Labcorp Holdings Inc.

Good day and thank you for standing by. Welcome to the Q4 and full year 2022 LabCorp conference 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 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Chas Cook, head of investor relations. You may begin.

Thank you, operator. Good morning and welcome to LabCorp's fourth quarter 2022 conference call. As detailed in today's press release, there will be a replay of this conference call available via telephone and internet. With me today are Adam Schechter, chairman and chief executive officer, and Glenn Eisenberg, 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 GAAP financial measures discussed during today's call. Additionally, we are making forward-looking statements. These forward-looking statements include, but are not limited to, statements with respect to the estimated 2023 guidance and the related assumptions, the proposed spinoff of the clinical development business, the impact of various factors on the company's businesses, operating and financial results, cash flows and or financial condition, including the COVID-19 pandemic and general economic and market conditions, future business strategies, expected savings and synergies, including from the Launchpad initiative, acquisitions and other transactions, and opportunities for future growth. Each of the four 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.

Thank you, Chas. Good morning, everyone. It's a pleasure to be here with you today to discuss our fourth quarter results, as well as the progress that we've made towards our strategy. 2022 ended strong for LabCorp, with accelerated revenue growth in diagnostics and continued strong underlying fundamentals in drug development. Drug development continued to have a tough year-over-year comparison, mostly due to less COVID-related work. In 2022, we took decisive actions to navigate a challenging operating environment. We advanced our strategy with the announcement of the planned spin of our clinical development business, and we closed several important hospital laboratory partnerships. I'll now discuss our fourth quarter performance. In the quarter, Revenue totaled $3.7 billion, adjusted earnings per share was $4.14, and free cash flow was $536 million. The base business remained strong. On a constant currency basis, excluding COVID testing revenue, enterprise-based business revenue grew 6% in the fourth quarter versus prior year. Growth in diagnostics-based business revenue in the fourth quarter was strong, due to both routine and esoteric testing and revenue from the Ascension Partnership. COVID PCR testing volumes declined during the quarter as expected, totaling 1.4 million tests performed and averaging 16,000 per day. Looking forward, our diagnostic business will accelerate with 10.5 to 12.5% base business growth, benefiting by around five percentage points with a full year of our extension partnership. For drug development, fourth quarter base business revenue in constant currency declined 1% versus prior year. Early development and clinical development both grew, but were offset by lower central laboratory revenue due mostly to COVID-related work. Drug development ended the quarter with a strong trailing 12-month book to bill of 1.27. Looking forward, We expect the momentum to continue in drug development orders, and we expect that site enrollment and kids' return will continue to increase throughout the year. We also anticipate the drug development business to return to 5% to 7% growth, with a stronger second half than first half due to early development and the annualization of an FSP contract loss. Finally, in the quarter, The Board authorized a $1 billion increase to the company's share repurchase program, bringing our remaining total share repurchase authorization to $1.5 billion. Glenn will provide more detail on our quarterly results and will review full year 2023 guidance in just a moment. Moving now to an update on the planned spin of our clinical development business. We have been pleased with the positive response and we remain on track to complete the SPIN in mid-2023, subject to satisfying certain customary conditions. Recently, we unveiled Fortria as the name of the clinical development business post-SPIN. You can learn more by visiting fortria.com. Also in January, Tom Pike joined LabCorp as President and CEO of our clinical development business. Tom will serve as Chief Executive Officer and Chairman of the Board of Fortria upon completion of the spend. Tom brings significant CRO experience, including serving as CEO of a public CRO. He has worked with many of our customers and he knows the business well. We welcome Tom and look forward to working with him as we continue making progress towards the completion of the spend. Upon completion through a tax-free transaction, we will have two strong independent companies LabCorp, and Fortria, which will emerge from the transaction with the ability to better meet customer needs, to drive sustainable and profitable growth, and deliver attractive shareholder returns. In the coming months, we plan to announce the board of directors of Fortria, including the lead independent director and other members of the executive leadership team. We also intend to host an analyst day in advance of the spin, and I look forward to working with Tom on timing. I'll now move to our enterprise strategy. We made significant advances on our strategy in 2022. We accelerated and closed several hospital and health system partnerships and acquisitions during the year. Most recently, we completed the integration of certain Ascension assets and operations. LabCorp now provides laboratory management services for nearly 100 hospitals across the Ascension hospital system. We are pleased with the smooth transition and we want to thank our partners at Ascension for enabling our teams to help deliver the best patient care possible. In addition to Ascension, we entered strategic relationships with RWJBarnabas Health, Atlantic Care, Prisma Health, and St. Dominic's during the year. The pipeline for hospital and local laboratory acquisition and investment is robust and will be a key area of opportunity for growth in 2023 and beyond. We also made progress in using digital technology and data to deliver better outcomes for patients. By significantly improving our web, mobile, and digital channels, we've made it easier for customers to access critical data and health information. Using digital technology and artificial intelligence, we are reimagining our result reports to provide deeper insights, scientific expertise, and clinical information to guide patient care. Additionally, we're encouraged by increased customer adaption of Lobcorp's Diagnostic Assistant, a tool that equips physicians with the information they need to improve care. Also, our investment in call center automation is improving the customer experience by enabling patients and providers to get answers faster through self-service features. Turning to oncology, we continue to expand our oncology capabilities to serve clinicians and drug development customers. In the fourth quarter, we launched a liquid biopsy test called LabCorp Plasma Focus. This test is used to match cancer patients with FDA-approved therapies using the patient's circulating tumor DNA taken from a blood draw. This is the first new product stemming from LabCorp's acquisition of personal genome diagnostics in 2022. Today, LabCorp offers customers and patients access to the most comprehensive oncology portfolio in the market. Our teams are evaluating and executing on growth opportunities in areas such as neurodegenerative, autoimmune, and liver disease, as well as cell and gene therapy and more. In 2022, our team supported over 5,000 clinical trials, worked with over 90% of new FDA approvals, and launched over 130 new tests. In the area of neurodegenerative disease, for example, we launched new tests to assist in diagnosis and treatment of Alzheimer's multiple sclerosis, and Parkinson's disease. We anticipate more innovative launches in 2023. Finally, we made progress in our direct-to-consumer business. In 2022, we introduced LabCorp OnDemand, a platform aimed at providing consumers with easy and convenient access to our leading diagnostic tests. We now offer over 45 tests that cover over 100 biomarkers to help consumers monitor health, stay current with wellness screening, plan for families, and manage a broad range of chronic health conditions. The progress we made this year is a direct result of the commitment of our employees who fuel our confidence in the outlook for 2023. We are recognized by Forbes on its list of the world's best large employers in 2022, and we also earned a top score in the 2022 Disability Equality Index. Attracting and retaining the best talent is key to our success, and we remain focused on being an employer of choice and destination for talent. As I look to 2023, I am optimistic about the growth and strategic opportunities before us. Our business fundamentals remain strong, and we are well positioned for the future. With that, I'll turn the call over to Glenn.

