Earnings Call Transcript - LUCD Q3 2022

Adrian Miller, Vice President of Investor Relations

Thank you, operator. Good afternoon, everyone. This is Adrian Miller, Vice President of Investor Relations at Lucid Diagnostics. Thank you for participating in today's business update call. Joining me today on the call are Dr. Lishan Aklog, Chairman and CEO of Lucid Diagnostics, along with Dennis McGrath, Chief Financial Officer of Lucid Diagnostics. The press release announcing our business update and financial results will be available on Lucid's website. Please take a moment to read the disclaimer about the forward-looking statements in the press release. The business update press release and this conference call both include forward-looking statements, and these forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in our filings with the Securities and Exchange Commission. For a list and description of these and other important risks and uncertainties that may affect future operations, see Part I Item 1A entitled Risk Factors in Lucid's most recent annual report on Form 10-K filed with the Securities and Exchange Commission and any subsequent updates filed in the quarterly report on Form 10-Q and any subsequent forms 8-K. Except as required by law, Lucid disclaims any intentions or obligations to publicly update or revise any forward-looking statements to reflect changes in expectations or in events, conditions or circumstances on which those expectations may be based or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. With that said, I would like to turn the call over to Lishan Aklog. Dr. Aklog?

Lishan Aklog, Chairman and CEO

Thank you, Adrian. So thanks everyone, and welcome to our quarterly call. I'd like to first start by thanking our long-term shareholders for their ongoing support and commitment. As we discussed at our last quarterly call, we had some recent transformational milestones that we put behind us, and the team is now intensely focused on executing on our long-term strategy that we are very satisfied with the solid results they've delivered over this past quarter. We are particularly proud that they did so well under budget for the quarter and the year as we have been able to keep a close eye on cash preservation. I will note that for the first time we have changed the format here, moving from a truly audio conference call to a webcast. We did so in response to feedback, including one from our long-term patent investors suggesting that this would be more useful, and we look forward to ongoing feedback to ensure we are providing the type of transparent communications that we have always aspired to. So let me start with some quarterly highlights; EsoGuard testing volume has increased 28% sequentially quarter to quarter and 436% annually to 1,088 tests performed in the third quarter, and we're happy that we've crossed the 1,000 tests per quarter milestone. We now have 13 test centers that are operating in 11 states, and three more are due to open during this coming quarter. The satellite LTC activity, a concept we introduced on our last call and I'll describe in more detail later, has been increasing rapidly and now includes about 22% of the patients undergoing the EsoGuard testing. Our laboratory, LucidDx Labs, is operating independently with enhanced quality and efficiency metrics that in our view, we are starting to receive payments and recognize revenue on EsoGuard claims that were submitted under LucidDx Labs starting in August. We have clinical utility studies to support private and public payer reimbursement that are underway. We completed the transfer of EsoCheck to a high-volume manufacturer, and as I mentioned, we are executing on our growth strategy while continuing to focus on conserving cash. We are running well ahead of our budget for both the full year and for this past quarter. Lucid Diagnostics is a commercial-stage cancer prevention medical diagnostic company. We're focused on early pre-cancer detection in the tens of millions of patients with gastroesophageal reflux or chronic heartburn who are at risk of developing highly lethal gastroesophageal reflux cancer. Our mission is to prevent these deaths from these cancers and at-risk patients with chronic heartburn. Esophageal cancer is highly lethal and is becoming more prevalent, with around 16,000 patients diagnosed every year. We've faced a 500% increase in cases over the last few decades, and it remains the second most prevalent cancer with an 80% overall mortality rate. The key statistics on this slide, however, are that we stage a one mortality rate of five years is 40%, unlike nearly all other common cancers like colon cancer and breast cancer where Stage I diagnosis is considered a victory. Because of this, early pre-cancer detection is really necessary to prevent these deaths, and unfortunately, less than 5% of those who have been recommended for screening have historically undergone endoscopy. Lucid's products include two innovations: EsoGuard, our esophageal DNA test and our EsoCheck cell collection device, which are the first and only commercially available tests capable of serving as a widespread screening tool to prevent these deaths through early detection of esophageal pre-cancer. We have previously announced that the society guidelines from the major gastroenterology society now recommend EsoCheck in conjunction with EsoGuard as an acceptable alternative to endoscopy, and the further updates also no longer consider having symptomatic heartburn as a mandatory prerequisite, which has significantly expanded the population of patients who are candidates for EsoGuard testing. The commercial opportunity is enormous; the updated guidelines target approximately 30 million patients who are at risk and who have chronic heartburn and are recommended for screening. This increase reflects an unequivocal recommendation as well as an established Medicare payment at $1,938, resulting in a multibillion-dollar market opportunity with an estimated over 90% gross margin. Our sales strategy includes targeting primary care physicians and specialists, including gastroenterologists, surgeons, and related doctors, along with institutions and large practices. With these practices, our goal is to introduce them to the EsoGuard test and for specialties and institutions, we're looking to build an EsoGuard program, making the case that by detecting more patients with esophageal pre-cancer, we can create downstream revenue opportunities for additional procedures. We continue to see steady growth in EsoGuard volume, 1,088 tests performed in the third quarter, representing a 28% increase from the second quarter and a 436% increase from the third quarter last year. I'm excited about the progress we are making in our primary goal: to increase awareness and adoption of our proprietary tests, EsoGuard and EsoCheck.

