Operator
Greetings, and welcome to the Personales First Quarter 2026 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. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. 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.
Thank you, Operator. Welcome to Personnel's first quarter 2026 earnings call. Joining today's call are Chris Hall, Chief Executive Officer, Aaron Tashibana, 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 U.S. security 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, product, 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 that differ materially from our current expectations. We encourage you to review our recent filings, including the risk factors described in our most recent filings. Personnel takes no obligation to update these statements, except as required by applicable Our press release with our first quarter 2026 results is available on our website. www.personals.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. Our recording of today's call will be available on our website by 5 p.m. Pacific Time today. With that, I would like to turn the call over to Chris.
Good afternoon, everyone. Thank you for joining us. I'm incredibly proud of what our team has accomplished in this first quarter. But 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, and 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 roadmap. Now, for those of you new to our story, first analysis 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 and a background of a million. Now, let me be clear. This level of ultra sensitivity 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 dollar opportunity and personalists 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 de-risk 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 to $80 million. with strategic revenue expected to more than double year-over-year to a range of $30 to $32 million. Now, let's dig deeper into the three pillars of our win-in-MRD strategy that are fueling this growth. Our first pillar of our strategy is clinical adoption. Our clinical or commercial engine reached a new high-water mark 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 NextPersonal 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. And we continue to innovate as we launch the pilot for our real-time variant tracker module. This new approach pushes MRD testing beyond ctDNA detection to track how the biology of a 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 a 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 Moldex 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 ultra-sensitive approach and three points stand out. First, the Neoprism CRC data. Our collaborators used NextPersonal 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 supermolecular 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 ultra-sensitive 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 NextPersonal is a strong predictor of a long-term immunotherapy success in lung cancer patients. Patients who clear DNA early during treatment are five times more likely to remain progression-free at the three-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 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 NextPersonal. 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 NextPersonal anymore. We're actively seeing it translate into clinical volume, biopharma adoption, and a robust data set. The momentum we build in these first few months gives us immense confidence in our full-year trajectory. I want to thank the Personales 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.
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. And third, to continue to innovate and extend our technology lead within the AMRD 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 one-time license Breaking down our core revenue, biopharma testing services with $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 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 ultra-sensitivity and ability to detect cancer recurrence much earlier than other technologies. Our backlog of contracted businesses 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 an 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 two quarters of the year, but begins to improve when we receive reimbursement coverage for I.O. The margin dynamic is driven by the strong growth and 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, so 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 two to three 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 ultra-sensitive leadership position. The first quarter R&D expense was $14.5 million compared to $12.6 million for the same period of the prior year. and 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 loans. 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 to $80 million, and this assumes clinical revenue of $10 to $11 million, specifically from breast and lung cancer surveillance tests recently covered by Medicare. Revenue from pharma tests and services and all other customers to be in the range of $55 to $56 million. MRD revenue from these customers is expected to grow rapidly and be in the range of $20 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 two 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 a balance sheet, we have the ability to invest this year and drive scale. We are leading the ultra-sensitive MRD market with our technology, and a 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. And with that, I will turn the call back over to the operator to begin the Q&A session. Operator? Thank you. We will now be conducting a
Operator
question and answer session. If you would like to ask a question, please press star and then one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. If I may just ask if you could please limit your questions to one question and one follow-up question. For participants using speaker equipment, it may be necessary for you to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. First question comes from Subbu Nambi from Guggenheim. Please proceed with your questions, Subbu.
Hey, guys. Thank you for taking my question. 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?
In terms of the volume, Suba, so, you know,
we achieved 20%, 26% growth quarter over quarter, 7,800 tests. In terms of the first and third quarters, they're typically the 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 ultra-sensitive capability, and we couldn't be happier with where we're at today.
Yeah, I would just note, Sabu, you know, we set the overall annual target on clinical tests, you know, with a disciplined land grab and nailed it this quarter and trending exactly inside of existing clients. So we crossed the same point in time, you know, that.
Super helpful, Chris. And then any color on how to model 2Q should be expected similar volume step up? And when you are onboarding new physicians, can you talk a bit about the arc of volume growth? How long does it take for a new doc to ramp on ordering to steady state? And today, is there a mature ordering number you're seeing from any of the early adopters?
Yeah, I mean, I think we see physicians, you know, in general, you know, jumping in in many different ways. You know, there's obviously physicians that are using MRD testing for the first time. There are people that have some experience with LG, and I've always felt like the way to make this, and in general, and all.
Operator
Thank you so much. Commissario from BTIG. Please proceed with your questions, Mark.
Thanks for taking the questions. I know some of us have been hopping various calls, so pardon me if any of these have been asked before. But I wanted to get a sense for how strong the lung versus breast volumes are in the quarter. And can you also just speak to, you know, I.O. monitoring as well? Any color on those indications would be helpful.
Hey, 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 percent. Give or take a point or two there. Either way. Lung is between, you know, 15 and 20 percent. It's closer to 15% in terms of what we saw in Q1. So it's trend, you know, in terms of the trends that we've been seeing and the expectations, the volumes by cancer type have been, you know, in the ranges we've been expecting. In terms of I.O. coverage, the I.O. coverage, I'll let, you know, Rich and Chris maybe take that.
Well, there's two questions, which is the samples we're getting there, no change there, but the actual only submitted in August.
That's helpful. 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 and would be helpful if you could discuss any areas of focus?
Yeah, it's always tricky because of embargoes and things like that, but Rich will take this, Mark.
Hey, Mark. Hey, it's Rich. Yeah, so, you know, we have an exciting app. You know, one of the things that you can look for is more colorectal data, which has been a focus of ours as sort of a next step in terms of coverage and all that data, and it will build on the data that you saw last year. Imagine we're not sitting still. You know, we did a lot with breast and lung and focused there for a few years, but now we're starting to expand into other cases.
