Operator
Greetings and welcome to the Personnelis Fourth Quarter 2025 Earnings Conference. 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 your host, Caroline Corner. Thank you. you may begin.
Thank you, Operator. Welcome to Personnel's fourth 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 Chen, Chief Medical Officer and EVP R&D. All statements made on this call that do not relate to matters of historical facts should be considered forward-looking statements within the meaning of 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, expansions of clinical volume, reimbursement goals, the outcome and timing of reimbursement decisions, expectations for 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. Personnel's undertakes no obligation to update these statements, except as required by applicable law. Our press release with our fourth quarter and full year 2025 results is available on our website, www.personnel's.com, under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5 p.m. Pacific time today. With that, I would like to turn the call over to Chris.
Good afternoon, everyone. Thank you for joining us to discuss our fourth quarter and full year 2025 results. As we stand here at the beginning of 2026, I'm incredibly proud of the progress our team made over the past year and the momentum that we have today. 2025 was the year we validated our winning MRD strategy. 2026 is the year we expect to scale. Physicians increasingly trust our next personal test. Our clinical volumes are building, and our strategic roadmap is being validated by the medical community. For those listening in for the first time, Personalis is a leader in MRD testing services, and we're helping patients, partners, and doctors see more in cancer samples. We operate at the leading edge of MRD sensitivity. Our ultra-sensitive next personal test is capable of detecting approximately one single fragment of tumor DNA in a million. This is not merely a technical improvement, it's a clinical necessity. This level of sensitivity allows physicians to detect cancer recurrence months ahead of standard imaging and provides them with far greater confidence in a negative result. The clinical market for these types of tests known as minimal residual disease or MRD test is growing rapidly and is expected to mature into a $20-plus billion opportunity, and Personalis is exceptionally well positioned to command a significant share of that opportunity. Beyond clinical testing, we remain a leader in supporting biopharma companies through clinical trials and drug development. Our platforms are used by our partner companies to analyze tumors and identify new biomarkers serving is the foundation for the next generation of personalized therapies. We are the engine that supports researchers as they explore new treatments and allow physicians to personalize treatment for every cancer patient. Now turning to our results, the headline of our performance is our explosive clinical growth and our achievement of two Medicare coverage decisions. In the fourth quarter, we delivered 6,183 clinical tests. This represents a 41% sequential growth over the third quarter of 2025 and a 329% increase year over year. Now to put that in context, in Q4 of 2024, we delivered just 1,441 tests. Our performance this quarter reflects the strong uptake of next personal in the marketplace for the full year of 2025 we delivered more than 16 000 clinical tests growing 394 percent over 2024. we achieved 17.3 million dollars of revenue in the fourth quarter in line with our preliminary announcement last month our full year revenue of 69.6 million reflects the trans transitional period for our top line as we previously discussed we've shifted our commercial focus from lower-value project work to higher-value MRD partnerships, which meant that we experienced a nearly $20 million year-over-year decline in revenue from Natera while we set the stage for growth with our MRD engine. The uneven biopharma spending environment we discussed last year has persisted, creating variability in the timing of large, project-based translational research. However, it is critical to note that the underlying demand for our strategic MRD offering remains exceptionally strong. We grew our MRD biopharma revenue by nearly 240% over 2024. We believe we are the partner of choice for biopharma companies who need to, quote, see what others cannot. And we expect penetration of our MRD testing into biopharma companies to be a growth driver for years to come. NextPersonal has the potential to help these partners fail in early clinical trials sooner, succeed in these trials quicker, and enroll the right patients into their studies. Now, innovation is the heartbeat of personnel. Just as we've led the way in pioneering ultra-sensitive MRD detection down to one part per million, we recently announced the next evolution of our NextPersonal MRD test, our real-time variant tracker report. Cancer changes over time, and it can change in reaction to treatment. The real-time variant tracker allows for the detection of mutations targetable with therapy and the identification of resistance mutations during MRD surveillance with NextPersonal. As an example, in metastatic HR-positive breast cancer patients, the ESR1 gene can acquire mutations over time that cause resistance to the hormone therapy patients may be receiving. Knowing when these mutations can happen allows physicians to adjust therapy proactively. The addition of this opt-in report is intended to give clinicians a dynamic window into how a patient's cancer is evolving in real time. We announced the early access program for this module for clinical and academic leaders in January of this year. The feedback from early discussions with doctors has been positive, and we believe this provides a powerful new tool for physicians as they seek the best possible outcome for their patients. This new addition to NextPersonal underlines our continued innovation in MRD and, most importantly, our commitment to innovate for patients. Looking ahead to 2026, we expect total revenue to be in the range of $78 million to $80 million. However, to understand the velocity of the business, you