Natera Q4 2024 Earnings Call Transcript

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Provided by Quartr
February 27, 2025

There are 16 speakers on the call.

Operator

As a reminder, this conference call is being recorded today, 02/27/2025. I would now like to hand the call over to Mr.

Operator

Michael Brophy, Chief Financial Officer. Please go ahead, sir.

Speaker 1

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our fourth quarter of twenty twenty four. On the line, I'm joined by Steve Chapman, our CEO Sotman Moskovich, President, Clinical Diagnostics John Sesko, President and Chief Business Officer and Alex Aleshin, General Manager of Oncology. Today's conference call is being broadcast live via webcast.

Speaker 1

We will be referring to a slide presentation that has been posted to investor.natera.com. A replay of the call will also be posted to our IR site as soon as it's available. Starting on Slide two, during the course of this conference call, we will make forward looking statements regarding future events and our anticipated future performance, such as our operational and financial outlook and projections, our assumptions for that outlook, market size, partnerships, clinical studies, expected results, opportunities and strategies and expectations for various current and future products, including product capabilities, expected release dates, reimbursement coverage and related effects on our financial and operating results. We caution you that such statements reflect our best judgment based on factors currently known to us and that actual events or results could differ materially. Please refer to the documents we will file from time to time with the SEC, including our most recent Form 10 ks or 10 q and the Form eight ks filed with today's press release.

Speaker 1

Those documents identify important risks and other factors that may cause our actual results to differ materially from those contained in or suggested by the forward looking statements. Forward looking statements made during the call are being made as of today, 02/27/2025. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information. Atera disclaims any obligation to update or revise any forward looking statements. We will provide guidance on today's call, but will not provide any further guidance or updates on our performance during the quarter unless we do so in a public forum.

Speaker 1

We will quote a number of numerical growth changes as we discuss our financial performance. And unless otherwise noted, each such reference represents a year on year comparison. And now I'd like to turn the call over to Steve. Steve?

Speaker 2

Thanks, Mike. Let's get to the highlights on the next slide. 2024 was a transformational year for Natera, and I think the Q4 results demonstrate that we ended the year with a lot of momentum coming into 2025. Revenues in the quarter were $476,000,000 up 53% year on year and $4,000,000 above our January preannouncement of $472,000,000 dollars Volumes were up 26% compared to Q4 of last year and included an excellent showing for signature unit growth. I'm pleased to report that gross margins in the quarter were 63%, which is significantly above the 51% we posted just one year ago and highlights the progress we made on both COGS and realized pricing in 2024.

Speaker 2

Finally, we generated roughly $46,000,000 of cash flow in Q4, wrapping up the full year with about $86,000,000 in total cash flow generation. On top of the financials, we discussed a series of milestones across the business in the last few months. We announced our innovation roadmap and shared several impressive datasets at the ASCO GI conference in January. Most notably, we announced the 80,702 data in colorectal cancer that underscores the predictive abilities of Signatera. We also had our first readout in early cancer detection and we are excited to share some additional data on that program on today's call.

Speaker 2

In Women's Health, The Green Journal published our clinical validation study for our fetal RHD test, which demonstrated excellent test results. We also have two meaningful novel studies coming out of Oregon Health later this year that we look forward to discussing today. We are also pleased to see NCCN strengthen its position on cell free DNA testing across several tumor types as well as an expansion of the Medicare coverage for patients with Stage one-three lung cancer. This makes Signatera more accessible to a population with a significant unmet need for risk stratification and recurrence monitoring. Great.

Speaker 2

Let's jump into some of the business trends on the next slide. As discussed in the preannouncement, volumes exceeded expectations in Q4 with strength across the portfolio. These longer term slides really highlight the progress we've made in just a few years with Q4 volumes up more than 2.5 times since 2020. In Women's Health, we delivered very strong organic growth as we continue to deliver a stream of new features and datasets. This was augmented by the Invitae win, which helped us well.

Speaker 2

Oregon health volumes were up almost 50% year on year as volumes continue to ramp across the portfolio. Of course, Signatera had a transformational year with clinical volumes up approximately 60% versus Q4 twenty twenty three and nearly 15,000 units of growth over Q3 of twenty twenty four. Looking back over 2024, we can see in retrospect that the twenty four month overall survival data presented at ASCO GI early last year proved to be a critical catalyst for broader adoption and early returns suggest that the three year overall survival data presented at ESMO is having a similar impact. We will spend more time on the seven zero two data later in the call, but the feedback has been positive and in Q1 we're once again tracking to one of our strongest volume quarters ever for Cygnatera. Total revenue growth continued to accelerate as well in Q4, which came in above our preannouncement as I mentioned at the top of the call.

Speaker 2

Volume growth has also been strong, but revenues grew almost twice as fast as volumes as our ASPs continue to improve across the board. Signatera clinical ASPs improved to roughly $1,100 in Q4 and we continue to see steady progress for both Panorama and Horizon ASPs. We launched a significant effort in late twenty twenty two to better secure reimbursement for all the coverage services we provide, including significantly increasing staffing and automation tools. Those efforts continue to bear fruit in Q4 and give us confidence in modeling ASPs for the 2025 guide as Mike will discuss later in the call. We're excited about our ASP increases thus far, but looking several years out, we think we have the potential to double the revenue from the volumes we are already running today as we expand coverage and reimbursement.

Speaker 2

While ASPs have continued to climb, the cost of goods sold per unit has continued to fall, driving a significant improvement in gross margins in 2024. We had about a 3% true up benefit to margins in the quarter, which represents excellent execution from our team in driving receipts above prior estimates. Even stripping out those true ups yields a gross margin of 59% in Q4, which is another record for the company. While we do have a number of initiatives on tap to reduce costs further in 2025, I'm very pleased that the major cost projects that have consumed significant R and D resources over the last few years are now launched, which frees up resources to focus on delivering new products, features and clinical evidence. As we ramp revenues and gross margins, we've been able to generate cash even as we began to increase investments in our platform.

Speaker 2

This longer term slide shows the evolution of the company since early twenty twenty two when we were making investments that are now generating significant benefits for both our patients and shareholders. While the $46,000,000 in cash flow represents a significant new record for Natera, it's worth noting that we actually made an approximately $20,000,000 asset acquisition during the quarter. So I'd argue the operational cash flow in the quarter was approximately $65,000,000 in Q4. On our current trajectory, we could begin to generate meaningful cash flows in 2025. I think the last two quarters have been a critical case study in the efficiency of our business model and the ROICs we are now seeing on investments in R and D and SG and A.

Speaker 2

The major clinical trials we're running, the new features we are launching and the investments we are making to further refine our service to patients and physicians are translating to additional volume growth and our track show and gross margins makes every new unit increasingly valuable. So, we want to take advantage of our position by taking the cash flows we are generating and reinvesting them in the business in 2025. We feel strongly that this approach has the potential to enhance the growth profile of the business in 2026 and beyond. Part of these investments have been in teams tasked with expanding payer coverage and unlocking new insights from the massive amounts of data we generate every day. I'd like John Sesko to now expand on each of these initiatives.

