Quanterix (QTRX) Q4 2025 Earnings Call Transcript

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Date

March 2, 2026

Call participants

• President and Chief Executive Officer — Everett Cunningham
• Chief Financial Officer — Vandana Sriram
• Head of Investor Relations — Joshua Young

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Takeaways

• Total Revenue -- $43.9 million, representing a 25% increase year over year and a 7% sequential rise.
• Organic Revenue -- Declined 22%.
• Diagnostics Partner Revenue -- $3.1 million recognized; 25 active partnerships generated $9.6 million for the full year, up from $6 million prior year.
• Simoa Revenue -- $27 million, reflecting a 22% organic decline compared to the previous year.
• Spatial Revenue -- $17 million, down 23% year over year, including $2.5 million from a now-terminated diagnostic agreement; excluding that, Spatial declined 16%.
• Instrument Revenue -- $6.1 million, made up of $3.2 million from Simoa and $2.9 million from Spatial platforms.
• Instrument Placements -- 21 Simoa and 17 Spatial instruments placed; Simoa placements compared to 18 in the year-ago period.
• Consumables Revenue -- $23 million, up $3.8 million sequentially, including $15.4 million from Simoa and $7.6 million from Spatial products.
• Accelerator Lab Revenue -- $8.3 million, comprised of $5.3 million Simoa and $3 million Spatial, with Q4 performance exceeding expectations, especially in consumables and lab services.
• Academic Customer Mix -- Approximately 55% of business; on a pro forma basis with Akoya, academic revenue declined about 24% for the quarter.
• Pharma Revenue -- Decreased 21%, primarily driven by a reduction in large Accelerator projects.
• Lucent AD Complete Reimbursement -- Centers for Medicare & Medicaid Services approved a reimbursement rate of $897, establishing a national reference price for the test.
• Lucent AD Complete FDA Submission -- 510(k) premarket notification submitted in January 2026.
• Product Launches -- 13 new assays introduced in 2025, including Simoa pTau-205 and pTau-212 assays; new Spatial Phenocode panels for metabolism and mouse neurology also launched.
• Gross Profit and Margin -- $20 million gross profit with a GAAP gross margin of 45.7%; non-GAAP gross profit was $21.9 million with a 50% gross margin.
• Operating Expenses -- $44.8 million total, including $6.4 million in acquisition and restructuring costs; non-GAAP operating expenses were $37 million, down by roughly $1.5 million sequentially.
• Adjusted EBITDA -- Loss of $7.9 million, improving $4 million versus the prior quarter's loss of $11.9 million.
• Cash Position -- $122 million in cash, cash equivalents, marketable securities, and restricted cash at quarter-end.
• Cost Synergies -- $74 million in synergies achieved toward the $85 million target, with completion expected by end of Q1.
• Material Weakness Remediation -- Issues related to revenue and inventory fully remediated as reported this quarter.
• Cash Usage -- Adjusted cash usage was $3 million for the quarter, down from $16.1 million in Q3, attributed to synergies and improved working capital management.
• 2026 Revenue Guidance -- Company projects $169 million to $174 million, assuming no academic or pharma end-market uplift; pro forma 2026 revenue, excluding the terminated agreement, expected to grow approximately 2% at the guide's midpoint.
• 2026 Margin Guidance -- GAAP gross margin expected between 45% and 49%; non-GAAP gross margin anticipated between 49% and 53%.
• Cash Flow Breakeven Target -- Management expects to reach cash flow breakeven in the second half of 2026 and finish the year with about $100 million in cash and no debt.

Summary

Quanterix (NASDAQ:QTRX) reported material sequential and annual revenue expansion, with ongoing cost optimization driving significant improvement in adjusted EBITDA and cash usage. The company executed substantial operational synergies, mainly from completed integration activities, while deploying new assay launches and reinforcing its diagnostics portfolio with regulatory and reimbursement milestones. Critical progress was recorded in the Lucent AD Complete test for Alzheimer's, including both a CMS-approved reimbursement rate and a pending FDA review that may allow first regulatory clearance by late 2026. Management introduced a cautious outlook by guiding 2026 revenue growth assumptions to minimal core market improvements and reinforcing a measured investment approach to support strategic diagnostics priorities. Quanterix remediated all cited material weaknesses in its control environment during the quarter, solidifying its compliance foundation.

