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Earnings Call Transcript

Personalis, Inc. (PSNL)

Earnings Call Transcript 2023-12-31 For: 2023-12-31
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Added on April 26, 2026

Earnings Call Transcript - PSNL Q4 2023

Operator, Operator

Greetings, and welcome to the Personalis Fourth Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. Brief question-and-answer session will follow the formal presentation. Reminder, the conference is being recorded. It is now my pleasure to introduce your host, Caroline Corner, Investor Relations. Thank you. You may begin.

Caroline Corner, Investor Relations

Thank you, operator. Welcome to Personalis’ fourth quarter and full year 2023 earnings call. Joining today’s call are Chris Hall, Chief Executive Officer and President; Aaron Tachibana, 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 fact should be considered forward-looking statements within the meaning of U.S. securities laws. For example, any statements regarding trends and expectations for financial performance this year and longer-term, cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for existing and future collaboration activities, cost expectations, 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. Personalis undertakes no obligation to update these statements, except as required by applicable law. Our press release with full-year and fourth quarter 2023 results is available on our website, www.personalis.com, under the Investors section, and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today’s call will be available on our website by 5 PM Pacific Time today. Now, I would like to turn the call over to Chris for his comments and full year and fourth quarter business highlights.

Christopher Hall, CEO

Thank you, Caroline. Good afternoon, everyone, and thank you for joining us. 2023 was a year of strong performance for Personalis, as we built a culture of execution and winning. We focused on the MRD market, reduced our annual expenses by $35 million and extended our cash runway to two years, and delivered on all of our commitments to investors, positioning our company for a pivotal 2024. We ended the year with $73.5 million in revenue, a 13% year-over-year growth. Our culture of execution yielded many important wins. We received Medicare coverage for NeXT Dx, which is our high-performance comprehensive genomic profiling or CGP test. We launched an early access program for our ultra-sensitive MRD test NeXT Personal. We presented compelling early-stage lung cancer MRD data with our partners at TRACERx. We entered collaborations with multiple leading cancer centers to develop robust clinical evidence. We secured partnerships with companies including Myriad, Tempus, and Moderna, and extended our agreement with Natera. With momentum across our business, we’re excited for what lies ahead. Taking a step back, we’re focused on achieving scale in our $100 million in 2025 plan where we intend to cross $100 million in annual revenue in 2025, and we have put in place a growth strategy with three engines to propel us there. First, and most importantly, we are executing on our Win-in-MRD strategy. The MRD market using liquid biopsy to find evidence of molecular residual disease or cancer recurrence is estimated to mature into a $20 billion opportunity, and we are establishing Personalis as the leading company in the space. The clinical evidence is coming together to demonstrate that an ultra-sensitive test provides tremendous value to patients, doctors, and partners, which positions Personalis well for rapid growth. Secondly, we’re leveraging our core ImmunoID NeXT platform to support biopharma customers in their drug discovery efforts and personalized cancer vaccine companies in their efforts to establish a new generation of therapies. Our proprietary solutions create a unique molecular fingerprint of a patient’s cancer, allowing for new insights and pushing the entire field forward. Thirdly, we are deepening and expanding our relationships with our enterprise customers such as Natera and the VA MVP with our Personalis and side approach that allows customers to leverage our technology and ability to produce cost-effective assays. I will now walk through a more tactical view of our 2024 strategy as we push to deliver on our $100 million in 2025 plan. Starting with NeXT Personal, our first growth engine. I will quickly remind you that our Win-in-MRD strategy has four pillars: first, we focus on launching our test in cancer types where an ultra-sensitive liquid biopsy test can unlock significant value for patients, payers, and partners; second, we drive reimbursement by developing robust clinical evidence and partnering with top global collaborators; third, we leverage our deep pharma relationships to accelerate adoption and drive revenue growth using NeXT Personal in clinical trials; and fourth, we commercialize NeXT Personal with a partner-centric model. Delving into the first pillar, we previously explained how we’re developing evidence to support NeXT Personal’s clinical usage in early-stage lung cancer, breast cancer, and IO-therapy monitoring. Our focus on these cancers is intentional, as we believe we can win with our ultra-sensitive approach. In each indication, we believe that detecting a recurrence as early as possible can dramatically impact a