Thank you, Adam. I'm going to start my comments with a review of our fourth quarter results, followed by a discussion of our performance in each segment and conclude with our 2023 full year guidance. For reference, we've also included additional business information that can be found in our supplemental deck on our investor relations website. Revenue for the quarter was $3.7 billion, a decrease of 9.4% compared to last year due to lower COVID testing and the negative impact from foreign currency. This was partially offset by organic-based business growth and the impact from acquisitions. COVID testing revenue was down 79% compared to COVID testing last year, while the base business grew 4.8% compared to the base business last year. Organically, in constant currency, the base business grew 4.7%, benefiting from the Ascension Lab Management Agreement, which contributed approximately 4% of the organic growth. While the outreach business that we acquired from Ascension is treated as an acquisition, the lab management agreement is treated as organic growth. Operating income for the quarter was $91 million or 2.5% of revenue. During the quarter, we had $61 million of amortization and $88 million of restructuring charges and special items, primarily related to acquisitions, launchpad initiatives, and the proposed spin of Fortria. In addition, the company recorded $270 million of goodwill and other asset impairment, primarily related to the early development business, due to short-term labor and supply constraints. This impairment represents approximately 2% of LabCorp's goodwill and intangible assets. Excluding these items, adjusted operating income in the quarter was $510 million, or 13.9% of revenue, compared to $902 million, or 22.2% last year. The decrease in adjusted operating income and margin was due to a reduction in COVID testing. The benefit from Launchpad savings and lower personnel expense were essentially offset by lower COVID-related demand and inflationary costs. Our Launchpad initiative continues to be on track to deliver $350 million of savings over the three-year period ending 2024. The adjusted tax rate for the quarter was 20% compared to 24.6% last year, The lower adjusted tax rate was primarily due to the geographic mix of earnings, as well as the benefit from increased R&D tax credits and year-end true-ups for completed tax returns. We expect our 2023 full-year adjusted tax rate to be approximately 24%. Net earnings for the quarter were $76 million or 86 cents per diluted share. Adjusted EPS were $4.14 in the quarter, down from $6.77 last year, due to lower COVID testing earnings. Operating cash flow was $654 million in the quarter compared to $698 million a year ago. The decrease in operating cash flow was due to lower COVID tested earnings, partially offset by higher base business earnings. Capital expenditures totaled $118 million, down from $150 million last year. For the year, capital expenditures were 3.5% of base business revenue. and we expect that to continue into 2023. Free cash flow in the quarter was $536 million, bringing our full-year free cash flow generation to $1.5 billion. During the quarter, we invested $150 million on acquisitions, paid out $64 million in dividends, and repurchased $300 million of stock, representing approximately 1.4 million shares. At the end of the quarter, we had $532 million of share repurchase authorization remaining. The Board recently approved an additional $1 billion for share repurchases, taking our total available authorization to approximately $1.5 billion. For the full year, we invested $1.2 billion on acquisitions, paid out $195 million in dividends, and repurchased $1.1 billion of stock. We continue to have a robust pipeline of potential acquisition opportunities that will supplement our organic growth. In addition, we continue to believe that our shares are undervalued and that our share repurchase program is an important part of our capital allocation strategy. At year end, we had $430 million in cash, while debt was $5.3 billion. Our leverage was 1.9 times gross debt to trailing 12 months EBITDA. Excluding COVID testing earnings, our leverage was around 2.5 times, in line with our targeted range of 2.5 to 3 times. Now I'll review our segment performance, beginning with diagnostics. Revenue for the quarter was $2.3 billion, a decrease of 12.8% compared to last year, primarily due to organic revenue being down 14.3%, which was due to COVID testing, partially offset by acquisitions of 1.7%. COVID testing revenue was down 79% compared to COVID testing last year, while the base business grew organically by 8.6% compared to the base business last year. The Ascension Lab Management Agreement contributed approximately 7% of the growth, while the negative impact of weather and fewer revenue days constrained growth by approximately 1.2%. Relative to the fourth quarter of 2019, the compound annual growth rate for base business revenue was 6.9%. Total volume decreased 11.8% compared to last year, as organic volume decreased by 13.8%, primarily offset by acquisition volume of 2%. The decline in volume was due to COVID testing. Base business volume grew 3% compared to base business last year, including the benefit from acquisitions of 2.4%, but was constrained by unfavorable impact from weather and fewer revenue days of