DermTech, Inc.

Ladies and gentlemen, thank you for standing by. Welcome to DermTech's third quarter 2023 financial results call. At this time, all participants are in a 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 like now to turn the conference over to Steve Concebo. Please go ahead.

Thank you, operator. Welcome to DermTech's third quarter 2023 earnings call. With me on today's call are Brett Christensen, our president and chief executive officer, and Kevin Sun, our chief financial officer. Our call today will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact are considered forward-looking statements. Forward-looking statements made during this call, including statements regarding projections of the future performance or financial outlook of DermTech, the performance, patient benefits, cost effectiveness, commercialization, and adoption of our products, and the market opportunity for our products are based on management's expectations as of today and are subject to various factors, assumptions, risks, and uncertainties which change over time. Actual results could differ materially from those described in such statements. Several factors that may continue to cause such differences are described in today's press release and our most recent filings with the SEC, including our annual report on Form 10-K, filed on March 2, 2023, and our quarterly report on Form Q filed on November 2nd, 2023. We undertake no obligation to update these statements except as required by applicable law. Our third quarter 2023 earnings press release and SEC filings are available on our investor relations website. A recording and transcript of this call will be available on our website later today. With that, let me turn things over to Brett.

Thank you, Steve, and thank you, everyone, for joining us. We're really excited by the significant improvement in many of our top-line and operating metrics. We're just a few months into our strategy of prioritizing reimbursed tests and revenue growth, and we're already seeing faster progress than we expected. In the third quarter, ASP for DermTech melanoma tests, or DMT, and test revenue grew at solid year-over-year and sequential rates. We also reported an improvement in the Medicare proportion of billable samples to an all-time high mark, which is about half of our addressable market, as well as an increase in our total proportion of reimbursed tests. We recorded a positive gross margin and significant expense and cash burn reductions. Nearly all of our key performance indicators are heading in a positive direction, and we believe that with more time to refine our commercial tactics, we will continue to improve our operating results. Before I take you through several elements of our recent progress, let me take a step back to reframe the opportunity. First, we have a great technology that can significantly enhance the standard of care for evaluating melanoma. Melanoma is the most aggressive form of skin cancer and claims approximately 8,000 lives annually in the U.S. Dermatologists are working hard to provide great patient care, but they face capacity constraints and limitations with traditional methods such as surgical biopsies. The DMT detects genomic markers that are correlated with an increased risk for melanoma and can aid decision by clinicians. Second, we believe there's a place for the DMT in every dermatology office alongside established protocol. The DMT is non-invasive and rules out melanoma with a 99% negative predictive value. Whether it's using the DMT in a sensitive area such as the face or providing clinicians and patients with peace of mind for a clinically suspicious lesion that the clinicians don't want to biopsy, there is room for it to be used in several ways. As an example, if we capture just 5% of the approximately 4 million surgical biopsies performed each year at a price that's in line with the Medicare rate, the revenue potential is over $150 million annually. And third, we can lower costs to the healthcare system by ruling out the need for certain surgical procedures while also providing a better patient experience. Insurance providers continue to expand access to our tests, and we've cleared administrative and billing hurdles with certain payers where a favorable coverage policy and agreement were in place earlier this year. For example, we're now seeing consistent reimbursement from two national government payers and one of the regional Blues plans. We also signed an agreement with Highmark during the third quarter, bringing the DMT as an in-network benefit to one of the largest Blues plans in the U.S. with approximately 7 million members. We will continue to reinforce our message around the clinical and health economic benefits of the DMT with payers that don't yet cover our test and continue to improve reimbursement patterns where coverage already exists. There's more to do, but we're on the right track with 133 million covered lives today. Our visibility with payers also improves through state legislative efforts. Bills mandating insurance coverage of genomic testing or biomarker bills are gaining visibility across the U.S. as lawmakers advocate for improving access to potentially lifesaving genomic tests. One example was the recent passage of the California Biomarker Bill, which mandates coverage based on specific criteria effective in January of 2024. California's profile as a large state with a significant Medicare population makes this an important step in strengthening access for patients. More than 10 states have now passed biomarker bills, and several states currently have bills making their way through the legislative process. Our TRUST II study, which we initiated in 2022, should provide additional real-world evidence regarding the DMT's performance. The results, if positive, may support re-engagement with payers. This study is designed to follow a cohort of 2,000 to 3,000 patients with negatively tested lesions for up to one year and also assesses the histological diagnosis of up to 1,000 lesions that tested positive with the DMT. We expect to have top-line data before the end of 2023. As we consider the evolution of our commercial business during the quarter, it's worth quickly reviewing the tactical initiatives we undertook in July to prioritize reimbursed tests and maximize revenue. We're still in the early days of evaluating feedback from the field and our customers, but it is evident that the immediate impact has been positive on boosting ASPs and test revenue. First, we aligned incentive compensation for our sales team with prioritizing reimbursed tests and revenue over volume growth. We've also improved reporting and made our operating dashboards more robust to support the field with targeting reimbursed tests. Throughout the rest of the organization, we've aligned incentive compensation and projects to prioritize ASP and revenue growth. We've also dissolved certain territories and merged others to focus on reimbursed samples where we already have insurance coverage or where we have healthy volumes that can facilitate positive discussions with payers. As a result, we reduced our sales territories from approximately 70 to roughly 60. Third, we've shifted our spending more closely to sales team enablement rather than broad-based marketing efforts. We've improved our customer and patient-facing collateral and highlighted key insurance providers that cover our test. We still plan to participate in national dermatology conferences such as Fall Clinical, which we attended in mid-October, to meaningfully engage key opinion leaders and support presentations that highlight the clinical value of the DMT. We're also recalibrating our direct-to-consumer marketing tactics to capitalize on areas where we have insurance coverage. Lastly, we appointed Mark Aguilar in September as our Chief Commercial Officer. Mark is a proven commercial leader with over 20 years of experience driving the commercialization of multiple novel molecular diagnostics. He served in commercial leadership roles with leading healthcare companies directing sales, marketing, medical affairs, customer success, and market access teams. We're grateful to have him on our team during this transformational period. As we've shared, we are intentionally pursuing a strategy that prioritizes robust ASP and revenue growth over volume growth in the short term. The third quarter results reflected this shift. In addition, we anticipate that the reduction and realignment of sales territories could further impact billable sample growth over the next few quarters. We'll prioritize test volume again when we're further down the path of sustained revenue growth. In closing, my vision is for the DMT to be deployed universally as part of the melanoma care pathway. We've begun taking important steps to execute against this goal. We're prioritizing reimbursed tests over volume growth to grow revenue. We're engaging clinicians with a clearer message to improve traction in communicating the DMT's clinical value proposition. We're continuing to improve payer coverage for the DMT. And finally, our total operating expenses and cash burn are at the lowest levels in approximately two years while we're generating higher revenue. I look forward to a strong finish in 2023. With that, let me turn the call over to Kevin for a more detailed financial review.