Billiontoone Q2 2026 Earnings Call Transcript

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August 5, 2026

Key Takeaways

  • Positive Sentiment: Q2 revenue rose 64% year over year to $109.4 million, driven by 35% test-volume growth and a 21% increase in average selling price. Oncology revenue surged 176% to $13.7 million, while prenatal revenue increased 56% to $95.8 million.
  • Positive Sentiment: Gross margin expanded to 70.5% from 65.3% a year earlier, while the company generated $5.5 million in GAAP operating income, a 15% adjusted EBITDA margin, and $5.1 million of free cash flow. Cash and equivalents ended the quarter at $549 million.
  • Positive Sentiment: BillionToOne highlighted several growth catalysts, including strong early adoption of Unity Confirm, the upcoming 130-gene Fetal Risk Screen, Northstar Origin, and a planned tumor-naive MRD launch by year-end. Management also expects the newly completed Epic Aura integration and expanded sales force to support health-system growth over the next two to four quarters.
  • Positive Sentiment: A peer-reviewed study supported Northstar Response’s utility in monitoring immunotherapy, and management expects to pursue MolDX Medicare coverage by year-end. Coverage could improve oncology reimbursement and economics, although the company said future MRD growth may temporarily dilute margins.
  • Negative Sentiment: The company held more than $10 million in claims pending in-network implementation by national payers, creating uncertainty around the timing and amount of future collections and contributing to lower quarterly true-up revenue. BillionToOne reiterated its 2026 revenue guidance of $450 million to $465 million and is not including additional true-up revenue in that outlook.
AI Generated. May Contain Errors.
Earnings Conference Call
Billiontoone Q2 2026
00:00 / 00:00

There are 10 speakers on the call.

Operator

Good day, and thank you for standing by. Welcome to the BillionToOne second quarter 2026 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that this conference is being recorded. I would now like to turn the conference over to your speaker today, Gabby Gable in Investor Relations. Please go ahead.

Speaker 1

Good afternoon, everyone. Thank you for participating in today's conference call. Joining me on the call from BillionToOne, we have Oguzhan Atay, Co-founder and Chief Executive Officer, and Ross Taylor, Chief Financial Officer. Earlier today, BillionToOne released financial results for the second quarter ended June 30, 2026. A copy of the press release is available on the company's website. Before we begin, I want to remind you that during this call, we may make forward-looking statements within the meaning of Federal Securities Laws. Such statements about future events may include statements about our financial outlook and performance, market size, our products and services, reimbursement coverage, future clinical performance, and other similar statements. We caution you that such statements reflect our current best judgment, and actual results may differ materially from those expressed or implied in any forward-looking statements.

Speaker 1

Risk factors that may cause our results to differ are discussed in our filings with the SEC, including our previously filed annual report on Form 10-K, our quarterly report on Form 10-Q, to be filed following this call, and the current report on Form 8-K filed today. Any forward-looking statement made during this call is made as of today, August 5, 2026. If this call is replayed or reviewed after today, the information made during this call may not contain current or accurate information. BillionToOne disclaims any obligation to publicly update any forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. With that, I will turn the call over to Ozan.

Speaker 2

Good afternoon, everyone. Thank you for joining our second quarter 2026 earnings call. I would like to start by thanking our patients and providers who trust us with incredibly important healthcare decisions and our employees who show up every day with tremendous effort to build and deliver superior tests that improve our patients' care and remove the fear of the unknown. Before diving into our quarterly results, I would like to remind you of the four pillars that I believe make us a different category of molecular diagnostics company. The first pillar is our revolutionary technology platform, enabled by our patented QCT, Quantitative Counting Template technology. Our technology achieves single-molecule level sensitivity and precision with next-generation sequencing. This has allowed us to build unique category-defining products in both prenatal and oncology.

Speaker 2

In turn, in our second pillar, our products have allowed us to scale rapidly from zero to $438 million in annualized revenue run rate in six years. We believe we are still in the early days, perhaps at less than 1% of what is possible, as we believe prenatal and oncology cell-free DNA testing can exceed an estimated $100 billion in the U.S. alone. Importantly, in our third pillar, with the higher signal-to-noise advantage that our unique technology offers us, and with our relentless focus on COGS reductions and ASP growth, we have been able to couple our rapid growth with a superior gross margin profile. We now have margins above 70%, with still significant room for expansion through ASP growth and COGS per test reductions.

