QTRX - NASDAQ

Ladies and gentlemen, thank you for standing by. My name is Colby, and I will be your conference operator today. At this time, I would like to welcome you to the Quanterix Corporation Q4 2025 Earnings Call. [Operator Instructions] I will now turn the call over to Joshua Young. You may begin.

Thank you, Colby, and good afternoon, everybody. With me on today's call are Everett Cunningham, Quanterix President and CEO and Vandana Sriram, Quanterix Chief Financial Officer. Today's call is being recorded, and a replay of the call will be available on the Investor Relations section of our website. During the course of today's presentation, we will make forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act. These forward-looking statements are based on management's beliefs and assumptions as of today, March 2, 2026. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements. To supplement our financial results presented on a GAAP basis, we have provided certain non-GAAP financial measures. These non-GAAP measures are used to evaluate our operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in our business and our competitors. We believe that such measures are important in comparing current results with other periods results in assessing our operating performance within our industry. Non-GAAP financial information presented herein should be considered in conjunction with and not as a substitute for the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to the most directly comparable GAAP financial measures set forth in the presentation posted to our website and in our earnings release issued earlier today. Finally, any percentage changes we discuss will be on a year-over-year basis, unless otherwise noted. Now I'd like to turn the call over to Everett Cunningham. Everett?

Thanks, Josh. And I'm so excited to be with you this afternoon. I'm looking forward to meeting many of you over the coming weeks and months. Now for those of you that I have not met, I want to share some information about my background and what brought me here to Quanterix I've spent my entire 3-decade-plus career in health care with a diverse background in pharma, tools and diagnostics from a variety of commercial and enterprise operational roles which is very relevant for where Quanterix is and as we scale our business. Now in my last role as the Chief Commercial Officer at Illumina. I led the commercial strategy and execution for this $20 billion market cap company as we go deeper into sequencing and array-based solutions. During my tenure at Illumina, I work with the team that delivered one of the most transformational technologies in the analytical instruments market. Now my work there built on my experience as a Chief Commercial Officer at Exact Sciences, where my team encompass sales, marketing and customer service in precision oncology diagnostics and screening. Now my prior roles at Quest, GE Healthcare and Pfizer effectively round out my commercial and my operational portfolio and combined, provide you with the insights needed to accelerate Quanterix' overall growth. Now I believe that Quanterix is well positioned to achieve a leadership position in the diagnostics industry. And I'm just very excited to work with my colleagues to achieve our commercial and our financial goals. Now there are several reasons why I'm very excited to be leading Quanterix at this time. First, Quanterix has developed differentiated technologies in disease states that need health care breakthroughs and also need solid business partnerships in neurology, oncology and immunology. Second, we have a compelling base business in the research tool space that exceeded our expectations in the fourth quarter and will drive us to breakeven profitability this year. Now this continued operational rigor will also provide a steady normalized growth path. Third, there's a massive opportunity for growth in the diagnostics market, starting with Alzheimer's disease, and Quanterix' ultrasensitive platforms are uniquely positioned here. Next, we have a strong foundation here at Quanterix, including a talented and dedicated team and a solid balance sheet with more than $100 million of cash and no debt. And lastly, I'm just thrilled to be joining Quanterix at this inflection point. I'm also looking forward to leading this company this year and beyond. Now my immediate focus area will be to spend as much time as possible with my leadership team and the employee base to fully understand Quanterix' potential from an insider's perspective and to ensure that our culture supports our priorities. I also fully need to understand the business and technology from a customer and strategic partner vantage point. So I'll be spending a lot of time with customers and partners, too. Now my objective is to continue to focus on what's working well and to evolve Quanterix into a stronger, more agile and scalable company. Now that entails fully understanding where we are the strongest and have the best opportunities to win, working together with our team and drawing on my years of experience in this field to guide our direction forward. I also want to establish an open and transparent communication process with our analysts and investors. I'm sure that many of you have a range of ideas and insights about our path forward, and I welcome your ideas. We will, of course, keep you updated as we move forward. So now let me turn it over to our Chief Financial Officer, Vandana Sriram. Vandana.

