Thanks, operator. Good afternoon.

Thank you for joining our conference call to discuss the results of our second quarter of 26. On the line, I am joined by Steven Leonard Chapman, our CEO Solomon Moshkevich, president, clinical diagnostics and Alexey Aleshin, general manager of oncology and our chief medical officer.

Today's conference call is being broadcast live via webcast. 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 is available. Starting on Slide 2.

During the course of this conference call, we will make forward looking statements regarding future events and our future performance, such as our operational and financial outlook and projections, our assumptions for that outlook, market size, partnerships, clinical studies, and 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 file from time to time with the SEC including our most recent Form 10 k or 10 Q, and the Form 8-Ks filed with today's press release. 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, August 6, 2020. If this call is replayed or reviewed after today, information presented during the call may not contain current or accurate information.

Natera 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.

We will quote a number of numeric or growth changes as we discuss our financial performance. And unless otherwise noted, each such reference represents a year on year comparison.

And now I would like to turn the call over to Steven. Steven?

Great. Thanks, Mike.

Let's get to the highlights on the next slide. We had an exceptional quarter.

We processed approximately 1.044 million tests in the second quarter once again exceeding 1 million units and setting a new company record with strong volume performance across the business. In oncology, we processed 283 thousand clinical MRD units.

Representing year over year growth of approximately 56% compared to Q2 of 2025. Clinical MRD volumes grew 34 thousand units over Q1 which is the largest sequential increase to date.

Beyond volume growth, we met several crucial milestones in oncology. Signatera became the first MRD test to get US FDA approval as a companion diagnostic and the first MRD test to get Japanese PMDA approval.

In addition, the NCCN Guideline Committee issued a Category 1 recommendation for Signatera guided adjuvant treatment in muscle invasive bladder cancer. We will get into all of these topics later on the call.

We generated approximately $753 million in revenue in the quarter, which represents approximately 38% growth over Q2 of last year. Ex revenue true ups, our revenues grew approximately 40% year on year.

Gross margins were strong again at approximately 65% driven by another quarter of sequential improvement in ASPs. We were also pleased to generate positive cash inflow again this quarter and trim operating losses while continuing to invest in growth initiatives in R&D.

On the guide, we are in a position to completely reset the revenue range. Raising it $100 million at the midpoint.

Our new range is $2.85 billion to $2.91 billion in revenues, and we are holding OpEx steady. The guide implies 31% revenue growth this year ex true ups, and we feel very good about hitting this range.

We are clearly on a roll, I am excited to review the progress since our call in May. Okay.

Let's get into some of the business trends on the next slide. I think the growth of total tests over time is remarkable.

When you look at the longer term picture here in the chart. In the quarter, women's health results were particularly strong on a seasonally adjusted basis with high-single-digit growth versus Q2 of last year.

Q2 is typically our softest quarter for women's health due to seasonality. But we counteracted that effect this year with particularly strong new account wins, driven by fetal focus adoption, and early returns on the launch of our newly enhanced panorama test.

We think this puts us in a strong position to continue executing in women's health for the rest of the year. We also had another strong Oregon Health quarter as volume continued to ramp.

And then, of course, we had our best quarter yet for Signatera. The next slide shows our clinical oncology units over time.

As a reminder, that is primarily Signatera clinical units but also includes a small number of Latitude cases. Our sequential growth of 34 thousand units was well above our internal expectations performance fueled by a few drivers.

Let's first look at the change in units between Q1 and Q2. You will recall that on the Q1 call in May, we described weather related events that suppressed Q1 MRD volumes by several thousand units, a lower Q1 number.

We do not think we necessarily recovered those units in Q2 but the change quarter over quarter is exaggerated by that artificial-- Mike will expand on this as it relates to the guide later in the call. In addition, last year we made a significant investment in the size and the breadth of our commercial team.

Most of these folks were hired in the first half of 25, so we are pleased now to see them hitting their stride. We also achieved some critical milestones for Signatera.

Including FDA approval, and we have seen an uptick in general for Signatera as a result. We are seeing this in new accounts and new patient starts.

Which were both very strong again this quarter. This broad based acceleration is happening across tumor types.

With colorectal and breast remaining our largest indications. I am also really encouraged by the contribution from the long tail, both because it demonstrates broad adoption of Signatera in clinical practice, and also because it increases the revenue opportunity as we expand coverage to additional tumor types.

At the end of the quarter, we got the NCCN guideline in muscle invasive bladder cancer and the PMDA approval in colorectal cancer. Both of which we think bode well in terms of future adoption.

So we feel really good about where we are and the ongoing momentum. Moving to revenue on the next slide.

Total revenues grew approximately 38% year over year as continued ASP execution accelerated growth on top of the volume performance. Maintaining this level of top line growth given the size of our revenue base is pretty remarkable.

We had about $52 million in revenue true-ups this quarter, which is trending down in both absolute terms and as a percent of revenue. Ex true ups, our revenues grew about 40% year on year.

We had another good quarter in women's health and organ health ASPs, and we are pleased to see Signatera ASPs increase again. Signatera ASPs were up to roughly $12.75 as we continue to drive more consistent reimbursement from Medicare Advantage and commercial plans in biomarker states.

We made a significant investment in revenue cycle management a few years ago to get more consistent reimbursement for covered services. While we have completed most of the major initiatives for women's health and organ health, still think Signatera ASPs have the potential to grow substantially over time both from operational initiatives as well as potential additional MolDX coverage decisions and broader guideline inclusion.

We talked in the past that we think a mature Signatera ASP can reach around $2,000 and we still feel good about that as our long term target. The next slide shows our gross margin progress across 2 time periods.

