Quanterix Corporation Q4 2025 Earnings Call - On track for cash flow breakeven in H2 2026 as diagnostics push gains CMS pricing and 510(k) progress

Colby, Conference Operator, Conference Services: Ladies and gentlemen, thank you for standing by. My name is Colby, and I’ll be your conference operator today. At this time, I would like to welcome you to the Quanterix Corporation Q4 2025 earnings call. All lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. If you would like to ask a question at that time, please press star, then the number one on your telephone keypad to raise your hand and enter the queue. If you’d like to withdraw your question at any time, simply press star one again. I’ll now turn the call over to Joshua Young. You may begin.

Joshua Young, Investor Relations, Quanterix Corporation: 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. Any % 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.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Hey, thanks, Josh. 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. 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 three-decade-plus career in healthcare 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. In my last role as a chief commercial officer at Illumina, I led the commercial strategy and execution for this $20 billion market cap company as we dove deeper into sequencing and array-based solutions.

During my tenure at Illumina, I worked with a team that delivered one of the most transformational technologies in the analytical instruments market. My work there built on my experience as a chief commercial officer at Exact Sciences, where my team encompassed sales, marketing, and customer service in precision oncology diagnostics and screening. My prior roles at Quest, GE HealthCare, and Pfizer effectively round out my commercial and my operational portfolio and combined provide me with the insights needed to accelerate Quanterix’s overall growth. 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. There are several reasons why I’m very excited to be leading Quanterix at this time.

Quanterix has developed differentiated technologies in disease states that need healthcare breakthroughs and also need solid business partnerships in neurology, oncology, and immunology. We have a compelling base business in the research tool space that exceeded our expectations in the fourth quarter and will drive us to break even profitability this year. This continued operational rigor will also provide a steady, normalized growth path. There’s a massive opportunity for growth in the diagnostics market, starting with Alzheimer’s disease, and Quanterix’s ultrasensitive platforms are uniquely positioned here. 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. 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.

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’s 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. I’ll be spending a lot of time with customers and partners too. My objective is to continue to focus on what’s working well and to evolve Quanterix into a stronger, more agile, and scalable company. 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. Now let me turn it over to our Chief Financial Officer, Vandana Sriram. Vandana.

Vandana Sriram, Chief Financial Officer, Quanterix Corporation: Thank you, Everett. Good afternoon. Total revenue for the fourth quarter was $43.9 million, an increase of 25% from the previous year, 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. 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, 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 were 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 two significant milestones for LucentAD Complete. Firstly, in Q4, the Centers for Medicare & 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. In January 2026, we submitted a 510(k) pre-market notification to the U.S. Food and Drug Administration for this test. Both these milestones further our mission to provide superior, non-invasive, 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 two new Simoa tau assays, p-Tau 205 and p-Tau 212. We have seen strong interest in both products during the initial launch period. 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 two new PhenoCode Discovery panels in Q4 2025, a metabolism spike-in panel, and a mouse neurology panel. The mouse neurology panel expands our Spatial Biology 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 margin was 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 $30 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 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 non-recurring 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-$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%-49% and non-GAAP gross margin to be in a range of 49%-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. 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.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Thanks, Vandana. You know, I’m confident in our base business. I’m also confident in our plan for break-even profitability this year. Lastly, I’m confident in scaling our business into areas of profitable growth. Now I want to turn it back over to Josh.

Joshua Young, Investor Relations, Quanterix Corporation: Thank you, Everett. Colby, please assemble the Q&A roster.

Colby, Conference Operator, Conference Services: Thank you. We will now begin the question and answer session. Again, if you would like to ask a question, please press star then the 1 on your telephone keypad to raise your hand and enter the queue. If you would like to withdraw your question at any time, simply press star one again. We’ll pause just for a moment to compile the roster. Your first question comes from Kyle Mixon with Canaccord Genuity. Your line is open.

Alex DeChello, Analyst (on behalf of Kyle Mixon), Canaccord Genuity: Hi, this is Alex DeChello. I’m on the line for Kyle Mixon. Thank you for taking our questions. Congratulations, Everett, on the new role. We look forward to working with you. This one’s for Everett. In your assessment of Quanterix’s core high sensitivity proteomics as well as Spatial Biology businesses, what do you feel the company has been executing on effectively? Additionally, what are some aspects of the current strategy that you would like to adjust or change with these two businesses in the near term? Thank you.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Yeah, no, thanks for that question. I’m looking forward to working with you also. You know, as I come on, I’ve been now with the company for 35 plus days and, you know, 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. You know, before Akoya, we were, what, 90% neurology, 10% oncology immunology. With Akoya and the spatial technology and expertise, we’re now more diversified. We’re now, you know, 60% neurology and plus 40% spatial and oncology and immunology. I like that diversification. You know, what I like is 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. What that’s gonna allow us to do, it’s gonna 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. The footprint, the technology that they bring on, the customer relationships that they have, I think really, you know, makes us really appropriate to drive our growth strategy this year and beyond.

Alex DeChello, Analyst (on behalf of Kyle Mixon), Canaccord Genuity: Got it. Just one more from me. You noted earlier on the call that you launched about 13 new assays in 2025 alone. On the pipeline, any new assay or new product launches we’re planning for 2026? 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? Thank you.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: I’ll have Bondona take the first, and I’ll take the Simoa, One question second.

