Personalis, Inc. ($PSNL)

Earnings Call Transcript · May 7, 2026

NasdaqGM US Health Care Life Sciences Tools and Services Earnings Calls 47 min

Earnings Call Speaker Segments

Operator

Operator
#1

Greetings, and welcome to the Personalis First Quarter 2026 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. It is now my pleasure to introduce Caroline Corner of Investor Relations. Thank you, and you may proceed, Caroline.

Caroline Corner

Attendees
#2

Thank you, operator. Welcome to Personalis' First Quarter 2026 Earnings Call. Joining today's call are Chris Hall, Chief Executive Officer; Aaron Tachibana, Chief Financial and Chief Operating Officer; and Rich Chen, President and Chief Medical 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 the U.S. securities laws, including any statements regarding trends and expectations for our financial performance this year and longer term, cash runway and liquidity position, revenue expectations and timing, size and booking of orders, products, services, technology, expansion of clinical volume, reimbursement goals, the outcome and timing of reimbursement decisions, expectations for our existing and future collaboration activities, cost expectations, market size and our market opportunity and 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 recent filings, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release with our first quarter 2026 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 5:00 p.m. Pacific Time today. With that, I would like to turn the call over to Chris.

Christopher Hall

Executives
#3

Good afternoon, everyone. Thank you for joining us. I'm incredibly proud of what our team has accomplished in this first quarter. More importantly, I'm energized by where we're going. Since we launched NeXT Personal, we haven't just validated our win in MRD strategy, we have disrupted the market. Last year, in 2025, we established the power of our platform. This year, in 2026, we are scaling it. We're squarely focused on driving volume in this large and rapidly expanding market. Physicians trust NeXT Personal, our clinical test volumes are accelerating and the broader medical community is validating our road map. Now for those of you new to our story, Personalis is changing how cancer recurrence is detected and monitored. We operate at the absolute leading edge of sensitivity for tracking cancer in the blood. Our test requires just a simple blood draw to detect a single fragment of tumor DNA in a background of 1 million. Now let me be clear, this level of ultrasensitivity is no longer just a technical leap forward. It's a clinical necessity. This precision allows oncologists to detect recurrence months and years ahead of standard imaging. It also provides unprecedented confidence when delivering a negative result. The clinical market for tracking cancer in the blood or MRD is advancing towards a $20-plus billion opportunity, and Personalis is armed with the right technology to win. Now beyond the clinic, we are the engine powering the next generation of precision oncology. Biopharma companies rely on our platforms to analyze tumors, identify novel biomarkers and derisk their clinical trials. Now turning to our Q1 results. We are executing aggressively. In the first quarter, we delivered more than 7,800 clinical tests. This represents a 26% sequential growth over the fourth quarter and a 258% year-over-year increase. We're thrilled with this momentum, especially considering that the first quarter is typically the industry's most challenging due to standard seasonality. First quarter revenue of $15.5 million reflects our planned transition towards high-value, high-margin testing. In this quarter, total strategic revenue, which is revenue derived from the clinical testing and biopharma MRD adoption reached $4.5 million. We remain on track to achieve our full-year guidance of $78 million to $80 million, with strategic revenue expected to more than double year-over-year to a range of $30 million to $32 million. Now let's dig