Speaker 2

John?

Speaker 3

Thanks, Steve. Within our core business, we have a significant potential opportunity to unlock reimbursement from test volumes that we're already running, and we've had several promising wins on this front recently. Many of you have seen that we secured a strong increase in our Medicare ADLT rate this year, which was driven by strong pricing achieved in our commercial contracts. Steve also touched on the new MolDX decision to cover Signatera and NSCLC. Based on the written requirements of the ADLT regulations, we believe no other MRD test is eligible to receive ADLT status unless they obtain FDA approval.

Speaker 3

We are also now seeing formal policies from commercial health plans announcing leading benefits management company who supports a large number of health plans across the country published a formal policy detailing cancer biomarker mandates across 20 different states. Additionally, a top five national health plan updated their own medical policy in Q4 to reference state coverage mandates. Additional plans have also begun coverage and we are hopeful that others will follow suit. I will caution that we still expect ASP improvements from biomarker loss to flow in gradually over time, but these are early wins that we can build on. Within our women's health business, we also saw numerous plans and policy coverage for expanded carrier screening, including a large national payer and several large Blues plans.

Speaker 3

We also saw the first meaningful Medicaid coverage in expanded carrier screening with a published policy in one of the largest state Medicaid programs. Many other states have added expanded carrier codes to their fee schedules. We're excited about the momentum we're seeing here. Steve touched on the time and investment we've put into our operations to get reimbursed for covered services and the positive impact that's had on revenues, margin and cash flow. We are now deploying new tools based on artificial intelligence to drive further improvement.

Speaker 3

Natera has developed AI tools to identify errors on claims, to spot patterns and denials and take corrective action, to scan payer response letters and to develop custom patient specific appeal letters. We're spending significant time and effort to refine these AI tools with initial focus on driving quality. We are very excited about what's possible here. This is just one of many examples of how our team is deploying cutting edge AI and large language models to optimize productivity and business operations. It's only scratching the surface of how we are deploying AI to improve our customer experience, to optimize the performance of our core products and to identify new prognostic and predictive signatures from our vast trove of clinical and genomic data.

Speaker 3

We believe we have one of the largest cancer exome databases in the world with over 200,000 cancer exomes and genome sequence, many of which are in early stage cancer patients, both tumor and germline. So we have a great opportunity to leverage that database to further improve patient care. 2024 was a good year from that perspective. We generated meaningful revenue from our data initiatives and we expect to build on this effort in 2025. We are pleased to report that we've already signed over $10,000,000 in data related contracts this year, so we have some positive early momentum.

Speaker 3

Okay. With that, let me hand it over to Solomon to review some recent clinical trial results and product updates. Solomon?

Speaker 4

Thanks, John, and good afternoon, everyone. First, I would like to provide an update from the women's health side on our non invasive fetal RHD test, where we continue to see growing demand and adoption. We were pleased to see the publication of our clinical validation study in the Journal of Obstetrics and Gynecology in November. This was the largest study of its kind performed in The U. S.

Speaker 4

To date. It demonstrated excellent performance with sensitivity of 100% and specificity of ninety nine point three percent. The study provides compelling scientific evidence on the ability of our tests to identify fetal RHC status and demonstrate the potential to assist patients and clinicians in the prevention and management of RHC allo immunization. Thanks to the growing base of evidence together with guidelines from ACOD supporting the use of fetal RHC testing in certain patients, Adoption among eligible patients have been strong, and we were pleased to see commercial coverage initiated by one of the largest payers in the country. This new policy, which became effective last month, expands access to fetal RHD testing that can significantly improve precision medicine during pregnancy.

Speaker 4

Building on this successful launch from last year, we look forward to additional product and future announcements later this year in women's health. Transitioning now to organ health, I want to share some details on three unique studies on PASPERA that we expect to read out in the coming months and we believe will have a meaningful impact on the field. The first is the PEDAL study, which is a first of its kind prospective clinical trial of kidney transplant patients that is designed to evaluate the dynamics of donor DNA monitoring during treatment of a rejection event. This is similar to the cancer setting where circulating tumor DNA monitoring with Signatera for immunotherapy response has become an important use case. We expect that Prosera based therapy monitoring will also have utility for organ transplant recipients dealing with a rejection event.

Speaker 4

Incomplete resolution of rejection remains a significant risk factor for long term graft survival. And up until now, there has been limited research into this area. With the PEDAL study, we hope to address whether on treatment monitoring with Prospera can aid clinicians in understanding resolution of rejection and the risk of ongoing injury and whether discrete trends are associated with outcomes at one year. Ultimately, understanding how each patient is molecularly responding to treatment may allow physicians to make dynamic adjustments to the treatment plan. Enrollment in the study included more than five eighty patients across 28 leading sites in The U.

Speaker 4

S. And internationally, including UCLA, Cleveland Clinic, Wash U, Mayo and more. Patients were monitored with Prospero for eight weeks following rejection, with tests performed at two week intervals in the rejection cohort and clinical outcomes assessed at twelve months. We've submitted the results for peer reviewed publication and we look forward to sharing those results once they're available. We are also outlining here a second novel study for CRISPERA, this one for hearts monitoring.

Speaker 4

The DEFINE study is a large scale prospective multicenter longitudinal study of donor DNA in heart transplant patients that evaluated more than 100 patients and over 1,000 time points. The objective for DEFINE is to assess serial donor DNA dynamics along with serial endomyocardial biopsies and their association with clinical outcomes in the first year after heart transplant. It's the first of its kind longitudinal study, we believe, and the first to evaluate the dynamics of Prospera's unique two threshold collar using the donor quantity score in conjunction with serial biopsies and all compared to outcomes at one year. The defined study is being submitted for publication, so we look forward to a readout later this year. We believe this can make a meaningful impact on the standard of care in heart transplant monitoring.

Speaker 4

Turning now to oncology. The first big news is that we announced Medicare coverage of Signatera for serial recurrence monitoring in non small cell lung cancer, including stages one, two and three and including both resectable and nonresectable diseases. This coverage was secured based on three PUREVY public patients showing the validity and utility of Signatera in lung cancer. We think the coverage is important for several reasons. First and foremost, there's a significant unmet need for lung cancer patients in this surveillance setting.

Speaker 4

Timely detection of recurrence is a core principle of care, but serial imaging has limitations in sensitivity and specificity. It's often hard to interpret, especially after surgery and radiation. Additionally, this is the first time we have secured reimbursement in stage one disease based on the strength of our data in that setting. Lung cancer is a lethal disease, hard to treat, where even Stage one patients have a five year rate of recurrence that is higher than the rate of recurrence in Stage two and three colorectal cancer. Finally, this coverage expands on Signatera's pre existing coverage for immunotherapy monitoring, where immunotherapy is already commonly prescribed in the adjuvant setting as well as in the neoadjuvant and metastatic settings for non small cell lung cancer.