The left chart shows reported gross margin versus Q2 of 25. With solid progress mainly driven by ASP improvements over the past year.

On the right hand side, we are zooming in on sequential growth ex-true-ups where we had a roughly 50-basis-point improvement over Q1. This was due to several factors, including both ASP wins And returning to a more normalized ratio of reported to a session units compared to Q1.

COGS increased slightly in Q2 as we saw an uptick in volumes from some of our recently launched products. Particularly for fetal focus, Latitude, and Signatera genome.

When we launch these products, we leave a lot of room to achieve COGS improvements over time as volume scales. And we are already executing on that road map.

Latitude and fetal focus also present ASP upside over time, For example, we have a latitude submission in currently to MolDX. We think we can keep improving margins slightly in the near term despite this new product COGS impact as we did this quarter.

Longer term, we feel very comfortable about reaching our target of 70%+ gross margin. The margin improvement going forward is driven mostly by major events, like MolDX coverages, or the completion of key internal COGS projects.

If you look at our progress, on gross margin from the mid-40s to the mid-60s, it was not strictly linear. We had periods of incremental progress, and also step-function changes.

I think we will have a similar trajectory in the future. Okay.

With that, let me turn it over to Solomon to discuss some of the exciting clinical and product developments this quarter. Solomon?

Thanks, Steven. Will talk through some of the catalysts that hit in the second quarter.

And I want to start in women's health with our launch of the enhanced Panorama test. Because it addresses something that has been a gap in prenatal screening for a long time.

Achieving reliable test performance at low. During pregnancy, fetal fraction is the proportion of placental DNA circulating in the mother's blood, and when that fraction is low, detecting chromosomal abnormalities becomes significantly more difficult.

With 1 prior study indicating sensitivity as low as 62% for trisomy 21 using a different technology. Despite this limitation, most other labs who use a counting-based approach will routinely provide results at low fetal fraction without sufficient clinical performance data to back it up.

Historically, Natera would return a no call in such cases. About 2% of the time.

Our new enhanced panorama test closes that gap. Powered by our novel SNP-informed deep-sequencing technology, Panorama is now the only NIPT with clinical validation data for common trisomies specifically in low fetal fraction patients.

Combines the best of both worlds. The power of SNPs for fetal fraction measurement, triploidy detection, and twin zygosity, and more.

Along with excellent performance at low fetal fractions. Bringing the overall no call rate down to 0.5%.

An improvement of roughly 80% compared to our prior version of the test. The prospective blinded studies supporting this launch included over 3.3 thousand patients with more than 240 low fetal fraction cases.

And we detected 100% of the trisomy 21 cases in that cohort. We launched this in May, and the reception among OBGYN has been very enthusiastic.

Resulting in many new account wins. This reflects a set of customers who always wanted to order SNP based testing with Natera but had held back due to the no call rates which is now resolved.

We think this sets up nicely for volume growth in the back half of the year. This new panorama also rounds out a multiyear run of innovative launches in prenatal health.

Last year, we launched Fetal Focus, our next gen single gene NIPT to detect inherited conditions like cystic fibrosis, has continued to exceed our expectations driven by the strength of the EXPAND trial. And the year before in 2024, we launched our fetal RHD test, addressing a significant unmet need given the nationwide rhodium shortage that year.

Amazingly, the demand for RHD testing has continued to steadily increase, despite the alleviation of that original shortage. Taken together, these 3 launches reflect the breadth and consistency of our innovation and growth trajectory in women's health.

Moving now to organ health. The final Medicare LCD for organ transplant surveillance was published in July.

And it represents a meaningful expansion over the initial CMS proposal. Now in year 1 after surgery, Medicare will cover 6 tests for patients with kidney transplant at 12 tests for patients with heart and lung transplants.

Then in years 2 and 3, Medicare will cover 4 tests per year across all 3 categories. is significantly higher than their original proposal.

This improvement reflects strong advocacy from the clinical community. After the draft was originally published by Medicare in July 2025, Major transplant medical societies submitted letters to MolDx in support of expanded frequency.

This included supportive comments from the American Society of Transplant Surgeons, the American Society of Transplantation, and the International Society of Heart and Lung Transplantation. We believe their unified voices helped move the needle on this final policy.

We have spent years building the clinical evidence base, that made this outcome possible. And the August 30 effective date on the policy means we will start to see the benefit of Medicare reimbursement in the second half of the year.

We expect this to drive improvements in Prospera ASP and in Prospera volumes. As physicians update their surveillance protocols to reflect the new policy.

Turning now to oncology where we had a great quarter. Both in terms of commercial adoption and major milestones.

In May, the FDA approved Signatera as a companion diagnostic for patients with muscle invasive bladder cancer. This is not just a Natera milestone.

it is an industry first for the field of MRV testing. Backed by the global Phase 3 INVIGOR01 trial, it validates the whole-tumor concept of 'treat on MRD'.

At the highest level. Then in June, the Japanese PMDA approved Signatera for patients with colorectal cancer.

Supported by the Galaxy study. We expect a commercial launch later this year pending final pricing and reimbursement determination, which is on track.

That commercial launch will be supported by society guidelines, from JSCO and JSMO, already strongly supportive of MRD assessment in the adjuvant setting. And then in July, Signatera received IVDR certification in the EU.

Making it the first MRD test for solid tumors to achieve this designation in Europe. Under this certification, Signatera is indicated across more than 20 tumor types.

This streamlines future clinical trial launches across the EU, creating a competitive advantage for us with biopharma. While also ensuring continuity of access for patients after the expected IVDD transition deadline in 2028.

Also sets Natera up nicely. To achieve future reimbursement in Europe a key part of our long term global vision.

