Co-Diagnostics, Inc.

Diagnostics fourth quarter and full year 2023 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference 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. To withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Andrew Benson, Investor Relations. Please go ahead.

Good afternoon, everyone. Thank you all for participating in today's conference call. On the line today from CoDiagnostics, we have Dwight Egan, Chief Executive Officer, and Brian Brown, Chief Financial Officer. Earlier today, CoDiagnostics released financial results from the fourth quarter and full year ended December 31, 2023. 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 the listeners that certain statements made by co-diagnostics during this call may constitute forward-looking statements. Any statement about company expectations, beliefs, plans, objectives, assumptions of future events or performance are forward-looking statements. For example, statements concerning 2024 financial and operational guidance, the development, regulatory clearance, commercialization, and features of new products, plans, and objectives of management and market trends are all forward-looking statements. This includes statements concerning the company's forthcoming Codex PCR testing platform, which requires regulatory approval and marketing authorization for diagnostic use, is currently being reviewed by the US FDA, and is currently not for sale. The company believes these statements are based on reasonable assumptions. However, these statements are not guarantees of performance and involve known and unknown risks and uncertainties that may cause the actual results to be materially different from any future result expressed or implied by such 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 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 shortly before this call, which contains reconciliation to the non-GAAP financial measures presented through their most comparable GAAP results. At this time, I would like to turn the call over to CoDiagnostics Chief Executive Officer Dwight Egan.