Speaker 4

We look forward to working more closely with the thoracic oncology community to improve care and outcomes for patients with lung cancer. Looking beyond lung cancer now to the NCCN guidelines. We were pleased by the recent guideline updates, which for the first time included ctDNA in management guidelines of colorectal cancer as well as Merkel cell carcinoma. These updates are a significant validation of our Signatera clinical data strategy as well as the core strength of our technology. The inclusion of Signatera every three months for surveillance of Merkel cell carcinoma is a big step forward for the management of this rare but aggressive form of skin cancer.

Speaker 4

The guidelines specifically reference the peer reviewed publication about Signatera from a study that was initiated several years ago and published last year. Adoption in Merkel cell carcinoma has been strong. Additionally, we were pleased to see Signatera included in the guidelines, colon and rectal cancers, specifically acknowledged as a high risk prognostic marker in the adjuvant setting. Based on the initial positive feedback from physicians, we believe these recent guideline updates will support the use of Signatera in more CRC patients than before and likely to support adoption by new physicians. It's worth noting that this language in colorectal cancer was discussed and voted on by the committee in the early fall of last year before the publication of key data sets, including the overall survival data from the Galaxy study, the surveillance data from the BESPOKE study and the predictive data from the CalGB SWOG 08/2002 study.

Speaker 4

We believe this recent data has the potential to support further guideline updates in the not too distant future. Now, I will turn it over to Alex to discuss the data in greater detail and our product roadmap in oncology. Alex?

Speaker 5

Thanks, Solomon. I want to start by highlighting the CalGB SWOG 80,702 study, the results of which were presented in an oral session at this year's ASTHO GI conference. Signatera was utilized to examine in a pre specified manner the tumor and plasma from around one thousand stage three colorectal cancer patients in this randomized cohort. The results found that in Signatera positive patients, the addition of celecoxib to standard adjuvant chemotherapy resulted in a three year DFS improvement and a reduction in all cause mortality of over forty percent. Signatera negative patients, by contrast, had no significant improvement in overall survival from receiving celecoxib.

Speaker 5

The results were very well received by the scientific and clinical community with multiple leading GI oncologists already telling us that they have started discussing celecoxib with their stage three patients who test Signatera positive. This also represents another major proof point along with the INVIGR 10 data in bladder cancer published back in 2021 that Signatera can be predictive of therapy benefit across multiple cancer types and drug classes. We look forward to publishing this study later this year. We expect 2025 to be a pivotal year for oncology business with multiple significant clinical readouts as well as expansion of our product portfolio. Before reviewing our new product launches, I wanted to spend a minute discussing the underlying technology that powers and differentiates our MRD product offerings.

Speaker 5

Over the past fifteen years, Natera has developed, patented and optimized a multiplex PCR NGS technology that allows for deep and targeted detection of tumor derived mutations in plasma, resulting in exquisite sensitivity and specificity while controlling costs. While our technology can multiplex thousands of targets simultaneously, as we do with Panorama NIPT, for example, we believe the best approach for tumor informed MRD detection is to select a targeted set of the highest quality clonal variants where Natera has significant experience using proprietary methods. Also, to optimize the primer designs and the amplification protocols to sequence these targets at extreme high depth of over 100,000 reads per target. And then to deploy a calling algorithm based on our proprietary error model. Some competitors have tried to replicate this approach but have been enjoined from using our patented multiplex PCR technology and so have been forced to go a different route, for example, by using hybrid capture technology.

Speaker 5

MRD labs who use hybrid capture typically track hundreds or thousands of targets but sequence them at a shallower NGS depth to control COGS. This is why MRD test performance depends on much more than simply the number of targets tracked. The technology truly matters. This is why Signatera's clinical performance remains outstanding for detecting recurrence in published clinical studies. This debate of targeted and deep versus wide and shallow is similar to the early days of NIPT, where Natera deployed a deep targeted SNP based strategy based on multiplex PCR NGS competing with shallower shotgun sequencing techniques, and we all see how that played out.

Speaker 5

While Signatera designed on exome continues to be the assay of choice for the vast majority of oncologists with over 100 peer reviewed studies supporting its broad clinical utility and emerging predictive claims. We are also now receiving positive feedback on our genome based product launched at the end of last year. Early interest from both the pharma and academic community has been strong for the role this product can play in clinical trials in certain clinical situations. We'll be presenting clinical data from our genome assay this year. Furthermore, we're excited to make progress on our tissue free assay with launch expected mid-twenty twenty five and with promising data presented at ASCO GI several weeks ago showing competitive performance.

Speaker 5

Right now in the lab, we're processing a large scale prospectively collected study of over 1,000 samples that will support the launch of the tissue free assay in the adjuvant and surveillance settings. We believe the evidence will support reimbursement by Medicare and will follow quickly with applications and other cancer types. With that, let me turn it back to Steve to discuss early cancer detection. Steve?

Speaker 2

Thank you, Alex. As we previously shared at JPMorgan, we presented our first prospective validation of our ECD technology showing 95% sensitivity and 91% specificity with minimal degradation of performance in the asymptomatic screen detected population. We continue to make rapid progress on this program and I'm happy to announce that we've confirmed our CRC sensitivity in another independent data set where the majority of patients were Stage one and two. We are encouraged by these results in CRC and look forward to reporting out a more definitive study later this year for the PROSCEED trial. The big announcement for today is a readout of our prospective advanced adenoma trial.

Speaker 2

As a reminder, we've collected roughly 3,000 patients using a protocol similar to what we would use in an FDA enabling trial. All samples were asymptomatic patients and collected prior to a screening colonoscopy. We're pleased to report that in the patients analyzed for the study, we found an eighteen percent sensitivity for advanced adenoma with a specificity of ninety one percent. Because of the manner in which these samples were collected, we don't expect to see the type of performance degradation that's been observed in other ECD trials. Based on the excellent results in CRC and advanced adenoma, we decided to kick off the FDA enabling FIND study, which is expected to enroll over the next eighteen months.

Speaker 2

The PROCEED study has allowed us the opportunity to better estimate both the possible enrollment rate and the cost of the definitive study. We believe this improves the chances for executing the study on schedule and within budgeted costs. This is already baked into our guidance for the year and has limited the impact on our cash trajectory. Finally, as we look at the overall opportunity, we're pleased to see the Medicare rate confirmed at ninetwenty and given that we will seek FDA approval for this test, we believe ADLT pricing at a higher level is possible. This elevates the opportunity for Deterra, which is exciting given our mission to help as many patients as possible.