These regulatory wins are the culmination of a long road Natera in developing our regulatory and quality capabilities. it is remarkable that these approvals have come in multiple different disease indications at the same time.

These are also major proof points for our biopharma partners. We are building on this momentum with our newest submission to the Japanese PMDA for Signatera as a companion diagnostic in bladder cancer.

With this submission, we are advancing in lockstep with Chugai, which markets atezolizumab in Japan. Japan reports approximately 34 thousand new cases of bladder cancer per year, of which around 20 percent to 25 percent will be the INVIGOR011 trial, and notably, that trial had more than 20 participating clinical sites in Japan.

So the leading urologic oncologists in Japan already have experience with the protocol. Similar to what we saw with the Galaxy trial in CRC.

We think bladder represents a compelling second indication for Signatera in Japan. With strong evidence for serial testing every 6 weeks and we expect regulatory approval later this year or early next year.

Finally, we were very pleased to see the NCCN issue its Category 1 recommendation in support of Signatera testing in bladder cancer. Category 1 is NCCN's highest designation, and based on the most compelling randomized evidence.

Furthermore, the NCCN specifically called for ctDNA testing using a personalized tumor informed multiplex PCR NGS assay. Which is language that uniquely describes Signatera.

This is now the third NCCN guideline to positively recommend tumor informed MRD testing. With prior recommendations coming in Merkel cell carcinoma, and diffuse large B cell lymphoma.

All of which reference Natera's data. This guideline update is expected to drive adoption across multiple vectors.

As Steve described earlier in the call, it is already resulting in new customer starts and more systematic use among existing customers. Those who like to wait for NCCN recommendations prior to adoption into standard clinical use.

it is really creating an inflection point in the field. For which Natera is exceptionally well positioned based on our gold standard clinical evidence our operational excellence, and our industry leading analytical performance especially with the phase variant technology acquired late last year from Foresight Diagnostics.

The NCCN guideline is also driving new positive coverage policies among commercial payers. Far beyond what we could achieve with just the biomarker legislation alone.

Some commercial plans already had blanket coverage policies in place, for FDA approved companion diagnostics or NCCN recommended tests. But most commercial plans are publishing new coverage policies, to cover Signatera.

We expect this to drive meaningful ASP improvement. Finally, as more clinical evidence is published in support of MRD guided precision medicine, we expect further progress with Medicare coverage, and CCN guidelines and commercial payers.

With that, I will hand it over to Alexey to discuss our clinical road map.

Thanks, Solomon. I want to spend a couple of minutes on the depth of the clinical evidence engine we have built behind Signatera.

And why we think it is such a durable advantage. If you look at slide 13, you can see the shape of that engine.

For years, much of the MRD field ourselves included, built its early evidence on retrospective biobank studies. These studies are valuable.

They are efficient, and they let you establish prognostic performance across many tumor types quickly. But retrospective data on its own only takes you so far.

What actually moves guidelines and then logs broad reimbursement is prospective evidence. Studies designed upfront, run in real time, and in many cases, randomizing patients or tying Signatera directly to a treatment decision.

That evidence is a different order of magnitude. It carries far more weight with guideline committees and with payers.

It also takes real effort and takes years to generate. We made the decision to invest in that harder path early.

We have been signing and initiating prospective studies since 2019. And we have been building this flywheel quietly in the background for more than 7 years.

Today, as the chart shows, we have opened more than 70 prospective studies of various forms. Spanning our own sponsored trials pharma partnerships, and academic and cooperative group collaborations.

The key point on this slide is what happens next. For most of that period, we were putting studies in.

Investing ahead of the return. Now the flywheel is starting to really turn.

These studies are beginning to read out. You can see this inflection on the right side of the chart.

And we expect the pace of readouts to accelerate meaningfully over the next few years. Each readout is a potential catalyst.

For guidelines for reimbursement and ultimately for volume. This is the part of the story that compounds.

And it is very hard for anyone starting today to replicate. We are just now entering the harvest phase of an investment we began 7 years ago.

I want to discuss in more detail the Natera sponsored portion of our clinical trial portfolio. I am excited to introduce SIGNAL-ER101 the first interventional prospective study that Natera is sponsoring and operationally running ourselves.

End to end. The study is now open, and early reception from investigators has been excellent.

Let me frame the clinical question because it is a big 1. In early stage HR positive HER 2 negative breast cancer, the most common form of breast cancer, the vast majority of patients today may be overtreated.

When a patient is considered high risk, the standard is to add a CDK4/6 inhibitor on top of endocrine therapy. But these are difficult drugs to take.

More than 60% of patients experience serious adverse events, and a full course of therapy can carry a US retail cost north of $400 thousand. And the reality is that many of these patients were likely already cured by standard perioperative therapy alone.

SIGNAL-ER101 asks a simple but powerful question. Can we use Signatera to identify patients who actually need that escalation?

In the study, patients are surveilled with Signatera after surgery, and treatment is escalated to CDK4/6 inhibitor only when we detect molecular residual disease. MRD negative patients are spared a toxic and expensive therapy they may never have needed.

This is exactly the kind of high value clinical question MRD is uniquely positioned to answer. And the addressable population is large.

Representing a meaningful share of the more than 200 thousand women diagnosed each year in the US with HR positive HER2 negative breast cancer. the majority of them early-stage.

I want to be clear about why this matters strategically. SIGNAL-ER101 is the first of a broader interventional portfolio.

The SIGNAL program. And we have multiple additional interventional studies launching over the next few months.

Covering a significant portion of the largest tumor histologies. These studies are designed to a pharma standard.

They can be viewed as equivalent to a Phase 2 or a Phase 3 trials. With the same implications if they succeed.