patient’s health, enabling de-escalation of ineffective therapies and potentially saving payers money. You might recall that we launched our NeXT Personal Dx LDT for MRD in October 2023, and we are currently selectively rolling that out under an early access program, or EAP. We are the first ultra-sensitive test-to-market, and adoption of our test has been rapid, indeed exceeding our initial targets. We now have characterized and are monitoring more than 250 patients referred to us by only 10 doctors involved in the program. We have capped the number of MDs in our early access program and currently have a wait list of over 150 doctors who have expressed interest in being included. Moving on to our second pillar, many of you may have seen the compelling early-stage lung cancer clinical MRD data presented by Professor Charles Swanton and Dr. James Black with TRACERx in October. The TRACERx study greatly advances our understanding of lung cancer and cancer biology. NeXT Personal enables ultra-sensitive, specific detection of ctDNA before and after surgery, through treatment, and during surveillance for recurrent cancer, which we believe will ultimately allow clinicians to make more informed decisions about patient care. Simply put, our ultra-sensitive approach can detect cancer up to 11 months before imaging. We are completing testing of the full cohort for the TRACERx study and expect our collaborators to submit for publication in 2024. We anticipate that work, once published, will form the basis for a Medicare submission for lung cancer. In breast cancer, we completed processing samples from our collaboration with the Royal Marsden, one of the leading global institutions of breast cancer. Our work here is focused on patients with early-stage disease for several subtypes, including ER-positive, HER2-positive, and triple-negative breast cancer. The Royal Marsden collaboration provides access to a well-annotated set of samples with clinical outcomes. We plan to utilize this work to create a clinical data set to support Medicare coverage for breast cancer, expected to be showcased in mid-2024. We're also working with the Dana-Farber Cancer Institute in breast cancer, which gives us a robust set of HER2-positive prospectively gathered samples, in addition to our partnership with the Curie Institute, which provides access to a study in triple-negative breast cancer. These collaborations are vital, as we have multiple cohorts that we can leverage to drive commercial success and underpin our reimbursement submission. Additionally, our own perspective clinical trial called B-STRONGER is underway, and we’ve made progress establishing committed sites, and we’ve begun enrolling patients. Breast cancer is a priority for us, and we continue to deepen our collaborations and expand our clinical evidence. Regarding IO-therapy monitoring, our key study is a pan-cancer data set with the Vall d’Hebron Institute of Oncology, or VHIO, designed to demonstrate and leverage the efficacy of NeXT Personal. VHIO provides access to a large, well-annotated bank of prospectively gathered samples that are crucial for achieving reimbursement coverage for pan-cancer IO-therapy monitoring. We have begun testing VHIO patient samples and expect clinical data to be presented in mid-2024. This exciting collaboration complements our existing work on melanoma and IO-therapy with the University Medical Center Hamburg-Eppendorf, also known as UKE, and our relationships with Duke and UC San Diego. These data sets will form the core of our Medicare submission for coverage for IO-therapy monitoring. Reimbursement coverage is achieved through strong products that demonstrate clinical utility and a relentless focus on execution to build and publish the data. Our Personalis team is dedicated to delivering data to collaborators that highlight the compelling performance of our approach, followed by submitting for reimbursement coverage for all three cancer types this year. The third pillar of our NeXT Personal strategy is to leverage our biopharma relationships to drive the use of NeXT Personal in clinical trials. We are collaborating with many of the world's leading biopharma customers and have received positive feedback on our platform. Customers desire an ultra-sensitive approach to ensure that only the most suitable patients enter clinical trials. The promise of an ultra-sensitive assay is that patients testing negative are far less likely to recur. This would mean for our biopharma customers that these patients are less likely to benefit from therapeutic interventions. Data analyzed by the TRACERx team on lung cancer indicated that patients testing ctDNA negative with our assay primarily did not recur and were still alive five years later. This potential indicates that NeXT Personal could be an excellent strategy to optimize biopharma trials. In the first quarter, we have already booked record new orders for NeXT Personal, and we believe it will drive revenue moving forward and will play a significant role in enhancing the clinical utility of NeXT Personal. Now, I’ll move on to the fourth and final pillar: commercializing NeXT Personal with a partner-centric approach. In our last call, we mentioned that we are pursuing partnerships that help amplify our message in the marketplace, allowing us to market and sell our test in a capital-efficient manner. In December, we