Speaker 2

Finally, this superior gross margin, combined with a culture of fiscal discipline and efficient operations incorporating AI, has allowed us to achieve GAAP profitability. We have done this at a much lower scale than our public competitors, with an accumulated deficit that is approximately 10% of theirs. In summary, we continue to track toward our long-term goal, which has remained the same: to build a category-defining generational company, transform molecular diagnostics and the standard of care for millions of patients, and become a member of the S&P 500. Our second quarter performance was strong across all pillars as we delivered another quarter with high growth, excellent margins, and positive operating income and cash flow. I will cover each pillar in more detail, to summarize, we are launching new products both in prenatal and oncology, and we have published data that we believe will support MolDX coverage for Northstar Response.

Speaker 2

Our rapid growth continued with test volume up 35% year-over-year and revenue up 64% year-over-year. We maintained our superior gross margin profile, which was 70.5% in the quarter, an expansion of five percentage points year-over-year. Our gross margins stayed remarkably consistent in the past few quarters despite an increase in COGS per test as our mix shifts toward a higher proportion of oncology tests. Lastly, even as we accelerated our investments in commercial scale and R&D, we maintained a strong level of profitability, achieving $5.5 million of GAAP operating income, a 5% operating margin, and a remarkable 15% adjusted EBITDA margin. As a result, we increased our cash position to $549 million at the end of the quarter. Let me take you through the quarter pillar by pillar. Starting with our first pillar, our platform and products.

Speaker 2

In prenatal, Unity Confirm has seen strong adoption following the launch on May 28th. As a reminder, it is the first and only non-invasive confirmation assay for high-risk pregnancies. It captures and sequences intact circulating fetal cells to provide 100% fetal fraction, a fundamentally different category from conventional cell-free DNA tests. We launched it as a specialized follow-on for high-risk pregnancies identified on our Unity Aneuploidy Screen. Unity Confirm gives patients who cannot or choose not to proceed to invasive diagnostic testing a non-invasive option they didn't have before, at a sensitive time when options may feel limited. The early reception of Unity Confirm has been exceptional. Providers are already ordering Unity Confirm on more than 50% of their eligible high-risk Unity Aneuploidy patients. We also continue to enroll patients in what we believe is the largest prospective circulating fetal cell-based study ever conducted.

Speaker 2

In the meantime, Unity Confirm is opening doors even to no-see health systems that typically do not allow any sales reps. We expect its long-term impact for the Unity franchise to be significant, especially as future readouts from the study mature, and it is established as the next paradigm in non-invasive testing. Our prenatal product engine did not stop there. On August 17, we are expanding our UNITY Fetal Risk Screen to 130 genes, the largest panel on the market that doesn't rely on partner testing, by far leapfrogging competitive offerings. Approximately 50% of all providers prefer large panels for these inherited conditions. We believe that this expansion will meaningfully increase our serviceable market. The panel screens for prevalent actionable conditions selected from ACOG, ACMG, and RAST guidelines, and it reinforces Unity's position as the leader in cell-free DNA testing for recessive conditions.

Speaker 2

Turning to oncology, we generated important new clinical evidence this quarter. On June 24, we published a peer-reviewed study in the Journal of Liquid Biopsy validating Northstar Response for monitoring immunotherapy and immuno combination therapy. This study included 142 patients and more than 750 samples across two prospective cohorts and 12 tumor types. Molecular progression strongly predicted worse survival, notably a stronger predictor than imaging alone and stronger still when the two were combined. The test also separated radiographically stable patients into true responders and non-responders, further demonstrating value over standard of care imaging. This publication is designed to support our pursuit of MolDX Medicare coverage for Northstar Response in the IO and IO combination therapy settings. Since response accounts for almost two-thirds of our oncology test volume, this coverage remains one of our most meaningful catalysts and is still expected by the end of this year.

