Earnings Labs

Personalis, Inc. (PSNL)

Q2 2022 Earnings Call· Wed, Aug 3, 2022

$5.27

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Transcript

Operator

Operator

Good day, and thank you standing by. Welcome to the Q2 2022 Personalis Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker’s presentation, there will be a question-and-answer session [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Caroline Corner, Investor Relations. Please go ahead, Caroline.

Caroline Corner

Analyst

Thank you, Operator. Welcome to Personalis’ second quarter 2022 earnings call. Joining me on today’s call are John West, President and Chief Executive Officer; and Aaron Tachibana, Chief Financial Officer. All statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements within the meaning of US securities laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, 2022 cash use, cash runway, the timing for initiating clinical revenue from our new facility, new orders, products, services, technology, clinical and regulatory milestones and our market opportunities, business outlook. These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, including the risk factors described in our 10-Q for the second quarter of 2022 to be filed today. Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release for the second quarter 2022 results is available on our website, www.personalis.com, under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today’s call will be available on our website by 5 PM Pacific Time today. Now, I'd like to call -- turn the call over to John for his comments on second quarter business highlights.

John West

Analyst

Thank you, Caroline, and good afternoon, everyone. I'm pleased with our progress this quarter as we drove growth from our oncology business by 74% over the same period with the prior year. This reflects increasing demand for our highly differentiated and comprehensive cancer tests. Our pharmaceutical customers are increasingly seeing the value of our platform, and they are incorporating it in their clinical trial designs right from the start. In fact, approximately two-thirds of our backlog were orders received for, which we are awaiting samples is for prospective trial patients. Prospective trials are conducted with current patients who are being followed over time, whereas, retrospective studies are based on patient samples collected in the past. In addition, we remain focused on preparing the company for success in the clinical diagnostic market, which I will highlight later. Our customer base continues to broaden. More than 70 customers have now ordered services using our NeXT Platform, including most of the top 10 global pharmaceutical companies as measured by their annual revenues. We are also in discussions with several potential pharmaceutical customers about NeXT Personal, our MRD test and our funnel of business opportunities continues to expand. We expect biopharma orders for NeXT Personal to ramp throughout the remainder of this year with the potential for significant revenue acceleration in 2023 and beyond. Our NeXT Platform provides biopharmaceutical customers with the most comprehensive analysis of tumor burden and biomarker identification available today to provide a better understanding of each cancer patient's genetic profile. We also believe that tissue and liquid biopsies together can provide a more complete view, leading to optimal therapy and treatment decisions. Our tissue and liquid biopsy-based offerings provide data on all of the approximately 20,000 human genes, a breadth and depth that notably differentiates us from competitive offerings. Tissue…

Aaron Tachibana

Analyst

Thank you, John, and good afternoon, everyone. During my prepared remarks, I will provide detail about our financial results for the second quarter of 2022 and guidance for the full year. Total company revenue for the second quarter of 2022 was $18.2 million. Biopharma and all other customers, excluding the VA MVP accounted for revenue of $14.2 million in the second quarter, a 74% increase over the same period of the prior year. The year-over-year increase in oncology revenue was driven by the continued adoption of our -- next platform, which accounted for more than 75% of the oncology revenue in the quarter. For the second quarter, the VA MVP revenue of $4 million was 70% lower compared with $13.5 million for the same period of the prior year and the decline was consistent with our expectations. As of the end of the second quarter, we have fulfilled all of our VA MVP backlog. Gross margin was 23.5% for the second quarter compared with 37.7% for the same period of the prior year. The year-over-year decrease of 14.2 percentage points was primarily due to the expected underabsorbed overhead costs from the 70% lower revenue volume from the VA MVP and an increase in expenses to support our growing oncology revenue. Within our production laboratory, we use more direct materials and sequencing equipment capacity for the VA MVP whole genome samples, while our oncology business requires a higher proportion of labor and overhead expenses such as direct and indirect labor, lab supplies, facility footprint and other related costs compared with the VA MVP. Over the next couple of years, we expect gross margin variability due to headwinds from the lower VA MVP volume, investments in new capabilities such as dedicated production lines for liquid biopsy offerings providing diagnostic tests while we…

Operator

Operator

Thank you very much. At this time, we will conduct the question-and-answer session. [Operator instructions] Tejas Savant. Our first question comes from the line of Tejas Savant with Morgan Stanley. Tejas, your line is now open.

