ICON plc

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Good day and thank you for standing by. Welcome to the ICON Q4 and Fall Year 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 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, Kate Haven. Please go ahead.

Thank you. Good day, and thank you for joining us on this call covering the quarter and full year ended December 31st, 2022. Also on the call today, we have our CEO, Dr. Steve Cutler, and our CFO, Mr. Brendan Brennan. I would like to note that this call is webcast and that there are slides available to download on our website to accompany today's call. Certain statements in today's call will be forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. Actual results may differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, and listeners are cautioned that forward-looking statements are not guarantees of future performance. Forward-looking statements are only as of the date they are made, and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events, or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by the company, including the Form 20F filed on March 1, 2022. This presentation includes selected non-GAAP financial measures, which Steve and Brendan will be referencing in their prepared remarks. For a presentation of the most directly comparable GAAP financial measures, please refer to the press release section titled condensed consolidated statements of operations. While non-GAAP financial measures are not superior to or substitute for the comparable GAAP measures, we believe certain non-GAAP information is more useful to investors for historical comparison purposes. Included in the press release and the earnings slides, you will note a reconciliation of non-GAAP financial measures. Adjusted EBITDA, adjusted net income, and adjusted diluted earnings per share exclude stock compensation expense, restructuring costs, foreign currency gains and losses, amortization and transaction-related and integration-related costs, and their respective tax benefits. We will be limiting the call today to one hour and would therefore ask participants to keep their questions to one each with an opportunity to ask one brief related follow-up question. I would now like to hand over the call to our CFO, Mr. Brendan Brennan.

Thank you, Kate. In quarter four, ICON achieved gross business wins of $2.7 billion and recorded $355 million worth of cancellations. This resulted in net awards in the quarter of $2,350,000,000 and net book to bill of 1.2 times. Full year 2022 gross business wins were $10.99 million and cancellations were $1.54 billion. resulting in net business wins of $9.45 billion and a net book-to-bill of 1.22. With the addition of the new awards in quarter four, our backlog grew to a record $20.7 billion, representing an increase of 2.4% on quarter three of 2022, or an increase of 8.7% year-over-year. Our backlog burn was 9.7% in the quarter, in line with quarter three levels. Revenue in quarter four was $1,962,000,000. This represented a year-on-year increase of 4.3% on the adjusted revenue, or 7.6% on a constant currency organic basis. The revenue impact from year-over-year changes in foreign currency exchange rates resulted in a headwind of approximately $63 million in quarter four. Full year revenue was $7,741,000,000. This represents a year-on-year increase 41.2% or 45.4% on a constant currency basis. Revenue from our top 25 customers consisting of a range of customer sizes increased from quarter three. Concentration in our top customer represented 9.2% of revenue and our top five customers represented 29.3% of revenue. Our top 10 represented 44.5% while our top 25 represented 67.8%. In the full year 2022, our top customer represented 8.8% of revenue and our top five customers represented 28.3% of revenue. Our top 10 represented 42.7%, while our top 25 represented 63.1%. Gross margin for the quarter was 29.9% compared to 29.5% in quarter three. Full year gross margin was 28.9%. Gross margin strength was driven by continued direct fee revenue growth and improved resource utilization in quarter four. Total SG&A expense was $182.2 million in quarter four, or 9.3% of revenue. In the comparable period last year, total SG&A expense was under $97 million, or 10.5% of revenue. We expect total SG&A expense to be similar absolute level in quarter one. Full year SG&A expense, with $757.4 million. Adjusted EBITDA was $405 million for the quarter, or 20.6% of revenue. In the comparable period last year, adjusted EBITDA was $332.5 million, or 17.7% of revenue, representing a year-on-year increase of 21.8%. Full year 2022 adjusted EBITDA was $1,479.5 million, or 19.1%. Adjusted operating income for quarter four was $377.7 million, a margin of 19.3%. The net interest expense was $70.4 million for quarter four. Full-year net interest expense totaled $210 million in 2022. This represented an increase of approximately $50 million from our initial assumptions for full-year interest expense when guidance was issued. back in January 2022. The effective tax rate was 16% for the quarter. The full year 2022 effective tax rate was 16.5%. Adjusted net income attributable to the group for the quarter was $257.7 million, a margin of 13.1%, equating to adjusted earnings per share of $3.13, an increase of 19% year over year. Full year adjusted net income attributable to the group with $968.7 million equating to adjusted earnings per share of $11.75, an increase of 21.7% year over year. In the fourth quarter, the company recorded $10.7 million of transaction and integration-related costs. Full-year transaction and integration-related costs were $39.7 million. U.S. GAAP income from operations amounted to $203.4 million, or 10.4% of revenue during quarter four. Four-year U.S. GAAP income from operations amounted to $795.2 million. U.S. GAAP net income attributable to the group in quarter four was $117.4 million, or $1.42 per annuity share, compared to $0.92 per share for the equivalent prior year period. Full year US GAAP net income attributable to the Group was $505.3 million or $6.13 per diluted share compared to $153.2 million or $2.25 per diluted share for the full year 2024. The additional dynamics we discussed on the third quarter call for the year remain in place with the expectation of a continuing revenue headwind from foreign exchange in the first half of the year with the largest impact expected in the first quarter. Backlog conversion is expected to average 9.5% for the full year, as we continue to see a mixed shift towards longer-duration, full-service programmes in our backlog and a lower overall contribution from vaccine-related studies. Additionally, COVID-related programmes are expected to represent approximately 4% of our total revenue for the full year, down approximately 200 bps from the 2022 levels. Separately, we will see a sequential increase of approximately $10 million in our quarterly interest expense in quarter one. Net accounts receivable was $1,182,000,000 at 31 December 2022. This compares with a net accounts receivable balance of $934 million at the 30th of September 2022. DSO was 54 days in the quarter, up from 31 days on a comparable basis for December 31st, 2021, and up from 43 days on a comparable basis September 30th, 2022. Cash outflow from operating activities in the quarter was $59 million. We saw an increase in our DSO as we continue to align billing payments and collection processes. We are, however, encouraged by the record billing quarters we had in quarters three and four in 2022, resulting in an increase in total billed accounts receivable coming due within the first half of 2023. Our target DSO is still circa 45 days and we expect to see positive movement as we proceed through 2023. At December 31st, 2022, the company had a cash balance of $288.8 million and debt of $4,654,000,000, leaving a net debt position of $4,364,000,000. This compared to net debt of $4,239,000,000 at September 30th, 2022, a net debt of $4,682,000,000 at December 31st, 2021. Capital expenditure during the quarter was $57,000,000. We ended the quarter with a net debt to trailing 12 months adjusted EBITDA ratio of 2.9 times. Down substantially from our net leverage ratio of 3.4 times adjusted EBITDA at the end of 2021. Our capital deployment priorities continue to be the pay down of debt And as such, we made payment $200 million on our term loan B facility in the quarter, bringing our total repayments to $800 million for the full year 2022. As previously communicated in January, we finalized our hedging strategy at the end of the fourth quarter to provide more certainty around our total interest expense in 2023 due to the volatile interest rate environment. The hedging solution resulted in the proportion of our fixed rate debt mounting to circa 60% of our total debt. Our current 2023 full year guidance assumes total interest expense for the full year to be in the range of $280 to $300 million. Based on our current projections on rate movements throughout this year, we anticipate the full year interest expense will be at the higher end of that range. With all of that said, I'd now like to hand over the call to Steve.

