Akoya Biosciences, Inc. (NASDAQ:AKYA) Q4 2022 Earnings Call Transcript

Akoya Biosciences, Inc. (NASDAQ:AKYA) Q4 2022 Earnings Call Transcript March 7, 2023

Operator: Thank you for standing by. And welcome to the Akoya Biosciences Fourth Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. As a reminder, today’s conference call is being recorded. I will now turn the conference over to your host, Mr. Priyam Shah, Head of Investor Relations. Please go ahead, sir.

Priyam Shah: Thank you, Operator, and thank you to everyone who is joining us today on this call. I’m Priyam Shah, Head of Investor Relations at Akoya Biosciences. On the call today, we have Brian McKelligon, Chief Executive Officer; and Joe Driscoll, Chief Financial Officer. Earlier today Akoya released financial results for the fourth quarter ended December 31, 2022. 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 Akoya business, please refer to the Risk Factors section of our Form 10-K filed with the Securities and Exchange Commission today, March 6, 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, March 6, 2023. Akoya 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 Investors section of our website later today under the heading Events. We would also like to inform listeners that Akoya will be participating in the Cowen Health Care Conference tomorrow, March 7th. If you’re not planning to attend in person, please see our Investor Relations page for webcast information for this and other recent or upcoming investor events. And with that, I will now turn the call over to Brian.

Brian McKelligon: Thank you, Priyam, and good afternoon and evening to everyone. We appreciate you joining us on the call today. 2022 was an excellent year for Akoya capped off by a strong finish with yet another record-breaking quarter. As an organization, we delivered solid commercial execution and consistently strong revenue growth, installed base growth and publication growth within the spatial biology market. We reported record revenue of $21.2 million in the fourth quarter and $74.9 million for the full year of 2022, a 36% growth over the prior year. We sold a total of 71 instruments in the fourth quarter and 237 instruments for the full year 2022, a 61% growth in placements from the prior year and we ended the year with an installed base of 934 instruments.

Akoya has the largest installed base of spatial instruments in the industry and we are on track to reach 1,000 instruments by early this year, a major milestone for the company. Additionally, the rapidly accelerating publications volume featuring Akoya’s platforms now at 772 publications to-date, is the largest amongst spatial biology providers. Our consistent execution, large and growing installed base and publication growth gives us increasing confidence in the momentum of our business and the spatial biology market in 2023 and beyond. Akoya’s product portfolio is setting the industry standard for next-generation tissue analysis. The company was founded on the vision and fundamental assumption that the market requires rapid imaging-based NC2 technology or comprehensive tissue analysis, enabling the understanding of the molecular and cellular interactions at a single cell level across whole tissue sands.

In 2022, we solidified our instrument portfolio with the launch of the Fusion. We expanded our footprint across all market segments and made significant progress on our long-term clinical goal of impacting patient care. Akoya brings to the spatial biology market a full suite of end-to-end and purpose-built platforms across the discovery, translational and clinical market segments. Our continuity of technology, reagents and methods across our entire portfolio allows us to own the biomarkers journey from discovery to the clinic. At our recent Special Day event in December, we previewed our 2023 priorities and product roadmap and the summary is as follows. First, we are introducing platform and workflow improvements across our entire instrument line that will further advance our leadership position in spatial imaging and drive additional reason pull-through across our nearly 1,000 instruments in the market.

Second, we will build on our commercial and partnership success in the translational clinical markets to further advance our goal of improving patient care. And third, we will focus on driving operational efficiencies, including more targeted investments in 2023. Now let me address each one of these in more detail. Our platform improvements include further simplification and acceleration of our workflows on both the PhenoCycler Fusion and the PhenoImager HT. To take full advantage of these improvements, we are introducing expanded reagent menus of ready-made panels for both the PhenoCycler Fusion for high plex discovery and the PhenoImager HT for high-throughput translational studies. These new biomarker panels will be marketed under the brand name PhenoCode.

PhenoCode discovery panels for the PhenoCycler Fusion and the PhenoCode signature panels for the HT. Our projected reagent pull-through increases will be driven by improved system capacity and throughput, ready-made panels to increase plex and application breadth and an ecosystem of software partners to reduce the time from data to answer. Beginning next quarter, the Fusion 2.0 release will be rolled out. It is the primary system improvement on the PhenoCycler Fusion for 2023 and results in a significant increase in throughput and workflow simplification. This 2.0 release includes a multi-slide carrier for parallel processing and tissue samples and effectively doubles the system throughput up to 20 to 30 samples per week. This upgrade also supports the rollout of Bio-Techne’s RNAscope on the PhenoCycler Fusion.

I’ll remind you, RNAscope is the industry’s gold standard RNA NC2 assay with over 6,000 publications to-date and broad adoption across the life sciences market. RNAscope is an ideal solution to complement protein-based spatial phenotyping in a targeted manner and to validate discoveries made with higher plex spatial transcriptomics approaches. And in parallel, in the second half of 2023, we will introduce Akoya’s proprietary high-plex spatial transcriptomics solution to support RNA and ultimately multiomic spatial studies. On the PhenoImager HT, we are continuing our efforts to simplify and streamline our informatic workflow and post-processing to a true clinical standard. In mid-2023, we will introduce further improvements to the HT that moves the post-processing tissue analysis steps directly onto the HT for on-instrument compute.