Speaker 2

Speaking of catalysts, we remain on track for our highly sensitive tumor-naive MRD launch by the end of the year as well. It is important to note that our liquid biopsy assays have a QCT failure rate below 1%, compared to 15%-30% typical of assays that require tissue sequencing. We are also updating Northstar Select on September 1st in two important ways. First, we are expanding the panel to 102 genes to cover recent and upcoming FDA therapy approvals, including the highly sensitive detection of MTAP copy number loss. MTAP loss is present in approximately 15% of all cancer patients and is the target of several promising ongoing clinical trials. As we previously discussed, copy number losses are extremely difficult to detect in liquid biopsy, a problem that our technology resolves.

Speaker 2

Second, we are launching Northstar Origin, a tissue of origin add-on, which we believe will deliver best-in-class performance. With higher call rates than any similar offering. Roughly 3% of patients present with cancer of unknown primary, which results in a lack of effective therapy options. Moreover, the percentage of patients with uncertain diagnoses can reach 10% in community oncology settings, especially when they do not have access to detailed pathology workups. Northstar Origin uses QCT-based molecular counting of methylation to deliver 91% top 3 and 86% top 1 accuracy in identifying the tissue of origin, helping these patients get to a diagnosis and effective therapy. Turning to our second pillar, scalable rapid growth. In the second quarter, total test volume grew 35% year-over-year to approximately 196,000 tests, up approximately 8,000 sequentially. Our growth was in line with our expectations for prenatal and above expectations for oncology.

Speaker 2

Importantly, we added approximately 70 sales representatives in the first half of the year, ahead of our plan, given the strength of our hiring pipeline. While this rate of hiring did have some impact on our short-term sales productivity, we expect our hiring to translate into faster growth exiting the year and into the early part of the next year, as these representatives become fully productive and penetrate the health systems, especially as these health systems also become EMR-integrated. Speaking of EMR integrations, we launched on Epic Aura platform in under five months, a record speed for any laboratory to launch on Epic Aura, and completed our first Aura health system integration in just two weeks from start to first test order. Epic Aura removes a critical barrier to health system adoption.

Speaker 2

It will still take time to convert health systems, since each health system's IT team must slot our integration into a roadmap that is often two to four quarters out. We expect the impact to be meaningful as we enter next year. Given how quickly our oncology tests are scaling, we also signed a lease for a dedicated 62,000-square-foot oncology production lab directly across from our existing prenatal production lab in Union City, California. Design and build-out are underway, with production expected by the end of 2027, and the facility is designed to support oncology capacity of approximately 5,000 tests per day over time. Looking at each product line, both prenatal and oncology contributed meaningfully to our growth. Prenatal revenue in the second quarter was $95.8 million, up 56% year-over-year, driven by strong commercial execution and rising ASPs.

Speaker 2

Oncology was even faster, with its revenue growing 176% year-over-year, nearly three times to $13.7 million, an annualized revenue run rate of approximately $55 million. Our total revenue performance in the quarter demonstrates the remarkable growth we have delivered in the last six years, rising from approximately zero to $438 million in annualized run rate. Total revenue was $109.4 million in the quarter, representing 64% year-over-year growth, driven by strong year-over-year increases in both tests delivered, up 35%, and ASP, up 21%. I would note that while reported revenue was only slightly up sequentially, that understates our underlying momentum. Excluding True-Up revenue, total revenue grew 8% sequentially quarter-over-quarter. The sustained level of growth continues to be an important part of our pillars. Moving to our third pillar and starting with our ASPs. Overall ASP increased 21% year-over-year to $551 per test.

Speaker 2

ASP did decline about $20 sequentially. This is simply a result of True-Up timing. True-Up was $49 per test in the first quarter versus $14 per test in the second quarter. Importantly, excluding the True-Up's impact, ASPs increased $15 quarter-over-quarter. During the quarter, through a mutual agreement, we held more than $10 million of claims while waiting for the in-network implementation of our codes by national payers. This had a temporary impact on cash collections, slightly impacted the ASPs that we could realize, and potentially reduced the True-Up revenue for the quarter. We expect this to resolve through the second half of the year as these claims are processed and paid. The more important underlying signal is this: excluding True-Up, overall ASP continued to increase sequentially, driven by a record number of payer contracts signed in the quarter.

