Personalis (PSNL) Q1 2026 Earnings Transcript

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DATE

Thursday, May 7, 2026 at 5 p.m. ET

CALL PARTICIPANTS

• Chief Executive Officer — Christopher M. Hall
• Chief Financial and Chief Operating Officer — Aaron L. Tachibana
• President and Chief Medical Officer — Richard Chen
• Chair of the Board — Caroline V. Corner

TAKEAWAYS

• Clinical Test Volume -- More than 7,800 clinical tests delivered, reflecting 26% sequential growth and 258% year-over-year increase.
• Total Revenue -- $15.5 million, with a 25% decrease year over year, attributed to the planned shift from lower-margin enterprise revenue to higher-value strategic clinical and biopharma MRD revenue.
• Strategic Revenue -- $4.5 million derived from clinical testing and biopharma MRD, with management reiterating expectations to more than double to $30 million-$32 million for the full year.
• Biopharma Testing Revenue -- $11.2 million, influenced by a decline from Moderna revenue after the conclusion of a large Phase 3 trial enrollment; Moderna baseline now projected at $2 million-$3 million per quarter for 2026.
• Biopharma MRD Revenue -- $3.1 million in the quarter; management reiterates the annual target of $20 million-$21 million, expecting a significant ramp in the second half due to large committed trials.
• Clinical Revenue Growth -- $1.4 million, up from $300,000 in the prior-year period, driven by Medicare coverage for breast and lung cancer surveillance.
• Gross Margin -- 1.8%, down from 35% in the prior year, with margin compression described as "intentional and temporary" due to unreimbursed test costs and the focus on market share gain.
• Operating Expenses -- $32.4 million, versus $24.9 million prior year, reflecting increased investment in commercialization, R&D, and studies to support future reimbursement.
• Research & Development Expense -- $14.5 million, up from $12.6 million year over year.
• SG&A Expense -- $17.9 million compared to $12.3 million in the comparable quarter last year.
• Net Loss -- $30.0 million, versus $15.8 million a year ago, attributed to scaling and investment in growth initiatives.
• Cash Position -- $233.2 million in cash and short-term investments, with no significant debt; $28 million cash used during the quarter, which included $5 million of non-recurring incentive compensation.
• Physician Adoption -- Over 1,000 ordering physicians in the quarter, with patient retention rates above 98% among oncologists integrated with NeXT Personal.
• Clinical Volume Guidance -- Annual clinical test volume guidance of 43,000-45,000 tests reaffirmed.
• Indication Mix -- Breast cancer volumes accounted for approximately 20%, and lung cancer for about 15% of Q1 clinical testing.
• Partnership Contribution -- Tempus generated just over 80% of clinical test volume during the quarter; internal commercial sales were described as "flattish" in absolute volume terms.
• Reimbursement Expansion -- New submissions for neoadjuvant breast cancer and pan-cancer immunotherapy monitoring under review; management expresses confidence in supporting data.
• Product Innovation -- Pilot launch of Variant Tracker module, enabling real-time tracking of tumor biology and resistance variants.
• Backlog and Pipeline -- Growing backlog of contracted biopharma MRD business, with increasing visibility into conversion over the next 12 months.
• Real-World Evidence -- Data from 10,000 NeXT Personal-tested patients found that 40% of all positive detections occurred in the ultrasensitive range, below 100 parts per million, across 14 cancer types.
• Clinical Evidence -- "NeoPrism CRC" study reported 100% negative predictive value for disease relapse post-surgery using NeXT Personal in colorectal cancer patients.
• DARWIN II Study -- Data showed that lung cancer patients who clear ctDNA early during immunotherapy are five times more likely to remain progression-free at three years.
• 2026 Financial Guidance -- Company-wide revenue expected to reach $78 million-$80 million, gross margin in the 15%-20% range, net loss approximately $105 million, and cash usage near $100 million.