Unidentified Analyst

Analyst

Hi. This is Neil [ph] on for Tejas. Thanks for taking my question. Just to get the ball rolling. Can you speak to some of the month-over-month trends you've been seeing as far as delays on the prospective trial side of things? And any high level color on how you're thinking about utilization heading into the second half?

Aaron Tachibana

Analyst

Yes. So, this is Aaron. Hi, Neil. In terms of what we're seeing month-over-month, we have been seeing some slowdown since the beginning of this year, and it's continuing right now, primarily because of the summer months we're heading into here. During the month of July, we have seen some slowdown. And it's our estimation that we'll continue to see this through the month of September.

Unidentified Analyst

Analyst

Got it. Thank you. And how about in the Shanghai Lab, how are operations progressing there? I know you mentioned a slowdown due to COVID driven delays in the first quarter. Do you see any foreseeable risk in the second half as well?

Aaron Tachibana

Analyst

Yes. So just to be clear, Neil, we don't have any revenue being produced from our Shanghai operation just yet. We're going through internal lab qualification. Shanghai was closed down for about three months due to the lockdown that they had several months ago. For the last couple of months, our employees have been back in the lab, and we're going through internal qualifications. We expect to get through these protocols through the next month, month and a half or so, but then expect to begin working with our first customer from whom we have orders from, and we expect to maybe realize or recognize a very small amount of revenue later this year in the fourth quarter ramping in 2023, obviously.

Unidentified Analyst

Analyst

Okay. And then, any comments on how the partnership with Natera is progressing, and how we should think about that heading into 2023?

John West

Analyst

Yes. This is John. I think the partnership with Natera has been going quite well. I think the things that we do are quite complementary. Personnel has a lot of experience in sequencing difficult FFPE samples from all different kinds of cancer and Natera has years of experience doing cell-free DNA sequencing through their non-invasive prenatal testing and so forth. So, having a combination where we do some of the upfront tissue sequencing from FFPE and then they do their Signatera test on the back end makes a lot of sense and gets out the strengths of each of the two companies. So that's -- revenue that's been growing for us, and I think a good relationship.

Unidentified Analyst

Analyst

Great. And one last from me. So, just given some of the disruption seen with genetic testing peers, how are you thinking about these events in relation to the clinical long-term and the potential for winning any mind or market share?

John West

Analyst

Yes. I think -- this is Jon. I'd say that the there's always an issue of being able to access customers. So, when the pandemic started after that we were pretty concerned about not being able to meet with customers. But actually, we found that we've been operating the business for now well over two years on kind of working from home mode and an amount where we cannot physically meet with customers hardly ever. On the other hand, I think what we've found is we've gotten good at that. And that in some cases, it's actually easier. I'd say, in the past, particularly if you needed to have a group meeting with people, might be hard to find a time that there wasn't always somebody out of the office. On the other hand, with travel being so significantly reduced particularly business travel, we found that often it's easier. So, we ended up catching people, maybe we catch them on Zoom, but we can actually get a group together. So, I think we're pretty optimistic about the ability to move forward. We found that we've been able to be very effective with engaging pharmaceutical customers and the people that we've been hiring for our clinical sales team are deeply experienced and have a lot of connections in the field. So, I think that they'll have good access to those potential customers.

Unidentified Analyst

Analyst

Great. Thank you.

Operator

Operator

Thank you. We will prepare our next question. Our next question comes from Max Masucci with Cowen. Go ahead.

Stephanie Iannetta

Analyst · Cowen. Go ahead.

Hi, this is Stephanie Iannetta on for Max. Thanks for taking my question. Aaron, appreciate the color you provided earlier on gross margin. In addition to the lower VA and BP revenues along with the growing oncology-related investments, were there any abnormal or non-recurring factors that impacted gross margin performance in Q2? And how should we think about the variability in gross margins for the coming quarters?

Aaron Tachibana

Analyst · Cowen. Go ahead.

