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Earnings call · FY2025 Q2
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Positive
Net tone +35 · moderate hedging
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| Metric | Period | Guided | Basis |
|---|---|---|---|
|
Full year revenue
full year
|
$70M – $80M | — | |
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NeXT Personal revenue from biopharma year-over-year growth
this year
|
300% – 400% | — | |
|
Clinical business quarter-over-quarter growth
quarter-over-quarter
|
30% – 40% | — | |
|
Total biopharma revenue
third quarter
|
$11M – $13M | — |
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Ladies and gentlemen, greetings and welcome to the Personalis Second Quarter 2025 Earnings Conference Call. At this time, all participants are in the listen-only mood. A brief question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please signal the operator by pressing star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host for today, Caroline Conner, Investor Relations. Please go ahead.
Thank you, Operator. Welcome to Personnel's second quarter 2025 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President, Aaron Tashibana, Chief Financial and Chief Operating Officer, and Rich Chan, Chief Medical Officer and EVP R&D. All statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements within the meaning of U.S. security laws. For example, any statements regarding trends and expectations for our financial performance this year and longer term, cash runway and liquidity position, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, expansion of clinical volume, future publication, 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 most recent filings with the SEC, including the risk factors described in our most recent filings. Personneles undertakes no obligation to update these statements, except as required by applicable law. Our press release with our Our second quarter 2025 results is available on our website, www.personaos.com, under the Investors section includes additional details about our financial results. Our website also has the latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5 p.m. Pacific time today. With that, I would like to turn the call over to Chris.
Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. Our second quarter was defined by outstanding execution of our winning MRD strategy. The clinical adoption of Next Personal is accelerating dramatically, with test volume growing 59% sequentially. We delivered nearly 3,500 clinical results in Q2, and today, our base of ordering physicians has expanded to over 600. Our commercial partnership with Tempest is gaining momentum, with reps now commercializing next personal across four major indications, breath cancer, lung cancer, and colorectal cancer, as well as immunotherapy monitoring. We believe we're on a path towards securing Medicare coverage for two indications by the end of this year. For those new to our story, PIRS analysis is at the forefront of the minimal residual disease market, or MRD market, which is poised to exceed $20 billion annually. We believe we are transforming cancer care. Using a simple blood draw, our next personal test monitors therapy and detects residual cancer with ultra-sensitivity, capable of finding just one fragment of tumor DNA in a million. This allows us to see cancer recurrence months ahead of imaging and positions personalists to capture a significant share of this transformative market opportunity. Turning to our results, we delivered $17.2 million in revenue for the second quarter. Our performance reflects two distinct stories. First, our core clinical business is exceeding our internal plans and demonstrating momentum. Second, we're actively managing the near-term, industry-wide headwinds in biopharm R&D spending. Political changes in the healthcare sector and the uncertainty of tariffs have impacted our customers' translational research projects, resulting in revenue from a few significant contracts shifting out of Q2 and an overall weakness the rest of the year. In light of these industry dynamics, we're updating our full year revenue guidance to a range of $70 to $80 million. While this range reflects the current variability in the BioPharma project timing, we have a concrete three-point action plan to aggressively pursue the high end of this range and expect to finish the gear with maximum momentum. Here are the three key drivers that give us conviction. First, we're converting our deep biopharma pipeline, especially for MRD. While project timelines have shifted and affected translational business, demand for our MRD technology is robust with growing adoption of Next Personal for MRD by our biopharma customers. Next Personal gives our customers a tool with ultra-sensitivity to measure therapeutic efficacy, and we remain on plan to grow this segment by 300 to 400 percent this year with a meaningful revenue contribution expected in the fourth quarter. Second, we are capitalizing on our clinical momentum. Our clinical business is a growth engine as we continue to project 30 to 40 percent quarter-over-quarter growth fueled by exceptional traction with our partner Tempus and our expanding base