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RISKS

• Gross margin decreased significantly to 1.8% from 35% in the prior year, with management anticipating continued margin pressure in the near term due to unreimbursed test volumes.
• Net loss doubled to $30.0 million versus the prior year's $15.8 million, primarily from deliberate increases in R&D and SG&A investment.
• Gross margin was 1.8% in the first quarter, compared with 35% for the same period of the prior year. Management indicated that this margin compression is both intentional and temporary, with margin dilution expected to continue throughout 2026, reaching the lowest point in the first two quarters, and then beginning to improve as reimbursement coverage for IO is received.
• Full-year cash usage projected at $100 million, suggesting ongoing high burn as the company drives clinical growth ahead of margin improvements from future coverage decisions.

SUMMARY

Personalis (NASDAQ:PSNL) reported rapid sequential and year-over-year clinical test volume growth alongside a substantial shift toward higher-value strategic revenue streams. Management emphasized intensifying efforts to expand physician adoption and secure further Medicare reimbursement, with clinical volumes and evidence generation both strengthening. Data from key studies showcased the clinical utility and differentiation of the NeXT Personal test, particularly in sensitivity and early detection across multiple cancer types.

• Results indicated robust progress in both clinical and biopharma MRD businesses but highlighted margin and loss headwinds as temporary outcomes of the current growth and reimbursement strategy.
• Statements during the call clarified that over 1,000 physicians ordered tests in the current quarter alone, not on a cumulative basis.
• Operational plans call for most biopharma MRD revenue to materialize in the second half, supported by committed large-scale clinical trial projects already under contract.
• Management expects future gross margin improvement primarily from expanded reimbursement and increasing average selling prices, while investing heavily to solidify market leadership now.

INDUSTRY GLOSSARY

• MRD (Minimal Residual Disease): Laboratory testing to detect small numbers of cancer cells that remain after treatment, often measured through molecular assays such as ctDNA analysis.
• ctDNA (circulating tumor DNA): Fragments of DNA released from tumor cells into the blood, enabling non-invasive cancer monitoring and recurrence detection.
• MolDX: A program by Medicare administrative contractors to evaluate and determine coverage for molecular diagnostic tests, including clinical utility and evidence requirements.
• ASCO: American Society of Clinical Oncology, a major medical society and annual conference where oncology research findings are presented.
• AACR: American Association for Cancer Research, a leading organization and conference for cancer science, where new clinical and translational results are showcased.
• NeoPrism CRC: A colorectal cancer research collaboration specifically referenced for clinical validation of MRD performance.
• DARWIN II study: An externally cited long-term trial highlighted by Personalis for demonstrating the effectiveness of its MRD testing platform in predicting immunotherapy outcomes.
• Variant Tracker: A Personalis software feature allowing real-time monitoring of tumor genetic changes from longitudinal test data.

Full Conference Call Transcript

Caroline V. Corner: Thank you, operator. Welcome to Personalis, Inc.'s first quarter 2026 earnings call. Joining today's call are Christopher M. Hall, Chief Executive Officer; Aaron L. Tachibana, Chief Financial and Chief Operating Officer; and Richard Chen, President and Chief Medical Officer.

All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements within the meaning of U.S. securities laws, 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, Inc. 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, wwwpersonnel.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 PM Pacific Time today. With that, I would like to turn the call over to Chris.

Christopher M. Hall: Good afternoon, everyone. Thank you for joining us. I am incredibly proud of what our team has accomplished in this first quarter, and more importantly, I am energized by where we are going. Since we launched NeXT Personal, we have not 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 are 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.

For those of you new to our story, Personalis, Inc. 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 a million. Let me be clear: this level of ultrasensitivity is no longer just a technical leap forward; it is 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 toward a $20+ billion opportunity, and Personalis, Inc. is armed with the right technology to win. 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 are 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 toward 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 us dig deeper into the three pillars of our win-in-MRD strategy that are fueling this growth. The first pillar is clinical adoption. Our commercial engine reached a new high watermark this quarter.

