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spk00: The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1 1. Good day, and thank you for standing by. Welcome to the Quantirix Corporation Q4 2022 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 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker, Mr. Mike Doyle, CFO. Please go ahead.
spk01: Thanks very much. Good morning, everyone. Thanks for joining us today. With me on today's call is Masoud Toulou, President and Chief Executive Officer of Quantarix. Before we begin, I would like to remind you about a few things. The call will be recorded and will be available on the Investor Resources section of our website. Today's call will contain forward-looking statements within the meaning of the U.S. Private Security 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 our most recent filings with the Securities and Exchange Commission. To supplement the company's financial statements presented on a GAAP basis, the company has provided certain non-GAAP financial measures. Management uses these non-GAAP measures to evaluate the company's operating performance in a manner that allows for meaningful period-to-period comparison and analysis of trends in its business. Management believes that such measures are important in comparing current results with other period results and are useful to investors and financial analysts in assessing the company's operating performance. The non-GAAP financial information presented here 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 their most directly comparable GAAP financial measures set forth in the appendix of this presentation and the earnings release issued earlier today. With that, I'll turn the call over to Massoud.
spk05: Thank you, Mike, and good morning, everyone. So on today's call, I'll cover three topics. First, an update on our corporate transformation Then highlights on our Q4 and 22 results. And then finally, progress that we've made on our translation path. So in August of last year, we announced a comprehensive restructuring and business realignment plan to fully realize the potential of our Samoa platforms. And we continue and to continue showing our leadership role in ultra-sensitive biomarker detection. Two quarters in, I'm pleased to say we're on track. Our assay redev program designed to improve our ability to manufacture and deliver high-quality assays at scale is on target and moving forward. The initial phase evaluation of our components to streamline assays for improved manufacturability and reduction in variability has been completed and will begin transition into production starting the first half of this year. As we noted in our last call, we'll be feathering improvements into production and believe progress on our transformation can be improved or is best measured by sequential gross margin improvements. We have made gross margin improvements since Q2 due to our transformation activities, and the next wave is expected to be directly linked to our assay REDEF program. Third quarter progress was mainly due to restructuring efforts, and more recently in Q4, Progress was due to assay manufacturing process improvements, which resulted in efficiencies. On a non-GAAP basis, our Q4 gross margin was 41.3% versus Q3 non-GAAP gross margin of 34.9%. And this approximate 600 basis point improvement was driven by changes to manufacturing planning and a few one-time events. Moving on to the fourth quarter, we delivered $25.8 million in total revenue, As shared last quarter, we continue to manage demand during our REDEV program. In Q4, consumable revenue increased by 13 percent compared to prior quarter, while instrument placements in Q3 and Q4 were the same at around 39. Lower instrument revenue in Q4 versus Q3 was due to timing of our collaboration with UltraDx in China. Changing focus to year-over-year, we closed 22 with 105.5 of revenue, compared to 21 revenue of 110.6 million, which included 5.2 of non-reoccurring revenue under the NIH RADx grant. In conjunction with our transformation plan, year-over-year consumable growth declined as expected, while instrument placements were nearly flat. Finally, we significantly improved operating losses relating to our core operations in the second half of the year. We made solid progress in our assay redev program and have begun using those learnings to prime our product development engine. Now, turning to our translation path. Following our PTAH 181 LDT release in Q3, in early January, we announced the expansion of our LDT menu with the launch of neurofilament light, which can be used as an aid in the evaluation of individuals for possible neurodegeneration conditions or other causes of neuronal and central nervous system damage. Samoa NFL is the most widely published NFL test with hundreds of research papers demonstrating its validity for assessing neurodamage and has become widely adopted in therapeutic clinical trial design. So our core strategy is turning proteins into biomarkers, into measurable biomarkers, to unlock proteomics research and translate those discoveries to improve human health. ESI's Lekembe approval in January 6th from the FDA via the accelerated approval pathway was a great example. Quanterix is leveraging its ultra-sensitive detection capabilities to accurately measure Alzheimer's disease directly in plasma. Simoa P-tau-181 was identified as a biomarker endpoint on the Lekembe label. The study concluded that Lekembe every two weeks reduced mean plasma P-tau-181 24% from baseline in 79 weeks, a highly significant decrease. Overall, this is a very exciting milestone for the Alzheimer's solution space. Now, I'll turn over the call to Mike to discuss some more financial details.