Thank you, Everett, and good afternoon. Total revenue for the fourth quarter was $43.9 million, an increase of 25% from the previous year and up 7% sequentially. Organic revenue was a decline of 22%. Revenue from our diagnostics partners was $3.1 million in the quarter. During the quarter, we saw better-than-expected revenues from the release of pent-up demand from our academic customer base. From a product perspective, Simoa contributed $27 million, a 22% organic revenue decline and Spatial reported $17 million, down 23% year-over-year. Spatial revenues include $2.5 million from a diagnostics development agreement that is now terminated. Excluding this agreement, Spatial revenues were down 16% year-over-year. The terminated agreement was dilutive to the company's financial results and will have a minimal impact on our core business in 2026. Instrument revenue was $6.1 million, comprised of $3.2 million of Simoa and $2.9 million Spatial instruments. We placed 21 Simoa and 17 Spatial instruments in the quarter, as compared to 18 Simoa instruments in the fourth quarter of 2024. Consumables revenue was $23 million, up $3.8 million sequentially. This consisted of $15.4 million in Simoa and $7.6 million in Spatial consumables. Accelerator lab revenue was $8.3 million, $5.3 million in Simoa and $3 million in Spatial. Our customer mix was slightly skewed to academia, which represented approximately 55% of the business in Q4. On a pro forma basis, assuming Quanterix and Akoya will combined for the full year, academic revenue for the fourth quarter declined approximately 24%. Pharma revenue declined 21% year-over-year primarily due to lower large accelerator projects versus the prior year. From a diagnostics perspective, we now have 25 partnerships that generated $9.6 million in revenue during 2025, up from $6 million in the prior year. This includes our recently announced partnership with Life Line Screening a national health screening group focused on identifying asymptomatic risks for chronic conditions in a community health setting. We continue to deliver key milestones in our Diagnostics business as we execute our long-term strategy. Our LucentAD complete test, which is a multi-analyte algorithmic blood test for Alzheimer's disease remains a highly differentiated test in the market. We recently achieved 2 significant milestones for LucentAD complete. Firstly, in Q4, the centers for Medicare and Medicaid services approved a reimbursement rate of $897 for the test. This milestone provides a nationally recognized reference price for the test. We are now focused on generating clinical utility data in support of LucentAD complete in various payer conversations. Secondly, in January 2026. We submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for this test. Both these milestones further our mission to provide superior, noninvasive, high-performance diagnostics tools to aid in the evaluation of patients with cognitive symptoms for possible Alzheimer's disease. During 2025, we also launched 13 new assays, including 2 new Simoa Tau assays, pTau-205 and pTau-212. We have seen strong interest in both products during the initial launch period. In the coming year, we expect Tau biomarkers to remain of high interest and plan to launch additional products addressing this growing field. On the Spatial side of the business, we launched 2 new PhenoCode Discovery panels in Q4 25, a metabolism spike in panel and a mouse neurology panel. The mouse neurology panel expands our Spatial biology and neurology offerings into mouse models and complements our previously launched human neurology panel. Moving on to the P&L. Gross profit and margin for the fourth quarter was $20 million or 45.7%. Non-GAAP gross profit was $21.9 million and non-GAAP gross margins 50%. Operating expenses for the quarter were $44.8 million. Included in operating expenses are approximately $6.4 million of costs related to acquisition, integration, restructuring and purchase accounting and $1.4 million of shipping and handling costs. Non-GAAP operating expenses were $37 million a decrease of roughly $1.5 million sequentially as a result of synergies. As Everett mentioned, we've completed major integration activities and are turning our attention to profitable growth and delivering on our commitment to be cash flow breakeven in 2026. We have already implemented $74 million of our $85 million cost synergy target, and we're on track to meet our target by the end of Q1. Additionally, we remediated our material weaknesses related to revenue and inventory. By putting these material weaknesses behind us, we have established a stronger foundation for future growth. Our adjusted EBITDA was a loss of $7.9 million, a sequential improvement of $4 million as compared to a loss of $11.9 million in the third quarter. We ended the quarter with $122 million of cash, cash equivalents, marketable securities and restricted cash. During the quarter, we made a $10 million milestone payment for the EMISSION acquisition and spent $3.5 million related to severance and other nonrecurring expenses. Adjusted cash usage during the quarter was $3 million compared to $16.1 million in Q3, a marked sequential improvement as a result of synergies and improved working capital. I will now turn to our guidance for 2026. We expect to report approximately $169 million to $174 million of revenue, which assumes no underlying improvement in the academic or pharmaceutical end markets. In 2026, we expect a minimal impact to our core business from the terminated diagnostics development agreement, which yielded $5.6 million of revenue for the full year of 2025. Excluding this agreement, we expect pro forma revenue for 2026 to increase by approximately 2% at the midpoint of the guide. We expect GAAP gross margin to be in a range of 45% to 49% and non-GAAP gross margin to be in a range of 49% to 53%. We anticipate achieving cash flow breakeven in the second half of the year and expect to end the year with approximately $100 million of cash and no debt. And finally, in terms of our quarterly cadence, we expect similar seasonal pacing to revenue as in prior years. I will now turn it back over to Everett for closing remarks.

