Quanterix - Q2 2024

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the Quanterix Q2 2024 Earnings Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You'll then hear an automated message advising that your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Francis Perrault, Head of Investor Relations.

Francis Perrault (Head of Investor Relations)

Thank you, and good afternoon. With me on today's call are Masoud Toloue, Quanterix's President and CEO, as well as Vandana Sriram, our Chief Financial Officer. Before we begin, I would like to remind you of a few things. This call will be recorded, and a replay will be available on the Investors section of our website. Today's call will contain 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 and on information available as of the date of this call. 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 the forward-looking statements.

The risks and uncertainties that we face are described in the filings with the Securities and Exchange Commission. To supplement our financial statements 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 assessing our operating performance within our industry. Non-GAAP financial information presented herein should be considered in conjunction with, and not a substitute for, the financial information presented in accordance with GAAP. Investors are encouraged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures set forth in the appendix of the presentation posted to our website and in the earnings release issued 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 Masoud Toloue.

Masoud Toloue (CEO)

Thank you, Francis. Starting with our second quarter results, total revenue of $34.4 million grew 11%. Despite a constrained capital funding environment and overall muted growth in the tool space, demand for Simoa sensitivity continues to expand by double digits. This quarter's results were driven by 35% growth from our accelerator lab, where customers can access our tech without the CapEx, 7% growth from our consumables business, and very early signs of progress with partner enablement in diagnostics. Second quarter non-GAAP gross margin of 52.3% was solid as we continue to invest in our assay development, which we expect will yield future growth. Our balance sheet remains strong, with nearly $300 million of liquidity.

Cash usage in the period was approximately $5 million. Vandana will touch on these results and our updated guidance in more detail. Recall, our three core growth objectives are, one, high growth in menu, specifically maintaining our leadership position in neurology and growing into immunology and oncology adjacencies. Two, the ubiquity of Simoa in all labs, where we are allocating heavy resources and investment into pushing forward a new frontier for multiplexed, ultrasensitive protein detection that we expect will culminate in a new platform. And three, a leadership position in diagnostic testing for Alzheimer's disease. Starting with menu, we commercialized 3 new assays this quarter for a total of 8 in our first half of 2024, and are on track to complete 20 by end of year.

In neurology, we're building on the successful launch of BD-Tau and plan to launch an N4PD assay in Q3, which combines BD-Tau with additional relevant markers in a neurology-focused multiplex test. We also expect to launch several exciting cytokine panels in the back half of 2024, which we will discuss later this year. Simoa has a clear leadership position in neurology, and our menu continues to accelerate this lead, powering exciting research, clinical trials, and neurotherapies. Starting with neurology, in a recent June publication of Nature Medicine, researchers using Simoa were able to demonstrate that plasma, extracellular vesicle tau, and TDP-43 were effective biomarkers in both frontotemporal dementia and ALS, suggesting new modalities for evaluating disease progression and clinical trial targeting.

Next, in oncology, in the International Journal of Molecular Sciences, researchers using Simoa showed that NfL and GFAP were promising targets to evaluate brain metastases in patients with lung cancer. Patients with brain metastases showed higher serum NfL and GFAP compared to those without, suggesting these biomarkers can effectively identify patients at high risk and potentially improve the efficiency of MRI screenings. Staying on NfL, there's a growing recognition by the FDA that this biomarker is important in drug development and clinical trials. In May, the Foundation for the National Institute of Health received acceptance from the FDA for its intent to qualify NfL as a biological indicator of frontotemporal degeneration. This builds upon the agency's 2023 accelerated approval of Biogen's drug, tofersen, for treatment of ALS, which relied in part upon extended review, evaluating trends in reducing NfL levels.