must look at our strategic growth engines, that is, our clinical revenue and our biopharma MRD revenue. We expect our strategic revenue to grow from approximately $14 million in 2025 to a range of $30 to $32 million in 2026, which would be roughly 121% growth, driven by the expectation that clinical volumes will quadruple. I will now dig deeper into the three pillars of our winning MRD strategy that are driving us forward. The first pillar is clinical adoptions. Now, the numbers speak for themselves. Last quarter, we had more than 900 oncologists ordering our test, and we're seeing strong retention among those who adopt next personal. We're scaling our commercial footprint to onboard more oncologists and drive testing volumes. We now have more than 10 dedicated reps in the field working in close coordination with our partner, Tempest. In 2025, we expanded our relationship with Tempest to include colorectal cancer, and our commercial efforts are fully aligned to champion the market shift towards ultra-sensitive MRD testing. We're setting our initial 2026 annual volume guidance at 43,000 to 45,000 tests, which would be about 170% growth year over year. This underscores the tremendous momentum we are seeing and our confidence in our commercial team and our physician partners. Our second pillar is building clinical evidence and the data we need to support continued positive reimbursement decisions. We made massive strides here in 2025. We submitted three dossiers for coverage to Medicare, backed by industry-leading clinical data. In the fourth quarter, we successfully achieved Medicare coverage for breast cancer with favorable pricing, and just a few weeks ago, we received Medicare coverage for lung cancer. These coverage decisions validate the value of our technology and changing patient lives, and I'm proud of our team for these accomplishments. Both reimbursement frameworks are for ongoing cancer surveillance for patients, so our tests can be used at multiple time points along the patient's cancer journey and across many years. We currently have an additional dossier under review with Moldex for the use of next personal to monitor immunotherapy and metastatic cancer patients. Though exact timing remains subject to Moldex review, we remain confident in our data. Our drive towards coverage has been powered by data and the strong performance of our next personal test. These last several months, we continue to build upon our foundation to transform personalis from a high-growth testing company into a high-margin reimbursed clinical powerhouse. The landmark studies with TracerX, Roe-Marston, and VHIO published in Cell, Annals of Oncology, and Clinical Cancer Research, respectively, are the anchors of our evidence base. The TracerX lung cancer study is one of the largest, longest, and most rigorous lung cancer MRD studies to date with over 400 patients. In this study, NextPersonal showed exceptional sensitivity and specificity throughout the patient journey from diagnosis to surveillance, even in lung adenocarcinoma, the most common yet difficult to detect subtype. Our Royal Marston breast cancer study also showed exceptional sensitivity and specificity across HR positive, HER2 positive, and triple negative breast cancers with 15-month-plus medium lead time ahead of imaging. The VHIO study across 24 cancer types showed that advanced cancer patients receiving immunotherapy who achieved durable molecular clearance had 100% overall survival. The pan cancer UCSD I predict study was just published in NPJ precision oncology and it showed the next personal identified molecular progression a medium of 161 days over five months before imaging in late stage cancer patients receiving immunotherapy. Yale University is leading the case study to demonstrate the utility of next personal and breast cancer. Furthermore, our prospective Be Stronger 1 trial in triple negative breast cancer is well underway, having now enrolled more than 200 patients. Overall, we're now involved in 35 plus additional studies that are powering the next generation of evidence, and that number just continues to grow. In 2026, we're focused on neoadjuvant breast cancer and colorectal cancer and submitting for coverage there. As a reminder, we've presented data earlier From PREDICT and Scandari, those studies show the power of next personal in neoadjuvant breast cancer. And the British Columbia Cancer Study showed the power of the technology in colorectal cancer. The third pillar is leading in the biopharma sector. IBAR-D, or next personal biopharma revenue, grew nearly 240% this past year. Biopharma companies are realizing that to prove the efficacy of their next-generation therapies, they need the most sensitive detection tools available. And this has led to our success in driving their adoption of NextPersonal. We made tremendous strides this last year with biopharma companies in terms of their adoption of NextPersonal. As a part of that progress, our business has been evolving towards more prospective work where revenue from a project has spread out over several years compared with retrospective analysis where an entire study is analyzed in one batch. In 2026, we expect our biopharma revenue to be in the range of $20 to $21 million. This growth in our core MRD offering is expected to propel our entire biopharma segment, providing a stable and high-value revenue stream that complements our clinical expansion. In closing, Personnelis is a different company than it was just a year ago. We've proven that we can build world-class clinical evidence and win Medicare coverage. and we've proven that our technology is the gold standard for sensitivity. We're starting 2026 with the wins at our backs and the confidence that we are winning in MRD. Changing the way medicine is practiced is never easy, but progress like we've seen over the past year shows our efforts have been worthwhile. I want to thank our employees and collaborators for a great year and thank our biopharma partners, physician champions, and their patients for trusting us to provide results that truly matter. Thank you, and I'll now turn it over to Aaron to dig deeper into our financial results.