Speaker 2

In addition to driving ASP growth, we have remained committed to our operating philosophy of continuous improvements to reduce COGS per test. Overall COGS per test was $161 in the second quarter, up from $152 in the first quarter and $156 a year ago, with the increase driven by the shift in our volume mix towards oncology. Underneath that mix effect, the operational discipline is very much intact. Prenatal COGS was approximately flat sequentially, even with the Unity Confirm launch, and we achieved COGS reductions of more than 10% quarter-over-quarter in oncology. As oncology continues to grow faster than prenatal, we expect overall COGS per test to rise gradually over time.

Speaker 2

Result, our gross margin held at 70.5% in the second quarter, approximately five percentage points higher year-over-year, driven by higher ASPs, even as our earlier-stage, lower-margin oncology tests grew more than 100% during this same period. Importantly, small quarter-over-quarter differences in gross margin over the past four quarters are almost entirely attributable to quarterly true-up differences. Excluding true-up, our gross margin has been remarkably stable at around 70%, even with the significant mix shift towards oncology. By continuing to drive ASP increases across both prenatal and oncology, and by continuing to reduce COGS in oncology, we expect to maintain strong gross margins at or above 70%, even as oncology becomes a much bigger part of our overall business. With that, I will turn the call over to Russ to review our financial results and guidance before I conclude.

Speaker 3

Thank you, Ozan. Ozan mentioned, in Q2 of 2026, we had a strong performance that combined 64% year-over-year revenue growth with a 5% GAAP operating margin and a 15% adjusted EBITDA margin. Total revenue in the second quarter of 2026 was $109.4 million, compared to $66.6 million in the second quarter of 2025, representing an increase of 64%. Both our prenatal and oncology product lines demonstrated strong growth in the quarter. Prenatal revenues, consisting of clinical testing revenues and revenues from clinical trial support and other services, increased 56% to $95.8 million in Q2. Oncology revenues increased 176% to $13.7 million in Q2 of 2026 versus Q2 of last year. Our total revenue growth was driven primarily by test volume growth across both prenatal and oncology, as well as continued expansion of both our prenatal and oncology ASPs year-over-year.

Speaker 3

True-up revenue was $2.8 million in the second quarter of 2026, compared to $9.2 million in the first quarter of 2026 and $2.1 million in the second quarter last year. Excluding true-up revenue, total revenue grew 8% sequentially versus the first quarter of 2026. Gross profit in the second quarter of 2026 was $77.1 million, compared to $43.5 million in the second quarter of 2025, resulting in a gross margin of 70.5% in the second quarter of 2026 versus 65.3% in the second quarter last year. The increase in gross margin was primarily attributable to continued increases in our overall ASP. Total operating expenses were $71.6 million in the second quarter of 2026, compared to $45.1 million in the comparable prior year quarter, representing an increase of 59%.

Speaker 3

Within total operating expenses, R&D expense was $17.3 million in the second quarter of 2026, compared to $11.8 million in the comparable prior year quarter. SG&A expense was $54.3 million in the second quarter of 2026, compared to $33.3 million in the comparable prior year quarter. Operating income was $5.5 million in the second quarter of 2026, compared to an operating loss of $1.6 million in the second quarter of 2025. Our Q2 operating profit margin was 5%, compared to the 16% operating margin we delivered in the first quarter of 2026. Slightly over half of the difference in operating profit compared to Q1 was due to the difference in true-up revenue between the two quarters. The remaining portion was driven by continued investment in our commercial and R&D organizations, as well as faster growth in oncology.

