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Good day, and thank you for standing by. Welcome to the Q2 2025 Labcorp Holdings Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Christin O'Donnell, Vice President of Investor Relations. Please go ahead.
Thank you, operator. Good morning, and welcome to Labcorp's Second Quarter 2025 Conference Call. As detailed in today's press release, there will be a replay of this conference call available. With me today are Adam Schechter, Chairman and Chief Executive Officer; and Julia Wang, Executive Vice President and Chief Financial Officer.
This morning, in the Investor Relations section of our website at www.labcorp.com, we posted both our press release and an Investor Relations presentation with additional information on our business and operations, which include a reconciliation of the non-GAAP financial measures to the most comparable GAAP financial measures, both of which are discussed during today's call. Please see the Use of adjusted measures section in our press release and Investor Relations presentation for more information regarding our use of non-GAAP financial measures. Additionally, we are making forward-looking statements.
These forward-looking statements include, but are not limited to, statements with respect to the estimated 2025 guidance and the related assumptions, the projected impact of various factors on the company's businesses, operating and financial results, cash flows and/or financial condition, including global economic and market conditions, future business strategies, expected savings, benefits and synergies from the LaunchPad initiative and from acquisitions and other strategic transactions and partnerships, the completed holding company reorganization and opportunities for future growth. Each of the forward-looking statements is subject to change based upon various factors, many of which are beyond our control.
More information is included in our most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and in the company's other filings with the SEC. We have no obligation to provide any updates to these forward-looking statements even if our expectations change. Now I'll turn the call over to Adam Schechter.
Thank you, Christin, and good morning, everyone. We appreciate you joining us today to discuss our second quarter financial results and progress on our strategy. During the quarter, we delivered double-digit top line growth and solid margin expansion. Our financial results reflect continued strength of our Diagnostic Laboratories business and momentum in our biopharma laboratory services business.
Enterprise revenue reached $3.5 billion, representing 10% growth versus last year. Diagnostics revenue grew 9%, reaching $2.7 billion, driven equally by organic growth and acquisitions. Margin improved slightly, including the impact from Invitae. And Invitae continues to perform very well and remains on track.
BLS delivered strong revenue performance and grew 11% or 8% constant currency to $785 million, while margins improved 50 basis points. Central Laboratories grew 8% or 4% constant currency and early development grew 20% or 18% constant currency. Importantly, the quarterly book-to-bill was strong at 1.18 with a trailing 12-month of 1.11. Enterprise margin improved 20 basis points and adjusted earnings per share of $4.35 grew 10% year-over-year. Based upon our performance year-to-date and our expectations for the second half of the year, we are raising our enterprise guidance.
Julia will provide more details on our results and full year 2025 outlook in just a moment. But first, I'll highlight how our strategy is continuing to enable our growth and our leadership in the industry. First, in our Diagnostics Laboratory segment, one of our objectives is to be the partner of choice for health systems and regional local laboratories. By focusing on these customers, we've expanded our presence in hospitals, we've strengthened customer relationships, and we've broadened patient access in key geographies, which helps improve patient outcomes and also accelerate growth.
Through technology solutions such as Labcorp Diagnostic Assistant, we've been able to provide data and analytics and important insights to our customers. Many of these customers are thought leaders in specialty areas, and our collaboration with them mutually benefits our collective scientific expertise. In the quarter, we announced acquisitions and partnerships with several health systems and regional local laboratories, including acquiring key clinical and anatomic pathology assets from Incyte Diagnostics in the Pacific Northwest; extending our long-term agreement with UHealth, the University of Miami Health System to serve as their preferred laboratory partner; progressing our acquisition of select oncology and clinical testing assets from BioReference Health.
The transaction is on track to close in the second half of 2025. And subsequent to quarter end, we announced an agreement to acquire select assets of the outreach business from Community Health systems across 13 states. CHS is one of the largest health care companies in the United States. Looking ahead, we have a strong deal pipeline, and we look forward to sharing our progress in the coming quarters. Second, we continue to launch new and innovative tests in our specialty focus areas, including oncology, women's health, neurology and autoimmune diseases.
This focus has helped to accelerate our growth in those categories as well as across our core testing portfolio as physicians utilize our broad test menu to meet the comprehensive needs of these patients. We have leading expertise, both scientifically and in the marketplace in these areas, which also complements our BLS business. We partner with many pharmaceutical and biotechnology companies as they develop novel therapeutics as well as products which require companion diagnostics. In the second quarter, we made important progress launching innovative tests in specialty areas and introducing new capabilities to our customers.