Thank you, Brendan, and good day, everyone. 2022 marked another year of success for ICON as we continued our journey to become the world's leading healthcare intelligence organization. The year was certainly not without its challenges as the effects from the war in Ukraine, ongoing pandemic related issues and several macroeconomic headwinds impacted our operations and financial results. Against this backdrop, ICON continued to deliver consistent and predictable results for our investors through the deployment of our comprehensive clinical services, strong customer focus, and rigorous cost management. We recognize another important milestone for ICON this week as we approach the two-year mark of the announcement of our union with PRA Health Sciences. We've made significant progress on creating a unified employee experience through the harmonization of systems, processes, and facilities across the organization. Our approach in utilising the best of both companies has benefited our teams and most importantly our customers as we evaluate every decision through the lens of how we can optimally position ourselves to deliver our expanded capabilities efficiently and effectively as one icon. Progress towards achieving our synergy targets has continued as previously communicated. with the expectation to realize the full $150 million of cost synergies in 2023, one year ahead of our initial target timeline. Our revenue synergy of $100 million exiting 2024 remains on track after continued success in securing cross-sell awards, which exceeded $100 million for the full year 2022. The fundamentals of our industry remain healthy, as demand for efficient, patient-centric clinical development services continues across biopharma customer segments. We have seen consistent trends with regard to overall RFP activity, as well as our resulting business development performance, as mid and large biopharma customers have continued to show strength across these areas. In the emerging biotech segment, we have seen sponsors continue to closely manage overall spending levels and optimise development strategies as the broader funding environment impacts their decision making. We are encouraged that we have not seen an uptick in cancellations, bad debts or material project delays as a result of the current environment, but RFP activity in the biotech segment has been muted in the second half of 2022 and we expect this to continue this year. Nevertheless, as biopharma customers navigate the uncertain macroeconomic environment and assess potential implications for their portfolios, we believe opportunities will emerge to find new ways of supporting our customers as they evaluate their outsourcing strategies. Our diversified and well-balanced portfolio appeals to customers across segments, as we are uniquely positioned to customise our offering for their specific needs and gain market share. Further to this point, I am pleased with the success we had in securing additional strategic partnerships in 2022 across our business segments. One highlight was a recent strategic partnership we executed with a mid-sized pharma sponsor to be their sole provider, delivering a customized integrated model of development, leveraging several ICON services, including full service and functional offerings. ICON has worked closely with this customer for a number of years, and together we constructed an optimal end-to-end solution that will provide efficient portfolio execution and outcomes. By drawing upon ICOM's wealth of expertise and unique broad service offering, we believe this partnership can achieve our customers' goals of bringing innovative treatments to patients faster through a scalable development model. In our biotech solutions business, we are continuing to gain traction with program wins utilizing our customer-centric engagement approach. This is predicated on early consultation with customers, including medical, regulatory, and therapeutic experts alongside our operational teams to truly understand our customers' needs and bring valuable insights to their development plans. For instance, we had recent success with a mid-sized customers program in lung cancer, collaborating on a novel development plan to target accelerated approval of their drug, utilizing ICON's leading therapeutic expertise and experience in this complex area of development. These recent wins are select examples of a broader trend we are seeing in the industry, which requires CROs to adapt and customize offerings, leveraging innovation, technology, experience, and expertise to further evolve outsourcing delivery models. we remain committed to our structure of focused operational units that serve distinct customer segments and development models. This uniquely positions ICON to provide flexible solutions that address customer needs regardless of size or preferred outsourcing practice. Our approach, along with our significantly increased capabilities and scale, has allowed us to engage in discussions with a number of potential new partners and we are excited about the opportunities that lie ahead. As we build towards our vision of becoming the world's leading healthcare intelligence organisation, we are investing in and executing on important initiatives across ICON to position us for further success in our market. Innovation at ICON is a critical element of our strategy and value proposition as we develop integrated technologies and advanced analytics that are focused on outcomes that matter most to our customers. We continue to simplify and streamline processes throughout clinical development and across our service offering, enabled by the application of tools like AI, machine learning and robotic process automation. RPA had a very impactful year in 2022 as we processed over 1 million hours of activity through automation. Separately, ICON Labs recently launched the SOLAR platform, a digital tool utilized for customers to improve efficiency in our study setup process. This platform provides sites a sophisticated interface with technology features to reduce rework, minimize manual data entry, and reduce errors. SOLAR is one component of our long-term strategy in driving towards greater use of mobile applications to automate site activities and enhanced sample management capabilities. Additionally, following the release of our 2021 report, our ESG program was awarded a silver medal from EcoVadis, the world's most trusted provider of sustainability ratings, achieving an overall score improvement of 40% from 2020 through 2022 and placing ICON in the top quartile of companies participating in its program worldwide. We have also launched Icon Cares, a company-wide initiative that demonstrates our ongoing commitment to ESG and monitors progress across our goals in this important area. We aim to engage our employees and identify further opportunities for advancement in areas like diversity, inclusion, and belonging, where we can make a positive impact on our people, partners, communities, and patients. Turning to our financial performance in quarter four, ICOD delivered very solid results with 4.3% revenue growth or 7.6% revenue growth on a constant currency organic basis over quarter four of 2021. Excluding COVID related work, revenue growth increased over 10% year over year on the same basis. Net bookings were flat sequentially and continued to be impacted by foreign currency and the strengthening of the US dollar on a comparative year over year basis. Backlog grew 8.7% over backlog at the end of December 2021, as demand for our service was particularly strong from the mid and large pharma customer segments. We also saw strong expansion of our gross margins as increased utilization and direct fee revenue growth helped drive sequential and year-over-year improvement. Further, our focused cost management and initiatives to leverage our best-in-class global business support model resulted in an adjusted EBITDA margin in Q4 of 20.6%, an increase of 110 BIPs sequentially and 290 basis points from Q4 2021. Finally, adjusted earnings per share met our expectations in both Q4 and the full year, resulting in an increase of 19% and 22% year-over-year respectively. We continued our progress in reducing our floating rate debt exposure by making a $200 million payment on our Term Loan B facility in quarter four, bringing total repayments for full year to $800 million and resulted in a ratio of 2.9 times net debt to adjusted EBITDA at the end of the quarter. We expect to continue our payments on our Term Loan B facility averaging $200 to $250 million per quarter in 2023. Our capital deployment strategy remains focused on debt pay down in the near term, while our increasing activity in building our M&A pipeline. On that note, we currently see a number of interesting opportunities to enhance our existing capabilities and further differentiate our service offering. Our strong performance in quarter four and in 2022 positions us well for continued growth this year. We are reaffirming our full year 2023 financial guidance that was issued in January, with revenue in the range of $7.94 to $8.34 billion, representing growth of 2.6% to 7.7% on a year-over-year reported basis, and adjusted earnings per share in the range of $12.40 to $13.05, representing 5.5 to 11.1% growth on a year-over-year basis. This guidance assumes very strong adjusted EBITDA growth continuing for the full year 2023. We remain focused on the longer-term growth targets we have set for 2025 as we continue to successfully navigate an uncertain environment supported by the fundamental drivers of demand for outsourced clinical development. Our revenue ambition of $10 billion remains in place as we envision M&A contribution to revenue returning in the back half of this year and into 2024. We've already made excellent progress toward our adjusted EBITDA margin target of 21%, as well as strong earnings per share growth despite the significant movement in interest rates over the past year. To turn towards our organisation for a moment, Our employees are at the forefront of what we do at iPhone, and during the year, the commitment of our team shone through regularly as we continue to find ways to meet customers' needs and support patients and sites across the globe. We are constantly challenging ourselves to be the employer of choice in our industry. To this end, we are making focused investments in our people in areas such as career development, leadership training, compensation, and talent acquisition. This will ensure our success in recruiting and retaining talent, as well as maintaining an environment where people are proud to work and feel supported and challenged in their roles. We believe this has contributed to the positive trends we have seen in employee retention, which improved sequentially every month throughout 2022, despite the very competitive labour market in our industry. we were named to Forbes America's best large employers list for the fourth time since 2018. Furthermore, ICON was recognized with a number of industry awards throughout 2022, and I was particularly proud of our team being recognized at the 2022 Scripps Awards as the best full-service CRO. In closing, and before we move to Q&A, I want to recognize the resilience engagement and strong performance of our colleagues across ICON. We are grateful for your commitment to excellence and ongoing efforts for our customers, sites and patients. Operator, we're now ready for questions.