Dennis McGrath, CFO

Thanks, Lishan, and good evening, everyone. Our summary financial results for the third quarter were reported in our press release that was published earlier today. On the next three slides, I’ll emphasize a few key highlights from the quarter, but I encourage you to consider those remarks in the context of the full disclosures covered in our quarterly report on Form 10-Q that was filed with the SEC earlier today. Our balance sheet shows a sequential decrease in cash between quarters of $5.7 million. Our vendor payables decreased by $2.2 million when considering not only accounts payable reflected there, but other recurring accrued expenses. This is offset by intercompany debt to the current company PAVmed of a $4.2 million increase. However, both boards have agreed that this could be settled up in stock in the coming weeks. We have a committed equity facility with the possibility of $50 million in stock issuances. During the quarter, we recorded $1.8 million in proceeds from this initiative. Our current shares outstanding, as of today, is 39.1 million shares, and we are now S3 eligible. Similar to what we have done at PAVmed, the Lucid board considers it good governance to have a shelf registration with an embedded ATM on file with the SEC, which we plan to do in due course. Regarding our P&L, the revenue for the quarter reflects 39 tests at an average payment rate of $19.45 per test. This rate is slightly higher than the Medicare rate of $19.38 as we received one payment closer to the amount of $24.99, which skewed the average slightly higher. The prior year reflects the fixed monthly fee received from the third-party lab we used before establishing our own lab earlier this year. The key determinant in revenue recognition is the probability of collection for the vast majority of patient out-of-network claims. This means revenue recognition occurs when the claim is actually collected versus when the patient report is invoiced. Our GAAP and non-GAAP loss for the third quarter is fairly flat sequentially. Our non-GAAP loss per share is $0.28 for this quarter, exactly the same as for the prior quarter. The total non-GAAP operating expenses were relatively flat sequentially. The cost of revenue, composed of EsoCheck devices, lab supplies and fixed lab facility costs, is now being presented in our 10-Q as an operating expense, consistent with the practices of other diagnostic companies. Sales and marketing expenses remained flat sequentially, while G&A decreased by 35%, primarily due to the allocation of nearly a million dollars in lab costs from the prior quarter. R&D expenses decreased by 22% sequentially. With that operator, we can open the floor for questions.

Operator, Operator

Our first question is from Mike Matson with Needham & Company. Please proceed with your question.

Mike Matson, Analyst

Yeah, thanks. Just doing some rough math on the test center and some of the numbers you guys gave, if you had it, I think that it's about 240 tests at the $10.88 rate across your 13 centers. That puts you at around $18 to $19 per center in the quarter, about 1.5 tests per week. Does that sound right? Also, can you comment on what you've seen at the centers, knowing that some are newer, what volumes you've seen there on a weekly or monthly basis?

Lishan Aklog, Chairman and CEO

Let me make a couple comments on that, Mike, then I'll let Dennis chime in. One caveat is that the numbers on that slide are still kind of improving our tracking ability to understand tests coming through to the lab, who the referring physician was and who actually performed the procedure. We haven’t broken it down yet, so I'm a little cautious to confirm your extrapolation. We do have test centers in Arizona that have been operational for over a year and are significantly busier than newer centers where growth has accelerated over the last couple of months. We are capturing data that will shed light on these trends, but it's a complex interaction between referring physicians, locations, and center performance. Dennis, do you want to add more to that?

Dennis McGrath, CFO

Yes, I would say that while that math is indicative, the variability across test centers and their respective operational phases makes it challenging to develop a reliable predictive model for future forecasting. Our analysis will improve with further data collection as we gain insights from our ongoing operations.

Mike Matson, Analyst

Okay, thanks. The volume number looks pretty good. The backlog has been substantial, but you mentioned that many tests haven’t been paid for yet. Have any gotten to the point where they are deemed final denials, or are all still potentially in review?

