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spk12: Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Akoi Biosciences Incorporated third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a Q&A session. To ask a question during the session, you will need to press star 1-1 on your telephone keypad. If you wish to withdraw yourself from the queue, please press star 1-1 again. At this time, I'd like to turn the conference over to Mr. Priyam Shah. Mr. Shaw, you may begin.
spk16: Thank you, operator. And thank you to everyone who's joining us today on this call.
spk15: I'm Priyam Shah, head of investor relations at Acquire Biosciences. On the call today, we have Brian McKelligan, chief executive officer, and Johnny Eck, chief financial officer. Earlier today, Acquire released financial results for the third quarter and it's September 30th, 2023. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in the forward-looking statements. due to a variety of factors. For a list and description of the risks and uncertainties associated with the QIS business, please refer to the risks identified in our filings with the U.S. Securities and Exchange Commission, including in the risk factor section of our annual report on Form 10-K for the year ended December 31, 2022, filed on March 6, 2023, and subsequent filings with the SEC, including our quarterly report on Form 10-Q for the quarter ended September 30th, 2023 filed today, November 8th, 2023. We urge you to consider these factors and you should be aware that these statements are considered estimates only and are not a guarantee of future performance. This conference call contains time sensitive information and is accurate only as of the live broadcast today, November 8th, 2023. ACOIA disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. The audio portion of this call will be archived on the investor section of our website later today under the heading events. ACOIA plans to participate in several upcoming investor conferences, including the Stevens Investment Conference, the Canaccord Genuity MedTech and Diagnostics Forum, and the Piper Sandler Healthcare Conference. Details can be found under events on the investor section of our website. And with that, I'll now turn the call over to Brian.
spk22: Thank you, Prem, and good afternoon or evening to everyone. We appreciate you joining us today. During today's conference call, I will begin by giving you a broad overview of our performance in the third quarter. I will touch upon our business advancements and provide insights into the latest developments in our product offerings. Following that, Johnny will delve deeper into our financials and key business trends, and provide an outlook for the future of our business. Okoye had a strong third quarter in 2023, marked by several noteworthy achievements, including record-breaking revenue of $25.2 million, representing a strong 34% growth compared to the previous year. Gross profit was $15.3 million in the third quarter, representing a 40% growth over the prior year period, and gross margin has now grown to 60.6% for the third quarter. All of this was achieved while also contracting our operating expenses versus the prior year and quarter. Our ongoing efforts to leverage our cost structure to drive the business towards positive cash flow are well underway as we work to ensure that a more substantial portion of the expected revenue growth continues to fall to our bottom line. The cumulative install base now stands at 1,132 instruments, the largest in the field, and it's a testament to our team's commitment to scaling spatial biology workflows for our customers and setting the standard in the industry. ACOIA's consistent and sustained growth year after year and quarter after quarter since our IPO in the spring of 2021 can be attributed to our unwavering dedication delivering a top-tier portfolio of products that cover the entire spectrum of the spatial biology market, from biomarker discovery to translational research to clinical applications, all backed by a strong intellectual property portfolio. Our incremental investments moving forward are strategically targeted, allowing us to maintain operating expenses at a constant level while we continue to rapidly scale our footprint in spatial biology. We are pleased to report the continued expansion in peer-reviewed publications, now over 1,070 as of the end of the third quarter, a 55% increase in the prior year period. This volume of accelerating publications is a testament to the great science being done by our customers, and we expect this trend to continue. Recent highlights include a published study in the inaugural issue of Gen Biotechnology last month, detailing the powerful results of a study done by the team at the University of Queensland to comprehensively map the spatial proteome of head and neck squamous cell carcinoma using a panel of over 100 protein markers run on the phenocyclic fusion. Through this effort, these researchers have identified distinct immune and metabolic signatures to help advance the understanding of the heterogeneity of tumors and the mechanistic basis of variable clinical response. OCOIA is now at the forefront of ushering in the next era of spatial biology, or Spatial Biology 2.0, with a focus on delivering faster and more powerful solutions across more than 1,100 instruments in the field. Our R&D and operational efforts are now dedicated to further scaling our platforms by introducing significant workflow efficiencies, launching expanded panels and ready-to-use content, broadening our application menu, and expanding our range of partner software solutions. This holistic approach to delivering ongoing improvements to our platforms from sample to answer is transformative for our customers, driving further adoption and accelerating utilization of Akoya's solution. This Spatial Biology 2.0 initiative, announced at last week's Society for the Immunotherapy of Cancer Meaning, or CIPSI, in San Diego, is grounded in the following principles. First, spatial phenotyping with whole slide imaging at high throughput is a requirement, whether it's a discovery, translation, or a diagnostic application. Second, the time from sample to answer needs to be rapid. to support a researcher's ability to expeditiously complete their study. Whether it's a 50-sample discovery project or a 300-sample translational study, time matters. Sample processing times need to be minutes to hours, not days to weeks. Third, given the significant investment our customers are making, scientists expect a future-proof solution with frequent improvements and upgrades. Some specific examples of ACOIA's spatial biology 2.0 deliverables include the following. First, the recent rollout of the phenocycler fusion 2.0 field upgrade represents a significant milestone, setting a new industry standard on the speed of whole slide spatial phenotype. With this upgrade, customers can now process twice as many samples per week, establishing the phenocycler fusion as the highest throughput spatial discovery platform available in the market. Second, our PhenoImager HT 2.0 upgrade similarly represents a transformative enhancement, resulting in an astounding five-fold increase in workflow speed. One of the key new features of the HT 2.0 is its ability to perform real-time image analysis directly on the instrument. This not only expedites the sample-to-answer process, but also enhances the overall efficiency of the workflow. These instrument upgrades have been welcomed with great enthusiasm by our customers, and we expect the adoption to continue to accelerate. Coupling the integration of these 2.0 instrument upgrades with the COIA's ready-to-use phenocode-discovering signature panels provides an accelerated and streamlined solution. Akoya continues to expand its portfolio of phenocode panels, building on our existing content in oncology, immuno-oncology, and inflammation, while also expanding into new areas like neurobiology and preclinical animal models. Given the rapid expansion of commercial and open-source spatial biology software solutions, Akoya continues to prioritize our resources on delivering rapid, and real-time primary analysis for our customers and partnering with industry-leading third-party software providers for the downstream analysis. Our proprietary file compression algorithm and rapid image analysis deliver our data in a standardized format called QPTIF. This standardized data format delivers manageable data files compressed nearly 30-fold to tens of gigabytes and catalyzes the ability of third-party software providers to easily develop and support analysis of ACOYA-derived data sets. We have established partnerships with leading software providers, including Enable Medicine, VisioPharm, IndicaLabs, PathAI, OracleBIO, and open-source solutions like QPAP. The result is a comprehensive suite of desktop, cloud-based and open-source software solutions, ensuring that researchers have the flexibility to select the software solution that best aligns with their specific needs and requirements. At the CITSE conference last week that I already mentioned, ACOIA had a strong presence as we highlighted our Spatial Biology 2.0 initiatives. It was also clear that spatial phenotyping is gaining significant traction and is becoming central to both early and late stage clinical biomarker efforts, especially in the field of immuno-oncology. ACOIA has played a pioneering role in driving these efforts by offering a clinically platform that meets the stringent requirements of our biopharma partners, Precision Medicine and Companion Diagnostic Groups. Our Advanced Biopharma Solutions CLIA Lab in Marlborough or AVS, is increasingly focused on ladder stage high value projects. And we are confident in our ability to continue to meet the accelerating needs of the spatial biology clinical market. To expand and strengthen our clinical pipeline, ACOIA is actively leveraging the capabilities of our HT 2.0 workflow and cross-pollinating the best practices from our Advanced Biopharma Solutions CLIA Lab directly to our CRO partners. To date, we have expanded our rapidly growing Qualified Service Provider Network, which now includes 18 industry-leading CROs. With their direct promotion of ACOIA-based biomarker solutions, our platform adoption in more and more clinical studies is further amplified. On the operational front, Our focus is on supply chain simplification and manufacturing robustness and efficiency to meet the rapidly growing demand for our reagents. In parallel, we have a dedicated effort to drive meaningful margin improvements on these reagents as they become a larger percentage of our overall revenue year over year. This drives continued increase in our overall gross margin, which we anticipate being above 60% as we exit 2023. In summary, our strategic focus for the remainder of 2023 is centered on three key initiatives. First, enhancing applications and workflow efficiency as we usher in spatial biology 2.0, including system improvements and upgrades, expanding our phenocode menu of offerings, and driving increased pull-through of reagents on both the phenocycler fusion and phenol imager HT. Accelerating the clinical adoption with clinically directed workflow improvements, expanding late stage biomarker programs with our top tier biopharma through our ABS lab, and leveraging our growing network of CRO partners through our qualified service provider network to drive further adoption in the late translational and clinical markets. And third, driving operational excellence and financial sustainability by focusing on improving efficiencies and cost effectiveness and executing on targeted investments to support our strategic goals and working towards achieving cashflow positivity in 2025. And with that, I will turn the call over to Johnny to discuss our financial results. Johnny?