announced our key partnership with Tempus to commercialize NeXT Personal Dx in clinics with oncologists. We are excited that Tempus selected us as their MRD tumor-informed choice to offer to their customers. Under the agreement, we will leverage Tempus’ sales channel, which includes over 200 sales professionals calling on oncologists, to co-commercialize NeXT Personal Dx and accelerate growth. Personalis will process samples in our lab, obtain reimbursement, and invoice health insurance payers and patients under the arrangement, while paying Tempus fair market value for the commercial services they provide to us. Overall, the deal is worth approximately $30 million for Personalis should all the milestone payments be triggered and if Tempus fully exercises their warrants. More importantly, it allows us to ramp up our commercial efforts quickly with minimal cash investments. We will work through 2024 to expand our early access program to include Tempus, and we will learn how to collaborate as partners, integrating our business systems and refining our messaging to oncologists. This is an exciting relationship that paves the way for achieving commercial traction in a capital-efficient manner. We’ve made strides with our first growth engine, and our Win-in-MRD strategy to establish NeXT Personal as a leading MRD test is progressing, but we’ve also advanced with our second growth engine, leveraging our ImmunoID NeXT platform to deepen relationships with biopharma customers using our offering to pioneer new therapies and enterprise customers as they develop and ramp up volume for tissue-informed products. We previously shared details about our partnership with Moderna and Personal cancer therapies, where Moderna is utilizing our platform in their mRNA cancer program. We have several other partners active in this space as well. Moderna and its partner, Merck, are enrolling patients in clinical trials, and we expect our collaboration with Moderna to be a revenue driver for us in 2024 and 2025. In November, we disclosed that Myriad is expanding its pharma service offerings by incorporating our ImmunoID NeXT platform into their pharmaceutical partnerships with Myriad’s cancer testing. This is another exciting opportunity for us to continue growing our biopharma customer base. Last month, we announced a partnership with ClearNote Health. ClearNote has an epigenomic platform that we believe is gaining traction with biopharma customers, allowing partners to detect cancer earlier, monitor disease progression, and understand mechanisms of resistance to identify promising drug targets and biomarkers. Our biopharma sales team will introduce ClearNote’s products to our customers, creating another growth avenue. Relationships like those with Myriad and ClearNote exemplify how we expect our partner-centric approach to drive our revenue moving forward. We remain laser-focused on adding value to biopharma customers with a comprehensive suite of products and services to accelerate our growth rate. You will know, when Aaron walks through guidance for the year ahead, that we expect our biopharma segment to grow in 2024 by over 20%. This reflects the progress we are making serving this segment. The third engine of our growth strategy is enhancing our Personalis and side approach to service enterprise customers. In these relationships, partners adopt our platforms and technologies to power their solutions and provide new insights to their customers. We have two large relationships where this is in effect. The first is with Natera; we’ve partnered with Natera for a few years, and they have leveraged our sequencing platform to analyze the exome as part of their signatory product. At the end of the year, we extended our agreement with Natera through the end of 2024. In collaboration with them, we expect to evolve our platform so that we can reduce their prices while improving our margins. Consequently, we expect a decline in revenue from Natera this year, but we anticipate improved margins and are optimistic about continuing our relationship over time. Our second key enterprise relationship is with the VA. The VA utilizes our whole genome sequencing capabilities to support the Million Veterans Program, a national research project investigating how genes, lifestyle, military experience, and environmental exposure affect the health and wellness of veterans. We have powered this program with the VA for years, and we look forward to continuing this work in 2024. Both of these relationships exemplify how our platforms deliver value to partners. We’re focused on expanding our efforts with additional partners this year. We’ve progressed significantly across multiple fronts, and we appreciate our collaborators, partners, and investors being part of our journey to establish an ultra-sensitive test at the forefront of the MRD market. I want to especially thank my colleagues and the Personalis team for their extraordinary efforts in 2023. They have navigated through a challenging climate, reduced headcount, increased revenue, launched new products, achieved coverage, and showcased truly transformative clinical data. 2024 is poised to be an exciting year, and we look forward to updating you on our progress toward our $100 million in 2025 initiative and our Win-in-MRD strategy. With that, I will now turn it over to Aaron to review our financial results.