We expanded our oncology portfolio with new solutions for cancer detection, diagnosis and monitoring. Key launches include expansion of our MRD portfolio through Labcorp Plasma Detect, a liquid biopsy test that assesses colon cancer recurrence risk and PGDx elio plasma focus Dx, the first and only FDA-authorized pan-solid tumor liquid biopsy test for targeted treatment guidance. We continue to advance our leading position in Alzheimer's disease and plan to offer Fujirebio's FDA-cleared biomarker test that aids in diagnosing the disease in the coming weeks. We also expanded our consumer offerings.
We launched several consumer-initiated tests through Labcorp OnDemand, including tests that measure an individual's cortisol and leptin levels. We also introduced a new and improved Ovia app, providing women with a single platform to support their health journey. We introduced Labcorp Whole Health Solutions for functional medicine, integrative medicine and primary care practices. The solution offers specialized test panels and a test menu of more than 1,000 scientifically backed biomarkers for cardiometabolic health, hormones, micronutrients, longevity and wellness.
Finally, our central laboratory business added digital pathology capabilities, including advanced image scanning to preserve critical sample data and AI-powered solutions to provide analysis on large data sets instantly. These enhancements complement our existing global anatomic pathology capabilities our full-service tissue-based testing and our companion diagnostic development across cancer, NASH and other diseases. And third, we are focused on enhancing customer and employee experiences and leveraging technology to drive ongoing operational and process efficiencies. We're using digital technologies and AI to drive improvements in areas such as Net Promoter Score, our LaunchPad initiatives and margins.
We expect to see continued benefits as we incorporate technology across our business. To summarize, we delivered very strong results in the quarter and continue to make significant progress on our strategy. We remain committed to delivering sustained value to our customers, our employees and our shareholders. With that, I'll turn the call over to Julia to discuss our financial results and 2025 outlook in further detail.
Thank you, Adam. As Adam just shared in the opening remarks, we delivered strong underlying performance from both segments in the quarter as we have continued to win in the marketplace and execute against our strategy. The strong quarter, combined with favorable foreign exchange rates, enables us to raise our full year guidance. Now let me start with a review of our Q2 financials.
Revenue for the quarter was $3.5 million, an increase of 9.5% compared to last year, driven by organic growth of 5.4%, the impact from acquisitions of 3.5% and foreign currency translation of 0.6% Operating income for the quarter was $395 million or 11.2% of revenue, which is 15.1% on an adjusted basis. During the quarter, we had $69 million of restructuring charges and special items, primarily related to acquisitions and LaunchPad initiatives. Excluding these items and amortization of $68 million, adjusted operating income in the quarter was $532 million or 15.1% of revenue compared to $480 million or 14.9% of revenue last year.
The increase in adjusted operating income was due to organic demand as we leveraged well on our revenue growth. Our LaunchPad initiative continues to be on track in the quarter, which offset typical increases in personnel costs. Despite a 30 basis point headwind from Invitae, adjusted operating margin increased 20 basis points. The adjusted tax rate for the quarter was 23.1% compared to 23% last year.
We continue to expect our adjusted tax rate for full year 2025 to be approximately 23%. Net earnings for the quarter were $238 million or $2.84 per diluted share. Adjusted EPS was $4.35 in the quarter, up 10.4% from last year as we leveraged well our revenue growth. Operating cash flow was $621 million in the quarter compared to $561 million a year ago.
Capital expenditures totaled $78 million in the quarter. For the full year, we continue to expect capital expenditures to be approximately 3.8% of revenue. Free cash flow for the quarter was $543 million compared to $433 million last year. This $110 million increase in free cash flow was driven by higher earnings and the timing of capital expenditures.
During the quarter, the company invested $25 million in acquisitions and partnerships, paid out $60 million in dividends and repurchased $200 million of stock. At quarter end, we had $647 million in cash, while total debt was $5.6 billion. Our debt leverage as of quarter end was 2.5x gross debt to trailing 12-month adjusted EBITDA at the low end of our targeted leverage range of 2.5x to 3x. Now I will review our segment performance, beginning with Diagnostics Laboratories.
Revenue for the quarter was $2.7 billion, an increase of 8.9% compared to last year, with organic growth of 4.5% and acquisitions of 4.5%, partially offset by foreign currency translation of 0.1%. Total volume increased 4.9% compared to last year, with organic volume contributing 3.4% as we continue to execute our strategy and drive strong demand. Acquisitions contributed 1.5%. Price/mix increased 4% versus last year due to organic growth of 1.1% and acquisitions of 3%, partially offset by foreign currency translation of 0.1%.
Organic price/mix was up due to mix as we benefited from an increase in test per accession and lab management agreements. Diagnostics adjusted operating income for the quarter was $483 million or 17.6% of revenue compared to $442 million or 17.5% of revenue last year. Adjusted operating margin was up 10 basis points. We continue to be pleased with the progress we are making in Invitae, which will annualize next quarter.