More recently, in Q2, NfL was again used as an effective biomarker by Annexon Biosciences. Annexon announced positive top-line results for their pivotal phase III trial in Guillain-Barré syndrome, a condition in which the body's immune system attacks the peripheral nervous system. Utilizing data generated by our accelerator lab, Annexon was able to demonstrate that their phase III trial met its primary endpoint. In addition, Annexon established their therapy delivered improvements compared to placebo with other secondary pre-specified endpoints, one of which demonstrated early reduction in the biomarker NfL between weeks 2 and 4 of therapy. Moving forward, we expect more clinical trials will incorporate monitoring NfL levels, and we'll be ready to support our customers as the market leader for this biomarker. Simoa's leadership among key opinion leaders, researchers, and pharma was evident at the Alzheimer's Association International Conference, or AAIC, last week.

Simoa has helped build the field of highly sensitive biomarker detection in neurology, as evidenced by our technology, cited in approximately 150 posters and platform presentations at the conference. Our platform is entrenched with academia and pharma, and we continue to work with our customers to generate data for key publications and evidence for pivotal clinical trials. The highlight of our week at AAIC was important new data on our multi-marker approach to Alzheimer's testing. Our presented data was derived from Bio-Hermes and CANTATE trials, two independent and diverse cohorts, and highlighted that combining amyloid beta 42, 40, NfL, and GFAP with p-Tau 217, and using an algorithm, can improve the accuracy of diagnosis compared to a standalone p-Tau 217 test. We believe the future of Alzheimer's diagnostics therapy selection with blood-based biomarkers will follow a multi-analyte roadmap.

30% of the approximately 7 million symptomatic Alzheimer's patients in the U.S. today have pathologies other than Alzheimer's. We believe these patients will benefit from the diagnostic clarity that multi-marker tests can provide. We will launch a multi-marker LDT later this year, and we'll share further data on our test at CTAD this fall. Staying on diagnostics, I wanna make a clear point on why Simoa is best in class for early detection of Alzheimer's disease. To date, the Simoa platform has provided a numerical result for every single Lucent p-Tau 217 patient sample tested. Other competing platforms are not able to provide results for up to 30% of patients due to limits of those platforms' sensitivity.

To be clear, that means for every 1,000 patients visiting a neurologist to get blood testing, up to 300 may not get a numerical result if a platform other than Simoa is used. It is well understood that amyloid progresses over time. Someone with family history and early memory concerns should get blood-based testing. Of the blood-based tests available, we believe Simoa is best for measuring this early to late progression for the simple reason that there is a numerical value to measure each time someone is tested in the clinic. Our commercialization efforts for Alzheimer's diagnostics are also progressing. Within the quarter, we engaged four new partners, representing both large hospital systems and reference labs with broad geographic reach. More specifically, we announced three new partnerships in the U.S., including Mount Sinai, Banner Health, and UCSF, which see approximately 5 million patients annually.

We also announced a partnership with KingMed, which has 49 labs set up in mainland China, Hong Kong, and Macau. These partnerships build upon our previously announced relationships and are early steps in building the infrastructure for Alzheimer's testing. Vandana will now discuss our financial performance in more detail.

Vandana Sriram (CFO)

Thank you, Masoud. I will now go over our second quarter results and our updated guidance for 2024. As Masoud described, Q2 was another strong quarter of execution, with double-digit growth compared to the prior year. Total revenue for the second quarter of 2024 was $34.4 million, an increase of 11% compared to the prior year. Accelerator lab revenue was $10.1 million, an increase of 35%, as demand remains robust for Simoa sensitivity. Consumable revenue was $17.4 million, an increase of 7%, and instrument revenue was $2.5 million, a decrease of 29%. In terms of revenue stratification, our customer mix in the period was approximately 55/45 between pharma and academia, and 85% of our assay and accelerator sales were for neurology disease states.

In addition, we recognized $0.7 million of revenue in the quarter related to enabling our diagnostics partners to perform LDT testing by selling them instruments, consumables, and licenses. Revenue from patient testing under our Lucent platform was immaterial for the quarter. Our revenue growth was led by North America and Europe, which grew 15% and 25%, respectively, in the quarter. Our business in the Asia Pacific region was down 36% in the period, as China remains a challenging end market despite its relatively small size in our portfolio. In addition, we did not have a repeat of a one-time revenue adjustment from Q2 2023 in that region. For the quarter, our total installed base increase mirrored our performance in Q1. While not a surprise, the capital budget environment remains difficult, and we continue to expect this overhang to persist through the balance of 2024.