Aaron Tachibana, CFO

Thank you, Chris. Our fourth quarter and full year 2023 financial results, along with milestone achievements, demonstrate our capacity to execute effectively. Importantly, we continually meet our financial commitments. I will provide details about the fourth quarter and full year 2023 financial results as well as guidance for the first quarter and full year of 2024. Total company revenue for the fourth quarter of 2023 was $19.7 million, an increase of 18% compared to $16.7 million for the same period last year. The increase in revenue was due to the higher volume for biopharma customers and the VA MVP. For the full year of 2023, total company revenue was $73.5 million, which is a 13% increase compared to $65 million for the full year of 2022. This full-year revenue increase was attributed to heightened volume from biopharma customers, Natera, and the VA MVP. Gross margin for the fourth quarter was 26.5%, compared with 13.8% for the same period last year. The year-over-year increase of 12.7 percentage points was primarily due to operating leverage from the 18% higher revenue volume and an increase in work performed for product development and clinical evidence generation categorized as R&D expense. For the full year of 2023, gross margin stood at 24.8%, compared to 20.5% for the full year of 2022. The increase of 4.3 percentage points in margin was primarily due to favorable operating leverage from the 13% revenue growth. Operating expenses were $29.2 million in the fourth quarter, which included a one-time expense of $4 million for employee severance costs resulting from the reduction in workforce, compared to $34.4 million for the same period last year. Excluding employee severance costs, operating expenses were $25.1 million, which is a decrease of $9.3 million from the same period last year. R&D expenses totaled $13.6 million in the fourth quarter, compared to $16.6 million for the same period last year, while SG&A expenses were $11.5 million, compared to $17.8 million for the same period last year. For the full year of 2023, operating expenses totaled $128.1 million and included severance and lease impairment costs of $13.6 million, compared to $128.9 million for the full year of 2022. In 2023, we significantly reduced our expense base by approximately $35 million annually. The net loss for the fourth quarter was $26.6 million, compared to a loss of $31.1 million for the same period last year. This loss included $4 million for employee severance costs and an additional $4 million of non-cash expense related to the fair value accounting of outstanding warrants issued to Tempus. This non-standard expense arose from the increase in fair value of the warrants by December 31, 2023, compared to the fair market value when the warrants were issued. The net loss per share for the fourth quarter was $0.54, while the weighted average basic and diluted share count was 49.6 million, compared to $0.67 with a weighted average basic and diluted share count of 46.3 million for the same period last year. For the full year of 2023, the net loss was $108.3 million compared to a loss of $113.3 million for the full year of 2022. The full-year net loss included $8.1 million for employee severance costs, a $5.6 million lease impairment write-down for the vacated Menlo Park facility, and a $4 million expense connected to the fair value accounting of the outstanding warrants issued to Tempus. The full year net loss per share for 2023 was $2.25 based on a weighted average basic and diluted share count of 48.2 million, compared to $2.48 based on a weighted average basic and diluted share count of 45.7 million for the full year of 2022. Now moving on to the balance sheet, we ended the fourth quarter with a strong balance sheet, having cash and short-term investments of $114.2 million. During the quarter, we utilized $6.5 million, and for the full year of 2023, we used $53.5 million in cash primarily for operations. In the fourth quarter, we received $6 million from Tempus related to the first two milestone payments and estimate the remaining $6 million of payments to be received equally in 2024 and 2025. We have approximately two years of cash on the balance sheet, which is expected to last through the first quarter of 2026. Regarding guidance, for the first quarter of 2024, we anticipate total company revenue in the range of $18 million to $19 million, revenue from pharma tests, enterprise sales, and other customers in the range of $16 million to $17 million, and revenue from population sequencing of about $2 million. For the full year of 2024, we expect total company revenue in the range of $73 million to $75 million, with oncology revenue from pharma tests, enterprise sales, and other customers between $65 million and $67 million, and population sequencing revenue approximately $8 million. Our full-year revenue guidance of $73 million to $75 million considers a projected revenue decline of about 25% from Natera, reducing our total revenue by 10% to 12%. In late 2023, we amended our volume supply agreement with Natera, extending minimum quarterly volumes through the end of 2024, compared to Q1 in the previous agreement. Additionally, we have adjusted selling prices to Natera in this amendment, alongside the ability to convert to a cost-optimized product, making the amended terms beneficial for both companies. We expect revenue growth from biopharma customers to offset the decline from Natera. We also expect a net loss of approximately $80 million, which is $28 million lower than the loss recorded in 2023. This estimate does not include any income or expense associated with the outstanding warrants issued to Tempus. Our cash usage is projected to be around $62 million, including approximately $3 million in employee severance payments related to the Q4 2023 reduction in headcount. 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. The first question comes from Tejas Savant. Your line is open.