Speaker 2

For distribution, we're considering partnering with a national distributor or using our direct sales channel or a combination of both. Directly, we believe today we are already covering nearly all female patients through our OB GYN channel and all major hospital systems through our strategic accounts team. We can augment this with sales reps in select markets for a solid distribution strategy. We also think the idea of partnering is enticing as well, either as a standalone strategy or alongside our direct team. In either case, we can do this without significantly impacting our operating expenses.

Speaker 2

With that, I'll pass it back to Mike to review the financials. Mike?

Speaker 1

Great. Thanks, Steve. The first slide is just a summary of our Q4 financials. If you look at the year on year change column to the right, you'll get a sense of the progress we made across every metric of the business. As Steve covered at the top of the call, the large increase in revenues with even faster growth in gross margins move the P and L to a different level in 2024.

Speaker 1

Even as we made substantial investments in future growth, our loss per share narrowed significantly and we generated a meaningful amount of cash. You'll recall that we retired the convertible notes early in Q4, so that leaves us with just under $1,000,000,000 in cash and effectively no debt on the balance sheet aside from the relationship line of credit from UBS. Okay. Let's get to the 2025 guidance on the next slide. Steve touched on the revenue guide at the top of the call.

Speaker 1

We are pleased to be guiding to $1,870,000,000 to $1,950,000,000 in revenues to start the year off. Our base assumption for this guide is really just having the positive trends we've been seeing the last few quarters continue rolling into 2025. That means steady volume growth and stable ASPs in Women's Health, continued market share capture and end market growth in organ health. And of course, we expect Signatera to continue to grow sequentially. We've also obviously seen Signatera clinical volume now grow consistently above the 8,000 to 10,000 sequential unit growth threshold we've previously set as a target.

Speaker 1

The guide presumes we will modestly outpace that 8,000 to 10,000 level in 2025. The guide does not attempt to forecast any revenue true ups. While we think the true ups represent good execution on cash collections, the fact that they can be lumpy and unpredictable means that we will just guide based on what we think the underlying business can deliver. Consistent with our philosophy, we are setting this guide at the beginning of the year acknowledging that we have several meaningful sources of upside potential. For example, those of you that have followed us for a long time know that for us to guide to stable ASPs in women's health is a fairly bullish signal and we are cautiously optimistic that we could actually see continued growth in women's health ASPs this year through our own organic efforts as John described.

Speaker 1

We haven't spent a lot of time dwelling on ACOG guidelines recently, but of course if we get either of 22q or expanded carrier screening that would be another great upside outcome and the feedback we get on both continues to be positive. Solomon covered some of the extremely impactful clinical trial results we have on TAP and organ health and accelerated adoption of both RENACITE and PROSPERA on the back of those data readouts would be upside to the guide. Of course, the pace of adoption and realized pricing of Signatera in the clinical setting offer the largest potential sources of upside to the model this year. Between the three year overall survival data from Circulate, the Celebrex readout at ASCO GI, sales and operations currently executing at a very high level and significant additional investments flowing into the business, we've never been in better position to change the way cancer is treated in The United States. The guide presumes some modest ASP growth for Signatera consistent with better allowed rates in Medicare Advantage, but does not require any significant level of traction with either NCCN guidelines or with biomarker state reimbursement.

Speaker 1

We remain cautiously optimistic we could see some green shoots in the results in the second half from biomarker laws. And of course, we will do everything we can to broaden Signatera adoption. The gross margin guide presumes continued progress above the 59% gross margin we posted in Q4 ex the true ups. The margin growth can come from several sources and much like the revenue, we believe there are several sources of upside to the guidance. For example, better than expected realized pricing in any of our major products.

Speaker 1

A note of caution on the gross margin is that we are launching these two complementary products in the MRD menu, neither of which have optimized unit economics. Our model presumes some modest uptake of both tumor naive MRD and the genome backbone product and we expect this volume to be largely additive to core Signatera volumes as existing customers avail themselves of the menu from us on a broader set of their patients. If uptake from either offering exceeds our expectations that would create a short term headwind for margins, but I would argue that uptake is a very healthy signal for the longer term development of the Signatera franchise. As Steve covered, the SG and A and R and D lines demonstrate that we are not taking our foot off the gas in pursuit of innovation, great clinical trial results and customer service across our business. We could hold expenses completely flat in 2025 and it wouldn't affect our growth at all in 2025 or 2026.

Speaker 1

Indeed, if you look back to 2023, we held expenses approximately flat that year and still grew revenues 32%. We are already seeing high ROICs from investments we made in early twenty twenty four and we think every dollar we invest in our platform now puts us further ahead of the field for years to come. Steve unveiled some very promising ETD data today, but the spend in early cancer detection this year and next year is incremental to the core mandate we have to deliver the best possible offering to our patients in our core products. We will remain focused on ensuring we are getting excellent returns on these investments and we are going to manage the business with a goal to deliver a cash flow positive result again in 2025.

Speaker 6

Okay. One more slide just to put

Speaker 1

the revenue guide in its proper context. As I mentioned, we are not guiding to any true ups in the 2025 guidance. Although, we will likely have some true ups as we continue to drive reimbursement from appeals on older test volumes, as ASP growth moderates, I do expect true ups to moderate as well. And I think the simplest framework for understanding quarterly progress is to review the results with the true ups stripped out. Accordingly, when you remove the true ups from the 2024 results and then evaluate the guide on an apples to apples basis, you'll note that the implied revenue growth rate is roughly 24% at the midpoint.

Speaker 1

While this growth is much faster than most other businesses operating at our current scale, we are setting this guide as a starting point with the goal of exceeding this target through the course of the year. Okay. With that, let's open it up for questions. Operator?

Operator

Thank you. We'll go to Doug Schenkel, Wolfe Research.

Speaker 7

Hey, good afternoon and thank you for taking my questions. I think a couple of questions, following up on your prepared remarks. So Steve, in your prepared remarks, you talked about, I think it was the ability to double Cigniterra revenue at the current level of volume over the next few years. Just maybe dumbing it down for me as a math person, cutting through all of that, does that mean that you would expect to potentially get Signatera ASPs up to around $2,000 over the balance of the decade? And then I guess one for Solomon, you talked about the rationale behind why more targeted approaches have resonated on the clinical side with Signatera.

Speaker 7

Obviously that continues to resonate. That said, some pharmaceutical companies have indicated they want a broader panel. How is the introduction of your genome based products resonating with pharmaceutical and biotech customers in the early going? And how is that factored into guidance? Thank you.

Speaker 2

Yes. Thanks, Doug. This is Steve. So, yes, just first on the ASP or on the revenue per test. I think the idea is today, there's a significant number of tests that we process where we don't get paid by the insurance companies.

Speaker 2

And that's sort of baked into the average ASP that we show you guys, you know, when we're talking about ASP. So, as time goes on, as we get more coverage policies in place for things like, you know, expanded carrier screening, other tumor types, commercial coverage for Signatera. We think we can see the revenue per test effectively double as we start to get paid for some of the tests that we run today that are already baked into our cogs, we're not getting paid on. And so that the comment I made was more general about the business overall, but it also really does hold true for Signatera. And I think your math is reasonable as you sort of look out into the future.