Invitae remains on track to achieve 10% revenue growth and to be slightly accretive for full year 2025. Excluding the impact of Invitae, margins would have been up approximately 50 basis points. Now I will review the segment performance of Biopharma Laboratory Services or BLS. Revenue for the quarter was $785 million, an increase of 11% compared to last year due to an increase in organic revenue of 7.8% and foreign currency translation of 3.2%. In constant currency, Central Labs revenue was up approximately 4%, while early development was up approximately 18%.
The growth in early development was primarily driven by a relatively easy compared to prior year as well as timing of study starts. We still expect both businesses to grow in the mid-single digits on a constant currency basis for the full year, with early development facing more challenging year-over-year comparisons, particularly in the fourth quarter. BLS adjusted operating income for the quarter was $123 million or 15.7% of revenue compared to $107 million or 15.2% of revenue last year. Adjusted operating income and margin increased primarily driven by organic demand and operating efficiencies.
We ended the quarter with a backlog of $8.7 billion, and we expect approximately $2.7 billion of this backlog to convert into revenue over the next 12 months. Our segment quarterly book-to-bill was strong at 1.18, bringing the trailing 12-month book-to-bill to 1.11. The strength was driven by several large study awards in central labs. Now I will discuss our updated 2025 full year guidance, which assumes foreign exchange rates effective as of June 30, 2025, for the remainder of the year. The enterprise guidance also includes the impact from currently anticipated capital allocation, utilizing free cash flow for acquisitions, share repurchases and dividends.
Our guidance has taken into account various scenarios as the macro and regulatory landscape continues to evolve. We are raising guidance for enterprise revenue, adjusted EPS and free cash flow, primarily driven by currency as well as the underlying strength of our businesses. We raised the 2025 enterprise revenue guidance by 70 basis points at the midpoint and narrowed the growth range to 7.5% to 8.6% when compared to 2024. Diagnostics continues to execute well in the marketplace. We raised Diagnostics revenue guidance by 40 basis points at the midpoint and narrowed the growth range to 7% to 8%.
In BLS, we increased the midpoint by 280 basis points due to the favorable impact of foreign currency and narrowed the growth range to 6.1% to 7.5%. We continue to expect full year enterprise margins to increase with margins improving in both Diagnostics and BLS in 2025 versus 2024. For Diagnostics, we expect margin expansion in the second half of the year versus prior year. For BLS, we expect margins to be stronger in second half than first half, albeit overlapping a stronger prior year comparison. Our guidance range for adjusted EPS is $16.05 to $16.50 with an implied growth rate at the midpoint of 12%.
As compared to our prior guidance, we have narrowed the range and raised the midpoint by approximately $0.23, benefiting from both currency and strength in our underlying businesses. Our free cash flow guidance range is $1.125 billion to $1.275 billion. We raised the midpoint by $25 million versus prior guidance. And due to normal seasonality, we expect to generate the majority of free cash flow in the second half of the year.
In closing, we continue to be encouraged by the strong performance across both business segments this quarter. The results reflect the effective execution of our strategy, the resilience of our operations and the dedication of our teams across the organization. As we look ahead, we remain confident in our ability to deliver sustainable growth and long-term value for our shareholders. Operator, we will now take questions.
[Operator Instructions] And our first question comes from Michael Cherny of Leerink Partners.
Congrats on a nice quarter. Maybe if I could just dive in a little bit on the volume dynamics and mix. I mean it seems like everything is fairly broad-based, Adam. Is there anywhere that you think you're pushing harder relative to customer base, payer mix, test type that could be more of, call it, an offensive approach to growth?
I'm just trying to parse through what exactly is going on in terms of driving the stability of growth this year, given that I know there's a number of potential moving pieces on the regulatory side that has been a big question for volumes for next year and beyond. So if we could parse those 2 pieces together, that would be great.
Yes, we'll do. And first of all, we appreciate the congratulations. It was a very strong quarter. And we saw the strength across both the diagnostics and the BLS business, which gives us a lot of momentum for the second half of the year as we go into next year.
Specific to your question on Diagnostics, the revenue was $2.7 billion, about 10% growth. But I think that the important thing is to look at the volume and where the growth came from. So about half of the 9% growth came from organic growth and about the other half, 4.5% came from acquisitions. So then I look separately at what was volume.
Overall, volume was up about 5% and then price/mix was up 4%. And then I take it to organic volume. If you look at organic volume, it was up about 3.5%. And I think that shows the strength of the underlying growth that we have.
Historically, that growth was 1% to 2%. So I do think we're seeing some accelerated growth. I think the accelerated growth is coming from several areas. One is the hospital regional local laboratory deals that we're doing are serving us well.
