Quanterix Corporation (QTRX) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the Quanterix update conference call. [Operator Instructions] Please note today's conference is being recorded. I will now turn the conference over to your speaker, Mr. Masoud Toloue, CEO. Please go ahead, sir.

Good afternoon. 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 and involve certain risks and uncertainties. The risks and uncertainties that we face are described in the most recent filings with the Securities and Exchange Commission. So thank you for joining today. Many of you who have seen our press release inviting third parties to partner with us by licensing our exclusive intellectual property for measuring Tau in bodily fluids. Our 092 patent describes our innovative approach to performing ultrasensitive tests for quantifying low levels of Tau protein in blood and blood-derived samples taken from patients suspected of suffering from neurological conditions. The types of Tau protein that can be quantified using the techniques described in the 092 patent include phosphorylated Tau or p-Tau proteins, some of which have received wide attention recently as biomarkers for Alzheimer's disease. Our patent is a result of many years of effort and expense, establishing the sensitivity of our technology in measuring a minute amount of protein in the blood. Our plasma p-Tau 217 LDT, which is marketed under the Lucent Diagnostics brand uses a 2-cutoff approach and achieved an overall accuracy that meets the criteria established by the Alzheimer's Association Working Group. The test has been granted breakthrough designation by the FDA and has been extensively validated in several large independent cohorts. We have begun working with a number of health systems with large footprints, and we'll continue to build this network. Through the use of our products and technology, these health systems will be able to expand their reach of testing and identification of patients who may respond to treatment. We want to make this test widely accessible to patients, and we'll continue to work with health systems, reference labs and research partners to enable access to the test. With the excitement in the field based on FDA approval of Leqembi and the potential for additional therapy approvals, there are, of course, other players looking to offer testing using other platforms. We want to emphasize that those testing Tau quantities using the innovative approach claimed by the 092 patent risk infringing on our intellectual property. Specifically, a Tau test -- a test for Tau that quantitates risks infringing our patent if the testing measures levels of Tau protein in blood or blood drive samples less than about 5 picograms per milliliter and has a limit of quantitation less than about 0.2 picograms per milliliter. We believe we have the most sensitive test enabling earliest detection of Alzheimer's disease, and we have made significant investments in our technology and patent portfolio to achieve this. Consistent with our stated mission, we are committed to building the global infrastructure necessary for AD testing and are open to discussions about using our products and providing a nonexclusive license to our intellectual property. We can now open the call for questions.

[Operator Instructions] And our first question, coming from the line of Sung Ji Nam with Scotiabank.

Maybe just a clarification question first. Would -- from a patent protection standpoint, are there methodologies that are not performed on the Simoa platform that could potentially impinge on the -- your -- the patent that's been filed? I'm just trying to better understand if it's assays on another platform, is there a possibility of the patent infringement from those?

Hi, Sung Ji. So the patent applies to both research and diagnostic applications. And as such, absent any extraordinary circumstances, anyone offering testing services of either, in nature, using the inventions in the 092 patent requires a Quanterix license. So this applies to research, IVD or LDT services. And I just want to be clear that, hey, we have a lot of research partners and they are integral parts of our ecosystem, and we're committed to working very closely with them.

Okay. Got it. And then, again, just to clarify on that, even if they're using it for research purposes, they would still have to license the technology from you? Or is it just for clinical applications?

Yes. So the license would apply to anyone who's interested in the test for Tau quantities that I described just earlier. So it applies for research, IVD or LDT services.

Okay. Got it. And then just could you talk about what are the next steps in terms of the criteria for diagnosis and staging of Alzheimer's disease that's been -- the draft has been published by Alzheimer's Association. I think -- I believe that's expected to be finalized soon. Is that -- do you think that's the criteria that, for example, the FDA might use when they're viewing the applications for these plasma p-Tau 217 test? Or just kind of trying to get a better sense of how do you see testing for plasma-based test being standardized going forward?