spk01: Thanks, Massoud. I'm going to provide some additional financial details about our fourth quarter and full year 2022 performance. Before I get into the details, I want to make an overall comment about our performance since we announced the realignment of the business in August. We indicated in August we've been managing demand in order to deliver quality products while we're redeveloping our assays. We achieved our revenue target in both Q3 and Q4. We indicated sequential improvement in our gross margin will be a good indicator of our progress, and we have seen sequential improvement in Q3 and Q4 of 2022. Finally, our cash fern has improved in the second half of 2022, and we end with a healthy cash balance at the end of the year. Now I'll review the details of our financials. For your reference, for those following on the call, I'm starting on slide four. Our total revenue in the fourth quarter of 2022 was $25.8 million, a decline of $4.5 million, or 15% versus the fourth quarter of 2021. We had product revenue in the fourth quarter of $16.7 million, a decline of $6.8 million, or 29% versus the fourth quarter of 2021. Within product revenue, consumables revenue was the biggest driver of the decrease, declining $5.6 million, or 33% versus the fourth quarter of 2021. As Massoud mentioned, we continue to manage production and demand for consumables while we address assay quality. Instrument revenue decreased 1.3 million, or 19%, versus the fourth quarter of 2021 due to timing and mix of instruments. Full-year instrument placements in 2022 were approximately the same as the prior year at 168. We had no grant revenue during the fourth quarter of 2022 as compared to $1 million of RADx grant revenue in Q4 of 2021. Fourth quarter services revenue increased 3.6 million or 54% versus the prior year fourth quarter to 8.8 million. Including within the services revenue is 2.7 million recognized during the fourth quarter of 2022 from our collaboration agreement with Eli Lilly. Overall, our revenue performance was in line with our expectations for the quarter and the year and reflects the guidance we provided when we announced the realignment of the business in August of 2022. Now I'd like to spend some time talking about gross margin for the business. As a reminder, we performed a deep dive review of the business in the second quarter of 2022. As a result of that review, we changed the cost allocation of three departments based on their focused activity on quality and operations. In addition, we are capturing freight and distribution costs recorded as operating expense as a non-GAAP adjustment to the cost of goods sold. Slide 4 and 12 show the impact of the non-GAAP adjustments for both the quarter and full year 2022 with the appropriate comparison to prior year. Both changes result in lowering operating expense with a corresponding increase in the cost of goods sold with no impact to the bottom line. We have made these changes to give greater visibility into our quality activity and to allow investors to better monitor our progress each quarter. We expect to continue providing the GAAP to non-GAAP reconciliation in 2023. Now I will review gross profit performance in the quarter versus prior year. In Q4 of 2022, our GAAP gross profit was $12.6 million and our gross margin was 48.8%. is compared to 16.3 million and 53.7% in the fourth quarter of 2021. Our non-GAAP gross profit was 10.7 million and our non-GAAP gross margin was 41.3% compared to 13.3 million and 47.2% in the fourth quarter of 2021. The approximately 590 basis points reduction, drivers are approximately 100 basis points of decrease due to non-recurring RADx grant in 2021. The remaining decrease include the change in allocation of resources associated with quality and operations in the second quarter of 2022, which negatively impacted the year-over-year margin by approximately 410 basis points, partially offset by reduced costs as a result of the restructure. However, as Massoud pointed out earlier, when we embarked on our plan to realign the company and realize the full potential of our Samoa platform, We said gross profit improvement quarter over quarter would be a good metric to monitor our progress. We have seen sequential improvement in each quarter since the second quarter of 2022, and non-gas gross profit improved approximately 640 basis points in Q4 versus Q3. Our operating expense performance in the fourth quarter improved by $1.6 million. However, we had a significant item hit restructuring and related charges. We incurred an additional impairment charge to our Bedford, Massachusetts lease facilities, which we will not be utilizing, of approximately $8.7 million, a non-cash charge to the P&L. This charge is an adjustment to reflect the softening of the commercial real estate market. SG&A expenses for the fourth quarter declined $9.2 million versus fourth quarter of 2021, and R&D expenses