The result will be a reduction in data post-processing from hours to minutes and an automated workflow for tissue and cellular annotation. This upgrade supports our translational and clinical customer demands for rapid and standardized analysis to drive throughput, consistency and ultimately adoption. Now to enable our customers to take full advantage of these system improvements on the PhenoCycler Fusion and the PhenoImager HT, we are introducing our new PhenoCode reagent offerings. These PhenoCode panels will deliver a suite of ready-to-use biomarker panels, focused on answering key biological questions with greater efficiency, speed and comprehensiveness. Our PhenoCode discovery panels are designed to run on the PhenoCycler Fusion for discovery-based applications.

The first product launch will be protein-based with RNA solutions coming later in the year. These panels will be — these panels will introduce — will be introduced throughout the year on a quarterly cadence. We will share more details at this year’s AACR meeting in early April, but at a high level, the PhenoCode discovery panels will be launched as modules of 10 to 20 biomarkers, enabling our customers to mix and match modules to quickly build a comprehensive high plex panel. We are focused on core biomarkers and are designed to address key biological questions in oncology, inflammatory disease and neurobiology. At the AGBT conference last month, Akoya and our partners at Stanford each presented PhenoCode discovery panels with simultaneous detection of protein and RNA across large sample cohorts, demonstrating great science at speed and scale.

Throughout this year and next, we will continue to build out these molecules for protein, RNA and multiomic applications, enabling high plex and high throughput discovery across a broad range of applications and customers. For the translational and clinical markets, our PhenoCode signature panels are designed to run on the PhenoImager HT. The initial five panels were created for the rapidly advancing immuno-oncology therapy landscape that includes nearly 6,000 ongoing clinical trials, which demand pre-design validated antibody panels with detection reagents and a ready-to-use format. The PhenoCode signature panels enable fast and scalable spatial signature development and deployment and will deliver higher revenue per sample, accelerated and increased system utilization, reduced assay optimization time and will result in a higher pull-through on the HT.

And now to pivot to software and data analysis, but to remind you, Akoya’s platforms already leveraged on instrument image processing and file compression that reduced file sizes by 30-fold from terabytes to gigabytes. This novel and proprietary technology enables ease of data transfer and analysis via our standardized file format called QPTIFF. This standardized format also simplifies and accelerates the development of third-party software solutions. Rather than develop and deploy a singular monolithic solution, Akoya strategy is to partner with a rapidly growing ecosystem of spatial biology software providers. Similar to the dynamics seen in other markets like microarrays and flow cytometry and NGS, rapidly adopted new technologies spur parallel development of supportive solutions.

This is especially true of software and is certainly happening now in the spatial biology market. We already have a full range of software partners to support the unique customer needs across all of our platforms and market segments. We have both commercial and free open source partners, we have cloud-based solutions and others that rely on local compute. The growing list of partners include established industry leaders like VisioPharm, Indica Labs and PathAI, new and rapidly emerging providers like OracleBio and Enable Medicine and open source software and the open source software QPS. In addition to this rich product roadmap, we are progressing several initiatives in the downstream translational and clinical markets, leveraging the PhenoImager HT and our Advanced BioPharma Solutions CLIA Lab or ABS at Marlborough.

We recently announced a partnership with Agilent to make possible a seamless end-to-end clinical workflow for multi-plex assay use in clinical trials. Akoya will leverage Agilent’s expertise and their clinical grade Omnis autostainer to support a full spectrum of multi-plex assays for biopharma. With Agilent’s Omnis, clinical antibodies and CDX expertise, and Akoya’s HT platform, CLIA Lab and technical leadership in clinical grade multi-plexing, we can together support clinical assay development, validation and use in clinical trials, creating a one-stop shop for our shared biopharma parts. The combined strength of Agilent and Akoya, two leaders in our respective fields, accelerates multi-plex companion diagnostic development programs and provides a global channel for subsequent commercialization.

Our agreement with Acrivon Therapeutics to exclusively co-develop and commercialize a first-of-its-kind spatial signature companion diagnostic for their targeted oncology aging continues to advance with a clinical trial ongoing and is yet another important milestone in furthering our clinical menu offering. In parallel, ABS continues to see robust growth and expansion of existing and new pharma partners. We made significant progress in 2022, pursuing the large spatial biology clinical TAM with key partnerships and developments that will continue to gain traction in 2023. To summarize our fourth quarter and full year 2022, we are very pleased with our strong financial and commercial performance this year as we continue to expand our leadership position in the spatial biology market.

As we outlined, we’re focused on the following initiatives in 2023. First, drive the continued adoption and improvements. PhenoCycler Fusion as a best-in-class NC2 imaging platform for Discovery spatial biology. Second, continue to deliver new applications and drive further workflow and speed improvements across the full instrument portfolio to drive an increase in pull-through. And third, we’ll continue to partner with leading biopharma, medical centers, CROs and diagnostic leaders to drive the adoption of the PhenoImager HT, translational research and clinical diagnostics. And lastly, we’ll drive operational efficiencies and more targeted personnel investments on our path to achieve profitability. And with that, I will now turn the call over to Joe to discuss our financial results.