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We will now go to your first question. One moment, please. And your first question comes from the line of Sandy Draper, Guggenheim. Please go ahead. Your line is open.

Great. Thanks very much. I guess first question, and I'll try to keep it short, just on Brendan, if you can just remind me, the change in the billing terms, was that dictated by the customers, and is that related to You know, the current macro environment, what caused you to change that? It sounds like you expect DSOs to come back down, and I think you're still targeting over a billion dollars in free cash flow. But just trying to understand, again, what happened there, and then how we should think about the improvement over the course of the year in terms of the cash flow.

I don't know if it was that complex, Sandy, to be honest. We did a lot of integration work during the course of 2022. Certainly some of that distracted us. The billing levels were probably a little lower than I would have liked earlier in the year. But as I said in my prepared comments, we really saw a significant improvement in that billing levels in Q3 and Q4 particularly. And we do see that having a positive cash flow impact in the first half of this year. So I would say it was more of that. I think our billing, our contractual terms, our commercial terms, relatively consistent. Our mix of business is we have a good mix of customers in terms of large and small and mid. So it hasn't really changed significantly, but I think what we have seen, as I said, very strong billing in Q3 and 4, and I'm very much hoping that that will have a positive impact as we go through H1 and, as a consequence, then get us back on track in terms of that cash conversion story that you'll be very familiar with.