Yes, hi Stephanie. So, in terms of what we saw in Q2, most of that impact taking the margins down to 23.5%, were really tied to under-absorbed labor and overhead. And most of that came from the expectation with the lower VA MVP volume. In addition, we do use a fair amount of capacity and capability in our lab to do work for research and development work, meaning some new product testing, testing and validation work for samples for some of our studies. And so we did see some of that volume being a little bit less in the second quarter as well, which contributes to the underutilization, okay, because some of those costs would be charged directly to R&D. So, those were the nuances. In addition, again, at a high level, the VA MVP, most of the costs there are variable with direct material. The only fixed costs used there are the sequencers, the equipment, and the small amount of the footprint. But pharma -- it's very, very labor-intensive and a lot of overhead. And so with biopharma continuing to ramp or starting to ramp the gross margin profile will improve out in time. But right now, we do have a fair amount of underutilization

Stephanie Iannetta

Analyst · Cowen. Go ahead.

Got it. Thanks so much for that additional color. Additionally, I know you've mentioned previously that you won't disclose specifics around forecast for material revenue. But given the large contribution from the previous quarter, is there any additional color or general guidance you can provide on how to think about the tariff contribution going forward? Would you still suggest looking at the average of recent quarters to forecast future contributions?

John West

Analyst · Cowen. Go ahead.

Yes, this is John. I think we see the -- this MRD area is one that has a lot of growth to it. And I can't speak directly to [indiscernible] products. They have to speak for their own products and I think they're speaking tomorrow afternoon. But in general, this is an area with enormous growth potential and they're one of the earlier companies in this space. And so I think it would be likely to expect that their business will continue to grow. And we'd be happy to support them in that regard. I think more than that, really, they have to be the one speaking to the volume on their product.

Stephanie Iannetta

Analyst · Cowen. Go ahead.

Got it. Understood. And if I could squeeze in one more. It's good to hear that you are in early access customer in Ultima's Platform. Would be curious to how your experience with Ultima sequences testing, as you explore the performance of the platform that you are offering?

John West

Analyst · Cowen. Go ahead.

Yeah. So this is John. I guess brings me back to old memories of Solexa when we had our first systems out before it became part of Illumina. These are early technologies. The one comment I would make is I think it's terrific that they're really pursuing the $100 genome and they are pricing at that kind of level now. So that's not just a concept for the future. That's what they have. We have the instrument in-house now since January. We've been trying it on various different applications. We don't have anything to announce specifically on that. But I'd say it is, I'd say, a very encouraging platform. It is not a drop in a substitute for the Illumina platforms. It does -- there are certain things that it does, frankly, better. There are other things that it doesn't do as well. And so I think we have to pick the right applications where that it's particularly suited to. And I think that was true when we brought out the Solexa sequencers back in 2006, 2007 time frame. We were -- people said, you're going to replace capillary sequencing, actually, capillary sequencing continue to happen. There were a lot of new applications that were made possible by us introducing next-gen sequencing back at that time. So I think we'll see some of the same kinds of things here, where the Ultima sequencer will enable some new applications that people have not done before and certainly personally would be open to that. But we see Ultima as one of the interesting platforms. Illumina certainly has talked about also being on the road to the $100 genome. They've talked about their new chemistry X coming next year, not clear to us whether that will come with a new instrument, but we remain very interested in advances in the Illumina platform also. And when they have things to say, we'll certainly be looking at that and being interested in being an early access site and so forth.

Stephanie Iannetta

Analyst · Cowen. Go ahead.

Got it. Thanks so much for your color. And thanks again for taking my questions.

John West

Analyst · Cowen. Go ahead.

Thank you.

Operator

Operator

Thank you. Mike Matson with Needham & Company. You're next.

Joseph Conway

Analyst

Hi, guys. This is Joseph on for Mike. Thanks for taking my questions. Maybe just one more on the backlog. I appreciate you guys given all the color that you did. But I guess as we're looking towards the rest of 2022, if you could maybe dissect some of the customers in the backlog, maybe the proportion of larger, more profitable pharmaceutical companies versus maybe some of the smaller ones who are burning cash right now? And how -- and if you're worried or the risk of maybe the smaller and profitable companies canceling orders in the future? Thank you.