of ordering physicians. This is a core pillar of our growth story, and it is accelerating. Third, we are advancing towards a pivotal reimbursement catalyst. Achieving Medicare reimbursement in two indications this year remains a top priority and is on track. This is expected to be a major inflection point for the company, unlocking a significant revenue stream. So let me be direct. We own the Q2 revenue shortfall. Moving forward, we're pushing hard on the levers we can control to finish the year strong instead of passively waiting for market conditions to change. Now let's walk through the pillars of our WIN and MRD strategy. First is accelerating clinical adoption. Through our partnership with Tempest, we delivered 3,478 tests this quarter, a 59% increase from the first quarter and over 575% growth from last year. This is a direct testament to how our ultra-sensitive approach is resonating with clinicians. Our growing base of over 600 physicians confirms that NextPersonal's ultra-sensitive results are a key differentiator, giving them greater confidence in their clinical decisions. This quarter, we expanded our Tempest partnership to include colorectal cancer, a major market where we believe our test ultra-sensitivity can address a significant unmet need. Initial feedback is extremely positive, and we're moving aggressively to capitalize on the opportunity. In light of this, we're also adding to our own personnel of Salesforce and expect to exit the year with 12 to 15 field professionals on the ground. Second is driving reimbursement through world-class evidence. The clinical data validating our approach is nothing short of outstanding. At ASCO in June, three studies underscored the power of our technology. The PREDICT and Skandari studies demonstrated that NEXT Personal can predict patient outcomes in neoadjuvant breast cancer, with nearly half of all positive detections found in the ultrasensitive range that our assay unlocks. Furthermore, an important study from AstraZeneca showed our test detecting cervical cancer progression up to 16 months ahead of imaging. We believe this is the caliber of evidence that doesn't just support clinical practice, it transforms it. Behind the strength of our clinical evidence, we continue to target achieving coverage for at least two indications this year. We have recently submitted our IO monitoring dossier for Medicare coverage, and so we now have two indications in process for coverage, and the lung cancer dossier is on track. Some aspects of the coverage process are beyond our control, but we continue to be confident that our data meets the bar for coverage. Third is leading with biopharma partners. Our technology gives partners a powerful tool to accelerate clinical trials. While total biopharma revenue of $11.1 million reflects the project delays I mentioned, the underlying growth in our strategic focus area is exceptional. As I stated, next personal revenue from biopharma is on track for 3% to 400% year-over-year growth, and the new customers noted in our last call remain on track to generate over $5 million each in revenue this year. We project total biopharma revenue will rebound to between $11 and $13 million in the third quarter. Our expectations are much higher for the fourth quarter, typically the best quarter of the year. In summary, PersonaLess is executing with precision on our strategy to win an MRD. Our team and our partners are deploying our ultra-sensitive technology that we believe can redefine the standard of care for patients with cancer. I'm proud of the progress that our team has made so far in 2025, and I'm thrilled with the commercial momentum and partnership with Tempest. This is a transformative year for our company, and most importantly, for the patients who benefit from our technology. With that, I will now turn it over to Aaron to review our financial results.
Thank you, Chris. I will discuss our second quarter 2025 results, and then cover guidance for the third quarter and the full year. Total company revenue for the second quarter was $17.2 million, representing a 24% decrease compared with $22.6 million for the same period of the prior year. The decrease in revenue was primarily driven by the expected volume decline of $5.6 million from Natera and $1.3 million from Moderna. We continue to expect the Natera business to conclude by the end of the third quarter. Biopharma revenue was $11.1 million in the second quarter, representing a 16% decrease compared to $13.2 million for the same period of the prior year. Most of the biopharma revenue decline was from Moderna, as previously mentioned. In addition, Chris discussed the customer project delays that we had in the second quarter. If these projects were not delayed, our biopharma revenue for the second quarter would have increased year-over-year, despite the decline from Moderna. For clinical revenue, we recognized 0.5 million of revenue from our next DX and next personal molecular tests, compared with 0.1 million for the same period of the prior year. Gross margin was 27.6 percent in the second quarter, compared with 35.6 percent for the same period of the prior year. The year-over-year decreased of 8% was primarily due to the lower revenue and unreimbursed clinical test