But that's coming off a really, you know, a really great AACR where we showed, you know, 15,000 real-world patients and a consistent limited detection, you know, adjuvant. We've got a lot of, we also.
Okay, great. And then my last question, you know, your large commercial partner recently disclosed that your tumor-informed test is, you know, well over 90% of their MRD volumes. that is a you know it speaks to the test of the value of your of your test um but it's interesting because you know garden just disclosed that reveal is you know a very rapidly growing uh product as well uh on the tumor naive side so i want to get a sense you know for how long do you think uh your tumor informed test will sort of be that lead pole position horse in the tempest portfolio versus, you know, their tumor naive, you know, somehow, you know, becoming more balanced as they think about promoting MRD?
Yeah, I mean, we've always felt, I mean, you certainly can ask them their perspective on this. You know, we've always felt like sensitivity was what was key in these indications and MRD testing. That's in our hypothesis, the tumor and approach, we think them work.
Thanks for the time, guys.
Operator
Thank you. The next question comes from Thomas Flatton from Lake Street Capital Markets. Please proceed with your questions, Thomas.
Hey, good afternoon, guys. Aaron, just a quick question on gross margin. So 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, you know, significantly better than that? And then following on from that, I guess question two 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, you know, additional indications as we roll through the year to help boost those margins? Or how are you thinking about that?
Yeah, so in terms of the full-year guide for gross margins, we said, so obviously the back half of the year will have higher margins as our myopharma MRD revenue and clinical revenue actually increases. In terms of the first quarter, 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, relatively. In terms of 2026, the margins of 15% to 20%. expectations are that this is going to be a low point for the company as well. As we get through the end of 26, heading to 27 and beyond, we see that reimbursement is going to continue to catch up. We've got a lot of things in the hopper. Collecting on the claims, margin expansion, decide to reduce the cash. The second is, are we disincentivizing or metering in any way some of a non-paid test. And so it's hard to do that to community oncologists. You know, they have patients and we don't want to, you know, at some point in time, we know that we have to go get.
I appreciate that. Thanks, guys.
Thanks so much. This is Joseph on for Mike. One question around the ordering physicians, the thousand physicians, just want to confirm, is that in the quarter or, you know, more like to date and then just wondering if you could maybe segment those thousand positions if you have you know any color on oh you know what percentage of those are reordering um after having using a competitor or or maybe reordering or maybe you know new to mrd and and maybe just that second part new to mrd depending on how how big that bucket is what what is that really telling you about how fast this market is growing?
When we report, 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. So in this quarter, I think that's a way to talk about it. Most of the physicians are, quite frankly, I mean, I think that's the experience, but we wanted to make sure that we didn't limit to that.
Okay, great. And 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 a year ago, how much has that grown and, you know, 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? Thanks so much, and congrats on the strong test volume in the quarter.
Appreciate it. Yeah, I mean, we – yeah, I don't know if I can compare everything, but what we really are focused into that is your funnel of –
Operator
TD Cohen, please proceed with your questions, Dan.
Great. Thank you. Maybe just kind of zooming out for a minute on a high level, I know there's a question asked on ASCO already, but when you zoom out and you think of the ultra-sensitive approach versus maybe first-generation approach? Is there anything at ASCO to speak to that or just, you know, anything you'd say from a high level about, you know, the interest in the market, kind of where it resides today, and how you think, you know, what the message will be coming up at ASCO?
Yeah, Rich is going to take this one, Dan.
Hey, Dan. Yeah, no, thanks for the question. You know, I think, you know, what's great is if you go to these corporate patients, I think it's really, it's before this, and I think what you'll see at ASCO is You know, that continued message, and it's really the data speaks for itself. I think, you know, for example, last year, you know, preliminary data, we showed that it made a big difference for the patients. Sensitivity, recognizing the cancer. And so you'll see some of those things being kind of reinforced with the data that is being put in colorectal cancer.
Okay, great. And 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, you know, first quarter was a little better than expected, just wondering how we think about the sequential path as we go through the year there.
We just reaffirmed guidance, Dan. We haven't changed anything at this point.
We've got a super strong Q1, but, you know, we continue to 45,000 this year, but doing that in a really – That's great, Chris.
And is there a typical – I know in the past you've given some color around typical moldex turns and how many times back and forth it requires. and no submission is, I'm sure, consistent, but between neoadjuvant breasts and I.O., like given when you submitted those, is there a framework by which, you know, that it would be logical to think we could get an answer?
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. But, you know, I think the back and forth here, I think it's very...
Perfect. Okay. Thank you both.
Operator
The next question comes from Bill Bonillo from Craig Hallam. Please proceed with your questions, Bill.
Hey, guys. Thanks a lot. So I think you said to Mark that about 35% of your, you know, testing is in covered or in reimbursed indications. And I know, you know, you're not specifically targeting, you know, or incenting people to focus on reimbursement versus non-reimbursed indications, but 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 end of the year? Is there any strategy to try and, you know, maybe grow the reimbursed indications a little more aggressively than the other indications?
Yeah, no, I think there is, Bill. I mean, I think always, you know, trying to push more aggressively into physicians who treat breast cancer or treat is what we're trying to do strategically. But I think what Aaron meant, but what Aaron had referred to, you know, is when you walk into an account and the doctor...
That's helpful. And then just, it looks like, and we may have this wrong, but Tempest, you know, gave some numbers on their call. And if we just sort of do the math on that, it looks like maybe the number of tests that... A little bit about what your internal...
Yeah, we are. We are building side-by-side with them, compete with them in the field, Bill.
Operator
Thank you for the questions, as well as today's teleconference. Ladies and gentlemen, thank you very much for joining us, and you may now...