approximately 1.2%. Price mix decreased 1% versus last year due to lower COVID testing of 6.4%, currency of 0.3%, and acquisitions of 0.2%, partially offset by base business growth of 5.9%. Base business price mix was up 7.6% compared to base business last year, benefiting from the Ascension Lab Management Agreement of approximately 7%. Diagnostics adjusted operating income for the quarter was $387 million or 16.9% of revenue compared to $776 million or 29.6% last year. The decrease in adjusted operating income and margin was due to a reduction in COVID testing as the COVID margin was approximately 50% for the quarter down from approximately 70% last year. We expect the COVID margin to be approximately 50% through the duration of the public health emergency at which point we would expect the margin to decline, but still be above the segment average. Base business margin was down approximately 30 basis points due to the impact from ascension, higher personnel expense, and other inflationary costs, partially offset by organic growth and launchpad savings. Excluding ascension, margin would have been up approximately 50 basis points. Now I'll review the performance of drug development. Revenue for the quarter was $1.4 billion, the decrease of 4.1% compared to last year, primarily due to foreign currency of 3.1%. Organic-based business revenues declined 1.4% compared to last year due to the negative impact from lower COVID-related work and the Ukraine-Russia crisis. Excluding these impacts, organic-based business revenue grew 3.7%. The central lab business continued to be the most constrained by these impacts. Central lab-based business revenues were down 11.5%. However, excluding these impacts, organic constant currency revenue was up 4.7%, while on a comparable basis, early development was up 3.4% and clinical development was up 3.2%. Reported fourth quarter drug development revenues on a compound annual basis grew 5.1% compared to the fourth quarter of 2019. Adjusted operating income for the segment was $209 million or 15% of revenue compared to $206 million or 14.2% last year. The increase in adjusted operating income and margin was due to launchpad savings and lower personnel costs, partially offset by lower COVID-related demand, the Ukraine-Russia crisis, and inflationary costs. We ended the quarter with backlog of $16.3 billion, and we expect approximately $4.9 billion of this backlog to convert into revenue over the next 12 months. Now we'll discuss our 2023 full-year guidance, which assumes foreign exchange rates effective as of December 31, 2022 for the full year. The enterprise guidance also includes the impact from currently anticipated capital allocation, with free cash flow targeted for acquisitions, share repurchases, and dividends. Also, our guidance assumes that Fortria will be part of LabCorp for the full year, Upon its spin, currently anticipated in the middle of the year, we expect to provide updated guidance. We expect enterprise revenue to grow 1% to 4% compared to 2022. This guidance includes the expectation that the base business will grow 8.5% to 10.5% while COVID testing is expected to decline 75% to 90%. This assumes a PCR volume range of 5,000 to 12,000 tests per day on average for the year. We expect diagnostics revenue to be down 2% to up 1.5% compared to 2022. This guidance includes the expectation that the base business will grow 10.5% to 12.5%, which has approximately 5% growth due to ascension. At the midpoint of our base business guidance, the compound annual growth rate compared to 2019 is 6.4%, including the benefit from ascension of approximately 2%. We expect diagnostics-based business margin to be slightly up in 2023 versus 2022, including the unfavorable mix impact from Ascension. We expect drug development revenue to grow 5% to 7% compared to 2022. This guidance includes the positive impact from foreign currency of 20 basis points. At the midpoint of our guidance, the compound annual growth rate compared to 2019 is 7.2%, primarily due to organic growth. While we have increased the number of NHP vendors with multi-year agreements to secure supply, lead times are projected to negatively impact drug development revenue between $80 to $100 million early in the year. As a result, we expect drug development first quarter revenue growth to be lower than the average for the year. We also expect drug development margin to increase in 2023 compared to 2022, with the first quarter coming in comparable to the first quarter of 2022 due to the early development supply constraint. Our guidance range for adjusted EPS is $16 to $18, compared to $19.94 in 2022. Adjusted EPS is expected to be lower compared to 2022 due to COVID testing, while base business adjusted EPS at the midpoint of guidance implies approximately 13% growth. Free cash flow guidance is $1 to $1.2 billion compared to $1.5 billion in 2022. The decline in cash flow is due to lower COVID testing. In summary, we expect to drive continued profitable growth in our base business, while COVID testing volumes are expected to continue to decline through the year. We expect to continue to use our free cash flow generation for acquisitions that supplement our organic growth, while also returning capital to shareholders through our share repurchase program and dividends. Operator, we will now take questions.