Namely the potential to change practice and help define a new standard of care. And, critically, we have built the infrastructure to run these ourselves.

Efficiently and cost effectively. Owning operational execution means we control the quality, the timelines, and the economics.

It lets us bring rigorous, potentially practice changing studies to questions that matter most to physicians and their patients on our own terms. Finally, let me update you on the progress in early cancer detection.

We continue to be enthusiastic about the data we previously presented. Proceed CRC demonstrated excellent performance including a 22.5% sensitivity and 91.5% specificity for advanced adenomas.

Notoriously difficult target and a strong signal for the underlying technology. Additionally, case controlled CRC performance showed a sensitivity of 95% and a specificity of 91%.

With stage 1 adjusted sensitivity of 91% in screen detected individuals. Our pivotal FIND study is now approaching full enrollment.

We are on track to complete enrollment in the third quarter of this year. With roughly 24 thousand average risk adults enrolled today.

Our conversations with the FDA have been productive and are ongoing. We plan to read out the FIND cohort in 2027, and we will provide additional color on the path from there at that time.

Stepping back, we remain very excited about this opportunity. We believe we are developing a genuinely differentiated product.

1 that from the very beginning was designed around high sensitivity for advanced adenomas. The precursors we most want to catch early.

With that, let me hand it back to Mike to walk through the financials. Mike?

Great. Thanks, Alexey.

The next page is just a summary of the financials compared to last year. I will not belabor all the points that Steven already covered, but there are a few items that I want to highlight.

The revenue growth over Q2 of last year is particularly notable because you will recall that Q2 25 itself was a strong quarter where we put up 20 thousand sequential Signatera growth units for the first time. Obviously, the 34 thousand-unit growth number this quarter shows you we moved yet again into new territory.

You can see positive gross margin trends here year on year and organically ex true ups sequentially versus Q1 despite our rapid cadence of launching new products this year that are not yet optimized for COGS. As Steve described.

I was pleased to see loss per share continue to narrow even as we aggressively double down on the future of the business. After ticking upwards last quarter, I was also pleased to see DSO come down again roughly 4 days to an average of 57 days this quarter as we continue to do a nice job converting our volumes to cash.

On the next slide, I would like to give more granular detail on our OpEx. Particularly in R&D.

Given the successful commercial team expansion last year, SG and A is relatively stable in 2026. And, obviously, that investment is paying off really well this year.

We did have some expenses in the first half on SG and A are not budgeted to recur in the second half. To the extent we exceed the SG and A guide range, this year, I expect the majority of the overage would come from noncash expenses like stock based compensation charges related to the business hitting long term incentive targets and litigation expenses.

In R&D, we are remaining very ambitious in our core areas of MRD, organ health, and women's health. You can easily measure our productivity over time just by reviewing the speed and breadth of the new products we have launched and the clinical trials we have read out over the last few years.

Given the speed of our revenue and gross margin growth, however, we can afford to make these investments to remain in pole position while getting scale on the enterprise. As you can see on the chart, while R&D in our core areas is clearly growing, the gross profit dollars are accelerating over and above this growth.

what is unique about our current R&D spend is the scale of the investment we are making in early cancer detection this year which at the moment does not yield any top line or margin benefits at all. You can see that visually as the large change on the chart which represents the roughly $100 million we are spending this year on development work and to fund the ECD trial.

I think that ECD has enormous future potential once launched, and we expect a growth wave from 0 currently to millions of tests per year. So we expect the scaling benefits to arrive for that fourth area of the business relatively soon.

Okay. Great.

Let's wrap up with the guide for the rest of the year on the next slide. We are going to significantly bump the revenue guide now at $2.85 billion to $2.91 billion which implies roughly 31% annual growth ex true ups.

And meaningful growth in the second half over the first half of this year. We feel good about hitting this guide range given the volume and AST trends in the business.

Obviously, with Signatera, but also given the better than expected seasonal dip we experienced in women's health. For Signatera volume growth assumptions, keep in mind Q2 sequential volume was exaggerated by several thousand units due to weather negatively impacting us in Q1 as Steven described.

So while we had another very strong month in July, We do not expect to set a new volume record again in Q3. We continue to think the right framework for forecasting Signatera growth units is this linear growth model we have described in the past.

If you take the average growth in units over the prior 4 quarters, that solves for randomness around weather, and any seasonality or receiving day variances over the past year. Overall, the guide is just driven by volume growth and stable ASPs through the balance of the year.

On Signatera, we have made a bunch of progress with biomarker state and Medicare Advantage coverage. So I think really to drive ASPs meaningfully higher, I think we are going to need to expand MolDX indication coverage get some benefit from the bladder NCCN guideline, and eventually get guidelines in additional indications.

Our approach this entire year has been that those drivers are going to help us in 2027, and so we will continue to keep them out of the guide. For 2026, the rest of the guide, we are going to hold steady.

Gross margins, we bumped 100 basis points last quarter. And what you have seen this quarter is the benefit from ASP improvement and a normalizing test reported to test a session ratio that was balanced out by step up in volumes in the new products.

Which, as Steven mentioned, we think is a healthy development and sets us up to generate returns from COGS reduction projects next year. We are holding steady on OpEx.

We will keep the same mindset we have to keep our foot on the gas and invest in future growth. If additional high return projects come our way, we are going to make the investments and update you on the quarterly calls.

Finally, we are in good shape to generate cash for the year again, which is a priority for us even as we are in growth mode. Okay.

With that, let's turn it over to the operator for questions. Operator?

Yeah. Hi, guys.