Got it. Okay, that's helpful. And then I think this is a related follow-up. In terms of capital deployment, it sounds like, Steve, you commented, it's really focused on debt pay down. You haven't bought back any stock in the last three quarters. My assumption, and I'd like to see if it's a fair one, is a pretty low probability of share repurchases given the interest rate environment and to focus on paying down debt. Just want to make sure I'm reading that right or hearing that right.

That would be a very accurate assumption, Sandy, yes. We will focus on debt pay down and share buybacks at this point. Well, you never rule them out, but at this point, really not high on our agenda.

Okay, great. I'll yield the floor. Thanks.

Thank you. Thank you. We will now go to our next question. And your next question comes from the line of Justin Bowers from Deutsche Bank. Please go ahead. Your line is open.

Hi. Good afternoon, everyone. Just a few on the background. Could you, sorry, the backlog, could you characterize the solutions that large pharma are requesting Let's say as we enter 2023 and how that shifted as we entered an endemic state. And then can you remind us on your backlog policy for the FSP business and whether the mix has increased or decreased over the last, let's say, 18 months or so?

Sure. I'll take the question on large farm adjustment. Maybe Brendan can talk about the backlog shift. We see large pharma talking to us about a number of different models. Sometimes I think we think that companies have very pure models. Most of them have a component of the various services that we offer, whether it be functional, whether it be full service, whether it be some sort of mix. And so most of them do that. There's certainly some of the larger farmers we're talking to more about the hybrid models or more about a functional. Others are continuing down the full service, the mid-sized farmers probably more down the full service as are the biotechs. You know, I don't think we see any sort of major push one way or the other at this stage. And that suits us fine because being so well positioned in the in the functional group with a leading purveyor of those services in the market and also well positioned in the full, we feel we can offer either of those solutions or a combination of those solutions. And so if there's any trend, I suppose it's probably more towards that combination, that hybrid model where they want functional for certain areas, but they're very cognizant of the benefits of full service for others as well. So if anything, it's probably moving towards, perhaps a bit more towards a hybrid, but really all of those, particularly large farmers, have a combination of those sorts of models in place already. And so the trends are minimal. Do you want to talk about that?

Yeah. In terms, Justin, of the actual how we book it into backlog, those FSP contracts, functional staffing contracts, we very much are fairly conservative around that. They're based on renewals, those on an annual basis. So we look at 12 months out in terms of how many heads we'll have on billing for that period. and then we'll make sure we've always got a 12-month period in front of us in backlog. We don't go beyond that. They can have MSAs, obviously, that go for three or four years, which we generally wouldn't take anything more than 12 months directly in front of us. In terms of the movement in the mix of backlog year over year, let's say end of year 21 to end of year 22, I wouldn't say that we've seen a significant increase in the FSP proportional to the full-service outsourcing. In fact, the full-service outsourcing had a very strong year in 2022, so... To Steve's point, it's always a blend. It's never straightforward, but certainly no massive shift that would impact on the backlog in terms of the mix.

Got it. And then just a quick one on the guide and then Steve's commentary. Does the range reflect some M&A, or would that be incremental to the top-line guidance?

The guidance was given with the assumption that there is no M&A in the adjusted service There would be some upside potentially if we're able to execute in the back end of the year.

Understood. Appreciate it.

Thank you.

Thank you. We'll now go to your next question. And your next question comes from the line of Patrick Donnelly from Citi. Please go ahead. Your line is open.

Hey, good morning. Good morning. Thank you guys for taking the questions. Steven, maybe one just on the biotech first, kind of mid to large pharma. It sounds like the biotech RFPs for the second half are a little softer. Sounds like you're expecting that to continue here for a little bit. Can you just talk about, I guess, the conversations you're hearing from customers, visibility into maybe that ticking back up, and then On the back of that, just the confidence level in terms of the mid to large remaining strong enough to kind of offset that in the near term. I'd just be curious to hear kind of the different conversations going on with customers there.

Yeah, Patrick. The conversations we're having with biotech is certainly the environment is more muted, I think, as I indicated in my comment, than it was, say, 12 months ago. They are being more careful and more deliberate in their spending and in their allocation of their capital. Interestingly, we've seen a reasonable uptick in the number of RFPs that we've received, but the value has been slightly down or certainly no better than flat. So that would sort of indicate smaller projects, again, perhaps focusing on asking specific questions or answering specific questions in the development program and get them to a point where they can raise further capital. So it's more cautious and more deliberate on the biotech space. On the other hand, in the mid and large pharma, we've had some pretty positive conversations around partnerships, about being more strategic, about being a greater part of their spendable focus. Certainly there are discussions around cost control and saving money there, but as a major player in the industry, we're able to go back to our larger pharma partners and talk about the sorts of savings we can generate if we receive a greater proportion of their spend, and we're able to cover a greater portion of their spend because we have the capability. So it's a different tone of conversation with our large farmer. Overall, we've seen the opportunities in that large and mid-size particularly sort of push upwards. It hasn't quite counted some of the downturn on the biotech, but as I look at biotech in the long term, we're coming back to a position on the long term that's sort of more in line with you know, the longer-term average, as I've said a number of times on these calls. You know, we had the sugar highs of a year or two ago, and we're coming back down to perhaps a more normal runway. I do expect that we've kind of hit the nadir and we'll be, you know, moving on and up going forward. I'm optimistic, but I think the next six to 12 months will be pretty much, you know, steady as she goes and much the same in the biotech segment.