deeper into the 3 pillars of our win in MRD strategy that are fueling this growth. Our first pillar of our strategy is clinical adoption. Our commercial engine reached a new high watermark this quarter. We've now surpassed 1,000 ordering physicians in the quarter, and we are seeing incredible retention of over 98% over the past several quarters among oncologists who integrate NeXT Personal into their routine testing workflows. We're continuing to scale our commercial footprint with our partner, Tempus and are extremely confident in our 2026 annual volume estimate of 43,000 to 45,000 tests. We continue to innovate as we launched the pilot for our real-time variant tracker module. This new approach pushes MRD testing beyond ctDNA detection to track how the biology of the tumor is changing in response to therapy. This feature allows physicians to not just monitor the presence of cancer, but to track how the biology of a tumor is changing in response to therapy. gaining insights into the changes of emerging or resistance variants can enable doctors to proactively optimize the patient's therapy. The early feedback has been positive. The second pillar of our strategy is building clinical evidence to secure and expand reimbursement, and we've come out of the gates fast in 2026. We submitted neoadjuvant breast cancer this quarter and both that and our pan-cancer submission to monitor immunotherapy are being reviewed for coverage. While exact timing is subject to MolDX reviews, we are confident in our data and submission. If you want to understand why we're so confident in our data, look no further than the AACR Conference in San Diego last month. The data showed off the power of our ultrasensitive approach and 3 points stand out. First, the NEOPRISM-CRC data. Our collaborators use NeXT Personal and demonstrated 100% negative predictive value for disease relapse following surgery in a group of colorectal cancer patients. They also used our test to identify super molecular responders who achieved a complete response after just the first cycle of neoadjuvant therapy. This opens the door in the future for potential non-operative management for some patients that could potentially save patients from unnecessary surgery and saving the healthcare system significant cost. The second point is our real-world evidence. Data from NeXT Personal testing of 10,000 patients revealed that 40% of all positive detections occur in the ultrasensitive range below 100 parts per million across 14 different cancer types and stages. These are crucial early signals that conventional tests simply miss. Third is the DARWIN II study. Our collaborators show that NeXT Personal is a strong predictor of a long-term immunotherapy success in lung cancer patients. Patients who cleared DNA early during treatment were 5x more likely to remain progression-free at the 3-year mark. The third pillar of our strategy is leadership in the biopharma sector. Our biopharma MRD pipeline is growing robustly. We're on track to achieve $20 million to $21 million in biopharma MRD revenue this quarter. While Q1 MRD revenue was $3.1 million, we expect this to scale significantly in the second half of the year as we commence the work for several large trials that are now committed. Biopharma companies recognize that to prove the efficacy of next-gen therapies, they need the highest resolution tools available. This realization is driving the adoption of NeXT Personal. The first quarter has provided us with a powerful launch pad for the rest of 2026. We aren't just talking about the potential of NeXT Personal anymore. We're actively seeing it translate into clinical volume, biopharma adoption and a robust data set. The momentum we built in these first few months gives us immense confidence in our full-year trajectory. I want to thank the Personalis team for hitting the ground running this year as well as the clinicians and patients who are moving the needle of cancer care with us. With that, I'll hand it over to Aaron to walk through the financials.