We have 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 integrating NeXT Personal into their routine testing workflows. We are 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 also 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, and enabling doctors to proactively optimize a patient's therapy. Early feedback has been positive. The second pillar of our strategy is building clinical evidence to secure and expand reimbursement, and we have 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 are 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 three points stand out. First, the NeoPrism CRC data. Our collaborators used NeXT Personal and demonstrated a 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 nonoperative management for some patients.

That could potentially save patients from unnecessary surgery and save the health care 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 long-term immunotherapy success in lung cancer patients. Patients who clear ctDNA 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 are on track to achieve $20 million to $21 million in MRD revenue this year. 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 adoption of NeXT Personal. The first quarter has provided us with a powerful launchpad for the rest of 2026.

We are not just talking about the potential of NeXT Personal anymore; we are 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, Inc. 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 will hand it over to Aaron to walk through the financials.

Aaron L. Tachibana: Thank you, Chris. I will discuss our first quarter 2026 results and then cover the outlook for the full year. Before diving into the details, I want to mention that our focus, priorities, and objectives remain intact: first, 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 MRD market. As I discuss our Q1 results, please keep these priorities and objectives in mind. Let us start with the top line. Total company revenue was $15.5 million for Q1 2026.

On the surface, this amount is 25% lower than a year ago, but underneath there is an important shift taking place. We are intentionally migrating from lower-margin legacy enterprise revenue over to higher-growth, strategic clinical and biopharma MRD revenue that Chris mentioned earlier. Additionally, as we previously forecast, this quarter reflects the planned decrease in revenue from Moderna due to the conclusion of the large Phase 3 trial enrollment that ended last year. We currently expect a baseline of $2 million to $3 million per quarter from Moderna for 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 fee. Breaking down our core revenue, biopharma testing services were $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 technology. 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 $300,000 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 2026. Next, I will address gross margin, as it is 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 is 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, and then beginning 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 cost diluted margins by more than 2,000 basis points.

We are securing positions 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 scales. 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 forge 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 investing in our technology, like our Variant Tracker feature, in order to maintain and increase our ultrasensitive leadership position. First-quarter R&D expense was $14.5 million compared with $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 $30.0 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 us 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 does not repeat throughout the rest of the year. Now let us 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 in 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 tests 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; and 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 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 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: Thank you. We will now open the call for questions. If you would like to ask a question, please press star and then one on your telephone keypad. You may press star and then two if you would like to remove your question from the queue. If I may ask, please limit your questions to one and one follow-up. 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. The first question comes from Subhalaxmi T. Nambi from Guggenheim. Please proceed with your question, Subbu.

Subhalaxmi T. Nambi: 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 a competitive win perspective to reinforce that the strategy is working?

Aaron L. Tachibana: In terms of volume, we achieved 26% growth quarter over quarter, 7,800 tests. The first and third quarters are typically lighter because of seasonality. In terms of competitive dynamics, we are doing really well in the marketplace. We are winning with our ultrasensitive capability, and we could not be happier with where we are today.

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

Subhalaxmi T. Nambi: Perfect. Super helpful, Chris. And then any color on how to model 2Q? Should we expect a similar volume step-up? When you are onboarding a new physician, can you talk about the arc of volume growth? How long does it take for the new doctor to ramp ordering to steady state? And is there a mature ordering number you are seeing from earlier doctors?

Christopher M. Hall: We see physicians jump in many different ways. Some are using MRD testing for the first time, some have experience and want to experience the ultrasensitivity we provide, and some have limited prior use and start to work with the technology. The way to make this standard of care is to really sell into that group and push usage significantly deeper on the back of an ultrasensitive approach, because you can have more confidence in the negative, which is what we have been focused on. Some physicians jump in with a lot out of the gate, others try a few and see what happens.

There is always a desire to test us operationally, to see whether we hit the lead-time goals that we commit to, which we have been largely able to do month after month. We feel like we survive those tests quickly. In general, physicians tend to order more every quarter as they build confidence. Across accounts, there is significant opportunity to go deeper. In very few accounts could anyone say that 100% of eligible patients are getting access to the test, so there are always ways to go deeper and continue to build business and the market.

Operator: Thank you. The next question comes from Mark Massaro from BTIG.