costs. In the second quarter, we saw an impact of approximately 12% to our gross margin from the unreimbursed clinical test costs. Excluding those expenses, gross margin would have been approximately 40%. We continue to expect total company margins to expand beyond 50% once we have obtained reimbursement coverage for more than a few indications and we achieve scale. Operating expenses were $26.6 million in the second quarter compared with $24.9 million for the same period of the prior year. Most of the year-over-year increase was attributed to selling expenses related to our clinical test volume growth. The second quarter R&D expense was $12.4 million compared with $13 million for the same period of the prior year, and SG&A expense was $14.2 million compared with $11.9 million for the same period of the prior year. Net loss for the second quarter was $20.1 million compared with $12.8 million for the same period of the prior year. The prior year's net loss included a $3 million non-cash gain related to the warrants issued to Tempest and were outstanding as of the second quarter of the prior year. Excluding the non-cash gain, the prior year net loss would have been $15.8 million for comparative purposes. Now onto the balance sheet. We finished the second quarter with a strong balance sheet with cash and short-term investments of $173.2 million and no debt other than some small equipment loans. The cash usage from operations and capital equipment additions for the second quarter was $13.2 million. We continue to operate cost-effectively, and as mentioned during our last conference call, we expect cash usage for the full year 2025 of approximately $75 million, an increase of approximately $30 million compared with the amount used in 2024, primarily due to investment in clinical test volumes in advance of reimbursement, expansion of our clinical evidence for next personal by conducting new studies, and additions to our clinical sales team. We expect these investments to help drive next personal revenue growth post-reimbursement later this year and into 2026. Now I'd like to turn to guidance. For the third quarter of 2025, we expect total company revenue in the range of 12 to 14 million dollars, revenue from pharma tests and services and all other customers in the range of 11 to 13 million, and revenue from population sequencing and enterprise customers of approximately 1 million. And for the full year of 2025, we revised our guidance and now expect total company revenue in the range of 70 to 80 million, which is reduced from 80 to 90 million. And this lower range encompasses the timing and variability of biopharma projects and sample receipts and Medicare reimbursement coverage for next personal. Revenue from pharma tests and services and all other customers in the range of 52 to 58 million which is reduced from 62 to 64 million population sequencing plus enterprise customers in the range of 15 to 16 million revenue from clinical tests reimbursed in the range of 3 to 6 million which is narrowed from 3 to 10 million gross margin in the range of 22 to 24 percent and our gross margin guidance for the full year is expected to be lower than the 32% for the full year of 2024 due to the impact of investing in clinical test volume ahead of reimbursement. Net loss of approximately $85 million, which includes approximately $20 million of unreimbursed test costs, which is increased from $83 million due to lower revenue. And cash usage of approximately $75 million. dollars. 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. Ladies and gentlemen, we will now begin the question and answer session. If you would like to ask a question, please press star and one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Ladies and gentlemen, we will wait for a moment while we poll for questions. The first question comes from Dan Brennan with TD Cowan. Please go ahead.
Great. Thank you. Thanks for the questions.
Maybe the first one just on clinical. So I know you said Medicare is on track. You did lower the top end of the guide from 3 to 10, 3 to 6. So maybe can you just walk through a little bit of like what was the rationale for that? Are you hearing anything back from Medicare? And then B, as we think about the back half of the year for clinical, like what's kind of assumed for Q3 and Q4 at this point?
So, Dan, in terms of the guide, the prior guide, our prior guide, we had a pretty wide range of $3 to $10 million on the clinical side, primarily due to the number of months we saw before we got to reimbursement. Now that we're in the month of August or early August here, we thought it'd be prudent to tighten the range or narrow the range, right? And that's how we come up with the $3 to $6 million estimate. And what we've modeled in the prior guide is we had a lot of different models that we ran or scenarios that we ran in terms of when reimbursement could occur, right? And so that's how we came up with the way. And net-net, you know, you could assume that, you know, we did have reimbursement for one indication, then the latter part of Q3, and then the second one in Q4. We're still targeting two cancer types for the full year, But in terms of the guide now, you know, it looks more reasonable that we'll get two-cancer type.