spk07: Thanks, Brian. As Brian highlighted, total revenue for the third quarter of 2023 was $25.2 million. a 34% growth compared to the same period in 2022. Our robust year-over-year growth was achieved globally across our diversified revenue channels and strong portfolio of products and services. Product revenue, including instruments, reagents, and software, totaled $18 million for the third quarter, representing 25% growth over the prior year period. Instrument revenue reached $12 million in the third quarter, representing a 27% growth over the prior year period. During the quarter, we sold 69 instruments, of which 27 were phenocyclers and 42 were from the PhenoImager portfolio. Our total installed base now stands at 1,132 instruments, which includes 327 phenocyclers and 805 PhenoImagers. A total of 209 fusion instruments have shipped since the full commercial launch at the start of 2022, and we now have a total installed base of 186 for the combined phenocycler fusion system, sold directly as a combined system or as an upgrade to standalone phenocycler instruments that previously utilized third-party microscopes. The majority of phenocyclers are being sold in combination with the fusion, And we expect this combination to drive increased reagent pull-through with an expanding menu of panels and faster workflows because of the ongoing 2.0 field upgrades. We project that approximately half the current installed base of phenocycler fusions and HTs will have upgraded to the 2.0 version by year-end. Reagent revenue reached $5.7 million in the third quarter, reflecting a 21% increase from the prior year period. The annualized third quarter reagent pull-through applicable to both the phenocycler and HG is now in the mid $30,000 range. This is a notable improvement compared to the annualized pull-through per instrument in 2022, which was in the low $30,000 range for both the phenocycler and the HG. This growth can be attributed to the increased utilization of phenocyclers paired with a fusion and a growing utility for HTs. As we continue to pair more fusions with phenocyclers, enhance our instruments through the 2.0 field upgrades with expanded workflow capabilities, and refine our operations planning and supply chain, we are strategically positioning reagents to play a more significant role in our revenue mix. as our customers increased their usage. Service and other revenue totaled $7.2 million for the quarter, an increase of 62% over the prior year period. Services have been a substantial growth segment for us as our install base and warranty revenue rapidly expand and as our lab services continue to drive additional higher scale studies. Gross profit was $15.3 million in the third quarter, representing a 40% growth over the prior year period, and gross margin was 60.6% for the third quarter. As we optimize our operations and leverage our manufacturing investments, we expect to further drive the expansion of our gross margins, which we project to be above 60% as we exit 2023. Operating expenses for the quarter totaled $26.8 million as compared to $27.6 million in the prior year period, indicative of a flattening or reduced spend pattern as we had previously indicated. Throughout 2023, we have had consecutive quarterly contraction in our spend while we continue our meaningful top line growth. As Brian highlighted, our efforts to leverage our cost structure to drive the business towards profitability are indeed well underway. We ended the quarter with approximately $78.6 million of cash and cash equivalents with the ability to draw an additional $11.3 million on our existing debt facility, bringing our total available capital to $89.8 million. Common shares outstanding and fully diluted shares including the impact of outstanding options and unvested restricted stock awards, are 49.1 million as of September 30, 2023. In summary, we are thrilled to report another exceptional quarter with record-breaking revenue of $25.2 million, marking a strong 34% growth over the prior year period. ACOIA's installed base has now reached 1,132 instruments, solidifying our position as the industry leader in spatial biology. Our strategic focus remains on the rapid expansion of our installed base while driving reagent revenue growth and increasing pull-through across our systems to realize the scalability of spatial biology. We've also implemented important organizational changes to enhance efficiency, drive gross margin improvement, and achieve cost advantages all while maintaining strong top line growth. As such, we are confident in our ability to sustain strong growth throughout 2023 and beyond while driving towards the goal of cash flow positivity in 2025. We are pleased to reaffirm our 2023 revenue guidance, range of $95 to $98 million, given the direction of our business and the favorable trends we are observing in the dynamic spatial biology market. Back to you, Brian.
spk22: Well, thank you, Johnny. We're pleased to report a strong quarter, and we look forward to executing on our strategic objectives throughout the remainder of the year as we drive the business towards positive cash flow. We're thankful for the hard work of our fellow dedicated Akoyans, as well as for the support of our customers and shareholders. Akoya remains well-positioned for growth, and we're excited about the opportunities that lie ahead as we deliver new spatial solutions from the discovery to the clinical markets. At this point, we'll turn the call over to the operator for questions. Operator?
spk12: Yes, sir. Ladies and gentlemen, if you have a question or comment at this time, please press star 1 1 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the pound key. Again, if you have a question or comment, please press star 1 1 on your telephone keypad. Please stand by while we compile the Q&A roster. Our first question or comment comes from the line of Tejas Savant from Morgan Stanley. Mr. Savant, your line is open.
spk03: Good evening, guys. This is Edmund. Thank you for the time. Hey, Edmund. Thank you. Hey, Brian. Just to start, on the 2.0 rollout progress, I think on the call you guys mentioned expect about 50% of both platforms to be upgraded by year end.
spk19: Yeah.
spk03: I recall you previously had noted that it would be a little faster for the imager because it's a software upgrade or something. Has there been any changes or what caused the change in expectation here?
spk22: I don't think there's any change. I think that's kind of what we had expected. It certainly could potentially accelerate. you know, approximately 50% across the board by year end. It's kind of what our expectations have been. So it's really in line with what we have planned.
spk03: Got it. And given the fact that the RNA chemistry isn't going to be capable until the customers have the 2.0 rollout, is it fair to assume that you won't be releasing anything that provides RNA context until next year? And if you could, could you provide some color on what this initial panel would look like? Would it be... I think, Brian, you've mentioned you plan on designing panels for more targeted experiments on the scale of 30 to 100 samples. So would it be more of a mid-plex range RNA co-detection capability?
spk22: So at a high level, Edmund, our objective is to look at RNA as an absolutely complementary analyte to our high-plex protein profiling. And then with respect to the details of the RNA rollout, We'll be providing some more specific announcements on our RNA strategy in the near future, so we're going to hold off on a little bit more detail at this point.
spk03: And then the final question. On the call, Brian, you mentioned some clinical-driven workflow improvements on DHT. Is that from the 2.0 rollout that's ongoing right now?
spk22: There's a couple of parts to that. It's a good question. Overwhelmingly, the 2.0 rollout really does simplify the primary informatic analysis by doing it in parallel having your data come off sort of ready for, you know, kind of what you call tertiary analysis, which is to get the meaning, the meaning of, you know, understand the sort of the value of your study. That's part one, and that's certainly, that workflow improvement is certainly meaningful. There's also some additional workflow improvements and expertise that's coming out of our partnership with Acrobon that we're going to be able to leverage as part of some of our forthcoming partnerships, and Some of those things include kind of reporting additional workflow improvements, reagents, et cetera. So those improvements are, I think, more second order but really clinically relevant and embedded within our conversations with many of our biopharma partners as we see our pipeline of opportunities and projects move farther and farther downstream.
spk02: Got it. Thank you for the time. Thank you, Edmund.
spk12: Thank you. Our next question or comment comes from the line of Lucas Baranowski from UBS. Mr. Baranowski, your line is now open.
spk08: Actually, from Sour Beer calling in. Thanks for taking the question and congrats on the quarter. Maybe just start off first on the gross margin. Sounds like, you know, 60% rate at city in the year. Just any color there on, you know, what is some of the puts and takes and the margin improvement and just, you know, thoughts on the path to us. positive cash flow.