Joe?

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Joe Driscoll: Thanks, Brian, and hello, everyone. As Brian highlighted, the total revenue for the fourth quarter of 2022 was a record $21.2 million, 31% growth over Q4 2021 and full year revenue was $74.9 million, 36% growth over full year 2021. Our extremely strong performance in 2022 despite a challenging macro environment gives us increasing confidence that we are in a high growth market with a strong portfolio that meets the needs of a broad customer base across multiple verticals and revenue categories. Product revenue, which includes instruments, reagents and software was $15.7 million for the fourth quarter and $57.7 million for the full year, representing 30% growth over full year 2021. Instrument revenue was $11.1 million for the fourth quarter and $38.6 million for the full year, representing 35% growth over full year 2021.

We had another strong quarter with 71 total instruments sold, of which 25 were PhenoCyclers and 46 were from the PhenoImagers portfolio. We sold 237 instruments for the full year and ended 2022 with a total installed base of 934 instruments, which includes 254 PhenoCyclers and 680 PhenoImagers. As of yearend 2022, a total of 120 Fusion instruments have been shipped since the full commercial launch at the start of the year and we now have a total installed base of 105 for the combined PhenoCycler Fusion system sold either directly as a combined system or upgraded from a previous standalone PhenoCycler instrument. The number of combined units is an important metric, because this combination is projected to drive significant increase in reagent pull-through over the next few years.

Reagent revenue was $4.5 million for the fourth quarter and $18.4 million for the full year, representing 29% growth over full year 2021. In 2022, we experienced some FX headwinds in Europe and COVID lockdowns in China, which impacted our reagent revenue. With an annualized pull-through in the mid-$30,000 range per instrument for the PhenoCycler and the PhenoImager HT, we project the pull-through to increase significantly by as much as 2 times to 3 times over the next several years as more PhenoCycler Fusion are up and running, along with our rollout of new consumable offerings and instrument field upgrades. With the PhenoCycler Fusions shipped during the early phase of the launch for which researchers have been trained and are now actively using for projects, we are already noticing significant increases in pull-through compared to PhenoCycler’s with third-party microscopes.

As researchers continue to become fully trained and the installed base of PhenoCycler Fusion is continue to expand, we expect the further acceleration in throughput and application expansion to impact reagent pull-through even more. The new highly optimized PhenoCode signature panels and higher plex PhenoCode discovery panels, which will be rolled out throughout 2023, will not only contribute meaningfully to pull-through and accelerate time to answer, but we’ll also increase our share of reagent revenue as the panels are wholly offered through Akoya as ready-to-use. We continue to target annual reagent revenue growth of approximately 40% per year for the next several years as the new innovations hit a commercial stride and our installed base continues to rapidly expand.

Services and other revenue totaled $5.5 million for the quarter and $17.2 million for the full year, representing an increase of 65% over full year 2021. Our Advanced BioPharma Solutions, CLIA Lab, continues to gain significant traction with large pharma and we also signed other meaningful clinical partnerships throughout 2022, such as Acrivon Therapeutics and Agilent. Gross profit was $12 million in the fourth quarter and $43.4 million for the full year, representing full year gross margin of 58%. We continue to make investments in the CLIA Service Lab to support clinical trial enrollment, which has a near-term impact on margins as we build out these clinical grade capabilities. We have also experienced some impact on margin from inflationary cost pressures, consistent with what most other companies are experiencing.

Operating expenses for the quarter totaled $29.6 million and $109.5 million for the full year. With significant investments on business expansion efforts throughout 2022, we have laid the groundwork for the commercial rollout of the PhenoCode panels throughout the year, field upgrades for the PhenoCycler Fusion, partnered software expansion and a full end-to-end discovery to clinical workflow. Our plan for 2023 includes making more targeted investments in areas that will generate the highest returns as we create a path to profitability over the next several years. We ended the quarter with approximately $81 million of cash and marketable securities and $11 million in additional debt capacity. We continue to take a balanced approach to accessing capital as needed to ensure we maintain our exceptional growth throughout 2023.

Common shares outstanding are $38.3 million as of December 31st and fully diluted shares, including the impact of outstanding options and unvested restricted stock awards totals $38.9 million. To summarize, we had another record-breaking quarter with $21.2 million in revenue and $74.9 million for full year 2022, 36% growth over the prior year. We sold 71 instruments across the product portfolio this quarter, 237 instruments throughout 2022 and now have a total installed base of 934 instruments, the largest in the industry. The shipment of 120 Fusions in the first year since the launch demonstrates the robust demand for our new instrument offering. Now with 772 publications featuring Akoya’s platform as of year-end 2022, we remain very confident in our ability to deliver continued growth in 2023 with the adoption of our current platform and new commercial product rollouts.

At this time, we are providing a preliminary revenue guidance range of $95 million to $98 million for 2023 as we continue to see tailwinds for our business and the spatial biology market. We project that seasonality will be consistent with prior years with Q1 having the lowest quarterly revenue and Q4 having the highest. Now I’ll turn it back over to Brian for closing remarks.

Brian McKelligon: Thank you, Joe. We’re pleased to report a strong quarter and full year performance. We announced multiple exciting new partnerships and developments across the portfolio and we’ll look forward to executing them throughout the year. 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 very 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. And at this point, we will open up the call for questions. Operator?

