管理層發言
Greetings, and welcome to the Exagen Inc. Q2 2026 Earnings Call. The conference is being recorded. It is now my pleasure to introduce your host, Tina Jacobsen, Investor Relations. Thank you. You may begin.
Thanks, operator. Good morning, and thank you for joining us to discuss Exagen's financial results for the quarter ended June 30, 2026. Today, I'm joined by John Aballi, our President and Chief Executive Officer; and Jeff Black, our Chief Financial Officer. The recording of this call, the press release announcing our financial results and a slide presentation can be accessed on our website at www.exagen.com. Today's call will include forward-looking statements. We encourage you to review the statements contained in today's press release and the risks 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. We also will discuss non-GAAP financial measures on this call. Descriptions of these non-GAAP financial measures and the reconciliations of GAAP to non-GAAP financial measures are included in today's press release. And now I will turn the call over to John Aballi. John?
Good morning, everyone, and thank you for joining us today. The second quarter was an outstanding one at Exagen, and there's a lot to be excited about. So I'll get right into the details. This morning, we reported revenue of $19.9 million, up 16% year-over-year and the highest quarterly revenue in company history. And while total revenue was a record, we also achieved several other records in the quarter, including quarterly AVISE test volume, trailing 12-month ASP and pharma services revenue. We delivered those top-line achievements while narrowing adjusted EBITDA loss to $0.1 million, essentially breakeven and a significant improvement compared to the $1.7 million loss in the second quarter of last year. Based on the strength of the first half of 2026, we are increasing full year revenue guidance to $72 million to $75 million. Results like these don't happen by accident. They reflect execution against the same three core objectives we've prioritized for the last several years. First, expanding adoption of our products; second, increasing ASP through disciplined revenue cycle management; and third, delivering a steady cadence of innovation to address the unmet needs of our clinicians. In our business, individual quarters will always have some variability, but the structural changes we've made are clearly improving our long-term trajectory of both volume and ASP. Q2 was the strongest demonstration yet that our strategy is working and our business can scale. As always, we anchor to our mission. Autoimmune disease is diagnosed too late and too inconsistently, and it's the patients that suffer. Exagen exists to bring clarity to that complexity. We have now surpassed 1.2 million AVISE CTD results delivered to clinicians and their patients since product inception. That's a meaningful milestone, but we're just getting started. With just over 3% share of an autoimmune testing market we estimate at more than $2.2 billion and growing about 5% annually, the opportunity ahead of us is significant. We intend to continue to earn share the same way we build trust in this underserved channel through the best science, more timely answers and world-class service. Let me start with clinical adoption. AVISE CTD volume reached nearly 39,000 tests in the second quarter, up 11% year-over-year and the highest quarterly volume in Exagen's history. I also want to put that volume record in context. In 2023, we deliberately reset our ASP strategy and rebuilt our commercial approach, accepting that volume would contract as a consequence. This quarter, volume exceeded those previous levels, and we crossed that threshold with a trailing 12-month ASP nearly 40% higher than it was back then. We established the right strategy, executed with discipline and have now rebuilt the volume base on a dramatically stronger economic foundation. The quality of that growth is exactly what we want to see. Over 2,800 clinicians ordered AVISE CTD in the quarter, up approximately 9% year-over-year, which speaks to the value our testing has established within the rheumatology community. Sales force productivity reached record levels with trailing 12-month AVISE CTD revenue per territory of over $1.4 million in the second quarter. This is compared to roughly $1.3 million for the full year 2025. The investments we've made to upgrade, expand and enhance the training of our sales organization are delivering. We continue to advance the clinical aptitude of the team and the momentum has carried into the current quarter. Turning to ASP. Trailing 12-month ASP is the metric we use as operators to assess the performance of our business because it smooths the variability associated with accrual accounting and the timing of collections. We believe it's the most reliable indicator of progress in what is a highly critical area of our business. In the second quarter, trailing 12-month ASP expanded to $446, up $18 per test or 4% versus last year and marking our 13th consecutive quarter of growth. Our revenue cycle team deserves recognition for another quarter of strong collections, including meaningful recoveries on older claims. The performance