spk07: Sure. As you saw, our Q3 results of 60.6% gross margin is really indicative of where we think the business is when we operate the way we've been preparing to do. We expect to see those improvements in the next year as we take advantage of initiatives that we're putting in place now to bring in-house some manufacturing capability, improve our supply chain, which drives efficiency. You'll recall in prior quarters, some of the headwind on gross margin was related to scrap and excess and yields and things like that. And so we're taking action on many of those items, which will allow our gross margin to improve over the next year or so, coupled with the fact that as our revenue mix changes, over time more to reagents, which are a higher margin product for us, that will supplement the cost efforts that we're putting in place as it relates to gross margin.
spk08: Thanks. And apologies, I was a little late joining the call, but I think last quarter you talked a little bit about some of the broader market demand, like China, maybe a pullback in some capital purchases. Just any updates there on thoughts on the market and just as you look out to the fourth quarter, even next year?
spk22: Yeah, it's a really good question. I think as we look across the market segments, you know, obviously, you know, a 34% growth year over year and, you know, a 31% growth full year to date. I think those are solid growth numbers. As we drill in a little bit, you know, it's really interesting to look at. The largest market for us really is the Americas. And that market, you know, year over year, We've been able to grow in the mid-40% range year over year in the Americas. EMEA is doing pretty strong at the mid-20%. Like others, APAC has been a challenge. That said, we've still been able to grow in mid-single digits in APAC, certainly well below our hope and expectations coming into the year. But given the strength in the Americas, the continued performance in the EMEA, and the ability of the APAC team to you know, to continue to get some growth out of that business. That's what's enabled us across the board to continue to grow, you know, this quarter at a 34% year over year.
spk23: Got it. Thanks for taking the question. Thanks, Lucas.
spk12: Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star 1-1 on your telephone keypad. Our next question or comment comes from the line of David Westenberg from Piper Sandler. Mr. Westenberg, your line is now open.
spk09: Hi, thanks for taking the questions. This is John on for Dave. So in the interest rate environment, do you feel that that's impacting any capital equipment, like the appetite for capital equipment? And considering that you have a more affordable platform, do you think that's helping you? Thank you.
spk22: I mean, certainly we're seeing more diligence around capital purchases. So there's a slight lengthening and visibility around platforms like ours. It hasn't gotten to a point where it's impacting our ability to perform. And I do think certainly the affordability of our platform certainly helps. I think the other way that we look at it is the meaningful throughput of our instruments really allows our customers, as you think about amortizing costs, over a number of samples per unit time. It's really helped our business, and that's particularly true as you look at groups, whether they're CROs or core labs or research-based CROs, that want to leverage our platforms as a business opportunity for them across multiple users. The fact that we can do, you know, 60, 80 samples a day, 300 samples a week on the HT, and 20 to 30 samples on the phenocycler fusion, That throughput coupled to the affordability and the amortization of samples per unit time has really allowed us to take those platforms and continue to grow in areas where it's being used as a service offering.
spk09: Got it. Thank you. And I'm aware that you're not giving any guidance towards 2024 revenues, but are there any other macro factors that we should consider when looking forward to that?
spk22: I don't think anything different than our peer group, just in terms of the macroeconomic environment. I just, I think for us, as we look to 24, you know, generally thematically, as Johnny alluded to, it's about really, you know, continuing to see, you know, solid top line growth while at the same time, we're really going to be holding our expenditures in 2024 at a level that's consistent with what you'll see at the second half. So I think we feel like in terms of our multi-year strategy to really forward invest in 21 and 22, to solidify our commercial team and portfolio. And then in the subsequent years, 23 and 24, continue that revenue growth while really holding our expenses and investing in gross margin. That really has been our plan. And it's certainly of magnified importance in this environment. And so we think that strategy will continue into 2024. So as you noted, while we're not getting specifically, again, still thematically, it's continued top line growth. with real eye towards expenditures equivalent in 24 to second half, to reiterate. John, anything to add to that?
spk07: No, I think that's exactly right. It's the three focus. It's continuing to grow revenue at a meaningful rate. It's improving gross margin, ratably through the year. And then it's continuing to hold OpEx at an appropriate rate, given the forward investment. And that's to your point. Not guiding for 24 yet, but it's how we look to the future. Those are critical.
spk06: critical areas of focus for us.
spk04: Got it. Thank you for your time.
spk06: Thank you.
spk12: Our next question or comment comes from the line of Rachel Vattensdahl from JP Morgan. Ms. Vattensdahl, your line is now open.
spk20: Hello. This is Martha on for Rachel from JP Morgan. Thank you for taking the question and congrats on the quarter. I just wanted to dig into your assumptions for 4Q. Maybe you can provide a little bit more color on the pollster and placement assumptions. And just to clarify, in light of the macro, are you assuming some sort of 4Q budget flush for 4Q?
spk22: Thank you. So, yeah, so right now, I think I heard your question. It's about 4Q, guidance on that, and budget flush. And while we explicitly don't guide on the fourth quarter, you know, like our typical seasonality, We do expect a top line step up in Q4 relative to Q3. Yeah, in terms of budget flush, it's a really good question. I think for us, obviously it's not a binary event where there's either a flush or not. I think for us, we're being fairly muted in our expectations of a meaningful freeing up of CapEx money amongst our customers and thinking this is gonna be sort of more of a typical step up similar dynamic in 2022 because I think the environment is similar. Johnny, want to add anything?
spk07: No, I think that's how we think of it. And the only thing I would add is, you know, as we reiterated guidance, you do math on Q4 and you get right into our guidance, which is where we expect for the full year.
spk20: Thank you. And then in terms of pricing this year, can you discuss how much you were able to raise pricing? What are your expectations for 24? And then are you seeing any pricing pressure from your competitors this year?
spk22: Yeah, I'd say like this fiscal year 23, it'll be a similar scale of price increase in 24. You know, taking into account, obviously, the economy and interest rates and, you know, what we think is a fair price increase. But I think it'll be within standard range. You know, nothing that's sort of an outlier. Johnny, you want to add anything to that?
spk07: No, I mean, I think, you know, with a high inflation environment, we're seeing, we expect to be able to get price increases that are what we've seen in prior years and appropriate. And we're not seeing meaningful pressure on price. I think that's part of your question is we're not seeing that in the field.
spk05: That's not a major, you know, a major item we're contending with.
spk00: Thank you.
spk12: Thank you. Our next question or comment comes from the line of Kyle Mixon from Canaccord Genuity. Mr. Mixon, your line is now open.
spk10: Yeah. Hey, guys. Thanks for taking the questions. Congrats on the quarter. Brian, can you kind of talk about, like, maybe update us on your push into the genomics market? Because, like, as we think – I mean, I remember, like, asking, like, a year ago or so, like, when you talked about RNA for the first time. you know, how has that gone so far? And are you going to really like kind of pull back and really lean more into, I guess, proteomics still? I mean, just how are you thinking about this whole multi-omic strategy as we look ahead in 2024?
spk22: Yeah, I think longer term, Kyle, it's still of absolute importance to have a multi-omic solution. I think for us, as we talked earlier, I think we really look at RNA as an absolute complementary analyte. And, you know, just as an example that we alluded to in the opening comments, you know, the recent publication in Gen Biotechnology and a lot of the discoveries that were able to be realized with 100 plex multinomic, I mean, 100 plex spatial proteomic study on the PCF and the immense value that was gotten out of that, it really does highlight how much discovery you can get out of spatial proteomics. And we're seeing, I think, a growing realization of that. As we look at RNA, it's absolutely a complementary approach where it's used to either look at translational, transcriptional-translational concordance or not, but probably more importantly, leveraging it to look at analytes where protein might not be the most ideal methodology. Still at a high level, Kyle, looking at it as a highly complementary approach, you know, still committed to it, but as noted earlier, we're going to give a little bit more color on the RNA strategy in the coming months.
spk10: Okay. Maybe just to clarify what I was asking was, you know, it's pretty noisy in that market today. Does it make sense to sort of pull back a bit, I guess, and just kind of focus on your red and butter?
spk22: The way I would characterize it is our number one priority is to continue to be great at our workflow, to deliver on the continued workflow improvement, workflow simplification, throughput, flexing, et cetera, and then layering in RNA as complementary. versus, you know, having RNA be the number one top priority. It's amongst the priorities getting towards a multi-omic solution.