Yes. I think, Sung Ji, I think the answer to that is that the Alzheimer's Association Working Group put together criteria that is initial baseline, a strong baseline for what a test should be. Not all tests are created equal and a high accuracy test that formed -- comprises of p-Tau 217 should be used from a blood standpoint for diagnosis of patients with Alzheimer's disease. So I think it's a good and strong valid baseline. And it also comprises with what we've received breakthrough designation for from the FDA.

[Operator Instructions] Our next question, coming from the line Matt Sykes with Goldman Sachs.

I guess my first question is, why haven't you been enforced in these patents previously? Like, why now? I know there's been a flood of introductions of 217 tests over the last 3 to 5 weeks. But if they had been infringing upon these patents, why not sooner?

Hi, Matt. So I would say that our test, our p-Tau 217 test, we launched somewhere around several months ago. And the p-Tau 181 test, as you're referring to, it's some time before that. So I would just say, simply, other tests are emerging or new tests outside of Quanterix, we're learning more. And we believe it's now the appropriate time to address any potential infringement. We'll continue to monitor the space, and we'll follow up as needed.

Got it. And then just secondly, when you speak to KOLs and people who are involved in the Alzheimer industry and where testing is relevant, do they understand that, like, at least, when we look at some of these other tests, they are either a single cutoff and they only rule out and not rule in, they tend to reference papers that use Simoa as the basis of those papers. So I guess my question is, when you speak to KOLs, do they spend time to look through that and understand that you still have probably the most sensitive test with or without patent infringement? And then shouldn't that really kind of help you succeed over the long term?

Yes, Matt, that's what we believe. I mean, I think there's a lot of confusion here. And I think it's -- maybe I'll take a moment and then make sure we get you -- you have one more question there. I think when we speak to people who are familiar in the space and want to offer the testing, our meeting and discussion with them about our test is very clear. And maybe I can answer some confusion. I think what you need to do is -- and anybody thinking about a test needs to think about it from a clinical utility standpoint. How will the test be used to diagnose amyloid pathology? And practically, how does it help a physician do this? And there's 3 distinct advantages of our test. First, p-Tau 217 tests with lower sensitivity, such as cumulative medicine platforms, are being positioned as rule in. A rule in test uses a high cutoff that is set to provide a high positive predictive value and high specificity for amyloid. But when you go to a typical memory center, only about 30% of individuals are going to be positive. So what does that mean? It means the physician will not be provided with clear actionability for the majority of the individuals they see. Since someone with a negative test may still have a significant probability of having amyloid, that physician is going to need to determine follow-up testing from any of the individuals. And so -- you referred to the 2 cut-off tests that we have. The benefit is with ultrasensitivity that it enables a lower cutoff or rule out as well as a higher cutoff for a rule in decision. And our 217 test has been validated in independent cohorts and achieves accuracy that is meeting the criteria of the standards. Secondly, research is showing that brain amyloid plaques are starting to form years before the onset of symptoms. And you need an ultrasensitive test that's capable of detecting elevated levels of plasma 217 and individuals with the earlier stages of disease. So there's several ongoing trials to evaluate the benefits of these therapies and presymptomatic individuals with evidence of amyloid pathology. But this just puts more emphasis on the enhanced clinical utility that's going to be provided by ultrasensitive test that can discriminate small changes. And then finally, I would say, look at the data. Multiple large independent cohorts are needed to power an analysis of the sensitivity and specificity to give strong confidence intervals. So think about it. Physicians will be treating individuals with mild cognitive impairment and early Alzheimer's, and you need a test to discriminate between amyloid positivity and negative individuals within those groups. So we've been doing a lot of work. Our tests have been validated with over 800 individuals on the Amsterdam Dementia Cohort as well as BioHermes with MCI and early Alzheimer's disease. And we believe these cohorts provide breadth for robust validation with representation across multiple geographies, races and ethnicities. And so we're going to continue building on that. And so finally, simply put, I think the way to think about this and the way we talk to our KOLs is that a test has to maximize actionability and have the best utility. So in performing a test, does a neurologist want to be able to test the broadest range of patients and get confident results using a high sens and spec test? Or do they want to be limited to only a fraction of the patients they see with a low sensitivity test. I think that answer is clear.

