Ladies and gentlemen, thank you for standing by. At this time, I would like to welcome everyone to the IQVIA Third Quarter 2021 Earnings Conference Call. All lines have been placed on mute to prevent any background noise.

After the speakers remarks there will be a question and answer session [Operator Instructions] As a reminder, this call is being recorded. Thank you. I would now like to hand the conference over to your speaker today, Nick Childs, Senior Vice President, Investor Relations and Corporate Communications. Mr. Childs, please begin your conference..

Thank you. Good morning, everyone. Thank you for joining our third quarter 2021 earnings call.

With me today are Ari Bousbib, Chairman and Chief Executive Officer; Ron Bruehlman, Executive Vice President and Chief Financial Officer; Eric Sherbet, Executive Vice President and General Counsel; Mike Fedock, Senior Vice President, Financial Planning and Analysis; and Bryan Stengel, Associate Director, Investor Relations.

Today, we will be referencing a presentation that will be visible during this call for those of you on our webcast. This presentation will also be available following this call in the Events and Presentations section of our IQVIA Investor Relations website at ir.iqvia.com.

Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements.

The actual results could differ materially from those stated or implied by forward-looking statements due to risks and uncertainties associated with the company's business, which are discussed in the company's filings with the Securities and Exchange Commission including our annual report on Form 10-K and subsequent SEC filings.

In addition, we will discuss certain non-GAAP financial measures on this call, which should be considered a supplement to and not a substitute for financial measures prepared in accordance with GAAP. A reconciliation of these non-GAAP measures to the comparable GAAP measures is included in the press release and conference call presentation.

I would now like to turn the call over to our Chairman and CEO, Ari Bousbib..

Thank you, Nick, and good morning, everyone. Thank you for joining today for our third quarter results. Our strong momentum from earlier in the year has continued despite the resurgence of COVID-19 due to the Delta variant. This has not had an impact on our operations as we have learned to manage through these disruptions.

Our outlook for the longer term remains unchanged. The backdrop for the life science industry continues to be very strong. Biotech funding continues to run at record levels according to the National Venture Capital Association. Funding total of $35.8 billion through September 2021, already exceeding the full year of 2020.

The pipeline of late-stage molecules continues to expand and is at an all-time high with almost 3,000 molecules in active Phase II or Phase III development. Clinical trial starts are trending well ahead of recent years with the year-to-year date starts up 23% over 2020 and 13% over 2019.

And finally, new drug approvals by the FDA are keeping pace with the historically high levels of 2020, with 40 new drugs approved year-to-date, which set the stage for a strong volume of upcoming commercial launches.

The bottom line is the dynamics in the industry are strong, and we remain bullish on our outlook for our end markets and for IQVIA in particular. As we think about our longer-term plans, I want to remind you of our upcoming analyst and investor conference on November 16 in New York City.

At that meeting, we will provide financial guidance for 2022, ahead of our usual time line which is normally coinciding with the end of year results in early February. And we will share as well our midterm outlook and plans for the next phase of our Qs growth. We look forward to seeing everyone and hope you can join us then.

With that, let's review the third quarter. Revenue for the third quarter grew 21.7% on a reported basis and 21.1% at constant currency and was $64 million above the midpoint of our guidance range. The beat was driven primarily by higher pass-throughs, which, as you know, dilutes our margins somewhat as well as by stronger organic revenue growth.

Third quarter adjusted EBITDA grew 20.5%, reflecting our revenue growth as well as productivity measures. The $8 million beat above the midpoint of our guidance range was entirely due to the stronger operational performance. Third quarter adjusted diluted EPS of $2.17 grew 33.1%.

That was $0.07 above the midpoint of our guidance, with the beat coming from the adjusted EBITDA drop-through as well as favorability in below-the-line items. Let me now provide an update on the business. Our real-world evidence business continues to take a leading role in informing health care.

In late September, the FDA released their draft guidance on how electronic health records and medical claims data can support regulatory decision-making, and it cited several IQVIA publications.

