Personalis - Q2 2023

Transcript

Operator (participant)

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Caroline Corner, Investor Relations. Please go ahead.

Caroline Corner (Head of Investor Relations)

Thank you, operator. Welcome to Personalis's second quarter 2023 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President, Aaron Tachibana, Chief Financial Officer and Chief Operating Officer, and Rich Chen, Chief Medical Officer and EVP, R&D. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of U.S. securities laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, price expectations, the outcome of legal proceedings to enforce patents, the validity or enforceability of our patents, and our market opportunity 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 most recent quarterly report on Form 10-K. Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release with our second quarter 2023 results is available on our website, www.personalis.com, under the Investor section, and includes additional details about our financial results. Our website also has the latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5:00 P.M. Pacific Time today. Now, I would like to turn the call over to Chris for his comments and second quarter business highlights.

Chris Hall (CEO and President)

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. I'm proud of our team as we continue to execute well, pursuing near-term milestones that we expect to fuel our revenue growth ahead. We made progress this quarter in deepening our collaborators for NeXT Personal, preparing the test for clinical use this year, and lastly, establishing NeXT Personal as the assay of choice for global biopharma customers. Personalis is uniquely positioned to grow rapidly over the next several years, as we'll benefit from two very important developments occurring in oncology: the necessity of personalized diagnostic tests to monitor patients with cancer and the development of personalized therapies. Both of these shifts in cancer management require discriminating technology to illuminate the uniqueness of a patient's disease and the ability to provide actionable information to change the arc of their treatment.

Personalis' technology platform enables the solutions needed to impart the big shifts occurring in oncology today. Earlier this year, we laid out our win in MRD strategy to go after what we estimate to be a $25 billion monitoring market. Our product addressing this space is a tumor-informed, personalized liquid biopsy test called NeXT Personal. Our focus strategy involves deepening evidence and pursuing coverage in three cancer indications: early-stage lung, early-stage breast cancer, and immunotherapy monitoring. We focused on these cancer types because we believe that the ultra-high sensitivity of our technology is uniquely suited to both detect recurrence very early and also to guide treatment decisions in these areas. Let me elaborate about high sensitivity and what that means, as it is at the heart of our strategy. We aim to achieve cancer detection levels down to one part per million.

What this means is that NeXT Personal may find residual or recurring disease when there is only as few as 1 circulating cancer DNA fragment among 1 million normal DNA fragments in the blood. We believe it can do this not just for a few patients, but consistently for most patients across many different cancer types and stages. We believe NeXT Personal can detect cancer well before competitive technologies, and importantly, can provide confidence that, one, when we detect cancer, we see it earlier, when patient management can be modified to result in more favorable outcomes. two, when we don't see cancer, the patient will likely remain disease-free and may not need additional therapy. Over the last few months, we've seen early data demonstrating NeXT Personal's performance, and we expect additional data to be published in our focused cancer types.

On our last call, we mentioned that we were chosen by AstraZeneca and TRACERx for their MRD studies. AstraZeneca will use NeXT Personal to explore ultra-sensitive MRD measurement for clinical research and drug development. We're working with the TRACERx samples and Dr. Charles Swanton and his leadership group to demonstrate the value of an ultra-sensitive assay, such as NeXT Personal and lung cancer patients. I'll add more color to the TRACERx relationship and how the evidence developed supports reimbursement in a minute. It's important to point out that these high-end collaborations are validations of our technology and performance claims. We're proud that global leaders are choosing to work with us, and we're thrilled that our ultra-sensitive MRD capability is being recognized and deployed. At the heart of our win in MRD strategy is to make progress with clinical evidence to support reimbursement for NeXT Personal.

You may recall that our goal is to have reimbursement in one disease area by the end of 2024. While it's an aggressive timeline, we have already established key collaborators and studies in each of our focused cancer types, and we continue to believe that this goal will be realized next year. We now have anchor studies lined up in each of our key indications and are on target to be able to submit for coverage in 2024. Let's run through the focused indications. I'll start first in lung cancer, where the TRACERx collaboration is our anchor study. The TRACERx consortium is led by lung cancer expert Dr. Charles Swanton, and teams at Cancer Research UK, the Francis Crick Institute, and University College London. Previously, this group conducted research on prior generations of MRD assays and identified significant opportunities for detection improvement.