Thanks, Vandana. I'm confident in our base business. I'm also confident in our plan for breakeven profitability this year. And lastly, I'm confident in scaling our business into areas of profitable growth. Now I want to turn it back over to Josh.

Thank you, Everett. Colby, please assemble the Q&A roster.

[Operator Instructions] Your first question comes from Kyle Mikson with Canaccord Genuity.

This is Alex Vukasin on the line for Kyle Mikson. Congratulations, Everett on the new role. We look forward to working with you. This one is for Everett. So in your assessment of Quanterix' core high sensitivity proteomics as well as Spatial Biology businesses, what do you see the company has been executing on effectively? And additionally, what are some aspects of the current strategy that you would like to adjust or change with these 2 businesses in the near term?

Yes. No, thanks for that question. I'm looking forward to working with you also. As I come on, I've been now with the company for 35-plus days, and I'm taking this opportunity to really assess our diversified strategy, which I love. I'll mention a couple of stats about what Akoya has done in our Spatial business, before Akoya we were, what, 90% neurology, 10% oncology immunology. Now with Akoya and the Spatial technology and expertise we're now more diversified. We're now 60% neurology and plus 40% Spatial and oncology and immunology. So I like that diversification. What I like is that, I like the fact that they have a broad footprint. I like the talent that the business has brought on to Quanterix. I also like the fact that there's been a lot of work around synergy targets and making sure that we can take advantage of that, as you heard from Vandana, we will hit our $85 million target at the end of Q1. Now what that's going to allow us to do, it's going to allow us to really focus on how do we now execute our growth plan in the Simoa space, but also in the Akoya Spatial space. And the footprint, the technology that they bring on, the customer relationship that they have, I think really makes us really appropriate to drive our growth strategy this year and beyond.

Got it. And just one more for me. So you noted earlier on the call that you launched about 13 new assays in 2025 alone. On the pipeline, any new asset or new product launches for 2026? And more specifically, what is the timing for the more general availability of your higher plex Simoa ONE platform? Any feedback from the early access program that gives you confidence this new platform and its capabilities could drive greater proteomics performance in the near term?

I'll have Vandana take the first, and I'll take the Samoa ONE question second.

Alex, you're right. We did 13 assays in 2025. We did about 20 assays in 2024 before that. This is really an indicator of the fact that our innovation engine is now moving and we expect to have a regular cadence of assay launches every quarter. We have a couple that are already in the pipeline for Q1 that will be coming out shortly, but the intent really is that this is a continuous stream throughout 2026.

Yes. And as far as Simoa ONE, we rolled out our early access program for Simoa ONE at the end of last quarter. And right now, what we're doing is we're currently executing the test plans with our customers. So we're going to continue to gather feedback and that feedback will actually steer our decision-making. The benefit of me taking over recently is, I'm also in the process of doing a holistic review of all of our product development and launch initiatives here at Quanterix. I will say this. We have attractive segments on both sides, the Samoa and the Spatial side. The one thing that we will have to do because of that attractive segments, we'll have to make some decisions. And our decision will be based on return on investment and bringing growth back to Quanterix as quickly as possible.

Your next question comes from the line of Puneet Souda with Leerink Partners.

First one, Everett for you. You emphasized Alzheimer's diagnostics. Obviously, you're coming with significant experience in sales and commercial side. So I wanted to get a view from you going forward, as you talked about the diagnostics opportunity, how should we think about the overall prioritization or when you look at the diagnostics versus the Simoa proteomics versus the Spatial business that you have? And how are you thinking about those 3 segments and also, if you can provide an expectation for the investments needed to drive growth on the Alzheimer's diagnostic side? Can you still reach the cash flow breakeven expectation by the year-end after the addition of those sales and commercial investments that you are potentially planning here?

