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Q4 2024 Exagen Inc Earnings Call

In This Article:

Participants

Ryan Douglas; Investor Relations; Exagen Inc

John Aballi; President, Chief Executive Officer, Director; Exagen Inc

Jeff Black; Chief Financial Officer; Exagen Inc

Kyle Mikson; Analyst; Canaccord Genuity Group Inc

Ross Osborn; Analyst; Cantor Fitzgerald & Co Inc

Mark Massaro; Managing Director; BTIG LLC

Daniel Brennan; Analyst; TD Cowen

Andrew Brackmann; Analyst; William Blair & Co LLC

Unidentified Participant

Presentation

Operator

Greetings and welcome to Exagen Inc fourth quarter 2024 earnings conference call. (Operator Instructions) As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Ryan Douglas, Investor Relations. Thank you, you may begin.

Ryan Douglas

Good morning and thank you for joining us. Earlier today, Exagen Inc released financial results for the quarter and year-ended December 31, 2024. John Aballi, our President and Chief Executive Officer; and Jeff Black, our Chief Financial Officer, will host this morning's call. A recording of today's call and the press release announcing our results can be found on the company's website at www.exagen.com.
As today's call includes forward-looking statements, we encourage you to review the statements contained in today's press release and the risk and uncertainties described in our SEC filings, which identify certain factors that may cause the company's actual events, performance, and results to differ materially from those contained in the forward-looking statements made on today's call.
In addition, we'll discuss non-GAAP financial measures on this call. Descriptions of these non-GAAP financial measures and reconciliations of GAAP to non-GAAP financial measures are included in today's press release. I'll now turn the call over to John.