Thank you, Chris. I will be discussing our fourth quarter and full year 2025 results and then cover guidance for 2026. Total company revenue was $17.3 million for the fourth quarter of 2025. While this is a modest 3% increase year-over-year compared with $16.8 million for the same period last year, The headline number masks a positive rotation in the quality of our revenue. We are successfully replacing low-margin and sporadic legacy revenue with high-velocity clinical volume. And for the full year, 2025, total company revenue was $69.6 million. As Chris mentioned, we navigated a planned $19.5 million decline in revenue from Natera during the year and also the conclusion of the Moderna melanoma trial enrollment, which was a $10 million decline from 2024. Despite these headwinds of nearly $29 million, we delivered 239% growth in biopharma MRD revenue over the prior year. We are no longer dependent on a single legacy contract. We are building a diversified and sustainable high-growth engine, which is centered around our WIN and MRD strategy. Moving to our core revenue, biopharma was $10.9 million in the fourth quarter, compared with $12.2 million for the same period of the prior year. And for the full year, 2025, biopharma revenue was $49 million, compared with $51 million for 2024. Both the fourth quarter and the full-year declines were due to the expected decrease in the Moderna volume mentioned earlier. For clinical revenue, we recognize $0.9 million in the fourth quarter and $2 million for the full year of 2025, compared with $0.2 million for the fourth quarter and $0.8 million for the full year 2024. The fourth quarter, 2025, includes initial breast cancer surveillance revenue, which was covered by Medicare in the fourth quarter. Now, I want to address gross margin directly, as it's a critical indicator of our MRD investment strategy. Gross margin was 11% in the fourth quarter and 22.7% for the full year. It's vital to understand that this margin compression is intentional, but temporary. We foresee margin dilution to continue into 2026, with the lowest point expected to be in the first quarter of the year, until the time when our third reimbursement coverage, which is expected to be I.O., begins to convert to revenue. The margin dynamic is driven by the strong growth in volume of next personal tests ahead of reimbursement revenue. In the fourth quarter alone, unreimbursed costs diluted margins by approximately 1,900 basis points. We are securing the oncologist and the volume now, so when coverage decisions like the recent wins in breast and lung cancer come online, that volume run rate begins to convert 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 $27.2 million in the fourth quarter, compared with $22.7 million for the same period of the prior year. And for the full year 2025, operating expenses were $103.8 million, compared with $95.1 million for the full year 2024. for. Our clinical business is thriving and we are investing for future growth. Most of the year over year increase was related to commercial expenses for ramping up test volume and also R&D investments for clinical evidence to support reimbursement initiatives and technology development. The fourth quarter R&D expense was $13.1 million compared with $11.5 million for the same period of the prior year, and SG&A expense was $14.1 million compared with $11.2 million for the same period of the prior year. Net loss for the fourth quarter was $23.8 million compared with $16.4 million for the same period of the prior year, and for the full year 2025, net loss was $81.3 million, which was the same as 2024. Now let's review the balance sheet. We finished the fourth quarter with a strong balance sheet with cash and short-term investments of $240 million and no debt other than some small equipment loans. For the full year of 2025, we used approximately $74 million, just below our $75 million guidance. We operated with discipline throughout the year, and even as revenue fluctuated, we managed more than $12 million in downward spending adjustments to protect our cash runway. Now looking into 2026, we entered the year with a focus on scaling volume. Our guidance reflects reimbursement coverage decisions received to date. Any upside may be realized from faster coverage expansion, payer adoption, faster volume growth for clinical tests, and continued strength in biopharma MRD demand. Additionally, we are guiding annually this year and not providing detailed quarterly ranges due to the variability and seasonality that may occur throughout the year. Our 2026 guidance is as follows. Total company revenue 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 in the range of $55 to $56 million. MRD revenue from these customers is expected to grow rapidly and to 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 percent, with the first quarter potentially being the lowest point 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. This estimate reflects our decision to accelerate volume and gain market share. With $240 million of cash on hand, we expect to have the capital to execute our plans. Additionally, our success is opening up additional clinical studies that may be able to influence guidelines. And therefore, we are stepping up investments in this area, too. What you are hearing from both Chris and I is unwavering confidence in our ability to execute a win-an MRD strategy and plans. We have proven that our ultra-sensitive technology can help change patient care. The market is expanding fast towards the $20-plus billion estimate. it. We have growing test volume, and we are turning on the reimbursement engine to drive revenue growth this year and beyond. 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?