And just one last follow-up for Vandana. As you think about sort of the balance sheet is fine. So it's more of like a cash usage over the course of the year. And you think about sort of the litigation track versus sort of further investment in commercialization given sort of the position of your test, how are you thinking about balancing those 2? I mean, ideally, I think you probably want to put money into commercial, but if litigation is going to have to take place, how you're thinking about from a cash spend standpoint or OpEx standpoint over the next few years?

Yes. Thanks for the question, Matt. We believe that this is a significant opportunity. We think the diagnostics opportunity has really long-term potential. And for all the reasons that Masoud just mentioned, we think we are very well positioned to be the leaders in this space. So our primary focus here is to expand access and reach through partnerships. But as I said, we do have a strong balance sheet, and we will take the appropriate steps to both grow and protect the business. And frankly, if that comes with some level of short-term costs, we'll balance that out. But clearly, we have the balance sheet and the cash resources to do so.

And our next question, coming from the line of Puneet Souda with Leerink Partners.

Masoud. So my first question is on the 092 patent. I mean, correct me if I'm wrong, but the patent looks, I mean, fairly broad. And I'm not seeing that it's specific to 217 or 181. So maybe just help us understand sort of what -- how broad is this and sort of how broad is the defensibility here?

Yes, Puneet. So the 92 patent -- 092 patent looks at quantifying low levels of Tau protein in blood and blood-derived samples from patients suffering from neurological conditions. So this includes phosphorylated tau, p-Tau proteins, and really, it refers to any test that measures Tau quantities in bodily fluid at levels identified in the band, irrespective of platform. So at a high level, a test that measures level of Tau protein in blood-derived samples less than about 5 picograms per ml and has a limited quantitation than about 0.2 picograms per ml risks infringement.

Got it. And then just following up on that, you said irrespective of the platform. So does this defend against the mass spec-based test in the marketplace as well?

Yes. It's irrespective of immunoassay or mass spec platform.

Okay. And then in terms of physician education, can you take a step back and tell us what do you need to do in terms of physician education? There are a number of physicians, I mean, you have the neurologists, you have Alzheimer's disease experts and other physician specialties that are working with Alzheimer's patient. So what's your sense of their understanding of the 2 cutoff tests versus the other generic tests that might be available on the market? And what sort of education that you need to do here in order to get that clinical community fully up to speed?

Puneet, yes, I think the main thing here, it comes down to what is -- like I said, the clinical utility for that patient. And I think it's important to offer these tests. But once you double-click or once you look at the test and actionability, what does it practically do? How is it practically going to help in a clinical setting? And when we have those conversations, it's pretty well accepted and understood that look, you want to be able to access the largest cohort of patients and have as much of an impact, you need a test where you have a result that's going to actually end up in something that's going to be done with a majority of individuals tested. So I gave the example of in the memory center. You don't want to look at 20%, 30% of the patients, you want to look at 70% or more of those patients. And there, using a 2-cutoff approach gives you that option. It enables the lower cutoff for a rule-out decision as well as a higher cutoff for a rule-in decision. So that flexibility in various settings, I think, is critical. Number two, you want the data in those settings to be able to back up the test. And I think there's very few that have -- very few tests out there that have this level of clinical trial data that's supporting the test. And I believe Quanterix has a leadership role there. So those conversations are happening at multiple levels. And so far, they've been positive.

And our next question, coming from the line of Kyle Mikson with Canaccord.

I guess just one multipart question, just to clarify some of the things that were touched on earlier. Masoud, are there any companies currently or commercial tests out there that do infringe on the 092 patent? And are you planning on any litigation in the near to medium term? And I guess, just like given the recent announcements from these other players, like why are other companies announcing 217 tests that don't use Simoa given the risk of that platform? Like you've talked to the benefits of that so much over the months and years. Even just curious like what we're seeing recently.