• The newly consolidated enterprise stands more diversified, with management stating, "We are now 60% neurology and 40% Spatial and oncology/immunology," versus a previously more concentrated neurology profile.
• Vandana Sriram confirmed immediate focus on "profitable growth and delivering on our commitment to be cash flow breakeven in 2026," while maintaining investments in clinical evidence and commercial infrastructure for Lucent AD Complete.
• For the Lucent AD Complete test, management expects FDA clearance in "six to nine months" following the January 2026 submission, targeting potential decision in the fourth quarter.
• Ongoing innovation was emphasized through the launch cadence: 13 new assays in 2025, continuous quarterly product introductions projected for 2026, and expansion of tau biomarker offerings to capture rising neurology demand.

Industry glossary

• Simoa: Single Molecule Array, a proprietary ultra-sensitive immunoassay platform enabling high-precision protein detection.
• Spatial biology: Analytical approach integrating spatial distribution and context within tissue samples for multiplexed biomarker analysis.
• 510(k): Premarket submission to the U.S. Food and Drug Administration demonstrating a medical device's substantial equivalence to a legally marketed predicate.
• Lucent AD Complete: Multi-analyte algorithmic blood test developed by Quanterix for Alzheimer's disease diagnosis.
• Accelerator Lab: Quanterix's contract research and lab services operation, supporting sample testing and custom assay development use cases.
• Phenocode panels: Thematic multiplex assay panels introduced as part of Quanterix's Spatial biology product offerings.

Full Conference Call Transcript

Joshua Young: Thank you, Colby, and good afternoon, everybody. With me on today's call are Everett Cunningham, Quanterix Corporation President and CEO, and Vandana Sriram, Quanterix Corporation Chief Financial Officer.

Operator: 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, 03/02/2026. 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 and 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. I will now turn the call over to Everett Cunningham.

Everett Cunningham: Hey. Thanks, Josh. I am so excited to be with you this afternoon. I am 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 Corporation. I have 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 Corporation is 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 $20,000,000,000 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 operational portfolio and combined provide me with the insights needed to accelerate Quanterix Corporation's overall growth.

I believe that Quanterix Corporation is well positioned to assume a leadership position in the diagnostics industry, and I am very excited to work with my colleagues to achieve our commercial and financial goals. There are several reasons why I am very excited to be leading Quanterix Corporation at this time. First, Quanterix Corporation has developed differentiated technologies in disease states that need healthcare breakthroughs and also need solid business partnerships, in neurology, oncology, and immunology. Second, we have a compelling base business in the research tools space that exceeded our expectations in the fourth quarter and will drive us to breakeven profitability this year. This continued operational rigor will also provide a steady normalized growth path.

Third, there is a massive opportunity for growth in the diagnostics market starting with Alzheimer's disease. Quanterix Corporation's ultrasensitive platforms are uniquely positioned here. Next, we have a strong foundation here at Quanterix Corporation, including a talented and dedicated team and a solid balance sheet with more than $100,000,000 of cash and no debt. Lastly, I am thrilled to be joining Quanterix Corporation at this inflection point. I am 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 Corporation'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, so I will be spending a lot of time with customers and partners too. My objective is to continue to focus on what is working well and to evolve Quanterix Corporation 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 am sure that many of you have a range of ideas and insights on our path forward and I welcome your ideas. We will, of course, keep you updated as we move forward. I will now turn it over to our Chief Financial Officer, Vandana Sriram.

