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spk00: Thank you for standing by. Welcome to the Quinteros Corporation First Order 2023 Earnings Conference 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 PAR11 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that the conference is being recorded. I would now like to hand the conference over to your speaker today, Mike Doyle, Chief Financial Officer. Please go ahead.
spk04: Thanks very much. Good afternoon, everyone, and thanks for joining us today. With me on today's call is Masoud Toulou, President and CEO of Quantarix. Before we begin, I'd 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 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 statement. 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 the most directly comparable GAAP financial measures set forth in the appendix's presentation and in the earnings release issued earlier today. With that, I will turn the call over to Massoud.
spk05: Thank you, Mike, and good afternoon, everyone. On today's call, I'll cover progress on our comprehensive transformation plan, results, and recent developments in the clinical use of plasma biomarkers. We see 2023 as a year of focus and disciplined execution as we build the organization for future growth. I'm pleased to say we continue to make progress on our transformation plan in order to deliver quality products to our customers. Since initiating the plan, we have identified the gaps required for industrial manufacturing taken steps to improve the stability and scale of common assay components and have begun early stages of validating and transitioning these improvements into operations, a process that will continue throughout this year. While still early, several of the recently implemented operational processes have positively impacted yield and efficiencies. Successful outcomes of our transformation will be new products used and operating lines to efficiently manufacture those products by the end of this year and transitioning customer demand from our existing assays to new assays through 2024. In making these changes, we believe our customer experience will be significantly improved and operating efficiencies will benefit our margins, setting us in the right trajectory to scale revenue profitably. I've never been more confident and proud of our talented people. Transformations like these usually don't happen in such high intensity and tight timeframes, but it's the individuals in the company and their resolve that are propelling us forward. Led by our operating, commercial, and service leaders, and talented executive leadership team, it's a focused march towards successfully running the company while implementing the transformation by end of year. Moving on to first quarter results, we delivered $28.5 million in total revenue, up 10% from the fourth quarter of 22. Q1 consumable revenues increased by 25% quarter-over-quarter, while collaboration and instrument revenue modestly declined, collaboration being the reduction in licensing and 3% decline in instruments primarily due to softness in Asia-Pac related to economic uncertainty. One of our advantages in this area is that macro uncertainties and reluctance for CapEx purchases can be partially offset by customers performing research and clinical trial work through our accelerator program. GAAP gross margin was 59.5%, and non-GAAP gross margin was 53.1%, which both represent sequential increases of over 1,000 basis points over Q4-22. I do want to point out that we expect gross margin headwinds in the second half of 23 as we begin implementing assay efficiency improvements and carry two SKUs for our top products into our manufacturing lines. This work is often noisy as we refine the assay in the final stages and can increase scrap and other costs in the near term. That said, we still expect to exit 23 with gross margins higher than 22. Our cash decreased approximately $9.1 million since last quarter in line with expectations. And we ended Q1 with $329 million in unrestricted cash. Given the first quarter results, we are modestly adjusting upwards our guidance for the full year. We are targeting revenues in the range of $104 to $111 million and non-GAAP gross margins in the mid-40s on a percentage basis and GAAP gross margin in the high 40s. The sales guidance increase is driven by consumables, accelerator services, and continued collaboration revenues, offsetting potential softening of instrument revenue. Now I'll turn over the call to Mike to discuss some more financial details. Mike?
spk04: Thanks, Massoud. First, an overall comment about our performance. It's nice to start the year with a solid performance out of the gate. First quarter performance was ahead of our expectations and consensus for both revenue and gross margin. As Massoud mentioned, we've bumped our guidance slightly to reflect our Q1 performance and expectations for 2023. That said, our guidance also reflects our continued management of demand as we continue to do our work redeveloping our assays and dealing with the broader macroeconomic pressures in the global economy, which we believe is creating softness in our instrument demand. Now let me review the details of our first quarter 2023 performance. For your reference, for those following on the call, I'm starting on slide four. Our total revenue for the first quarter of 2023 was $28.5 million, a decline of $1.1 million, or 3.7%, from the first quarter of 2022. In the first quarter of 2022, we had $1.2 million in licensing revenues, from our agreement with Lilly, which is not recurring in 2023. Excluding the impact of this license revenue, total revenue was flat year over year. We had a product revenue of $19.3 million in the first quarter, a decline of $1.4 million, or 6.6% versus the first quarter of 2022. Within product revenue, instrument revenue is the biggest driver of the decrease. declining $1 million, or 15.4%, versus the first quarter of 2022, primarily due to reduced demand in our Asia-Pac region. First quarter consumables revenues declined slightly from the first quarter of last year, down 0.4 million, or 2.8%. As we have stated previously, we continue to manage production and demand for consumables as we address the assay quality. Services and other revenue were 8.6 million for the quarter, down 0.2 million, or 2.6% from the first quarter of 2022. Now let's move on to gross