Speaker 2

Then on I'll briefly comment on the Geno side and then turn it over to Solomon. Certainly, there's some interest from pharma and in a select areas, some clinical providers. I think the product's been received very well largely with the idea of kind of clinical using it for clinical research. But at this point, if the doctor wants genome, pharma company wants the genome, we have it available. And the product performs exceptionally well.

Speaker 2

So we're excited about it. Solomon, you want to

Speaker 4

make any further comments? Sure.

Speaker 8

Yes, I'll add that there are situations where we do research projects with pharmaceutical companies or academic consortia where they seek to answer more translational or research y questions of interest. And we routinely run custom versions of our technology that can include hundreds of targets if that's something that the customer wants. Generally, we think about building a product for the clinical setting that's going to become a workhorse and highly scalable and also cost efficient. So I think that's where you're seeing attractive levels of adoption in the clinical setting. So we do think about these the end products a little bit differently for those different settings.

Speaker 8

But the underlying core technology leveraging multiplex PCR, we think provides the advantages across both of those settings depending on the application type. And increasingly, we're able to add more services and more genomic insights from our tissue whether that's with the genome or an exome and from the normal DNA and being able to run additional side assays like RNA C for example. So there's a lot that we're able to do. Hopefully that answers the question.

Speaker 5

Yes, that was great. Thank you guys.

Operator

The next question is Rachel Bietenstall, JPMorgan.

Speaker 9

Perfect. Thank you. Good afternoon, you guys, and thanks for taking the questions. First up here just on Signatera. If we look at the volume growth that you saw throughout 2024, you did roughly 14,000 sequential unit growth throughout last year.

Speaker 9

You said you're going to do above that 8,000 to 10,000 per quarter or sequential per quarter in 2025. But can you just give us some more color on how much above you could do versus that 8,000 to 10,000 kind of like the old long term plan that you guys had had? And then could it be something in that range of 14,000 like we saw last year?

Speaker 4

And then I have a follow-up as well.

Speaker 2

Yes. Thanks for the question. So I'll let Mike comment a little bit on the guide. But first, I'll just say, we're very under penetrated. This is a very large market.

Speaker 2

We generated over 100 peer reviewed papers, and we're seeing very significant interest from physicians. And that interest is accelerating as we generate data like the 07/2002 study that really provides an actionable predictive use case for the product. So, as we said in the prepared remarks, Q1 volume growth in Cygnatera is looking to be one of the best quarters that we've ever had in the history of the company. So we're feeling very good about volume growth in Cygnatera. Mike, do you want to comment on sort

Speaker 4

of how we do the guide?

Speaker 1

The guide, I mean, we covered the philosophy kind of in detail in the prepared remarks. So the guide presumes that we can do better than the 8% to 10%. It's not necessarily anchored at 14%. It's going to be, it wouldn't surprise me if you just look at last year, you know, averaging out, you're kind of in that thirteen, fourteen range, but obviously the lump in you had 15,000, you got 11,000. It wouldn't surprise me if you have those types of kind of typical fluctuations through the course of the quarters.

Speaker 1

And that's really more driven by just different numbers of receiving days that are available to you in a given quarter. So I think the spirit of the guide is that the momentum continues and it's a strong but still an achievable target as a starting point for the guide for the year.

Speaker 9

Great. Thanks for that color. Then I just wanted to dig into the concept of true ups here as well. So you mentioned that you're not including true ups within the current guide for 2025. You've also talked about how the magnitude of those true ups are going to come down as you guys continue to do better on collections and have more visibility in that.

Speaker 9

So could you just level set for us, what should we expect in terms of that true up, getting more standard as we go forward in the trajectory there over the next few years? Thanks.

Speaker 1

Yes. I mean, I think the Yes. I mean, the goal for the true the reason why we have true ups is that the historical cash collections are exceeding the historical accruals. And as we get history with better and better cash collections per test, obviously the accrual increases the sympathy, okay. And so, invariably that's going the change in the ASPs in these products is going to moderate.

Speaker 1

And when it does for a period of time, you'll have the, you'll have the troops kind of decline kind of on a glide slope. So I do think that they'll kind of moderate over time back to kind of what we saw historically, which was sort of like a five five million kind of true number every quarter. The reason why we don't guide to it though is that that's hard to predict quarter to quarter. So I'll just give you an example. I mean, we're working very hard to win appeals on cases that we ran in the fourth quarter of twenty twenty three.

Speaker 1

So we've already kind of collected 100% of the revenue that we needed to collect for twenty twenty three Q4. But if we win more of those appeals, if they arrive the cash arrives in Q1 or arrives in Q2, then we'll book revenue in that period. So fully expected to be lumpy. But you've seen the ASP go up quite a bit and I expect over time on average those to moderate down on a more or less linear glide slope.

Operator

Next up from Morgan Stanley is Tejas Savant.

Speaker 10

Hey guys, good evening and thanks for the time here. Just to start, maybe one for Alex here. You know, I know in the deck you talked about the number of targets only being one variable impacting tumor informed MRD assay performance. But how many markers do you anticipate tracking for your personalized whole genome panels that are 16 like the current version of Signatera? And, how did you think about that choice in terms of COGS considerations versus optimizing for perhaps higher sensitivity?

Speaker 10

And can you just share some early color on feedback from the oncologist community?

Speaker 2

Yes. Let me make a couple of comments and then throw it over to Alex. So, yes, on the genome product, we're tracking 64 variants. And remember, we're using the same multiplex PCR NGS approach that we use with the 16 variant assays. So, the philosophy is to go extremely deep at a very highly curated targeted set of variants.

Speaker 2

So, we think that's the best approach. We could do 2,000 variants. We can do we actually do 30,000 variants, in a single reaction when we run certain tests. So we do that all the time in the laboratory. But we chose specifically to do 16 and now in this case of genome sixty four because we think that's the right approach where you're optimizing sensitivity, and specificity.

Speaker 2

And I think that's proving to be the right decision. If you look at our clinical performance data, you look at our very strong data that we published for recurrence monitoring, it's really good. So, this looks like to be the right approach and we're excited about it. Alex, you want to comment further?

Speaker 5

Yes. Maybe just one or two quick points. I think the first is we've seen really very positive and very strong feedback with this launch both from the broader academic community, the consortia community, as well as the pharma community. So we're very pleased with that. And the way we think about it, as Steve mentioned, is there's a few factors that go into asset performance.

Speaker 5

Number of variance is just one of many. So error model is super important, the quality of the variants selected, and then the ability to sequence and call those variants very, very deeply. And I think when we did the math, 16 was really kind of the optimal number for exome. And kind of when we did the math for Genome, at least initially, the number is 64. That kind of optimizes performance across those metrics while kind of keeping COGS contained.