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Q&A Session

Operator: Thank you. Our first question comes from the of John Sourbeer of UBS. Your line is open.

John Sourbeer: Hi. Congrats on the finish for the year and thanks for taking the question.

Brian McKelligon: Thanks, John.

John Sourbeer: Just on the 2023 guidance, any color just on how to think about instrument pull-through and consumable mix through the year and what’s really embedded in guidance there? And then if you look back at the customers that adopted the Fusion in the first half of 2020, 2022, do you think that most of these customers have now started to hit that full utilization or just how do we think about those dynamics and what’s embedded?

Brian McKelligon: Just to clarify the second part of your question, you’re referencing those customers that have the new PhenoCycler Fusion?

John Sourbeer: Yeah. That’s correct.

Brian McKelligon: Yeah. Let me take that second part and Joe can give qualitatively on the 2023 with the caveat that to-date we’ve only really guided on the number. I guess what I would say in terms of the aggregate PhenoCycler user base, recognizing that we launched in March, we really started shipping in bulk a year ago with really strong performance throughout the year. So if you sort of average in assume it takes a quarter, sometimes too for people to get up and running, I would say we probably don’t have the majority of those PhenoCycler Fusion user customers at full stride just yet given how long it takes. And given that if you sort of average in that total number that we’ve sold, we’re probably less than halfway there in terms of full system utilization and then the aggregate impact that those higher throughput users have on the total resin number, but also on the average pull-through. Does that makes sense.

John Sourbeer: All right. That makes sense.

Brian McKelligon: Yeah.

John Sourbeer: And I guess just a follow-up. You ended the year with $81 million in cash on hand. Any just color around the cash burn and then any potential financing plans?

Brian McKelligon: Yeah. Let me talk on that, and then, Joe, I didn’t give Joe a chance to talk a little bit about the first part of your question on 2023. Yeah, $81 million cash on hand with $11 million additional debt capacity, and again, as Joe noted, a more targeted investments this year with higher revenues to less burn. So we’re in a really solid cash position right now. But Joe, you can add a little bit more color there, if you’d like, but also address John’s question around 2023 and any additional color.

Joe Driscoll: Yeah. I think your answer on cash is spot on. In terms of the guidance for next year, the $95 million to $98 million, we don’t break down the guidance by individual categories. But the way we think about reagents, for example, is that there will be a build throughout the year as we roll out new products, as more and more customers get up and running on the PhenoCycler Fusion. So I think you could think about pull-through as being a gradual increase quarter-after-quarter, that combined with the increase in the number of instruments that we sell, that’s what hopefully will get us to that 40% growth number for reagents. That’s our internal target anyways.

John Sourbeer: Got it. Thanks for taking the questions.

Brian McKelligon: Thanks, John.

Operator: Thank you. One moment, please. Our next question comes from the line of Kyle Mikson of Canaccord. Your line is open.

Kyle Mikson: Hey. Thanks guys for the questions. Yeah. Congrats on the year. Great outlook as well. Maybe look a multipart financial question to start then a follow-up question. So on pull-through, actually, just on your last point, Joe. I mean it sounds like it’s going to continue to increase. I mean, you said 30,000 though, still, I mean, I’ve heard that for a few years, I feel like, I mean, what’s stopping customers from really using the boxes more. Okay, just — I think that would have increased or at least accelerated kind of recently. And then you just mentioned, Joe, this 40% growth rate going forward and I think like over 50-50 mix with consumables and instruments would be good as well. I mean can you kind of do that if pull-through remains in this 30%, 40% kind of range? Thanks.

Brian McKelligon: So the — in terms of the pull-through, I think, are you saying how do we get to 40% reagent growth?

Kyle Mikson: Yeah.

Brian McKelligon: Is that…

Kyle Mikson: Is a predict based on — yeah, is a predict based on the 30,000 or does it have to expand to some other higher level?

Brian McKelligon: It would have to expand, but not a tremendous amount. So instead of the sort of the mid-30 range, mid $30,000 range per instrument, you’re talking about kind of low $40,000 range per instrument. That combined with the increase in the number of instruments out there, that will get you — that will get the reagent numbers that we’re talking about. So it’s not like it has to go from mid-30,000s to 50,000 in 2023 to generate that kind of number as long as the instrument number hangs in there.

Kyle Mikson: Okay. And then, Brian, just on my first part of the question, but that was about kind of like what’s preventing customers from really cranking up the usage of the boxes. I know you have these new products coming out that should increase pull-through going forward. But I mean, to-date, though, like what’s been some of the…

Brian McKelligon: If you just — if you look back historically on sort of an annual basis, Kyle. And Joe can keep me honest on the numbers here and granted these are somewhat contaminated by COVID. I think if you go back around 2019, 2020, the pull-through for the PhenoCycler on third-party scopes went from like 20 or so up to 30. And now we’re starting to see that amongst the PhenoCycler users customers go beyond 30. So we’re already seeing that trend. It’s just a matter, Kyle, as you look across the 254 PhenoCycler that are out there. A minority have the Fusion attached to it. So that’s already starting to impact the overall pull-through number into the mid-30,000s for the PhenoCycler. So we’re starting to see that impact begin to happen already for the FUSION, coupled to what we’ve seen historically that pull-through climb in a more gradual manner up to the 30,000 or so where it was that we articulated on our last Q call. And just one other

Kyle Mikson: Thank.