Speaker 3

Adjusted EBITDA in Q2 represented a 15% margin. Net income available to common shareholders was $8.1 million, or $0.15 per diluted share in the second quarter of 2026, compared to a net loss of $0.2 million for the same period in 2025. Looking at the cash flow statement for the second quarter, the cash flow from operations was $9.1 million, while capital expenditures were $4.0 million. This resulted in free cash flow of $5.1 million in the second quarter of 2026. We are well capitalized with a very healthy balance sheet. We ended the second quarter with $549 million in cash and equivalents. We believe our balance sheet positions us for strong growth moving forward, particularly given our intent to continue to manage the business for profitability and positive cash flow. Finally, I will provide an update on our full year guidance for 2026.

Speaker 3

We are reiterating our 2026 total revenue outlook of $450 million to $465 million, representing growth of approximately 48%-52% compared to full year 2025. We also expect to operate the business such that it will continue to generate profitability similar to current levels, even with significant continued investments. I will now turn the call back to Ozan to conclude.

Speaker 2

Thank you, Ross. In summary, we are transforming healthcare one molecule at a time, one patient at a time. My confidence, as always, is rooted not in any single element, but in the compounding nature of what we have built. Each product we launch makes our platform more powerful, from Unity Confirm to our expanded fetal risk screen to Northstar Origin, and each study we publish further validates the clinical utility of our technology as our Northstar Response publication did this quarter. Our financial profile remains best in class for our industry. Once again, this quarter, we demonstrated strong revenue growth to $438 million in annualized run rate. We held gross margins above 70%, and we show that rapid growth does not have to come at the expense of profitability.

Speaker 2

We are powered by a team of highly motivated, mission-driven individuals who show up every day with a shared purpose to make a meaningful difference in patients' lives. Our ambition remains clear: to transform molecular diagnostics, build a category-defining company, and earn a place in the S&P 500. We are pleased with our progress and look forward to updating you as the year progresses. Thank you. Over to the operator.

Operator

Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered or you wish to remove yourself from the queue, please press star one one again. We will pause for a moment while we compile our Q&A roster. Our first question comes from Mark Massaro with BTIG. Your line is open.

Speaker 4

Hey, guys. Thank you for taking the questions. Maybe the first one, obviously it looks like the true-up number dropped by approximately $6 million or so, in Q2 relative to Q1. I guess, Ozan and Ross, I just wanted to check if, ex true-ups, just double-checking that your prenatal test revenue would've increased sequentially. Is that correct?

Speaker 2

That is correct, Mark. Both test volumes and ASPs for prenatal ex true-up actually increased, so the combination increased significantly as well. Ross, do you want to comment on the actual numbers?

Speaker 3

For the actuals.

Speaker 2

On the prenatal revenue.

Speaker 3

Prenatal revenue, honestly, Mark, you can assume that virtually all of the True-Up is related to prenatal. We do have a chart, I think it's slide 14 in the deck, where I think you can make some pretty good estimates as to where the prenatal revenue is ex True-Up. Sorry, I don't have the actual numbers right in front of me, and we haven't given out those specifics in the past, but it is up more than a couple million dollars sequentially ex True-Up.

Speaker 4

I do understand you guys operate in a competitive market. There are many other players operating in the space. I know you've been taking share for years now. I guess, can you just speak to what you might be seeing in the competitive market? Related to that, my last question, you did accelerate hiring of sales reps, it sounds like, relative to your plan. Just curious if any of those stepped-up hires might have something to do with the competitive environment.

Speaker 2

Second quarter volumes were almost entirely as we expected in the quarter, Mark. We did grow as much as we expected in prenatal and slightly above expectations in oncology with respect to test volume. We weren't.

Speaker 2

Doing the hiring due to the competitive environment, but actually due to continued opportunity that we have, especially with respect to health systems. We are managing the business for more medium to long-term growth. There are maybe about 4 factors that we believe that will come together in the next 2 to 4 quarters that will really derive significant growth in prenatal. The hiring of sales reps is one, but of course, that takes time for them to be onboarded and be productive and start penetrating health systems. Just as we onboard these sales reps, Unity Confirm is opening up doors to new health systems. We believe that will be further accelerated with more data readouts that we'll have in the next 2 to 3 quarters. Third, we completed the onboarding to Epic Aura platform faster than any other lab.