Aaron Tachibana

Executives
#4

Thank you, Chris. I will discuss our first quarter 2026 results and then cover the outlook for the full-year. Before diving into the detail, I wanted to mention that our focus, priorities and objectives remain intact. First, is to gain market share and scale our clinical test volume. Second, to invest in the best possible studies in order to support and secure Medicare reimbursement. Third, to continue to innovate and extend our technology lead within the MRD market. As I discuss our Q1 results, please keep these priorities and objectives in mind. Let's start with the top line. Total company revenue was $15.5 million for the first quarter of 2026. On the surface, this amount is 25% lower than a year ago, but underneath, there's an important shift taking place. We are intentionally migrating from lower-margin legacy enterprise revenue over to higher growth and strategic clinical and biopharma MRD revenue that Chris mentioned earlier. Additionally, as we previously forecasted, this quarter reflects the planned decrease in revenue from Moderna due to the conclusion of the large Phase III trial enrollment that ended last year. We currently expect a baseline of $2 million to $3 million per quarter from Moderna the rest of this year. Our full-year revenue guidance of $78 million to $80 million reflects a healthy growth rate of 26% at the midpoint when comparing with the 2025 full-year revenue of $69.6 million and excluding $6.9 million for the non-strategic enterprise amounts and the onetime license fee. Breaking down our core revenue, biopharma testing services was $11.2 million in the first quarter compared with $13.6 million for the same period of the prior year. The first quarter decline was entirely due to the expected decrease in revenue from Moderna previously mentioned. Looking ahead, our biopharma MRD engine is poised to accelerate. We realized $3.1 million of biopharma MRD revenue in the first quarter, and we remain confident in our revenue goal of $20 million to $21 million of biopharma MRD revenue for the full-year. We expect the majority of this revenue to be realized in the second half of the year as larger projects ramp up. We are winning many new pharma MRD projects because of our ultrasensitivity and ability to detect cancer recurrence much earlier than other technologies. Our backlog of contracted business is growing as well as our funnel of future opportunities. This gives us confidence about our biopharma growth potential for this year and beyond. For clinical revenue, the story is about exponential 2026 growth and expanding our ASPs as we achieve reimbursement milestones. We recognized $1.4 million of revenue in the first quarter compared with $0.3 million for the same period of 2025. Although the absolute number is small, this is important now that we are driving revenue from the Medicare reimbursement coverages of breast and lung cancer surveillance received to-date. As a reminder, breast cancer was covered in November 2025 and lung cancer in February of this year. Next, I will address gross margin as it's an important component of our investment strategy to win in MRD. Gross margin was 1.8% in the first quarter compared with 35% for the same period of the prior year. It's vital to understand that this margin compression is both intentional and temporary. We foresee this margin dilution to continue throughout 2026 with the lowest point expected to be in the first 2 quarters of the year, but begins to improve when we receive reimbursement coverage for IO. The margin dynamic is driven by the strong growth in NeXT Personal test volume ahead of reimbursed revenue and our goal of gaining market share now. In the first quarter, unreimbursed test costs diluted margins by more than 2,000 basis points. We are securing physicians and volume now. When coverage decisions like the recent wins in breast and lung cancer come online, that volume run rate converts to higher margin revenue. We expect to realize the benefits from investments to gain market share over the next 2 to 3 years as our clinical revenue gets to scale. Operating expenses were $32.4 million in the first quarter compared to $24.9 million for the same period of the prior year. Our expense base is increasing as we are forging ahead with key investments in order to win market share. We are investing in commercial resources to drive volume, investing in new and existing studies to support reimbursement, and we are investing in our technology like our variant tracker feature in order to maintain and increase our ultrasensitive leadership position. The first quarter R&D expense was $14.5 million compared with $12.6 million for the same period of the prior year. SG&A expense was $17.9 million compared with $12.3 million for the same period of the prior year. Net loss for the first quarter was $30 million compared with $15.8 million for the same period of the prior year. The increase in net loss stemmed from all of the investments previously discussed. Now let's review the balance sheet and our strong cash position. We finished the first quarter with cash and short-term investments of $233.2 million and no debt other than some small equipment loan. We used approximately $28 million of cash in the first quarter, which included approximately $5 million of incentive compensation that do not repeat throughout the rest of the year. Now let's review our 2026 outlook. Our full-year 2026 guidance is unchanged. As a reminder, our guidance only assumes paid tests from reimbursement coverage decisions received to-date. Upsides may be realized from faster coverage expansion, accelerated payer adoption, additional volume growth for clinical tests and increased strength in biopharma MRD demand. We expect total company revenue to be in the range of $78 million to $80 million, and this assumes clinical revenue of $10 million to $11 million, specifically from breast and lung cancer surveillance tests recently covered by Medicare. Revenue from pharma test and services and all other customers to be in the range of $55 million to $56 million. MRD revenue from these customers is expected to grow rapidly and be in the range of $20 million to $21 million, population sequencing plus enterprise customers of approximately $13 million. Gross margin is expected to be in the range of 15% to 20% with the first 2 quarters being the lowest points of the year. Net loss of approximately $105 million, and we expect our cash usage to be approximately $100 million as we continue to invest in our win in MRD strategy in order to gain market share, fund pivotal clinical studies to support Medicare reimbursement and help change medical guidelines in our favor. With $233 million of cash on our balance sheet, we have the ability to invest this year and drive scale. We are leading the ultrasensitive MRD market with our technology and the proof point is our ramping clinical test volume. The market is expanding rapidly and is expected to grow to $20 billion or more, and we are positioned to win. We look forward to updating you on our progress during the next conference call in a few months. With that, I will turn the call back over to the operator to begin the Q&A session. Operator?