Okay, that's helpful. And then maybe one for you, Brendan, just on the margin piece, you know, nice to see you guys be able to pull forward the synergies. Can you just talk about, I guess, the moving pieces this year in terms of some of the wage inflation pressures and then the offsets, obviously, being the synergies, maybe a little bit on pricing, just trying to get a feel for, you know, obviously you pulled forward the synergies, you know, pulled a big lever there. What's kind of left beyond this in terms of as you think about the model? You know, not necessarily 24, but just, you know, the 23 moving pieces. And then again, you know, the comfort that there's continued expansion beyond this after pulling the synergies forward. Thank you guys.

Yeah, I think that's, you know, I think one of the things we said from the commencement of the deal was that we hadn't fundamentally changed our spots. So we're always very careful cost managers. I think that's been apparent, obviously, since we completed the transaction as it had been before. I think one of the things as we go into 2023 and indeed out through 2024, and we look at that margin progress, we obviously want to see the good progress, the very, very good progress that we made in 22 and the back end of 22 sustained and developed as we go through 23. So I think it's more of that story. It's about slow development during the course of the year. I mentioned on the start of the call in my prepared remarks that SG&A, for example, in quarter one would be at a similar dollar level to what we saw in quarter four. So thematically, again, it's about controlling the call space while leveraging that top line. Very happy with the gross margin progress, obviously, in Q4 as well. It was very, very solid. So for me, 2023 is about establishing and stabilizing those levels and making sure we're considering and staying at those levels as we walk towards our kind of more midterm goal of getting to 21%. And obviously, as you can see, with the progress we made through 2022, we're well ahead of that target. I think, in all honesty, when we think about the further leverage that's left in the organization beyond that point, we never really put our feeling on our ambition. So we think about the 21%. We're going to move towards that, certainly, during the course of this year. And then it will be for us to have another look at the organization and see where we can go from there. I won't predestine that at this point in time, but I would say we would continue to be ambitious about further margin expansion beyond that point.

Great. Thank you, guys.

Thank you. We will now go to the next question. And your next question comes from the line of Eric Caldwell from Baird. Please go ahead. Your line is open.

Thank you. I have two. I'll start with just conceptually on the revenue guidance. I know in the prepared remarks there was a mention of some activity on the preferred provider front. If I'm not mistaken, I believe later last year there were comments that – or maybe early this year there were comments that if some of the larger opportunities in the pipeline emerged, it could bias your revenue towards the higher end of the range as you exit this year. I'm just curious, are there any updates on the pipeline for larger preferred deals, perhaps how many you're looking at or in negotiations on? what kind of timing might be available if some of those do materialize?

Yes. Eric, thanks for the question. I'd be hesitant to get too far ahead of ourselves in terms of pushing towards the upper end of the range at this point. We've always said these preferred provider discussions take a while. They typically award you some work and they expect you to deliver it well before they sort of fall into a full sort of partnership mode. We're in that sort of mode with a number of customers. I will say we've been able to engage with a number of significant large pharma players on partnership discussions that wouldn't have happened had we not formed the union with PRA. So we feel one of the key rationales for the deal was to be in those conversations, and we are. But as always, these things take a little bit of time to come through. So I wouldn't necessarily push us towards the high end of the range of our revenue guide at this stage. That may change if we look in the next quarter or two, but we'll certainly be ready to update you on one of these calls if that's the case.

Yeah, that's very fair. And then my additional question is around the comments on M&A. I'm curious if you could share with us what your current thinking is on areas of interest, what the pipeline of opportunities looks like, thoughts on sponsor or seller valuation at this point, and then just a confirmation or commentary around the old string-of-pearls approach that ICON undertook versus perhaps something a bit larger and meatier being in the pipeline or in the consideration here. Thank you so much.

Sure. So, you mentioned the string-of-pearls, and that is really our – so, we're sort of back to that sort of operational, sort of modus operandi, if you like, on an M&A. We don't see any you know, real transformational type big deals in the pipeline. I think we've done that. We're very happy with the progress we're making in that area, but I don't think we're going to go down that track again anytime soon. We are looking, you know, it's the usual area. There's some technology plays. There's some real-world evidence. We've seen great progress in the real world evidence group. Our late phase group has done very well over the last 12 months. We've made significant progress there. And so we feel there's some opportunity to continue the growth in that space. Our labs, we still believe we're a little behind where we'd like to be ultimately in the lab space. So that's an opportunity. And there's some areas around building on some of the previous acquisitions we did around MAPI and those sorts of areas. There's a number of tuck-ins and areas that we feel we can meaningfully contribute to our top line particularly, and of course the bottom line as well. In terms of pricing, you know, I don't think it's fair to say we haven't seen much of a decline. The pricing is still fairly frothy and the market is still fairly frothy in that space. And so, you know, we're going to be sensible and careful with how we allocate. Obviously, we can still continue to focus on the on the debt pay down and so I'm very cognizant of wanting to continue the good progress we've made there. So I think we'll look at all of the opportunities in the context of where we can best apply the capital that we have and we won't be doing anything crazy from a pricing or from a multiple point of view or from an overall cost point of view. But it's something that we're actively looking at and believe we'll have some opportunities come through in the next Well, you know, six to nine months.

That's great. Thank you very much.

Thank you. We'll now go to your next question. And your next question comes from the line of Luke Turgot from Barclays. Please go ahead. Your line is open.

This is Salomon for Luke, and thanks for the question. So just one on 1Q and pacing for the year. Some of your peers are guiding to a lighter 1Q compared to the remainder of the year. Just wondering if you're seeing a similar trend. So any color there would be appreciated. And on the free cash flow story and 4Q, anything else to call out there other than the billing process? Thanks.