Mark Massaro: Hey, guys. Thanks for taking the questions. I know some of us have been hopping various calls, 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. And can you also speak to IO monitoring as well? Any color on those indications would be helpful.

Aaron L. Tachibana: Hey, Mark. In terms of breast volume, it is roughly 20%, give or take a point or two. Lung is between 15% and 20%, closer to 15% in Q1. So trends by cancer type have been in the ranges we have been expecting. In terms of IO coverage, I will let Rich and Chris take that.

Christopher M. Hall: There are two questions there. On the samples we are getting, there is no change, which is a similar percentage. On the actual coverage journey, we feel confident that we are making progress there. We only submitted in August, so this process is always variable. But we feel like the data looks really good in that indication, and we feel like all of our interactions have been positive, and we are optimistic that we will be covered for IO based on the strength of the evidence that we have.

Mark Massaro: That is helpful. I was wondering if you could speak to ASCO coming up. Should we expect any releases of data, and could you discuss any areas of focus?

Richard Chen: Hey, Mark. We have an exciting ASCO coming up. One thing to look for is more colorectal data, which has been a focus of ours as a next step in terms of coverage and also evidence generation. We are excited about that data, and it will build on the initial data that was presented last year around this time. There is also an expansion to additional cancer types. We are not sitting still. We did a lot with breast and lung and focused there for a few years, but now we are starting to expand into other cancer types, so you can look to see additional data there.

That is coming off a really great AACR, where we showed 15,000 real-world patients and a consistent limit of detection across those patients, with almost 40% of the results in the ultrasensitive zone, some really great colorectal adjuvant usage, and the power of an ultrasensitive approach there. We also debuted data for our new product extension, the real-time Variant Tracker. We had a lot of impactful data that is moving the needle in the field with physicians.

Mark Massaro: Great. And then my last question: your large commercial partner recently disclosed that your tumor-informed test is well over 90% of their MRD volumes. That speaks to the value of your test. Guardant just disclosed that Reveal is a rapidly growing product on the tumor-naïve side. How long do you think your tumor-informed test will be the lead horse in the Tempus portfolio versus their tumor-naïve becoming more balanced as they promote MRD?

Christopher M. Hall: We have always felt sensitivity is key in these indications and MRD testing. That has been our guiding principle and has fueled innovation of our ultrasensitive approach in all of our R&D efforts. Our belief is that the tumor-informed approach will carry the day in terms of sensitivity, and that is what most physicians demand. I think the market will continue to be very much focused on the power of a tumor-informed approach.

Aaron L. Tachibana: Thank you, Mark.

Operator: Thank you. The next question comes from Thomas Flaten from Lake Street Capital Markets. Please proceed with your questions, Thomas.

Thomas Flaten: Hey, good afternoon, guys. 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? And then, 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? How are you thinking about that?

Aaron L. Tachibana: Thanks for the questions, Thomas. For the full-year gross margin guide of 15% to 20%, the back half of the year will have higher margins as our biopharma MRD revenue and clinical revenue increase. In the first quarter, we were just shy of 2%. In Q2, we see that maybe ticking up a little bit. The first half will be the lowest point for the year. For 2026, the 15% to 20% margin range is also expected to be a low point for the company. As we move through 2026 into 2027 and beyond, we see reimbursement continuing to catch up. We have a lot in the hopper.

We are doing really well in terms of collecting on claims, so ASPs are expected to increase as well, which will help both top-line growth and margin expansion and will also start to reduce cash usage. On your second question, whether we are disincentivizing or metering non-paid tests: it is hard to do that when selling to community oncologists who have patients with all different cancer types. We do not want to discourage any physician from bringing in any cancer type. We want all comers because at some point we know we have to secure reimbursement for other cancer types, and we have a lot of progress being made. It is not showing up yet, but it is to come.

We want to make sure physicians are treated really well.

Christopher M. Hall: As we go forward.

Thomas Flaten: Appreciate that. Thanks, guys.

Aaron L. Tachibana: Thanks, Thomas.