Operator
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star and then one on your telephone keypad. The 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. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. The first question we have is from Subhu Nambi of Guggenheim. Please go ahead.
Hey guys, thank you for taking my question. Moving in a short period of time from no reimbursement to now two indications, potentially more here early in 2026. How does that affect the focus of reps internally, externally with Tempest for clinical, and also your eye for still building the pharma business longer term?
If you think about it, I mean, what we're starting to do is, you know, increasing, we had the number this year, we think represents a good mix between, you know, at the same time making sure that...
Thank you for that, Chris. So, Chris, how has reimbursement changed receptivity from clinicians compared to other competitors in the field? Have you seen an acceleration in ordering since the reimbursement announcement?
Yeah, I mean, I think overall, what you have, getting reimbursement gives you, gives you legitimacy in the conversations. I think being able to say that process and the rigors of Medicare is, gives you legitimacy. see. I think there's a wide recognition among people who are reviewing the evidence.
Operator
Thank you so much, guys. The next question we have is from Mark Massaro of BTIG. Please go ahead.
This is Vivian. I'm from Mark. Thanks for taking the questions. I just wanted to ask one on the biopharma outlook. So are you seeing push-outs or cancellations of contracts there? And then just at a higher level, you're investing into next personal MRD and focusing more on the clinical side of your portfolio. So just how material do you think MRD side of biopharma is versus other areas that you've done historically, like PCV is longer term?
Yeah, thanks. I think we're seeing the sector stabilize right now. We haven't seen any push outs or any big jolts. We're not seeing biopharma companies come rushing back in a major way Thank you so much for that color.
And then next personal, can you share any detail in the mix of volumes you expect to run in 26 in your reimbursed indications versus your not reimbursed indications? I think the volume in WebGuide, yeah, go ahead.
Yeah, go ahead. I mean, yeah, go ahead and finish the question if you want.
Okay, sure. I was just going to say, I think the volume in WebGuide implies that a good chunk of the volumes you're running today are not lung and breast. So, just want to understand what indications are there.
Sure. Aaron, I'll take this one.
Yeah. So, if you just look at the volume at the top level, so for the 43,000 to 45,000 tests, roughly 20% or so is coming from breast. 15% to 20% is coming from lung. IO is somewhere between 20 and 25%. CRC is around 20%. And all other is the remaining 20% or so. And it's true. There's a fair amount that we're running for zeros, right? We're not getting paid for the lung at this point in time, less than half of the tests, right? And Medicare and the fee-per-service is half of that half. And so, again, we are running a lot of tests with zeros. But when you're dealing with physicians, you have to accept samples of all different cancer types, and that's what we're doing. We're doing really, really well, and we're finding that our ultra-sensitive test is really sticky with physicians. Now, as we want to go forward here to drive more growth, we're going to be adding more physicians, right? We're adding more commercial heft on the tempus side and internally. You know, we're going to add, you know, another 10 or so reps. We ended the year with 10 reps. We're going to double it at this point in time. That's our current plan. And we could invest even further depending on how things go here at the first time. So things are going really, really well.
And note the guy didn't assume I... You know, we expanded the relationship, the data that we have to apply at all.
Perfect. That's super helpful. Thank you.
Thanks for the questions.
Operator
The next question we have is from Thomas Fletten of Lake Street. Please go ahead.
Hey, good afternoon. Thanks for taking the questions. Hey, Aaron, just to follow up on your last prepared comment about having the cash to execute your plan, should I read that as having cash to break even, or should I not read that far into it?
Yeah, so we haven't said anything about cash to break even or cash to profitability or anything like that, so that's probably reading a little bit more into it. What we meant by that statement, Thomas, is that we had $240 million of cash at the end of the year. We're going to use approximately $100 million in 2026. So you can see just by the simple math, which means we have plenty of capital here for the next share. And that's the focus right now, really investing for market share.