The study will now deploy NeXT Personal to determine the clinical value of an ultrasensitive assay for early-stage lung cancer. We expect data to be presented at an upcoming scientific conference this year. Second, in breast cancer, we secured a relationship with Royal Marsden in the UK. Royal Marsden is one of the leading institutions globally in breast cancer. Our work with them will focus on patients with early-stage disease for several subtypes, including ER positive, HER2 positive, and triple-negative breast cancer. The Royal Marsden collaboration provides access to a large, well-annotated set of samples with clinical outcomes that we believe will provide a foundation for coverage in breast cancer. Additionally, our prospective trial, B-STRONGER, has kicked off, and we plan to enroll approximately 900 patients at up to 30 U.S. sites.

We made significant progress with establishing committed sites this quarter and expect to be enrolling patients this year. The B-STRONGER-1 trial is a collaboration with the Academic Breast Cancer Consortium and Criterium, and will be carried out in two stages. In the first stage, samples will be collected from each patient for both pathological complete response, or pCR, and MRD analysis, to assess whether MRD using NeXT Personal correlates with standard of care pCR measure. The second stage will involve a five-year follow-up to further establish clinical validity and performance of NeXT Personal at early-stage triple-negative breast cancer. We're expecting these studies and trials to showcase NeXT Personal's ultra-sensitivity and ability to provide insights important for patient therapy decisions. Third, we have a new collaboration with Vall d'Hebron Institute of Oncology, or VHIO, to demonstrate and leverage the efficacy of NeXT Personal for IO therapy monitoring.

Notably, the VHIO gives us access to a large, well-annotated bank of retrospective samples that are the cornerstone of our efforts to achieve reimbursement coverage for pan-cancer IO therapy monitoring. This exciting collaboration joins existing work we've announced on melanoma and IO therapy with the University Medical Center, Hamburg-Eppendorf, also known as UKE, and our previously announced Duke and UCSF relationships. As a reminder, we have presented compelling data already for the work with the UKE at the AACR and ASCO this year. Also, as we march towards establishing Personalis as a market leader in MRD, we remain on track to launch NeXT Personal as a clinical laboratory-developed test, or LDT, to be used by oncologists in the fourth quarter of this upcoming year. Excuse me, of this year.

Our proprietary technology is key to enabling our NeXT Personal product to transform the cancer diagnostic market, and it's also powering the next generation of our customers' oncology biopharma products. We've made strong progress with multiple global biopharma customers this quarter, including the recently announced collaboration with National Cancer Center Hospital East and Ono Pharmaceutical Company, to better predict immunotherapy response for rectal cancer. This is yet another validation of our technology by a world-renowned KOL and large pharmaceutical companies wanting to be a part of our journey to change the paradigm for cancer detection as well as treatment. We are investing heavily to win an MRD, and our proprietary platform is a leap forward for the field.

It's important to defend our investment, which is why we continue to aggressively defend our industry-leading intellectual property portfolio and initiated a second patent infringement lawsuit against Foresight Diagnostics with three additional patents, which means we now have a total of seven patents asserted in our lawsuits against Foresight. We have continued to expand our patent estate, and we believe it reinforces our market leadership position. We intend to continue to vigorously defend the investment we're making in transforming the active management of cancer through breakthrough personalized testing for the benefit of our investors, our customers, and our patients. While NeXT Personal has the potential to lead the industry in personalized assays to monitor cancer progression, equally exciting is how Personalis technology is powering the development of the best personalized therapies.