Yeah, so, Dan, it's Chris, and we still feel confident about that. We've had good engagement. You know, Palmetto always does a great job evaluating these tests and these technologies, and we've been engaged with them. Evidence meets the bar that they've established. We've, you know, got the I.O. submitted, which is new news, And we feel like we have tracer X data being published in lung cancer. So it's our expectations. We're going to have three shots on goal to get two of them done by the end. We're in a good position. You know, it's always tough to nail down the exact final timelines on this stuff.
And could you speak a little bit to some of the early use cases? You know, you talked about, I know you gave some numbers out in terms of the number of doctors that are using it. Just speak to, like, how is that going? I know it's early. you don't have coverage yet, but how is the, you know, the number of doctors using it and kind of where do you find doctors are using it specifically? Like what types of areas do you think your ultra-sensitive test plays, you know, a differentiated role?
Yeah, I mean, we, you know, we've got some great, I didn't plan, I think, you know, this last quarter we added CRC to the call cycle.
I know there'll be a bunch of questions on pharma. Just kind of one more on the balance sheet. So you have $173 million in cash. I think you burned $13 million. Can you just remind us of the pathway forward? Like how long does that cash last? I know everyone talked about the gross margin expansion you expect, but you also have the deal with Tempest, which just kind of walk us through a little bit of how we might contemplate your kind of cash flow and any kind of cash flow you even have going forward. Thank you.
Sure, Dan. So we ended the quarter with $173 million of cash. We have a strong balance sheet. We believe we have plenty of cash to get us not only to the other side of reimbursement, but to get us the cash flow breakeven. In terms of having to go raise money, we're not in that position like we were in the past. So there's no plans contemplated to having to raise money. We still have plenty of cash to be able to invest in studies, invest in growth of volume here in advance of reimbursement and post-reimbursement. And then once we get to the other side of reimbursement, then we're really ramping our test point, then we can sit back and look at other investments that may be required to grow even faster.
Terrific. Thank you. Thanks, Dan. Thank you. The next question comes from Mark Massaro from BTIG.
Please go ahead.
This is Siddhii and I'm from Mark. Thanks for taking the questions. And so just one on biopharma, is it fair to think about the $10 million reduction as a push-out of revenue rather than being canceled outright? So is it fair to think about that being reflected in 2026? And is it correct that the – yes, go ahead.
Go ahead. What was the second part of the question?
Yeah. And then just to clarify, would that push out related to the personalized cancer vaccine deal that you have with Moderna? And if so, just how do you feel like that value prop is resonating more generally?
Yeah, Noah. Great. So, let's start with the PCV or the INT individual, Moderna, that is on pace and has been sort of a bedrock relationship, and we couldn't be happier with how that's progressed. We had expected that revenue to be down this year because they had enrolled a significant number of patients in their melanoma trial last year, and we didn't see anything there. What we've seen in the Q2 was that some of the projects got pushed into Q3 and Q4, and some of the Q3 started to get pushed back, and we started to see some softness. That's been in the translational sector, you know, and I think what's happening is these biopharma companies, you know, we've seen a slowdown and we've seen a jigsaw. We expect to go profiling work. The plug might get pulled on that, but we haven't seen any significant push outs and certainly the clinical.
That was great color. Thanks so much. And then just to follow up on the MRD front, just on the 3,500 next personal tests, could you guys just discuss if you're seeing maybe an increased number of test time points per patient, or is it more so lift in new physician ads? And then just any attachment to call out a next personal to your next DX CGP test as well. Thanks.
Yeah. Yeah. So we're seeing growth both in the number of physicians, and I think we talked about we've crossed over 600 now we're in, which is just phenomenal given where we are. And we are seeing us go, we're going deeper into those accounts, meaning we're getting more samples per physician. And then we're starting to pull through the subsequence. And that's all been on the bedrock of what's been a phenomenal relationship with Tempest. I mean, we work so well with them and we couldn't be more happy with how that really, you know, deeply starting to power the numbers and the performance. And so it's happening across all the metrics. On NextDX, the CGP test, I think we had our highest quarterly revenue this quarter. You know, that's been the CGP NextDX. It's appended onto many of the tests that we do without Tempest. Tempest sells their CGP. We get the MRD metrics. You know, it's increasing tests per doctor, increasing number of doctors, phenomenal.