With the growth of rare disease therapies and personalized medicine driven trials, the number of single-arm clinical trials increases every year and external competitors provide important context for these studies for both regulators and payers. Our clients recognize our leading expertise in this area.

For example, we had a recent major win to deliver an external comparator in a cardiovascular study for a top 20 pharma clients. In another example, we were awarded a 15-year follow-up study to demonstrate the long-term effectiveness and safety of a newly launched gene therapy.

Regulatory guidance requires extended follow-up for patients exposed to cell and gene therapy. And IQVIA's innovative real-world capabilities combining direct-to-patient solutions as well as IQVIA technology platforms to capture secondary data was pivotal in this award.

On the technology front, our suite of offerings continue to be adopted in the marketplace. You are familiar with our OCE platform and other commercial technology applications. And we have, of course, continued to expand our footprint here. We have 10 new client wins in the quarter, bringing the total number of OCE wins to date to 169 customers.

But we are also very excited to see increased adoption of our orchestrated clinical trial suite, OCT. This quarter, for example, a leading biotechnology company in Asia selected our site portal module within OCT to power site engagement across all of their trials.

We now have 165 customers that have bought the site portal module, representing 155,000 sites and 1,716 active studies that are using our site portal module. Similarly, our award-winning eCOA platform continues to experience strong demand. We have successfully deployed over 150 projects across 35 different therapeutic areas.

To date, we have over 70 customers using this platform, including 8 of the top 10 pharma clients. The platform has processed over 10 million unique patient responses in 65 countries and across 28 languages. Now I want to say a few words about a fast-growing part of our industry. You're familiar with decentralized trials or DCT.

The IQVIA decentralized trial offering combined several tech modules within our OCT suite including eCOA, eConsent, telemedicine and connected devices as well as other service capabilities, including home nurses and phlebotomists along with our decentralized trial patient cancers and study coordinators, all organized around our decentralized trial platform.

Importantly, we've developed innovative clinical patient engagement offerings, including direct-to-patient services to accelerate recruitment and improve patient diversity and inclusion in clinical trials.

When we step back and look at the growing importance of DCT in our own portfolio, we find that up to 30% of our active full-service trials utilize one or more components of our DCT offering. Incidentally, when our competitors speak about their own DCT offerings, this is often with the report as their DCT business.

When we look at trials that actually fully utilize our DCT capabilities, meaning they are fully run on our decentralized trial platform, we've been awarded 89 trials to date totaling over $1 billion. These awards are with 34 unique sponsors, of which 10 have multiple decentralized trials ongoing with us.

These trials span 12 different therapeutic areas, 32 unique indications and have recruited over 200,000 patients in 40 countries.

Our ability to combine advanced clinical technology with an extensive network of investigators and care professionals differentiates us in this space and makes us a partner of chose for decentralized trials and utilize the full capabilities. Our overall R&DS business continues to build on its strong momentum.

We had approximately $2.6 billion of net new bookings in the quarter, bringing our LTM net new bookings for the first time to over $10 billion including pass-throughs. This resulted in a contracted net book-to-bill ratio of 1.39 including pass-throughs, and 1.28 excluding pass-throughs.

At September 30, our LTM contracted book-to-bill ratio was 1.38, including pass-throughs; and 1.37, excluding pass-throughs. Our contracted backlog in R&D, including pass-throughs, grew 12.7% year-over-year to $24.4 billion at September 30, 2021.

As a result, our next 12 months revenue from backlog increased to $6.9 billion, up $300 million sequentially versus the second quarter. As we have signaled several times in the past, we've ramped up investments in our lab capabilities. We recently announced the opening of our new 160,000 square foot innovation laboratories in North Carolina.

This facility provides customers with access to cutting-edge bioanalytical, vaccine and genomics capabilities, along with an expansion into exploratory human biomarker discovery services.

These new services will enable us to partner closely with sponsors in the development of essential biomarkers to support new molecules moving into clinical development and throughout the life cycle. And this expansion, of course, comes on top of the investment we announced last quarter in our 130,000 square foot facility in Scotland.