Thanks for taking the questions here and a really impressive quarter for Signatera. So first 1, if I could, Steven, you talked about a bit about the drivers But if you if you could double click on that, clearly, you are building very strong evidence that is playing out.

Could you elaborate a little bit on how should we think about how are these increases sort of sustainable? Any color you can provide into, you know, 2027.

And maybe just if you could double click on the what is powering this growth? Is it the sales rep, the commercial execution?

Clearly, data's strong. NCCN data readouts.

I mean, you could say all of those things, but maybe just the principal component that you think is driving this. And keeps this sustainable in terms of quarter-over-quarter growth, that remarkable growth that we are seeing here.

Yeah. Thanks for the question.

Yeah. So I think there is some things that happened this quarter that we think were very beneficial.

You know, you look at that FDA approval, you know, certainly, there is some halo effect coming off of that. That was received very positively after the INVIGA readout.

But, you know, if you take a step back and you look at the preparations that we have made over the last couple of years, you know, we made big investments in the commercial team. We made big investments in medical affairs.

We have been investing in large scale clinical trials and data readouts. So all of those things have put us in a position to now be executing and, you know, outperforming.

So we are super excited to see that the planning that we put in now coming to fruition. But, ultimately, we really focus on sort of the 4, 5 core things.

Across all of our businesses. 1 is, like, an extreme focus on a technology and being on that cutting edge of technology.

The second is backing everything with a very significant amount of peer reviewed evidence, and you can see we have continued to invest in that and continued to extend our lead. And then the third is focused extensively on user experience.

We have done a lot of things to you know, implement new ways to reduce TMP issues on tissue to be able to accept more samples. Mobile phlebotomy expansion, so forth.

And then the fourth is the team, and we have a excellent team of on the commercial side and the 34 thousand quarter over quarter is just a blowout record I think, compared to anything that we have done you know, previously. You know?

But you know, I would not say necessarily we are going to repeat that immediately. But, you know, if you look at, I think the previous record was maybe 25 thousand quarter over quarter or something like that.

And I think we can outperform that, you know, as we as we move forward. And, you know, Q3 is off to a very good start.

So, you know, I would expect us to be kind of somewhere right in the middle there.

Got it. And then follow-up for you on, maybe this is just going a bit deeper into Slide 13.

Thanks for providing that. I think it is a very good perspective, given the competition questions that we normally receive.

Could you, maybe dive a little bit deeper into it? Maybe Alexey if you can talk about it.

You know, how should you know, this clearly lays out 2027 to 2028. You know, readouts that are steadily going to be coming out.

But are there any specific readouts that you would point to? And maybe if you could just dial a little bit into the ER101 study again, how should we think about that?

Is that something a practice changing study? Is that how we should be thinking about that study?

Thank you.

Yeah.

Hey, Thanks, Puneet, for the question. So I think slide 13, this is just the prospective portion of our studies.

So on top of this, we still continue to invest and read out biobank studies as well. So we do expect a large bolus of readouts in the next few years.

The way I would kind of think about especially the prospective readouts, you know, would say there are definitely a few studies that we are kind of monitoring very closely. I think Vega is, for example, a good study that, you know, we have discussed in the past.

But a lot of these studies are also, I would say, important in smaller indications. And because they are perspective and many of them are now interventional, I think the readouts do have a significant impact in terms of changing care and possibly changing guidelines and reimbursement.

So we cannot, given the number, provide details on every single study, kind of an exact dates for when it will read out. Some of this is variable.

Some of this, we do not control. Because some of these are being done with collaborators.

But as we get closer to, kind of, entering 2027, we will try to provide a little bit more guidance about the studies that we think are important and a little bit more information about their timing. Going back to ER101 and the broader signal portfolio, I think we will be announcing additional studies as they come online.

We are extremely excited about the pipeline. Think the main point is these studies are designed to a high level.

I think we said in the prepared remarks, pharma-level. And many of them are actually randomized.

Signal ER is not randomized, but it is not randomized because we could not randomize it, but because we are actually looking for performance. So for the CTA negative arm to do so well that really, what we are doing is almost comparing to close to a 100% mean, that is how high of a bar we are setting.

And if the study is positive, we do believe that this study will be practice changing, and that is the mentality we have taken with every single signal study that we have designed and plan to initiate in the next few months. Got it.

Great. Thanks, guys.

And, Puneet, let me just add to that a little bit too. So Basically what we did is we sort of went across every histology that we thought could make a major impact on the business, and we said, let's design a practice changing, you know, potentially guideline enabling study and then we are going to fund those trials.

And that is sort of what we have done. And that is why you see, you know, a lot of our investment going into these clinical trials.

So SIGNAL breast is the first 1 that we are announcing, but there is going to be a suite across all different histologies You know? So stay tuned, and it is a it is a it is a big part of our strategy going forward.

Fabulous. Alright.

Congrats, guys. Thanks.

Great. Thank you.

Thanks for the questions. Congrats on a strong quarter.

Maybe could I start just on Signatera volumes again, given how strong it was this quarter. So a couple of thousand tests from the weather recapture, that is 32 thousand And I guess, Steven, you talked about that Salesforce expansion productivity, which is just beginning to hit.

So I am just kind of wondering how we should be thinking about the go-forward pace because it sounds like, you know, given the size of the Salesforce expansion, that possibly you could see really, you know, another couple of quarters here really significant volume quarter to quarter growth based upon-- I mean, new salespeople are probably just getting going. That productivity enhancement.

Yeah. I think that is right.

I mean, we have got you know, we got these sales folks that have just come online. We made a big investment in medical affairs.