spk10: Okay. That's super helpful. Don't need to go into so much detail there, but that was great. Maybe, I think you guys mentioned you're making efforts to achieve meaningful margin improvements for reagents. So that would be, that's something that we've been looking forward to for a while now, I feel like, you know, pull through, et cetera. Can you just kind of, you know, dive deeper into that and tell us what exactly you meant by that statement and what can we expect in the next, you know, a couple of quarters or a year or so that could really meaningfully improve margins as well as just consumables, you know, pull through and kind of like underlying margins for that business as well.
spk22: Yeah. So the two parts that obviously are compounding and more than additive, part one is enabling that higher throughput with the 2.0 releases with the continued rollout of additional phenocode panels, with the maturation and addition of additional software partners, you know, so that time to answer becomes faster and easier. That's sort of part one. And I think we sort of talked through all of the components of that. In fact, I just did. You know, the second part is in terms of improving reagent gross margins, you know, some of these, some of this includes rather than relying on external third parties and a chain of custody of third party suppliers amongst all the reagent components and antibody conjugations and fulfillment is beginning to take more control of that ourselves. And so that time from bill to customer shelf is shortened. And so is the amount of investment that we have to make both internally and externally to do that. So the overall cost of goods for an individual antibody or panel drops down while we simplify and streamline that supply chain, that chain of custody, and take on more of that manufacturing internally rather than relying on third parties, which is why we have an ISO 1345 facility and why we have that capability.
spk10: Awesome. If I could just squeeze another one in for Ipof. Maybe you could just talk about either qualitatively or quantitatively what percentage or what portion of the phenocycler kind of install base is using, you know,
spk22: standard or legacy microscopes rather than the fusion can i just be curious to hear that given the transition over the past couple years it's a good question it's a little bit over 40 that are still on third party um so if you look at you know the 330 still phenocyclers that are out there about 190 of them i'm rounding up a little bit about 190 of them have a um have a fusion attached to it So that's about the proportion, and we see as we go through next year, you know, almost every cycler that's sold is going with diffusion. So that's sort of part one. And then part two, we'll continue to upgrade those existing phenocycler third-party scopes throughout next year. So hopefully that gives you your answer.
spk11: Yeah, that was perfect. Thanks for the time, guys.
spk12: Thank you. Our next question or comment comes from the line of Timothy Chang from Capital One. Mr. Chang, your line is open.
spk25: Thanks. Hey, Brian, you know, just being at CITC last week, obviously you guys had a pretty big presence there. You know, you had a pretty well-attended reception as well. You know, how do you sort of leverage, you know, a big rollout of the Fusion 2.0 post the CITSE conference? I mean, did you guys get a lot of positive responses? Could you talk a little bit about that?
spk22: Yeah, I mean, there is huge positive response, not only at the booth, but also at some of the events that you might have been to, response to the poster publications. You know, I think simply the number one thing, Tim, that you get out of it is a high number of qualified leads amongst an audience that really is the most targeted customer base for our current platforms in the field of oncology, immuno-oncology. So, you know, the number one thing that you get out of it is high quality weeks. Obviously, the second benefit you get out of it, given that not only the massive increase in the size of that conference, but just our large presence, we get a lot more visibility. And with the rollout of both the 2.0 on the phenocyclic fusion and the HT point 2.0, that visibility is across multiple market segments, because there's researchers at CITC that are not only discovery researchers that have interest in the phenocyclic fusion, but absolutely translational and clinical companion diagnostic leaders in our market that have an absolute interest in the emerging clinical opportunities. So getting that visibility across that entire market continuum, I'd say, is the second biggest value.
spk25: And maybe just a follow-up question for Johnny. You know, obviously your gross margins are at 60% this quarter. And you mentioned some supply chain efficiencies that you're starting to benefit from. I mean, where can you get your gross margins down the road, Johnny?
spk07: So I think it's, as I mentioned, it's sort of comprised of several efforts that will evolve gross margin over time. Our first and sort of the quickest improvements to margin are on the cost supply chain, as Brian mentioned, the chain of custody of some of our reagents. Those things we can make moves there and have started making moves as you see this margin already improving that will drive margin, as I've sort of said in the past, a couple hundred basis points a year is sort of how we see margin moving. But as more and more long-term margin becomes revenue becomes more heavily weighted towards reagents, again, I think that margin continues to move north for the next several years, right? I mean, right now in the near term, it's cost initiatives as well as a revenue shift, but that becomes even more important as we fully leverage the 1,200 instruments we have in the field as that annuity or that pull-through increases per box That drives that margin improvement as well to something clearly north of the 60 that we're talking about now.
spk24: Okay. Got it. Thanks.
spk12: Thank you. Our next question or comment comes from the line of Mason Carrico from Stevens. Mr. Carrico, your line is now open.
spk13: Hey, guys. Thanks for the question. Sorry if these have already been asked. I'll ask two up front if that's all right. Sure. First, how are you thinking about the growth outlook for the services business going forward? Growth there has obviously been really strong this year. Is there anything that we should be taking into consideration when we're thinking about how to model that segment of your business next year? Or do you expect the demand and momentum that we've been seeing to really keep continuing?
spk22: Yeah, on the services front, you know, obviously we report that out, but don't guide it at that level of granularity. But I think I'd say qualitatively, there's two growth drivers to that service revenue. Obviously, the growing install base and warranty revenue. But, you know, some of the real material drivers, I think, as you're alluding to, are our current companion diagnostic partnerships and the continued expansion of our advanced biopharma solution service business. So, you know, we expect continued incremental growth across the services next year. The other thing I would say is, as I noted to in the commentary, we are increasingly working with our CRO partners through our qualified service provider network to really begin to leverage them as a partner and an amplifier in the translational and clinical research segments, given that we have a really solidified workflow at this point with the 2.0 and the reagents and some of the software improvements. So while we expect continued incremental growth in the services across the board from both of those contributors, warranty and lab services. We are also increasingly focused on taking those opportunities with our biopharma partners and turning those more into product revenue with our CRO partners while we have more shots ongoing, more clinical trials, giving us a higher and higher probability of more CDX opportunities that we will have in-house in 24 and beyond and And those CDX opportunities, I would say, Mason, really are upsides to the model. So took some liberties with your question on how it fits in strategically, but that's how we think about it.
spk13: No, that's helpful. And if I could take one more here. How is adoption of the FINA code panels trended, and how are you thinking about the timeline until when some of your higher utilization CRO customers could begin rolling those into regular use?
spk22: That's a really good question, and the latter part of your question is really our explicit strategy, and it's kind of embedded in our desire to build this qualified service provider network. Because we want to have that in place, because what we've talked about with our phenocode panels, whether the signature panels on the HT or the discovery panels on the phenocycler, those have sort of a rolling cycle release that we're really second half weighted and into 24. having that CRO network locked in, ready to grab those signature panels, having the systems upgrades on both of the two O's to leverage those panels to drive higher utilization. All of that does point to, as you're alluding to, you know, 2024 really as the realized year when we feel like those reagents are going to begin to contribute to the top line and continue that reagent revenue growth.
spk14: Thanks. That's helpful, Brian. Appreciate it.
spk12: Thank you. I'm sure no additional questions in the queue at this time. I'd like to turn the conference back over to Mr. McKelligan for any closing remarks.
spk22: Yeah, just very simply, I think to reiterate what both Johnny and I have said, you know, first and foremost, thank everybody for your time, your questions, your intention. And obviously, as we look forward to really reiterate our priorities, they're threefold. You know, number one is to continue to invest in our portfolio and that workflow. Continue to upgrade. The systems provide content and software solutions so that time to answer is both easier and faster. And that will help drive a growth in that reagent revenue portfolio, while at the same time, point number two, you know, we invest in our own operational excellence to get better margins out of those very reagents themselves and maintain our overall cost basis while we continue to go the top line, really securing our path to cash flow positivity. And number three, we really are seeing growing level of excitement in our later stage translational clinical partnerships and are growing increasingly confident in this real clinical opportunity. And so we'll look at that in the forthcoming years as real upside to our existing financial model that will really prove to the market that this clinical TAM is something real in the near term. Those are really the sort of the three legs of our growth strategy. And with that, I thank everybody for your time, and I look forward to seeing you all soon.
spk12: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day. Thank you. Thank you. Thank you. Thank you. Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Akoi Biosciences Incorporated third quarter 2023 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a Q&A session. To ask a question during the session, you will need to press star 1-1 on your telephone keypad. If you wish to withdraw yourself from the queue, please press star 1-1 again. At this time, I'd like to turn the conference over to Mr. Priyam Shah. Mr. Shaw, you may begin.