Got it. And then just a question on the real-time variant tracker. I think, Chris, in your prepared comments, you mentioned that was an opt-in test. So are people ordering it? I mean, of the physicians you went out to with the Early Access Program, are they ordering it? Do they literally have to click a box? Or just mechanically, how does that work, and how do you drive the stickiness on that?
Yeah, I mean, it would be – I mean, Rich is with me and can add any color to it. But it's an opt-in module. It's not something that just everybody gets by default. You know, and we're getting geared up for the early – but we expect that. One of the feedbacks has been, you know, it's not just being able to quantify the tumor, you know, in the blood, but being able to track how the tumor is changing, the key unmet need.
One quick last one. Of the clinical volume you're expecting this year, you mentioned that you had 900 oncologists ordering last year. Do you have a sense, you know, of how many docs are going to be responsible for that 43,000 to 45,000? And just, again, big ranges are fine. I'm just curious about depth versus breadth.
Yeah, I mean, we're, I mean, I think we're going to, I mean, this year we'll keep focusing on driving. You know, the 900 doctors ordering from us will continue.
Operator
Question we have is from Callum Tichmarsh of Morgan Stanley. Please go ahead.
Hi, this is Jason off of Callum. Thank you for taking our questions. So maybe just a question on 2026 guidance. How should we think about the Q over Q clinical volume growth? You delivered 6,200 clinical tests in the fourth quarter. Is that a good jumping off point for you guys from what you guys could grow 24%, 25% Q over Q to get to the midpoint of your volume guide?
Yeah, so we haven't given quarterly guidance, but if you take the 6,183 exiting 2025 in the fourth quarter and just maybe linearize it, that probably gets you close. there would be a little bit of seasonality. The second and the fourth quarters are going to be the strongest.
Yeah, I mean, Q1 is always, and Q3 are always.
Thank you. That was helpful. And then maybe just as a follow-up, so a question on the competitive landscape. There's a lot of new entrants in the MRD space, and there's been some consolidation in the space as well with one of the large MRD players recently making a large acquisition of another large MRD player in December and potentially integrating their IP to enhance the sensitivity of their assay. So could you just share your thoughts on the current competitive landscape and why you think you can gain share against arguably larger players with deeper pockets?
Yeah, I mean, I think we've proven this over the last couple of years that we can execute. We've been focused on pioneering this story. I think a lot of people are trying to either get to or debut to push forward. We're aligned with one, which is, I think if you look at where.
Operator
The next question we have is from Bill Bonillo of Craig Hallam. Please go ahead.
Hey, guys. Thanks a lot. So, you know, the volume expectations obviously look great, well above, I think, what people had been expecting. You know, the Tempest comments last night were incredibly bullish. I think what might, you know, surprise people is sort of where you're ending up on the clinical revenue, the gross margin and the cash flow guide and and you kind of talked about you know your your philosophy but maybe you can just give a little bit more color on what's prompting that I mean historically your approach had kind of as you said been you know to sort of be a bit gated with the sales I think there were some restrictions to Tempest in terms of kind of what what what you were encouraging them to do. You knew all along you'd be getting reimbursement. Is it response you're getting from the field or what is it that's made you decide to sort of put on the gas at this point of time and maybe move?
Hi, Bill. This is Aaron. Thanks for the question. And so exiting 2024, Before getting into 2025, we did meters in cancer and having a healthy price that we're really, really pleased with economics and helping the gas and going on T-plus.
It does, and I get the capital and the reimbursement. I was just curious if you were seeing things in the market that were saying, hey, we should really step up as well, too. But it sounds like it was more of another factor.
We see strong demand. And I mean, I think, and the guidance.
To the extent that you're allowed to talk about this, have you sort of given Tempest also the green light, maybe not to go full throttle, but do they have a little more freedom in what they can do with sales as well? The last thing is just cash burn for the year. I think you used no cash flow statement, but I think in your comment, you just said it was about $70 million for this year. Is that right?
Yeah, so we used, and that was in our preparation.
Perfect. Thank you so much. Thank you, Bill.
Operator
The next question we have is from Mike Madsen of Needham & Co. Please go ahead.
Hey, Chris, Aaron, Rich. Thank you very much for taking our questions. This is Joseph on for Mike. Just a couple here. In your prepared remarks, you called out, I guess, a heightened focus on CRC and neoadjuvant breasts moving forward. I'm just wondering, should we expect maybe a submission at least for reimbursement in 2026 for those two? And I have a couple more after that.