I will now turn it over to Ron for more details on our financial performance..

Okay. Thanks, Ari, and good morning, everyone. Let's start by reviewing revenue. Third quarter revenue of $3.391 billion grew 21.7% on a reported basis and 21.1% at constant currency. Year-to-date revenue was $10.238 billion, growing at 27% reported and 25% at constant currency.

Technology & Analytics Solutions revenue for the third quarter was $1.337 billion, which was up 10.8% reported and 9.9% at constant currency. Year-to-date, Technology & Analytics Solutions revenue was $4.38 billion, which was up 17.6% reported and 14.9% at constant currency.

In the third quarter, R&D Solutions had revenue of $1.853 billion, up 32.4% at actual FX rates and 31.9% at constant currency. Excluding the impact of pass-throughs, third quarter R&DS revenue grew 24.7% year-over-year. Year-to-date, revenue in R&D Solutions was $5.612 billion, up 37.7% reported and 36.2% at constant currency.

Finally, contract sales in Medical Solutions or CSMS revenue of $201 million was up 12.3% reported and 12.8% at constant currency. Year-to-date, CSMS revenue was $588 million, growing 6.5% reported and 5.1% at constant currency. Now let's move down the P&L to adjusted EBITDA, which was $728 million in the third quarter, up 20.5%.

Year-to-date adjusted EBITDA was $2.194 billion, growing 33.1% year-over-year. Third quarter GAAP net income was $261 million and GAAP diluted earnings per share was $1.34. Year-to-date, we had GAAP net income of $648 million or $3.32 of earnings per diluted share.

Adjusted net income was $423 million for the third quarter, and adjusted diluted earnings per share grew 33.1% to $2.17. Year-to-date, adjusted net income was $1.264 billion or $6.48 per share. Turning now to the R&D Solutions backlog. As already reviewed, R&D Solutions delivered another outstanding quarter of net new business.

Backlog now stands at $24.4 billion. In the last 12 months, net new bookings, including pass-throughs, rose to over $10 billion. Okay. Turning to the balance sheet. At September 30, cash and cash equivalents totaled $1.5 billion and debt was $12.2 billion. This resulted in net debt of $10.7 billion.

Our net leverage ratio at September 30 came in at 3.65x trailing 12-month adjusted EBITDA. Our cash flow was again quite strong in the third quarter. Cash flow from operations was $844 million, and with CapEx of $162 million. This resulted in free cash flow of $682 million.

This third quarter performance brought our free cash flow year-to-date, that is through the first 3 quarters, to almost $1.8 billion which continues the strong improvement trend we've had over the past 3 years.

In the quarter, we repurchased $125 million of our shares, which leaves us with $697 million of share repurchase authorization remaining under our latest program Okay. Let's turn to guidance. As you saw, we're raising our full year 2021 revenue guidance by $188 million at the midpoint.

This reflecting the third quarter strength in the continued operational momentum in our business. Our new revenue guidance is $13.775 billion to $13.850 billion, representing year-over-year growth of 21.3% to 21.9%. I'll note that included in this guidance is a $30 million headwind from FX versus our previous guidance.

Now looking at the comparison to the prior year, FX is a tailwind of about 120 basis points to full year revenue growth. We're also raising our profit guidance as a result of a stronger revenue outlook, we've increased our full year adjusted EBITDA guidance by $20 million at the midpoint.

Our new full year guidance is $2.980 billion to $3 billion -- $3.010 billion, rather, which represents year-over-year growth of 25% to 26.3%. Moving down to EPS. We're increasing our adjusted EPS guidance by $0.10 at the midpoint. The new guidance range is now $8.85 to $8.95, which represents year-over-year growth of 37.9% to 39.4%.

Now our full year 2021 guidance assumes that September 30 foreign currency rates remain in fact for the balance of the year. Of course, the full year guidance implies a fourth quarter guidance, which we show here.