Operator

Operator
#5

[Operator Instructions]. The first question comes from Subu Nambi from Guggenheim.

Subbu Nambi

Analysts
#6

You ungated volumes mainly for share gains and to push growth. What did you see in 1Q from like a competitive win perspective to reinforce that strategy is working?

Aaron Tachibana

Executives
#7

In terms of the volume, Subu, we achieved 26% growth quarter-over-quarter, 7,800 tests. In terms of the first and third quarters are typically lighter quarters because of seasonality, in terms of competitive dynamics, we're seeing that we're doing really, really well in the marketplace. We're winning with our ultrasensitive capability, and we couldn't be happier with where we're at today.

Christopher Hall

Executives
#8

Yes. I would just note, Subu, we set the overall annual target of 43,000 to 45,000 clinical tests with this idea that we'd be pursuing disciplined land grab with our partner, Tempus. We really feel like nailed it this quarter in terms of tracking and trending exactly where we need to be. We really have been focusing on depth inside of existing clients. We crossed 1,000 physicians ordering this quarter. That was tremendous progress. At the same point in time, that we focused on depth and we talked about really significant retention within the accounts that have adopted NeXT Personal and they stay with us because they see the clinical utility of what we're providing.

Subbu Nambi

Analysts
#9

Then any color on how to model 2Q? Should we expect a similar volume step-up? When you are onboarding new physicians, can you talk a bit about the ARCOP volume growth? How long does it take for a new doc to ramp on ordering to steady state? Today, is there a mature ordering number you're seeing from any of the early adopters?

Christopher Hall

Executives
#10

Yes. I mean I think we see physicians in general, jumping in, in many different ways. There's obviously physicians that we are selling to that are jumping in and using MRD testing for the first time. There are people that have experience with MRD testing and they want to experience the ultrasensitivity that we provide. Then there are people that have some experience that don't often use it. We see those people starting to work with the technology. I've always felt like the way to make this standard of care is to really sell into that group and really push usage significantly deeper on the back of an ultrasensitive approach because you can have more confidence in the negative which is what we've been focused on. Some physicians jump in and have a lot of experience and order a lot out of the gate, others try a few and see what happens, etc. I think there's always a desire to test us operationally to see whether we hit the lead time goals that we commit to, which we've been largely able to do across the board now month after month. We feel like that we survive those tests pretty quickly. In general, and we've got physicians who continue to order more every quarter. I think that's pretty common as new technologies are adopting and people feel confidence with it, they tend to pick up the pace. In general, in all these accounts across anybody using MRD, there's significant opportunity to go deeper. I mean I don't think in very many accounts, probably any of us that are working in the space probably can say that 100% of the patients that are eligible are getting access to the test. There's always ways to go deeper the patients and continue to build the business in the market.

Operator

Operator
#11

The next question comes from Mark Massaro from BTIG.

Mark Massaro

Analysts
#12

I know some of us have been hopping various calls, so pardon me if any of these have been asked before. I wanted to get a sense for how strong the lung versus breast volumes are in the quarter? Can you also just speak to IO monitoring as well? Any color on those indications would be helpful.

Aaron Tachibana

Executives
#13

Yes. Mark, this is Aaron. In terms of the breast volume, so it's in the ballpark of what we've been expecting and seeing. It's roughly 20% give or take a point or 2 there either way. Lung is between 15% and 20%. It's closer to 15% in terms of what we saw in Q1. In terms of the trends that we've been seeing and the expectations, the volumes by cancer type have been in the ranges we've been expecting. In terms of IO coverage -- the IO coverage, I'll let Rich and Chris maybe take that.