spk16: Thank you, Operator, and thank you to everyone who's joining us today on this call.
spk15: I'm Priyam Shah, Head of Investor Relations at Akoya Biosciences. On the call today, we have Brian McKelligan, Chief Executive Officer, and Johnny Eck, Chief Financial Officer. Earlier today, Akoya released financial results for the third quarter and it's September 30th, 2023. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in the forward-looking statements. due to a variety of factors. For a list and description of the risks and uncertainties associated with the QIS business, please refer to the risks identified in our filings with the U.S. Securities and Exchange Commission, including in the risk factor section of our annual report on Form 10-K for the year ended December 31, 2022, filed on March 6, 2023, and subsequent filings with the SEC, including our quarterly report on Form 10-Q for the quarter ended September 30th, 2023 filed today, November 8th, 2023. We urge you to consider these factors and you should be aware that these statements are considered estimates only and are not a guarantee of future performance. This conference call contains time sensitive information and is accurate only as of the live broadcast today, November 8th, 2023. ACOIA disclaims any intention or obligation except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. The audio portion of this call will be archived on the investor section of our website later today under the heading events. ACOIA plans to participate in several upcoming investor conferences, including the Stevens Investment Conference, the Canaccord Genuity MedTech and Diagnostics Forum, and the Piper Stamler Healthcare Conference. Details can be found under events on the investor section of our website. And with that, I'll now turn the call over to Brian.
spk22: Thank you, Prem, and good afternoon or evening to everyone. We appreciate you joining us today. During today's conference call, I will begin by giving you a broad overview of our performance in the third quarter. I will touch upon our business advancements and provide insights into the latest developments in our product offerings. Following that, Johnny will delve deeper into our financials and key business trends, and provide an outlook for the future of our business. Okoye had a strong third quarter in 2023, marked by several noteworthy achievements, including record-breaking revenue of $25.2 million, representing a strong 34% growth compared to the previous year. Gross profit was $15.3 million in the third quarter, representing a 40% growth over the prior year period, and gross margin has now grown to 60.6% for the third quarter. All of this was achieved while also contracting our operating expenses versus the prior year and quarter. Our ongoing efforts to leverage our cost structure to drive the business towards positive cash flow are well underway as we work to ensure that a more substantial portion of the expected revenue growth continues to fall to our bottom line. The cumulative install base now stands at 1,132 instruments, the largest in the field, and it's a testament to our team's commitment to scaling spatial biology workflows for our customers and setting the standard in the industry. ACOIA's consistent and sustained growth year after year and quarter after quarter since our IPO in the spring of 2021 can be attributed to our unwavering dedication delivering a top-tier portfolio of products that cover the entire spectrum of the spatial biology market, from biomarker discovery to translational research to clinical applications, all backed by a strong intellectual property portfolio. Our incremental investments moving forward are strategically targeted, allowing us to maintain operating expenses at a constant level while we continue to rapidly scale our footprint in spatial biology. We are pleased to report the continued expansion in peer-reviewed publications, now over 1,070 as of the end of the third quarter, a 55% increase in the prior year period. This volume of accelerating publications is a testament to the great science being done by our customers, and we expect this trend to continue. Recent highlights include a published study in the inaugural issue of Gen Biotechnology last month, detailing the powerful results of a study done by the team at the University of Queensland to comprehensively map the spatial proteome of head and neck squamous cell carcinoma using a panel of over 100 protein markers run on the phenocyclic fusion. Through this effort, these researchers have identified distinct immune and metabolic signatures to help advance the understanding of the heterogeneity of tumors and the mechanistic basis of variable clinical response. OCOIA is now at the forefront of ushering in the next era of spatial biology, or Spatial Biology 2.0, with a focus on delivering faster and more powerful solutions across more than 1,100 instruments in the field. Our R&D and operational efforts are now dedicated to further scaling our platforms by introducing significant workflow efficiencies, launching expanded panels and ready-to-use content, broadening our application menu, and expanding our range of partner software solutions. This holistic approach to delivering ongoing improvements to our platforms from sample to answer is transformative for our customers, driving further adoption and accelerating utilization of Akoya's solution. This spatial biology 2.0 initiative, announced at last week's Society for the Immunotherapy of Cancer Meaning, or CIPSI, in Cienega, is grounded in the following principles. First, spatial phenotyping with whole slide imaging at high throughput is a requirement, whether it's a discovery, translation, or a diagnostic application. Second, the time from sample to answer needs to be rapid. to support a researcher's ability to expeditiously complete their study. Whether it's a 50-sample discovery project or a 300-sample translational study, time matters. Sample processing times need to be minutes to hours, not days to weeks. Third, given the significant investment our customers are making, scientists expect a future-proof solution with frequent improvements and upgrades. Some specific examples of ACOIA's spatial biology 2.0 deliverables include the following. First, the recent rollout of the phenocycler fusion 2.0 field upgrade represents a significant milestone, setting a new industry standard on the speed of whole slide spatial phenotype. With this upgrade, customers can now process twice as many samples per week, establishing the phenocycler fusion as the highest throughput spatial discovery platform available in the market. Second, our PhenoImager HT 2.0 upgrade similarly represents a transformative enhancement, resulting in an astounding five-fold increase in workflow speed. One of the key new features of the HT 2.0 is its ability to perform real-time image analysis directly on the instrument. This not only expedites the sample-to-answer process, but also enhances the overall efficiency of the workflow. These instrument upgrades have been welcomed with great enthusiasm by our customers, and we expect the adoption to continue to accelerate. Coupling the integration of these 2.0 instrument upgrades with ACOIA's ready-to-use phenocode-discovering signature panels provides an accelerated and streamlined solution. ACOIA continues to expand its portfolio of phenocode panels, building on their existing content in oncology, immuno-oncology, and inflammation, while also expanding into new areas like neurobiology and preclinical animal models. Given the rapid expansion of commercial and open-source spatial biology software solutions, ACOIA continues to prioritize our resources on delivering rapid, and real-time primary analysis for our customers and partnering with industry-leading third-party software providers for the downstream analysis. Our proprietary file compression algorithm and rapid image analysis deliver our data in a standardized format called QPTIF. This standardized data format delivers manageable data files compressed nearly 30-fold to tens of gigabytes and catalyzes the ability of third-party software providers to easily develop and support analysis of ACOIA-derived data sets. We have established partnerships with leading software providers, including Enable Medicine, Visiopharm, IndicaLabs, PathAI, OracleBIO, and open-source solutions like QPAP. The result is a comprehensive suite of desktop, cloud-based and open-source software solutions, ensuring that researchers have the flexibility to select the software solution that best aligns with their specific needs and requirements. At the CIPSI conference last week that I already mentioned, ACOIA had a strong presence as we highlighted our Spatial Biology 2.0 initiatives. It was also clear that spatial phenotyping is gaining significant traction and is becoming central to both early and late stage clinical biomarker efforts, especially in the field of immuno-oncology. ACOIA has played a pioneering role in driving these efforts by offering a clinically platform that meets the stringent requirements of our biopharma partners, Precision Medicine and Companion Diagnostic Groups. Our Advanced Biopharma Solutions CLIA Lab in Marlborough or AVS, is increasingly focused on ladder stage high value projects. And we are confident in our ability to continue to meet the accelerating needs of the spatial biology clinical market. To expand and strengthen our clinical pipeline, ACOIA is actively leveraging the capabilities of our HT 2.0 workflow and cross-pollinating the best practices from our Advanced Biopharma Solutions CLIA Lab directly to our CRO partners. To date, we have expanded our rapidly growing Qualified Service Provider Network, which now includes 18 industry-leading CROs. With their direct promotion of ACOIA-based biomarker solutions, our platform adoption in more and more clinical studies is further amplified. On the operational front, Our focus is on supply chain simplification and manufacturing robustness and efficiency to meet the rapidly growing demand for our reagents. In parallel, we have a dedicated effort to drive meaningful margin improvements on these reagents as they become a larger percentage of our overall revenue year over year. This drives continued increase in our overall gross margin, which we anticipate being above 60% as we exit 2023. In summary, our strategic focus for the remainder of 2023 is centered on three key initiatives. First, enhancing applications and workflow efficiency as we usher in spatial biology 2.0, including system improvements and upgrades, expanding our phenocode menu of offerings, and driving increased pull-through of reagents on both the phenocycler fusion and phenol imager HT. Accelerating the clinical adoption with clinically directed workflow improvements. Expanding late stage biomarker programs with our top tier biopharma through our AVS lab. And leveraging our growing network of CRO partners through our qualified service provider network to drive further adoption in the late translational and clinical markets. And third, driving operational excellence and financial sustainability by focusing on improving efficiencies and cost effectiveness and executing on targeted investments to support our strategic goals and working towards achieving cash flow positivity in 2025. And with that, I will turn the call over to Johnny to discuss our financial results. Johnny?
