Lucid Diagnostics' Q3 2025: Contradictions in Medicare Coverage Timelines, Patient Engagement, and Commercial Strategies

Date of Call: November 12, 2025

Financials Results

• Revenue: $1.2M recognized revenue in Q3 (invoiced >$7.1M on 2,841 tests), representing a 4% sequential increase and a 3% year-over-year increase
• EPS: -$0.10 per share net loss (GAAP and non-GAAP), flat sequentially and improved vs. the trailing four-quarter average loss of $0.16 per share

Guidance:

• Draft MolDX LCD expected soon, followed by a mandatory 45-day public comment period and then a final LCD allowing claims backdated up to 12 months
• Targeting Medicare patients (~50% of addressable population) and shifting commercial reps to increase Medicare mix
• Maintain quarterly test volume target of ~2,500–3,000 to sustain payer engagements
• Pro forma cash ~ $47M after financing; runway through 2026 to cover reimbursement milestones

Business Commentary:

• Revenue and Test Volume Growth:
• Lucid Diagnostics reported revenue of approximately $1.2 million for Q3, with test volume at 2,841 tests.
• The revenue and volume are in line with the previous quarter and within the target range of 2,500 to 3,000 tests per quarter.

• Growth was driven by maintaining ongoing engagements with commercial payers and efforts to transition targeting towards Medicare patients.

• Market Access and Strategic Hires:

• The company recruited a world-class market access team, led by Danielle Scelfo, with over 75 years of combined experience.
• This team is focused on securing coverage and reimbursement across major insurers and expanding commercial insurance coverage.

• The strategic hires aim to strengthen Lucid's market access infrastructure and secure broader commercial insurance coverage.

• Medicare Reimbursement and Coverage Hopes:
• The Medicare Contract Advisory Committee meeting resulted in strong consensus for EsoGuard Medicare coverage based on clinical evidence and guidelines support.
• A draft LCD is expected following the CAC meeting, with a mandatory 45-day public comment period and a final LCD expected thereafter.

• The company anticipates receiving Medicare coverage, which will allow submission of claims dating back a year, significantly impacting future revenue.

• Firefighter Prevention Summit:

• Lucid Diagnostics is hosting the Firefighter Esophageal Cancer Prevention Summit to engage with fire departments and survivors.
• The event aims to advance cancer prevention efforts through early detection and highlight EsoGuard's role in protecting firefighters.
• This is expected to bolster the existing pipeline of contracted firefighter testing events, expanding access to the target population.

Sentiment Analysis:

Overall Tone: Positive

• Management repeatedly stated the MolDX CAC 'went extremely well' with unanimous clinical endorsement and public contractor corroboration; they completed an offering that 'netted approximately $27M' and said pro forma cash extends runway through 2026; multiple comments emphasized confidence that a draft LCD is imminent and that commercial momentum is accelerating.

Q&A:

• Question from Mark Massaro (BTIG, LLC): Could you share more about dialogue at the CCLA meeting and, assuming a positive draft LCD, whether the final would be a formality or consistent with the draft?
  Response: The public CCLA meeting reaffirmed the CAC outcome; MolDX and a Noridian medical director publicly said the meeting 'went well' and provided the information to draft policy, and because this is a reconsideration of an existing LCD the final is expected to be largely a formality following the draft.

• Question from Mark Massaro (BTIG, LLC): Is it reasonable to expect a draft LCD by year-end 2025?
  Response: Management considers a year-end draft a reasonable timeline; timing is driven by administrative workflow rather than new evidence and the recent shutdown did not materially slow issuance.

• Question from Mark Massaro (BTIG, LLC): Any movement with commercial payers since the CAC meeting, or are they waiting for Medicare?
  Response: Commercial engagement has accelerated, guided by guideline linkage (e.g., UnitedHealthcare explicitly referencing EsoGuard) and management expects contracting and positive commercial policies ahead of or concurrent with Medicare.