I think I covered everything.
Yeah, perfect. Thank you for taking the questions.
Thank you. The next question comes from Thomas Flatton with Lake Street Capital. Please go ahead.
Hey, good afternoon. I appreciate you guys taking the questions. You know, since now that you've run a few thousand samples through the system, I'm curious what you guys have seen in terms of turnaround time for the test, you know, from tissue and blood receipt from the patient's first visit and then to turn around to results. Have you seen any improvement in that? Has it been helpful to have this early access program to work out kinks, et cetera?
Oh, absolutely. You know, what we've done is we've had a good chunk of our R&D staff really focus this last 18 months on how do we start to scale this, and our lead times now have fallen dramatically. We think we're at a spot both on the subsequent and the base position. We've invested a lot of money in time and started to do it at scale. And, I mean, it's sort of hard to quantify that. But I will just note the market for service and the growth that we are seeing is attributed to our ability to actually run. Because if we were messing this up and we were, you know, going weeks and weeks and weeks and days and days and days and losing samples along the way, we would not see the retention and we would not see the quarterly growth because you can't solve that. So we've been rock solid there.
Got it. And I'm not sure how many ends you have to use to answer this question, but have you detected what kind of cadence physicians are using with repeat testing with patients that might have been kind of early on in the early access program?
I mean, I think we're seeing, you know, I think it's a little early to answer that definitively. I mean, we see that the recurrence monitorings, the IO therapy, we see more than the recurrence monitoring. I think it's what we expected, but I think it's a little early into the different use cases and where they are in the clinical flow. And I think we'll have a lot more as the numbers start to get bigger.
And then one quick final one. As you guys look to expand your sales team here in the second half of the year, remind us again how you and Tempest are going to kind of co-manage customers. You know, is there exclusivity depending on who the rep is? Can you explain a little bit more how that works?
Yeah. So, I mean, the relationship, I mean, we're depending on Tempest and, you know, they've they've powered us. And, you know, that's awesome. It really depends on what the doctor and how they want it. And usually it's honestly probably best for the physicians to drive through the Tempest infrastructure. They're set up in EMRs, and that's really important to clinicians. The logistics are often worked out within those institutions. That allows us to move quicker in a really seamless way and in a way that meets customer needs. and it was one of the driving forces in terms of it. And so I think by and large, you know, physicians tip us and, you know, we've always said we'll be scaling it and we're needed, and particularly in big academic medical centers with KOLs.
I mean, one of the things that I think it made personalists unique comes from Yuko Oku with Morgan Stanley. Please go ahead. Yuko, please go ahead with your question and unmute yourself in case if you're on mute.
Hi, this is Edmund on for Yuko. Can you guys hear me? Yeah. Thanks. Hey, I just wanted to start up in the biopharma end market. I was wondering if you guys provide an update to what you estimate the impact of all of these policy headwinds are going to be on your biopharma customers. I think you previously pointed to three to five million impact with your pipeline offsetting that. I was wondering if you have an updated estimate.
So, hi, Edmund, this is Aaron. So in terms of your question about the biopharma landscape, what's going on in the government front, in our prepared remarks, we did talk about revising our guidance from biopharma down from 62 to 64 million down to 52 to 58. In terms of what we're seeing is on the translational research side of the business, where ImmunoID Next is our offering. We are seeing delays of projects, and we've seen that, you know, occurring from Q2 and Q3. So projects in Q2 and Q3 have shifted to the right. It's our assumption that these projects are not lost. They're just delayed a little bit. So it's going to take two to four quarters before those, you know, get completed and convert to revenue. What's really strong for us right now is the MRD offering, NextPersonal with Biopharma. Our funnel continues to grow and expand. And as Chris said in the prepared remarks, we have two customers that are $5 million each, and we believe we're going to fulfill those.
Gotcha. And then on the competitive landscape, following the recent announcement of the coverage determination for Saga's Pathlight, could you elaborate on how NextPersonal is differentiated? And how are you thinking about balancing your MRD investments between near-term margin pressures versus immediate top-line benefits upon receiving reimbursement?
I didn't catch the last part, sorry.