We are seeing a lot of momentum you know, coming off the trials that have read out coming off the halo effect of the FDA approval. You know, there is some things like, you know, even in bladder, for example, where you know, the Invigor protocol is sort of moving to kind of an every 6 week protocol, as outlined in the in the approval.

Know? And I think things like that can kinda give us an upside, opportunity as well where people may be you know, starting to draw more frequently where they have traditionally drawn, say, quarterly or every 6 months.

So there is a lot of momentum right now. And, you know, I do not think we will do 34 thousand.

You know, obviously, we I think here we have really outperformed even our own internal expectations, but you know, like I said, our previous record all time record had been, I think, 25 thousand. And, you know, if we can outperform that, I think that would be you know, that would be a good achievement.

And, you know, we think we are in a position to be able to do that. And kind of continue to notch up as the year goes on.

But very strong momentum. I think we are crossing the sort of tipping point in the field where doctors are really starting to believe in MRD as a core part of their practice.

And I think we are we are the major beneficiary of that. Given the breadth of our presence in the field and the amount of data that we put out you know, the size of our sales team.

So everything's sort of starting to come together. Terrific.

Then maybe just on the price, you know, the $25 sequential increase, you know, ahead of expectations. I think you have had $25 and $22 the last 2 quarters sequentially.

But what I am hearing, you know, Mike talked about more of the benefit in 2027, but I heard Solomon say several commercial payers are kind of putting Signatera in their plans. You have got 3 NCCN guideline inclusions.

And, Steven, you talked about the benefits you had on rev cycle, as well. That you experienced in transplant women's health, and you are seeing really an opportunity now more so in Signatera.

So I am just wondering if you can unpack that all? Is there a chance this price really begins to take off here the next few quarters more so?

Or is, you know, $5 sequential still the right way to think about it for a little while? Thank you.

Yeah. Mike, do you want to take that?

Yeah. Dan, thanks for the question.

I mean, I think that so as we mentioned on the prepared remarks, the guide that we put out presumes just a stable ASP of $12.75 for Signatera through the balance of the year. I think, you know, if you are looking for, like what would be an upside case beyond the guide, which we normally set as something that is, you know, difficult but achievable.

I think it would be something in that ZIP code of another $25 through the balance of the year. And I can talk a little bit about why.

I mean, the things that drive immediate term ASP upside are things that we are basically getting paid on already right now. Or if you think about the timing of the accrual for Q3, we have gotta be receiving reimbursement for that unit effectively right now for us to count it in the Q3 results.

So that tends to be things that are kind of more tactical in nature. These are things like improving Medicare advantages, compliance with reimbursing for covered services.

Expanding coverage within the biomarker states, things like that. The things that we are mentioning on the call are the longer term drivers and will have a bigger impact on ASP.

I feel better about the long term vision for getting the $2,000. I feel better about that now than I really ever have since we launched Signatera.

6, 7, 8 years ago. But I think just if you are looking for kind of tactical moves over the next couple quarters, I mean, I think an upside case would be something like $25.

Just because these recent wins that we have had take a little while to get into the revenue recognition. Recognition.

Got it. Thanks, Mike.

Alright. Thank you for taking the question, and, yeah, congrats on the good MRD numbers.

So 1 of the things I think that was kind of fascinating, we see really good growth in a lot of the different MRD competitors or new entrants. Obviously, it is not having any impact on you with the 50% growth rate.

So can you tell us, you know, is there still, like, a market education from some of these competitors? And how do you think as these competitors come in?

Is there lanes for each, or is there, you know, some crossover? Or do you think maybe they are kind of just getting their own customers?

I just want to think about how it plays out as you know, they are on the market and they do seem to be getting traction at this point.

Yeah. that is a good question.

I mean, you know, there is always going to be competition, and, you know, we have seen that I think if you if you look at you know, probably, you know, 4 years now, maybe 3+ years, there is been major oncology competitors that have had MRD tests that are approved by MolDx on the market. So it is not it is not necessarily a sort of a new dynamic.

And you can see we have done really well in the face of competition. I think we are going to continue to do really well because we are doing all the right things.

So we are investing in the technology, you know, when we see an opportunity to round out the portfolio or enhance the portfolio. We are we are we are taking those opportunities.

We are doing all the right clinical studies. So, you know, I think we are in a really good spot going forward.

You know, I would just say, there is always going to be competition and other companies are gonna do well. But because it is such a large market, it really does not have a significant impact on us.

I mean, we are still very early and penetration in the overall market. You know, I would I would sort of say mid-single digits You know?

So we think there is a lot of upside here, and we are we are really in the in the best position to capture that upside. Now with that said, we are you know, very keenly watching what everybody else is doing.

And, you know, if we think there is an opportunity for us to you know, push harder in 1 particular area, or sort of close gaps in a particular area, we are gonna be really focused on that.

Great. Thank you very good.

And you mentioned in your prepared remarks some of the new patient starts again being extremely high in the gross margin commentary. Now I know you do not give out mix of brand new patient starts versus continued seeking the patient-paid continued patients, but can you maybe give some of the mix on terms of tissue types?

Are you gaining new or a lot more new patient starts in some of the covered versus uncovered indications, some of the more newer indications. Just trying to get a flavor of what might be coming down the pipeline.

In terms of what you are seeing in, say, tissue types in, say, 2028. Thank you again for the questions.

Yeah. it is a great question.

So, you know, as you know, we have we have many tissue types now that or many histologies that are covered by MolDx, and we have a handful you know, where we where we still do not have coverage, but we have submissions. And I think you know, we have sort of reported before that we had 7 submissions in, you know, which are at various stages.

And we are excited about the opportunity of getting coverage there. As far as what we are seeing in the field, and we are continuing to grow colorectal and breast which I think are the, you know, the 2 sort of largest as we said in the remarks.