Operator: Please press star and then one if you have a question. The next question comes from Michael Stephen Matson from Needham & Company. Please proceed with your questions, Mike.

Joseph Conway: Hi, guys. Thanks so much. This is Joseph on for Mike. One question around the ordering physicians—the 1,000 physicians. Is that in the quarter or to date? And can you segment those 1,000 physicians—what percentage are reordering after using a competitor or are new to MRD? Depending on how big that bucket is, what does that tell you about how fast this market is growing?

Christopher M. Hall: When I talk about the number of physicians ordering, we mean in the quarter. We do not mean cumulative that have ever ordered from us. In this quarter, there were more than 1,000 physicians that ordered from us. That is a more meaningful way to talk about it than mentioning someone who may have ordered several months ago. Most of the physicians have some experience ordering MRD. That is the simplest way to commercialize these tests—physicians who have some experience—but we did not limit it to that because almost half of physicians probably do not have a lot of experience ordering MRD, so we also target those physicians.

A good chunk—the vast majority—have had some experience at some point using MRD testing. They are probably using us in some cases exclusively, or using other providers collectively in their offices. Many physicians use different approaches simultaneously within their office. We are seeing the market continue to grow. There is a lot of energy and excitement around using blood tests as a way to better monitor cancer progression—both to see whether therapy is working, including immunotherapy, or whether the cancer has come back.

The power of an ultrasensitive approach is that you are able to give a lot more confidence to a patient that they are truly cancer free, and at the end of the day that is what a lot of patients are looking for. We are helping to deliver on that, and it is helping to grow the market. We are seeing that in the numbers.

Joseph Conway: Great. And then on the backlog of contracted pharma business, is there any way—either quantifying it or comparing it to this quarter a year ago—to frame how much it has grown? How long of a stretch of visibility does that backlog give you, given an average trial or average project with a pharma partner?

Christopher M. Hall: I cannot compare everything year over year, but what we are really focused on this year 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 had a good sense of that. As the year has gone on, that has only gotten firmer, and those are committed and in most cases contracted now. We feel like we are in a good position to deliver. From the very beginning, we saw that the second half of the year would be a bigger part of our biopharma revenue than the front half.

That was never simply hopes and dreams; we needed to make sure it was solidified as we went through the year, and that has happened this quarter. Typically, most of the business you end up doing for the year you have good visibility to by the middle to end of the second quarter. We feel at this point in the year we have good visibility and have affirmed where we are guidance-wise in being able to hit that $20 million to $21 million in MRD and the overall biopharma revenue.

Aaron L. Tachibana: To piggyback on what Chris said, the biopharma MRD backlog has continued to grow. The funnel of opportunities is also continuing to grow. It is really robust. Customers see the value of the ultrasensitive test we provide and can clearly see that we can detect recurrence before other technologies. In terms of backlog, we have a mixture of retrospective projects and prospective projects. Some prospective projects will go beyond 12 months, which gives clarity beyond just 12 months. Financially, we rely on backlog inside 12 months because that is what will potentially convert to revenue, and we need to get samples in to run them and record revenue.

Joseph Conway: Got it. Thanks very much.

Christopher M. Hall: Thanks, Joe.

Operator: Thank you. The next question comes from Daniel Gregory Brennan from TD Cowen.

Daniel Gregory Brennan: Great. Maybe zooming out at a high level. I know there was a question on ASCO already, but when you think of the ultrasensitive approach versus first-generation approaches, anything you would say from a high level about interest in the market, where it resides today, and what the message will be at ASCO?

Christopher M. Hall: Rich is going to take this one, Dan.

Richard Chen: Hey, Dan. Thanks for the question. If you go to these conferences, it has really changed over the last few years. There is increasing recognition that ultrasensitivity is critical for patients. It is not just a nice-to-have, but a must-have at this point, on the heels of a lot of data that has come before. At ASCO you will see that continued message and the data speaks for itself. For example, in colorectal cancer, last year preliminary data showed that it made a big difference for patients in terms of sensitivity, recognizing cancer recurrence risk very early. You will see those things reinforced with data presented at ASCO this year.