Madison Pasterchick, Analyst

Hi, this is Madison Pasterchick on for Tejas. Thanks for taking the question. I think I just had two for you. One, starting within biopharma, I was just wondering if you could comment on whether you’re seeing any headwinds from the tightening of customer budgets or looking at stabilization on that front? And as we look at 2024, do you have any headwinds built into the guide, or do you expect to see a recovery in biopharma spend?

Aaron Tachibana, CFO

Yeah. Hi, Madison. This is Aaron. Thank you for the question. Regarding the biopharma landscape, over the last couple of years, there had been some slowdowns in trials and various aspects. However, we are not seeing significant obstacles today. Our sales funnel is building, and as Chris noted in the prepared remarks, we are observing a strong uptake for our NeXT Personal product in biopharma. Additionally, as part of the biopharma revenue, we also have our PCV business with Moderna ramping up their Phase 3 clinical trial, which has begun patient enrollment, and we are starting to receive samples from those patients.

Madison Pasterchick, Analyst

Okay. Got it. That’s good to hear. And then maybe just one more. I know you’ve mentioned Moderna being an important contributor to your top-line in 2024 and 2025. I was wondering if you could share how much is embedded into the 2024 guidance and how you see that ramping throughout the year and into 2024.

Aaron Tachibana, CFO

Yeah. We haven’t publicly disclosed specific figures from Moderna. Hence, we should probably steer clear of that. However, we’ve stated in the past that our total biopharma revenue, including BioFarma and PCV, will more than compensate for any decline in revenue from Natera for 2024, right? So our guidance for total oncology revenue in 2024 is $65 million to $67 million, which reflects a small increase from 2023.

Madison Pasterchick, Analyst

Got it. Thanks so much.

Operator, Operator

Next question comes from Mark Massaro with BTIG. Please proceed.