declined $2.1 million from the fourth quarter of 2021. Both SG&A and R&D declines are primarily driven by reduced headcount and related expenses as a result of the restructuring. As detailed on slide 5, during the fourth quarter of 2022, our cash balance decreased by $5 million from the end of the third quarter of 2022, which was better than expected and was driven by reduced operating expenses post the restructure, improved collections on aged accounts receivable, and reduced inventory. Ending unrestricted cash balance was $338.7 million at December 31, 2022, leaving us with over $9 per share in cash and no debt. Our balance sheet is in excellent shape, and we are well positioned with adequate resources to pursue our strategic objectives. Basic weighted average shares outstanding for EPS totaled $37 million for Q4 of 2022. I will now review our guidance for 2023, which is on slide seven. We expect product and services revenue to range between $103 million to $109 million in full year 23, representing modest growth year over year at the midpoint of the guidance, with a slight decline in the first half of the year and high single-digit growth in the second half of 2023. Our 2022 revenue of $105.5 million included $11 million for the Lilly Master Collaboration Agreement. and $94.5 million for our core products and services. The Lilly Master Collaboration Agreement in 2022 included a one-time $5 million payment for a technology license agreement that will not repeat and a $6 million collaboration project. The collaboration project has a quarterly renewal feature, which Lilly has triggered for the first and second quarter of 2023, and we've included $3 million in our current guidance. We expect our core product and services revenue to grow high single digits in 2023. We expect to end 2023 with GAAP gross margin in the mid-40s and non-GAAP gross margin in the low 40s. We expect to see approximately a 10% improvement in cash burn for 2023, and with our current transformation plan, be cash flow positive at around $170 to $190 million in revenues. With that, I'll turn it back to Massoud.
spk05: Thanks, Mike. So in closing, I would like to call attention to two recent noteworthy publications that highlight how our Samoa technology leads in converting protein signatures into biomarkers. Biomarkers are becoming critical for the near and long-term development of new drugs for MS and Alzheimer's disease and will play a diagnostic and disease monitoring role. Researchers at the University of Basel and collaborators extended on some of the initial groundbreaking work by Jens Cooley and colleagues that established serum neurofilament light, or SNFL, as a biomarker that correlates strongly with MS and its symptoms, showing that NFL can sensitively predict disease activity at an early stage. Now, in an extension of that work, researchers using Samoa technology showed that a second biomarker, GFAP, can be used to support therapy decisions in MS. The authors provide evidence that GFAP can be used to prognostically monitor disease activity, particularly in those patients experiencing progression independent of relapse activity. So, as NFL can be used to specifically measure neuronal damage in MS, GFAP in blood specifically indicates chronic disease progression in which astrocytes specifically are involved. Both biomarkers complement each other and can help make MS therapy more individually tailored and forward-looking. Now, the second publication I want to point your attention to is a community-based cohort prospective study of about 700 participants that were followed over 17 years. Dissociation among the blood-based biomarkers in Alzheimer's disease, vascular dementia, mixed dementia, and total dementia incidents were assessed. The study showed strong evidence that Samoa GFAP was associated with AD incidents of nine to 17 years before diagnosis. Now, Samoa NFL 181 were also strongly associated with AD diagnosis in the study. So really excellent work, groundbreaking publications. Now, before we get into questions, I want to reiterate our leadership position. We have, you know, with the new activities in the company, strong momentum. Five years since our IPO, we're one of the very few players in proteomics that has breakthrough tech with strong IP protection. We're the only in the proteomic space that's translating across the discovery to diagnostic testing continuum. We have a full sample to answer platform, strong financials, and commercial scale. ultimately primed to achieve breakthroughs in what we believe will be the neuro decade in therapeutics. These things don't happen overnight. We call them accelerants that come with scale, and with our transformation, will give us even more momentum to return to solid double-digit growth by 24, increasing our penetration of an immense discovery to diagnostics proteomics market opportunity. Let's take some questions. Operator?