Speaker 2

That will take 2 to 4 quarters to see a significant impact. We are executing extremely well there. Finally, I want to really underline the importance of the 130 gene Fetal Risk Screen launch. This is going to be a significant competitive advantage, but it will make an even bigger impact in health systems where they want a portfolio of offerings, including these large panels. We really believe that these 4 factors are going to come together in the next 2 to 4 quarters to create really an engine of health system adoption that can derive substantial volume growth.

Speaker 2

What we are really doing in the first half of the year is to, with the hiring pipeline that we have been able to generate, post going public, we have accelerated hiring so that all of these reps are joining and getting onboarded at the right time, so that as all of these opportunities are coming together, we have a really strong chance of converting these test volumes from health systems.

Speaker 3

Maybe just a quick follow-up, Mark. I did look up some of the numbers to try to answer the earlier part of your question. I'm not going to get overly specific, but I think quarter to quarter, we did see about a $4.5 million increase in prenatal revenues. If you exclude the true-up, it's about 5% growth sequentially. Just to get a little more specific.

Speaker 4

That's really helpful. All right. Thanks, guys.

Operator

One moment for our next question. Our next question comes from Dan Arias with Stifel. Your line is open.

Speaker 5

Hi, guys. Thanks for the questions. Oguzhan, I think you alluded a little bit to the volume trend there. Can you maybe just add some additional color to the trend sequentially in oncology if you strip out the ASP dynamic? To what degree was quarterly volume up as a trajectory? Then how should we think about things for the second half of the year relative to the way that maybe you were thinking about things earlier in the year?

Speaker 2

ASPs for oncology actually did not change in quarter-over-quarter. We are waiting and working on the MolDX coverage of Response. Until that happens, ASPs are pretty stable in oncology. If you look at the chart that Ross referred to, True-Up for oncology was both quarters was almost very minimal as well. All of the growth that you are seeing sequentially is coming from the test volume growth in oncology. Oncology test volumes are doing really well, even ahead of our expectations. That is one of the reasons that we have started to build this oncology lab to I think we are seeing that we are winning in the market with the products that we have, and as we are adding more competitive components to our oncology products, we are very confident on the trajectory.

Speaker 5

Do you think that trajectory will lead to sequentially up volumes each quarter? I mean, in 4Q can be a little bit of a funky quarter, but you do sound like you have good momentum. Not to put too fine of a point on it, but I'm just curious whether 2Q to 3Q can be up and then 3Q to 4Q can be up as well so that we model this thing correctly. Thank you.

Speaker 2

I think 2Q to 3Q, we certainly see very strong momentum. As you mentioned, 3Q to 4Q tends to be a little bit of a, in terms of number of providers that we add, it tends to be a strong quarter, but in terms of the number of accessioning days and how the test volumes and revenues translate, it tends to be a little bit of a shorter quarter. We are seeing that our oncology is progressing ahead of the plan.

Speaker 5

Okay. Thank you.

Operator

One moment for our next question. Our next question comes from Subbu Nambi with Guggenheim. Your line is open.

Speaker 6

Hi, this is Ricky on for Subbu. Thanks for taking our questions. You gave some color on the Unity Confirm launch and adoption and the 50% opt-in for the eligible results. While it's still early in the launch, do you think that's already starting to drive share gains in NIPT?

Speaker 2

I think it is certainly opening up doors, and it is reducing the tendency for at least some accounts to split. I think it is rare for prenatal clinics to split their test volumes over multiple labs, Unity Confirm does prevent that splitting, I think, more significantly. I think it is going to be a long-term driver rather than a much shorter-term driver, particularly because a lot of the remaining opportunities help systems, and they don't get onboarded within one or two months. Unity Confirm launched in May 28th, and it is already seeing strong adoption, and it's already getting us through the door in these health systems. These health systems require many other things like EMR before they can switch to another lab.

Speaker 2

This is why we are really confident that all of these factors are coming in together to drive an acceleration of growth, especially as we look to growth next year.

Speaker 6

Got it. That's helpful. You also announced the expanded 130 gene risk screen panel. Just wondering if there's any change to how you're thinking about the economics per test there, either in terms of reimbursement or the COGS. Thanks.