Yeah, I might take those ones. In terms of 1Q, I think we made reference to the fact that it probably is the toughest comp on the foreign currency side of things as we go into the quarter. We're all long-term contract businesses, so the contracts you're working in in Q4 are pretty much the same ones you're working on in Q1. So I think the moral of the story is about the incremental growth, obviously, but there's obviously a very, very hard FX comp where the dollar was obviously significantly moved. during the summertime of 2022. So I think that's probably true of Q1, Q2. So I think totally Q1, Q2, the comps will be, the DAPI at Harner, obviously in Q3, Q4, they should improve. And that's the way we'd be looking at it. But nothing outside of that, I suppose, in a Q1 perspective. On the free cash flow as well, you know, yeah, it was disappointing. The vast majority of that related to the DSO in Q4. As I said on my comments to Sandy, I do think that was more around You know, really making sure that we were back on top of billing. I think that that slipped a little behind earlier in the year, and it kind of caught us then as a consequence in the back end of the year in terms of cash collections. So we're looking, and as I said, we had a very good quarters of billing, obviously in Q3, Q4, looked to capitalize on that in the first couple of quarters. That said, there was obviously some additional payments that we were making, and certainly we were trying to make sure that we're on top of all of our payments to our different investigators and other elements of the critical path in terms of clinical research. which are very, very important to the whole process. So certainly I think the combination of those factors has that negative outlook on cash flow. Again, as we go into the course of the year, we haven't changed our expectations, our forecast in terms of the free cash flow. Still ambitious about getting back on top of that cycle and seeing good cash flow conversion as we go through all of the borders of 23. Great.

That's it for me. Thanks.

Thank you. We will now go to the next question. And your next question comes from the line of Casey Woodwing from JP Morgan. Please go ahead. Your line is open.

Great. Thank you. So a few of your peers are going through some notable reorganizations here. One's putting a new team in place ahead of a spinoff. Another is sort of reshuffled their business development team. I'm curious as to what employee attrition looks like from your perspective. And then on the same coin, can you maybe touch on the competitive landscape, particularly in SMID biotech? You know, have your win rates increased or decreased at all over the last several months?

Sure, Casey. Our attrition rates have actually been – I'm delighted with them. We've actually – I think, as I mentioned in my comments, we've improved our retention month on month as we went through 22 surveys. So we've got our retention right back to where it was pre-pandemic levels now. I think we see continued trends of improvement there. Maybe that's partly because of some of the challenges our competitors have been having. I don't know. You'll have to leave that one to them. But we're very pleased with the way our retention's been improving. We've been investing heavily in that space, and our employees overall have been doing a terrific job in delivering for our customers. In terms of the biotech space and the competitive nature there, it's always a competitive space. And our win rates have held up pretty well. We feel good about what the opportunity... If anything, in terms of some of the challenges on the sales side, it's really because there haven't been quite as much to build, but we feel our win rates and our engagement with these customers has been strong. I do think in the longer term, we'll have some opportunity to gain market share in this space. As you noted, some of our competitors have some challenges, and we feel we're gonna be ready and able to make the most of those sorts of opportunities. But win rates have been solid. They tend to be a little volatile up and down. We don't, of course, always have the close relationship with the smaller customers that we do with the larger ones. And, of course, they come and they go a little bit. But overall, you know, we feel we have a good model that works well with that market. We feel the biotech companies and customers trust us and they feel willing and able to work with, you know, ICON. That is a large organisation and we feel that the focused effort and the focused attention and resources we put in biotech, we have about 8,000 people focused entirely in the biotech space really gives them some reassurance that they're not lost in the company and that they get the services and they get the result and ultimately the outcomes, which is what they need, that they need and that they deserve.

That's helpful. And then maybe if I can just squeeze one more in. There's been some noise around the Inflation Reduction Act and its potential to impact large farm R&D spend. Just coming out of our conference, it sounded like many of those pharma companies that would be impacted are expecting to increase R&D spending this year. But just wanted to get your thoughts on if the IRA has come up in your conversations with pharma and if that could be a risk at all. Thank you.

The IRA hasn't come up much in our conversations with large pharma. I recognize there's some puts and calls with respect to that. And we're generally seeing, as I've indicated, that the large pharma markets, mid-market is, sorry, the mid-sized market is on the uptick. It's very positive for us, counteracting a little bit some of the more muted approach in the biotech space. So IRA, there are some challenges. My understanding is that those are going to hit several years down the track. We're talking really three, four years down the track before they really impact our customers. And at that point, there may be some impact But overall, at this stage, it's having no impact on our business.

Thank you. We'll now go to the next question. And your next question comes from the line of David Windley from Jefferies. Please go ahead. Your line is open.

Hi, thanks for taking my questions. I wanted to weave kind of some follow-ups into topics that have already been touched upon. From a cadence standpoint and thinking about operating expenses, Brendan, you talked about the SG&A. Margin has commonly kind of stepped out of fourth quarter into first quarter pretty similarly, if not better. your fourth quarter in 22 ended on a very significant positive spike in margin. And so I wondered if beyond the SG&A, if you could just talk more precisely about how you expect the overall EBITDA margin picture to look as you enter 23 relative to where you're ending 22.

Yeah, I suppose my comments will start off by the usual health warning that subject to the euro-dollar rate remaining pretty consistent with where it is at the moment. So, yeah, engage your crystal ball for that one. But, you know, we're pleased with the work we've done in terms of our cost control during the course of 2022. I think one of the things, some of the points we made during the course of 2022 was we were doing large-scale infrastructural projects that would allow us to take a step in terms of some of the pieces, and particularly SG&A costs. I think you saw that specifically as we went through, particularly from Q3 and Q4, in terms of 2022 and how that's trended. We are, I suppose, planning for that level to remain very much the same nominally in dollar terms as we go through the course of 2023. So that certainly is a significant year-over-year advantage, if you like, in terms of margin profiles. I think your point to the sequential nature of it was it's about maintaining the good progress that we saw in Q4 into Q1 and then throughout the course of 23. So while I think maybe the margin expansion from Q1 to Q4 of 23 may not be as spectacular as we saw during 22, the full year-over-year margin profile will have stepped up quite nicely off the back of the work done during 22, kind of delivered in quarter four of 22, and then sustained and built on in a smaller way, but still building quarter over quarter as we go through 23.

