OraSure Technologies, Inc.

Good day and thank you for standing by. Welcome to the Urashore Technologies, Inc. 2023 Third Quarter Earnings Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jason Plagman, Vice President of Investor Relations.

Thank you. Good afternoon and welcome to OraShare Technologies' third quarter 2023 earnings call. Participating in the call today for OTI are Kerry Eglinton-Manner, our President and Chief Executive Officer, and Ken McGrath, our Chief Financial Officer. As a reminder, today's webcast is being recorded and the recording can be found on our Investor Relations website. Before we begin, you should know that this call may contain certain forward-looking statements including statements with respect to revenues, expenses, profitability, earnings or loss per share, and other financial performance, product development, shipments and markets, business plans, regulatory filings and approvals, expectations, and strategies. Actual results could be significantly different. Factors that could affect results are discussed more fully in OTI's SEC filings, including its registration statements, its annual report on Form 10-K for the year ended December 31, 2022, its quarterly report on Form 10-Q, and its other SEC filings. Although forward-looking statements help to provide more complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today. OTI undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I'm pleased to turn the call over to Carrie.

Thank you, Jason, and thanks to everyone for joining us today. We are pleased to provide an update on the progress Orsha is making on the three pillars of our strategic transformation. One, strengthening our foundation. Two, elevating our core growth. And three, accelerating profitable growth. A few notable highlights during the quarter include We generated $37 million of operating cash flow in Q3 and grew our cash balance to $225 million. We continue to execute on our COVID-19 contracts, and we delivered stronger than anticipated IntelliSwab volumes during the quarter. And in September, we received an award for $5.7 million for future orders of IntelliSwab COVID-19 tests, from the U.S. government as part of the reopening of COVIDtest.gov. We delivered core growth, core revenue growth of 7% on a year-over-year basis. We continue to unlock cost savings as part of our enterprise-wide focus on driving improved operating efficiency. And with our stronger balance sheet, we are investing in our internal innovation roadmap and evaluating external partnerships and investments to expand and strengthen our portfolio of assays and sample management solutions and services in order to accelerate our long-term growth. Starting with cost, as we continue to strengthen our foundation, we remain highly focused on delivering greater operating efficiency, including reductions in our cost structure for both production and non-production related expenses. During the quarter, we successfully completed the final milestones included in our contract with the U.S. Department of Defense related to the completion of our automation capabilities and capacity expansion at our Opus Way facility in Bethlehem, Pennsylvania. Additionally, we have already collected the final $24 million of milestone payments here in Q4. With this phase of the expansion completed, We expect to make further progress in consolidating our manufacturing footprint to drive additional efficiencies and cost savings. Over the last year, we have made tremendous progress in establishing an enterprise-wide mindset that is focused on continuous improvement in operating efficiency. We expect to generate additional productivity enhancements over the coming years, including further leveraging our automation capabilities consolidating facilities, and controlling our non-production costs. These initiatives give us confidence that we will achieve our target of operating cash flow breakeven for our core business by the end of 2024. Moving to COVID-19, our intelliswap volumes were stronger than expected, generating $50 million in revenue in Q3. Our relationship with the U.S. Department of Health and Human Services continues to be positive and we have good visibility to order trends that could complete the remaining portion of our existing contract during the first half of 2024. Additionally, as I mentioned earlier, in September we received an award for $5.7 million for future purchase orders from the U.S. government for COVID-19 tests that are available for free to households across the U.S. as part of the reopening of COVIDtest.gov. And on the product side, the U.S. FDA approved the shelf life extension of IntelliSwab from 18 to 24 months in September. Looking at our core business, which excludes COVID-related products, total core revenue in Q3 grew 7% on a year-over-year basis. And our HIV franchise, the Together Take Me Home program, continues to demonstrate strong traction in expanding access to HIV testing to at-risk and underserved populations. And we look forward to continuing to collaborate with our partners as we enter the second year of this important five-year initiative. We believe the positive outcomes from this program could create additional opportunities for our infectious disease business. Our differentiated HIV product also continues to resonate in international markets. which contributed to our growth in diagnostics in the quarter. Additionally, we are expanding our menu of tests available in international markets through a new partnership agreement that will launch late this year. Through this partnership, our international team will be able to offer three new infectious disease tests for syphilis, hepatitis B, and hepatitis B in key markets through our existing sales channels and existing client relationships and new opportunities. We believe this expansion of our international test portfolio can provide additional fuel for future growth. Additionally, in our substance abuse testing portfolio, we are pleased to announce the expansion of our point of care toxicology offerings through a distribution agreement with a manufacturer of these devices. This agreement allows us to leverage our sales team and channel presence and expand our services in the substance abuse testing market. As part of this agreement, we will add several oral toxicity panels covering a range of drugs including THC, opiates, and amphetamines. Shifting to molecular, we continue to see signs of stabilization in our sample management solutions despite softness in some end segments that we discussed previously. And we are seeing positive momentum in establishing new partnerships and commercial relationships as well as extending existing relationships. As an example, we are pleased to announce a multi-year extension of our relationship with Ambry Genetics. Ambry will be using our Origin DX device for a variety of testing related to hereditary cancer, rare hereditary disease, reproductive health, and pediatric disorders. As we continue to expand and diversify our customer base, We're also proud to share the recent success we've delivered in the companion animal segment. Our performer gene product has been selected as the sample collection device for new canine health offerings that are being launched by two leaders in the space. Overall, we continue to make progress on our initiatives to accelerate profitable growth through investments organically and inorganically, including external investments and potential acquisitions. Our strong balance sheet and positive cash flow generation are key differentiators in the current market and economic landscape. We believe that these factors, as well as our strong client and channel relationships, our track record of execution and consistent delivery for our customers, plus our experience navigating complex regulatory approval processes, positions OTI to be the partner of choice to help power precision health into the future. With that, I'd like to turn the call over to Ken to discuss our financial results and guidance.