Speaker 2

We do not expect much of a difference in the economics with respect to 130 gene panel. It's not going to be immediately a large portion of our test volume either, but I think it is going to enable us to get into some of these health systems and other places that strongly prefer existence of a large panel. Because this is the only large panel with the cell-free DNA offering, I think it is going to be a big competitive advantage for us.

Operator

Thank you. One moment for our next question. Our next question comes from Tycho Peterson with Jefferies. Your line is open.

Speaker 7

Hi, this is Noah Kavan for Tycho. Thanks for taking our questions. Wanted to ask on the Northstar Origin announcement today. What percentage of your patient base do you think is relevant for potential attach here? How are you assuming that the economics pan out here over the next couple of quarters?

Speaker 2

Northstar Origin will not necessarily change the economics of the product that much. It is going to, I think, derive incremental adoption of our products. In particular, this has been an increasingly important point of discussion with providers that we are seeing. It is, I think, it is becoming very important, especially in community oncology settings, where the percentage of cases is not 3%. CUP cases, the truly unknown primary case is about 3%. That can be an important reason for some of the oncologists to prefer one platform over others. We are also seeing that in the community oncology settings, this problem is more than a 3% problem, especially as they do not have access to all these pathology workups. There, one in 10 patients might actually have an uncertain diagnosis.

Speaker 2

That really makes the next steps very difficult for these patients. I don't think it will change the economics, but it will be another driver of adoption, similar to what we have seen so far with our ChIP-seq as well as the PGx offerings that we launched in the first quarter.

Speaker 7

Thanks. For my follow-up here, one of your competitors noted incremental payer friction in prenatal testing, more so on the carrier screening side of things. Curious if there's anything you can comment on there, if you're seeing any friction there.

Speaker 2

We are not seeing any friction there, but that is also because we have been, I think, very intentional about how we went about coding in this particular field. We bill almost vast majority of our tests using the PLA codes that we have obtained, rather than relying on some of the bundled or stacked billing that tends to be more common. This is something that we have observed, especially with some of the national payers requiring these panels not to be unbundled and billed with separate codes. We were able to get our PLA code effective January 2025. We do not have the problem that I think some of the other prenatal testing companies might have with respect to friction.

Speaker 7

Thank you.

Operator

One moment for our next question. Our next question comes from David Westenberg with Piper Sandler. Your line is open.

Speaker 8

Hi. Thank you for taking my question. I wanted to ask on, if you look year-over-year, you actually on slide 14, and thanks, that's a lot of data. I think Ross mentioned $4.5 million sequentially revenue. It looked year-over-year, it looks like the same. I'm just kind of curious. I know Natera reports seasonality in Q2. I know traditionally you guys have said you haven't seen it, but you were a lot smaller percentage of the market. Do you think you might have additional seasonality in Q2 in non-prenatal testing and that maybe it would follow the same exact trends where you'd see Q3 and Q4 potentially doing better?

Speaker 2

Certainly, there are fewer patients that are getting tested in the accounts that we already have. There is, I think, certainly a small impact with respect to seasonality. We do not model that seasonality, and we were able to be ahead of our plan even with that seasonality. We didn't want to refer to seasonality in a quarter where we were able to be at or ahead of what we had modeled without the seasonality. It is certainly true. If you look at the number of pregnancies and births or even the number of tests that you get from accounts that you know you are getting 100% of the test volume, there is a drop in Q2 in terms of the test volume. That seasonality, I think, is real.

Speaker 2

I think the effect tends to be relatively small, but I think as you pointed out, as we get larger, there is certainly the seasonality can have a bigger impact. We didn't want to refer to it because we didn't model it that way.

Speaker 8

I just want to talk about the disclosed claims of $10 million, I think, pending in Q2 network by national payers that you suppressed up to your true-ups. Can you help us bridge this? Once those specific claims are processed, how does that $10 million flow through? I just want to make sure, clarification, I think it's always been the case, but you are not modeling true-ups in the back half with your guidance, correct? I think that's been how you've always done it, but just want to confirm. Thank you. Thank you guys so much.

