question and answer session as well as conference call. Thank you for attending today's presentation. You may now disconnect your lines and have a great day.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: Okay.
Speaker Change: [music].