Speaker 10

Got it. That's helpful. And Mike, a quick follow-up on the guide for you. So first, how are you thinking about any potential benefit from the NovaSeq X transition? And second, on the Medicare lung reimbursement for Signatera, any color you can share in terms of peer mix, Medicare versus commercial and non small cell lung?

Speaker 10

And how many tests will be covered in the surveillance setting?

Speaker 2

Yes. Thanks for the question. Let me comment on one, Mike, and then you can maybe jump in on the COGS projects that we've executed on. But obviously, we're really positive on lung. We're seeing a lot of interest there from providers.

Speaker 2

That's an area where historically, we did really well engaging with the KOLs and some of the top centers, but we weren't reimbursed. So it wasn't necessarily I think the first thing that our sales representatives and medical team were talking about when they were out

Speaker 6

in the

Speaker 2

field. But nevertheless, we still have a lot of volume coming through. There's a lot of interest. So this is a big opportunity for us as we look at just the number of patients that are diagnosed. I think the clinical importance of this type of testing and the value that we can provide from surveillance.

Speaker 2

So, I think this represents a new vector of growth for Natera, that could potentially even help us push significantly past maybe some of the record volume quarters that we saw in 2024. Mike, you want to talk on cost projects?

Speaker 1

Yes. So, just first as we're on lung, I mean, I think the Medicare mix is going to be broadly similar to the average that we see kind of across the business there. So I do think it'll be kind of a contributor as similar to the rest of the tumor types. There's not like a very meaningful skew, I think, within that Medicare mix. Similarly, I mean, I presume that there will be, now that we have the coverage, we'll go back and just confirm on the pricing decisions with MolDX.

Speaker 1

But I think it's safe to presume that the similar kind of setup in terms of a bundle pricing would be the standard there for the adjuvant setting. In terms of the cost projects, yeah, I mean, we definitely were going to have some improvements to COGS, I think, here in 2025 and that's part of the guide. That's part of the kind of the gross margin improvement that's contemplated in the guide. It's pretty meaningful gross margin improvement versus the underlying 59% we just posted in Q4. Steve's comments in the prepared remarks were more used to be up until the middle of last year, it was really the overwhelming thrust of the R and D effort was we were forced to kind of prioritize just getting these COGS projects out the door.

Speaker 1

And now we can be a lot more nimble and focused on some interesting product launches and features and data sets. So it's a much more kind of balanced portfolio.

Speaker 10

Got it. Appreciate the color guys. Thank you.

Operator

The next question is Tycho Peterson, Jefferies.

Speaker 11

Hey, this is Noah on for Tycho. Thanks for taking our questions. I wanted to start by asking about the 07/2002 study and particularly interested in what the initial reaction has been like there. Anything you would point out as an indicator that this will lead to broader use of clinicians?

Speaker 2

Yes. Thanks for the question. So I guess I'll make a comment and then, maybe hand it over to, Alex or Solomon if they want to come in further. But, you know, anytime you have something like this, it's very actionable for the doctors. There's going to be significant interest, particularly when it has that predictive impact as well.

Speaker 2

And I can just say from my view, coming out of the conference, one of the leading colorectal physicians came up and said, hey, look, I've already started prescribing to cost in my practice to MRD positive patients based on this data. So, I think to hear that really gave us confidence that this is very important, and it's going to change practice. So, Alex or Solomon, you guys want to comment further?

Speaker 5

No. I think the initial feedback is overwhelmingly positive. I think there's also additional data that was presented at ASCO GI about the benefit of aspirin in some early stage colorectal cancer patients. I think that further kind of reinforced this concept that cuts to inhibition, especially when biomarker directed can be very, very impactful for these patients. And just to put this into context, there's not been a new therapeutic development in the adjuvant management of colon cancer for over twenty years since the MOSAIC study.

Speaker 5

So I think because of this, I think patient advocacy groups, physicians, I think there's just broad excitement across the board. And we'll see how this translates into further guideline changes. We can't predict that, but you're looking kind of forward to see what the NCCM committee kind of may weigh in on this data.

Speaker 4

Okay. That's helpful. Thanks.

Speaker 11

Thanks. And then one more from us. On MRD, obviously, a number of competitors will be launching in the next year. So just wondering what your competitive strategy is in order to try to maintain the marketing position there? Thanks.

Speaker 2

Yes. So there's always been competitors coming in. I think a couple of them have sort of been enjoying because of our IP position. But for the last couple of years, there's been competitors selling MRD testing in the marketplace clinically. So, we feel like we're in a good position.

Speaker 2

You have to just do the fundamental things. You have to deliver high quality clinical data. You have to have an amazing customer experience. You have to have a strong medical and commercial team. And we're continuing to do that.

Speaker 2

The other area of this is innovation. And I think we're in a very strong position, because we're able to invest very significantly in R and D. And you can see we're not burning cash. We're cash flow positive. We're at one of the highest levels of R and D spend that we've been at.

Speaker 2

And that's because we think there's a lot of opportunities for product line extensions, product line enhancements, new versions of products and, most importantly, big, large scale market moving clinical trials. So, we're doing all those things and we think we're doing the right things. But competition is a good thing too. It's great to see that this market is very meaningful and that it's growing. And I mean it's what like 3% penetrated or something like that.

Speaker 2

So, this is probably, the largest molecular diagnostic opportunity in the history of oncology molecular diagnostics. So, certainly, there's going to be a lot of competitors coming in.

Operator

And the next question is Puneet Souda, Leerink Partners.

Speaker 12

Yes. Hi guys. Thanks for the questions here. Maybe first one, on the cadence, can you remind us maybe Mike, how should we think about growth through the year? You have a number of drivers, obviously data reading out, products launching.

Speaker 12

And on top of that, John talked about a number of ASP drivers. So just trying to understand how to think about Q1 and the cadence through the year. And the gross margin lift that you have in the guide was also strong. So just is that largely ASP or how much sort of COGS reduction are you thinking about again, looking at both oncology and women's health? And I have a follow-up.

Speaker 2

Yeah, Mike. Yeah.

Speaker 1

Thanks, Toni. Yeah. I think the, it's a good question on the cadence. Typically, the women's health business, I actually think that we will return to our normal form there where Q1 is a very strong quarter for women's health. Just seasonally, Q2 tends to be softer and then you kind of return to Q1 levels and beyond in Q3 and Q4.

Speaker 1

Last year, the cards are kind of scrambled a little bit just because we added those Invitae units and that was kind straddled between Q1 and Q2. So you can quite see that trend in the financials this year. But this is a pretty clean year from ads as far as that's concerned. So I think women's health return to kind of the normal seasonality we've seen over the last decade. Signatera and Prospera, there's not really a seasonal component there other than the dynamic that I mentioned earlier in the call, which is just the number of receiving days will vary.

