– Lucid Diagnostics Inc. (Nasdaq: LUCD) (“Lucid” or the “Company”) a commercial-stage, cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ( “PAVmed”), today provided a business update for the Company and presented financial results for the three and nine months ended September 30, 2023.
Conference Call and Webcast
The webcast will take place on Tuesday, November 14, 2023, at 8:30 AM and will be accessible in the investor relations section of the Company’s website at luciddx.com. Alternatively, to access the conference call by telephone, U.S.-based callers should dial 1-833-816-1418 and international listeners should dial 412-317-0511. All listeners should provide the operator with the conference call name “Lucid Diagnostics Business Update” to join.
Following the conclusion of the conference call, a replay will be available for 30 days on the investor relations section of the Company’s website at luciddx.com.
Business Update Highlights
“I can confidently say that Q3 was the most important quarter in Lucid’s history,” said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. “We crossed several critical milestones necessary to translate test volume growth into revenue and revenue growth. The initial impact that we saw in the second quarter from the upgrade to our revenue cycle management infrastructure has been sustained, driving record revenues this past quarter. Key metrics, such as the percentage of allowed claims and the average allowed payment, have held up nicely during this period. A key driver supporting in-network payor coverage engagement, along with claims history, is a solid base of clinical utility data. We went from no clinical utility data in the second quarter to over 1,500 patients across three clinical utility studies with near-perfect results—two published and one pending peer review.”
Highlights from the third quarter and recent weeks:
- Lucid’s CLIA-certified clinical laboratory performed 2,575 commercial EsoGuard® Esophageal DNA Tests in 3Q23, which represents a 17 percent increase sequentially from 2Q23 and a 137 percent annual increase from 3Q22. Lucid personnel performed cell collection for 82 percent of tests in the quarter, reflecting a steady increase in Satellite Lucid Test Center activity. High-volume #CYFT testing events continue to strongly contribute to test volume growth. Gaining traction with strategic accounts at health systems and academic medical centers.
- For the quarter, EsoGuard revenue was $783K, which represents a 392 percent increase sequentially from 2Q23 and a 930 percent annual increase from 3Q22.
- Upgrade to revenue cycle management infrastructure showed sustained impact during the quarter. Allowed claims percentage and average allowed payment amount also held up well. Active pipeline of claims going through appeals with success based on medical necessity vs. guidelines.
- Substantial increase in clinical utility data to support in-network payor coverage engagement. Near-perfect clinical utility data (99-100 percent concordance) from three studies—CLUE, the PREVENT Registries, and the SAFD Study—totaling over 1,500 patients released during the quarter. Two manuscripts published in peer reviewed journals, and one pending peer review.
- Accelerating activity in Direct Contracting with employers to offer EsoGuard as a benefit. First contract signed and on-site testing has begun. New VP, Employer Markets with 30 plus years of experience in employer benefits sales starts this week.
- EsoGuard 2.0 with multiplexed triplicate consensus launched last week, improving already unprecedented cancer and precancer detection results. Analytical validation studies to be presented at this week’s Association of Molecular Pathology Annual Meeting (AMP 2023). Upgrading NGS-sequencing platform to a higher-throughput NextSeq 1000 to accommodate increased EsoGuard testing volume. Updated assay and platform expected to significantly lower per-sample sequencing costs.
- For the three months ended September 30, 2023, EsoGuard related revenues were $0.8 million. Operating expenses were approximately $11.9 million, including stock-based compensation expenses of $1.3 million. GAAP net loss was approximately $14.2 million, or $(0.34) per common share.
- As shown below and for the purpose of illustrating the effect of stock-based compensation and other non-cash income and expenses on the Company’s financial results, the Company’s preliminary non-GAAP adjusted loss for the three months ended September 30, 2023, was approximately $9.3 million or $(0.22) per common share.
- Lucid had cash and cash equivalents of $24.1 million as of September 30, 2023, compared to $32.6 million as of June 30, 2023.
- The unaudited financial results for the three months ended September 30, 2023, will be filed with the SEC on Form 10-Q on November 14, 2023, and available at www.luciddx.com or www.sec.gov.
Lucid Non-GAAP Measures
- To supplement our unaudited financial results presented in accordance with U.S. generally accepted accounting principles (GAAP), management provides certain non-GAAP financial measures of the Company’s financial results. These non-GAAP financial measures include net loss before interest, taxes, depreciation, and amortization (EBITDA), and non-GAAP adjusted loss, which further adjusts EBITDA for stock-based compensation expense and other non-cash income and expenses, if any. The foregoing non-GAAP financial measures of EBITDA and non-GAAP adjusted loss are not recognized terms under U.S. GAAP.
- Non-GAAP financial measures are presented with the intent of providing greater transparency to the information used by us in our financial performance analysis and operational decision-making. We believe these non-GAAP financial measures provide meaningful information to assist investors, shareholders, and other readers of our unaudited financial statements in making comparisons to our historical financial results and analyzing the underlying performance of our results of operations. These non-GAAP financial measures are not intended to be, and should not be, a substitute for, considered superior to, considered separately from, or as an alternative to, the most directly comparable GAAP financial measures.
- Non-GAAP financial measures are provided to enhance readers’ overall understanding of our current financial results and to provide further information for comparative purposes. Management believes the non-GAAP financial measures provide useful information to management and investors by isolating certain expenses, gains, and losses that may not be indicative of our core operating results and business outlook. Specifically, the non-GAAP financial measures include non-GAAP adjusted loss, and its presentation is intended to help the reader understand the effect of the loss on the issuance or modification of convertible securities, the periodic change in fair value of convertible securities, the loss on debt extinguishment, and the corresponding accounting for non-cash charges on financial performance. In addition, management believes non-GAAP financial measures enhance the comparability of results against prior periods.
About EsoGuard and EsoCheck
Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer (“EAC”). Over 80 percent of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500 percent over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5 percent to 15 percent of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.