Accelerate Diagnostics, Inc.

Good day and welcome to the Accelerate Diagnostics, Inc. 2023 Third Quarter Results Conference Call. All participants will be in listen-only mode. After today's presentation, there will be a question and answer session. Please note this event is being recorded. I would now like to turn the conference over to Laura Pearson of Accelerate Diagnostics.

Please go ahead. Before we begin, it is important to share that information presented during this call may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Security Exchange Act of 1934. Forward-looking statements include projections, statements about our future, and those that are not historical facts. All forward-looking statements that are made during this conference call are subject to risk uncertainties, and other factors that could cause our actual results to differ materially. These are discussed in greater detail in our annual report on Form 10-K for the year ended December 31st, 2022, and other reports we file with the SEC. It is my pleasure to now introduce the company's president and CEO, Jack Phillips.

Thank you, Laura. Good afternoon, everyone, and welcome to our third quarter earnings call. In the quarter, we initiated our clinical trial for AHRQ, continued to hit development milestones with our WAVE platform, and continued to grow the market through our partnership with Beck and Dickinson. Turning first to AHRQ, as a reminder, the AHRQ system is designed for clinical laboratories as a simple load-and-go workflow that automates direct-from-positive blood culture sample preparation for downstream microbial identification using MALDI-TOF. This solution enables on-demand processing of samples without the need for an overnight culture incubation, reducing the wait time for identification results. Customers will now have an automated, cost-competitive alternative for rapid positive blood culture ID compared to molecular solutions by using their existing MALDI-TOF systems. Clinical laboratories are under pressure to run FDA-cleared devices with increased legislation and enforcement of laboratory-developed tests. Thus, there will be great value in providing labs with an FDA-cleared device. We have already initiated our clinical trial and one site has already completed fresh sample enrollment. Our intent is to submit to the FDA over the coming months, which will ensure seamless laboratory adoption with the first FDA-cleared automated sample preparation. We are making great progress with ARK and hopefully more exciting news to come shortly. Moving on to WAVE, our next generation rapid AST platform. We made good progress in the quarter and achieved several milestones. As a reminder, WAVE will provide a comprehensive susceptibility testing menu which will address both the 130 million tests performed from isolated colonies as well as the over 7 million tests performed from positive blood culture samples globally. Based on customer workflow pain points, we built WAVE to optimize lab workflows. Key differentiators between WAVE and existing emerging susceptibility platforms includes high throughput sample processing with improved time to result of less than four and a half hours on average. Random access for continuous sample loading and platform scalability to service all hospital segments. Wave beta modules are now fully operational in our labs. The systems perform well with minimal challenges, have great reliability, and our lab technicians love the easy-to-use features. Time to result and performance continues to look good. We have developed a comprehensive image library for evergreen data analysis. Our goal is to see clearance for approximately 300 gram-negative bug drug combinations. This is over twice the size of the current menu on Pheno. Most results are available well within four and a half hours. We are seeing drug-induced morphology changes well within four and a half hours, which is what allows us to produce accurate early results. Time to result is a significant differentiator of the WAVE system by enabling labs to deliver same-shift reporting for all antibiotic susceptibility testing. Marketing has received significant voice of customer feedback on the WAVE system. Customers continue to confirm their excitement about WAVE, driven by the differentiated features of a consolidated AST menu on a single platform. Same-shift reporting, scalability, and improved economics. We plan to produce data readouts and submit an ECMID abstract by year end, complete a preclinical trial early next year, followed by clinical trial for the WAVE system and comprehensive gram-negative PVC menu. We will look to submit to the FDA in mid-2024 with a commercial launch in early 2025. Overall, we are excited about the progress of the WAVE program. and the promise of this game-changing technology. With plans to begin pre-marketing activities next year, we are actively exploring wave commercialization options. Turning to our performance in the quarter, while the new contracted Fino systems were less than anticipated for the quarter, our commercial partner BD continues to develop new opportunities and progress the funnel. We successfully secured a large portion of our customer base to long-term contracts in preparation for the wave launch. Now, I would like to turn it over to David Patience, our Chief Financial Officer, to review our preliminary third quarter results. David?