Brian McKelligon: One other quick

Kyle Mikson: Yeah.

Brian McKelligon: point, the COVID lockdowns in China did hit our reagent revenue in 2022 and that’s part of the pull-through calculation is total reagent revenue. So if that didn’t happen, our reagent revenue would have obviously been $1 million plus higher in 2022.

Kyle Mikson: Okay. No Thanks, guys. I will ask just one follow-up here. Bigger picture, a very kind of top question, obviously. You did a great — you had a great quarter with placements, I think, at least 70 or so and I think nothing — doesn’t look like anything slow down in terms of customers getting kind of distracted by the Imager is kind of like launch at the end of the fourth quarter. But what are you seeing kind of recently, I guess, these products are fresh in the market. I’m aware of a few folks that are obviously buying these Imagers. Is that impacting your ability to kind of get in front of customers and potentially close deals?

Brian McKelligon: Yeah. It’s a good question. So with the launch of the competing Imager products, the Cosmic, the Zenium , it really hasn’t impacted our pipeline and our instrument performance at all. The COSMIC is not a new event, because they’ve been reselling that throughout the year and Zenium is fairly new. I still think, Kyle, that’s largely within the genomics discovery segment and given where we compete in discovery, but all the way through to the translational and clinical side, we’re still really not feeling any competitive impacts from them. Now as we launch our RNA and we start participating more and more in that genomic segment, I think, we might have more color on that, because I think we’ll be more directly competing.

Kyle Mikson: Right. Yeah. That last part is important, Brian. Thanks a lot for that.

Brian McKelligon: All right.

Kyle Mikson: I’m going to hop off. Thanks, guys. Appreciate it.

Brian McKelligon: Thanks, Kyle.

Operator: Thank you. One moment, please. Our next question comes from the line of Mason Carrico of Stephens. Your line is open.

Mason Carrico: Hey, guys. Thanks for the question. Congrats on a strong 2022. Maybe just starting with reagent revenue during the quarter. I think it came in slightly lighter than we were modeling. Could you expand on some of the dynamics that played out specifically in the fourth quarter? I know you called out some factors that weighed on this revenue in 2022. But I guess just any incremental color on what played out during Q4 and if any of those dynamics have continued in 2023?

Brian McKelligon: Yeah. Joe can address that. I mean, but there’s a lot of contributing factors. Maybe, Joe, you can talk to you a little bit of those.

Joe Driscoll: Yeah. I think it’s pretty much what we’ve talked about already. The COVID lockdowns in China, that was a problem from Q2 through Q4, some softness in Europe with currency issues, kind of held back some spending. So I don’t think it was any one thing. But as we’ve rolled into Q1, we’ve definitely seen order volumes pick up so — versus Q4. So I think we’re going to be fine in 2023 in terms of reagent performance.

Brian McKelligon: And then there is still…

Mason Carrico: Got it.

Brian McKelligon: Look, there’s still a little bit of lumpiness in the revenue realization within each quarter, but almost certainly also on the comps from the prior year.

Mason Carrico: Got it. Okay. Perfect. Thanks. And on the macro environment, are you still seeing an elongation in capital purchase time lines, and as we kind of think about the 2023 guide, has any conservatism been baked in around that dynamic this year? How are you thinking about it?

Brian McKelligon: So I’ll make a comment and then Joe can add on. Where we saw some expansion of capital purchase timelines and approval strings was in EMEA. But it didn’t have a material impact on the quarter or even looking forward. It’s just really a dynamic that we have to be cognizant to manage and as we’re including that in 2023, we did not. But the other concept that we did talk about was still fairly anemic reagent revenue, albeit coming back slowly in China. I think we still contemplating some of that. Joe, do you want to add any more color?

Joe Driscoll: Yeah. Just, overall, we’re not anticipating a massive economic turnaround in our 2023 guide. I guess the guide that we’ve given presumes that things are kind of going to be what they are right now in terms of overall macro environment. So we’ll obviously keep a close eye on that. But that’s kind of our basic assumption.

Mason Carrico: Got it. That’s helpful. Thanks, guys.

Brian McKelligon: Thanks, Mason.

Operator: Thank you. One moment, please. Our next question comes from the line Tejas Savant of Morgan Stanley. Your line is open.

Tejas Savant: Hey, guys. Good evening. Thanks for the time here. Brian, maybe to kick things off one for you. So other than scheduling, where do things stand and what remains to be done for the Fusion 2.0 rollout. I think you mentioned you expect that to start in 2Q. And then by when do you expect to be done with those field upgrades? And then, Joe, as a follow-up to that, is the increase in throughput that the Fusion 2.0 enables, I think, it said from 10 to 20 to 30 samples. To what extent is that sort of baked into your guide at the midpoint?

