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Greetings and welcome to Personalis Second Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Caroline Corner, Investor Relations. Please go ahead.

Thank you, operator. Welcome to Personalis' second quarter 2023 earnings call. Joining me on today's call are Chris Hall, Chief Executive Officer and President; and 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 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, 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, health 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 recent Annual Report on Form 10-Q. Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release for the second quarter 2023 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 P.M. Pacific Time today. Now, I would like to turn the call over to Chris for his comments and second quarter business highlights.

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 go rapidly over the next several years as we'll benefit from two very important developments occurring in oncology. The necessity of personalized diagnostic test to monitor patients with cancer and the development of personalized therapies. Both of these shifts in cancer management required discriminating technology to eliminate 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 -- we had an 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 focused 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 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 one circulating cancer DNA fragment among a 1 million normal DNA fragments in the blood. And 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 and patient management can be modified to result in more favorable outcomes. And 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 Astra

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 VAMVP 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 test 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 nonrecurring restructuring charge of $0.1 million associated with the closure of our China Lab operation compared with $32.2 million for the same period of 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, and 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 of 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 increase. We now expect total company revenue to be $70 million to $72 million with oncology revenue from pharma, enterprise sales, and other customers to be $61 million to $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. And with that, I will turn the call back over operator to begin the Q&A session. Operator?

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] First question comes from Tejas Savant with Morgan Stanley. Please go ahead.

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, plan to expand your book of business now that you have Moderna and then a couple other people signed up?

Hi, Tejas. This is Aaron. Thanks for the question. In terms of the PCB opportunity, so as we had mentioned on the in the prepared remarks, Moderna and Merck, they both, started the Phase 3 clinical trial enrolling patients, and 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, the revenue could be moderate and start to ramp significantly as we get into 2024. On our 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.

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

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

Yes. So, we'll take the MVP one first because that one's probably easier to deal with in terms of MVP. So, 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, we'll assume somewhere in the $9 million to $10 million range in 2024. Probably fulfilled over the first three quarters of the year, okay? In terms of the question on Natera, so consistent with our last call, we did have, 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. And 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 things could be flattish from the second quarter through the rest of this year. In terms of what happens beyond that, it'll depend upon what's happening with the Natera's volumes. I think their volumes continue to grow. And to the extent that they do need an outsource partner for additional capacity and capability, we could be that partner for them. And so more to come here. We don't have exact clarity on the volumes into 2024. But we -- our estimates would include them tapering off in the Q1 timeframe at this point in time based upon what we know.

Very helpful. Thanks guys. Appreciate the color.

Sure. Thanks Tejas.

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

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

Yes, so 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. And, 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 upon what we're doing with collaborators. In addition, on the Natera side, so on the last call we did mention that volume should start to taper off. We're seeing that, volume is probably going to be flattish the second half of the year compared to what we saw here in the second quarter.

Great, thank you. And then moving on to the cash usage for the quarter, so 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?

Yes, so year-over-year, we're declining cash usage by about $50 million. In 2022, we had a heavy amount of investment, $45 to $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, 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.

Great. Thank you.

Sure.

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

Hey, guys. Thanks very much for the questions. My first one is on the TRACERx trial. 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 third or maybe the fourth test. What was it about the first couple of tests that may have had a limitation and what exactly was the interest in the next Personalis test? And then as a follow-up to that, you guys talked about reading out 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?

Awesome. Mark, it's Chris. Rich is here and is going to jump in and talk about the TRACERx. since he's worked with the collaborators, TRACERx Collaboration.

Yes, hi, Mark. This is Rich. Great. Thank you for the question. So, I think, as you noted, Charlie has been in this field of MRD testing for many, many years, looked at other platforms. And I think as many have noted, not just Charlie, that there's a, there are areas of not just lung cancer, but other cancers where, the first generation of tests was not sensitive enough to pick up the cancer. So I think that's a, it's a large reason he chose to work with us. He noted that we have an ultra-sensitive platform. He saw the promise of that very early on. We started working with him, 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 start this collaboration with us. And then in terms of the data generation, 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 I think the data is looking encouraging.

And to give you a step back, I mean, we've always seen it, one part per million, the Personalis technology being up to 100 times more sensitive. And that gives us the opportunity to be able to see, 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. So we're really positioned to be able to be a leap forward in MRD detection.

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

Yes, so that's a great question, Mark. So the TRACERx cohort is actually a retrospective cohort. So the collection has already been done for all these patients. And the great thing there is that Charlie and his team had the foresight to, collect a lot of plasma along the way, longitudinally for these patients. And now we know, because they've been followed up for many, many years, we actually know the clinical outcomes for these patients. So it makes it up for an ideal cohort for us 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. And we can also examine, if we're going to be looking at data from all those time points that were collected, and looking at sort of, what kind of decisions could be made with all the, any of those time points along the journey of the patient. And I think we're going to find that there's going to be utility in the test at various points in the patient journey, and that's part of what we want to establish here.

What we think, if you step back, we talk through the pipeline of studies across the three focused cancer indications. And 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.

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

Thanks, Mark.

[Operator Instructions] Next question comes from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.