It expands access in the hospitals and the surrounding geographies. But I think when you win those hospital deals, the access in those geographies works to your benefit and you actually gain share. The second thing is the focus on our specialty products in the areas of oncology, neurology, autoimmune disease and neurology. Those areas are growing 3 to 4x faster than the overall diagnostic market.
And by focusing on those areas, you not only do well in those areas, -- but typically, those patients have more severe disease. And with more severe disease, physicians typically look for more tests in order to understand the diseases. So therefore, the routine tests that we do actually grow faster when you have a focus on the specialty areas. And I think those 2 things are helping us accelerate our growth faster than you would expect, which gives me a lot of -- gives us a lot of momentum going into 2026.
Our next question comes from Ann Hynes of Mizuho.
I just want to ask about the legislative and regulatory outlook. Obviously, there's a lot of changes coming over the next few years. Maybe how we should think about PAMA going into 2026. Do you think the risk has increased of those cuts coming back? And just on the legislative front, as time goes by, it probably seems clear that the ACA subsidies are not being extended.
How do you think those enhanced subsidies have positively impacted your business? And how should we view the risk in 2026? And just on the Medicaid side, could you remind us what Labcorp's Medicaid exposure and how changes to enrollment over the next few years could impact you?
Yes. So let me start overall with how I think about the momentum we're going into the year next year with. And I think that the strength that you see in the quarter is going to serve us well. As I look at the legislative changes and you look at the one beautiful bill, you look at PAMA and so forth, I look at them individually.
So let me start with PAMA. PAMA, we are continuing to work with ACLA, the trade organization to try to get legislation approved that actually would be more apt to what they were trying to achieve with PAMA in the first place. And we're going to continue to work on a legislative solution. If that doesn't happen, we'll continue to seek ways to see if it can be delayed again so that we can get appropriate legislation approved, of which we have very strong support from both Democrats and Republicans.
If the delay doesn't occur, then we could also work to see, is there a way to ensure that the appropriate data is available to help calculate PAMA in the way which it was intended to be calculated, meaning that you need more data than just some of the laboratories. You need a lot of the hospital laboratories to get all the data you need. All 3 of those things are things that we'll be working on as we go through this year. In my base case, I've always said, assume PAMA comes next year.
And I've said that for the last probably 5 years now. And we build our base case that it's coming because we don't know if any of these other strategies will actually occur. If PAMA does come next year, it will be about $100 million impact top and bottom line, of which we've work hard to offset as much of that as we possibly could through things like LaunchPad and even going further than what we've done with LaunchPad. Separate and distinct from that, when I think about other legislation, I would say, in broad terms, we see some tailwinds and we see some headwinds.
But if you look at it altogether and you look at all the different scenarios for our business, we think it's manageable. First of all, if you look at lab testing, it's a very small fraction of U.S. health care spend, but it's an essential tool and it's used in almost every health care decision. So people realize the importance of laboratory testing. If you think about the legislation, I think it's going to be hard in some of our customers like hospitals.
And it could have hospitals work with us faster and want to do even more deals with us in terms of outreach business and also running the hospital laboratories. In addition to that, if you look at the health care exchange and expiration of the tax credits, there could be a negative impact, and we've measured that to be as high as 30 basis points. If you look at Medicaid, I don't think anything is going to really happen until 2028. And the key is going to be, do people find insurance through other ways through states or spouses that might have insurance. To me, the key is if people have insurance, we find ways to be successful.
When there's a very large group of people that could become uninsured, that's where we get concerned. I don't think that's likely. I don't think it's very likely in the United States that you'll have a very big group of people automatically become uninsured in a specific period of time. So net-net, boiling it all down, PAMA put aside, we'll do everything we can to either change the legislation delay or offset as much as we can.
The other legislative things are manageable when you look at the impact net- net.
The only thing I would add is we do not expect the one big beautiful bill to have a material impact on our overall effective tax rate. We continue to expect our tax rate to be approximately 23% for full year 2025 and beyond.
Our next question comes from Kevin Caliendo of UBS.
Congrats. Really, really impressive performance, guys. Can I ask about the Community Health deal a little bit. We didn't get a lot of details from you around it.
I understand it's not going to close until 4Q, and so the impact this year isn't great. But from an absolute size perspective, $195 million is meaningful. Is this deal expected to be accretive in the first 12 months flat? Can you talk a little bit about maybe the mix of the business or the profitability of that?
Does it need to be repriced? As much detail as you can provide because obviously, it's going to be a somewhat interesting piece of the bridge when we think about 2026.
Yes. No, absolutely, Kevin. First thing I'd say is that if you recall, we actually increased the range that we thought that inorganic growth would happen. It used to be 1% to 2%.
Now we say 1.5% to 2.5%. And a lot of that is incorporated because of the hospital deals that we're doing, of which this is one. If I look at the deal and the hospital deals, our bar is high. We want them to be accretive in the first year, return our cost of capital in a couple of years and be something that we know how to do and integrate with a good partner we can work with.