In those infrastructure points that you're making, I know one of the things that is kind of core to ICON's cost management strategy is offshoring some of your HR legal accounting finance functions. Is that essentially what disrupted the billing activity that you're kind of dismantling the domestic U.S. PRA finance function and moving those activities over to, I presume, India?

Well, I mean, Dave, anytime you're doing significant integration work, there's always a bit of an issue around that. So it would be naive of me to say, no, nothing happened on that front at all. I mean, there was an element of that. However, I do think we have a structure now that is well-suited to what we need to achieve. We've got a great organization in place, and we've got the systems in place now. So we did an awful lot during the course of 22. We looked at where our staff were. We looked at the implementation of the Oracle project across the organization. I think those two things taken together were probably an awful lot to bite off and chew. In the course of a year, we're delighted we got there, and now it's a focus in the first half is obviously getting to make sure we get that cash in the door.

Okay, and then maybe a second follow-up to just come – at this topic slightly differently on the revenue front. So here you are on the dollar-euro. I don't have the math in front of me, but I'm thinking the headwind is the highest in the first quarter for 23, but wouldn't be any worse than the fourth quarter faced. And so I'll ask it one of two ways. Is that right and or From a burn rate standpoint, should we be thinking about the burn rate hanging in pretty consistently with the fourth quarter, or is that something that kind of steps down toward that 9.5% number that you're looking at for the full year?

I think on your FX comments, yes. I think fourth quarter into Q1, it shouldn't be materially different. We haven't got the average rates in those quarters, at this point at least. It's fairly consistent, so it shouldn't be. So that's what the... Constant currency uptick that we talked about in Q4 shouldn't be materially different in quarter one. Again, that's assuming we don't move around too much between now and the end of the month or the end of the quarter, I should say. On the conversion rates, you know, I think, you know, there's two parts at play there. There's obviously we talked about, you know, we're still seeing the vaccine work being a lesser part. Obviously, COVID, I made reference to that coming back a bit over the course of last year. We probably expect that to continue a bit as we go into this year. So it's still more around mix and mix of business going back to that more traditional model, I'll call it. So yeah, I think, Dave, that's something you probably will see a bit of a step down, and we guided at the full year. We're thinking about 9.5%, so I would expect a little step down on that one from Q4, Q1. As always, we'll do our absolute best to try to maximize it as we go through quarter by quarter.

Okay, that's great. Thanks for the perspective.

Thank you. We will now go to our next question. And your next question is, comes from the line of Elizabeth Anderson from Evercore. Please go ahead. Your line is open.

Hi, guys. Thanks so much for the question. I was wondering if you could talk a little bit more about the $100 million in cross-sells. What are you cross-selling? Is there a predominant directionality of the cross-sells? Where do you see that opportunity now, 18 months plus post the transactions?

Yeah, Elizabeth, the cross-sell, we monitor the cross-sell pretty carefully. It's not just anything that comes in the door. It's really looking at what we're selling in services that we had in the legacy icon organization, particularly to the legacy PRA organization or essentially our biotech group that they didn't have. So the best example of it is in the lab business. We've sold A lot of, well, that's the predominant, it's not just labs, but that's the predominant sort of the 100 million we sold last year. Lab business, because the legacy PRA group didn't have a lab. So all of their, you know, they're now proposing and selling Icon Lab into their biotech projects, which is a positive. Then there's things like our imaging group. Again, imaging is being sold in there. IRT is being sold in there. Firecrest. is being sold in there, our seller care site network is being sold. So lab being the biggest, but there's a number of other sort of more varied services that are now coming into the organization or coming into our biotech group that wouldn't have done in the past, and we've measured that fairly carefully, and as I said, the results are solid. Now it's gonna take a little while, of course, for that work to come in and allocate and then burn, and we don't anticipate being at that revenue synergy until we exit 24. But we feel we're well on track to make that progress, and the selling is happening.

Got it. That's very helpful. And one last question, just sort of cleaning up on the COVID commentary before. Do you expect that sort of 4% revenue total to be kind of like a go-forward rate at this point? I mean, I know it's hard to say. Or is it kind of, there's some discrete projects that definitively end this year, and you think going forward it's sort of more, you know, half that or some other amount, you know, on an ongoing basis?

Yeah, it's more the latter scenario that you painted, Elizabeth. I would say 4% is where we are at the moment. You know, we didn't win a lot of COVID work in the second half of last year, so it's going to be a declining part of our portfolio, I think, going forward. There'll probably be always be, for a long time, several years, be a component of COVID work, treatment work, whatever, long-term follow-ups. But it'll certainly decline from the 4% level it is at the moment.

Got it. Super helpful. Thank you.

Thank you. We will now go to our next question. And your next question comes from the line of Dan Leonard from Credit Suisse. Please go ahead. Your line is open.

So thank you for taking my question. Just a clarification, the net bookings were down the last couple of quarters year on year, and I know foreign currency is a driver, but do you think these trends are a reflection of aggregate industry RFP value or Has strength in the mid-to-large pharma part of your business been enough to overcompensate for small biotech caution?