Certainly. As a reminder, to ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. Please limit yourself to one question. Please rejoin the queue for any follow-up questions. Please stand by while we compile the Q&A roster.

One moment.

And our first question will come from Kevin Caliendo of UBS. Your line is open.

Thanks. Thanks for taking my call right away. I appreciate it. There's a lot to unpack here. I guess I'll start with a couple. Is there any cost being built into the business right now ahead of the spin? I don't want to say the stranded costs or IT costs, but there's a couple line items. It looks like corporate's been higher The intersegment eliminations seem to be a lot higher as well. I'm just trying to understand what's driving that, if there's any investment being made there that would show up there or in a way that we can't necessarily see. And then secondly, I guess this is such a wide range of earnings. Can you tell us, is it all just based on COVID? Is it based on the spin timing? It's unusual to have such a wide range, and I'm wondering what would be sort of low-end versus high-end, what would be driving that? Thanks.

Yeah. Good morning, Kevin. And I'll take the second question first. I'll ask Glenn to provide some impact on your first question. So, you know, the range that we gave is $16 to $18, the midpoint of $17. And we kind of focus and target in on that midpoint. But there are things, particularly around COVID, that could still happen where we've given a pretty broad range of COVID coming down between 75% and 90%. It's still very difficult to predict that. The second thing is we gave a range for NHP of $80 million to $100 million. The good news is we've started to receive supply and we've started to receive shipments, but it's still early as we get those shipments in and it takes time to get the study starts up. And then the third thing I would say is while we're waiting for supply, we're still hiring people. As you recall, last quarter, we noted that in early development, we needed to hire more people. So I'm not slowing down the hiring process while I'm waiting for some of the supply shipments that we have. So we're going to hire people while we can't yet run some of those trials. So those are some of the pushes and pulls. But I would focus on the midpoint more so than the lower end of the range I think is highly unlikely.

Yeah, no, and just to follow up on that, when you look at the guidance ranges for both of our base businesses, we keep those rates within, call it 2% each point. And it's really the COVID, given the volatility in COVID, we provide a wider range, which causes that overall EPS number to be a little bit wider. Kevin, when you talk about the SPIN costs, you'll see that we treat that as kind of an unusual item. Obviously, we're going through a SPIN. These are one-time costs. You'll see that in the reconciliation between, call it, our GAAP and our adjusted earnings, you'll see in the footnotes that we incurred around $29 million of costs during the quarter related to the SPIN. So again, those would be backed out of our adjusted numbers when you look at our enterprise and segment performance.

Great, thanks. Can I ask a quick follow-up just on PAMA, the benefit you saw from PAMA and also the change in the code that occurred in December? That was obviously a positive benefit to the company. Did you reinvest those dollars or is all of that sort of you're letting that fall to the bottom line? How should we think about that in terms of the way you accounted for it or thought about it?

Yeah, so again, when we gave our range to two things. One, for diagnostic business, 10.5% to 12.5% growth, I think, is pretty extraordinary. But if you look at PAMA, we've included, when we talk about margins, that we expect margins to be slightly improved, even with the impact of ascension. And if you just look at fourth quarter, for example, our margins were down 30 basis points Ascension was a negative 80 basis point hit. So you can see the impact from Ascension. For us to be able to offset that impact on margins, it's due to the lack of PAMA being implemented this year, as well as some of the benefits from the draw fees.