spk00: Certainly. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please stand by while we compile the Q&A roster. One moment for our first question. And our first question comes from Matt Sykes of Goldman Sachs. Your line is open.
spk04: Hi. Good morning, Masoud and Mike. Thanks for taking my questions. Hey, Matt. Masoud, maybe just to start out, hey, Maybe just to start out, you talk about the revenue management that you're putting in place as you'd work on the assay redevelopment. Could you maybe talk a little bit about customer feedback as you're doing that revenue management and how you're able to kind of retain those customers over the long term as you work on the redevelopment and if there's been any impact from that revenue management that you've been putting in place?
spk05: Yeah, thanks for the question, Matt. We have, I would call it, we're triaging and managing while we're doing this Redef program of the demand. So we're managing the demand of customer inquiries coming in, and I would say we've been doing a pretty effective job. Some of our customers are going to our accelerator where we're offering services, where some of the availability of our assays are easily accessible, and then some are waiting or some of the projects are delayed. And then some aren't experiencing delays at all. So, you know, we've been, I would say, overall doing a pretty decent job in managing this while we're doing the redevelopment program at the same time.
spk04: Got it. Thanks for that. And then, Mike, just a two-parter on the guide for 23. When you look at that sort of high single-digit growth for core products and services, could give a little bit of more color on sort of instrument versus consumables breakdown, as well as Accelerator Lab, just so we can how we can think about that composition of revenue growth. And then just secondly, on the gross margin cadence for 2023, you talked about sort of like year end where you'd like to land, but can you maybe talk about sort of the sequential cadence of gross margin improvement throughout the year?
spk01: Sure. I'll give you my perspective, and I think Masoud can add some color. You know, I would say that Certainly in the first part of the year, I would think you'll see a continuation of sort of our existing performance, both in instruments and consumables. Accelerator services probably continue to be strong. So I wouldn't look for spike-ups in instruments and consumables, you know, in the first quarter of the year. And, you know, so I think it's going to be sort of what I would call steady improvement. I think margins similarly. We had a pretty dramatic improvement in the fourth quarter. I expect from here on out it's going to be much smaller increments. And, you know, ideally, you know, our goal obviously is always to exceed, but I think we're still keeping our targets sort of in the mid-40s on non-GAAP to end the year and in the low 40s in non-GAAP. And, again, slow, steady improvement as the year progresses. When you look at year-over-year comparisons, you know, we're going to be down a bit in the first half. But, you know, I think you're going to see us accelerate in the back half of the year. And, again, our core products, we will end at high single digits for the year.
spk04: Great. Thanks very much for taking my questions.
spk06: Thanks, Matt.
spk00: One moment for our next question. And our next question will come from Puneet Sauda of SVP. SVB Securities, your line is open.
spk02: Yeah, hi, Masood. Mike, thanks for the question. So first one, just wanted to clarify, with just given the reductions here that you have implemented, how should we think about the total sort of OPEX expectations for the year and sort of what the cadence for that is? And then I have a couple of follow-ups.
spk01: Yeah, as I think about OPEX, Puneet, I would say that, and I would take out sort of when you look at the impairment, you know, we've taken two hits to impairment on real estate for the quarters. So I expect that's going to be much smaller if, in fact, that changes. Ideally, the market gets a little better, but we've taken the bulk of the hit there. I would say the core expenses, when you look at R&D and SG&A, I would expect them to stay pretty consistent. We'll have some slight bump up because of the normal merit increase that occurs in Q1, but nothing dramatic. And then towards the back half of the year, you may see some increase as we start ramping for double-digit growth. You could see some increase in selling costs. But again, I don't expect a dramatic bump up. It's going to be slow and steady for SG&A and R&D.