Christopher Hall

Executives
#14

Well, there's 2 questions, which is the samples we're getting there, no change there, which is in a similar percentage. The actual coverage journey, we feel confident that we're making progress there. We only submitted in August. This process is always variable. We feel like the data looks really good in that indication, and we feel like all of our interactions have been positive, and we're optimistic that we will be covered for IO with the strength of the evidence that we have.

Mark Massaro

Analysts
#15

I was wondering if you could speak to -- I know that the abstracts are embargoed, but speak to the importance of ASCO coming up here. Should we expect any releases of data? Would be helpful if you could discuss any areas of focus.

Christopher Hall

Executives
#16

Yes. It's always tricky because of embargoes and things like that. Rich will take this, Mark.

Richard Chen

Executives
#17

Mark, it's Rich. Yes. We have an exciting ASCO coming up. I think one of the things that you can look for is more colorectal data, which has been a focus of ours as sort of the next step in terms of coverage and also evidence generation. We're excited about that data, and it will build on the data that you saw last year that the initial data that was presented last year around this time. Then there's also an expansion of additional cancer types. As you can imagine, we're not sitting still. We did a lot with breast and lung and focus there for a few years, but now we're starting to expand into other cancer types. I think you can look to see that we'll have additional data there.

Christopher Hall

Executives
#18

That's coming off a really great AACR, where we showed 15,000 real-world patients and a consistent limited detection across those patients, almost 40% of the results, the ultrasensitive zone, some really great data on colorectal neoadjuvant usage and the power of an ultrasensitive approach there. Then we debut data for our new product extension, real-time barrier tracker. We've got a lot of -- we also at AACR had a lot of, I think, really impactful data that's moving the needle in the field of physicians.

Mark Massaro

Analysts
#19

Then my last question, your large commercial partner recently disclosed that your tumor-informed test is well over 90% of their MRD volumes. It speaks to the value of your test, but it's interesting because Guardant just disclosed that Reveal is a very rapidly growing product as well on the tumor-naive side. I want to get a sense for how long do you think your tumor-informed test will sort of be that lead pole position horse in the Tempus portfolio versus their tumor-naive somehow becoming more balanced as they think about promoting MRD?

Christopher Hall

Executives
#20

Yes. I mean, we've always felt -- I mean, you certainly can ask them their perspective on this. We've always felt like sensitivity was what was key in these indications and MRD testing. That's always been our guiding principle. That's what's fueled the innovation of the ultrasensitive approach that we've had on all of our R&D efforts. Our hypothesis and our belief has been that the tumor-informed approach is what will carry the day in terms of sensitivity, and that's what most physicians demand. We think the market will continue to be very much focused on the power of a tumor-informed approach.

Operator

Operator
#21

The next question comes from Thomas Flaten from Lake Street Capital Markets.

Thomas Flaten

Analysts
#22

Aaron, just a quick question on gross margin. You mentioned the second quarter was also going to be a bit of a low point. Does that mean another 2% gross margin quarter or something significantly better than that? Then following on from that, I guess, question 2 is, as you look to maximize the reimbursed indications, are you disproportionately incentivizing the sales team to push for those indications that are reimbursed today and maybe additional indications as we roll through the year to help boost those margins? Or how are you thinking about that?