Vidyun Bais, Analyst

Hey, guys. This is Vivian for Mark. Thanks for taking the questions. I apologize if I missed anything, but could you walk me through how we should be thinking about the NeXT Personal launch with Tempus? What steps you need to take before the launch, how the test will be marketed? Also, I wanted to circle back to whether we should still expect the NeXT TRACERx readout around the middle of this year?

Christopher Hall, CEO

Yeah, great question. We’ve launched the test with Tempus as an early access program, so it is commercially available. As I mentioned during the call, we have established baseline and created a unique molecular fingerprint for over 250 patients and are now monitoring those patients using our liquid biopsy approach. The response has been phenomenal; I have worked on many product launches, and I must say this is one of the most impressive demand scenarios I’ve come across for an ultra-sensitive test. We’re thrilled with the response. With Tempus, we will work with them throughout this year, starting with a few representatives and gradually increasing as the year progresses. Our goal in the forthcoming year is not to seek reimbursement for the test, resulting in a relatively low volume scenario initially. We’ve been clear about this until we secure reimbursement. Therefore, this year's focus is on collaboration, systems integration, and ensuring we deliver appropriate samples to them and provide their customers with our services. We have launched this journey and we feel positive about our partnership. This provides us confidence in pursuit of our $100 million in 2025 plan, which we are excited about. As for the TRACERx data, I have Rich in the room with me, and he can provide some insight on that and how we anticipate it progressing this year.

Richard Chen, Chief Medical Officer

Yes, the TRACERx expansion is moving forward as planned. We are actively engaged in this, and we expect that the data will be published sometime this year.

Vidyun Bais, Analyst

Perfect. Thanks, guys. How should we approach reimbursement for NeXT Dx and your outlook on the test's impact in 2024?

Christopher Hall, CEO

We have secured reimbursement. As previously stated, we used the reimbursement process for the test to build relationships with payers. This was really our strategy moving forward with the test, and we are excited that we have initiated discussions with Palmetto and MolDx, who now recognize us as a player. We successfully navigated our first test, which assists in introducing NeXT Personal, demonstrating to investors that we are knowledgeable in this area. As we progress through the year, our aim is to expand the number of payers reimbursing the test. We will engage with several large payers to increase our coverage. This approach will allow them to experience the quality of our NeXT Dx product, demonstrating our quality processes and organization. Consequently, when we present NeXT Personal, we will enter as a recognized entity. The Medicare reimbursement rate was situated in the $3,200 range. Aaron, what was our disclosed guidance?

Aaron Tachibana, CFO

Our guidance for oncology revenue is $65 to $67 million. This guidance includes a couple of million dollars attributed to NeXT Dx.

Vidyun Bais, Analyst

Understood. Thanks for addressing my questions.

Christopher Hall, CEO

Thank you. Awesome. Thank you.

Operator, Operator

The next question comes from Daniel Sammarco with TD Cowen. Please proceed.

Daniel Sammarco, Analyst

Hey, Chris and Aaron, I’m here for Dan Brennan tonight. Thanks for taking my questions. First, in the reduction in force press release, you stated that you intend to develop clinical evidence across 10 different clinical studies. Could you share how much R&D expenditure you anticipate for publishing evidence in MRD?

Christopher Hall, CEO

Certainly. This is one of the reasons we allocate a significant budget toward R&D, as we have invested heavily in this test. The ten studies you referenced include the TRACERx collaboration, which is primarily around sample processing and submission. We are on track, and much of that work is already completed. In breast cancer, we are collaborating with the Royal Marsden, Dana-Farber, and the Curie Institute. A portion of those samples has been processed, and we plan to share that data around mid-2024. We are also advancing a prospective clinical trial called B-STRONGER, where we have begun patient enrollment, although that may still be in its early days in terms of expenditures. Establishing the clinical evidence for the value of the ultra-sensitive approach is crucial. In IO-therapy, we are progressing with samples for VHIO. You will see the data around mid-2024. We are concurrently pursuing our collaborations with Duke and UKE, as well as adding to our project portfolio. We can't provide an exact percentage, but we believe a significant portion of our R&D budget will be concentrated on these ten studies. As you know in this field, we are not just stopping at ten; we will deepen our exploration in the three major indications as we move forward. This ongoing effort is essential in proving the clinical utility that will ultimately make our product the standard of care.