• Question from Kyle Mikson (Canaccord Genuity Corp.): Could the end of the shutdown create a 'rubber band' acceleration to complete draft LCDs?
  Response: Possibly; the shutdown did not materially delay policy work and full CMS staffing could accelerate the administrative processing required after draft issuance.

• Question from Kyle Mikson (Canaccord Genuity Corp.): If Medicare coverage is in place by mid-2026, how will the commercial channel mix change among concierge, test-setters, health systems, etc.?
  Response: The company is shifting emphasis to Medicare-eligible patients to reach ~50% of tests by mid-2026 while maintaining other channels; headcount stays mostly flat but experienced reps are being reallocated for Medicare focus.

• Question from Kyle Mikson (Canaccord Genuity Corp.): Any change in call points or rep structure to execute the Medicare push?
  Response: Yes — incentivizing and deploying more experienced reps, adding director-level hires to call on health systems, and reallocating reps to target practices with Medicare-rich populations.

• Question from Kyle Mikson (Canaccord Genuity Corp.): COGS per test rose to ~$600 this quarter; any drivers and how to think about future costs?
  Response: Variable costs remain steady (~$185–$200: EsoCheck ~$50 and lab ~$120–$125); quarterly uptick reflects fixed costs and GAAP noncash charges, not higher variable per-test economics.

• Question from Anthony Vendetti (Maxim Group LLC): How many commercial payers currently cover EsoGuard?
  Response: One positive commercial policy (Highmark New York); active contracting discussions and an active pipeline of conversations with dozens of other payers.

• Question from Anthony Vendetti (Maxim Group LLC): What is physician ordering behavior and repeat ordering for higher-volume users?
  Response: While not tracked precisely, management reports physician adoption is 'sticky' once they buy into the paradigm; leveraging nurses and satellite test centers increases uptake and retention.

• Question from Anthony Vendetti (Maxim Group LLC): For referrals to EsoGuard, what's the conversion rate from referral to completed test?
  Response: Referral-to-test conversion is very high (>90%); patients testing positive proceed to confirmatory endoscopy at ~85% compliance (about double typical compliance).

• Question from Joseph Conway (Needham & Company, LLC): Given the 12-month lookback on claims, why engage Medicare patients now rather than later?
  Response: Because management believes they are in the 'zone' of imminent approval and are pursuing Medicare-rich patients to maximize look-back revenue; Medicare Advantage claims are payable now and strengthen future collections.

• Question from Joseph Conway (Needham & Company, LLC): Are you ramping total volume or just increasing the Medicare mix? Any headcount changes?
  Response: Total volume target is maintained; the company is shifting the mix from ~10–15% Medicare toward an epidemiology-based ~50% via reallocation of experienced reps without materially increasing headcount.

• Question from Joseph Conway (Needham & Company, LLC): Details and timeline for the NIH/VA studies and how results will affect adoption in asymptomatic patients?
  Response: The NIH study targeted ~600–900 patients (depending on positivity rate) and the VA study is enrolling faster; no firm readout date; results are positioned as longer-term market-expansion drivers, not prerequisites for near-term commercial growth.

• Question from Edward Woo (Ascendiant Capital Markets LLC): Has inflation materially impacted the variable cost per test and should we expect changes?
  Response: Variable costs are expected to remain steady (~$185, with EsoCheck ~$50 and lab ~$120–$125); inflationary impact is negligible and future cost reductions are possible via lab automation and process improvements.

Contradiction Point 1

Medicare Coverage Timeline

It involves differing expectations regarding the timeline for Medicare coverage, which is crucial for business strategy and investor expectations.