Aaron Tachibana

Executives
#23

Yes. Thanks for the questions, Thomas. In terms of the full-year guide for gross margins, we said 15% to 20%, right? Obviously, the back half of the year will have higher margins as our biopharma MRD revenue and clinical revenue actually increases in terms of the first quarter, so we were just shy of 2%. In Q2, we see that maybe ticking up a little bit. The first half of the year is definitely going to be the lowest point for the full-year comparatively. In terms of 2026, the margins of 15% to 20%, our expectations are that this is going to be a low point for the company as well. As we get through the end of '26, head into '27 and beyond, we see that reimbursement is going to continue to catch up. We've got a lot of things in the hopper. We're doing really, really well in terms of collecting on claims. The ASPs are expected to increase as well. That's going to help with not only the top line growing, margin expansion and also we'll start to subside or reduce the cash usage as we go forward, okay? That was the first part of the question. The second is, are we disincentivizing or metering in any way some of the non-paid tests. It's hard to do that, Thomas, when we're selling to community oncologists, they have patients with all different cancer types, and we don't want to discourage any physician from bringing in this cancer type versus that. We want all comers because at some point in time, we know that we have to go get reimbursement for other cancer types. We have a lot of progress that's being made at this point in time. It's not showing up just yet, but it's to come, right? I hope that answers your questions about incoming volume and what we're doing with the commercial field and how physicians are treated as well. We want to make sure that patients are treated really, really well.

Operator

Operator
#24

[Operator Instructions]. The next question comes from Mike Matson from Needham & Co.

Joseph Conway

Analysts
#25

This is Joseph on for Mike. One question around the ordering physicians, the 1,000 physicians. Just want to confirm, is that in the quarter or more like to-date? Then just wondering if you could maybe segment those 1,000 physicians, if you have any color on what percentage of those are reordering after having using a competitor or maybe reordering or maybe new to MRD? Maybe just that second part, new to MRD, depending on how big that bucket is, what is that really telling you about how fast this market is growing?

Christopher Hall

Executives
#26

Yes. Whenever I talk in the script about the number of physicians that are ordering, we mean in the quarter, we don't mean cumulative that have ever ordered from us. In this quarter, there were more than 1,000 physicians that ordered from us. I think that's a more meaningful way to talk about it than mentioning some physician who may have ordered something several months ago, it's kind of an irrelevant sort of thing. That's how we think about it and talk about it internally. Most of the physicians are physicians who have some experience ordering MRD, quite frankly. I mean, I think that's the simplest way to commercialize these tests are physicians who have some experience, but we wanted to make sure that we didn't limit to that because that's almost half of the physicians probably don't have a lot of experience ordering it. We hit those physicians, but a good chunk of our physicians, the vast majority have had some experience at some point using MRD testing. They're probably using us in some cases, exclusively or using other providers all collectively in their offices. I mean people think physicians often use different approaches simultaneously within their office. I don't think that's uncommon. I think we're seeing the market just continue to grow. There's a lot of energy and excitement around using these blood tests as a way to better monitor cancer progression, both to see whether the therapy is working in immunotherapy or whether to see whether the cancers come back. I think the power of this ultrasensitive approach is that you are able to give a lot more confidence to a patient that they're truly cancer-free. At the end of the day, that's what a lot of patients are looking for. We're hoping to deliver on that. I think that's helping to grow the market and you're seeing that in the numbers.

Joseph Conway

Analysts
#27

Then just on the backlog, you guys mentioned of contracted pharma business. I'm just wondering if there's any way whether it's quantifying it or maybe just comparing it to this quarter or a year ago, how much has that grown? How long of a stretch of visibility does that backlog give you? Just, I guess, your average trial or your average project with a pharma partner. Congrats on the strong test volume in the quarter.

Christopher Hall

Executives
#28

No, I appreciate it. Thanks. Yes, I mean we -- I don't know if I can compare everything year-over-year, but what we really are focused on was this year and what are the clinical trials that we see both kicking off and starting and trials that we plan on characterizing for biopharma companies, both in MRD and for the tumor profiling product. When we kicked off guidance, we kicked off the year, we had a good sense of that as the year has gone on. That's only got firmer and those are committed in most cases, contracted now. We feel like it's like we're in a good position at this point to deliver on it. From the very beginning, and we talked about this at the beginning of the year, we saw that the second half of the year would be a bigger part of our revenue number in biopharma than the front half of the year. That was never hopes and dreams, but we did need to make sure that it was that it was better solidified and circled as we've gone through the year. Typically, and that's what's happened this quarter. Typically, what happens in this business is that most of the business that you end up doing for the year, you have pretty good visibility to by the middle to the end of the second quarter in general. We feel like at this point of the year, we have good visibility and have affirmed where we are guidance-wise and being able to hit that $20 million to $22 million in MRD and then the overall biopharma revenue.