Brian McKelligon: So I’ll take that first part and then Joe can talk about how that impacts the guide. So the 2.0 is a field upgrade that will begin next quarter. And there was just some final, I would call it, a validation of verification work sort of the final stages of being development. There’s not any sort of technical risk associated with that. So, again, really standard product development methodologies. And just reminding you that Fusion 2.0 is going to meet the requirements for the multi-slide carrier, some improvements to the operating software and the reagents, but also, as noted in the commentary, the RNAscope for — and also for future RNA. So that will all happen in Q2. In terms of — for the existing customers, how long will it take, that’s a really good question.

Obviously, we want to do it as fast as we can. I would say, the shortest would be six months to nine months. It could maybe take a little bit longer than that, depending upon customer preparedness and whether or not it would interrupt existing studies.

Joe Driscoll: And on your question about what is baked into the guide. So we’re really looking at going from the mid-$30,000 per instrument on average to the low $40,000 on average. And really, there’s a wide array of customers in that mix, right? Some do very little. Some are doing $200,000 per instrument per year. So that’s really what’s baked into the guide right now and it seems very achievable from where we sit right now.

Tejas Savant: Got it. Okay. And then on the PhenoCode panels, similar sort of question really. You talked about really strong traction there at AGBT, as well as the upcoming launches over the course of the year on the discovery side. How much of that is sort of like factored into the guide here?

Joe Driscoll: Not a tremendous amount. It’s certainly a part of the guide, but you’re talking about $1 million or $2 million for the whole year.

Tejas Savant: Got it. Okay. That’s helpful. And then on the multiomic front, Brian

Brian McKelligon: Yeah.

Tejas Savant: is early access sort of eminent in terms of that 100 plex panel rollout. Can you just remind us again how high could protein plex go on that panel? And then by when do you expect to get co-detection and early access, I believe this was — the first version is going to be sequential sections of the data, is that right?

Brian McKelligon: Yeah. So we’ll start with sequential, whether or not we do early access like via services, we’re still sort of debating whether or not we have to do that, because again, as we talked about, we will have probably by the time it comes out, 300 boxes in the market, we just want to make sure that we’re sort of commercially ready for the high-plex RNA and high-plex protein on these serial sections. But, again, as you noted, the multiomics will come earlier. In terms of how high can we go on the protein, we sort of think — there’s no upper limit, but there’s a scientifically reasonable limit and also a cost limit. So I think 100 plex is about as much as I think we think people need right now. And just by comparison, there’s been discussions out amongst the scientific community and others as you think about comparative plex between RNA and pricing.

And there’s commentary that in terms of scientific value, a protein can be, say, 5/10 equivalents of RNA given that sort of a direct measurement of the activity. So we think 100-plex protein is probably where we’re going to stay for a while and then the RNA will be kind of somewhere similar into that range versus serial and then multiomic.

Tejas Savant: Got it. That’s helpful. And then, Joe, back to you for your comments around just taking a more targeted approach to investments. Are there any guiderails you can put around sort of OpEx vis-à-vis last year? I mean I think your 4Q OpEx was a little bit higher than where we were by $2 million or $3 million. Is that sort of $30 million-ish run rate a good benchmark to use when you think about 2023?

Joe Driscoll: Yes. So, I would say, we’re going to hire people in 2023, but sort of spread throughout the year. It’s not going to be a massive number of people. So I think you could look at something like $30 million in Q1 and then maybe it goes up $0.5 million each quarter throughout the year, something like that.

Tejas Savant: Perfect. Very helpful. Thanks, guys. Appreciate it.

Brian McKelligon: Thanks, Tejas.

Operator: Thank you. One moment, please. Our next question comes from the line of Mark Massaro of BTIG. Your line is open.

Mark Massaro: Hey, guys. Thank you for the question. Congrats on a strong year. So a lot has been asked, but I’m curious if you could comment about some of the economics with respect to the PhenoCycler Fusion 2.0. I don’t believe you’re looking to drive incremental economics on that instrument relative to the 1.0. Can you just clarify that? And then I guess what I’m really trying to determine is the guide does not look like there is a significant step-up as a result of new products. And so Joe, I appreciate your commentary about $1 million to $2 million on the PhenoCode panels. But other than perhaps negligible revenue contribution for the PhenoCycler Fusion 2.0 upgrade, is it fair to say that you’re baking in a very modest contribution all in from new products in 2023?

Brian McKelligon: I think some — a lot of it is — thanks for the question, Mark. Maybe your first part. So the 2.0, the ASP is the same of the versions built and shipped with and then the future — without and the future versus with 2.0. So we’re not — there’s not a price increase because of the 2.0, if that was your question on the instrument. And then

Mark Massaro: Yes.

Brian McKelligon: Okay.

Mark Massaro: Yeah.

Brian McKelligon: And then in terms of the NPIs, you can see that these are beginning this quarter and throughout the year. And these are continuous rollouts of additional panels, upgrades to systems, software partnerships and it’s all really centered around an accelerating realization of these over time. So I think you have to maybe pull the affinture back outside of a single quarter and the thesis here is all of these improvements that we’ve outlined are really the drivers getting that pull-through from its current level to the low 40s to the low 50s, et cetera. So this is sort of the internal framework or OS within Akoya to drive these continuous improvements from workflow, to content, to software partnerships, so you can do more samples per unit time, faster time to answer. So the realization is not a single binary event, but rather in aggregate over time.

Mark Massaro: Okay. That makes sense.