Yes, Puneet, thanks for the question. I appreciate that. I'll touch on a few things and maybe have Vandana talk about the breakeven piece. I'm excited about the diagnostics opportunity. I spoke about it in my initial remarks. And we're well -- really set up to make an impact in the Alzheimer's diagnostics opportunity. As Vandana said, we had a good price crosswalk from CMS. We had our CMS approved pricing like I said, of $897 per LucentAD. We now have several ongoing clinical utility studies for LucentAD, and we look to work with 3 organizations, 2 in academia and then as we track the results, we're looking for releasing those results in the second half of this year. What that's going to do is that will really guide us with our payer engagement and reimbursement strategies. From my past, I've learned that you really need to get the payers on board, good reimbursement scalable strategies that will allow for our customers to pull this amazing opportunity through. Now that's our Alzheimer's diagnostics opportunity. I also feel that we have an oncology diagnostics opportunity. But again, 35 days into this, give me time to really look into this, focus on it and really invest in how we bring that to market. Now the impact for that will probably be starting in '27, but I'll let Vandana talk about that.

Yes. Hey Puneet, in terms of our framework for investment in diagnostics, as you know, over the last couple of years, we've been somewhat pacing the market, but we've been putting in additional investments where needed. We already have a double-digit sales force that's out there that right now has been focused on partnerships, but very quickly is shifting their focus to really bringing LucentAD complete to the market. So in our cash plan for 2026, we have contemplated all of the work that will go into the reimbursement pathway, as well as into building the infrastructure required from an order to cash perspective, et cetera, to be able to support volume in that company. So our plan for now contains all of those relevant investments and still gets us to breakeven in that second half of the year. Now if the market were to move faster or things were to develop faster, those would be good problems to have in a way. And we would welcome speed of adoption in this area.

Got it. Okay. That's helpful. And then on the FDA submission side, can you just update us on any dialogue with FDA? What they're looking for -- sorry, you have a breakthrough designation earlier on. So I just wanted to get a sense of potential time line and approval of the product. It's good to see that you already have reimbursement, but just wanted to get a sense on feedback that you have received.

Yes. Thanks, Puneet. We're working very well with the FDA. Again, we submitted the 501(k) in January. We expect the approval to take anywhere between 6 to 9 months, and then we anticipate securing that same thing by Q4 of this year. But again, 6 to 9 months is what we're looking for. I think the most important thing around that, that Vandana said is working sequentially with waiting for the FDA approval, making sure that we have good order to cash within our own lab. And then I'd tell you that making sure that we have a good payer strategy around when we develop that clinical evidence. So we're excited about our surround sound strategy.

[Operator Instructions] Your next question comes from Tom DeBourcy with Nephron Research.

Sorry about that. Can you hear me?

Yes. We got you, Tom.

So I just wanted to understand your Accelerator Lab and lab services. It seems like Q4 was stronger than expected, maybe even particularly in Simoa. And so just in terms of the level of demand from pharma customers? And then as you look out, at least for the next first half of the year, have you seen the rebound in activity and demand for lab services, I guess the pipeline had previously, I guess, maybe run down a little bit there?

Yes. Let me take the Q4 question and then Everett and I will tag team on what we're seeing for Q1. So Q4, again, a strong finish to the year. We were generally very pleased with all of our sectors, consumables and lab services in particular. On the Simoa Accelerator side, as we've mentioned before in 2025, the interest for the offerings continue to remain strong. In Q4, we saw a handful of projects come to an end, and we also saw, again, a good diversity of projects that basically helped on the revenue side.

Yes. I like our Accelerator business. And I think my first week here, they were talking about how profitable our Accelerator business is. And we have a lot of good partnerships that are out there. Right now, my goal is to really understand our accelerated business. Our projects are about $50,000 on average. My goal is, I want to get bigger projects with pharma. I think there's an opportunity to do that with how important solving this Alzheimer's dilemma is. So we'll continue to invest in our Accelerator business. We'll establish broader partnerships with pharma, and it will be an opportunity for us to continue to grow that segment.