margin for the quarter. Our GAAP gross profit and margin was 16.9 million and 59.5% for the first quarter of 2023, compared to 14.6 million and 49.3% in the first quarter of 2022. Our non-GAAP gross profit margin was 15.1 million and 53.1% in the first quarter, as compared to 12.8 million and 43.2% in the first quarter of last year. The improvement in gross margin on both a GAAP and non-GAAP basis was driven by a few things. We have a one-time benefit year over year due to the timing of our physical inventory, which was in the first two weeks of January last year. This one-time productivity benefit was approximately 300 basis points on our margin. We did a good deal of inventory cleanup last year, scrapping over a million dollars in materials in Q4 alone, and made a number of changes to our inventory management practices, which resulted in lower than typical inventory adjustments in the first quarter of 2023. This had a positive benefit of approximately 500 to 600 basis points on gross margin. We had open positions in our manufacturing organization and overall lower headcount year over year due to the restructuring we executed in August of 2022. This benefited our gross margin by 250 basis points. Overall, a strong gross margin performance for the quarter aided by a few items that are non-recurring. Our updated full-year guidance reflects our go-forward view on gross margin for 2023. Our overall operating expenses declined $6.4 million from $32.7 million in the first quarter of 2022 to $26.3 million in the first quarter of 2023. The primary driver was reduced costs due to the restructuring action we took in August of last year. Our net loss declined from a negative $18.2 million in the first quarter of 2022 to a negative $6.1 million in the first quarter of 2023 due to improved gross margin, reduced operating expenses, and a $3.4 million increase in interest income. I will now review cash, which is on slide five. We ended the first quarter with $332.3 million in cash, a decline of $9.1 million from our year-end cash balance of $341.3 million. The first quarter of the year is often our largest cash burn period as we make our annual bonus and year-end commission payouts. Our balance sheet remains in excellent shape, and we remain well positioned in a difficult economic environment. Let's turn to guidance, which is highlighted on slide seven. As mentioned earlier, we are modestly increasing our guidance for 2023. We expect our revenues to be in the range of $104 to $111 million. And as a reminder, we're still managing our demand and shipments as we continue our assay redevelopment. For the full year of 2023, we expect GAAP gross margin to be in the high 40s and non-GAAP gross margin percent in the mid 40s. As Massoud mentioned, we expect margin headwinds in the second half of 2023 as we fill open positions and increase staffing, incur greater scrap and excess costs as we do initial runs of new assays on our production line, and oscillate some materials as we complete the assay redevelopment. With that, I'll turn it back to Massoud.
spk05: Thank you, Mike. In closing, I would like to mention the recent FDA decision granting accelerated approval of the SOD1 ALS drug, Topfersen, based on neurofilament light as a secondary endpoint. As with many neurodegenerative diseases, a lack of quantitative primary indicators of disease has hampered the development of new therapeutics in the space. For example, changes in SOD1 indicate Topperson is working as intended, but it's not necessarily a predictor of clinical efficacy. It's the blood biomarker NFL, which researchers do believe has a relationship with clinical efficacy, leading to what you saw was accelerated approval of the therapy. This new approach to NFL as a neuro drug development tool will be an important long term tailwind for investment in future neuro research, approval, and reimbursement of therapies. To date, pharma and biotech companies have already incorporated the tracking of NFL into over 100 clinical trials for Alzheimer's, Parkinson's, Huntington's, MS, and we expect this to grow in the long term. Second, As you know, the history of Alzheimer's therapeutic development has not been a happy story. There's a graveyard of over 200 compounds tested in various clinical trials that have failed with a failure rate of over 99%. Today, over 50 million people around the world suffer from Alzheimer's disease or dementia, and within the next 30 years, that number was expected to triple without a therapy. The recent announcement by ACI and Lilly are real hope that this doesn't happen. We're encouraged by recent results and hope these therapies provide relief to the sufferers of this relentless and debilitating disease. It is becoming clear that Samoa blood-based biomarkers are going to play an integral part of research and clinical applications. Most recently, as demonstrated by Samoa's PTAU217 role as an important early blood biomarker for Alzheimer's disease. Quantirix's SAMOA technology is one of the very few platforms out there that can reliably detect these difficult to measure tau proteins. You need high sensitivity detected in blood, and we have demonstrated that in research, clinical trials, and soon diagnostics. Our expectations for the long-term growth of this company and its leadership role in neuro are high. The combination of the FDA approving the first-ever blood-based neurosurrogate biomarker, along with recent positive readouts on Alzheimer's drugs, have signaled a true kickoff and start to what we believe will be a neurodecade of new discoveries and therapies. Quanterix is poised to be part of that. Let's take some questions. Operator?
spk00: Thank you so much, presenters. And as a reminder, to ask a question, you will need to press bar 11 on your telephone. And please stand by while we compile the Q&A roster. Your first question comes from the line of Puneet Sudha from SVB Securities. Your line is now open.
spk02: U.S. telephone for Puneet. Thanks for the question and congrats. Maybe just a question on... You mentioned software instruments contemplated in the guide and in the quarter, I think, around APAC. Can you just elaborate on what types of customer segments you're seeing this in? And, you know, although I think Quinterix mostly skews later stage, do you see a possible macro impact to, like, neuroclinical trials if there's any smaller biotech exposure there? Thanks.