Aaron Tachibana

Executives
#29

Maybe just to piggyback off of what Chris just said. In terms of the biopharma MRD backlog, it has continued to grow. The funnel of opportunities as well is continuing to grow. It's really, really robust. We're happy about it. I think the customers are seeing the value of the ultrasensitive test that we provide and can clearly see that we can detect recurrence before other technologies, which is important. In terms of the backlog, so we have a mixture of different types of projects in the backlog. We have retrospective projects as well as prospective. Some of the prospective projects will go out past 12 months, right? It's great to have some of that because it gives you clarity beyond just 12 months, but in terms of what we rely on financially as we look at the backlog inside 12 months because that's what's going to potentially convert to revenue. We need to get samples in, right? Even if the backlog is growing, we still need to get samples in so we can run them and record revenue.

Operator

Operator
#30

The next question comes from Dan Brennan from TD Cowen.

Daniel Brennan

Analysts
#31

Maybe just zooming out for a minute at a high level. I know there was a question asked on ASCO already. When you zoom out and you think of the ultrasensitive approach versus maybe first-generation approach, is there anything at ASCO to speak to that? Or just anything you can say from a high level about the interest in the market, kind of where it resides today and how do you think what the message will be coming up at ASCO?

Christopher Hall

Executives
#32

Yes. Rich is going to take this one, Dan.

Richard Chen

Executives
#33

Dan, yes. No, thanks for your question. I think what's great is if you go to these conferences, it really has changed over the last few years and the increasing recognition that the ultrasensitivity is critical for patients. I think it's really something that that is seen as not just a nice to have but a must have at this point for patients. It's on the back heels of a lot of the data that's come. Before this, I think what you'll see at ASCO is that continued message, and it's really -- the data speaks for itself. I think, for example, in colorectal cancer, last year, preliminary data, we showed that made a big difference for the patients in terms of sensitivity, recognizing the cancer recurrence risk very, very early for the patients. You'll see some of those things being reinforced with the data that is being presented at ASCO this year. That's true in colorectal cancer, but it's also going to be seen in some of the other cancers that we present data for.

Daniel Brennan

Analysts
#34

Then in terms of the updated guidance, I mean, I joined a little late, but just on the molecular volumes, was there any change in your thought there? I mean first quarter was a little better than expected. Just wondering how we think about the sequential path as we go through the year there.

Aaron Tachibana

Executives
#35

We just reaffirmed guidance, Dan. We haven't changed anything at this point, right?

Christopher Hall

Executives
#36

We had a super strong Q1, but we continue to -- I think we have an aggressive plan to go from 16,000 samples last year, 43,000 to 45,000 this year, but doing that in a really disciplined way and being thoughtful about how much money we're spending and gaining that by the number of resources that we apply. That's both our partner, Tempus and both the number of sales reps that we put in the field, and we feel like we're on plan to do that we're managing in a really responsible way, but yet a way that seizes the opportunity and pushes us closer towards realizing the goals of our winning MRD strategy.

Daniel Brennan

Analysts
#37

Is there a typical -- I know in the past, you've given some color around typical MolDX turns and how many times back and forth it requires. The submission is, I'm sure, consistent, but between neoadjuvant breast and IO, like given when you submitted those, is there a framework by which that it would be logical to think we could get an answer?