Thank you so much.

Yep, thank you.

One moment.

And our next question will come from Jack Meehan of Nefron Research. Your line's open.

Thank you. Good morning. Good morning, Jack. Good morning. My question's on just commercial payer negotiations. You know, we're coming up on the five-year anniversary of the UnitedHealth announcement. I don't know if you want to address that directly or national payers kind of broadly speaking, but are there any notable shifts you're seeing in the structure of your contracts and just how do you feel about the ability to maintain price?

Yeah. So obviously we work with the payers all the time, you know, whether it's a year we have a negotiation with them or not, we're constantly in contact and working very closely with them. And, you know, we've seen continued pressure over the last five years. And I think that pressure will continue again, But it's not accelerating. It's kind of very steady. And where we can get price concessions, we do. But in general, I would say that there's continued pressure, but no different than what we've seen in the past.

The other thing, too, Jack, just to add on that, too, is that when we think about price mix, we've always talked about unit pricing being a headwind, but the favorability of our mix of esoteric growing faster than routine or test per session. When you look at the growth rate that we have envisioned for 23 in our guidance, it assumes both, and mostly, but favorable volume appreciation, but also favorable price mix, even with unit pricing headwinds.

Got it. And I heard your commentary, Glenn, on some of the revenue pacing to start the year. Is there a finer point you can draw on EPS, just either expectations, percentage of the full year, or just any color to help on that would be great.

Yeah, it's interesting. If you go back and look to even pre-pandemic levels, 2023, even though we have some pluses and minuses, the trend in the earnings would come in similar. So I think that'll give you roughly a good approximation. Interestingly enough, plus or minus, it comes in fairly quarter each time, but you'll see it's a little bit different in the first quarter, a little bit lower, a little bit higher throughout the rest of the year. But I think it'll give you a good proxy. Great. Thank you.

Thank you.

One moment for our next question. Our next question will come from Erin Wright of Morgan Stanley.

Your line is open.

Great. Could you give us a little bit more of a breakdown of what you're seeing across the different sub-segments at Covance, the central lab business in terms of volume trends, RFP flow at the clinical level, and then And then on the early development side, you know, what's your level also of commitment to early development business as you kind of retain that as part of your spin process here? Thanks.

Sure. Good morning, Erin. Thanks for the question. So I'll start with drug development and performance. What you saw for the fourth quarter was early development grew 5% on a constant currency basis. And I always give the CAGR as well from 2019 because that's before all the COVID-related work. It was about 6% CAGR from fourth quarter of 2019. If you look at the clinical business, we saw about 2.5% growth in the corner, a constant currency basis. If you compare that to the fourth quarter CAGR of 2019, it was about 5%. But both of those were offset by a 9% decline in the central laboratory business versus prior year. That's, again, constant currency. But if you look at the business for the central laboratory on a CAGR basis in 2019, it actually grew about 5%. So it shows you that that business remains healthy. It's just, as you recall, in the fourth quarter of 2021, we were doing a huge amount of COVID work for boosters for vaccines because that was right when the Omicron variant hit. So that's why you see such a tough year-over-year comparison for the central laboratory business. As I look at RFPs across the segments, meaning I look at them in total, the RFPs remain very strong and very consistent. So we haven't seen a change. As I look through last year in cancellation rates, I haven't seen a change. The cancellation rates remain low. They're up a little bit from one quarter, down a little bit from the next quarter, but relatively flat and remain very low. And then to me, the most important thing is the book-to-bill ratio. And as you see, the book-to-bill was very strong. It was a 1.27. And if you were to look at each of the individual segments for the quarter, although we don't typically give individual segments book-to-bills, you would see that they are all above the 1.2. So we feel good about each of the segments about the book-to-bills as we move forward. In terms of the... Oh, I'm sorry. Go ahead. I'll answer the second question after you... Oh, no, go ahead.

Go ahead.

Okay. And then in terms of if you look at the ED business, we think it's a good business. It's a global business. We're looking to bring our innovative diagnostic tests globally, and we think that they'll be able to help us do that with their global laboratory footprint. So we remain committed to that business, and we think it's a good business.

And I guess just my follow-up as you prepare for the spin, how we should be thinking about the priorities around capital deployment, the M&A pipeline, as well as buybacks, and how we should be thinking about that. Thanks.

Yeah, so after the spin, which we are on track for the middle of this year, we will continue to provide a dividend. We expect to get dividends approved moving forward for LabCorp. And then we would continue to look to do these hospital and local laboratory deals of which our pipeline is very full. And there's a significant number of those that we're looking at evaluating. We will win some of those this year. And then we believe our shares are still significantly undervalued. So we have now $1.5 billion of authorization for share purchases, and we'll use those as appropriate.