And I would say CHS deal, it meets all those criteria. Obviously, it's going to depend on how fast we can close and so forth to see what the impact will be, but we're going to try to work with them to close as quickly as we possibly can. As you said, we paid $195 million of cash. And I think it's going to prove to be another really good hospital deal for us.
It's the outreach business, which is typically the higher-margin business. It's the hospital laboratory when we run those laboratories that you have the lower margin, albeit a high return on cost of capital business. So this is outreach, which actually is better for margins.
Our next question comes from Patrick Donnelly of Citi.
Maybe one on the BLS segment, nice performance there. Nice to see the bookings pick up as well. Can you just talk about what you saw in the quarter? I guess, both central lab and then particularly the early development business looked like it picked up a little bit of momentum as the quarter went.
Obviously, you've heard from the CRO group this week, quite positive in terms of some of those prints. So are you -- did you see improvement as the quarter went? Can you just talk about some of those customer conversations? I know if we rewind 3 or 6 months, there's a lot of concern about this business.
It seems like it's turning the corner a bit. So I would love to pull the curtain back a little bit there. And what you saw as the quarter went and then again, expectations going forward, just given the bookings.
Sure. So I'll start off with the BLS revenue was 11% increase year-over-year. It was 8% if you look at it in constant currency. And we had good growth for both businesses.
We had 8% or 4% constant currency for our central labs and 20% or 18% for ED. But let me break that apart for you, and then I want to talk about the book-to-bill. If you look at the ED, it was a relatively easy compare to the prior year, which accelerated the growth. If you look at fourth quarter of this year, it's going to be a much more difficult compare for ED than the second quarter was.
The other thing is when studies start, you tend to get a bolus of payment at the start of the study. So we had some additional study starts in the quarter. But putting all that aside, ED is back to growth, and we expect it to grow for the full year in the mid-single digits, which is a good place for us to be. And if you look at ED, what I look at is our number of RFPs that come in, which remain consistent.
I look at our win rate, which remains consistent. And the thing that I look at most carefully now is whether the trials start on time. And that's something we're going to continue to look at very closely. But when I look at the second quarter, the win rate, the RFPs and the timing of studies looked good.
If I look at central laboratory, that's where I focus a lot on book-to-bill. If you look at the whole business, PLS, the book-to-bill was very strong, and it was a 1.1 if you look at the trailing 12-month book-to-bill, which is a very good place to be. I've always said you have to be above 1. We're at 1.1. That was driven by a couple of large trials that we won in the central laboratories. The good thing about large trials are they give you fuel for a longer period of time.
So I feel really good about the book-to-bill that we posted. And I think it gives us momentum when you think about the central laboratory business moving into the future.
Our next question comes from Lisa Gill of JPMorgan.
Adam, can you maybe just discuss anything on the horizon around managed care contracting? Do you have any large contracts that are up for renewal going into '26? Any changes around how you're contracting with managed care?
Yes. So as I look at our managed care contracts, they typically vary length anywhere from 3 years to 5 years. So each year, we're renewing maybe 20%, 25% of our contracts. We continue to see unit price relatively flat, which is a good place to be.
I'm confident that we've got the renewals that we need for this year, and I feel good. Those are secured. They're reasonable terms and reasonable rates. They're supportive of our near long-term guidance.
And as I look into the future, I feel confident that we have very good relationships. And one of the things that helps is the hospital deals that you do actually causes the rates to go down for the payers. And I think the more hospital deals we do, the more we're able to talk to payers about the benefit that we're providing to them above and beyond just talking about the cost of our individual tests. So I think that has served us well in those discussions, but I feel very good about our position.
Our next question comes from Jack Meehan of Nephron Research.
So we're almost at the 1-year anniversary, the Invitae deal, I wanted to hear just how you feel like revenue is tracking there, how competitive dynamics are in the market? And then finally, just confidence in getting the business profitable.
So I am very confident in our position with Invitae. The integration is going extremely well. I'm confident in the revenue growth of 10% yearly, and I'm also confident in it being slightly accretive for the full year. The team is doing a great job.
We've improved the customer experience. The customers are excited -- so everything is right on track, and I feel very good about where we are in the position. It's a great add to the offerings that we had for both women's health and specialty areas. And our sales reps are excited to have it as part of us, but also the physicians are excited that we now have that offering as part of Labcorp.
Jack, maybe I can provide some additional color as it relates to margin overall, inclusive of Invitae. Once again, we are very encouraged by our strong performance in the second quarter, whereby we grew top line by almost double digit with 20 basis points of margin expansion despite a 30 basis point headwind from Invitae. This enterprise margin expansion in the quarter was actually supported by the improvements in both business segments. Given the first half results, we actually expect to drive margin expansion in the second half at a level that will enable us to deliver full year margin ratio growth, once again supported by both segments.