Lishan Aklog, Chairman and CEO

To give you a sense of where we are in this process: as of now, if you total the number of tests performed over Q3 and Q2, we discuss over 2,000 tests that have been or need to be submitted. We only started the submission process in August, thus we are just beginning to see payments and some initial denials. It might still be early to have final denials for claims submitted that month, but we anticipate that data will develop in the coming quarters.

Mike Matson, Analyst

That makes sense. I guess I forgot how early it was in the process. For the payments received, have they all come from a single insurer or have you been able to secure payments from multiple insurers at this point?

Lishan Aklog, Chairman and CEO

Yeah, it's from multiple insurers. We are still compiling the numbers, but I can share that we have been receiving payments that respect our list price, which is encouraging. Until we generate a comprehensive claims history, highlighting the out-of-network payment percentages and bargaining power, it’ll take a few quarters for overall insights.

Operator, Operator

Thank you. Our next question is from the line of Ross Osborn with Cantor Fitzgerald. Please proceed with your question.

Ross Osborn, Analyst

To start off, could you describe how the female population performed during the quarter and how you plan to increase awareness going forward?

Dennis McGrath, CFO

We don’t have a breakdown by gender yet, but we are seeing a consistent referral of appropriate patients according to guidelines. So we feel confident about our patient demographics and expect that this positive trend can help in discussions with payers.

Ross Osborn, Analyst

Thinking about next year, do you expect any staffing headwinds with getting nurse practitioners in your testing centers, and how are you mitigating these risks ahead of broader commercialization?

Lishan Aklog, Chairman and CEO

To reiterate, our plan is not to continue to grow the test centers, our nurse practitioner group, or our sales team throughout the year. We previously articulated our goal to establish 16 test centers and to have sufficient nurse practitioners and 58 sales personnel. We feel this plan will allow us to maintain consistent volume growth. We are not ruling out future pivots, but currently focus on resource allocation and cash preservation strategies. We are pleased with the quality of candidates we have recruited despite some challenges in recruitment.

Operator, Operator

Thank you. Our next question is from the line of Kyle Mikson with Canaccord. Please proceed with your question.

Unidentified Analyst, Analyst

Hi, this is Alex for Kyle Mikson. Great quarter, guys. Could you discuss the new high-volume manufacturer, Coastline, and whether this change was due to capacity constraints or is this more of a proactive measure?

Lishan Aklog, Chairman and CEO

It's absolutely the latter. This was a proactive measure as we anticipate future growth and scalability. Transitioning our manufacturing from a small batch to a high-volume producer allows us to respond quickly to meet demand, ensuring we don’t face capacity constraints as we ramp up our operations. We still maintain our previous manufacturer for dual sourcing.

Unidentified Analyst, Analyst

I know this is looking a little farther ahead, but regarding 2023, can you provide any color on possible revenue breakdown by customer type or trends?

Lishan Aklog, Chairman and CEO

Currently, trends show we are successfully obtaining out-of-network payments with broad coverage. However, we need a few more quarters to establish a robust claim history for predictive revenue. Gathering detailed payment data and clinical utility will support our negotiations with private payers as we move forward.

Dennis McGrath, CFO

We aim to approach this with a focus on evolving our claims data to develop a reliable evaluation of our revenue prospects.

Operator, Operator

Our next question is from the line of Ed Woo with Ascendiant Capital. Please proceed with your question.

Ed Woo, Analyst

Have you noticed any significant increases or decreases in either nurse practitioners' input costs, medical supplies costs, or any effects from inflation?

Lishan Aklog, Chairman and CEO

Regarding inflationary pressures, we haven't seen a significant impact. While there are challenges in the supply chain, we have managed our costs effectively, allowing us to maintain stable budgeting for personnel and supplies. Overall, the inflationary challenges have not significantly impacted our business moving forward.

Dennis McGrath, CFO

Indeed, the inflationary pressures have not affected our operational expenses to a degree that would undermine our revenue opportunities. The margins from each patient remain strong.

Lishan Aklog, Chairman and CEO

Operator, do you have any more questions?

Operator, Operator

There are no further questions at this time.

Lishan Aklog, Chairman and CEO

Okay, with that, I'd like to thank all of you for taking the time to listen to our update today. Hopefully, you found the webcast portion useful and informative. We look forward to your feedback, and we encourage you to stay connected with our progress through news releases and periodic calls such as this. Don’t hesitate to reach out to us via Adrian Miller, our VP of Investor Relations. Thank you again, and have a great evening.

Operator, Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.