As announced earlier this year, we are a key partner for Moderna's clinical trial work as they pursue regulatory approval of their personalized therapy. As Merck and Moderna disclosed, they have begun enrolling patients in their phase three clinical trial. This is an exciting development for us, and as we've said, while it's still early days, we expect this to be a significant driver of revenue in 2024. With thousands of new cancer patients each year in the U.S. alone, our aspirations are for Personalis technology to power the development of the next-generation vaccines and therapies, as we're doing with our Moderna partnership. Turning to population sequencing, we were recently notified by the United States Department of Veterans Affairs Million Veteran Program, the VA MVP, that they exercised the next year option, which starts in September 2023.

As a reminder, we received last year's task order for up to $10 million late in September, and our expectation is that we would receive the 2023 task order late this coming September. We are excited to continue supporting the VA MVP and their initiatives. We're also excited that Dr. Ken Widder has joined our board of directors. Ken brings to us an extensive experience set within the healthcare and molecular diagnostic industry, in addition to his wealth of public company experience, and we're pleased to have him working with us. It's an exciting time at Personalis, and we continue to make progress on multiple front-.

... We appreciate all of our partners and investors being part of our journey. With that, I'll now turn it over to Aaron to review our financial results.

Aaron Tachibana (CFO and COO)

Thank you, Chris. We executed well in the second quarter and continue to meet our financial commitments. I will be providing detail about our second quarter financial results and guidance for the third quarter and full year. Total company revenue for the second quarter of 2023 was $16.7 million, and decreased 8% compared with the same period of the prior year, primarily due to the timing of customer sample receipts, biopharma economic headwinds, reducing unprofitable business, and VA MVP revenue. Gross margin was 28.7% for the second quarter, compared to 25.1% for the prior quarter, and 23.5% for the same period of the prior year.

The sequential increase of 3.6% and year-over-year increase of 5.2% were primarily due to dedicating more operational resources to perform tests required for clinical evidence generation, which is non-revenue and therefore categorized as R&D expense. This includes sample processing for collaborations that include TRACERx, Duke, UKE, and others. Operating expenses were $30.1 million in the second quarter and included a one-time, non-recurring restructuring charge of $0.1 million associated with the closure of our China lab operation, compared with $32.2 million for the same period as the prior year. Excluding the restructuring charge, our operating expenses were $30 million and decreased $2.2 million from the same period last year.

R&D expense was $17.9 million in the second quarter, compared with $16.3 million for the same period last year. SG&A expense was $12.1 million, compared with $15.9 million for the same period last year. Net loss for the second quarter was $24 million, compared with a net loss of $27.5 million for the same period as the prior year. The net loss per share for the second quarter was $0.50, and the weighted average basic and diluted share count was $47.7 million, compared with the net loss per share of $0.60 and a weighted average basic and diluted share count of 45.6 million for the same period of the prior year. Now on to the balance sheet.

We finished the second quarter with a strong balance sheet, with cash and short-term investments, $137.2 million. In the second quarter, our net cash usage was $11.7 million, which was significantly down compared with the last five quarters, primarily due to completing the new facility build-out and paying for it earlier this year. Also, the timing of payments received from customers was optimal in the second quarter, which helped our cash flow. Now, I'd like to turn to guidance. For the third quarter of 2023, we expect total company revenue of approximately $17 million, revenue from pharma tests, enterprise sales, and other customers of approximately $14 million, and revenue from population sequencing of approximately $3 million. For the full year of 2023, we tightened our revenue guidance range with the midpoint increasing.

We now expect total company revenue to be $70 million-$72 million, with oncology revenue from pharma, enterprise sales, and other customers to be $61 million-$63 million. Population sequencing revenue to be approximately $9 million and expected to be recognized during the first three quarters. Net loss of approximately $103 million, which is $10 million lower than the loss of $113 million in 2022. Cash usage of approximately $70 million, which is now $5 million lower than our prior estimate from last quarter and represents a reduction of almost $50 million from 2022. We look forward to updating you on our milestones as we make progress throughout the rest of the year. With that, I will turn the call back over to the operator to begin the Q&A session. Operator?