Aaron Tachibana

Analyst

Sure. Hi, Joseph, this is Aaron. So I'll take a shot at that and maybe just at a high level, so I won't give any specific backlog numbers, but just in general, we're doing business now with our -- with more than 70 customers on the next platform. And so that's far different than three years ago when we had just a handful. And so, our customer base is far more diversified today than it was before. Having said that, large pharma is a bigger portion of our revenue. And so, therefore, more the backlog is going to be weighted towards larger pharma, okay? In terms of the smaller biotechs and biopharma customers, we do have a fair amount of business with them, and they are included in our backlog. In terms of some of those customers, the – with the equity markets where they're at today, they've had some challenges in terms of burning capital and some might be even going out of business. So we have seen some of our backlog deteriorate from that. But I would say, where we're at today, the backlog is in a very healthy position compared to where we were a year ago or even two years ago. And that gives John and I confidence that we can grow this business 50% per year as we go forward from an oncology revenue standpoint.

Joseph Conway

Analyst

Okay, great. That's very encouraging. Thanks for that. And then --

Aaron Tachibana

Analyst

Sure.

Joseph Conway

Analyst

Obviously, you guys did give some more information on the patent infringement case. I know, you guys can't really comment on the case itself, but could you maybe just give a little bit more detail on the strength of the patents that you have? I believe they go back to somewhere around 2013, or could you maybe give any color about any previous cases that have been filed or litigated and maybe the result of those?

John West

Analyst

Yes. This is John speaking. Yes, you have it right. We have a number of different patents. The earliest ones go back to January of 2013. These are the things we filed when -- my prior experience with Solexa and other sequencing companies before that, we've been working on a human genome for -- actually, I have been involved in for almost 40 years now. And when we sequenced the first human genome, it seemed like this huge thing. And then with the Solexa technology, we could sequence the first one on our next-gen platform, just on one instrument that was amazing. So when we started the company, it was based on having had some of the first genomes in the whole world done. We had my family sequence actually, and we had realized that we could phase the genomes, which was something other people hadn't done up to that point. So we had a lot of experience with cold genome sequencing right at the beginning of the company. And that led us to look at how do we go beyond that? Because at that point, getting somebody's whole genome sequence, that seemed like the complete answer, you had all of -- the entire genome, what else could there be. And starting personnels, we thought there could be a lot of opportunity to build on this. And so we spent a lot of time really understanding in detail both, with the performance of full genome sequencing, but thinking about how do you combine genome. If you have multiple genomes, how do you combine those for phasing, how do you combine that with exome sequencing, for example, how do you combine things where you maybe have a whole genome from tissue sample with other things based on a liquid biopsy sample.…

Joseph Conway

Analyst

Yes. Okay. Absolutely. That makes sense. And then if I could just fire one quick one out in relation to the head count in China. I believe you said last quarter that around 10 people have been hired. I guess just wondering if that number has changed? And should we expect a large uptick in staff I guess, in 2023 when volumes are expected to start ramping?

Aaron Tachibana

Analyst

Yes. So Joe, this is Aaron. So the headcount in Shanghai is still in that ballpark plus or minus a few. We have not hired a significantly higher number than that. And it's our anticipation to get through the next few months, get through early customer qualification here with what we have, prove things out. And then in 2023, we'll hire to support whatever that revenue need is, right? So as we receive more orders, and we have more volume if we need to add more variable capacity or capability in the form of labor, we'll do so other than that, we're trying to preserve capital to make sure that we can extend our runway. So we're going to be cautious in all areas.

Joseph Conway

Analyst

Okay. Great. That makes sense. Well, thank you guys for taking our questions and congrats on the quarter.

John West

Analyst

Thanks.

Aaron Tachibana

Analyst

Thank you.

Operator

Operator

Thank you very much. Just queuing up our next question. Thank you. Our next question comes from Jason Weaver with Citibank. Go ahead.

Unidentified Analyst

Analyst · Citibank. Go ahead.

Hi. This is Lee on for Patrick and Jason. I was just wondering if you could talk about -- on the NeXT Personal side, you talked about progress there. Just broadly what milestones should we look at as we go into the second half of the year? Thank you.

John West

Analyst · Citibank. Go ahead.