But there is a lot of opportunity beyond that. And as we turn out new publications, we generate new data, We start to see, you know, uptick in these other histologies as well.

And we think we are in a really good position to continue to drive growth across the business, both in CRC and breast, but also across this longer tail of other histologies. Thanks.

Hey, guys. Congrats on the good results, and thanks for taking my questions.

First, I wanted to ask on Signatera ASP it is nice to see the continued progress there. Steven and Mike, you both had some helpful comments on the step function improvements that we could see from specific catalyst.

So what I wanted to specifically ask about is the 7 indications submitted to MolDX. Should we think about that in 2027?

Is it coming online in the first half, and maybe it will take a few quarters? Get fully rolled out and realized?

And then once it is fully ramped, in terms of the P and L impact, could it be, like, $200+ contribution to ASPs on that path to $2,000? And are there any incremental costs that come with it?

Like, the way I am thinking about it, could be a really nice step up to the ASPs and also a nice inflection towards positive EBITDA. Is that the right way to think about it?

Any color would be super helpful.

Yeah. it is a great question.

I would say you know, with regards to the timing, you know, it is it is always hard to say. You know, but, generally, we have been able to sort of work through these submissions very successfully over time.

Mean, usually, if you have a good peer reviewed published paper, and you submit to MolDx, there is gonna be some back and forth. there is gonna be a couple of rounds of revision, and then, you know, ultimately, you will you will end up getting coverage.

And so that is why we feel like we are in a good position on these. I do not think that timeline of you know, at some point over the kind of second half of 26 and then kind of into the first half of 27, I think that is a reasonable time line.

You know, which is basically you know, rolling coverages over the next sort of 12 months or, you know, something in that range. And frankly, I think it is good that they are very sort of strict in the way that they are, and I think that is benefited us because we generated so much data and so much quality data.

And it really, in some ways, is a competitive moat. For others that are now entering the market where you know, it really takes a long time to generate this level of evidence that you can go to MolDX with.

So we think we think it is an opportunity. On the path to 2000, you know, certainly, this would make a major impact on the path to 2000.

But, Mike, do you want to comment specifically on sort of what number you think this might give us?

Yeah. I mean, I think if you just kind of sum up the indications where we have got submissions in-flight or we are planning on submitting to MolDx.

I mean, I would estimate that is worth something like $150 to the ASP, perhaps $200. So, Daniel, I think your estimate's roughly in the right range.

So, obviously, that is that is a transformational difference. When you started December and you add that Steven mentioned the timing to, you know, to starting to get these coverages, and I think that is right.

I mean. I think over the next 12 months, I think you start to get these coverages, and I would just reiterate what Steven was just mentioning on the process.

it is, you know, it is hard to forecast with precision. But, I mean, I think rolling approvals over the next 12 to 18 months is probably the right way to think about Great.

Thank you. And then the second thing I wanted to ask about was the progress in biomarker states.

It sounds like that got a little bit better this quarter. Are we seeing an inflection of this starting to flow through?

And then will you be able to be trued up on, like, retrospectively, since biomarker bills went into effect? So in other words, should we expect some outsized true ups in the quarters and years to come based on the biomarker states?

Thanks again for taking the questions, guys.

Yeah. I am not really expecting Yeah.

Thanks. Thanks for that question.

I am not I am not really expecting you know, a lump of, you know, of true ups specifically from biomarker. I mean, the way that you see this happening is you get a biomarker state law, and then you interact with payers in that state.

And it is kind of a linear kind of grinding process that takes quite a bit of time as we have described in the past. So that kind of linear process of getting payers on, you know, 1 by 1 sometimes it feels like it is unit by unit.

That contributes to the drip of continued true ups rather than a bolus. I mean, more generally, we said this in the prepared remarks.

I mean, the ambition is to is to you know, have the trips kind of gradually come down, and you have seen that happen both in terms of absolute dollars, but particularly as a percent of revenue. So that is the plan.

Hey, team. This is Noah on for Tycho.

Thanks for taking the questions and congrats on the quarter. Wanted to ask on Women's Health.

I think the high-single-digit growth a little bit better than we were expecting. curious, what are you seeing from an underlying market growth standpoint?

And then when your competitors flagged some share loss there, so curious if you think you have been a beneficiary of share gain there.

Yeah. it is a good question.

Yeah. We definitely think we are we are we are benefiting from share gains here.

You know, we had, in the last couple of years, we have had we have had some big investments sort of behind the scenes in technology development, you know, that led us to beginning of this year and launching the Fetal Focus product and then, you know, more recently, launching an enhanced version of Panorama that really closed 1 of the major gaps that you know, people had with the product. So I think right now, we are in probably the best position we have been in from a competitive standpoint.

And we really started to see the impact of that, you know, over Q2. You know, typically, it is you know, Q2 can be a softer quarter.

Just because of seasonality. And we were really able to overcome that this quarter, I think, with just the interest in the product portfolio and the interest in the enhancements and the sales team is feeling very positive right now in women's health.

Thanks. that is helpful color.

And then for my follow-up, I wanted to ask on the SG and A guidance. It looks like you are expecting a step down in the second half versus the dollars last year around $80 million Just curious where these efficiencies coming from.

I think you mentioned an AI project last year that could drive $200 million in cost savings over time. So any incremental progress there?

And how are you thinking about the longer term path to profitability?

Yeah. Mike, do you want to take that?

Yeah. Sure.

Thanks. Yeah.

Thanks for the question. Yeah.

I think, you know, I mentioned in the prepared remarks, there were a couple of onetime expenses in Q1 that I would not forecast in the guide to have them repeat in the second half, around noncash accruals of stock-based comp and some litigation expenses. So that is that makes up the majority, I think, of that delta.