Dwight. Thank you, Andrew. Good afternoon, everyone. Thank you all for joining CoDiagnostics' fourth quarter and full year 2023 earnings call. 2023 was an exciting year for CoDiagnostics as we expanded industry awareness of our CoPrimers technology and the CoDxPCR platform. Throughout the year, we participated in several industry and investor conferences where we spoke about the value proposition of our platform and our commercial and regulatory strategies. We also achieved several key milestones. including the receipt of several prestigious grants, the expansion of manufacturing capacity, and an emergency use authorization submission to the FDA for the Codex PCR Pro and Codex PCR COVID-19 test kit. Today, we will provide an update on our fourth quarter and full year 2023 financial performance and discuss recent activities at the company as we continue to execute across our business and test developments. During the fourth quarter, we were pleased to submit an emergency use authorization application to the FDA for our new Codex PCR Pro instrument, mobile app, and Codex COVID-19 test kit. Our easy-to-use, real-time PCR platform is differentiated by several exciting features and capabilities. Tests run on our instrument utilize CoDiagnostics' unique patented CoPrimers PCR technology. CoPrimers ensure reliability by providing higher quality test results through the significant reduction of primer dimers, which often lead to false positive results. The most notable feature of the platform is our cloud-based analytics, which delivers test results from the instrument to the mobile app in just 30 minutes. The nature of our app also enables Kodiak's PCR real-time HIPAA-compliant integration into the EMR, which we anticipate will allow physicians, public health officials, and even governments to examine and monitor results, tracking outbreaks in communities and countries around the globe. I am proud of the CoDiagnostics team for their collective efforts in finalizing our EUA submission which we anticipate will be the first regulatory submission of many related to the new platform, and the importance of which is difficult to overstate. We are excited for the platform's first regulatory review, which includes several never-before-seen technologies and our strong clinical and analytical results. I would like to thank our world-class team of developers and regulatory experts who contributed to a strong regulatory submission for this platform, which we believe has the potential to revolutionize how and where infectious disease diagnostics take place. We also have already collected enough samples in the ongoing clinical evaluation to allow us to pursue a 510 clearance for our Codex PCR Pro and CODIx COVID-19 test, which we anticipate will be submitted in the first half of this year. We look forward to providing you with more updates on this current regulatory review process as they become available. While we plan to initially launch the platform with our COVID test, we also have several other tests currently under development, including tuberculosis and upper respiratory multiplex. followed by HPV and strep throat. We plan to begin clinical evaluations for our TB test later this year in geographies where the disease is most prevalent. Specific clinical trial testing sites will be located in Africa, Australia, and India, where we have a strong operational presence with our joint venture, CoSERA Diagnostics. Tuberculosis is the most deadly disease in the world. and the eradication of TB remains a focal point for the World Health Organization, or the WHO, as well as the Bill and Melinda Gates Foundation, from whom we have already received two grants to accelerate our TB platform and to expand manufacturing capacity. We plan to first pursue regulatory clearance for this test through two jurisdictions that are recognized by the WHO for diagnostics recommendations. the TGA, or the Australian Regulatory Pathway Authority, and the CDSCO in India. After these submissions, we plan to submit to the WHO for a recommendation. A recommendation from the WHO would aid in the commercialization of our TB test across many regions of the world, especially markets in Africa, where a WHO recommendation is required before a test can be used as a diagnostic. Importantly, India, where we have domestic manufacturing and distribution capabilities with Coursera, is a large and underserved market. We believe that our platform and TB test have the potential to dramatically improve the state of TB testing in India, where there are 69,000 hospitals, over 115,000 pharmacies, and where roughly 220 million people were screened for TB in 2021. according to the World Health Organization. In addition to TB, we have continued the development of the multiplex upper respiratory test with support from the NIH RADx-TEC grant. Co-diagnostics plans to initiate clinical evaluations during the next flu season later this year in order to collect sufficient data for an FDA submission. Another important indication of focus in our pipeline is our HPV test. which was also the subject of a Gates Foundation grant last year. HPV is an additional high priority infection for the WHO, as it remains the most common STI and the greatest risk factor for cervical cancer, which has many associated deaths in low-income countries. Our development efforts for HPV are currently focused in India, where there is a significant underserved population. Lastly, with the CODIX COVID-19 test through the development stage and currently under FDA review, we have begun actively developing a strep throat test, which we believe has the potential to increase the attractiveness of the platform as a point-of-care solution. As we approach the launch of the CODIX PCR platform, we have begun to ramp our internal processes to ensure we are adequately prepared to serve our target markets. Over the past year, CoDiagnostics has made substantial investments to ensure that we have the appropriate infrastructure for commercialization, and we are fully prepared to begin scaling manufacturing pending authorization. The Codex PCR Pro system has been designed for the point of care setting, and we plan to initially target U.S. assisted living facilities, skilled nursing facilities, and physician's offices. We are prioritizing institutional settings where test volumes and overall demand remain high. We firmly believe that our highly accurate, accessible, and low-cost device can drive improved patient outcomes, both in institutional settings in the U.S. and in low to middle income countries where accessibility to testing has been a consistent barrier in healthcare. While testing volumes have fallen from their peak in the height of the pandemic, COVID-19 is second only to tuberculosis in terms of lives lost every year, and it remains one of the most in-demand tests worldwide. This includes for regions like India, Saudi Arabia, and Australia, where we believe we will be able to begin commercializing the Kodiak's COVID-19 test following regulatory clearance or registration in those countries. We believe that our COVID-19 test will be the first of many indications on our Codex PCR Pro instrument to serve the diagnostics market. As we expand to additional indications, such as tuberculosis, we plan to market our platform even more broadly outside of the United States. A principal component of our successful commercialization launch strategy is increased manufacturing capacity. We have recently completed the build out of a new facility in Salt Lake City for both cups and instrument manufacturing with capacity to add additional lines for both while we also continue to increase speed and efficiency. In addition, plans are in place and activity is underway in India where COSERA is adding capacity to manufacture instruments and cup lines in country. Large-scale manufacturing in India is not only an important aspect of our global ambitions to be able to serve Asian and African markets, but it is also required in order to qualify under the Make in India initiative. The Make in India initiative was launched nearly a decade ago to promote India as a preferred global manufacturing destination, and qualification under this initiative removes roadblocks to commercialization in India. We want to highlight that we are now producing our own oligonucleotides or co-primers in Salt Lake City, which we believe will improve costs and efficiencies. We are also currently in the process of building in-house co-primers manufacturing capacity at our manufacturing plant in India with support from the Gates Foundation grant. We are excited about these initiatives and the improvements that in-house manufacturing will bring to co-diagnostics and to patients around the world. Among our most prominent accomplishments in 2023 are the several grants that we received from organizations focused on solving the most pressing health issues in the world. The significant support that we received in the past year has enabled further development of tests in our pipeline, including our tuberculosis test, upper respiratory multiplex test, and HPV test. The support and recognition that CoDiagnostics has received is a testament to the value proposition of our platform, including our technology, scientific team and approach, and platform capabilities. We are currently in active discussions with other organizations and have implemented an internal team who is working diligently to drive the grant application process forward for CoDiagnostics. Before passing things over to Brian, I wanted to share a brief update with you regarding our attendance at industry and investor conferences in the fourth quarter. In November, we presented at the Piper Sandler Conference, where we outlined our business strategy anchored around the development of the Codex PCR platform and associated ongoing pipeline developmental efforts. Codiagnostics also attended the Utah Life Sciences Summit and the Association for Molecular Pathology, or AMP, in Salt Lake City. in which we hosted a booth displaying our disruptive technology and delivered a presentation. We also attended the Consumer Electronics Show, or CES, in Las Vegas this January for the second time. Outside the U.S., we had a very well-attended booth at Med Lab Africa, where we discussed our development and commercial plans with many regional players. And earlier this year, we hosted a booth at Med Lab Middle East 2024 in Dubai, Attending prominent industry events has allowed us to highlight our recent achievements and has given our team further confidence in our platform and how it can address underserved areas of the market. And the productive conversations we have had with potential customers and distributors provide helpful feedback on our development pipeline and commercialization strategies. In 2024, we look forward to progressing our dialogue with prominent market constituents as we work towards our common goal of making diagnostics more accessible around the world. In closing, we are proud of our achievements in 2023 and look forward to an exciting 2024. We have developed an accurate, affordable, and valuable point of care platform to help communities and patients across the globe. The company also remains well-funded with $58.5 million in cash cash equivalents, and marketable securities on our balance sheet. We look forward to updating you on our development and commercial progress throughout the year. Now, I will turn the call over to Brian to discuss our fourth quarter and full year 2023 financials in greater detail. Brian?