Yes. I think in terms of NeXT Personal, this is John. I think we're seeing a lot of adoption there. Individual pharmaceutical companies that by end of that, some of the opportunities we're looking at are fairly large. But generally, pharmaceutical companies are not looking for us to talk about the individual cases. So we may be able to comment on as the orders ramp more or less ideas of the scale of that and the uptake of the platform. I would say that if I look back to where we were three months ago, I think we've made a lot of progress on the interest side. People are beginning to realize the power of this, the scale of it. I think you'll see more as we go forward with -- we're working with a number of very high-end academic cooperators. And some of those, we expect that we will be able to announce. And I think there'll be some really good opportunities there. I expect that we'll have access to quite a few samples through that. That will lead to some pretty impressive data probably fairly quickly because, in some cases, the samples are already banked samples. So I think as we have more and more data there, I think that will be something people will look to and see the potential of the platform, and that will lead to the more and more uptake on the pharma side. I think the funnel of potential customers is large. Almost every large pharmaceutical company we've spoken to is intensely interested in this area. In particular because there's this opportunity to move cancer drugs from only late-stage patients now more and more into adjuvant treatment of patients. So this almost doubles the cancer patient population, which is an enormous change and opportunity in the pharmaceutical world. And so tests like ours that could be involved in that kind of work. I think an enormous opportunity with pharma and then obviously, ultimately, on the diagnostics side.

Unidentified Analyst

Analyst · Citibank. Go ahead.

Great. Thank you. And then just -- as you talk about it a little bit earlier. Can you -- I guess, how did that pan out versus your expectations? And for the rest of the year, what's your thoughts around that? And that's it for me. Thank you.

John West

Analyst · Citibank. Go ahead.

Yes. I think it's been panning out very well relative to expectations. I think we always knew that -- I mean what we've done is so much more sensitive than what other people have had before us that sometimes it takes people a little while to realize that -- it's actually real. I remember we had some of this when we introduced the idea of next-gen sequencing as well. That was so astonishingly further ahead that it took a little while for people to appreciate that what you were talking about was real, and it was that big of a difference in how to think about, how it can transform what they're doing. So I think we do see people where maybe they ask about it to start with, they don't -- they're interested, they don't quite get it. And some wins see the light bulk goes off and say, really. And sometimes we've done pilot studies. And after the pilot, people have been just astonished at the results, and that's led to some pretty serious interest certainly multi-multimillion dollar potential contracts to work on things with pharmaceutical companies. So I think you'll see that going being, as Aaron said, I think in his remarks, we expect to see that the orders ramping this year and the revenue, particularly ramping next year with exports.

Aaron Tachibana

Analyst · Citibank. Go ahead.

Just to add to what John just said. So if you look back three years ago, again, we had just a handful of customers on the NeXT platform. Sitting here today, we have more than 70 customers on the NeXT platform. More than 75% of our revenue in the second quarter was from the adoption of NeXT, our MRD offering, we believe, is very, very sensitive, more sensitive than other comparables in the marketplace today. And like John said, the interest from pharma set of our revenue in the second quarter was from the adoption of NeXT. Our MRD offering, we believe, is very, very sensitive, more sensitive than other comparables in the marketplace today. And like John said, the interest from pharma is enormous. And so the funnel has grown significantly over the last three to five months. And we're anticipating a lot of orders coming in later this year and into 2023. So we're really excited about what this ramp can be in terms of revenue in 2023. And today, most of our revenue is from our tissue-based offering from NeXT. As we go into 2023 and beyond, we're going to complement the tissue offering with liquid biopsy, the MRD offering. And that's going to add multiple time points. So our market -- our total available market is going to expand significantly, and we're really excited about the revenue opportunity.

Unidentified Analyst

Analyst · Citibank. Go ahead.

Great. Thank you.

John West

Analyst · Citibank. Go ahead.

Sure.

Operator

Operator

Thank you. Just queuing up our next question, our next question comes from the line of Mark Massaro with BTIG.

Mark Massaro

Analyst · BTIG.

Hey guys. Thanks for the questions, and I've been hopping around call tonight. So if you covered this, I apologize, but -- can you maybe just provide an update on NeXT Dx, Obviously, that's your ontario into the clinic? Are you on track to submit to MolDx. I think it's pretty soon and -- are you still hoping to obtain Medicare reimbursement by year-end?

John West

Analyst · BTIG.

Yeah. This is John. Thanks for being on the call. So NeXT Dx, we are pretty much on track. We do expect to be in the site. We actually have our first salespeople on board now. And we'll be beginning to bring in customers there. MolDx, we expect to actually submit to MolDx by the end of this year. We expect the -- if things go well, we'd have a reimbursement -- positive reimbursement decision early in 2023.