reflects years of disciplined work to structurally improve how this team operates. This year, our revenue cycle strategy has shifted more towards optimization of our processes. We're leveraging analytics and AI to prioritize where the highest-value opportunities lie, to automate appeals and to streamline medical record extraction. Together, these initiatives have driven trailing 12-month ASP from $284 at the end of 2022 to $446 today, and I'm confident there's more ground to gain. Pharma services also delivered a record quarter with quarterly revenue crossing the $1 million point for the first time. This is a business we've built deliberately over the past couple of years and the strong results are early proof that the unique data, biobank and scientific capabilities we've assembled serve not only clinicians, but also partners developing the next generation of autoimmune therapies. During the quarter, we began to build on the success we've achieved in incorporating AI across RCM processes by investing in the development of customer-facing applications. This AI-powered commercial infrastructure is designed to deepen clinical engagement, support AVISE utilization and embed Exagen directly in the rheumatology workflow. It's early, and we'll share more as development progresses. But over time, we believe the investment will complement our commercial team and reinforce Exagen's leadership within autoimmune diagnostics. On the evidence front, we published a systematic review validating real-world AVISE Lupus performance. This manuscript is one of the most extensive evidence generation efforts behind any novel lupus diagnostic, pooling years of data representing 3,100-plus patients across 14 medical centers into the most diverse analysis of the AVISE test to date. Most notably, AVISE Lupus identified approximately 25% of SLE patients who were missed by conventional markers. And this was noted by the authors, including some of the most prominent lupus physicians in the space. AVISE meaningfully influences diagnosis, physician confidence and patient management. This is the kind of clinical impact we strive to deliver across our portfolio, and this manuscript helps make the impact clear. And on that note, our innovation engine remains on track. Our myositis offering, the first new stand-alone product for Exagen in many years, continues to progress towards commercialization in early 2027, and we remain committed to a cadence of approximately one new product every 12 or so months thereafter. We've deliberately built an R&D-to-commercial machine that can deliver on that cadence, and our channel is eager for what's to come. Before I hand it over, I want to take a second to highlight the immense progress we've made. In 2022, our full-year adjusted EBITDA loss was around $40 million and worsening. This quarter, we approached breakeven adjusted EBITDA while setting records across the business, and we did it before our next wave of products has even launched. This is what disciplined execution compounds into, a business that grows, innovates and generates cash. Sustained profitability is within reach, and we intend to cross that threshold through the same disciplined execution that brought us here, delivering on our commitments and building a durable long-term organization. With that, I'll turn it over to Jeff for additional comments on the financials.
Thank you, John, and good morning, everybody. As John just highlighted, our second quarter results reflect another strong quarter of execution across the business. We achieved record top-line performance driven by record testing volume and trailing 12-month ASP and a record contribution from our pharma services offering. Starting with revenue, we generated $19.9 million in the second quarter, an increase of 16% year-over-year and 15% sequentially. AVISE CTD test volume grew 11% year-over-year, reflecting continued strength in clinician adoption and utilization as well as the impact of last year's investment in commercial expansion. Our commercial investments are delivering solid returns. Even with several sales territories under one year old, productivity continued to ramp. Trailing 12-month CTD revenue per territory grew about 6% year-over-year and ordering clinicians increased approximately 9%. AVISE CTD trailing 12-month ASP expanded to $446 per test, up 4% compared to last year. Execution of our revenue cycle management initiatives supported a strong in-period ASP result, which included over $1 million collected from claims older than 360 days. Notably, our total cash collections in the first half of 2026 exceeded first half 2025 levels by $9 million. Over time, we continue to target an ASP of at least 50% of our Medicare reimbursement or approximately $600 to $650 per test, recognizing that this will take time and that quarterly contribution from our revenue cycle initiatives can be variable. Pharma services generated revenue of just over $1 million in the second quarter, up over 200% compared to the second quarter last year, reflecting continued execution against contract backlog and broadening contribution from this offering. To put our 2026 performance in perspective, in 2024, we generated just over $100,000 in full-year