I mean, more generally, I think we are getting a lot more efficient. and we are deploying AI really across the business at a at a pretty frenetic pace.

And we are just seeing efficiencies all the time. We have given a bunch of examples in the past.

Where we can deploy that in a large operation like this. So you got a large lab.

You got a lot of employees, a lot of patients, a lot of volumes. there is lots of opportunities to automate workflows.

And to move the employees up the value chain as it were. So we continue to see just a lot of progress there.

Maybe first 1 on the Japan launch. Could you just help us understand a little more how that ramp could look in 2027?

How quickly do you think reps could get out there into accounts? And then maybe just talk through your confidence in securing coverage for perhaps more frequent testing based on some of the studies that you have run in the region?

Thank you.

Yeah. that is a good question.

So, Solomon, I will have you kind of comment on the sales penetration but I will I will comment first on the coverage. So I think as we said on the last call, you know, we are sort of initially looking for that sort of adjuvant you know, coverage.

And then I think following on after that, you know, at some point, the surveillance coverage. Now we think we will be in a position to be able to offer surveillance you know, but that we think the coverage will probably come sort of shortly after that.

You know, there is a lot of opportunity there just given the number CRC patients that are diagnosed. And then now also, I think, bladder as well is gonna be a big opportunity.

So Solomon, do you wanna comment on the penetration?

Sure. Hi.

Thanks for the question. Yeah.

With the launch in Japan for CRC expected at the end of the year, we think we are poised for penetration or market adoption, I would prefer to say, that meets or exceeds the rates we saw in The United States. When we introduced Signatera for colorectal cancer, and that is because of the we are starting further along, you know, with more significant published data with medical societies having published guidelines and strengthening those guidelines, over time.

Including expected updates this year. From multiple different guideline bodies in Japan And then the reimbursement is really gonna be the unlock.

Because it is not the way the tests are ordered. it is really a for the reimbursement to be in place in order for clinics to order the test.

I will just add 1 other thing. You know, we have a really strong partner in Japan.

But we are supplementing that distribution partner with direct sales effort, sales and effort. and marketing in Japan.

So we feel pretty confident we are gonna be able to get awareness out very quickly. We think given the Japanese thought leadership with the Galaxy study, that there is already a strong understanding appreciation for the technology and it is really gonna be about user experience, making it easy to order, easy to get results, and we look forward to launching.

that is great color.

And, Mike, maybe just 1 for you. Outside of the ASP uptick, highlighted some internal work that is being done to drive down COGS.

Could you maybe just detail in a little more what those actions are and when you think those can come through the P and L? Thanks, guys.

Yeah. Thanks for the question.

This is really kind of our standard playbook. We launched new products very frequently.

You have seen that pace of the new launches been quite intense over the last year. As those products launch, obviously, they are not yet optimized for COGS as they kind of they get to volume scale.

So as they scale, you get some natural efficiencies with workflows in the lab. And then also once you see you confirm that you do have the demand for the new product and the investment is worth it, then it is relatively straightforward to then deploy resources then to the workflow itself for COGS.

Those are some of my favorite R&D projects because you can see what the demand is. You can see what the savings per unit is, and so it is quite easy to calculate returns on invested capital for those for those projects.

And we have generated very high returns on these cost reduction projects. Over the last decade.

So just given the pace of the new product launches we have had over the past year, we are well set up to have another wave of cost reduction projects that hit over the next 12 to 18 months.

Hey, guys. Thank you for taking my questions.

There are 2 topics I wanna address, and 1 of it was partially addressed. But I will touch on it anyway.

First on R&D, it looks like you increased the budget for early cancer detection program. Are you accelerating timelines here What is driving the investment?

And second, on margins, in a huge revenue quarter, gross margins did not increase by that much sequentially. There are some good reasons that could happen, things like a jump in new Signatera starts, or more latitude growth.

Is that right? 1, and then do these mixed dynamics start to flip later this year?

Thank you so much.

Yeah. Thanks for the question.

So I will take the first 1 on ECD. So, you know, we are actually really tracking along at where we thought we would on the f enabling study, the FIND study.

We think we are gonna be done recruiting this quarter, which is sort of what we outlined in the prepared remarks. So, you know, that is really on schedule.

We are excited about that. You know, we have kind of backed that with just readout of proceed that we had early, you know, I think, at the JPM conference previously, which we are excited about.

So now we are doing the development work. You know, we are getting the assay ready to be in a position to run the FIND study.

When all after all the samples are collected and then be in a position to submit to the FDA. So these are all expenses that you know, over time will go away.

You know? But I think for now, you know, this is sort of what needs to be done to be in a position to submit to the FDA.

We think this is a huge market opportunity, and we are in a position to be you know, potentially 1 of the key players in this space. So, Mike, do you wanna comment on the margin?

Yeah. it is very similar to the, you know, to the topic we were covering with Kallum, which is yeah.

We did have a huge number of new Signatera starts commensurate with the blowout in volumes that we had for Signatera. And then we had some very promising growth in a bunch of these new products.

The COGS are not yet optimized. But as I just mentioned, we have got ample opportunity now, now that we see the volume coming in.

To go and tighten down those COGS and optimize those workflows, which we are excited to do, again, over the next kind of 12 to 18 months.

Yeah. And I will just reiterate this point on new patients.

I mean, new patients coming in for Signatera was way up. So we are seeing this you know, very significant excitement And the good thing about that is that sort of usually kind of foreshadows, you know, significant growth in recurrence monitoring and surveillance in the future.

Perfect.

Thank you so much, guys.