Vandana Sriram, Chief Financial Officer, Quanterix Corporation: Alex, you’re right. We did 13 assays in 2025. We did about 20 assays in 2024 before that. You know, 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’ll be coming out shortly, but the intent really is that this is a continuous stream throughout 2026.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Yeah, as far as Simoa One, you know, we rolled out our early access program for Simoa One at the end of last quarter. Right now what we’re doing is we’re currently, you know, executing the test plans with our customers. We’re gonna continue to gather feedback, and that feedback will actually steer our decision-making. Now 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 Simoa and the spatial side. The one thing that we will have to do because of that attractive, you know, segments, we’ll have to make some decisions.

Our decisions will be based on, you know, ROI and bringing growth back to, I mean, to Quanterix as quickly as possible.

Alex DeChello, Analyst (on behalf of Kyle Mixon), Canaccord Genuity: Got it. Thank you very much.

Queue Operator, Conference Operator, Conference Services: Your next question comes from the line of Puneet Souda with Leerink Partners. Your line is open.

Puneet Souda, Analyst, Leerink Partners: Yeah, hi, Everett. One, thanks for the questions here. First one, Everett, for you. You emphasized Alzheimer’s diagnostics. Obviously, you’re coming with, you know, significant experience in sales and commercial sides. Wanted to get a view from you know, going forward, as you talked about the diagnostics opportunity, how should we think about the overall prioritization or, you know, when you look at the diagnostics versus the Simoa proteomics versus the Spatial business that you have and how are you thinking about those three segments? Also, if you can provide an expectation for the investments needed to drive growth on the Alzheimer’s diagnosis side?

you know, can you still reach the cash flow break even expectation by the year-end after the addition of those sales and commercial investments that you are potentially planning here?

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Yeah. Puneet, thanks. Thanks for the question. Appreciate that. I’ll touch on a few things and maybe have Vandana talk about the break even piece. I’m excited about the diagnostics opportunity. I spoke about it in my initial remarks. You know, 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 for LucentAD. We now have several ongoing clinical utility studies for LucentAD, and we look to work with three organizations, two in academia. 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. You know, from my past I’ve learned that you really need to get the payers on board, get good reimbursement scalable strategies that will allow for our customers to pull this amazing opportunity through. That’s our Alzheimer’s diagnostics opportunity. I also feel that we have an oncology diagnostics opportunity. Again, 35 days into this, you know, give me time to really look into this, focus on it, and really invest in how we bring that to market. The impact for that will probably be starting in 2027, but I’ll let Vandana talk about that.

Vandana Sriram, Chief Financial Officer, Quanterix Corporation: Yeah. 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. 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 when that comes in. You know, our plan for now contains all of those relevant investments and still gets us to break even in that second half of the year.

If the market were to move faster or things were to develop faster, those would be good problems to have in a way. You know, we would welcome speed of adoption in this area.

Puneet Souda, Analyst, Leerink Partners: Got it. Okay, that’s helpful. On the FDA submission side, can you just update us any dialogue with FDA, what they’re looking for? Sorry, you have a Breakthrough designation earlier on, so just wanted to get a sense of, you know, potential timeline and, and approval of the product. It’s good to see that you have already have reimbursement, but just wanted to get a sense on feedback that you have received. Thank you.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Yeah. Thanks, Puneet. We’re working very well with the FDA. We submitted the 510(k) in January. We expect the approval to take anywhere between 6 to 9 months, and then we anticipate securing that same, you know, thing by Q4 this year. 6 to 9 months is what we’re looking for. I think the most important thing around that Bindu just said, is working sequentially with, you know, waiting for the FDA approval, making sure that we have good order to cash within our own lab. I tell you that making sure that we have a good payer strategy around when we develop that clinical clinical evidence. We’re excited about our surround sound strategy.

Vandana Sriram, Chief Financial Officer, Quanterix Corporation: Got it.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Okay. Thank you, guys.

Colby, Conference Operator, Conference Services: Again, if you’d like to ask a question, please press star then number one on your telephone keypad. Your next question comes from Tom DeBourcy with Nephron Research. The line is open. Tom, your line is open.

Tom DeBourcy, Analyst, Nephron Research: Hi, sorry about that. Can you hear me now?

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: Yep, we got you, Tom.

Tom DeBourcy, Analyst, Nephron Research: All right. Sorry about that. Thanks for taking the question. I just wanted to understand your Accelerator Laboratory and lab services. It seems like Q4 was stronger than expected, maybe even particularly in Simoa. 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 a rebounded activity in demand for lab services? you know, I guess the pipeline had previously, I guess, you know, maybe gone down a little bit there.

Vandana Sriram, Chief Financial Officer, Quanterix Corporation: Yeah. Let me take the Q4 question and then Everett and I will tag team on what we’re seeing for Q1. Q4, again, you know, 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, we also saw, again, a good diversity of projects that basically helped on the revenue side.

Everett Cunningham, President and Chief Executive Officer, Quanterix Corporation: I like our Accelerator business. 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 Accelerator business. You know, our projects are about $50,000 on average. My goal is I wanna get bigger projects with pharma. I think there’s an opportunity to do that with how important, you know, solving this Alzheimer’s dilemma is. We’ll continue to invest in our Accelerator business. We’ll establish broader partnerships with pharma, it will be an opportunity for us to, you know, to continue to grow that segment.

Tom DeBourcy, Analyst, Nephron Research: Great. Thank you.

Colby, Conference Operator, Conference Services: Thank you. With no further questions in queue, that concludes our question and answer session. Thank you all for joining. You may now disconnect.