Speaker 2

Ross, do you want to take the true-up question, and then I'll take the $10 million question?

Speaker 3

Sure. Yeah, that's correct regarding the true-ups and our guidance. David, we really are not including any true-ups in our kind of forward-looking guidance here beyond what we've already reported.

Speaker 2

With respect to the $10 million of health claims, while a portion of it is embedded in realized revenue, as we are required under ASC 606, we have been very conservative in how we approach this, there is meaningful upside if all these back claims process and pay. We want to be conservative here. We don't yet know the full timing or amount of what will ultimately be collected on the claims held. That is why we are maintaining guidance until that is clearer.

Operator

Thank you. One moment for our next question. Our next question comes from Casey Woodring with J.P. Morgan. Your line is open.

Speaker 9

Great. Thank you for taking my questions. Maybe just one. You talked a lot about launching on Epic Aura in the quarter and that you've integrated faster than any other lab. Is there a scenario where you can be fully integrated by the time we enter 2027? You talked about a meaningful impact next year. Maybe any way to quantify what the impact would look like from full integration in your base case?

Speaker 2

Thank you, Casey. We are fully integrated with Epic Aura. The issue is that even after the full integration with Epic Aura, there is still work that each health system needs to do to turn on their Epic Aura and make sure that everything goes back and forth correctly with respect to orders and test results. Typically, a time that the lab takes to integrate with each health system separately, like uniquely, still tends to be with many labs, six months or more. This is what we heard in the field. Our integrations have been lightning fast in comparison. Our first integrations have been two to four weeks, which is a record time even for these individual health system integrations. We are using that to try to get these health systems to prioritize our integrations and slot the kind of individual integration into their roadmap.

Speaker 2

It can still be 2 to 4 quarters ahead. As soon as we are green-lighted, we can do these integrations extremely fast. Once they are done, I think we see meaningful test volume growth. Just to give you a sense, once a health system is onboarded, each one can be anywhere between 1 to 3,000 tests per quarter. The issue tends to be, this tends to be a funnel, and the funnel really started as of May or June. As we are getting into their roadmaps, I think it is going to be slow initially, and it will accelerate over time pretty significantly. In terms of how much test volume that it is going to incrementally bring, that is very difficult to say because, again, it is not about our own teams and what they can do.

Speaker 2

It is how many health systems that we can convince to put our individual integration into their roadmap.

Speaker 9

I see. That's helpful. Then maybe just one on the gross margin profile. You did 70.5% here. How should we think about that progression once Northstar Response is reimbursed? Kind of like what's the forward-looking trajectory there once you're able to turn that on? Thank you.

Speaker 2

Thank you. That's a good question. One way to think about this is that we are really managing the business for balancing that growth and with gross margin and profitability. Even when Northstar Response comes in with the MolDX coverage, we will be launching MRD at that time, and we are not going to be throttling the MRD test volume. What that will mean is that, as the Northstar Response ASPs goes up and as our oncology gross margins increase, we will have dilutive gross margins that will be coming from that growth that we will see from MRD. The way that we are thinking about this is that if the business operates as planned and modeled, we expect to maintain 70% gross margin, regardless of the mix or growth of oncology or lumpiness of the True-Up revenue.

Speaker 2

This is what we have seen in the last four quarters, where the gross margin was 70% without True-Up every quarter despite the really fast growth that we had in oncology. I think we will continue to see that and we will continue to, I think, manage the business to be above 70% gross margins by increasing ASPs in different product lines and reducing COGS, especially in oncology. That said, an unexpected acceleration in oncology business far beyond what we are modeling could even result in gross margins to be temporarily below 70%. The important thing here is that every product is designed to generate 70%-80% gross margin in the long term with scale and appropriate coverage.

Speaker 2

It is just that, as some of our products that are more mature that get closer to 80% gross margin, we are building and launching new products that become dilutive to gross margin. The balance becomes something in the range of 70% gross margin.

Speaker 9

Understood. Thank you.

Operator

I'm not showing any further questions at this time. As such, this does conclude today's presentation. Thank you for your participation. You may now disconnect and have a wonderful day.

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