Vandana Sriram: Thank you, Everett, and good afternoon. Total revenue for the fourth quarter was $43,900,000, an increase of 25% from the previous year and up 7% sequentially. Organic revenue declined 22%. Revenue from our diagnostics partners was $3,100,000 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 $27,000,000, a 22% organic revenue decline, and Spatial reported $17,000,000, down 23% year over year. Spatial revenues include $2,500,000 from a diagnostic 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 $6,100,000, comprised of $3,200,000 of Simoa and $2,900,000 of Spatial instruments. We placed 21 Simoa and 17 Spatial instruments in the quarter, as compared to 18 Simoa instruments in 2024. Consumables revenue was $23,000,000, up $3,800,000 sequentially. This consisted of $15,400,000 in Simoa and $7,600,000 in Spatial consumables. Accelerator Lab revenue was $8,300,000: $5,300,000 in Simoa and $3,000,000 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 Corporation 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 $9,600,000 in revenue during 2025, up from $6,000,000 in the prior year. This includes our recently announced partnership with Lifeline 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 Lucent AD 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 Lucent AD 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 Lucent AD 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 diagnostic 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, 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 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 were $20,000,000 or 45.7%. Non-GAAP gross profit was $21,900,000 and non-GAAP gross margin was 50%. Operating expenses for the quarter were $44,800,000. Included in operating expenses are approximately $6,400,000 of costs related to acquisition, integration, restructuring, and purchase accounting, and $1,400,000 of shipping and handling costs. Non-GAAP operating expenses were $37,000,000, a decrease of roughly $1,500,000 sequentially as a result of synergies.

As Everett mentioned, we have 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 $74,000,000 of our $85,000,000 cost synergy target, and we are 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 $7,900,000, a sequential improvement of $4,000,000 as compared to a loss of $11,900,000 in the third quarter. We ended the quarter with $122,000,000 in cash, cash equivalents, marketable securities, and restricted cash.

During the quarter, we made a $10,000,000 milestone payment for the Emission acquisition, and spent $3,500,000 related to severance and other nonrecurring items. Adjusted cash usage during the quarter was $3,000,000 compared to $16,100,000 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 $169,000,000 to $174,000,000 of revenue, which assumes no underlying improvement in the academic or pharmaceutical end market. In 2026, we expect a minimal impact to our core business from the terminated diagnostics development agreement, which yielded $5,600,000 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 $100,000,000 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: Thanks, Vandana. I am confident in our base business. I am also confident in our plan for breakeven profitability this year. Lastly, I am confident in scaling our business into areas of profitable growth. I want to turn it back over to Josh.

Operator: Thank you, Everett. Colby, please assemble the Q&A roster. Thank you. We will now begin the question-and-answer session. If you would like to withdraw your question at any time, simply press 1 again. We will pause just for a moment to compile the roster. Your first question comes from Kyle Mikson with Canaccord Genuity. Your line is open.

Alex Dickerson: Hi. This is Alex Dickerson on the line for Kyle Mikson. Thank you for taking our questions, and congratulations, Everett, on the new role. We look forward to working with you. This one is for Everett. In your assessment of Quanterix Corporation's core high-sensitivity proteomics as well as Spatial biology businesses, do you feel the company has been executing 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: Thanks for that question. I am looking forward to working with you also. As I come on, I have been with the company for 35-plus days, and I am taking this opportunity to really assess our diversified strategy, which I love. I will mention a couple of stats about what Akoya has done in our Spatial business. Before Akoya, we were 90% neurology and 10% oncology/immunology. Now, with Akoya and the Spatial technology and expertise, we are more diversified. We are now 60% neurology and 40% Spatial and oncology/immunology. I like that diversification. I like the fact that they have a broad footprint. I like the talent that the business has brought to Quanterix Corporation.

I also like the fact that there has 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 $85,000,000 target at the end of Q1. That is going to allow us to really focus on how we execute our growth plan in the Simoa space and in the Akoya Spatial space. The footprint, the technology that they bring, and the customer relationships that they have, I think, really position us to drive our growth strategy this year and beyond.

Alex Dickerson: Got it. And just one more for 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 should expect for 2026? Specifically, what is the timing for the more general availability of your HighPlex 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: I will have Vandana take the first, and I will take the Simoa One question second.

Vandana Sriram: Hey Alex, you are 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.

Everett Cunningham: As far as the Simoa One, we rolled out our early access program for Simoa One at the end of last quarter. Right now, we are executing the test plans with our customers, so we are going to continue to gather feedback, and that feedback will steer our decision-making. The benefit of me taking over recently is that I am in the process of doing a holistic review of all of our product development and launch initiatives here at Quanterix Corporation. I will say this: we have attractive segments on both sides, the Simoa and the Spatial side.