One moment for our next question. Our next question will come from Tim Dally of Wells Fargo.

Your line is open, Tim.

Great. Thanks. So on the first one, I'm not trying to step on Tom's toes or anything here, but just isolating the drug development assets that will stay part of RemainCo. Could you just give us some color, directionally, size, size, magnitude, anything here? on the EBITDA margins for early development and central lab, just, you know, how they looked at 22, not trying to ask for stranded cost adjustments or anything like that?

Hey, Tim, this is Glenn. As you know, we break out the two segments, and then with that, the revenue OI and margins. So, for drug development, you know, we provide that. We haven't broken out the pieces, if you will, because, again, of all the interrelationships and shared services and so forth. Part of the issue of doing this spin, obviously, is now we're standing up an independent company with where we have a lot of direct costs, but then we also have a lot of indirect costs. And we're working through, obviously, all those costs and including transition services that we would be providing for a period of time. So we're currently in the process of getting all the numbers done. Once we're complete with that, we'll obviously be sharing kind of the spin code view, both on the top line and the bottom line. at the appropriate time, including in an anticipated investor analyst day, if you will, prior to the spin. And obviously, to the extent we have those financials done prior to that, we can also share them. But at this point, we've talked in the past about here's the segment average and that the businesses are for the plus or minus in line before you get to those independent stand-up costs.

All right. Appreciate it. Thought I'd give it a shot. Secondly, on the, I'm just saying here, on the early development business, so if we were to exclude the 80 to 100 million NHP headwind, you guys are baking into the guidance, would AD be growing in FY23? And what's the price assumption embedded in there for the year?

So the short answer is yes, it would be growing for the year with the 80 to 100 million in there growing nicely. And what was your second question?

The pricing assumption embedded in the ED business for 23.

In terms of the pricing. So the first thing I'd say is that we expect the primary pricing to go up significantly because of the supply issues. And I think, therefore, you would expect to have better pricing overall.

Thank you.

Yeah, and just to be clear, that pricing, especially for primaries, it does get passed on to customers, so it doesn't impact our margins. It will impact the margins because we don't get a margin on that, but the pricing can be passed on to the customers.

One moment for our next question.

And our next question will come from Patrick Donnelly of Citi. Your line's open.

Hey, guys. Thank you for taking the questions. Good morning. Maybe one on the NHP side. You know, certainly it was expecting a headwind, maybe a little bit higher than we were thinking. Can you just remind us, I guess, kind of your full exposure there, just thinking about that $80 to $100 million, what the supply disruption looks like currently? And then, again, I guess visibility there. into that normalizing? I'm just trying to figure out, I guess, that 80 to 100, you know, is that kind of fully grappling it? Is that a conservative number? Maybe just kind of walk us through your thought process, and again, maybe what the sizing was and what that looks like. Appreciate it.

Yeah, you know, we've said before that the NHP as a part of our total revenue is less than 2%, and the 80 to 100, and we've also said that it will not be a full year impact. So, you can see the 80 to 100 million is within those guidelines that we've said previously. The majority of the impact will be in the first quarter, and there'll be some impact into the second quarter. Over the past three months, we've contracted with multiple organizations to secure supply for the near, but also, importantly, for the longer term. And as I just said, that we believe that these are going to be temporary because we've already begun to receive, you know, the beginning of the shipment. So I feel that the 80 to 100 is a realistic range. Um, but, you know, we'll hopefully be more towards the lower end of that, but we'll know with time.

Okay. But you, you've got decent visibility into things normalizing by call.

Yeah, we have, we have visibility that we have the contracts in place that we've started to begin to receive some of the shipments. So I feel good about those things.

Also, Patrick, when, when you think about the growth rate for 23, the five to 7% growth within drug development. you know, that 80 to 100 or obviously the midpoint gets you to around a point and a half of a headwind that's captured within that growth rate. But similarly, we expect to have less COVID-related vaccine and therapeutic work in 23 versus 22, which is at a similar number. So, you're looking at around three percentage points of headwind from those two issues that are reflected in that five to seven percent growth, which obviously would have been greater without those constraints. But both of which we would expect to then be done with through, you know, 2023. Right. Appreciate it, guys.

Thanks.

Yep. Please stand by for our next question. And our next question will come from Brian at Tankwilit of Jeffries. Your line's open.

Morning, Brian.

Hey, good morning. Good morning. Glenn, as I think about guidance, you know, obviously COVID's rolling off here, but as I think about margins, I mean, anything you can share with us in terms of what drives your confidence in the margins, especially in the core lab business going forward?