Mark Massaro

Analyst · BTIG.

Okay. Perfect. And then, I understand that the NeXT Personal is certainly gaining interest from biopharma. But maybe I wanted to just double check to see where you're at in terms of the clinical launch. I think in the past, you've talked about first half of 2023? And maybe can you just give us some expanded color on your path to reimbursement. In the last month or so, there were pretty I think, three significant MRD tests that received MolDx reimbursement. I think all of those develop the evidence to support that. I guess maybe just an update on where you are in terms of evidence development to secure reimbursement?

John West

Analyst · BTIG.

Yeah. So this is John. I think the -- our expectation, as you say, the first customers we have for NeXT Personal already are pharmaceutical customers. We expect that, that will be the biggest revenue ramp for us next year. I don't think we've said exactly when in 2023. We'd expect that to be available as a lab-developed test, but that is certainly on our radar for 2023. We do see that as being something we'd want to take to MolDx. We've been laying out the right validation plan for that. I think in terms of the evidence development, it's likely to be clinical validity that's needed as opposed to the clinical utility of early detection. In this case, has already been pretty well established. So at least in the clinical indications for which other people already have reimbursement, we expect that we'd be in a position to show that we are I think non-inferior is the official word. We expect to be, frankly, a hell of a lot better. But the -- we'll be showing that. I think we'll have a pretty good validation to talk with MolDx about. Our expectation is that positive MolDx decision on that could be in 2024, but I don't think we've been any more specific about that. Yeah, we do see it as a big opportunity. But frankly, I see pharma is a pretty big opportunity in the near-term as well. There's a lot of movement to this area in pharma.

Mark Massaro

Analyst · BTIG.

Okay. Awesome. And then one final question on MRD, the market leader, I think, looks at 16 variants and aspiring entrants are looking somewhere between 40 and 80 or so. I think you're looking to track about 1,800. I guess, can you just comment on what early feedback you're getting from pharma customers about the size of monitoring 1,800 different variants? And maybe just what you're hearing? And are there any concerns about how to interpret this and what you're doing to kind of instill confidence that tracking more is superior?

John West

Analyst · BTIG.

Yeah. This is John. So – we don't ask the customers to look at every one of the 1,800 variants. We take care of that part for them. So, our end up – we end up with a very simple result, which is just, did we detect the tumor or not? And if we detect it, at what level it was, so that's pretty easy to understand. I think, the key thing is, we can see that we're at a much lower level than other tests do. And the sensitivity difference can translate into -- if you're thinking about the development of a tumor, different cancer types have different growth rates, but the tumor volume doubling time can be anywhere between a few months and even as long as a year. So if you're 10 times to 100 times more sensitive, you can be looking at detecting recurrence potentially even in some cases, years earlier. And so I think as we have the clinical data that we expect to have from collaborators that shows that more. I think people get – but already – people understand this field enough to see the difference in terms of sensitivity. The other piece though, I'd say is that, in addition to the 1,800 variants that we look at, for the recurrence detection or the quantification. We actually look at almost that same number as well. That's part of what we call the fixed content of the assay. So it's not tumor-informed – that's – that's the same for every patient. And that gives us a broader view so that, if you've detected recurrence, you don't know, what can I do about it? What drug should I give the patient or if I'm giving them a particular drug is the tumor beginning to escape…

Mark Massaro

Analyst · BTIG.

That sounds great. Thanks so much for the color.

John West

Analyst · BTIG.

Great. Thank you.

Operator

Operator

Great. Our next question comes from the line of Derik De Bruin, Bank of America.

Derik De Bruin

Analyst

Hey, thanks for taking my questions. I've also been bouncing around and Mark just took all the ones I wanted to ask. So I'll do this one. Can we talk – can we just talk preliminarily on what your sort of initial thoughts are in 2023? I mean, I know it's early, but there's a lot of moving parts. You're trying to manage OpEx. Any incremental color you can give us this time. You know, where the consensus estimates are? And just some general thoughts on capital raise and stuff like that? Just some general thoughts given that it's such a touchy topic these days?