Operator (participant)

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. We ask that you limit your questions to one and one follow-up so that others may have an opportunity to ask questions. You may reenter the queue by pressing star one. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. First question comes from Tejas Savant with Morgan Stanley. Please go ahead.

Tejas Savant (Executive Director and Senior Healthcare Equity Analyst)

Hey, guys, good evening, and thanks for the time here. Maybe to kick things off, Chris or Aaron, perhaps, can you help us think through the personalized cancer vaccine opportunity? You flagged it a couple of times now as a very important growth driver for 2024, but any color you can share in terms of the revenue potential here, and how you sort of, you know, plan to expand your book of business now that you have, you know, Moderna and a couple of other people signed up?

Aaron Tachibana (CFO and COO)

Hi, Tejas, this is Aaron. Thanks for the question. In terms of the PCV opportunity, as we had mentioned in the prepared remarks, you know, Moderna and Merck, they both started the Phase III clinical trial, enrolling patients. There are multiple sites. In terms of sample flow to us, it's been a little bit slow right now, so it's our expectation that through the rest of this year, here in the second half, you know, the revenue could be moderate and start to ramp significantly as we get into 2024. You know, on the last call, we did talk a little bit about the Natera business tailing off in Q1, and it's our expectation that the ramp on the Moderna side could potentially offset what we lose on the Natera side of the business.

Chris Hall (CEO and President)

Yeah, I would note, it's Chris, that we've, we've always talked that we have had over the, over the arc of time, 18 clients for personalized cancer vaccines. Some of those companies, you know, are not, are not around anymore, but many of them still are, and we believe we are by far the market leader, partnering with companies with personalized cancer vaccines, because the platform that we have has been uniquely designed to be able to support people building those personalized therapies. So we're positioned well as that industry comes together to, you know, be the partner of choice.

Tejas Savant (Executive Director and Senior Healthcare Equity Analyst)

Got it. That's helpful. Then, Aaron, one quick one for you here. You, you mentioned Natera here, heading into 2024. How are you thinking philosophically about, you know, that contribution? Will you essentially assume it to be zero when you guide with the possibility of, you know, a more modest, sort of like, step down, if you will? Same question on the MVP side of things. Now that you have the renewal, and you're expecting the top quarter in by the end of September here, should we expect sort of a $3 million-ish contribution per quarter, you know, through sort of September of 2024?

Aaron Tachibana (CFO and COO)

Yeah. We'll take the MVP one first, because that one's probably easier to deal with. In terms of MVP, we expect an order at the end of September. We don't know exactly how large it'll be, so our expectation or our estimates don't include anything in the fourth quarter of this year. We're assuming it's the same size as the last order, so you know, we'll assume somewhere in the $9 million-$10 million range in 2024, probably fulfilled over the first 3 quarters of the year. Okay? In terms of the question on Natera, consistent with our last call, you know, we did have a revised agreement on volumes with Natera, so we've agreed to minimum quantities, and that agreement takes us through the end of Q1, with volume starting to taper off.

We're seeing that here in Q2, or we saw it in Q2, down from Q1. Our expectation now here for the second half is, you know, things could be flattish from the second quarter through the rest of this year. In terms of what happens beyond that, you know, it'll depend upon, you know, what's happening with Natera's volumes. I think their volumes continue to grow, and to the extent that they do need, do need an outsourced partner for additional capacity and capability, we could be that partner, you know, for them. You know, more to come here. We don't have exact clarity on the volumes into 2024, but our estimates would include them, them tapering off, you know, in the Q1 timeframe at this point in time, based on what we know.

Tejas Savant (Executive Director and Senior Healthcare Equity Analyst)

Very helpful. Thanks, guys. Appreciate the color.

Aaron Tachibana (CFO and COO)

Sure. Thank you.

Chris Hall (CEO and President)

Thanks.

Operator (participant)

Next question, Patrick Donnelly with Citi. Please go ahead.

Speaker 10

Hi, you have Brendan On for Patrick. I wanted to start it off with the revisions to the guidance. You raised the midpoint by $1 million, mainly driven by the pharma and enterprise sales. I just want to know if you could provide any commentary or color on what's driving that confidence.