Just how are you balancing, thinking about balancing your MRD investments between suffering from near-term margin pressures versus seeing more of a top-line impact upon reimbursement?
Yeah, no, we, I mean, first of all, Saga got reimbursement in breast cancer, and yeah, I think that's great. I think that's great that another player has gotten it. They were published several months ahead of us. And so our assumption has been always that they had submitted well ahead of us, you know, and their data, their data was good. And we feel like we clear the bar. And, you know, when we saw that, you know, we continue to invest deeply in evidence developed longer trial and triple negative breast cancer, focus on it in this call, continue to invest aggressively there.
And we think that that I think the other question that Edmund, you had was balancing the volume with margins so what we can say there is 24 million dollar margin guide of 22 to 24 percent
thank you for the time and the color Aaron and Chris thanks Evan thank you the next question comes from Subhu Nambi from Gogenheim please go ahead hey guys thank you for taking my questions can you talk through some of your conversations at ASCO you touched on this a little in the previous Q&A, how did that reinforce the approach you guys are taking right now, and what are some of the things you've learned to implement in the second half of this year and beyond?
Yeah, hi. Thanks for your question. This is Rich. Yeah, so we had a really great ASCO, as Chris alluded to, and notably at ASCO, we introduced our first neoadjuvant breast cancer data in triple negative breast cancer with two studies, Predict and Scandare. And what was really terrific about that was that they showed very similar findings, that our test was highly, highly predictive of relapse, you know, for patients who relapse versus those who were negative favorably with the industry standard. So that was really, you know, an important step before, and what they showed was our test was highly predictive, independent of past CR. So what that kind of sets us up to do is really, you know, you can expect that we'll be submitting for reimbursement for neoadjuvant breast cancer once these studies get published, much in the same way we've been pursuing these.
So the way to think about it is that this year we go for, you know, the breast along, next year, you know, we'll be bringing CRC along and expanding breast cancer, as this paper, papers could explain.
Got it, Chris. And Chris, I know it's still early and you guys are still waiting for Medicare reimbursement, but any conversation with pricing at all or all that will only happen once you have the coverage?
Yeah, it does only happens after we get the coverage. But, you know, we've told people to put in their models similar to what's being reimbursed because we think that that's sort of the floor of reimbursing cost-intensive approach along with $1,800 on goal. They go higher, but we've encouraged people to build the models where that's upside. And when we talk about the ability to have transformational economics, we do that assuming.
Got it.
And then more of a high-level question, but the longer reimbursement takes, have you seen any erosion and interest from DOCS who currently cannot serve due to getting volumes and they choose other competitors who are available or is it too early for any of these things to be a factor no we haven't seen we haven't seen any any of that and we've been expanding out the number and been able to you know continue to expand and i think at this point it's a rate of how fast you know we still have some physicians on the wait list but you know we've we've been growing out pretty significantly and making sure We take care of people that really, really want access. But we spend a lot of our time, both with ourselves and our partner, going deeper into accounts and really reinforcing the power of the ultras, since that's what some men see the value of.
Makes sense. Thank you so much, Chris.
Absolutely. Thanks for being on the call.
Thank you. The next question comes from Mike Mattson with Needham and Company.
Please go ahead. yeah thanks um you know so just had a question kind of on the tempest arrangement so you know let's say that in the third quarter you were to get the reimbursement for say lung cancer um you know is i my understanding is that you know they've just been kind of selling this or you know i guess pitching it to doctors to use with you know any kind of cancer essentially um so is there a way that you can sort of incentivize them or Tempest can incentivize those reps to, you know, focus more on the cancer types where you will initially have, you know, coverage or, in other words, to try to, you know, ramp the revenue more quickly and reduce the cash burn, I guess, while you're working on the other, you know, cancer indication coverage?