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

Well, so we'll be launching the test into the clinical market at the end of this year, towards the end of this year, towards the end of this year, which means for the first time, next person will be available to doctors around the United States to be able to use on patients. And that's significant because it'll be one of the next entrants into the market, and we're super excited about it. We've gotten a lot of feedback. And we will take the TRACERx. Ultimately, we expect it to be published at some point. And our hope is that that will drive the foundations of getting covered for the product so that we get paid by health insurance companies who are doing testing in early stage lung cancer. So that's one snapshot. But the other snapshot of the business is that we have a large, robust biopharma set of clients with many of the big biopharma companies. They're all deeply involved in MRT, 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 Duke and UCSF and Royal Marston and BHIO, et cetera. We expect all those to help us fuel additional conversations and or business from biopharma customers, and form the foundation to get insurance coverage, which ultimately will build a base of revenue around the clinical samples that we get from patients and doctors around the country. Is that helpful, RK?

Yes, thanks for that. Then on the Be Stronger trial, that includes like a five-year follow-up in these breast cancer patients. So does that mean we will be continuously getting data in the interim, or is it one of those things where you have to wait for a longer time period to get the full data set?

Yes, Rich could go into 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 and triple negative breast cancer. So we'll get data well before the whole five-year follow-up. Do you have anything to add, Rich, about?

No, that's exactly right. It's been specifically designed to follow-up -- follow those five years, but 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 time point.

Thank you. And thank you both for taking my questions.

No, absolutely. Thanks for the questions.

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

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

Yes. This is Rich. 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 is 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. And there's several other conferences later in the year that we're also targeting for additional data on the breast cancer side.

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

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

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

So we haven't said -- yes, we haven't said publicly anything about the exact numbers about MRD in terms of where it would be. But it's going to be single-digit millions later in the year.

So it's -- I mean 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 we're positioned with all the large biopharma customers because of the work that we've always traditionally done in the translational side with the ImmunoID platform to be able to capture a much bigger piece of the spending and move into the MRD market. And we've gotten a lot of interest from those companies. And they different types of trials and bake-offs and test with us, but we expect that to be a big driver moving forward of the revenue 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. So we're super excited to that be a growth driver. But the focus is right now 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 in terms of sales and marketing and moving along the journey. And then having the biopharma customers at the same point in time be driving revenue as we go through that commercial journey.

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

We have not disclosed the pricing, but now the next personal is available and is being used by biopharma customers. There is a version of it, an RUL [ph], 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 customers. We've not disclosed pricing on that, and we've not priced the clinical lab product yet.

Got it. Okay. And then, finally, I know you talked about maybe getting coverage by the end of next year, amongst the three lead areas, I mean, have you disclosed, which of the three, is it the lung, the breast, or the eye? Which of the three of the three?

No, I mean, in a perfect world, we'd get covered all three, right, at the same time. But our expectation is that we're driving data simultaneously. And what you have to do to get coverage, as you know, is the articles, the data needs to be put into an article. It needs to be accepted in a peer review journal. We need to submit for coverage. And then there's inevitably a period of back and forth and discussion that happens with Paul Meadow, [ph] 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, but then that process of getting it into the public domain and accept it is another set of journeys. And so we don't expect that all three of those will go at the same rate. Something -- some may go quickly into publication, some may go slower, some could go through a couple different iterations, et cetera. And so 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. And then there's a period of time in this journey where there's a back and forth between the collaborators and the journals, et cetera. And then we'll take it from there and drive it towards coverage. And so we're moving aggressively on these three fronts. And our expectation is that one of them will go and we'll be able to make progress. But that's the way we're thinking about it. And we'll keep you all updated, obviously, as data is submitted and as things come together, but that's the journey that we've laid out and we're committed to executing on.

And sorry, final one, just on the balance sheet, how should we think about the need for financing and how you guys address that going forward?

Yes, so we continue to extend our cash runway, Dan. At the end of Q2, we had $137 million of cash, which is two years of cash runway. So in terms of where we're at today we continuously defer expenses where we can. 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. So we're spending where, only where we need to. But in terms of where we're at today, right, short-term, I think we're in good shape.

Perfect. Okay. Thanks a lot.

Thank you, Dan.

Thanks, Dan.

[Operator Instructions] Next question comes from Mike Matson with Needham & Company. Please go ahead.

Yes, thanks. I joined the call a little late, so I apologize if you've been through this, but I figured out how to ask anyway. So the MVP renewal, do you have a feel for how much revenue that's going to generate over the next year?

Yes, so what we've said, Mike, thanks for the question. We basically said that we expect an order sometime late September this year. Don't know exactly how much it's going to be, so we're not assuming any revenue would be fulfilled in the fourth quarter from that new order. And then in terms of 2024, our assumption sitting here today is that it's the same level from an order standpoint or volume standpoint that we had last year. So, somewhere in the $9 million to $10 million range.

Okay. All right. And then it looks like you produce the expected cash burn by like $5 million. It's a small change but obviously in the right direction. So what is -- what's driving that?

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

Yes. Okay. All right. And then just the ramp down in Natera revenue, is that still consistent with your prior expectations?

It is at this point in time. And so we saw a ramp down from Q1 to 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. And then 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.

Okay, got it. Thank you.

Thank you.