pharma services revenue, growing to $1.7 million in 2025 and now to $1.3 million in only the first half of 2026. At the same time, we grew our contract backlog in Q2 by about $1 million to over $6 million. And while revenue recognition from this business can fluctuate significantly from quarter-to-quarter, we see this as another long-term growth lever with the trend line tracking positively. Moving to gross margin. We reported just over 61% for the second quarter, up approximately 90 basis points compared to last year. Gross margin in the quarter benefited from ASP expansion, operating leverage and ongoing COGS rationalization that has streamlined workflows in the lab and reduced costs across our supply chain. We remain confident that gross margin will progress to the mid-60s over time as we achieve further ASP expansion, generate additional scale and fixed cost leverage and further optimize costs. Turning to expenses. Total operating expenses for the second quarter were just under $14 million or approximately 70% of revenue, a significant improvement compared to 75% in the second quarter last year. And this performance reflects the operating leverage inherent in our model. We delivered 16% revenue growth while holding OpEx growth to 7%. While OpEx level will vary from quarter-to-quarter, that kind of discipline will continue as we scale even with planned investments in the R&D pipeline. Note that second quarter OpEx included noncash stock-based compensation of about $1 million, an increase of over $0.5 million versus second quarter last year. Breaking out the components of OpEx, second quarter SG&A was $12.5 million, an increase of just under $1 million compared to second quarter '25, driven primarily by increased stock-based compensation and investment in commercial talent and territory expansion. R&D was $1.4 million in the second quarter, down modestly compared to last year due primarily to timing of investments while continuing to support pipeline development, including the preparation for our myositis product launch expected in early 2027. Adjusted EBITDA loss, which excludes depreciation and noncash stock-based comp expense, improved significantly at a loss of just over $100,000 in the second quarter compared to $1.7 million loss in the second quarter last year. While we don't expect adjusted EBITDA to sustain at this level in the second half of '26, this quarter's roughly $20 million in revenue and near breakeven adjusted EBITDA are strong proof points for our operating model that demonstrate the leverage we believe the business will deliver as we scale. Turning to the balance sheet. We generated $3.1 million in cash in the second quarter, ending the period with cash, cash equivalents and restricted cash of just under $25 million. This improvement reflects the rebound following heavy cash used in the first quarter associated with our revenue cycle management process, where we hold claims in the first quarter of the year. With $37 million in cash and accounts receivable at June 30, we continue to believe that our balance sheet provides the runway needed to support the business to reach sustainable adjusted positive EBITDA and positive free operating cash flow. Shifting to guidance. Today, we raised our 2026 revenue outlook to reflect strong execution-driven first half performance. We now expect full-year revenue of $72 million to $75 million, up from our previous guide of $70 million to $73 million. Our updated outlook continues to assume high single-digit volume growth for the full year, reflecting improved revenue cycle management performance in the first half, supporting a full-year mid-single-digit ASP growth compared to our Q4 2025 ASP exit rate. Our guide also incorporates the seasonality impact we typically experience in the second half of the year. In closing, our second quarter results are a clear demonstration of the scale and leverage we've committed to building and reinforcing our view that the business is positioned to reach adjusted EBITDA breakeven at around $80 million in annual revenue. With that, operator, we will now open the call for questions.
分析師問答
The first question is from Dan Brennan from TD Cowen.
This is William on for Dan. So guidance was raised by $2 million at the midpoint. Is there any reason there isn't a fair amount of conservatism baked here on both ASP and volumes? Last year, you did see a sequential uptick in volumes from Q2 to Q3. So just trying to understand if there's conservatism there.
Thanks so much for the question. Very valid. Our thinking on this is for Q2, we had a very nice quarter. And relative to our original projections, we're a couple of million above where we expected to be. The second half of the year, you're right. Last year, we had a phenomenal second half, which didn't have the typical seasonality. It was relatively flat compared to our Q2, but wasn't down. We had 10 years of seasonality prior to that. And so I think from our standpoint, just keeping that in the back of the mind is an important factor as we crafted our guidance this time around.
Got it. And then how should we expect sales force expansion contribution to volumes in the second half? Are you expecting any contribution there?