Thanks, Dwight, and thanks to everyone who joined today's call. For fiscal year 2023, total revenue decreased to $6.8 million, as compared to $34.2 million in the prior year's same period. Grant revenue in 2023 was $5.8 million, and product revenue was $1.0 million, which declined year over year due to the impact of decreased global demand for COVID-19 testing. Gross profit for the full year 2023 decreased to $2.6 million, compared to $28.7 million in the prior year. Total operating expenses for the year ended December 31, 2023, decreased to $45.3 million compared to $55.7 million in 2022. The decrease from the prior year is a result of goodwill impairment charges recorded in 2022, partially offset in 2023 by strategic investments in research and development to support our development and commercialization initiatives for our CODI-X PCR platforms. Research and development expenses in 2023 were $23.0 million compared to $17.4 million in the comparable prior year. The year-over-year increase was largely driven by investments in our Codex PCR platform and COVID-19 tests ahead of our FDA submission, as well as ongoing developments of other tests in our pipeline. For 2023, Income before taxes increased to a loss of $38.1 million as compared to a loss of $18.8 million reported in the prior year. We experienced an income tax benefit of $2.8 million, representing an effective tax rate of 7.3%. We have previously discussed that our effective tax rate will differ from the U.S. federal statutory rate of 21.0% due to state taxes, permanent items, and discrete items. Net loss for 2023 was $35.3 million or a loss of $1.20 per fully diluted share compared to a net loss of $14.2 million or a loss of $0.45 per fully diluted share in the prior year. Adjusted EBITDA for 2023 was a loss of $33.0 million compared to an adjusted EBITDA loss of $3.1 million in the prior year. We ended the year with $58.5 million in cash, cash equivalents, and marketable securities, and continue to manage our spend as we look to maintain a healthy balance sheet to position ourselves for long-term growth. For the full year, 2023, we repurchased approximately 1.0 million shares at an average price of $1.41 per share. As of December 31st, 2023, we have repurchased just over 4.8 million shares at an average share price of $3.21 per share for an aggregate amount of $15.6 million within our $30 million repurchase program. We continue to evaluate strategic share repurchase opportunities as we see fit. We are committed to maintaining a strong cash position through diligent expense management to ensure co-diagnostics is well capitalized to execute on our long-term growth initiatives. As we exited the year, we have continued to invest responsibly in our commercial initiatives to position the company for a successful commercial launch upon authorization or approval from the FDA. We remain well capitalized to deliver on our 2024 plan and are optimistic about the prospects for the Codex PCR platform, first with COVID, followed by TB, upper respiratory multiplex, and HPV. 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. Before opening for Q&A, I want to thank our Kodiak shareholders, as well as our employees, distributors, and consultants who strongly believe in our platform and the value that it offers. I look forward to updating you again next quarter. We will now take calls from our analysts. Operator?

We will now begin the question and answer session. To ask a question, you may press star and then one on your touch tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two. Our first question comes from Yi Chen with HC Wainwright. Please go ahead.

Thank you for taking my questions. Could you comment on whether it has, has the FDA provided any feedback regarding the submission and when did the FDA complete the review process? Thank you.

Thanks for the question, Yee. The FDA is, once we turned it over to the FDA and made our submission, The timeline is the FDA's to decide when they're going to respond to us. So we don't have any update currently on our submission.

So after FDA approved the device, how soon can you launch the device in the U.S. and other global markets? Thank you.

The company is prepared to launch the device immediately upon authorization from the FDA. So, we have done a lot of work for some time now preparing to launch the product. So, we're simply waiting for the FDA to give us authorization.

Currently, could you comment on your expectation regarding potential sales in the U.S. and other geographic? Any rough estimates would be helpful. Thank you.

Yeah, Yi, this is Brian. We have not provided any formal guidance for 2024, given that our platform and product are still being reviewed by the FDA, and we're not prepared to provide any of that guidance either at this point in time.

And last question is, after the initial COVID test, how soon can the rest of the test, especially the multiplex test, can secure clearance from the FDA?

Yee, we expect to begin our clinical trials for our multiplex test, which as you know, has grant support from the National Institute of Health through their Radix Tech program. And we expect to be able to commence our clinical trials during the upcoming flu season. So that flu season where we have to gather a certain number of samples, after that, we will do the submission. I might also add that the COVID test, which is currently under review by the FDA for emergency use authorization, we have already completed the infill testing for that. And we have the sufficient samples to make a submission to the FDA for a full 510 . We are concluding the evaluations and analytical work that together with the infilled results comprise the total evaluation that will be submitted to the FDA we believe by sometime mid-year.

Got it. Thank you very much.

This concludes our question and answer session. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.