And before getting to the numbers, I'll say, for context, you'll probably recall that last year's fourth quarter was unusual due to a snapback in the general business as we rebounded from the effects of COVID-19, picked up incremental demand from meta vaccine studies in R&DS and government-related COVID work within TAS.

Fourth quarter revenue is expected to be between $3.537 billion and $3.612 billion, representing growth of 7.2% to 9.5%. FX in the quarter is a headwind to growth of about 100 basis points.

We expect fourth quarter TAS revenue growth to be mid-single digits reflecting the expected year-over-year decline in government COVID-related work and the FX drag. I'll note though that underlying constant currency organic growth for TAS will be in the high single digits, which is the level that TAS has recently accelerated.

R&DS revenue growth will be in the low teens with services growth in the mid-teens despite last year's difficult comparison due to the COVID vaccine work. CSMS will be slightly down.

Adjusted EBITDA in the fourth quarter is expected to be between $786 million and $816 million, up 6.9% to 11%, and adjusted diluted EPS is expected to be between $2.37 and $2.47, growing 12.3% to 17.1%. So in summary, we delivered a very strong third quarter with strong results on both the top and bottom line. R&DS backlog improved to $24.4 billion.

That's up 12.7% year-over-year. Next 12 months revenue from backlog increased to $6.9 billion, up $300 million sequentially versus the second quarter. We reported another strong quarter of free cash flow, which at $1.8 million through the first 3 quarters of the year, is a marked improvement over prior year.

And finally, we are once again raising our full year guidance for revenue, adjusted EBITDA and adjusted diluted EPS. And with that, let me hand it back over to the operator for questions and answers..

[Operator Instructions] Your first question comes from the line of John Kreger with William Blair..

Ari, thanks for all the detail around the OCT and DCT offerings. That was great.

Curious if you could just take that one step further, what do you think the operational implications are for you guys and your clients as you see greater adoption of some of these newer technology tools?.

Well, I mean, operationally, obviously, you know that one of -- the single most important challenge we and actually the entire industry has is the ability to deploy people, again, the strong book of business that we've all generated.

And so this is a great development because what DCT does is it kind of increased productivity, reduces labor and enables us to essentially execute more efficiently. So I think operationally, we are just adapting to this.

Now again, the full productivity only comes when the trial is fully decentralized trial that I explained because there's a lot of confusion in this space. As soon as someone uses a digital platform, they say, well, we've had a [Indiscernible] DCT award here, but that's not the case.

Now if we do that, as I mentioned, about 30% of our full clinical trials, which is just -- probably we have a little bit under 1,000 trials that are full-service clinical trials ongoing. So it's a larger number that already utilize one or several of our DCT modules, eConsent or eCOA or other connected devices.

Our clients are experimenting with smaller trials and trying the full DCT platform, which puts together all of the capabilities and the maximum utilization of the digital tools that we have at our disposal. I think hands down, I believe we are leader in this space..

Sounds good. And one quick follow-up on staffing. Obviously, we've -- there's a lot of talk about a tight labor market.

Is that proving to be any sort of a headwind for you guys on EBITDA margins? And have you seen your staff attrition rates change at all as we've moved through this year?.

I mean, there's no question about it. It's not a secret. This is true across industry sectors and in our sector, in particular, since we have such a strong industry backdrop. There's a lot of competition for talent. We have all of the peers in the CRO space are hunting ground for talent. So obviously, we are responding.

We are actively recruiting and hiring to meet this demand. We recruit dozens of employees every year. So we've got whole talent acquisition capability that's global and that's active, or does it create cost pressure? Yes. And it's already included in our guidance, that certainly a headwind.

But as you well know, by now, hopefully, you know that when you look at our overall results, you see that there has been margin expansion despite these cost headwinds. In fact, even when you see in this past, in this Q3 results, that our operating margins are flat to slightly declining.

When you actually take out the pass-throughs, you actually see that our margin -- the operating margins expanded quite nicely and this is despite the cost headwinds that we have. So yes, it is a headwind, and we are dealing with it and offsetting with the usual productivity and efficiency programs that I hope we've been demonstrating we're good at..