Christopher Hall

Executives
#38

No. I mean it's always a 60-day turnaround time from the time that you respond to those questions. I mean that's pretty typical. I think the back and forth here, I think it's variable always. I think they do a great job. We really respect and buy the work that they do. We feel like it's -- we're sitting well relative to how those processes typically go. We did think it would take a while to get through the breast cancer process just because it was the first time we went through it and they had to both assess the test, understand it, etc., but it always takes some time to work through it. I think it's going to be variable based on the indication, based on the evidence, etc., so we expect that at this point. I think most all the companies would tell you the same thing.

Operator

Operator
#39

The next question comes from Bill Bonello from Craig-Hallum.

William Bonello

Analysts
#40

I think you said to Mark, that about 35% of your testing is in covered or in reimbursed indications. I know you're not specifically targeting or incenting people to focus on reimbursement versus non-reimbursed indications. Just as you think about the opportunity, you look forward over the end of the year, how do you think about that shaking out? I mean will you be satisfied if we're at sort of a similar mix of indications by the end of the year? Is there any strategy to try and maybe grow the reimbursed indications a little more aggressively than the other indications?

Christopher Hall

Executives
#41

Yes. No, I think there is, Bill. I mean I think always trying to push more aggressively into physicians who treat breast cancer or treat lung cancer is what we're trying to do strategically. I think what Aaron had referred to is when you walk into an account and the doctor is an oncologist who sees patients across the board, we don't tell them to send us breast cancer patients and send everything else to a competitor. That's just not been typically our talk track. We've been there to serve and work with them. I think in doing so, there'll be evidence, and that's been the strategy to-date. I think the goal as we go through the year will be continue to grow the sequential growth, continue to push into the leading positions in some of these areas. At the same point in time, continue to drive the reimbursement. The reimbursement is picking up steam as we go across an ever broadening set of indications spots within these cancer types.

William Bonello

Analysts
#42

Then just -- it looks like -- and we may have this wrong, but Tempus gave some numbers on their call. If we just sort of do the math on that, it looks like maybe the number of tests that weren't -- that were sold by you, I guess, or not by Tempest maybe actually went down sequentially. Can you just talk a little bit about what you're doing? I mean I thought that maybe you were also building up your internal sales force a bit and just how you're thinking about that right now?

Christopher Hall

Executives
#43

Yes, we are. We are building side-by-side with them and both to continue to build capability, etc., but we don't compete with them in the field, though. We work synergistically. Tempest has a pretty deep and comprehensive infrastructure to serve customers. Sometimes, quite frankly, it's probably better for customers to work through them or we'll sell something and Tempus is there. Tempest also has to offer a comprehensive product snapshot. We've not -- we don't want to be competing in the field. If it's easier or better or more conducive to the way the business is built for it to flow through Tempest, then that's ultimately the way it will go. I would look at the total number, not so much how much is coming from each one of the companies because that's not how we're driving it in the field.

Aaron Tachibana

Executives
#44

Yes, in terms of the total volume, Bill, so total volume grew by 26% quarter-to-quarter. Tempus was a little over 80% of the volume. The volume from the internal commercial team did not really decrease. It was flattish. Again, Q1 is typically seasonally a little slower than Q2 or Q4. I wouldn't read anything really into that. Then some of our internal team is helping some of the Tempus reps as well from a marketing.

Christopher Hall

Executives
#45

We work together. What we've learned in having done these relationships over my career is that you just don't want reps fighting in the field over this stuff. One of the main -- we partnered with Tempus for so many reasons, but one of the couple of the key reasons were the deep EMR linkages, infrastructure and build-out with the nuts and bolts of the business that we just quite simply haven't had with portals, etc. Then the second is the ability to offer a comprehensive one-stop shop, and that's worked really well for us with them.

Operator

Operator
#46

There are no further questions, and this does conclude the question-and-answer session as well as today's teleconference. Ladies and gentlemen, thank you very much for joining us, and you may now disconnect your lines.

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