Kyle, so we're not commenting on any specific players today, but we do want to emphasize that those offering testing of Tau quantities in a bodily fluid at levels claimed in our patent, they do risk fringing on our intellectual property. As for other parties, we can't speculate on third-party decisions. But we can say that our p-Tau 217 test was launched late last year, and we're investing capital to broaden its reach in clinical settings. And then I think, look, we're open to discussions with all parties that are interested to collaborate on the front. So we announced 5 partnerships. We're continuing to have additional discussions with other reference labs and hospital networks that are ongoing right now. And we're going to continue to invest in developing the technology and the portfolio. And we're committed to protecting it, but also giving access to really broaden the reach of the test.

Okay. And then just given you are kind of putting your foot down now with this patent provides you pretty broad frame to operate and enforcement options and everything. What's the expectation with adoption of Simoa in your 217 test going forward? Could there be like this inflection point possibly given the patent in both research and diagnostic sides of your assets, particularly relative to others in the field?

Yes. I mean we -- our goal is -- we offer our LucentAD test here in Boston in our CLIA laboratory. And we're open to offering nonexclusive licenses on the Simoa platform to make the test as accessible as possible. So we invested significantly in the beginning of the year in conversations with our commercial team, with conversations with clinical providers. So that work continues, and we -- those conversations are happening. So we feel good about that.

Okay. And finally, I was wondering if you could provide an update on the partnerships for the 5 health networks. I think that was announced in February. As of the last update, not sure if rev recognition and cost structure was totally walked down yet. So just any update on that, and if there's a pipeline of partners similar to those 5 that were announced?

So nothing new beyond the announcement call. I mean we're continuing to work with the reference labs and hospitals. And we announced several we're engaged in several current discussions and hopefully plan to add to that. And I think in our press release, we said that we want to be able to announce some of these in the future.

And our next question, coming from the line of Dan Brennan with TD Cowen.

Great. Maybe just kind of a follow-up to the thread that's been happening. So while you're making this public push to investors now on your patent strategy, could you comment if there's already been litigation back and forth with any of your competitors behind the scenes on some of the -- on this patent?

Yes. So look, we -- there is no -- we do not expect any potential litigation at this point in time. And we're hopeful that third parties will see the numerous benefits by partnering with us to use our innovative technology, including technologies that 092 patent covered.

Got it. So in terms of the path forward -- and that was going to be my second question. In terms of the path forward for playing out the legal strategy, what we could see from our end? I guess, you're basically saying, there's going to be more partnering versus legal, you're not expecting to have to bring suits against any of these players who have a 217 test or others that could be coming forth with one.

That's right, Dan. We want to enable and have conversations. And we're starting -- we want to start those conversations with third parties and give access. This is not a situation where we're trying to limit testing access. It's just the opposite, where we want to provide the best tools and make this available globally. So we're absolutely open to discussions about our products and providing a nonexclusive license to the IP.

And then in terms of the companies that are already on the market or have launched with the 217 test, would that be the same case that you would look to negotiate a license with them? Or I guess, I'm sure a common thing that investors weren't -- kind of wondering about is you've got, I think, 2 companies in the market with the 217 tests, I believe. So I'm just wondering did they -- were they not aware of your patent? Did they see it and didn't believe it was valid? Were you guys not as forceful with kind of this push? Just trying to reconcile some of the early launches versus your kind of confidence in the patent.

So I think that, over the last several months, there have been some tests that have come to market. And from a customer perspective, we believe that our license is the only avenue to offer Tau-based testing at the levels they identified in our patent. So hard to speculate from industries of others, but we're willing to make this available and provide a nonexclusive license. Laboratories -- we want laboratories and reference labs and clinical sites offering this test, and so we want to engage in more of those conversations.

And I'm showing no further questions in the queue at this time. I will now turn the call back over to Mr. Masoud Toloue for any closing remarks.

Yes. Thank you. So in closing, I just want to emphasize, we're committed to building the global infrastructure necessary for Alzheimer's disease. And we want to make testing widely accessible to patients, and we'll work with health systems, reference labs and clinical partners to do so. Thank you.

Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may now disconnect.