Aaron Tachibana

Analyst

Yeah. So this is Aaron. Hi, Derik. In terms of 2023, so it is early for us to give any type of guidance. But in terms of maybe directional insight, we'll try and provide that. In terms of looking at the top line, our goal is to grow our oncology revenue at least 50% year-over-year. And so 2023, based upon what we can see today, we don't see a reason why that's not possible. We're going to be entering into the clinical diagnostic market with a favorable reimbursement rolling early in 2023, so we should have some NeXT Dx clinical revenue in 2023. We can't really say exactly how much that's going to be just yet. We'll have to wait and see, more to come in that regard. Biopharma has been strong for us in the past, and again, it's been predominantly our tissue-based offering. So as we get take up here with our MRD NeXT Personal from biopharma in 2023, we believe we have a great opportunity in terms of ramp up there. China is going to start to come online in 2023, right? It's probably going to be moderate revenue in terms of where we'll be. We have one customer that's placed orders with us. We've got several others that are evaluating our platform and capability in China. And so it's hard to know exactly where those will come in, but we're expecting a little bit of revenue from China as well. In terms of the OpEx and cash spend, we're being prudent right now. We have -- we've slowed down hiring quite a bit. We've hired quite a few employees over the last couple of years that's given us a lot of capability to get into the clinical market. We still have a commercial team to continue to expand in the clinical area, and we have the reimbursement capability and the billing teams that we have to continuously expand and those will be commensurate with volume, right, as we start to see the favorable reimbursement ruling and things are going to really take off, we'll add to that, but we're going to be prudent with cash spend, so to speak. And our goal is to continuously extend the runway as we get out in time, right? And in terms of -- you asked about capital raise, that's something that I can't really chat about right now. We don't really see that in the cards based upon where our equity value is at today. So we're going to, again, continuously stretch out our cash runway as far out as we can.

Derik de Bruin

Analyst

What you said on the call about the cash level too is that by the end of the year, because the efforts to bring cost down also helped on that.

Aaron Tachibana

Analyst

Yeah. So our cash usage in 2022 is expected to be about $125 million at this point in time. We've reduced it from $140 million just six months ago. If we can continue to reduce it, we will. And again, there's some one-time amounts in that $125 million, $40 million of it is for this new building, which won't repeat. So when we get into 2023, our operating cash burn is somewhere in the $80 million to $85 million range. And obviously, if we can grow top line even faster, that will help us from a gross profit standpoint and pay for some of the investments we need to make.

John West

Analyst

One more item I'd add is that when we look at other companies, sometimes they'll talk about liquid biopsies as being a substitute for tissue biopsies. But actually, in our case, with the kind of products that we've developed, we have our whole NeXT Platform that's been built on tissue-based samples. And now we've been adding liquid biopsy is, those are almost entirely additive. People are using those in addition to the tissue offerings, not instead of them. And so, with all of the new things like NeXT Personal, that's all has the potential to be purely additive as opposed to like being a new version of a product where we swap out the old one.

Derik de Bruin

Analyst

Great. Thanks for the detail there. Appreciate it. Thank you.

John West

Analyst

Thanks, Derik. Thank you.

Operator

Operator

Thank you. [Operator Instructions]. We have one more question. Our next question comes from the line of Arthur He from H.C. Wainwright & Company. Thank you.

Arthur He

Analyst

Hi good afternoon John and Aaron. Most of my questions have been answered. I just wonder, regarding the clinical diagnostics business, could you just give us more color on your inaction with the KL versions at the major center centers. Is there any pilot projects in place already for this business, we expect launching next year to try?

John West

Analyst

So this is John. So in terms of the diagnostic business and working with some of the KOLs, we actually do have some projects underway with a number of groups. We've talked about our work with UCSD in the past. For example, that's progressing -- we have work that's been going on at the Mayo Clinic with a group there. We have other collaborators that we haven't named yet, where we're beginning to get receipt. We actually have received samples, and we're now beginning to process them. So I don't have anything new in terms of names to announce today, but we're definitely making progress on sequencing samples, doing the analysis and having people get results. So I think in time, this is the kind of I think it was mentioned earlier, the evidence development that will put us in a position of credibility both for customer adoption and for reimbursement.

Arthur He

Analyst

Thank you. I appreciate that and congratulate on the quarter.

John West

Analyst

Okay. Thank you.

Operator

Operator

Great. At this point, there are no more questions. So we want to thank you for your participation in today's conference. This concludes the program. You may now disconnect.