spk02: Got it. Okay. And then, Ms. Su, when we look at the Likambi label, you know, there is obviously biomarker plasma A-beta 42 and 40 and P-tau that are mentioned on the label with the study results. Could you just help us clarify, you know, how those test can be utilized. Now, on the label, it also says that both of those plasma biomarkers should be interpreted with caution due to uncertainties in bioanalysis. And at least for administering the dose, the presence of amyloid beta pathology is required prior to initiating the treatment. So, it's not clear if the plasma biomarkers are required. So maybe just help us understand sort of, you know, how do you think the plasma biomarkers would be utilized here, mostly rather restricted to clinical trials or, you know, sort of, you know, where they can be potentially used in commercial as well.
spk05: Hey, Puneet. Yeah, so, you know, to clarify a little bit on the, you know, that label and the use of the quantarix biomarkers, First, in addition to 181, GFAP, NFL were also used. The 181 results were most remarkable, and I think that's kind of highlighted. That's why it was highlighted on the label. The key thing is clinical trials, yes, clearly it's not just this study, but several other pharma companies are using many of our biomarkers actively in clinical trials. The question I think you're going to point to is, hey, what's the next step? And there's nothing prescriptive on the label. However, I think what's becoming more and more clear is that in order to scale any sort of therapy for Alzheimer's, you're going to need a blood test. You have to be able to screen the sort of 40 to 55 million people who have the disease and traditional methods of PET scan or a spinal tap just aren't scalable. And so I think what you see are the early steps of, okay, let's get some results in blood so that we can have an aid to a diagnostic, so that we can use blood in addition to the memory test to be able to make a decision whether someone goes to a PET or another more invasive study. And we believe in the future, ultimately replaces the invasive study so nothing prescriptive you know on the label that you have to use this or you don't have to use that in fact the only thing that is required is the memory test in that in that study but we think it's a very important first step for the disease okay that's um helpful um and then um you know as we think about you know sort of the
spk02: potential readouts through the year. Can you just outline with the number of Alzheimer's trials ongoing, maybe some MS trials as well? So what we ought to be looking out for in terms of data releases where Quantirix data could be meaningful. Thank you.
spk05: Yeah, absolutely. So just a little bit of an update. As you know, we're collaborating with ADDF on a plasma diagnostic test. And we're collaborating with the VUMC Amsterdam University Medical Center on four phases of a clinical trial that we announced last quarter and this is for a multi analyte test and we believe you know with a multi analyte test we begin you know can begin to replace more invasive tests and so well you know happy to say that phase one was completed in q4 you know we looked at over 1,200 patient samples and phase one B is going to be our retrospective cohort, and Phase 2 will be the prospective trial, and those are expected to start this quarter. The second clinical test we're working on is in collaboration with the Global Alzheimer's Platform Foundation. And so that, again, we mentioned this last quarter, but 17 sites, 1,000 Alzheimer's patients. That closed in November 2022. And we're beginning to do the data analysis. We expect that data to be, you know, fully analyzed by Q2 of this year. And just as a reminder that this global Alzheimer's test is a prospective validation trial that's expected to support our regulatory filing for the FDA on the PTAL 181 test.
spk02: Got it. Okay. Thanks, guys.
spk00: One moment for our next question. Our next question comes from Kyle Mixon of Canaccord. Your line is open.
spk03: Hey, guys. Thanks for taking the questions. Ms. Sood and Mike, in the guidance, what's the implied revenue growth in the first half of 2023 compared to the second half? What's the revenue mix, I guess? And then jumping off that, do you expect the top-line growth rate and the gross margins will continue to expand sequentially each quarter heading into the second half of 2024 when the asset redevelopment program schedule is to be completed? And, I mean, if margins are, like, stable or decline a bit sequentially in any quarter, you know, here going forward, should we be concerned by that or could it be a little bit lumpy?