One thing that we will have to do, because of those attractive segments, is make some decisions, and our decisions will be based on return on investment and bringing growth back to Quanterix Corporation as quickly as possible.

Alex Dickerson: Got it. Thank you very much.

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

Puneet Souda: Yes. Hi, Everett. Thanks for taking the questions here. First one for you. You emphasized Alzheimer's diagnostics. Obviously, you are coming with significant experience in sales and the commercial side. I wanted to get a view from you: as you talk about the diagnostics opportunity, how should we think about the overall prioritization when you look at diagnostics versus the Simoa proteomics versus the Spatial business that you have? How are you thinking about those three segments? Also, can you provide an expectation for the investments needed to drive growth on the Alzheimer's diagnosis side? Can you still reach the cash flow breakeven expectation by year-end after addition of those sales and commercial investments that you are potentially planning here?

Everett Cunningham: Thanks for the question, Puneet. I appreciate that. I will touch on a few things and maybe have Vandana talk about the breakeven piece. I am excited about the diagnostics opportunity. I spoke about it in my initial remarks, and we are well 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 of $897 for Lucent AD. We now have several ongoing clinical utility studies for Lucent AD, and we look to work with three organizations, including academia, and as we track the results, we are looking to release those results in the second half of this year.

That is going to guide us with our payer engagement and reimbursement strategies. From my past, I have learned that you really need to get other payers on board and get good, scalable reimbursement strategies that will allow for our customers to pull this amazing opportunity through. That is 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. The impact for that will probably be starting in 2027, but I will let Vandana talk about that.

Vandana Sriram: Hey, Puneet. In terms of our framework for investment in diagnostics, as you know, over the last couple of years, we have been somewhat pacing the market, but we have been putting in additional investment where needed. We already have a double-digit sales force that is out there. That team right now has been focused on partnerships but very quickly is shifting their focus to really bringing Lucent AD 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, etc., to be able to support volume when that comes in.

Our plan for now contains all of those relevant investments and still gets us to breakeven in the 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, and we would welcome speed of adoption in this area.

Puneet Souda: Got it. That is helpful. On the FDA submission side, can you update us on any dialogue with FDA and what they are looking for? I am sorry, you had a breakthrough designation earlier on. I just wanted to get a sense of the potential timeline and approval of the product. It is good to see that you already have reimbursement, but just wanted to get a sense of the feedback that you have received. Thank you.

Everett Cunningham: Thanks, Puneet. We are working very well with the FDA. We submitted the 510(k)s in January. We expect the approval to take anywhere between six to nine months, and we anticipate securing that by Q4 of this year. Six to nine months is what we are looking for. I think the most important thing that Vandana has said is working sequentially: waiting for the FDA approval, making sure that we have good order-to-cash within our own lab, and making sure that we have a good payer strategy around when we develop that clinical evidence. We are excited about our surround-sound strategy.

Puneet Souda: Got it.

Puneet Souda: Okay. Thank you, guys.

Operator: Again, if you would like to ask a question, please press star then number 1 on your telephone keypad. Your next question comes from Tom DeBourcy with Nephron Research. Your line is open.

Tom DeBourcy: Hi. Sorry about that. Can you hear me now?

Everett Cunningham: Yes, we have you, Tom. Alright.

Tom DeBourcy: Sorry about that. Thanks for taking the question. I just wanted to understand your Accelerator Lab and Lab Services. It seems like Q4 was stronger than expected, maybe even particularly in Simoa. In terms of the level of demand from pharma customers, and as you look out at least for the first half of the year, have you seen a rebound in activity and demand for Lab Services? I guess the pipeline had previously gone down a little bit there.

Vandana Sriram: Let me take the Q4 question, and then Everett and I will tag team on what we are seeing for Q1. Q4 was 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 have mentioned before, in 2025 the interest for the offerings continued to remain strong. In Q4, we saw a handful of projects come to an end, and we also saw a good diversity of projects that helped on the revenue side.

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

Vandana Sriram: Great. Thank you.

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

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