I think that's probably a bit of both, Dan, if I can put it that way. We've certainly seen strength in the mid-size and the large pharma, and that has counteracted some downtick on the biotech space. Overall, we're about flat on the RFPs going forward and on a fairly 12-month basis. But they're still at pretty healthy levels. And when we do that, we focus on our win rates. And our win rates have been solid and strong. We believe we can improve them even going forward. So I think, as I say, the market has been changing, changing quite fast, quite dynamically over the last 12, 24, even 36 months. And we've certainly seen, as I say, a more muted biotech segment. But we're very pleased with the opportunities we're seeing in the large and mid-sized pharma. And we're taking advantage, full advantage of those. And that part of the business is doing very well.

Understood. And just a quick clarification on foreign currency for Brendan. Brendan, I think before you had discussed a 1% foreign currency headwind in the 23 guide. Is that still the case? Because it seems like currency could be a tailwind in the back half of the year.

I suppose, Dan, we should put a wager on this one. Well done on predicting what the FX rates might do. Yeah, 1% is where we were thinking coming into the year. It probably has softened a little bit from the 1%, in fairness, but it's still probably the best part of 1%. So I don't know if I'd really say it's materially moved enough to call out a different perspective. It's probably a little better than the 1%, so under 1% at this point, but as I said, not materially. Got it. Thank you.

Thank you. We will now go to your next question. And your next question comes from the line of Jack Meehan from Nefron Research. Please go ahead. Your line is open.

Hello, everyone. First question, both of my questions are sort of margin related. The first is on pricing. I was wondering if you could give us an update on the rate card and just in the inflationary environment if you've had any more success on putting price through.

I'll take that one, Jack.

I think we've had success in pushing forward rate increases, certainly above what the normal inflation rate is, although I would say it's probably more of a negotiation with our customers now than it was, say, a year ago. And so customers are happy to see sort of above inflation, I say happy, that's maybe a bit of an overstatement. They understand above inflation moves on rate cards, but if you're coming back two, three years in a row with that, that those discussions probably do get a little bit more challenging, shall I put it that way. So our customers do understand that we want to keep our employees competitive on a salary basis and all that good stuff, and that's to their benefit, of course, as well. So the discussions are always constructive. But the pricing environment is becoming probably a bit more competitive than it was, say, 12 months ago, particularly with, as I say, some of the challenges some of our competitors are having. So it's an area we watch carefully. But we feel, as I say, constructive discussions, but probably a little more challenging.

And then for Brendan, what are you thinking on gross margin progression for the year? And can you just provide some color on how wage growth and attrition trended throughout 2022?

Jack, I mean, I'm super happy with where we ended up in Q4 on margin progression. And I've said for a long time now, if we can If we can keep that in the ballpark at 30%, you know, I'll be happy. As we see the kind of competing elements of that coming through the course of the year, Steve made reference to a bit of a sharper pencils in terms of pricing. You know, there still is salary inflation there in 2023. So again, I suppose our story for 2023 is really about maintenance on that gross margin line as much as anything. Sorry, Jack, the second part of your question was? Oh, attrition.

Sorry. Yeah.

Yeah. No, so it was manageable during 22. As we said, we saw, you know, there's always two parts to, you know, wage growth. There's the underlying merit increase, and then there's the attrition piece, which is kind of the hidden increase, if you like. You know, we've seen, as Steve commented a couple of times, every month was better from a retention perspective. If you can work that down, you can certainly manage your call space efficiently as well, because obviously the new staff coming in are at a higher price. So I think that the blend of those things is still no worse than it was last year for 23, certainly, and certainly still workable within the margin profile. So we'll be looking at that in terms of 23. But it worked well, as you can see, from the margin profile during the course of 22. And I think the improved retention rates should offset some of that inflationary impact on salaries as we go through 23. Thank you, Brendan.

Thank you.

We will now take our last question for today. And your last question comes from the line of Derek De Bruyne from Bank of America. Please go ahead. Your line is open.

Hi, good morning. Thank you for fitting me in. So since a lot of things have been asked, I'll try to come up with something here. So a lot of the, we get asked a lot from investors about ex-COVID growth rates? I mean, some of the CROs report numbers differently and, you know, you've got some companies saying they're running 20% core like this. You call that a 10% sort of like ex-COVID growth rate in 4Q. What is sort of your ex-COVID core growth outlook, organic outlook for 2013? Just trying to get some impact on the headwind that comes in.

You're looking for

Guidance, essentially, on our- Yeah, yeah, basically, what your guidance would be ex-COVID. Yes, yes, yes, your core underlying growth, yeah. What our guidance would be.

So Derek is a, we called out, it was about, you know, it's sort of a 200 basis point headwind year over year from 22. The full year ex-COVID, you know, revenue, constant currency growth was about 14% in 22. So you can, I think, between those two sort of, you know, get to, get to what that looks like for, for 23. Great.

That's what I wanted. And, you know, I've had some investors asking, obviously there's been some issues in the early stage zero market with the NHPs. I don't think that's going to have a fallen impact to the late stage players like Icon, but we've had a number of investors asking, which sort of like appreciate your thoughts on, you know, do you see this sort of the, potential and studied delays in the early stage flowing through to the late stage. Thank you.

No, Derek, we haven't had any of our customers express any concerns about that in terms of the projects they're outsourcing to us. The NHBs are really focused in on, I think, on the preclinical CROs. I think they're the ones that have to deal with that. So it's not something that's really come up in discussions. with our customers and I don't anticipate it will impact certainly our late stage business, but even our early stage business, we're not seeing any impact at this point.

Thank you very much.

Thank you. I will now hand the call back to Steve Cutler for closing remarks.

Thank you, Operator. Thank you, everyone, for joining the call today. We look forward to updating you on our continued performance as we progress through this year. And again, recognize our employees for their continued dedication to ICON and our important mission in advancing drug development. Thank you all, and have a good day.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.

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