Shifting next to gross margin for Q2. GAAP gross profit and margin were $20.1 million and 58.3%, respectively, up $0.9 million and down approximately 340 basis points compared to the prior year. Second quarter non-GAAP gross profit was $18 million, and non-GAAP gross margin was 52.3%, up $0.5 million and down approximately 410 basis points, respectively, compared to the second quarter of 2023. As a reminder, we had several one-time items positively impacting gross margin in the second quarter of 2023, which included approximately $1 million of incremental revenue compared to Q2 2024, that flowed through at a 100% gross margin, an impact of 140 basis points on margin.

The remainder of the change in gross margin compared to the prior year is due to investments made in the operations and quality framework as part of our transformation. As a reminder, these investments took place in the second half of 2023. Moving down the P&L, second quarter GAAP operating expenses were $33.2 million, an increase of $4.5 million compared to the prior year. Non-GAAP operating expenses were $31.1 million, an increase of $4 million compared to Q2 2023. Within operating expenses, higher spending compared to the prior year was primarily due to continued investments in our R&D and commercial efforts. These investments are targeted towards our clearly defined near-term growth pillars, which Masoud highlighted to start the call.

More specifically, we are allocating resources to our new platform, the build-out of our Advantage Plus assay menu, and our sales, marketing, and regulatory efforts in diagnostics. We are making these investments because we see clear signs of demand. Pivoting to the balance sheet, we ended the second quarter of 2024 with $299.5 million of cash, cash equivalents, marketable securities, and restricted cash. Cash flow in the period was a net outflow of $5.1 million. Our liquidity remains strong, and we continue to prioritize investment in organic growth. Moving on from the second quarter, our updated full-year 2024 revenue outlook is a range of $134 million to $138 million, representing double-digit growth of 11% at the midpoint. This revenue range excludes revenue from Lucent AD diagnostic testing, which we expect will be immaterial in 2024.

The change in our guidance is driven by a challenging backdrop for instruments. We are assuming that Q3 and Q4 instrument revenue will be similar to the first half of 2024, whereas previously we had expected an uptick in the second half. We're also taking a cautious approach to forecasting consumables and are assuming that the weak capital environment will have a knock-on effect on consumables pull-through. These changes in our guidance are partially offset by anticipated strong execution and Accelerator, where demand for Simoa sensitivity remains robust. We expect that these updates, in addition to normal seasonality in our business, will result in Q3 being flat to slightly down compared to Q2, and then an uptick in sequential revenue in Q4. In total, our updated guidance indicates full-year double-digit growth, while also acknowledging a macro environment that remains challenging.

Throughout this period, we expect to continue to execute on our strategic priorities, setting us up well for strong growth in 2025 and beyond. We are maintaining our GAAP growth margin guidance of 57% to 61% and our non-GAAP growth margin guidance of 51% to 55%. Finally, we now expect cash usage to be at the higher end of our previous cash burn assumption of $25 million to $30 million, primarily due to the impact of lower revenue. We continue to believe that our research use-only business will be cash flow breakeven at revenue levels between $170 million and $190 million. I will now turn it back over to Masoud for his final thoughts before opening the call for questions.

Masoud Toloue (CEO)

I want to thank our team for their hard work and another great quarter. Your efforts are making a real difference in moving the shift from sick care to health care. It's an exciting time to be at Quanterix. If you're a super talented individual and want to participate in redefining protein detection boundaries and translating those to early detection of disease, I suggest you give us a call. Our business is growing double digits, our investment in scale will see gross margins expand, and the company has line of sight to positive cash flow. This, on a standalone basis, is an incredibly valuable asset in the growing field of protein tools. That said, there are now two new FDA-approved and reimbursed therapies for Alzheimer's. As access to treatment is broadened, we will invest resources and work diligently to ensure access to testing is available. Let's take some questions.

Operator (participant)

Thank you. We will now conduct the question and answer session. As a reminder, to ask a question, you need to press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. In the interest of time, please allow yourself one question and one follow-up. Please stand by while we compile the Q&A roster. Our first question today comes from Matthew Sykes with Goldman Sachs. Your line is open.