We definitely expect contribution. We're putting a lot of investment into those folks, and we're actually really excited about the caliber of individuals that we've been able to find and attract to our company. I sit in on the interview of anyone who comes into the company, especially on our sales organization, and we really have some fantastic folks. A few of them are here doing some training this week as well. So our investments in that group remain very strong. We have, I think, certainly the best autoimmune sales force out there. Therefore, we expect a pretty decent contribution. But most of these expansion territories were starting from a relatively low basis. It will take a little bit of time before they really move the top-line number in a meaningful way. But over time, call it the next six to twelve months, I think that 10% expansion in our sales force that we executed in the back half of last year should really start to drive some meaningful volume growth for our organization.
The next question is from Bill Bonello from Craig-Hallum Capital Group.
First one is just a simple housekeeping question. Can you give us the AVISE revenue for the quarter?
Yes. Thanks so much for the question. AVISE CTD revenue for the quarter was $17.7 million.
Perfect. That is what we calculated, but wanted to be sure we were doing it right. And then, just can you talk to us—great to see the progress on ASP. Just trying to get a sense of where you're at in terms of getting paid for some of the new markers that you've launched. To what extent is the improvement that we've seen in ASP more related to revenue cycle management versus opportunity in front of us on getting paid for additional markers?
Sure, Bill. I'll answer it a couple of different ways. I think we're starting to really look at the ASP on a blended basis across the entire AVISE CTD panel. I know we've communicated in the past what our expectation was on the new biomarkers. Combined T-Cell, RA33 and PAD4, our overall expectation we'd communicated was going to be somewhere in that $100 range. Where we're tracking today is really in the mid-90s. So we're tracking very well. We don't think there's any reason we couldn't ultimately get to that target, particularly since a lot of those claims in the last year are still going through appeals and revenue cycle management. So we're encouraged by the traction. It has been a contributor. It's in that mid-90s range and tracking very well.
The next question is from Kyle Mikson from Canaccord Genuity.
Congrats on the great quarter. I had a multipart guidance question on the components. On ASP, you raised that kind of guidance from low single-digit growth to now mid-single digit, even though the trailing 12-month ASP was kind of flat quarter-to-quarter. I'm curious what you're seeing with collecting and the RCM benefit, and any progress with commercial payers that you expect to help an inflection maybe towards year-end? And then on the volume side, it looks like roughly similar second half volumes to first half, but maybe pointing to areas of upside in volume specifically that we could hope for.
Thanks for the questions, Kyle. Very proud of now 13 consecutive quarters of increasing ASP. That's not easy to do as I think you'll see across the industry. And I think it speaks a lot to the fact that we have the right strategy in place, the right team, and we're executing diligently. A ton of credit goes to our revenue cycle team. They're firing on all cylinders. The more exciting thing is we still have a lot of optimization that we're working into the process and feel very optimistic about the future as well. If you take a look year-over-year, I believe we're up 4% on ASP. So I think we're tracking exactly as you said. Low single digits is what we've communicated in terms of growth expectations year-over-year in the past, progressing to mid-single digits is what's baked into the guidance. Projections on ASP improvement over time are always difficult to nail down timing and magnitude. That's what we think is a reasonable expectation for the second half. Progress with commercial payers continues to be very strong. Our Medicare rate is static. Progress over the last 13 quarters has really been with our private payer groups. We have been highly effective in our administrative law judge hearings. We've been very effective in our appeals efforts. We've continued to develop evidence, which substantiates our report and our processes have improved materially over the last few years. From our standpoint, that trailing 12-month progression and improvement in growth is 100% attributable to progress with commercial payers. We tend to focus more on cash collections and the blended ASP rather than activity related to some of those individual payers, because that's what really matters. There can be a dislocation between activity and results over time. That's what we've been consistent in communicating and I'm very proud of the way the teams have operated. On volume, first half roughly equal to second half, I think you nailed that as well. Just keep in mind, second half tends to have fewer actual business days with a pretty strong slate of holidays coming in, especially in Q4. We also tend to see from a physician standpoint, July through December tends to be higher on vacations for our clinical group. So functionally we often end up with fewer working days in the second half than in the first half. Last year was a phenomenal year for us. We're trying to continue to grow the business in the second half and match what we did last year, if not exceed it. But at the same time, I think you have to live in reality. Hopefully that addresses each of your points.