Aaron Tachibana (CFO and COO)

Yeah, great question. In terms of our confidence for the back half of 2023, we see the back half being a little bit higher than the first half. The funnel of opportunities with pharma for MRD continues to grow. You know, even though we haven't had a lot of revenue being recognized earlier this year or even last year from pharma with MRD, we believe it's poised to take off later this year, primarily because we're providing more clinical evidence into the marketplace based on what we're doing with collaborators. In addition, on the Natera side, on the last call, we did mention that volume should start to taper off. We're seeing that, you know, volume is probably gonna be flattish the second half of the year compared to what we saw here in the second quarter.

Speaker 10

Great. Thank you. Moving on to the cash usage for the quarter. Lowering the cash usage for the year from $75 to around $70. Can you kind of go through the puts and takes of what led to the decline there?

Aaron Tachibana (CFO and COO)

Year over year, we're declining cash usage by about $50 million. In 2022, we had a heavy amount of investment, you know, $45 million-$50 million for our new facility. Most of that is beyond us now. In terms of the headcount reduction that took place in the first quarter, you know, we reduced headcount by some 30%, which saved us $20 million on an annual basis going forward from a cash usage standpoint. In addition, we've been looking at all discretionary spend and being prudent in terms of what we could defer or reduce and not spend at all.

Speaker 10

Great. Thank you.

Aaron Tachibana (CFO and COO)

Sure.

Operator (participant)

Next question, Mark Massaro with BTIG. Please go ahead.

Mark Massaro (Managing Director and Senior Equity Research Analyst)

Hey, guys. Thanks very much for the questions. My first one is on the TRACERx trial. You know, Charlie Swanton has used, at least two other MRD tests, in his work in lung cancer. It would be really interesting to hear, what you know about why he chose-.

... Personalis as the, the third or maybe the fourth test, what was it about the first couple of tests that may have had a limitation? What exactly was the interest in the NeXT Personal test? As a, as a follow-up to that, you guys talked about reading out, a, a lung study, I believe, later this year. Can you give us a sense for the size of that clinical study and what the endpoints are?

Chris Hall (CEO and President)

Awesome. Mark, it's Chris. Rich is here and is gonna jump in and talk about the Tracer assay since he's worked with the collaborators, TRACERx collaboration.

Rich Chen (Chief Medical Officer and EVP, R&D)

Yeah. Hi, Mark, this is Rich. Great, thank you for the question. You know, I, I think, you know, as you noted, you know, Charlie is, is, is, has been in this field of MRD testing for many, many years, looked at other platforms. You know, I, I think, you know, as many have noted, not just Charlie, that there's a, the, the, there are areas of, of not just lung cancer, but other cancers where, you know, the, the first generation of tests, did not, was not sensitive enough to pick up, the, the cancer. I think that's a, it's a large reason he chose to work with us. He noted that we have an ultrasensitive platform. He saw the promise of that very early on.

We started working with him, you know, over a year, year and a half ago on this. So I think that was, that was really exciting for him to be able to, to, to start this collaboration with us. Then, you know, in terms of the data generation, we're, we're in the thick of it right now. We're on track to start to talk about this data before the end of the year. And, you know, I think the, the data is looking encouraging.

Chris Hall (CEO and President)

If I give you a step back, I mean, we, we've always seen it 1 part per million, the Personalis technology being up to 100 times more sensitive. You know, that gives us the opportunity to be able to see, you know, what others can't see, whether it's standard of care imaging or whether it's other, whether it's other assays in the marketplace. We're really positioned to be able to be a leap forward in MRD detection.

Mark Massaro (Managing Director and Senior Equity Research Analyst)

Okay, great. I know conceptually, hundreds of patients have enrolled in the TRACERx trial. Is the idea that, that each of the folks that are still alive would get a NeXT Personal test? If that's true, can you talk about the opportunity for repeat time points? Because clearly MRD has value over serial testing. I'd just be curious to get a sense for what type of visibility you have on, you know, the number of tests that you think you could generate over time.