spk07: Thanks, Brian. As Brian highlighted, total revenue for the third quarter of 2023 was $25.2 million. a 34% growth compared to the same period in 2022. Our robust year-over-year growth was achieved globally across our diversified revenue channels and strong portfolio of products and services. Product revenue, including instruments, reagents, and software, totaled $18 million for the third quarter, representing 25% growth over the prior year period. Instrument revenue reached $12 million in the third quarter, representing a 27% growth over the prior year period. During the quarter, we sold 69 instruments, of which 27 were phenocyclers and 42 were from the PhenoImager portfolio. Our total installed base now stands at 1,132 instruments, which includes 327 phenocyclers and 805 PhenoImagers. A total of 209 fusion instruments have shipped since the full commercial launch at the start of 2022, and we now have a total installed base of 186 for the combined phenocycler fusion system, sold directly as a combined system or as an upgrade to standalone phenocycler instruments that previously utilized third-party microscopes. The majority of phenocyclers are being sold in combination with the fusion, And we expect this combination to drive increased reagent pull through with an expanding menu of panels and faster workflows because of the ongoing 2.0 field upgrades. We project that approximately half the current installed base of phenocycler fusions and HTs will have upgraded to the 2.0 version by year end. Reagent revenue reached $5.7 million in the third quarter, reflecting a 21% increase from the prior year period. The annualized third quarter reagent pull-through applicable to both the phenocycler and HG is now in the mid $30,000 range. This is a notable improvement compared to the annualized pull-through per instrument in 2022, which was in the low $30,000 range for both the phenocycler and the HG. This growth can be attributed to the increased utilization of phenocyclers paired with a fusion and a growing utility for HTs. As we continue to pair more fusions with phenocyclers, enhance our instruments through the 2.0 field upgrades with expanded workflow capabilities, and refine our operations planning and supply chain, we are strategically positioning reagents to play a more significant role in our revenue mix. as our customers increase their usage. Service and other revenue totaled $7.2 million for the quarter, an increase of 62% over the prior year period. Services have been a substantial growth segment for us as our install base and warranty revenue rapidly expand and as our lab services continue to drive additional higher scale studies. Gross profit was $15.3 million in the third quarter, representing a 40% growth over the prior year period, and gross margin was 60.6% for the third quarter. As we optimize our operations and leverage our manufacturing investments, we expect to further drive the expansion of our gross margins, which we project to be above 60% as we exit 2023. Operating expenses for the quarter totaled $26.8 million as compared to $27.6 million in the prior year period, indicative of a flattening or reduced spend pattern as we had previously indicated. Throughout 2023, we have had consecutive quarterly contraction in our spend while we continue our meaningful top line growth. As Brian highlighted, our efforts to leverage our cost structure to drive the business towards profitability are indeed well underway. We ended the quarter with approximately $78.6 million of cash and cash equivalents, with the ability to draw an additional $11.3 million on our existing debt facility, bringing our total available capital to $89.8 million. Common shares outstanding and fully diluted shares including the impact of outstanding options and unvested restricted stock awards, are 49.1 million as of September 30, 2023. In summary, we are thrilled to report another exceptional quarter with record-breaking revenue of $25.2 million, marking a strong 34% growth over the prior year period. ACOIA's installed base has now reached 1,132 instruments, solidifying our position as the industry leader in spatial biology. Our strategic focus remains on the rapid expansion of our installed base while driving reagent revenue growth and increasing pull-through across our systems to realize the scalability of spatial biology. We've also implemented important organizational changes to enhance efficiency, drive gross margin improvement, and achieve cost advantages all while maintaining strong top line growth. As such, we are confident in our ability to sustain strong growth throughout 2023 and beyond while driving towards the goal of cash flow positivity in 2025. We are pleased to reaffirm our 2023 revenue guidance, range of $95 to $98 million, given the direction of our business and the favorable trends we are observing in the dynamic spatial biology market. Back to you, Brian.
spk22: Well, thank you, Johnny. We're pleased to report a strong quarter, and we look forward to executing on our strategic objectives throughout the remainder of the year as we drive the business towards positive cash flow. We're thankful for the hard work of our fellow dedicated Akoyans, as well as for the support of our customers and shareholders. Akoya remains well-positioned for growth, and we're excited about the opportunities that lie ahead as we deliver new spatial solutions from the discovery to the clinical markets. At this point, we'll turn the call over to the operator for questions. Operator?
spk12: Yes, sir. Ladies and gentlemen, if you have a question or comment at this time, please press star 1 1 on your telephone keypad. If your question has been answered or you wish to remove yourself from the queue, simply press the pound key. Again, if you have a question or comment, please press star 1 1 on your telephone keypad. Please stand by while we compile the Q&A roster. Our first question or comment comes from the line of Tejas Savant from Morgan Stanley. Mr. Savant, your line is open.
spk03: Good evening, guys. This is Edmund. Thank you for the time. Hey, Edmund. Thank you. Hey, Brian. Just to start, on the 2.0 rollout progress, I think on the call you guys mentioned expect about 50% of both platforms to be upgraded by year end. Yeah, I recall previously had noted that it would be a little faster for the imager because it's a software upgrade or something. Has there been any changes or what caused the change in expectation here?
spk22: I don't I don't I don't think there's any change. I think that's that's kind of what we had expected. It certainly could potentially accelerate. So, you know, approximately 50% across the board by year end is kind of what our expectations have been. So it's really in line with what we we have planned.
spk03: Got it. And given the fact that the RNA chemistry isn't going to be capable until the customers have the 2.0 rollout, is it fair to assume that you won't be releasing anything that provides RNA context until next year? And if you could, could you provide some color on what this initial panel would look like? Would it be, I think, Brian, you've mentioned you plan on designing panels for more targeted experiments on the scale of 30 to 100 samples. So would it be more of a mid-plex range RNA co-detection capability?
spk22: So at a high level, Edmund, our objective is to look at RNA as an absolutely complementary analyte to our high-plex protein profiling. And then with respect to the details of the RNA rollout, we'll be providing some more specific announcements on our RNA strategy in the near future. So we're going to hold off on a little bit more detail at this point.
spk03: And then the final question. On the call, Brian, you mentioned some clinical-driven workflow improvements on DHT. Is that from the 2.0 rollout that's ongoing right now?
spk22: There's a couple of parts to that. It's a good question. Overwhelmingly, the 2.0 rollout really does simplify the primary informatic analysis by doing it in parallel, having your data come off sort of ready for kind of what you call tertiary analysis, which is to get the meetings. the meaning of, you know, understand the sort of the value of your study. That's part one, and that's certainly, that workflow improvement is certainly meaningful. There's also some additional workflow improvements and expertise that's coming out of our partnership with Akravan that we're going to be able to leverage as part of some of our forthcoming partnerships. And some of those things include kind of reporting additional workflow improvements, reagents, et cetera. So that, those are, Those improvements are, I think, more second order, but really clinically relevant and embedded within our conversations with many of our biopharma partners as we see our pipeline of opportunities and projects move farther and farther downstream.
spk02: Got it. Thank you for the time. Thank you, Edmund.
spk12: Thank you. Our next question or comment comes from the line of Lucas Baranowski from UBS. Mr. Baranowski, your line is now open.
spk08: Actually, Sour Beer calling in. Thanks for taking the question and congrats on the quarter. Maybe just start off first on the gross margin. Sounds like, you know, 60% rate by city in the year. Just any color there on, you know, some of the puts and takes and the margin improvement and just, you know, thoughts on the path to a positive cash flow.
spk22: Yeah, John, you want to take that?
spk08: Sure.