Is a draft LCD expected by year-end 2025 based on the current timeline? - Mark Massaro (BTIG, LLC, Research Division)

2025Q3: The timeline remains reasonable, with no indication that the shutdown slowed the process. The workflow is expected to follow a usual pattern, and there is no reason to expect delays. The confidence remains in receiving a draft LCD within the estimated timeframe. - Lishan Aklog(CEO)

When will you hear back from MolDX and what will the response be? - Mark Massaro (BTIG)

2024Q4: We are hopeful that we will hear back from the CCLA in early 2025 and get a draft LCD. And we believe that once we get that draft LCD, we will also have a positive coverage. - Lishan Aklog(CEO)

Contradiction Point 2

Medicare Patient Engagement Strategy

It reflects a change in strategy regarding the engagement of Medicare patients, which could impact the timing and scale of revenue expansion.

What will the commercial channel mix be by mid-2026 with Medicare coverage? - Kyle Mikson (Canaccord Genuity Corp., Research Division)

2025Q3: We are now focusing on building infrastructure and doing more systemic engagement with Medicare patients. - Lishan Aklog(CEO)

How should we expect the volume metric to trend moving forward, and should we assume consistency with Q4's record? - Kyle Mikson (Canaccord Genuity)

2024Q4: The focus remains on the 30 million home-barrier patients for the near term. That means sales channels primarily focused on those patients. - Lishan Aklog(CEO)

Contradiction Point 3

Commercial Payer Engagement and Strategy

It reflects a shift in the company's strategy regarding commercial payer engagement and the focus on Medicare patients.

What should the commercial channel mix be by mid-2026 under Medicare coverage? - Kyle Mikson (Canaccord Genuity Corp., Research Division)

2025Q3: The focus is on transitioning towards Medicare patients, with a target of 50% of the target population. Additional team members with expertise are being hired to expand into health systems, with existing efforts showing success. - Lishan Aklog(CEO)

How should we view the volume metric going forward? Should we expect a constant level based on Q4's record? - Kyle Mikson (Canaccord Genuity)

2024Q4: The focus remains on the 30 million home-barrier patients for the near term. That means sales channels primarily focused on those patients. - Lishan Aklog(CEO)

Contradiction Point 4

Test Volume and Market Mix Strategy

It reflects differing strategies regarding test volume growth and the focus on shifting the market mix towards Medicare patients, which impacts revenue projections and market penetration.

Why engage Medicare patients now rather than wait for coverage? - Joseph Conway (Needham & Company, LLC, Research Division)

2025Q3: Engaging Medicare patients now aims to maximize the 1-year lookback period for claims once coverage is secured. The confidence in receiving Medicare approval soon drives this proactive engagement. - Lishan Aklog(CEO), Dennis McGrath(CFO)

What is the plan for direct contracting engagements for the rest of the year? - Ross Osborn (Cantor Fitzgerald)

2024Q2: We have three full-time employees working on direct contracting, targeting benefit brokers and self-insured entities. We expect to see contractually guaranteed revenue start to translate in coming quarters. - Lishan Aklog(CEO)

Contradiction Point 5

Medicare Coverage and Commercial Payer Engagement

It involves differing levels of optimism regarding Medicare coverage and commercial payer engagement, which are crucial for Lucid Diagnostics' revenue and market expansion.

Can we expect a draft LCD by year-end 2025 given the current timeline? - Mark Massaro (BTIG, LLC, Research Division)

2025Q3: The timeline remains reasonable, with no indication that the shutdown slowed the process. The workflow is expected to follow a usual pattern, and there is no reason to expect delays. The confidence remains in receiving a draft LCD within the estimated timeframe. - Lishan Aklog(CEO)

Did you present clinical utility data to the MolDX meeting? What is the timeline to submit a final dossier to MolDX? - Joseph Conway (Needham)

2024Q2: We did not have the recent data from the ENVET-BE study ready at the time of the presubmission meeting. Our next step is to gather data, prepare a dossier, and submit it. The gating item for this is the publication of the ESOGUARD BE-1 data, which is under peer review. We expect that data to be published soon, allowing us to submit our final package this year. - Lishan Aklog(CEO)