Rich Chen (Chief Medical Officer and EVP, R&D)

Yeah. That's a great question, Mark. You know, the TRACERx cohort is actually a retrospective cohort, so the, the collection has already been done for all these patients. The great thing there is that Charlie and his team had the foresight to, you know, collect a lot of plasma along the way, longitudinally for these patients. Now we know, because they've been followed up for many, many years, we actually know the clinical outcomes for these patients. It makes it up for an ideal cohort for us to, to test our technology on, because, in some sense, we already know what the outcomes for these patients are, and we can show that we can predict that using our test.

We can also examine, you know, if we're gonna be looking at data from all those time points that were collected, and looking at sort of, you know, what kind of decisions could be made, you know, with all those, any of those time points along the journey of the patient. I think we're, we're gonna find that there could, you know, there's gonna be utility in the test at various points in the patient journey, and that's part of what we want to establish here.

Chris Hall (CEO and President)

What I, what we think, if you step back, we, we talked through the, the pipeline of studies across the three focused cancer indications. Each one of those give us access to a large set of retrospective data set with multiple time points, with clinical truth, for us to be able to show the efficacy of the approach of an ultrasensitive assay in cancer types that have been hard to inform on traditionally.

Mark Massaro (Managing Director and Senior Equity Research Analyst)

Okay, that's it for me. Thank you, guys.

Chris Hall (CEO and President)

Thanks.

Rich Chen (Chief Medical Officer and EVP, R&D)

Thanks, Mark.

Operator (participant)

Once again, if you would like to ask a question, please press star one on your telephone keypad. Next question comes from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Thank you. Good afternoon, Chris and Aaron. Just to follow up from the previous set of questions. With TRACERx data that you will get at the end of this, obviously, it will define your test a little bit better. With that data set or with that experience, how would you monetize this beyond what is being done now?

Chris Hall (CEO and President)

Well, we'll be launching the test into the clinical market, at the end of this year, towards the end of this year, which means for the first time, NeXT Personal will be available, NeXT Personal will be available to doctors around the United States to be able to use on patients. That's significant because it'll be one of the, you know, next entrants into the market, and we're super excited about. We've got a lot of feedback. We will take the TRACERx data. Ultimately, we expect it to be published at some point, and our hope is that that will drive the, the, be the foundations of getting covered for the product so that we get paid by health insurance companies for doing testing in early-stage lung cancer. That's one snapshot.

The other snapshot of the business is that we have a large, robust biopharma set of clients with, you know, many of the big biopharma companies. They're all deeply involved in MRD usage or analysis, and having great data sets to be able to inform those conversations helps us continue to get studies and be a further revenue driver. So we see that data along with the other data sets that we're working with from Duke and UCSF and Royal Marsden and VHIO, et cetera. We expect all those to help us fuel additional conversations and/or business from biopharma customers and form the foundation to have to get insurance coverage, which ultimately will build a base of revenue around the clinical samples that we get from patients, and, and doctors around the country. Is that helpful, Ramakanth?

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Yes, thanks for that. On the B-STRONGER trial, you know, that includes, like a five-year follow-up in these, in these breast cancer patients. Does that mean these will be continuously getting data in, in the interim? Is it one of those things where you have to wait for a longer time period to get-

Chris Hall (CEO and President)

Yeah.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

A large, you know, data set?

Chris Hall (CEO and President)

Yeah. Rich, Rich can go into it a little deeper. We did structure it with a early, interim set of data that can help us get, we believe, coverage and ultimately payment and then clinical adoption in triple-negative breast cancer. We'll get data, well before the whole five-year follow-up. Do you have anything to add, Rich, about?

Rich Chen (Chief Medical Officer and EVP, R&D)

No, that, that's exactly right. It's been specifically designed to follow up. Follow those five years, we have specific interim readouts on the data that are planned, where we can get an early glimpse as to the performance at an earlier point, time points.

