Lucid Diagnostics Inc. Q4 FY2024 earnings call

• Commercial execution: Fourth quarter revenue was $1.2 million, with test volume over 4,000 tests (record). Restructured commercial team and comp model to focus on revenue driving activities. - Reimbursement milestones: Highmark Blue Cross Blue Shield of New York established positive commercial insurance coverage policy for EsoGuard. NCCN included screening for esophageal precancer with EsoGuard as an acceptable alternative to endoscopy. - Clinical evidence: Two clinical utility studies accepted for peer-reviewed publication. Submitted clinical evidence package to MolDX for Medicare coverage reconsideration. - Sales channels: Concierge medicine cash-pay program off to a great start with 20 contracts signed. Progress on direct contracting with employers and self-insured entities.

In the fourth quarter, Lucid Diagnostics generated $1.2 million in revenue. Test volume was just over 4,000 tests, which was a record quarterly test volume. The EsoGuard segment was the main contributor, with revenue of $1.2 million in the fourth quarter, relatively in line with recent quarters and even with the record third quarter.

• Expect 2025 to be a pivotal year with progress in reimbursement and sales channels. - Concierge medicine and direct contracting programs expected to start impacting revenue in the second half. - Anticipate scaling up operations with Medicare coverage to drive significant growth in test volume and revenue.

• Uncertainties in reimbursement decisions from payers like MolDX. - Potential delays in Medicare coverage determination. - Lumpy nature of test volume from health fair events. - Market risks related to competition and regulatory changes.

Q: About test volume going forward, should we assume a 4,000 times four level for 2025?

A: Lishan and Dennis noted to focus on revenue rather than just test volume, as volume can be lumpy and they're transitioning to focus on revenue. The burn rate is a factor, and concierge medicine and direct contracting will help cut burn.

Q: Why was the effective ASP low?

A: Dennis explained it's due to timing of payments rather than direct reflection on payment, with collections still elongated and a backlog of claims.

Q: On the $8 million NIH grant for EsoGuard study, size of the opportunity and off-label testing?

A: Lishan said about 40% of at-risk patients for esophageal precancer/cancer fall out of guidelines based on lack of GERD symptoms, potentially adding 20 million patients. Data from pilot study and grant suggests opportunity to grow market.

Q: If Medicare coverage is obtained, how quickly will the strategy switch?

A: Lishan said they would pedal to the metal, leveraging existing resources to target Medicare populations, with ability to scale lab and manufacturing. Revenue recognition would change to when report is issued rather than waiting for collections.

Q: How does NCCN inclusion help commercial payers?

A: Lishan said commercial payers ask about NCCN, and its inclusion reiterating guidelines with EsoGuard as an alternative to endoscopy is a powerful tool in discussions with payers.

Q: With Highmark coverage, details on covered lives and sales coverage?

A: Lishan said it's a precedent-setting milestone rather than immediate volume driver, with positive conversations with payers and focus on regional plans as precedents.

Q: If MolDX responds positively, what's the impact on sales team and revenue recognition?

A: Lishan said they would aggressively allocate resources to target Medicare populations, and revenue recognition would shift to when report is issued rather than waiting for collections, enhancing financial stability.

Q: On pipeline for cash-pay concierge and private insurers?

A: Lishan said concierge medicine sales cycle shorter than expected, with 20 contracts signed, and direct contracting with employers going well. Concierge aggregators and health systems in discussions.

Q: With increased testing volume from Medicare, potential operating leverage?

A: Dennis said with high margins (90%) and $2,000 price point, operating at scale can enhance financial stability and cash flow, changing dynamics of the business.