spk04: Yeah. I think from what we've highlighted right now, where we're seeing softness is in Asia-Pac. We have a couple of large distributors there, and their volume activity is off in Q1 versus last year in a meaningful way. It doesn't show itself as much in the actual revenue itself, so we're getting a better mix, and we're seeing some lift a little bit in Europe, but it's principally in Asia-Pac right now. And we expect that to persist throughout the year. You know, I think that there's, as Massoud highlighted, there's some tentativeness, but we get a benefit or other in our accelerator lab. So we think we can offset that, which is why our guidance reflects what it is. But I think Instruments is going to be soft all year long.
spk02: Got it. Thank you. That makes sense. And then maybe just a question on Alzheimer's. We've seen a number of updates from Pharma recently, but I just wanted to get your view on kind of how you're thinking about like a go-to-market strategy for commercial assay there. Can you kind of elaborate on what proteins are currently would be included in your assay and what kind of a final assay would look like in a potentially multiplex offering?
spk05: Yeah, absolutely. I can take that. So, you know, I think from A screening and diagnostic aspect, our plans are pretty clear and well articulated. First, our products are right now available for all reference and specialty labs that are running LDTs under the CLIA framework. And we can confirm many of our tests are being run in over tens of CLIA settings in the U.S., Europe, China. you know, around the world. And that's something that can be done today. And we're open to working with all these labs and, you know, the products that we have. And so, you know, those, as you've, you know, heard, are going to be, you know, mainly on the PTAL side and probably a few multiplexes. So this is our PTAL LDT that we currently offer as both in a service and a product, as well as in the near future, PTAL 217, and then our multiplex neuroassays. And then from a reimbursement standpoint, this is going to take regional reimbursement from Medicare administrative contractors and market support with uptake in clinical care and early adopters. And so that's the first step is all of this being done in these specialty and reference laboratories. And then second, we think the FDA approval of these biomarkers is going to be important. So we've received a couple breakthrough designations for two of our blood tests. And in the near term, we believe that these will be an aid to physicians streamlining clinical workflows, reducing the number of PET scans and what we believe in the future will place imaging.
spk02: Gotcha. Thanks. Makes sense. I'll back into you.
spk00: Thank you so much. Our next question comes from the line of Kyle Mixon of Catapult Annuity. Your line is now open.
spk01: Hi, this is Alex McKesson online for Kyle Mixon. Thanks so much for taking questions. One brief question. So this is kind of covering some of the stuff that you discussed at the beginning of the call. Could you just elaborate on the steps in the SME development program that you've kind of hit as of the first half, the first three out of the six quarters. Specifically, in the materials you previously discussed, manufacturing implementation of the first wave, raw material specifications, building qualification, as well as some automation. I'm just curious if you've kind of hit most of those targets at this point. Thanks.
spk05: Hey, Alex. Yeah, absolutely. You know, I would say that, you know, the way to sort of think of this transformation. First, there's a large transformation, corporate transformation. And as part of that corporate transformation, we have an assay redevelopment roadmap, which is one part of that. And I would call Q3 and Q4 of last year as completing the review, looking for sort of identifying the gaps to industrial manufacturing. And so, you know, as we said in prior calls, success, we've identified where those are. And then identifying, hey, what is going to feasibly transition in this year? And so I think in Q1 of 23, we've identified those. And we've begun making some changes to our raw materials and stability for those raw materials. And then the next quarter, what you're going to see is some more qualification of that material and beginning to start to insert that into our are operating manufacturing lines. And so this is obviously a long process of putting this into the operating lines. And we expect that by Q4 of 23 that several of our top products will launch using this redev assay program. So the next couple of quarters, more insertion into manufacturing lines and managing some of the couple of SKUs. All in all, the progress is as expected, and we're very happy with it.
spk01: Got it. Thank you very much.
spk00: Thank you so much. And your next question comes from the line of Matthew Sykes of Goldman Sachs. Your line is now open.
spk03: Jake on for Matt Sykes. Slight raising guidance. It was good to see some positive momentum. Can you give a little more color on the mix shifts between instruments, consumables, and accelerator that you're seeing throughout the year?
spk04: Yeah, Jake, this is Mike Doyle. As we think about it, I just think that we obviously saw a meaningful movement in consumables and accelerated services, which we're certainly very happy about, and that benefit does help us on the margin front also. I think that in looking at our instrument business, we believe that it's going to remain soft throughout the year. We think Clearly, because we've taken up guidance a bit, we believe we're going to cover it with a combination of consumables and accelerator services. So we did a fair amount of instruments last year in Asia Pacific. We see that slowing down. There's definitely a macro effect there, and there's potentially softness within North America. So look at it as higher percentage mix of accelerator services, consumables, and lower percent on instruments pretty much throughout the year.
spk03: Great. Thank you.
spk00: Thank you so much. And there are no further questions at this time. All right. Well, thank you so much for joining today's conference call. You may now disconnect.
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