Swayampakula Ramakanth (Managing Director and Senior Healthcare Analyst)

Thank you. Thank you both for taking my questions.

Chris Hall (CEO and President)

No, absolutely. Thanks for the questions.

Operator (participant)

Next question, Dan Brennan with Cowen. Please go ahead.

Daniel Brennan (Managing Director and Senior Research Analyst)

Great. Thank you. Thanks for taking the questions. Maybe staying with MRD, you mentioned in the prepared remarks about some presentations later this year. Wondering if you can kind of flush out a little bit what we can expect from that?

Rich Chen (Chief Medical Officer and EVP, R&D)

Yep. This is Rich Chen. Thank you for the question. Yes, we're on track to hopefully be able to report out on some of this data later this year. There's an upcoming conference at ESMO. It's a very large oncology conference in Europe, where we expect to present some of this early data on TRACERx. There's several other conferences later in the year that we're also targeting for additional data on the breast cancer side.

Daniel Brennan (Managing Director and Senior Research Analyst)

In terms of contribution from all the pharma, relationships here, just kind of apologize if you guys already discussed this, but, what kind of impact is kind of assumed in 2023? How do we think about the potential opportunity for pharma, in 2024?

Chris Hall (CEO and President)

Hey, Dan, this is Aaron. Thanks for the question. We didn't talk specifically about the pharma contribution, in terms of what's baked into the guide, somewhere in the $31 million-$32 million range for pharma, inclusive of TCV.

Daniel Brennan (Managing Director and Senior Research Analyst)

Got it. And, and specifically for, you know, MRD, like, what, what's, what's the contribution specifically for MRD within that? Just kind of trying to frame what the opportunity there is.

Chris Hall (CEO and President)

Yeah.

Daniel Brennan (Managing Director and Senior Research Analyst)

From a pharma.

Chris Hall (CEO and President)

We haven't said. Yeah, we haven't said publicly anything about the exact numbers about MRD in terms of where it would be, but it's gonna be, you know, single digit millions later in the year. It's, I mean, it's a, it's a smallish piece, but we. I mean, we're really super excited about the potential in 2024, 2025, especially as these data sets start to come together, and, you know, we're positioned with all the large biopharma customers because of the work that we've always traditionally done in the translational side with ImmunoID platform, to be able to capture a much bigger piece of the, of the, of the spending and move into the MRD market.

We've gotten a lot of interest from those companies, and they've, you know, different types of trials and, and bake off and, and, and test with us. We expect that to be a big driver moving forward of, of the revenue in 2024, 2025, especially as we deploy the NeXT Personal assay into clinical trial, into clinical trials, because that's where some of the bigger opportunities are than just doing translational work for biopharma customers. We're super excited to that be a, a growth driver. The focus is, is right now, you know, is getting the evidence out there and marching towards coverage and getting doctors to be able to use it and do that in a really smart, cost-effective way, you know, in terms of sales and marketing and, and moving along the, the journey.

Then having the biopharma customers, you know, at the same point in time, you know, be driving revenue as we go through that commercial journey.

Daniel Brennan (Managing Director and Senior Research Analyst)

Have you guys discussed at all kind of how we think about pricing for biopharma side on a, you know, per sample or any kind of quantification there?

Chris Hall (CEO and President)

We have not disclosed the pricing. Now the, the, the NeXT Personal is available and is being used by biopharma customers. There is a version of it, an RUO, which is substantially the same. We're just finishing the analytical validity work for the LDT, but it's being used right now by several biopharma-... We've not disclosed pricing on that, and we've not priced the clinical lab product yet.

Daniel Brennan (Managing Director and Senior Research Analyst)

Got it. Okay. and then finally, I know you talked about maybe getting coverage by the end of next year. You know, amongst the, the, you know, the three lead areas. I mean, have you disclosed, you know, which of the three, if it's the lung, the breast or the IO-?

Chris Hall (CEO and President)

No.