John Aballi

Good morning and thanks to everyone for being on the call today. I'll start off by recapping our results from 2024, give some color from the launch of our new markers, and comment on our outlook for 2025. Jeff will provide additional detail on the financials later in the call.
2024 was a great year at Exagen. We made major strides in continuing to build the leadership team needed to elevate our organization to the next wave of growth, and we've made significant progress in executing on our strategy towards profitability. From a top line perspective, we've delivered another year of record total revenue, growing to $55.6 million driven largely by continued improvement and reimbursement.
With this progress, our adjusted even a loss narrowed to approximately $10 million showcasing our focus and prudently operating our business. Our trailing 12-month average selling price increased to $411 for AVISE CTD, a gain of $75 per test over 2023. As a result of our ASP gains and continued excellent operational management, growth margins expanded just over 300 basis points in 2024 compared to the year prior. Coming in close to the 60% mark for the full year.
Perhaps most importantly, we developed and commercialized new biomarkers for the first major enhancements to AVISE CTD since the product's inception. We also finished the year with an incredible achievement testing our 1 millionth patient via AVISE CTD and are extremely proud of the many milestones our organization reached in 2024.
To dive deeper into the launch of our new biomarkers this past January, I'm very proud of the hard work and preparation exhibited by our operational and commercial teams. These efforts have resulted in a successful launch to the rheumatology community. The markers have been well received by our ordering physicians, and we are encouraged by the early signs we're seeing with both test volume and reimbursement.
We've already started to see an impact on patient care with the utilization of the new markers, and while we're working diligently to educate clinicians on the value we've demonstrated through our clinical studies, it doesn't truly start to resonate with folks until they have a positive firsthand experience themselves.
To share an initial example of what we've heard already. In Florida, one of the rheumatologists who leverages AVISE testing in her practice received a new patient with a prior diagnosis of fibromyalgia, typically a diagnosis of exclusion. There were no serological abnormalities, and the patient was being treated for pain management. The patient was not responding to therapy, and given that it was a new patient, the clinician decided to run our enhanced CTD panel in their own evaluation.
The entire profile came back negative except for two of our new RA markers which were abnormally high. The patient's diagnosis has since been changed to that of rheumatoid arthritis, and they started first line methotrexate therapy. This is a great example and case study of the impact we hope to have in the field. Obviously, the clinician is excited because this was a challenging patient who was refractory to treatment, and the clinical presentation of the patient had similarities to RA but lacked biomarker confirmation.
Now they have serological evidence to support a diagnosis and can proceed confidently with a treatment decision. (inaudible) this specific type of serological presentation tends to respond well to methotrexate, so this has a higher likelihood of turning out positive for the patient long term than the track they were on because the diagnosis was reached sooner, hopefully avoiding severe joint erosion and points them to a specific therapy.
Again, this is a great case study. We have several of these on the RA side which have come in, so it's very exciting to see the initial results here.
Overall, the feedback has been more heavily weighted towards the RA impact, but we are also hearing positive things on the lupus side with our new T cell markers. Physicians are still learning exactly what these markers mean, especially in the context of an otherwise negative AVISE profile, but luckily our manuscript detailing the unique additional benefit of T cell analytes was accepted and published in a high impact journal, Frontiers in Immunology, less than two weeks ago.
We really believe that our publication marks a significant step towards establishing T cell biomarkers as a powerful tool for SLE diagnosis as the publication details their superior and unique performance compared to conventional analytes. The study was a collaboration with four leading lupus KOLs, providing significant validation of our work within the rheumatology community.
Their collaboration not only strengthens the scientific foundation of our findings but also reinforces the broader clinical relevance of our assays in lupus diagnosis and disease management. This will be an essential tool in our educational campaign over the coming quarters.
At this point in the launch, it's still too early to provide a precise indication as to the full financial impact the markers will have, but we are seeing approximately $90 per AVISE CTD test in incremental revenue, and it could grow from here as we continue to gather details on our appeal success rates.
The $90 value is assumed for our Q1 guidance, and we'll have a more confident number as additional data come in by our Q1 call where we plan to provide an extended outlook for 2025. In short, and just to reemphasize this milestone for our organization, as it is truly a marquee accomplishment from the efforts last year, the additions of our T cell and RA33 biomarkers to our AVISE profile are catalysts on several fronts.
First, they were developed and intended to have a significant positive impact on patient care, and we are already seeing signs of that through clinical adoption and case studies. Second, they widen the GAAP on the clinical differentiation Exagen offers over our competition. We already have the lead in novel proprietary testing for best-in-class connective tissue diagnosis.
Third, our RA biomarkers open up a population of patients and clinicians that to date we have not meaningfully addressed, which could represent a market opportunity that is anticipated to be larger than our existing lupus market. Fourth, these product launches validate our ability to focus, prioritize, and execute on R&D pipeline initiatives that have a high impact and bring them to the clinic in a rapid manner.
The addition of these biomarkers are the first of more to come, and I look forward to continuing to share the full impact these markers have on patients and our company along with additional progress from our pipeline in the future.
With the momentum we have to start the year, we're very excited about what's ahead in '25. We continue to expect strong revenue growth driven by both ASP expansion and volume, and on that note, our performance relative to testing volume in 2024 did not meet our expectations and has been an area of heightened focus since the changes we implemented in 2023 to prioritize profitable volume. Again, some of this volume decline was expected and deliberate as we have prioritized profitable growth, but we have to do better this year and we're off to a good start with the launch of these new markers.
As our ASP increases, the profitability of our sales territories also increase, which opens the door for expansion. We are currently operating at 40 sales territories and anticipate adding a handful of new territories during 2025 in a measured fashion, but to continue to accelerate the utilization of AVISE in clinical practice.
Taking a step back at the end of the year to reflect on our transformation these past 30 months, I'm incredibly proud of what this team has been able to accomplish. It is not common to reduce losses by 70%+, driven mostly by reductions to OpEx, and still grow our top line. Our 40% or more gains to ASP over the past two years are uncommon within this industry, and while we've demonstrated this type of performance, we've dramatically improved the company culture, reducing voluntary turnover by more than two-thirds of what it was when I came to the organization.
People are better aligned to our overall goals, they understand the critical aims we need to accomplish, and as we've made progress, it's fueled the motivation within the company's walls for the next horizon. Specifically, I'm incredibly proud of our R&D and CLIA teams for their development of these new assays, achieving the regulatory approvals and the commercial launch we undertook to start the year.
As business partners, rest assured that you have a strong leadership team which is focused on creating long-term value, and we started to really generate momentum. We believe 2025 will be a step function for our growth, and I fully anticipate finding more opportunistic and creative ways to serve our existing customers while expanding our customer base in the future.
I'll now turn it over to Jeff for details on our financial results.