No, thanks. That's a great way to, you know, great question. And so they focus in on the lung cancer, the breast cancer, and the immunotherapy monitor, and increasingly CRC. Almost all of our samples get within those indications, both that we're getting ourselves and that they're getting. So they're all sort of tied. Most of them are tied to those core indications. And we don't receive a lot of samples all over. And I do think there's an opportunity. Let's say we got lung cancer or breast cancer first. I do think there's an opportunity to preferentially, you know, focus in on physicians that just treat those types of things. But it's hard to go to physicians and tell them, you know, only send us these types of patients, per se, because, you know, physicians want to be able to offer. I don't think we have complete control to pull those levers, but we do have some control to sort of push in the direction of, you know.
All right, I understand. And then just, you know, you announced you're going to pursue the colorectal cancer. It's reimbursement eventually. So, where do things stand with the data and the press release side of the victory data? But, I mean, is that sufficient? And then, you know, what are the milestones, I guess, does it need to be, I assume it needs to be published or something? And do you need any other studies or data there?
No, absolutely. So that data was, you know, phenomenal. We've got great feedback from it, but it's preliminary. You know, it's a prospective study, which is different than some of the studies that we worked on, which are retrospectively gathered samples, a little bit different because you get it all when you do it. This one, you know, it's going forward. And the investigator hasn't decided to quit the study yet. At some point, we will do that, and then the investigator will...
Okay, got it. Thanks. Thank you. A reminder to all participants, you may press star and 1 on your keypad to ask a question. The next question comes from Swayam Bhakula with H.C. Wainwright. Please go ahead.
Thank you. This is R.K.F. from H.C. Wainwright. Good afternoon, Chris and Aaron. I got on the call a little bit late, so I apologize if you kind of address some of these issues in opening remarks. Just looking at the former tests and services revenue and seeing how they did not perform to the level that you were expecting going into the second quarter, and also thinking about the full year, you know, after completing one half, you know, it looks like, you know, you're not going to, at least in your current mind, you're not really thinking about much of a growth from here onwards for the second half compared to first half. What has changed in the pharma business side of things that's not progressing as well as you thought you would. Is this their clinical programs or is this more than that? You know, if you can just give us a little bit of color and, you know, is this just for this year and once hopefully the market turns around and the funding is better for everybody, you know, should we see that growth?
No, I think that's great. I think we're seeing, And so a couple of snapshots here to think about. We're seeing phenomenal growth on the MRD side, inside biopharma customers, and that's all on track. And every time we've 200% annual growth, a couple of new customers are generating north of five, and we feel like we're performing. The other part of the business, which is the translational research phase, where we'll receive a large sample of a large group. we will run it through our tumor profiling engine, and the biopharma company will use that data to potentially find new biomarkers to fuel their drug development. That's like more futuristic type of research. That one we felt that's probably driven, you know, by, you know, a lot of the questions around how drug development processes go, drug pricing in the current system, and And certainly tariffs, and you're seeing layoffs with them. We think that that's temporary, and we think it'll sort itself out. But I would say that we're still expecting that product to be flattish to a little. We thought we would grow through.
Thanks for that. And the next question is on trying to understand in terms of the tempest relationship and also So how the reimbursement can provide, you know, a boost to the sales in Q4 if you get at least one, if not two, both of the reimbursements in place. So let's say you get the reimbursement earlier in the quarter, in the fourth quarter. So by the end of the quarter, would you be able to recognize the reimbursement amount? Or is there some additional paperwork and all that logistics that need to happen that this thing could drag into the first quarter where you can actually really see the benefit of that reimbursement? I'm just trying to understand how the logistics work in terms of really recognizing the revenue based on the reimbursement.
Yeah. So, hi, RK. This is Aaron. And in terms of some of the mechanics of it, we won't go into a lot of depth or detail here, but what's the most important fact here is that we do get a favorable coverage decision. Assuming we get a favorable coverage from Medicare, right, for two cancer types, our guide is three to six million dollars, right? So depending upon the timing, the number of samples, the price, it's six million dollars, and that's why we do have a range. But the key here is getting the favor.
Thank you. Thanks for taking my questions.
Thanks, Arke.
Thank you. Ladies and gentlemen, This concludes the question and answer session and the conference of personalists. Thank you for your participation. You may now disconnect your lines.
SEC filing · Item 2.02
Filed Aug 5, 2025 · complete as-filed document
SEC periodic report
Filed Aug 5, 2025 · complete as-filed document