Yes, that was great, John. Maybe for Jeff on the framework on the path to breakeven EBITDA. This quarter you're at that $80 million run rate. Going forward, how should we expect gross margin to track? Last time we spoke, it sounded like high 50s, close to 60s for the rest of the year. At this point, it seems like maybe you could eclipse that.
Yes, Kyle, thanks for the question. I think even last call, we had called 60% for 2026 more aspirational and to think about it more in the high 50s. We actually think there's now a track to ending the year at that 60% or above. So we've seen very good traction. ASP expansion, managing fixed costs and managing supply chain costs have all contributed. I think the 60% range is a lot more realistic now and less aspirational for the year.
The next question is from Max Masucci from ROTH Capital Partners.
Congrats on a strong print. First, on sales force productivity, the five territory reps you hired in 2025 are beyond the six- to nine-month ramp. Did those reps provide a noticeable boost to volume growth in Q2 or was the strength more broad-based across the entire force? And what's really driving the productivity higher—any new tools or strategies that are making an impact?
Great question. We added five territories last year; one of those additions essentially split existing territories so you could argue we started over a little bit in six areas. We see a pretty decent distribution of productivity at this point. One of our expansion territories has almost doubled since we added that group. We're seeing consistent growth on the lower end of the expansion territories around 10% to 11% up to 80% to 90% growth in higher-performing territories. Different reasons are at play: potential in the territory and ramp time for the individual rep. The territories we chose were the right areas to expand. We saw growth across the entire nation. What's driving that? The refresh of the product last year with the addition of the new analytes certainly reinvigorated the sales force, but it also expanded our utility into rheumatoid arthritis, where we had historically been focused more on the lupus side. That's a big deal, and I think you're seeing it play out. We saw it in the back half of last year and it showed up here in Q2. We're still working on getting that messaging out and articulating the clinical value in a more precise and tailored way. Our evidence generation efforts continue to mature. Our systematic review refreshes some of the lupus clinical data, and identifying 25% of patients missed by conventional serologies is a big value for clinicians. Having that published and marketable is enhancing the clinical value of the product, and our team is really pushing it. More to come.
Great. And just a follow-up: Historically, about one-third of ordering clinician growth has come from outside of rheumatology—GPs, internists, OB/GYN, pulmonology. Is that becoming a deliberate channel strategy? How do ordering trends for those types of doctors compare to what you're seeing in rheumatology?
We still see a general 80/20 rule—most of our business comes from rheumatology. At the same time, referral networks into rheumatology find significant utility with AVISE CTD, especially with the enhanced biomarkers. Workforce shortages within rheumatology are lending to that. With the myositis launch, the primary call point will be rheumatology, but it has applicability into pulmonology and other subspecialties. Internally, as we look for further sales expansion, understanding outside demand is a predicate for our next wave of expansion. We'll know more as we start 2027, but we're seeing decent growth within some of these other specialties.
The next question is from Mark Massaro from BTIG.
Congrats on a strong quarter. I wanted to ask about the myositis launch. Can you give a sense for what we should be on the lookout for in terms of any data readouts or timing? And can you give a preview of how you're thinking about pricing the test?
Very excited about the myositis opportunity. This is the number one asked-for product among our rheumatologist clinical base. When we ask clinicians how we can better serve them, this comes up well ahead of other requests. We're excited to provide a comprehensive solution that we think will dramatically impact patient care and identify patients at very high risk of dangerous clinical outcomes. Development remains on track. We had to bring two new platforms into our laboratory and get those analytically validated; that's occurred. We have to get the sample cohorts to conduct clinical validation; that's in process and remains on track. We're very happy with execution and remain in line with expectations to launch commercially in the first part of 2027. Pricing-wise, we'll launch similar to what we did with analytes we launched last year. There are methodology-based CPT codes that correspond with the various analyte tests—for example, ELISA-based testing has an established CPT code. Those codes have been vetted and we believe we have the right set of codes to build this out. We don't have a significant track record of billing all of these codes, so as we launch from a revenue standpoint, we'll mirror very close to cash collections and then over time establish an accrual rate and be able to set a public expectation as well. That's how we'll launch for reimbursement. Over time, as our clinical validation matures, we may provide algorithmic interpretation and potentially pursue value-based reimbursement, but that's down the line. The initial launch will use established CPT codes.