Daniel Sammarco, Analyst

Great. Thanks, Chris. Moving to gross margins for the guidance you provided, could you please go over your assumptions for 2024 and potentially how they could evolve into 2025?

Aaron Tachibana, CFO

Sure. In terms of gross margin embedded in our guidance, we are anticipating it to be around 25%, give or take a point in either direction for the full year. Looking ahead to 2025, we expect gross margins to improve further. We haven't set guidance for 2025 yet, but we should be in the low-30s by that time, especially if we reach our $100 million target, as we will not be adding substantial fixed costs; while we will need some variable costs as volume increases, most of our lab infrastructure is already in place.

Daniel Sammarco, Analyst

Awesome. Thank you. Have a good night, guys.

Aaron Tachibana, CFO

Thank you.

Christopher Hall, CEO

Thanks.

Operator, Operator

Our next question comes from Mike Matson with Needham. Please proceed.

Unidentified Analyst, Analyst

Hey, guys, this is Joseph on for Mike. Maybe just touching upon that 2025 revenue target, what are the primary assumptions necessary to reach that number? More broadly, do you require VA MVP revenue to stay stable or grow? Is most of this driven by biopharma, or is there VA MVP upside, considering the uncertainty around future task orders?

Christopher Hall, CEO

We walked through those three drivers. The core of our strategy lies in our Win-in-MRD approach. As we stand in 2024, we have made significant progress in evidence development across key indications. We plan to submit for Medicare reimbursement this year across these three significant indications, and we are on track to do that. We expect this to yield substantial revenue as we are also increasing our commercial connections with Tempus. As these elements align, we anticipate revenue from NeXT Personal and our clinical market to grow significantly and gain traction, which will be a notable driver. Secondly, we are experiencing considerable excitement among our biopharma customers regarding NeXT Personal, and that will catalyze our growth rate in 2024, as seen in our guidance. We believe that as we progress through 2024, awareness and uptake will continue to increase leading to growth in 2025. While we have a five-year renewable agreement with the VA for the Million Veterans Program, we don’t expect this segment to be a major driver in our strategy. We anticipate it will remain consistent, providing us a stable foundation.

Unidentified Analyst, Analyst

Okay. Thank you very much. That’s incredibly clear. To clarify the Tempus relationship regarding samples, are you operating under a cancer type-agnostic strategy, or is there a specific focus on submissions expected in 2024? I understand you are currently collaborating and integrating systems.

Christopher Hall, CEO

To clarify, we are directing our commercial focus to breast cancer, IO-therapy monitoring, and lung cancer—all three areas fall under exclusivity within the partnership. This remains our focus for collaboration and sales messaging. We are seeing a good volume of samples coming in from these areas. While we can’t guarantee that everything falls strictly into these indications, we are concentrating our efforts and are committed to success over the coming months and years. Our strategy deliberately targets indications where we believe our ultra-sensitive approach can deliver significant value by enabling earlier cancer detection and facilitating faster treatment escalations for beneficial therapies. This level of precision offers the opportunity to de-escalate unnecessary therapies and procedures for patients, a specific advantage we see in breast cancer treatment. We believe that covering these three major areas effectively captures a significant part of the market we want to dominate, which is estimated at $20 billion.

Unidentified Analyst, Analyst

Got it. Makes sense. Thank you for taking our questions. Much appreciated.

Christopher Hall, CEO

Thanks, Joe.

Operator, Operator

Thank you, ladies and gentlemen. This concludes today’s teleconference. You may disconnect your line at this time. Thank you for your participation and have a great day.

Christopher Hall, CEO

Awesome. Thanks.

Operator, Operator

Goodbye.