Jake Allen (Healthcare Equity Research Associate)

Hello, thank you for taking my question. This is Jake Allen on for Matt Sykes. So one thing I want to talk about is, given capital equipment weakness over the past year, have you thought about any potential reagent rental or financing options for instruments in order to continue to drive pull-through, given the fact that instruments have remained soft?

Masoud Toloue (CEO)

Hi, Jake. Yeah, that's—you know, fortunately, it's a, you know, great option with the instrument and reagent platform that we have. We're seeing, you know, good pull-through in our Accelerator program. So it's a good offset for somebody who doesn't have CapEx today. They've been sending our samples to Accelerator. That said, there's probably, you know, two or a couple cases where we had reagent rental programs where our customer had large consumable demand. So it's something that we absolutely have been able to offer.

Jake Allen (Healthcare Equity Research Associate)

Great. And then, for my follow-up, now that the FDA has approved Lilly's Kisunla, can you talk about, your relationship with Lilly throughout their Certuit AD LDT offering, and any feedback you've gotten from Lilly in regards to using, blood-based biomarkers to drive therapeutic uptick?

Masoud Toloue (CEO)

Yeah, so we're very excited about Certuit AD and the work that both Lilly and Quanterix have done together over the collaboration period that's culminated in, you know, this test. So if you look at the test details presented at AAIC, you know, high sense, high spec, high accuracy test with low indeterminate zone. And yeah, I mean, I think that both teams have a lot to be proud of. It was excellent work. In the sense of blood-based testing, these are tests to, you know, evaluate patients that could be candidates for therapy. So it's a test that, you know, we're going to continue to support folks with and hopefully in the future expand access.

Jake Allen (Healthcare Equity Research Associate)

Thank you for taking my questions.

Operator (participant)

Thank you. Our next question comes, excuse me, comes from Sung Ji Nam from Scotiabank. Your line is open.

Sung Ji Nam (Managing Director and Senior Equity Research Analyst of Life Science Tools and Diagnostics)

Hi, thanks for taking the questions. Just a couple on Alzheimer's disease testing. We'd love to hear the feedback you've gotten at AAIC on the multi-marker approach to testing. And when you launch this assay, do you expect it to be utilized predominantly over the standalone p-Tau 217 assay?

Masoud Toloue (CEO)

Yeah, you know, I think that's the answer is yes. So we think the future for blood-based testing is going to be a multi-marker test. And, you know, at AAIC, Sung Ji, as you alluded, we showed for the first time that additional biomarkers, when we added additional biomarkers to our p-Tau 217 and used a two-step algorithm, we can reduce the intermediate zone of an Aβ42 cutoff test by threefold, while we're able to keep the high accuracy of the test. So what that does is it helps provide more certainty for a greater number of symptomatic patients, and, you know, we were very pleased with the results. So, you know, there's probably, you know, some room for, you know, single marker tests, and this multi-marker test absolutely is exciting.

We've talked about launching this before the end of the year as a laboratory developed test.

Sung Ji Nam (Managing Director and Senior Equity Research Analyst of Life Science Tools and Diagnostics)

Great. And then just as a follow-up, you know, it's great to see you guys expanding on your collaborations with the large healthcare systems. Just kind of curious if, you know, the progress that you're making, you know, how quickly could they ramp up? And also curious, you know, if they're, more likely to do the testing internally, or, you know, are they planning on sending the samples directly to you? Just kind of if you could provide any color just from the ramp-up standpoint. Thanks.

Masoud Toloue (CEO)

Yeah, just taking a quick look at some of the ones that we've listed this time around. I would say that all of them have the ability to have our platform and have the ability to perform testing themselves. That said, you know, there will be some partners that, you know, if their order intake flow sort of exceeds capacity, they're always able to send things to us at in Boston. So, I think in this case, there's a lot of partners here that are performing themselves. But we have, you know, the option of test send out to our lab, and I think that's what makes, you know, the Quanterix Simoa offering unique.