Yeah, no, we actually feel good about how the business is performing. We obviously give guidance to the revenues within diagnostics, so that 10.5% to 12.5% Overall, again, the interesting part is part of that growth, a little less than half of it, call it with ascension, which will mix down our margins, but the underlying business growth is very strong in 23, in part due to the fact that 22 wasn't a full year, so the recovery is coming in. And with that incremental demand, mostly driven by volume, we're going to get good leverage on it. Helpful, again, that we don't have PAMA, but we believe that we can drive margin improvement slightly in 23 versus 22 with the headwind of Ascension, but again, without the headwind coming in from PAMA. But overall, Launchpad continues to be on track, good expense control, and again, fundamentally good growth in the business. All right. Thank you. Thank you, Patrick.

Please stand by for our next question. And our next question comes from Eric Caldwell of . Good morning, Eric.

Thanks. Good morning. So, yeah, going to come back to the NHPs, but hopefully pretty quick. Are the only supply constraints that you're seeing today related to the one Cambodian manufacturer in the news as the original source? your suppliers that receive some or all of their volume from that source, or have you seen supply constraints from other existing partners that you used to work with?

Yes, so again, some of the partners use that same supply source, so you might have some issues with that specific source. But what I can say with the contracts that we've signed and the suppliers that we have, we're confident that we'll be able to use that supply moving forward. So I feel good about the contracts that we put in place, Eric.

And then on margin in drug development, I thought I heard you say you expected flat margin here in Q1. Can you confirm that? So something around 11.5 percent? Is that reasonable?

Yes. So we're assuming that the margin will be flat versus this margin last year, so I think that's about right. You know, the big issue there is the fact that we not going to have the supply of the NHPs in the first quarter and therefore we won't be able to you know have we'll have most of that 80 to 100 million dollar impact with a lot of it flows through because we still have all of the uh people and hiring people for that group we have the facilities and so forth so we're not making any changes to try to manage that margin because we know the supply is coming in so that'll be the toughest There might be a little bit spillover in the second quarter, but overall, we expect that we'll have some margin appreciation for the drug development business for the full year, with the second half certainly being better than the first half.

Great. And then last one for me, if I can. Central Lab has apparently one more tough quarter on last year's activity. Q1-22 was pretty solid. Are you expecting Central Lab to be back to growth by the second quarter? Can you give any updates on how those past kits that were sent didn't come back? Are you seeing any changes in dynamics in terms of order flow on kits or returns on kits? Just trying to get a better sense on when we can expect the central lab business to resume year-over-year growth. Thanks.

Yeah, so the first quarter of 2019, we were still doing a lot of COVID-related work, particularly for the booster shots for Omicron. That'll be the toughest quarter of next year, will be the first quarter. As I look at orders in that business, they look great. And I'm actually very optimistic about our central laboratory business moving forward. I think we're just overlapping tough comparisons, but book-to-bill orders, I mean, everything I look at in a business is good. We are not yet at the kit return level that we were at in 2019. I still think that some sites are struggling to enroll as many patients as they have in the past. but we are seeing the KIT returns increase month over month, and I feel confident that we'll continue to see that as we go through this year.

Eric, the only thing I'd add to that is, to your point, the first quarter will be the one that would be down year on year before things annualize, and then we'll look at good growth throughout the remainder of the year, but we'll still have that constraint. We've talked about that we're still going to see, while the supply chain or Uh, issues, which was really more of a 21 issue. So we were down in 22 from the supply 22 supply levels were more normalized. So the year on year COVID related impact will still be with us doing less vaccine and therapeutic work. In 23, then we did in 22, even with that headwind that again, we sized up at around 90Million so called a point and a half for the overall segment. Obviously, it's a bigger constraint when you just look at it, because it's mostly within our central lab business. But even with that headwind, we still expect to see very good top line growth throughout the three quarters, second, third, and fourth quarter of 23. That's great.

Thank you.

Thank you.

Please stand by for our next question.

Our next question comes from Derek DeBruin of Bank of America. Your line's open.

Good morning, Derek.

Good morning. This is John on for Derek. Um, I wanted to ask, Hey, good morning. I wanted to ask about the free cashflow glide guide. Um, I obviously the last few years you've benefited from the COVID testing, but even when I look at the 2019 level, it was around over 1.3 billion. So, um, was wondering if you could dig into what sort of factors are in there. Um, maybe there's some large spend expenses, um, that you've mentioned before.

Sure, John. Well, first of all, obviously, we wrapped up the year of 2022 on a very strong level, over half a billion dollars of cash flow in the quarter, getting us to a billion and a half for the full year. When you look at the midpoint of our guidance at the 1.1 billion, the decline from 22 to 23 is all attributable to lower COVID testing earnings. In fact, we're looking at good growth in base business earnings. We've talked about earnings per share on a base business being up around 13% in our guidance. So we're getting good cash generation from our base business, and that's going to be partially offset by increased spending in CapEx. We kind of talked about around a 3.5% rate in revenues that are growing, so we continue to see good investments for capital investitures. And in addition, working capital will be a use of cash a bit. supporting the growth in the base business as well, albeit we do expect to see an improvement in our DSOs, which will help mitigate the cash needed for working capital. But overall, we feel a good year of free cash flow generation.