So when you think about the cadence for Diagnostics, we tend to see the margins being the highest in the second quarter and then sequentially moderating in Q3 versus Q2 and then Q4 versus Q3. For the BLS segment, we also expect margins to be up in the second half versus prior year. However, not necessarily at the pace that we saw in Q1 or Q2, considering we had significant margin progression throughout last year. So overall, I would say that as an organization, we are highly focused on continuing to deliver strong top line growth while driving margin expansion through operating efficiencies.
And our next question comes from Elizabeth Anderson of Evercore ISI.
Congrats. I was wondering if you could maybe expand a little bit more on your BLS commentary, if you have any comments on sort of biotech versus pharma or sort of pockets of strength that you're seeing in general, though, obviously, with the book-to-bill imagine, it's decently widespread. And then two, I was wondering if you can just remind us, as we think about the impact of FX on the business, I think we called it out -- you guys called it out obviously very cleanly on the revenue line, but just sort of remind us as we go down the P&L, how we think about the change in FX on the EPS line?
Yes. Elizabeth, I'll talk about BLS. I'll ask Julia to talk a little bit about the impact of FX. If you look at BLS, we saw strength in both businesses in the quarter, and we expect both businesses to grow for the full year in the mid-single digits.
If I look at CLS, CLS is heavily skewed towards larger pharma, later-stage trials, Phase III trials. And there, we had a couple of big wins. I feel good about that. I think under all circumstances, pharma is going to continue to support their Phase III pipelines, and that's a strength for us.
As I look at our early development, that is mostly smaller biotechnology companies, and we saw a good number of RFPs and win rate there, but that's something we're going to watch very closely to ensure that the funding environment remains favorable to ensure that they get the information they need to start studies on time as they move forward. So that one, I think we have to watch more closely than the CLS where I feel more confident based upon the later-stage trials and the larger companies. With all that said, ED is back to growth. It's important to note that the fourth quarter is going to be a very tough compare versus fourth quarter of last year.
But if you look at the full year, we expect it to grow in the mid-single digits.
Elizabeth, let me comment a bit on the FX impact. We clearly are operating in a very dynamic FX environment. If you step back and look at the composition of our businesses, obviously, the diagnostics side accounts for over 75% of our revenue, but it's primarily based in the United States. And the BLS side of the business is where we are more global in our footprint and therefore, having FX exposure.
The currencies that we have meaningful exposure to for BLS include the Swiss franc and the British pound. If you just look at the Q2 enterprise revenue growth of 9.5% year-over-year, it did include a favorable currency impact of 60 basis points due to BLS. And then when you move to look at the full year guide, which is provided at the midpoint, the enterprise revenue guide is 70 basis points, and we are expecting an FX impact based on the rate at the end of Q2 in that magnitude.
And our next question comes from Andrew Brackmann of William Blair.
Maybe just on pricing, I think you called out organic pricing up in the quarter. Can you maybe just peel that back a bit for us just in terms of the key drivers there? And then I guess, how should we think about that trending forward, especially as the mix continues to shift towards those specialty tests?
Okay. So if you look at pricing, I look at a few things. I look at our test per accession and our test per accession continues to show growth. And I think that, that's occurring -- if you go historically, I said that I thought that, that was a post-COVID acceleration because people didn't get diagnosed during COVID.
I actually think it's more than that. I think that there's an aging population. I think there's more severity of disease. So I think people are actually doing more test per accession.
We also include in that lab management. The second thing, I think that's helping to drive that is the specialty growth. So we are seeing asymptotic continuing increase in our specialty testing vis-a-vis the routine testing. And I think that also helps with the price per accession.
The only thing I would also complement is from a unit price perspective, we continue to see it as relatively flat. And therefore, when you think about the price mix impact, it's really been benefiting from the impact of mix. And as Adam already shared, the key contributors once again are the gradual yet consistent growth in test procession as well as management agreements.
Our next question comes from Tycho Peterson of Jefferies.
Congrats on the quarter. So I just want to probe on some of the new content launches, starting with Alzheimer's. Curious how you're sizing the opportunity for pTau-217/Beta Amyloid and any market development that needs to happen there? And then the follow-up is on MRD.
With PlasmaDetect, how has early adoption been? Any synergies you can point to with PGDx extra therapy selection? And how do you think about kind of broader menu build-out for MRD?
Yes, absolutely. I think that's a very important question as you think about specialty and where we're going. The first thing I'd say, though, Tycho, is that when I think about the specialty testing, I don't think about the individual test alone because the patient that gets that test is also going to get a whole host of other tests. So if you have somebody that's going to get an MRD test, they're probably going to get CBCs, WBCs, ALPs, ALTs and a whole host of other things to see and measure their organs as well as their minimal residual disease.