Sung Ji Nam (Managing Director and Senior Equity Research Analyst of Life Science Tools and Diagnostics)

Great. Thank you so much.

Operator (participant)

Thank you. Our next question comes from Dan Brennan with TD Cowen. Your line is open.

Speaker 7

Hi, all. This is Tom for Dan. Just another housekeeping one on the multimarker test. So, you know, given the improved performance, clearly you're launching for LDT later this year, but, you know, should we expect you to prioritize your FDA submission for that test, or do we need to see more studies first?

Masoud Toloue (CEO)

Yeah, that's a good question. You know, we've submitted a single marker test that we talked about. We received breakthrough designation for that single marker. As you know, and we've talked about kind of in earlier calls, we've completed our clinical trials, Bio-Hermes 1 and CANTATE. So phase I of those are complete. We're in phase II and phase III, where we're collecting data, both on the single marker and the multimarker. So, I would say the effort and the work that we're putting in should provide data for both. And, you know, we're gonna determine what might be most ideal for the, you know, for the IVD application that we have with the FDA.

Speaker 7

Thanks. Then just one follow-up on Simoa. So, you know, it was kind of announced in your quarter that two large players have signed up for partnerships with a different competitor, where sensitivity was inferior. So could you speak to the factors other than sensitivity that large labs are gonna be considering when choosing a platform partner? And maybe how your strategy will kind of differ going forward, if at all? Thanks.

Masoud Toloue (CEO)

Yeah, so you know, you know, very clearly there, the top three clinical grade p-Tau 217 immunoassays have been built on Simoa. And, you know, that's because it's the one platform that has the ability to quantify levels at the earliest stages of disease. So, you know, while, you know, there are p-Tau 217 tests out there that, you know, can achieve high accuracy, the important thing to remember is that the best clinical utility is when all patients can receive a result.

Speaker 7

Very much.

Operator (participant)

Thank you. Our next question comes from Kyle Mikson from Canaccord Genuity. Your line is open.

Speaker 6

Hi, guys. This is Alex. I'm live for Kyle. Just to start, I was curious, since the FDA approval of donanemab in July, have you noticed any uptick in interest in your diagnostics portfolio? And moreover, do you believe that we're getting closer to an inflection point in regards to AD drugs, or could it realistically take a bit longer to get sufficient drugs in the market that could, in turn, kind of help scale up the diagnostics effort? Thanks.

Masoud Toloue (CEO)

Yeah, so the, you know, the drug ramp for patients has probably been slower than most anticipated, but now that there are two, you know, FDA-approved therapies, we expect that, you know, ramp to improve from where it has been. And, you know, as more and more people are looking to the therapy, then you're gonna see, you know, obviously testing improve. And there, I think, you know, and whether, you know, it's been prior calls and prior discussions, that it's blood-based testing that's gonna be the real key infrastructure for folks that have memory concerns and want, you know, the first line test. You know, clearly, there's just not the infrastructure for PET and invasive CSF-based tests.

So we think that the first approach is going to be blood, and the tests are, you know, good enough that they can be confirmatory. So overall, you know, I think that things should tick up more in 2025, and we're gonna be building the infrastructure to be ready for that.

Speaker 6

Got it. Thank you. Just one more. I was wondering if you could just comment on the percentage or perhaps just a high-level commentary on the number of customers that have been converted to the new assays, and perhaps any feedback that you've gotten from these existing customers could also be helpful. Thanks.

Vandana Sriram (CFO)

Yeah. So we're still in the process of converting our customers to the new Advantage Plus assays and also releasing new assays that feed our menu. So both of those activities are going concurrently. That process is ongoing. As of Q1, we had converted slightly less than 5% of our customers to the new assays. As of Q2, that number is now closer to 10%. So good progress, but a little bit slow. And as we had anticipated, a lot of these assay conversions require customers to complete bridging studies to complete the number of the assets that they have on shelves, getting through those first, et cetera. So not unexpected, but we do think that this is gonna be a transition process that takes us through the remainder of the year, at least.

Speaker 6

Got it. Thank you very much.

Operator (participant)

Thank you.