Yeah, no, absolutely. We're not, I mean, we're not sort of laying out exact timelines because everything is dependent upon when we submitted with investigators and then accepted because we can't, but yet we're driving hard and ordered.
Okay. And I guess just building on that, in terms of, I guess, evidence generation, your guys' strategy around evidence generation for additional cancer indications, I'm just wondering, is there any difference now in strategy compared to breast and lung in terms of, you know, is the focus or, you know, at least part of the focus looking at trying to get into these very large, almost, you know, landmark studies, is now that you have reimbursement in two indications, do you think smaller studies can, you know, can pass the bar for Medicare? You know, you called out 35 clinical trials. So, is the idea here now, you know, quantity of trials rather than, you know, number of patients in the trial? I'm just trying to get, you know, know, some broad color on that.
Yeah, Rich will provide you at working with the top KOLs in the world, our reimbursement It's really paid off for us. We debuted, you know, very with top KOLs. And in addition to that, we are also, you know, we've had a lot of inbound interest for patients and then show that it actually makes a difference in outcomes. And this is really important for long term, not just for the field, but also getting it You'll begin to see more of that as well.
Okay, great. Yeah, that's helpful. Maybe just one last one. You know, to get to that high gross margin target you guys have laid out, obviously reimbursed test volume is the biggest factor there. But I'm just wondering, in terms of other things like lab optimization, automation, what have you, I'm just wondering, have those steps all been completed? Are there more planned?
You know, what inning would you say you guys are in in terms of, you know, really getting ready to ramp up reimbursed clinical volume yeah good question so we haven't said specifically what percent of completion are we on all of our operational aspects or projects we continue to to automate the workflow which means as we add capacity and you know all the capacity for this year is you have to buy equipment hire people and that's going to weigh even further on margins if you get too far ahead of your skis. And so we take it one step at a time. But having said that, we are continuing to automate, streamline the workflows, strip out costs from labor or overhead wherever we possibly can, right, as we go forward to be efficient. You know, over the last couple of years, as we launched the product, we've done a good job with getting ready. And so we believe we're in a good position sitting here today. In terms of getting to the upper end of the range on margins, right, some of that is dependent upon what happens with a fee for service. They pay for every test. In terms of, you know, some of the commentary Chris made earlier, we have not baked in I.O. into our guide, right, and so that's not contemplated. Depending upon what happens with reimbursement coverage, you know, that could, you know, move towards the upper end or beyond.
Okay, great. Yeah, that's all from us. and congrats on the reimbursement wins so far.
Operator
Ladies and gentlemen, just a final reminder, if you would like to ask a question, you may press star and then one. The next question we have is from Tom Stevens of TD Cohen. Please go ahead.
Hi, all. Thanks for taking my question here. Just a quick one on adjuvant reimbursement. So have you outlined any expectations over the next couple of years in breast and lung on the potential for adjuvant reimbursement and kind of what's the pushback from moldyx there any color would be helpful and then kind of secondary on the neoadjuvant opportunity i mean could you lay out um broad strokes you know where pharma is applying them in trials today neoadjuvant feels like an easier use case and maybe some initial market sizing on the neoadjuvant opportunity if you could also spare that thank you yeah rich is rich is going to grab this one thanks Yeah.
Thanks for the question. So, adjuvant, you know, that is something that we are also focused on, and we'll be pursuing that just like the other indications, so we know that's important. With regards to neoadjuvant or neoadjuvant use of the assay in biopharma, yeah, I mean, there's, you know, as you know, the oncology pipelines for drugs, there's an intense interest and bringing the drugs that are being used for patients. So then the neoadjuvant setting is one that's really important. And they want to know if these drugs are working. And so a highly sensitive tool for that. We actually, you know, if you look at the data that we presented last year in neoadjuvant breast cancer, triple negative breast cancer, and the current state-of-the-art biomarker that's used is something called PASCR. And so in those studies, very well compared to a lot of interest in using an assay on their neoadjuvant studies and whether they're being successful.
Great. And then just any initial view on the sizing of the kind of clinical market there and kind of what the potential for that could be long, long term?
There's definitely, we haven't estimated that. What I'd say is, you know, for MRD, you know, it does start with neoadjuvant, but, you know, it's a relatively small fraction of that entire patient journey. Surveillance, you know, over time, over many years, you know, there's going to be a lot of testing done there, both for breast cancer and that's why we started there. And now we're kind of working our way backwards.
Operator
Ladies and gentlemen, that concludes the question and answer session. and with that this concludes today's teleconference thank you for joining us you may now disconnect your lines goodbye