spk07: Yeah, as you saw, our Q3 results of 60.6% gross margin is really indicative of where we think the business is when we operate the way we've been preparing to do. We expect to see those improvements in the next year as we take advantage of initiatives that we're putting in place now to bring in-house some manufacturing capability, improve our supply chain, which drives efficiency to You'll recall in prior quarters, some of the headwind on gross margin was related to scrap and excess and yields and things like that. And so we're taking action on many of those items, which will allow our gross margin to improve over the next year or so, coupled with the fact that as our revenue mix changes over time more to reagents, which are a higher margin product for us, that will supplement the cost efforts that we're putting in place as it relates to gross margin.
spk08: Thanks. And, you know, apologies, I was a little late joining the call, but, you know, I think last quarter you talked a little bit about some of the, you know, the broader market demand, like China, maybe a pullback in some capital purchases, just any updates there on thoughts on the market and just, you know, as you look out to the fourth quarter, even next year.
spk22: Yeah, it's a really good question. I think as we look across the market segments, you know, obviously, you know, a 34% growth year over year and, you know, a, 31% growth full year to date. I think those are solid growth numbers. As we drill in a little bit, it's really interesting to look at the largest market for us really is the Americas. And that market year over year, we've been able to grow in the mid 40% range year over year in the Americas. EMEA is doing pretty strong at the mid 20%. Like others, APAC has been a challenge That said, we've still been able to grow in mid-single digits in APAC, certainly well below our hope and expectations coming into the year. But given the strength in the Americas, the continued performance in the EMEA, and the ability of the APAC team to continue to get some growth out of that business, that's what's enabled us across the board to continue to grow this quarter at 34% year over year.
spk23: Got it. Thanks for taking the question. Thanks, Lucas.
spk12: Thank you. Again, ladies and gentlemen, if you have a question or comment at this time, please press star 1-1 on your telephone keypad. Our next question or comment comes from the line of David Westenberg from Piper Sandler. Mr. Westenberg, your line is now open.
spk09: Hi, thanks for taking the questions. This is John on for Dave. So in the interest rate environment, do you feel that that's impacting any capital equipment, like the appetite for capital equipment? And considering that you have a more affordable platform, do you think that's helping you?
spk22: Thank you. I mean, I certainly we're seeing more diligence around capital purchases. So there's a slight lengthening and visibility around around platforms like ours. It hasn't gotten to a point where it's impacting our ability to perform. And I do think certainly the affordability of our platform certainly helps. I think the other way that we look at it is the meaningful throughput of our instruments really allows our customers, as you think about amortizing costs over a number of samples per unit time, it's really helped our business. And that's particularly true as you look at groups, whether they're CROs or core labs or research-based CROs that want to leverage our platforms as a business opportunity for them across multiple users. The fact that we can do 60, 80 samples a day, 300 samples a week on the HT, and 20 to 30 samples on the phenocycler fusion, that throughput coupled to the affordability and the amortization of samples per unit time has really allowed us to take those platforms and continue to grow in areas where it's being used as a service offering.
spk09: Got it. Thank you. And I'm aware that you're not getting... any guidance towards 2024 revenues. But are there any other macro factors that we should consider when looking forward to that?
spk22: I don't think anything different than our peer group, just in terms of the macroeconomic environment. I just I think for us, as we look to 24, you know, generally thematically, as Johnny alluded to, it's about really, you know, continuing to see, you know, solid top line growth, while at the same time, we're really going to be holding our expenditures in 2024 at a level that's consistent with what you'll see at the second half. So I think we feel like in terms of our multi-year strategy to really forward invest in 21 and 22 to solidify our commercial team and portfolio. And then in the subsequent years, 23 and 24, continue that revenue growth while really holding our expenses and investing in gross margin. That really has been our plan. And it's certainly of magnified importance in this environment. And so we think that strategy will continue into 2024. So as you noted, while we're not getting specifically, again, still thematically, it's continued top line growth with, you know, real eye towards expenditures equivalent in 24 to second half to reiterate. John, anything to add to that?
spk07: No, I think that's exactly right. It's the three focus. It's continuing to grow revenue at a meaningful rate. It's improving gross margin ratably through the year. and then it's continue to hold OpEx at an appropriate rate given the forward investment. And that's to your point, not guiding for 24 yet, but it's how we look to the future. Those are our critical areas of focus for us.
spk04: Got it. Thank you for your time.
spk06: Thank you.
spk12: Our next question or comment comes from the line of Rachel Vattensdahl from JP Morgan. Ms. Vattensdahl, your line is now open.
spk20: Hello, this is Martha on for Rachel from JPMorgan. Thank you for taking the question and congrats on the quarter. Just wanted to dig into your assumptions for 4Q. Maybe you can provide a little bit more color on the pollster and placements assumptions. And just to clarify, in light of the macro, are you assuming some sort of 4Q budget flush for 4Q?
spk22: Thank you. Yeah, so right now, I think I heard your question. Is there that 4Q guidance on that and budget flush? And While we explicitly don't guide on the fourth quarter, you know, like our typical seasonality, we do expect, you know, a top line step up in Q4 relative to Q3. Yeah, in terms of budget flush, it's a really good question. I think for us, you know, this, it's not, obviously, it's not a binary event where there's either a flush or not. I think for us, we're being fairly muted in our expectations of a meaningful freeing up of CapEx money amongst our customers. And thinking this is going to be sort of more of a typical step up, similar dynamic in 2022, because I think the environment is similar. Johnny, want to add anything?
spk07: No, I think that's how we think of it. And the only thing I would add is, you know, as we reiterated guidance, you do math on Q4, and you get right into our guidance, which is where we expect for the full year.
spk20: Thank you. And then in terms of pricing this year, can you discuss how much you were able to raise pricing? What are your expectations for 24? And then are you seeing any pricing pressure from your competitors this year?
spk22: Yeah, I'd say like this fiscal year 23, it'll be a similar scale of price increase in 24. You know, taking into account, obviously, the economy and interest rates and, you know, what we think is a fair price increase. But I think it'll be within standard range. You know, nothing that's sort of an outlier. Johnny, want to add anything to that?
spk07: No, I mean, I think, you know, with the high inflation environment we're seeing, we expect to be able to get price increases that are what we've seen in prior years and appropriate. And we're not seeing meaningful pressure on price. I think that's part of your question is we're not seeing that in the field.
spk05: That's not a major, you know, a major item we're contending with.
spk00: Thank you.
spk12: Thank you. Our next question or comment comes from the line of Kyle Mixon from Canaccord Genuity. Mr. Mixon, your line is now open.
spk10: Yeah. Hey, guys. Thanks for taking the questions. Congrats on the quarter. Brian, can you kind of talk about, like, maybe update us on your push into the genomics market? Because, like, as we think – I mean, I remember, like, asking, like, a year ago or so, like, when you talked about RNA for the first time. you know, how has that gone so far? And are you going to really like kind of pull back and really lean more into, I guess, proteomics still? I mean, just how are you thinking about this whole multi-omic strategy as we look ahead in 2024?
spk22: Yeah, I think longer term, Kyle, it's still of absolute importance to have a multi-omic solution. I think for us, as we talked earlier, I think we really look at RNA as an absolute complementary analyte. And, you know, just as an example that we alluded to in the opening comments, you know, the recent publication in Gen Biotechnology and a lot of the discoveries that were able to be realized with 100 plex multinomic, I mean, 100 plex spatial proteomic study on the PCF and the immense value that was gotten out of that, it really does highlight how much discovery you can get out of spatial proteomics. And we're seeing, I think, a growing realization of that. As we look at RNA, it's absolutely a complementary approach where it's used to either look at translational, transcriptional-translational concordance or not, but probably more importantly, leveraging it to look at analytes where protein might not be the most ideal methodology. Still at a high level, Kyle, looking at it as a highly complementary approach, you know, still committed to it, but as noted earlier, we're going to give a little bit more color on the RNA strategy in the coming months.
spk10: Okay. Maybe just to clarify what I was asking was, you know, it's pretty noisy in that market today. Does it make sense to sort of pull back a bit, I guess, and just kind of focus on your red and butter?
spk22: The way I would characterize it is our number one priority is to continue to be great at our workflow, to deliver on the continued workflow improvement, workflow simplification, throughput, flexing, et cetera, and then layering in RNA as complementary. versus, you know, having RNA be the number one top priority. It's amongst the priorities getting towards a multi-omic solution.