So to me, having the broad range of tests is as important as having the most important new tests. So we don't break out the new tests because none of them individually do I think is going to be that meaningful to change kind of the trajectory or be that material. But when you look at it as a whole, I think it actually is very material. Two reasons.
One is we are seeing a shift in mix towards specialty testing, but as importantly, the spillover from other tests for those specialty patients. As I think about oncology, I think it's important because oncology testing for precision testing is growing, and it's going to continue to grow, and there's going to be more and more products launched in those areas from pharma. And we continue to look at things like OmniSeq and PGDx and Invitae to say, how can we add to that portfolio so we have a full complement of what an oncologist would want. In addition to that, we're open to licensing other tests to bringing other tests that others have developed to market because once again, it's not about the individual test.
It's about having the broadest range of tests. And I would say the same thing for Alzheimer's disease.
Our next question comes from David Westenberg of Piper Sandler.
Congrats, particularly impressive on that operating leverage. I wanted to jump on some of Tycho's question -- and focus on the oncology section. You launched a few new products. You're getting CGP, liquid, MRD, et cetera.
How do you see that market shaking out over the next few years? I mean, currently, liquid and CGP NGS tend to be fairly oligopolistic. Do you see that market evolving to something where your reach, your breadth might have a bigger impact as that markets become a little bit more commoditized. Maybe that's not the best word there, but any way you can think about how that shakes up?
And then I just wanted a clarification. You mentioned 3% to -- or 4% -- I mean, sorry, 4x esoteric growth versus a regular test growth. Is that -- has that been accelerating of late? Or is that just the constant steady state, just sort of clarification.
Yes. So the 3% to 4% was for the esoterics in the 4 areas I mentioned, oncology, neurology, autoimmune and women's health. And that's been for quite some time now. So those areas have just been growing faster than the other diagnostic underlying diagnostic area, 3 to 4x.
With regard to oncology and MRD, I think you want a full portfolio. I want tissue capabilities, but I also want liquid capabilities. When I think about liquid capabilities, there's 3 things I think about. One is screening and the ability to screen patients for cancer.
I think that is going to be important, but it's going to take a very long time to develop that market and to gain reimbursement. And I think it will be very large trials and take some time. Then I think about therapy selection, and that's an area that we are heavily invested in that we're going to be a leader in because I think that as physicians are thinking about what therapy they want to use, having both tissue as well as liquid could be very helpful there. And then I think about minimal residual disease after their cancer has been treated, they're deemed cured, how do you monitor them over time.
That one, I think, will be reimbursed over time, particularly as we have the data to support that we can actually identify those early that have reoccurrence, and we'd like to be a leader there. So I want to be a leader in therapy selection. I want to be a leader in the minimal residual disease. I'm going to be more of a follower when it comes to screening because it's going to take so long and it's going to take a lot of money to develop over time.
But when you put it all together, if you are an oncologist, then you can come to one laboratory to get your tissue, your liquid and all the other tests that you might need for your oncology patient versus having to go to 2 labs or 3 labs with different reports, different ordering systems, not have as convenient sites for blood collection and turnarounds. I think over time, our size, our scale, combined with our scientific expertise will be a competitive advantage.
And our next question comes from Luke Sergott of Barclays.
I just want to follow up on the BLS strength and the bookings commentary that you guys have been giving and also the RFP. So anything that you can dig in on from like a therapy indication? We've been hearing a lot about metabolic disease from the other CROs. And so I want to know about how the funnel has been filling for you guys.
And if there's any like change in the trends from either the therapy regarding like metabolic, et cetera, or like from biotechs where you're seeing all of a sudden pent-up demand start flowing through from midsized biotech? Or is this coming from the pre-revenue biotech where the funding has just been really, really tough over the last few years.
Yes. So let me break apart the 2 businesses, and I'll start with CLS. CLS has been large pharma. With a lot of large pharma, we have either service agreements, MSAs with them.
And depending on which pharma company and what their pipeline is like, that's where our business goes and we kind of follow the business of our largest customers. So just like you would see in the marketplace, as you see more trials that are occurring in certain areas, you can assume that we would be strong in those areas. Obviously, oncology, neurology, metabolic are still the largest and fastest-growing areas for us. If you then go to the early development business and the central lab is more big pharma, big biotech.
If you go to our early development business, there, it's mostly smaller companies. That's where you'll see a lot of cell and gene therapies for some certain rare diseases. When it comes to large pharma, a lot of them do their own early development. So it's mostly individual companies on individual compounds or companies that are looking to develop multiple compounds in the same area.
There, it would be more in the esoteric areas.