Daniel Brennan (Managing Director and Senior Research Analyst)

which, which of the three are the-

Chris Hall (CEO and President)

No, I mean, in a perfect world, we get covered all three, right, at the same time. Our expectation is that we're driving data simultaneously. What, what you have to do to get coverage, as you know, is the data needs to be put into an article. It needs to be accepted in a peer-reviewed journal. We need to submit for coverage, and then there's inevitably a period of back and forth and discussion that happens with Palmetto, right? That process is a little bit beyond our control because both getting the data into publication is a bit on how the collaborators move, et cetera. That process of getting it into the public domain and accepted is another set of journeys. We don't expect that all three of those will go at the same rate.

Something, some, some may go quickly into publication, some may go slower, some could, you know, go through a couple different, you know, iterations, et cetera. That tail is largely beyond our control. What we can control is getting the data to the collaborators so that they can write the articles and get those submitted. There's a period of time in this journey where, you know, there's a back and forth between the collaborators and the journals, et cetera. We'll take it from there and drive it towards, towards coverage. We're moving aggressively on these three fronts. You know, our expectation is that one of them will go, and we'll be able to make progress, but that's, that's the way we're thinking about it.

We'll, we'll keep you all updated, obviously, as data is submitted and as things come together. It'll, but that's, that's the journey that we've laid out and we're committed to executing on.

Daniel Brennan (Managing Director and Senior Research Analyst)

Finally, just on the balance sheet, like, how should we think about the need for financing and how you guys address that going forward?

Aaron Tachibana (CFO and COO)

Yeah. We, we continue to extend our cash runway down. At the end of Q2, we had $137 million in cash, which is 2 years of, of cash runway. In terms of where we're at today, you know, we continuously defer expenses where we can, you know, we're being prudent in terms of discretionary spend. Obviously, we have clinical evidence and things like that that we have to go get done. We're spending where... Only where we need to. In terms of where we're at today, right, short term, I think we're in good shape.

Daniel Brennan (Managing Director and Senior Research Analyst)

Perfect. Okay, thanks a lot.

Aaron Tachibana (CFO and COO)

Thank you, Dan. Thanks, Dan.

Operator (participant)

Again, if you would like to ask a question, please press star one on your telephone keypad. Next question comes from Mike Matson with Needham and Company. Please go ahead.

Mike Matson (Managing Director and Senior Equity Research Analyst)

Yeah, thanks. I joined the call a little late. I apologize if you've been through this, but I figured I'd ask anyway. Just the, the MVP renewal, do you have a feel for how much revenue that's gonna generate over the next year?

Aaron Tachibana (CFO and COO)

Yes. What we said, Mike, thanks for the question. We, we basically said that we expect an order sometime late September this year. Don't know exactly how much it's gonna be, so we're not assuming any revenue will be fulfilled in the fourth quarter from that new order. In terms of 2024, our assumption sitting here today is that it's the same level from an order standpoint or vol, volume standpoint than we had last year. Somewhere in the $9 million-$10 million range.

Mike Matson (Managing Director and Senior Equity Research Analyst)

Okay. All right. It looks like, you reduced the expected cash burn by, like, $5 million. It's a small change, but obviously in the right direction. What is, what's driving that?

Aaron Tachibana (CFO and COO)

Well, we basically reduced expenses earlier this year, and each quarter we continue to reduce expenses, right? Defer.

Mike Matson (Managing Director and Senior Equity Research Analyst)

Yeah. Okay. All right. Just the ramp down in Natera revenue, is that still consistent with your prior expectations?

Aaron Tachibana (CFO and COO)

It is at this point in time. You know, we saw a ramp down from Q1-Q2 in terms of the Natera volume. Our assumption right now is that it stays relatively flat from Q2 through the rest of this year. Per our agreement with Natera, it could go down a little bit more in the first quarter, but we'll have to wait and see.

Mike Matson (Managing Director and Senior Equity Research Analyst)

Okay. Got it. Thank you.

Aaron Tachibana (CFO and COO)

Thank you.

Operator (participant)

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.