Joe Driscoll: Hey, Mark. Yeah.

Mark Massaro: Yeah. Sorry. Go ahead, Joe.

Joe Driscoll: To add on to that, basically seeing what Brian just said, but the 2.0 upgrade in and of itself doesn’t generate dollars, but it helps that reagent pull-through. That’s really where the dollars are going to come. So it’s not necessarily new products that are delivering that revenue, but it’s — the 2.0 upgrade is helping us drive that reagent revenue to a much higher level.

Mark Massaro: Right. And just to clarify, that reagent revenue growth target is approximately 40% this year, correct?

Joe Driscoll: Correct. Yes.

Mark Massaro: Okay. We’ve seen some other tools companies sometimes have push pulls between the razor/razor blade contribution and the services contribution. But in your case, we’re really not seeing that. So you drove a strong 65% growth year-over-year in services last year. I think, historically, you’ve talked about a services target of in the 30% to 40% range. Recognizing that you just did 65%, are there any qualitative factors perhaps that would suggest any reasons why that growth rate is likely to moderate other than just challenging comps?

Brian McKelligon: Maybe, Joe, you could describe kind of what’s in that and then I can take a

Joe Driscoll: Yeah.

Brian McKelligon: specific commentary around the Lab Services specifically.

Joe Driscoll: Right. So our services are going to have another good year in 2023. What we have in that bucket right now is really the CLIA Lab, which is doing projects for large pharma and I’ll let Brian comment some more on that. That’s been going very well. We’ve got a second services lab that focuses on PhenoCycler projects, so early stage discovery projects. And now we also — in that bucket, we also have CDx revenue. So this is the Acrivon deal that we signed in 2022. You’ve got a piece of that is in our 2022 revenue, but more will be in 2023, the milestones and things like that, that we get for doing the Acrivon deal. So those three pieces are really the bulk of that services revenue. So 2023 should be another good growth year for services.

Brian McKelligon: And then again, just to go back to — as promised, Mark. So Lab Services includes working with the biopharma groups really to drive adoption in early translational all the way through clinical trial studies and those were the services that Joe just alluded to. But it also includes the revenue that’s realized in doing our partnership as also as a Lab Service through Acrivon, where we have these milestone-based — milestone-driven these revenue milestones that we achieved throughout last year and this year, that’s also included within that and that helps explain Mark, why that number has grown so much, because of the success of both of those efforts.

Mark Massaro: Okay. Excellent. And last one for me. Joe, I think, I heard you say that you’re seeing volumes pick up nicely here in Q1. So reagents are off to a good start. It doesn’t seem like there’s a huge necessarily a challenge with respect to funding or budgets at the customer level. But maybe can you just speak to any conversations you’re having about forecasting orders throughout the course of the year and whether or not you’re seeing issues with budgets?

Joe Driscoll: We have not seen any issues with budgets. Really, the only hiccup we had in 2022 is really things like COVID lockdowns, which we really can’t control. But other than that, other than unusual things like that, budgets seem to be fine and back to normal.

Brian McKelligon: And Mark, a lot of what — a lot of the macro commentary around biopharma funding is really what — the discussions have been around the smaller emerging biopharma this year or the latter part of last year relative to 2020 and 2021. And two comments on that. That’s really not a meaningful percentage of our customer base. We’re mostly dealing with a multinational biopharma who have seen kind of a tremendous surge in R&D spend, particularly as their COVID spend has muted. So I don’t really think that the biopharma commentary is not restructure small pharma has not really impacted us. And again, large pharma funding in terms of their R&D has been pretty darn strong, particularly in oncology, where you’ve got clinical trials up something like — it’s like 38% of all clinical trials, a 10% CAGR, which is really where we play with our HT system.

Mark Massaro: Excellent. That all makes sense. Thanks for the color.

Joe Driscoll: Thanks, Mark.

Operator: Thank you. One moment, please. Our next question comes from David Westenberg of Piper Sandler. Your line is open.

David Westenberg: Hey, guys. Congrats on another solid print and a great guide. I’m going to ask Joe that commentary about the 30,000 to 2x, 3x that. Can you just give us more color on what you talk — are you talking about the entire PhenoCycler Fusion base or is that the one when they have or sorry, PhenoCycler base or is that just with the Fusion and how should we think about the total base in that ramp? Just a clarification on your

Brian McKelligon: Yeah. So..

David Westenberg: commentary there.

Brian McKelligon: Yeah. Our commentary and that’s really a multiyear commentary that we’re talking about 2 times to 3 times over a several year period. But this whole process is a building process quarter-by-quarter or year-by-year. Really, the key to get the overall PhenoCycler Fusion number up is to continue to transition as many customers as possible from just a PhenoCycler a PhenoCycler Fusion. That’s really were partway through that whole process of converting those customers to encourage them to buy a fusion. So that’s really a piece of the equation. And if we get the majority of PhenoCycler customers to shift to a PhenoCycler Fusion, that’s how you’ll get those kinds of numbers of, on average, $60,000 per year, $70,000 per year. But it will take multiple years to get there.

Joe Driscoll: Just to make sure, David, that growth — that is the total average amongst our PhenoCycler user base.

Brian McKelligon: Right.

Joe Driscoll: Yes.