Our next question comes from Erin Wright of Morgan Stanley.
So just more of a bigger picture question just on utilization trends in the Diagnostics segment. And you obviously increased your guidance. You mentioned the strength across utilization. And I just -- we're obviously hearing it from managed care companies and others.
But what's embedded in your guidance as we head into the second quarter? Is there any normalization in trend or just a continuation of the same? Or are you seeing this accelerate? And then just how durable you're thinking these trends can be?
I mean, excluding some of the policy dynamics that are some unknowns, but like outside of that, like this underlying kind of base utilization strength that we're seeing and the sustainability of that, if you could comment on it.
Sure. So the volumes continue to be very healthy, and they're tracking in line with our expectations. If you look at the midpoint of the Diagnostics revenue guide, it's 7.5%, and we assume about half of the revenue growth will come from organic growth and the rest comes from the annualization of our acquisitions. If you look at the organic growth, we expect a volume mix contribution of 3: 1, just like we saw in the second quarter.
So 3% for volume, 1% for mix. When we think about some of the factors that we think are driving that, and that will continue to support the utilization as we go into the future, there's an aging population. There's high rates of disease prevalence, and we continue to see improvements in advanced diagnostics in the specialty testing areas, including things like companion diagnostics. So I think those market factors actually support a healthy utilization environment.
In addition to that, I believe that we will continue to kind of continue to get some market share. So not only do I think we'll grow with the market, I think we'll continue with the hospital business and the laboratory business that we're doing to find ways to grow a bit faster than the overall market.
And the one comment I'd like to add is to Adam's point, we do expect the strong utilization to continue into the second half of the year as part of our guide. That's why when you look at the midpoint of our EPS, we raised the full year guide by $0.23. It's really driven by the continued strength in the utilization along with other momentum. And when you look at the $0.23 beat and raise actually about 1/3 is driven by operational strength with the other balance coming from FX.
And our next question comes from Michael Ryskin of Bank of America.
A couple of small questions tying up stuff you touched on earlier. I think in one of the very early comments, you provided some color on PAMA and how you see that playing out, very consistent with what you said in the past. But if you could just expand now that it's a little bit more likely that it's -- or it feels like it's a little more likely like we're going to have to deal with this next year. You talked about some of those offsets via Launchpad, et cetera.
Could you just sort of quantify that? Help us think through the timing of that, when you'll implement those, how those will be implemented? Just sort of how that should play out in 2026 if this does come back and take effect next year and sort of what the net impact would be? And then the other question was going to be Julia, you touched a couple of times on the strong margins in the quarter that really shown through.
If you could expand on that just a little bit sort of whether it's the cost controls or the volume mix, like how that contributed to the -- I think the 50 bps underlying ex Invitae, that would be helpful.
Yes. So Michael, first, I'll start with PAMA. So as I said before, we're going to do everything we can to work with ACLA to get the appropriate legislation through. We'll work with them if that doesn't occur to see if we can get another year of delay.
And if that doesn't happen, we'll continue to work with them to see if there's a way to get that data more accurately presented or represented through getting more collection of data across the industry. All of those 3 things would have an impact on what PAMA downside could be if it occurs next year. So it's hard to tell you in each of those scenarios what the impact would be. What I would say is that if none of that works, the impact is $100 million.
We won't be able to offset the whole $100 million. We will work to do everything we can to offset as much of that as possible. The key is going to be, we already have committed to $100 million to $125 million in savings due to LaunchPad, which we continue to commit to. This would be in addition to that.
We have things that we're doing right now as we speak, putting in projects for artificial intelligence, looking at ways to drive revenue through a better customer experience for ways to reduce cost through elimination of duplication and some other roles. So we're working on a lot of things to offset PAMA. If PAMA does not occur, it's just going to be more momentum for us. But if it does, we'll do whatever we can to offset as much as possible, and we'll be transparent with what we do as we provide 2026 guidance.
And from a margin perspective, I think the short answer to your question is the contributions are coming from all those sources. specific speaking, obviously, the revenue growth is absolutely helpful in addition to the ability to drive operating efficiency through cost management. But I also think that heading into the second half, in addition to all those strengths and contributions, the fact that we will be overlapping with Invitae annualizing in Q3 will enable us to deliver a margin expansion at a level in the second half that once again will enable us to deliver full year margin expansion, and we are very much looking forward to that expectation.
This concludes our question-and-answer session. I'd like to turn it back to Adam Schechter at this time for closing remarks.
Thank you, Didi, and thank you, everybody, for joining us today. Hopefully, you see we have momentum. We continue to focus on our strategy and that our strategy is working. We look forward to seeing you all soon and continuing our discussions with you. Have a great day.
This concludes today's conference call. Thank you for participating, and you may now disconnect.