Great. And I wanted to ask what the site access level is looking like. You've talked about a lot of puts and takes of the clinical lab and the ED, but compared to this quarter passed. Has there been any improvement and also on labor constraints? If you could comment on that, that'd be great.

Yeah, I mean, I would say there's still a difficult labor environment in healthcare in general. We have made some progress in acceptance rates that we make offers. We're getting more people that are accepting our offer than we have in the past. We're working hard on retention because what happens is once you get somebody in, you train them, it takes time. You have to find a way to retain them over time, and we're working hard on that. I would say that there's no doubt that it's getting a little bit better, but it's still not where it used to be, and there's still a lot of issues in terms of the labor market across all of healthcare, frankly.

Gotcha. That's all for me. Thank you.

Yeah, thank you.

Staying in file for our next question. And our next question comes from AJ Rice of Credit Suisse.

Your line's open.

Good morning, AJ. Hi, everybody.

I know you've given some very specific information about your assumptions around COVID testing, and we can, you know, develop our estimates around that. But I wondered, in the capacity that you've had historically the last three years devoted to COVID testing, Is that redeployment into other areas pretty seamless? Is there any drag that you're dealing with as that's been coming down that will then become a tailwind for you as that fully gets redeployed? Can you talk about that a little bit?

Sure, AJ. So just to give a sense, so in the fourth quarter, the volume was about 16,000 per day. We're giving a bit of a wide range because it's difficult to tell, but we're giving somewhere between 5,000 and 12,000 per day as guidance. If you just look at the month of January, just to give you a sense, it was about 11,000 per day. And what we're trying to do is make sure that we have capacity to do more than what we think we need, but we have nowhere near as much capacity as we had historically when we used to be able to do over 300,000 tests per day. We brought that capacity down. We can redeploy some of that equipment. We don't expect to have any large write-offs from equipment or anything like that. The equipment returns its cost of capital very quickly, as you can imagine. So I don't think it's neither a headwind nor a tailwind. I think it's basically, you know, we've done what we can do for COVID. Whatever we need to do for the tail end of COVID, we will do. But now we're really focused on driving our base business. And that's where we're excited because the base business looks really strong in the diagnostic area.

AJ, the only thing I'd add too is we commented that the COVID business obviously was still at a very attractive margin at 50%, and we've said that we've kept excess capacity available as long as we continue to be within the public health emergency. When that expires, which at least is anticipated in, call it the middle of May, the assumption is that the pricing or reimbursement will come down. And then from our perspective as well, we'll manage our cost structure appropriately and take out some of that excess capacity, still leaving enough to hopefully handle if there were to be an increase. But that'll result, obviously, in the margins coming down a bit as well. But still, COVID should continue to be at a margin greater than what the segment average would be.

Okay, that's great. And then maybe just on the hospital business, I think, if I remember right, you had assumed that Ascension really wouldn't contribute much on the bottom line in the fourth quarter as I was sort of ramping up, but that maybe as you get everything working well, you make sure the customer's happy, et cetera, you would see gradual margin improvement over the course of 23. Can you give us any more flavor for how much that is baked in? And with Ascension and some other high-profile deals announced, I know you guys mentioned the pipeline looks I wondered if sometimes deals, we get more deals, are you seeing even an acceleration activity behind the scenes and people that are interested in perhaps taking a look at this?

Yeah, so to answer the second part of the question, first, yes, we are seeing an increased number of people that are interested in looking at us running and acquiring parts of their hospital business. If you look at 2023, Ascension revenue is going to be about 5% of the base business growth. So if you do the math, it's approximately $550 to $600 million in 2023. That's consistent with the initial guidance that we gave at the time of the acquisition, so we feel good about where we are and how we've been achieving the goals of that deal. The margin is expected to be in the low to mid-single digits in the first year, but it will improve over time. It will never get to our average margins because the hospital business margins never get as high as our average diagnostic testing, but it certainly will improve as we go through this year and into next year and beyond.

Okay, great. Thanks so much.

I want to thank everybody for joining us today. Looking ahead, we are on track to achieve important milestones on this spin. We're looking to deliver on enterprise strategy and commitments, and we feel great about the future business. I want to thank you for joining us, and we'll look forward to talking to all of you soon.

I would now like to hand the conference back to Adam Schechter for closing remarks.

Thank you, everybody. It's been a pleasure to spend time with you. We appreciate that. Looking ahead, we're on track to achieve important milestones such as the spin, and we're excited about 2023 and beyond. So have a great day, and we'll talk to you all soon.

And this concludes today's conference call. Thank you for participating. You may now disconnect.