That makes sense and is helpful. On the EBITDA breakeven commentary—you're saying you can get to adjusted EBITDA breakeven at $80 million of revenue. It looks like you could do it sooner. How should we think about factors that would lead you to not getting there before $80 million? Are there investments you're making in the business you can quantify, like headcount or R&D?
If I understand, you're asking what the risks are to reaching adjusted EBITDA positivity and why not a little sooner. We're not guiding on the exact timing of adjusted EBITDA positivity, but I think we're very close given this quarter's results. Second-half seasonality will come into play with hitting sustained $20 million-plus revenue quarterly. We're also right around a product launch. Whether we're plus or minus a quarter, we've got the balance sheet to get there, and we want to get there in a measured, sustainable fashion. We've tried to grow with an eye towards profitability, and that's what we've executed on the last several years. Reimbursement risks always exist in this business. Theoretically there could be a volume hit from a key client, but nothing is foreseen. Most of what we're seeing is positive related to the team's efforts. I think we're well on track and it should be around the corner.
Fantastic. One last question: You guys have been collecting close to $1 million or a little over $1 million in prior period collections in the last couple of quarters. Should we expect these RCM initiatives to continue to yield collections from prior periods in the coming quarters?
Yes. As long as there is an appeals queue and we're focusing on revenue cycle management and maximizing the appeals process, then yes, we expect we'll continue to see excess cash. That said, the better we do in any given quarter, the higher our accrual rate will go, because the better we do typically impacts the accrual rate. We try to be conservative about the accrual rate and not get ahead of ourselves. The expectation is we're seeing nice momentum. In the first half of this year, we collected about $2.3 million in cash greater than 360 days. To put that in perspective, a year ago for the full year it was about $1.5 million and in 2024 it was $2.7 million for the full year. So we're tracking well ahead of historical trends.
The next question is from Matthew Parisi from KeyBanc Capital Markets.
This is Matt Parisi on for Paul Knight at KeyBanc. I was wondering if you could give an update regarding the local coverage determination. Last we heard, there was an expectation of an update in mid- to late-2026. Is that still the expectation?
Matt, thanks for the question. That is still our expectation, but we don't control it, and it's a fairly opaque process. As a reminder, we submitted our request to MolDX in the summer of 2022 and are waiting for their feedback. Our reimbursement with Medicare continues to be very stable and there have been no changes there. We're looking for the next step, which would be either a CAC meeting or a draft LCD to come out. We have no update right now. With the generation of the new systematic review, we're working to get that in front of the MolDX team and review it with them. We maintain a very good relationship with that group, but no update at this time.
Appreciate the insight. One more: Does Exagen expect to expand its sales force in advance of the myositis launch, or would the current sales force be focused on both AVISE CTD and myositis?
We anticipate selling myositis concurrently with the AVISE CTD offering and our portfolio. Our existing sales force will go through training on the myositis product at the end of Q3 in anticipation of the launch. It will be available to all 45 territories and clinicians within those territories. It's primarily a rheumatology call point with some applicability into the referral network and possibly more applicability into pulmonology than CTD currently. We will stick within our existing customer base and offer it with our existing team. We do anticipate evaluating sales expansion after the launch depending on uptake, which will change the opportunity rating for expansion opportunities. We'll get through the launch and then look to the next wave.
There are no further questions at this time. I would like to turn the floor back over to John Aballi for closing comments.
Fantastic. Thank you. I really appreciate everyone joining the call today. This was about as fun as quarters get from my perspective. We had records in revenue, volume, trailing 12-month ASP and pharma services revenue, all delivered at essentially breakeven adjusted EBITDA. That's been a milestone that has been a long time coming. Three years ago for our organization, that combination would have sounded crazy. Our team made it a reality through consistent disciplined execution, and I'm really proud of the group here. The talent and character across Exagen continues to transform the organization into what I think is the preeminent diagnostic company serving autoimmune patients. I'm as excited about the opportunity ahead of us as I've been since joining a few years ago. We're within reach of the financial inflection we've been building toward. While others are focused elsewhere, we'll keep chipping away to build a truly incredible autoimmune powerhouse. We appreciate the support of all our stakeholders and look forward to updating you on our progress. Thanks again.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.