spk01: Yeah, I would say the best way to think about it, at the low end of our guidance, it would imply, you know, a decline in the first, you know, half of the year, Kyle, and then, you know, a single-digit growth. At the midpoint, though, the best way to think about it, you know, probably, you know, slight decline in first half, and then high single-digit in the second half of the year. So that's how we're thinking about revenue growth. And I'd say gross margin, I would think about it in steady increments sequentially. That said, in any given quarter, we could have a mixed shift that could create a little bit of a move backwards, but I don't think anything would be dramatic, and we'd be able to articulate sort of the what and the why. But right now, we're just looking at sort of steady improvements. And I would expect that the question on 24, it would continue because as growth accelerates, we'll begin to get even more leverage there. So I expect that will continue. The gross margin should continue to increase into 24. All right.
spk03: Thanks, Mike. And maybe just one more on the financials. You noted the company should achieve cash flow at that 170, 190 billion revenue range. I'm sure you guys are doing under 170 in 2025, maybe 168 or so. So Maybe, like, regarding the timing of that quarterly positive cash flow, like, would during 25 being a reasonable estimate for that to occur?
spk01: Yeah, I think that's how, you know, we're thinking about it, that we would like to be exiting approximately 2025, you know, as hitting cash flow, break even. Kyle could, you know, obviously things could move a bit, but that's kind of 25, 26, how we're thinking about it. And you look at... Managing cash burn, I feel pretty good about that. So I look at our cash balances. We're not going to have a need to go to the market to sustain our existing business before we hit, you know, break even. So I feel pretty good about that.
spk03: Right, yeah, and sorry for cutting you off there, Mike. You guys are almost halfway through this AFI redevelopment program. Is most of the heavy lifting kind of done and the remainder here is just smooth sailing or is the second half of the plan more challenging? Okay.
spk05: Yeah, great question, Kyle. So I wouldn't say that necessarily, you know, one part is more challenging than the other. I would say that, you know, I think the beginning phase, the first quarter, we're actually two quarters in. We said it would be six quarters. The first sort of quarter is kind of, hey, what are we going to implement and what are the changes that are going to be most beneficial to scale? identifying the gap that we currently have to scale. And I would say that the team has pretty thoroughly accomplished that and begun to tackle some of those biggest gaps to being able to scale production and making these assays. And so I think that was the sort of most interesting and most important phase that we completed. And in terms of next phases, it's blocking and tackling and making the changes and implementing them and then putting them into production. So we feel confident here. Things are on track and going according to our progress.
spk03: Great. I could ask one final one on, I guess, the competitive landscape and neurology diagnostics as that kind of evolves here. Not all of these newer tests here are detecting beta-181 or beta-217, but the field is becoming more crowded, clearly. And some of these companies already have launched tests or have reimbursements, so it's interesting. I'm just wondering if you could speak to the recent dynamics in the space and how your 181 LDTs kind of faring in the research and, I guess, clinical possibly markets, and then any revenue expected this year from the LDTs, including MS, I guess, this year or in 2024?
spk05: Yeah, I would break the LDT revenue in sort of two phases. One, I would say, you know, I think 23 revenue from the LDT is not going to be, you know, are not going to have a significant impact. And the two phases I would break that down to is clinical studies. There are a lot of cases where the LDT is being used in a clinical phase or clinical study where the results are being reported back to a patient. And I think that probably, you know, is going to be more substantial than the other phase, which is, you know, the aid to a diagnostic or aid, you know, to a test or a therapy. I think for that to pick up, you know, any sort of materiality would require a drug in the market. So that's kind of how we view the LTT phase. And then on your question on the competitors, I think, you know, we've looked at this in Clearly, the folks coming and doing work on the neuro side is a great validation that this is a really important field, and others feel that this is going to be a neuro decade in the next several years. But I would say when you look at, hey, who has a sample to answer platform where you can go blood in and result out, where you can scale the platform and really look at phosphorylated versions of these complicated proteins, I don't think anyone else does it better than us.
spk03: That's really great. Thanks a lot for that. Congrats on the progress, guys. Appreciate it. Thanks, Kyle. Thanks, Kyle.
spk00: And I'm showing no further questions. This concludes today's conference call. Thank you for participating. You may now disconnect. The conference will begin shortly. To raise and lower your hand during Q&A, you can dial star 1 1.
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