spk10: Okay, that's super helpful. Don't need to go into so much detail there, but that was great. Maybe, I think you guys mentioned you're making efforts to achieve meaningful margin improvements for reagents. So that would be, that's something that we've been looking forward to for a while now, I feel like, you know, pull through, et cetera. Can you just kind of, you know, dive deeper into that and tell us what exactly you meant by that statement and what can we expect in the next, you know, a couple of quarters or a year or so that could really meaningfully improve margins as well as just consumables, you know, pull through and kind of what underlying margins for that business as well.
spk22: Yeah. So the two parts that obviously are compounding and more than additive, part one is enabling that higher throughput with the 2.0 releases with the continued rollout of additional phenocode panels, with the maturation and addition of additional software partners, you know, so that time to answer becomes faster and easier. That's sort of part one. And I think we sort of talked through all of the components of that. In fact, I just did. You know, the second part is in terms of improving reagent gross margins, you know, some of these, some of this includes rather than relying on external third parties and a chain of custody of third party suppliers amongst all the reagent components and antibody conjugations and fulfillment is beginning to take more control of that ourselves. And so that time from bill to customer shelf is shortened. And so is the amount of investment that we have to make both internally and externally to do that. So the overall cost of goods for an individual antibody or panel drops down while we simplify and streamline that supply chain, that chain of custody, and take on more of that manufacturing internally rather than relying on third parties, which is why we have an ISO 1345 facility and why we have that capability.
spk10: Awesome. If I could just squeeze another one in for Ipof. Maybe you could just talk about either qualitatively or quantitatively what percentage or what portion of the phenocycler kind of install base is using, you know,
spk22: standard or legacy microscopes rather than the fusion can i just be curious to hear that given the transition over the past couple years it's a good question it's a little bit over 40 that are still on third party um so if you look at you know the 330 still phenocyclers that are out there about 190 of them i'm rounding up a little bit about 190 of them have a um have a fusion attached to it So that's about the proportion, and we see as we go through next year, you know, almost every cycler that's sold is going with diffusion. So that's sort of part one. And then part two, we'll continue to upgrade those existing phenocycler third-party scopes throughout next year. So hopefully that gives you your answer.
spk11: Yeah, that was perfect. Thanks for the time, guys.
spk12: Thank you. Our next question or comment comes from the line of Timothy Chang from Capital One. Mr. Chang, your line is open.
spk25: Thanks. Hey, Brian, you know, just being at CITC last week, you know, obviously you guys had a pretty big presence there. You know, you had a pretty well-attended reception as well. You know, how do you sort of leverage, you know, a big rollout of the Fusion 2.0 post the CITSE conference? I mean, did you guys get a lot of positive responses? Could you talk a little bit about that?
spk22: Yeah, I mean, there is huge positive response, not only at the booth, but also at some of the events that you might have been to, response to the poster publications. You know, I think simply the number one thing, Tim, that you get out of it is a high number of qualified leads amongst an audience that really is the most targeted customer base for our current platforms in the field of oncology, immuno-oncology. So, you know, the number one thing that you get out of it is high quality weeks. Obviously, the second benefit you get out of it, given that not only the massive increase in the size of that conference, but just our large presence, we get a lot more visibility. And with the rollout of both the 2.0 on the phenocyclic fusion and the HT point 2.0, that visibility is across multiple market segments, because there's researchers at CITC that are not only discovery researchers that have interest in the phenocyclic fusion, but absolutely translational and clinical companion diagnostic leaders in our market that have an absolute interest in the emerging clinical opportunities. So getting that visibility across that entire market continuum, I'd say, is the second biggest value.
spk25: And maybe just a follow-up question for Johnny. You know, obviously your gross margins are at 60% this quarter. And you mentioned some supply chain efficiencies that you're starting to benefit from. I mean, where can you get your gross margins down the road, Johnny?
spk07: So I think it's, as I mentioned, it's sort of comprised of several efforts that will evolve gross margin over time. Our first and sort of the quickest improvements to margin are on the cost supply chain, as Brian mentioned, the chain of custody of some of our reagents. Those things, we can make moves there and have started making moves as you see this margin already improving that will drive margin, as I've sort of said in the past, a couple hundred basis points a year is sort of how we see margin moving. But as more and more long-term margin becomes revenue becomes more heavily weighted towards reagents, again, I think that margin continues to move north for the next several years, right? I mean, right now in the near term, it's cost initiatives as well as a revenue shift, but that becomes even more important as we fully leverage the 1,200 instruments we have in the field as that annuity or that pull-through increases per box That drives that margin improvement as well to something clearly north of the 60 that we're talking about now.
spk24: Okay. Got it. Thanks.
spk12: Thank you. Our next question or comment comes from the line of Mason Carrico from Stevens. Mr. Carrico, your line is now open.
spk13: Hey, guys. Thanks for the question. Sorry if these have already been asked. I'll ask two up front if that's all right. Sure. First, how are you thinking about the growth outlook for the services business going forward? Growth there has obviously been really strong this year. Is there anything that we should be taking into consideration when we're thinking about how to model that segment of your business next year? Or do you expect the demand and momentum that we've been seeing to really keep continuing?
spk22: Yeah, on the services front, you know, obviously we report that out, but don't guide it at that level of granularity. But I think I'd say qualitatively, there's two growth drivers to that service revenue. Obviously, the growing install base and warranty revenue. But, you know, some of the real material drivers, I think, as you're alluding to, are our current companion diagnostic partnerships and the continued expansion of our advanced biopharma solution service business. So, you know, we expect continued incremental growth across the services next year. The other thing I would say is, as I noted to in the commentary, we are increasingly working with our CRO partners through our qualified service provider network to really begin to leverage them as a partner and an amplifier in the translational and clinical research segments, given that we have a really solidified workflow at this point with the 2.0 and the reagents and some of the software improvements. So while we expect continued incremental growth in the services across the board from both of those contributors, warranty and lab services. We are also increasingly focused on taking those opportunities with our biopharma partners and turning those more into product revenue with our CRO partners while we have more shots ongoing, more clinical trials, giving us higher and higher probability of more CDX opportunities that we will have in-house in 24 and beyond and And those CDX opportunities, I would say, Mason, really are upsides to the model. So took some liberties with your question on how it fits in strategically, but that's how we think about it.
spk13: No, that's helpful. And if I could take one more here. How is adoption of the FINA code panels trended, and how are you thinking about the timeline until when some of your higher utilization CRO customers could begin rolling those into regular use?
spk22: That's a really good question, and the latter part of your question is really our explicit strategy, and it's kind of embedded in our desire to build this qualified service provider network. Because we want to have that in place, because what we've talked about with our phenocode panels, whether the signature panels on the HT or the discovery panels on the phenocycler, those have sort of a rolling cycle release that we're really second half weighted and into 24. having that CRO network locked in, ready to grab those signature panels, having the systems upgrades on both of the two O's to leverage those panels to drive higher utilization. All of that does point to, as you're alluding to, you know, 2024 really as the realized year when we feel like those reagents are going to begin to contribute to the top line and continue that reagent revenue growth.
spk14: Thanks. That's helpful, Brian. Appreciate it.
spk12: Thank you. I'm sure no additional questions in the queue. At this time, I'd like to turn the conference back over to Mr. McKelligan for any closing remarks.
spk22: Yeah, just very simply, I think to reiterate what both Johnny and I have said, you know, first and foremost, thank everybody for your time, your questions, your intention. And obviously, as we look forward to really reiterate our priorities, they're threefold. You know, number one is to continue to invest in our portfolio and that workflow. Continue to upgrade. The systems provide content and software solutions so that time to answer is both easier and faster. And that will help drive a growth in that reagent revenue portfolio, while at the same time, point number two, you know, we invest in our own operational excellence to get better margins out of those very reagents themselves and maintain our overall cost basis while we continue to go the top line, really securing our path to cash flow positivity. And number three, we really are seeing growing level of excitement in our later stage translational clinical partnerships and are growing increasingly confident in this real clinical opportunity. And so we'll look at that in the forthcoming years as real upside to our existing financial model that will really prove to the market that this clinical TAM is something real in the near term. Those are really the sort of the three legs of our growth strategy. And with that, I thank everybody for your time, and I look forward to seeing you all soon.
spk12: Ladies and gentlemen, thank you for participating in today's conference. This concludes the program. You may now disconnect. Everyone, have a wonderful day.
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