Speaker 1

And we're to scale particularly in Signatera, wherever receiving days is worth a lot of units. And so you just got to keep that in mind. So holidays will impact you. But that's the main process, kind of Q1 bigger because of women's health. Q2 softer because of again, seasonality of women's health and then kind of return the form in the second half of the year and not much seasonality in the organ health and Signatera.

Speaker 1

Sorry, good afternoon. Gross margins? Gross margins. Yes. So yes, I agree with you.

Speaker 1

I mean, look, I think that's important to think about those gross margins. The guidance actually it does imply very bullish outlook as it relates to continued gross margin improvement. And I do think as Page just asked, there are some five projects that are going to deliver in 2025 that I think will be useful. We're also just going to get some benefits on the COGS side just from the scale efficiencies as you kind of grow units the way that we're growing them. You do get kind of you do get a linear benefit to all the facilities and all the equipment and the people and things like that and we're getting more and more efficient there.

Speaker 1

So that's a component of it. I do think that, waiting them there's more of a waiting toward benefits in ASPs. So that's kind of the continued growth in the Signatera ASP and also just steady execution kind of women's health ASPs kind of continuing on kind of where we left them in Q4 and then annualize them for a full year would get you a strong uplift. But that does leave you room for upside and John kind of alluded to some of the potential sources of upside we have particularly in women's health ASPs.

Speaker 12

Got it. And then, if I could, I'll try my best with this question on NCCN, but we're also getting questions on the advanced adenoma data that you provided in the slide deck. So, NCCN ctDNA is prognostic, but not predictive. And then they also said ctDNA is not recommended for surveillance. I appreciate the Merkel cell support that you're getting there, but could you elaborate on the oncologist feedback?

Speaker 12

And one side there's the traction with payers potentially, but on the other side there's also the offset maybe in the community setting they might I mean the oncologists are still going to be looking for NCCN. So maybe just help us capture the NCCN and how you're thinking about that? And just on advanced adenoma, why should we not see any degradation there? Thank you so much.

Speaker 2

Yes. Let me just comment briefly and then maybe Alex, you can make a couple of comments on events and Emma. But on ACTN, it's being received very positively. There's been a lot of good feedback on the calls that we've done and meetings we've had over the last two weeks. I think certainly in adjuvant, was an enhancement.

Speaker 2

And as Solomon pointed out in the prepared remarks, some of the data that I think is very meaningful, like for example, the seven zero two couldn't be considered, where maybe you would have received that predictive claim. But certainly that's an enhancement. And on surveillance, we think it's sort of just administrative language cleanup. That's kind of some of the feedback we've been getting is there was no real intention there. And that makes sense.

Speaker 2

And that's kind of in line with what we're hearing out in the field as well. So, we don't think it will have any impact. There's also great surveillance data in Intercept, which is more and more people are talking about that now, out of MD Anderson, very significant trial. And then the BESPOKE study was received very positively at ASCO GI. So certainly we think that's going to have an impact as well.

Speaker 2

But I would say net NCCN readout was very positive for us. And then on Advanced Suddenoma, I'll

Speaker 9

turn

Speaker 2

it over to Alex on Advanced Suddenoma. Alex?

Speaker 5

Thanks, Steven. Puneet, I think this is our first readout. I think what makes us more comfortable to really think that we're minimizing the chance for degradation as much as possible is that these are samples that are collected prospectively, colonoscopy matched in the screening population, kind of really following the same ethos as our prospective FDA enabling study, that Steve announced that we're launching shortly. And again, this is the first of what we hope to be multiple readouts also for advanced adenoma. I think we're planning an additional readout later this year, again, following the same ethos of only running prospectively collected colonoscopy matched samples, following a very similar protocol to the FDA study.

Speaker 5

And the good news is that we still have a little bit more time before the algorithm has to be completely locked, right? So we do also think there could be room for further improvement beyond the number that we initially read out. So those are the things we're doing to try to minimize the chance of degradation as much as possible.

Speaker 4

Got it. Helpful. Thank you.

Operator

Next up is Catherine Scholte, Baird.

Speaker 13

Hey, guys. Thanks for the questions. Maybe first on biomarker bills. Is there any way to frame what your success rates have been in getting paid in those states to date? How has that evolved once the bill becomes effective?

Speaker 13

And then I know you aren't baking anything into guidance, but how do you think those success rates could realistically evolve over the course of the year?

Speaker 2

Yes, that's a good question. So, I think the outlook on biomarker is positive and it's great to see that we're seeing I think the first signs of the ship turning here. So let me turn it over to John Fesco to talk just briefly on what's happening there.

Speaker 3

Thanks, Steve. Catherine, we've been cautious on the impact of biomarkers because we didn't know the pace at which it would flow through. And it's taken a little longer than we had hoped for. But with these formal publications, we think that creates ammunition to go press other plans. And we have heard from other plans that they want to come into compliance with the law.

Speaker 3

So, we think that we will see conservative positive improvement over the course of this year and next year.

Speaker 13

Okay. And then maybe on R and D, just given the magnitude of the increase you're calling for this year, can you just talk through the spend buckets within that oncology versus women's health versus early detection? How much is the FDA enabling study? And then just how should we be thinking about R and D growth over the next couple of years or where that might settle out as a percent of revenue over time?

Speaker 2

Yes. Just one more comment on the biomarker bill. I mean, this goes back to this goes back to I think Doug's question at the beginning around our prepared comments that the revenue per test. So biomarker bill is a great example because today we will receive a test from a commercial payer and a lot of times they don't pay us. And this is an opportunity as the biomarker bill comes in where we can actually get paid on some of the tests that we're already running.

Speaker 2

So not only are we accelerating volume growth as time goes on by getting things like lung coverage in place and just the MRD market evolving, but we also have this impact of accelerating ASP that's happening over time. And the biomarker bill is very significant opportunity for us. R and D, so, yes, sorry, I just had to remember what the second question was. Yes, on the R and D side, look, the vast majority of the R and D is going to be on MRD. And that's clinical trials, and that's product line extensions, product line enhancements, that's COGS and scaling related projects and that's UX related projects.

Speaker 2

When you look at other areas of the business, certainly, we think women's health and organ health are very important. We've got some pretty exciting launches happening there with those businesses in the future. But and also some great clinical studies as we went over pedal and define. These are really the first time these specific things have ever been studied in this very rigorous perspective manner. And we think they can be very meaningful for the field.

Speaker 2

But yes, the main focus is MRD, in oncology. And we think that's where we should be putting our investment now. Of course, the ECD opportunity, although traditionally our investment there has been very targeted, and we'll continue with that philosophy. Now we're launching the FDA enabling study. That's already worked into the budget already worked into the guidance for the year, but there will be some spend there.