David Westenberg: Got it. Yeah. That last part — thank you very much, because that last part is actually what I was going to ask about how you came up with exactly that number.

Brian McKelligon: Yeah.

David Westenberg: So I appreciate the color there. Now can you just — one more part to this little part, are you seeing more adoption or can you talk about the percentage of adoption from PhenoCycler who get the microscope? Is this almost all of them? And then in terms of retroactive placements, I mean, how far do we have to go? What’s the kind of the goal penetration rate of that? I’m assuming it wouldn’t be 100% but could be close to 100% and where we are that in terms of the penetration rate?

Brian McKelligon: Yeah. I’ll take that last part and then Joe can give you a little bit more color. You’re right, it probably won’t go all the way to 100%, because there are some there are some labs that are — that preferentially use some third-party microscopes, but that’s a really — that’s going to be a very over time, decreasing a pretty small percentage of the total. But Joe can speak to kind of where we are in terms of the penetration amongst our existing user base and kind of the attachment we see going forward for new customers.

Joe Driscoll: Yeah. The attach rate, and when we say attach rate, we mean every time somebody buys a PhenoCycler, how often are they buying a Fusion at the same time. It’s really good. We initially modeled it at 55% or 60% attach rate. It’s coming in 80% plus right now. I think customers really see the value of buying the two instruments together. And so we — from what we can tell, there will be some people who still only buy a PhenoCycler without the Fusion, but that’s going to be the minority of people. So I think 80% is a good number to go with for now.

Brian McKelligon: And then for the existing installed base, David, we’re less than halfway there. I’d say, directionally, call it, 40% or so, maybe 30%, 40% of the total customer base that had the PhenoCycler before the Fusion came out, now has a Fusion. So we still have a lot of headroom

David Westenberg: Okay.

Brian McKelligon: to upgrade existing customers.

David Westenberg: I appreciate. I’ll ask the rest offline. Thank you. B Thank you.

Operator: Thank you. One moment, please. Our next question comes from the line of Tim Chiang of Capital One. Your line is open.

Tim Chiang: Well, yea, thanks. Brian and Joe, I think, there have been a lot of questions just about pull-through, the impact of the new Fusion 2.0 launch and also how that will benefit your reagent business. Is this kind of a lag effect in terms of when you expect a ramp with the reagent side of the business as more of the Fusions convert over to the 2.0?

Brian McKelligon: Well, yeah, there’s — I mean, there’s always a lag effect with any NPI new product introduction. And so the standard kind of instrument utilization lag, and I say standard, because doing this for 30 years, it’s pretty much formulaic where customer buys an instrument, initial pilot run in Q2 and in the first quarter, their assessments happened in the second quarter, and then coming out of that into the third quarter, they start to get real productive use, right? That’s a typical cycle for an instrument. So that is a lag. We’re now starting to see realized on the Fusion as it impacts our total pull-through given the PhenoCycler Fusion customers have higher pull-through than the PhenoCyclers alone. So that lag is most certainly real.

And then you have an adoption cycle with any new application or assay on that very system itself. So that is probably generally shorter, because you’re dealing with an instrument that’s ready to grab those new panels right away or that new applications if it was RNA. So, yeah, there is a lag effect amongst all of these. That’s why we’ve talked about this build over time of pull-through.

Tim Chiang: Great. And maybe just one follow-up, Brian. You signed this partnership with Agilent at the beginning of the year, how meaningful do you think this partnership will have — what sort of impact do you think it will have on your PhenoImager HT instrument?

Brian McKelligon: Yeah. The impact is going to be an expansion of projects that our pharma partners implement on the HT. That’s going to be the first impact and that’s not something that we will necessarily quantify externally, because we’re already seeing that happen. And that’s because of the clinical workflow that they support and the expertise that they bring to the table and leverage that workflow along with our expertise on the HP. That is the impact. Now that may result in — it should result in a much more robust pipeline, both for the HT system itself, the new panels that we’re launching, but also for our Lab Services business, because it’s going to galvanize these additional projects in the service CLIA Lab as well.

Tim Chiang: Got it. And Joe, just one last question. Gross profit margins around 57%. I mean, is that a pretty good starting number for 2023 and just sort of wondering how that sort of progresses as the year rolls out?

Joe Driscoll: Yes. We would project that, that number is going to go up in 2023. One of the keys for gross margin is getting more reagent business. So we’ve talked a lot about reagents here today. That’s really the key to driving that gross margin percentage higher. But we are projecting that we’re going to do better than what we did in 2022.

Tim Chiang: Right. And your gross margins on the reagent business are around 80%. That’s right?

Joe Driscoll: Yeah. Mid-70%s. Yeah.

Tim Chiang: Mid-70%s. Okay. Great. Super. Thanks much.

Joe Driscoll: Thanks.

Operator: I’m showing no further questions at this time. I’d like to turn the call back over to Brian McKelligon for any closing remarks.

Brian McKelligon: Well, yeah, just we’re at the top of the hour. So just I wanted to thank everybody for their time, their attention, their support and we look forward to following up with each of you. So thank you everyone.

Operator: Thank you. Ladies and gentlemen, this does conclude today’s conference. Thank you all for participating. You may now disconnect. Have a great day.