That is true in colorectal cancer but also in other cancers we will present data for.

Aaron L. Tachibana: On guidance and molecular volumes, we just reaffirmed guidance, Dan. We have not changed anything at this point. We had a strong Q1, but we have an aggressive plan to go from 16,000 samples last year to 43,000 to 45,000 this year, doing that in a disciplined way and being thoughtful about spend and gating by the number of resources we apply, with our partner Tempus and our own sales reps. We feel we are on plan and managing responsibly while seizing the opportunity and pushing us closer to realizing the goals of our win-in-MRD strategy.

Daniel Gregory Brennan: That is great, Chris. Is there a typical MolDX turn and how many times back and forth it requires? Given when you submitted neoadjuvant breast and IO, is there a framework by which it would be logical to think we could get an answer?

Christopher M. Hall: It is always a 60-day turnaround time from the time that you respond to questions. The back and forth is variable. We think they do a great job; we really respect and admire their work. We feel we are sitting well relative to how those processes typically go. We thought it would take a while to get through the breast cancer process because it was the first time we went through it, and they had to assess the test and understand it. It always takes some time to work through it, and it is going to be variable based on the indication and the evidence. We expect that, and most companies would tell you the same.

Operator: The next question comes from William Bonello from Craig-Hallum. Please proceed with your questions, Bill.

William Bonello: Hey, guys. Thanks a lot. I think you said to Mark that about 35% of your testing is in reimbursed indications. I know you are not specifically targeting or incenting people to focus on reimbursed versus non-reimbursed indications, but as you look forward over the year, how do you think about that shaking out? Will you be satisfied if we are at a similar mix of indications by the end of the year? Is there any strategy to try to grow the reimbursed indications more aggressively than the others?

Christopher M. Hall: I think there is, Bill. We are always trying to push more aggressively into physicians who treat breast or lung cancer. Strategically, that is what we are trying to do. But when you walk into an account and the doctor is an oncologist who sees patients across the board, we do not tell them to send us breast cancer patients and send everything else to a competitor. That is not our talk track. We are there to serve and work with them. In doing so, there will be evidence, and that has been the strategy to date.

I think the goal as we go through the year will be to continue sequential growth and push into leading positions in some of these areas, and at the same time continue to drive reimbursement so reimbursement picks up steam across a broadening set of indications and spots within these cancer types.

William Bonello: That is helpful. It looks like—based on Tempus numbers—maybe the number of tests not sold by Tempus, but by you, went down sequentially. Can you talk about what you are doing? I thought you were also building up your internal salesforce. How are you thinking about that right now?

Christopher M. Hall: We are building side by side with them to continue to build capability, but we do not compete with them in the field, Bill. We work synergistically. Tempus has a deep and comprehensive infrastructure to serve customers and sometimes it is better for customers to work through them. Or we will sell something and Tempus is there. Tempus also has the ability to offer a product snapshot. We do not want to be competing in the field. If it is easier, better, or more conducive to the way the business is built for it to flow through Tempus, that is ultimately the way it will go.

I would look at the total number, not how much is coming from each company, because that is not how we are driving it in the field.

Aaron L. Tachibana: In terms of total volume, total volume grew by 26% quarter to quarter. Tempus was a little over 80% of the volume. Volume from the internal commercial team did not decrease; it was flattish. Q1 is typically seasonally a little slower than Q2 or Q4, so I would not read anything into that. Some of our internal team is also helping some of the Tempus reps from a marketing perspective. We work together. What we have learned in these relationships over our careers is you do not want reps fighting in the field.

We partnered with Tempus for many reasons, including their deep EMR linkages, infrastructure build-out with the nuts and bolts of the business—portals, etc.—and their ability to offer a comprehensive one-stop shop. That has worked really well for us with them.

William Bonello: That is really helpful. I appreciate that.

Operator: There are no further questions. This concludes the question-and-answer session as well as today's teleconference. Ladies and gentlemen, thank you very much for joining us. You may now disconnect your lines. Goodbye.

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