Speaker 2

And we think that that's warranted given, what we think is really, really strong performance on the ECD product. And given the ASP, I think the $900 plus Medicare clinical FE schedule rate plus the opportunity to have a ADLT rate that could be in the $1,500 range. I think that that's actually that makes it a very significant opportunity for Natera. And given our ability to develop these types of work through the regulatory framework or historical success with distribution, but actually the built in channel that we already have for distribution, we think we can be a very major player in that space. And we think we can do it without really significantly increasing the operating expenses and have a very high gross margin product.

Speaker 2

So, certainly that's worth investing. And that's why we're putting money behind that.

Speaker 13

Great. Thank you.

Operator

Up next is Daniel Brennan, TD Cowen.

Speaker 6

Great. Thanks for the questions. Maybe just starting on price, Mike, just kind of walk us through, I think you said women's health prices flattened 25%. So kind of what are you assuming on Cimatera? And if you could let us know kind of on commercial payers, just what's the progress been there?

Speaker 6

And kind of what are you baking in implied in that price for $25 of commercial payers? And then I had a follow-up.

Speaker 2

Yes. Mike, you want to take that?

Speaker 1

Yes. Go ahead. Thanks, Dan, for the question. So yes, just on Signatera, we just expect kind of steady kind of continued improvement in the ASPs. Women's health, as you mentioned, is stable.

Speaker 1

What's going to drive the improvement in Signatera, at least in the base model, is just going to be continued execution on reimbursement for our Medicare Advantage volumes for covered services. So that's been an important driver for Signatera ASPs over the last well up to eighteen months is getting Medicare Advantage reimbursement from the 20% range to now kind of in the 60, yeah, next 60s range. And so we're going to make steady improvement on that. We fully expect in 2025. And that's what gives us confidence actually guide to improving Symantara ASPs in the year.

Speaker 1

And I just thought that again, I mean, the women's health ASPs have been really strong. We've been very encouraged by the results we've got from all the hard work there. So that's certainly a potential source of upside. If we can continue to see improved ASPs, particularly in expanded carrier screening, that would represent upside to what we've guided today.

Speaker 6

Great. And then maybe just a follow-up on lung. So can you just remind us what percent of the lung indication you have today like wasn't covered by IO? So of the two hundred thousand plus incidents many of those patients are already applicable to IO? So what's like the expansion that you see?

Speaker 6

And any other approvals we could expect this year, which tumor types are kind of high on the list? Thank you.

Speaker 2

And Sullivan, you want to comment on sort of how things are parsed out between maybe the adjuvant indication in lung where we were already covering quite a few of the patients with IO monitoring? And then what is this kind of very large surveillance opportunity that we just received coverage for?

Speaker 8

Sure. Thank you. In lung cancer, immunotherapy is already very commonly prescribed, even in early stages of disease. In many patients in the adjuvant setting in the early stages and some patients also in the neoadjuvant setting, so that's before surgery and some patients get both. So Signatera was already, covered for immunotherapy monitoring in those patients and that would

Speaker 4

be a single bundle payment,

Speaker 8

when a patient is starting monitoring for immunotherapy. The new coverage it provides, the new Medicare determination provides coverage in the surveillance setting. So this is for patients who complete their definitive therapy, who will have no more evidence of disease and in line with NCCN recommendations for monitoring in the surveillance setting, Signatera can now be used as well, and paid for by Medicare. So we think that's a big deal. We think it's in line with the evidence and in line with the opportunity for greatest impact for those patients.

Speaker 8

In terms of other disease types, we've published now in many additional cancer types. We have several submissions that are currently in progress and others that are being prepared that, the draft off of the evidence that's been established and published. So looking forward to provide further updates there. And thanks for the question.

Speaker 6

Great. Thank you.

Operator

The next question is Dan Leonard, UBS.

Speaker 14

Great. Thank you for running long. I'll ask a two parter on early cancer. First off, can you clarify the timing? I think you mentioned eighteen months trial.

Speaker 14

So does that mean, you know, we'll get data by the end of twenty twenty six and you'd hope for a 2027 FDA approval if all goes well? So that's the first part. And the second part, can you touch on the platform capability? Is this a platform where you could add other cancers as well on the same format? Or would any future multi cancer offering be a different technology platform entirely?

Speaker 2

Yes, it's a great question. So, yes, let me I think the timing is probably about right. Alex or Solomon, if you want to provide any more specifics there, but I think roughly kind of in the right ballpark. The good news is with the trial, we set up this entire infrastructure proceed study. So, we already have collected prospectively 3,000 samples there.

Speaker 2

We worked with different vendors to run the trial. And so, we're basically just sort of flipping a switch and moving into the new trial with the same infrastructure. And I think that's going to allow us to get it done, I think quickly and efficiently. And as Alex said, we've learned a lot through, I think the 3,000 patient proceed trial. On the platform that we built, I think you're exactly right.

Speaker 2

We spent two years building a discovery platform that allows us to identify novel markers. And we're just sort of pumping new data through that and using that to design assays now and this sort of pan cancer approach. Now, we're still assessing our strategy for the next version of where we want to go after CRC. And we think that the right approach is focusing on CRC initially. But certainly, as we said in tumor naive MRD, we're already moving to other tumor types.

Speaker 2

And I think in the field of early cancer detection, there's going to be that opportunity to do, to do the same thing based on the strength of the platform that we've built. Thank you.

Operator

And next we'll hear from Subbu Nambi, Guggenheim.

Speaker 15

Hey guys, thank you for taking my question. Two questions. One, could you elaborate on why you believe no one else will receive ADLD status? One could argue a first in class Tumor nine test for example? And then second, how much of an advantage is having a biobank with all the signature samples to develop in tumor naive and screening tests that you just touched upon?

Speaker 2

Yes. So look, I think if you go through, I would just point you to go kind of go through the ADLT regulation. There's multiple tumor naive MRD tests on the market. And that's one of the disqualifiers for an ADLT without FDA approval. So, I think there's several commercial CLIA validated on market, tumor naive products.

Speaker 2

And if you go through the specific legislation, that itself is a sort of disqualifier for a new ADLT approval. Now, of course, there's the FDA path that takes time. From a sample collection standpoint, I mean, this is one of the real values of Natera. You start to see remember, we've been at this since 2015. We started collecting biobanks.

Speaker 2

We started doing prospective clinical studies. We started collecting samples. So, when it comes to launching new products in the MRD space or new versions of the product, we have a real advantage because we've published over 100 peer reviewed papers And we have over 100 ongoing clinical trials and bio based, in studies that we're participating in. So, we're in like you said in tumor naive for colorectal, we already have a prospective, 1,000 patient sample covering surveillance and the adjuvant setting. It's already running in the lab today.

Speaker 2

So, you know, I think that just gives you a sense of how quickly we can execute on things.

Speaker 15

That's great. Thank you, guys.

Operator

And everyone, that does conclude our question and answer session as well as our conference for today. We would like to thank you all for your participation. You may now disconnect.

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