The next question is from the line of Eric Coldwell with Baird..

I have a couple as well. First one, I think the number one inbound this morning is on your M&A spend in the quarter. Obviously, a much higher number than we were anticipating with the Myriad deal sizing being known. I'm curious if you could address that in a couple of ways.

One, the type of deals, nature of deals, number of deals but also what impact you expect on a revenue basis, both in the fourth quarter as well as any thoughts on the run rate of the companies that you've recently acquired? And I might have a follow-up as well..

Okay. So let me take the latter part of your question first. In the quarter, the contribution of M&A was minimal. I mean, maybe a little over a point. And that's the same basically for R&DS and for TAS.

In the fourth quarter, Nick, a little bit more than that?.

Yes, fourth quarter total company were a little over 1.5 points..

Yes, 1.5 points of contribution to our revenue growth. Now yes, we had a big spend this year. It's going to be lumpy. We always see acquisitions is binary. It happens or it doesn't happen. I will note that we didn't spend very much last year. I think in the entire year, we spent $177 million.

And there are quarters where we spent $10 million or $50 million. And this quarter and this year, actually, we spent quite a bit more money. As you know, the largest acquisitions we've done is simply the consolidation of our joint venture request in the lab business, and that was a $760 million transaction we did in the second quarter.

So that represents really a very large portion, almost half of the spend to date. In the quarter, we were very active. We were -- we actually closed only a handful of transactions. The 2 largest accounts for the vast majority, let's say, almost 90% in sales, something like that ,80% to 90% of the spend. It's 2 transactions only.

One is the Myriad RBM Lab, which we had announced during our second quarter earnings and it actually closed in the third quarter. It's a lab that performs sophisticated biomarker detection and testing. It supports early- and late-stage drug development in very specific therapeutic areas, oncology, CNS and immunology. We also purchased DMD.

DMD is a leading provider of analytics and digital marketing solutions to health care professionals. It brings advanced tech-enabled analytics and insights for intelligent omnichannel marketing, and we consider that acquisition to be a strategic asset. And yes, it did come with a lot of -- it costs quite a bit.

So these 2 transactions, again, is basically the bulk of the spend..

Now Ari....

You have a second question, right?.

Yes. Just a clarification on the first one. So the last one, I think you said DMV, if I understood correctly..

DMD, as in David..

DMD. Okay. Got it.

And then is that actually a CSMS segment deal? Or is that a Tech & Analytics deal?.

Yes, it's a Tech & Analytics deal..

Okay. And then my follow-up is my typical burden on you to talk about COVID contributions in 3Q for revenue and bookings, specifically in R&DS but also other segments as necessary. If you could update us on the backlog of COVID work in total in R&DS and then talk about bookings in 3Q related to total COVID-related activity would be great..

Yes. I mean as we think our COVID work is obviously going to -- it continues a little bit. There is a tail to it. But certainly, on the TAS segment, it's a significant step-down. We have signaled this before. The government-related coverage work is gradually going away and certainly will start down dramatically in the fourth quarter and going forward.

And we're just going to return once you eliminate the noise of what that happened last year. The TAS underlying organic growth rate is in the high single digits.

You remember TAS historically was in a mid-single-digit grower and in our investor conference in June '19, we said that TAS would accelerate to high single digits, and that's where we've been most of the year. We've told you that when we reported prior quarters that the TAS growth rate included significant COVID-related work.

And excluding that the growth rate was in the high single digits, and it remains so when you take out the noise of the compares, et cetera.

On the RMBS, can you give us the numbers?.

Yes, sure. Look, first, we like to look at the contribution of COVID to the backlog. And if you strip out the mega vaccine trials, Eric, from the backlog of R&DS, it's less than 5% of the backlog. If you take out all COVID-related work, it's less than 10% of the R&DS backlog.

And you were asking about the contribution of COVID to revenue, I think, 2 in the quarter. And look, R&DS had very strong growth, even accepting the COVID-related work. If you take out the large fast burning COVID work, you were in the high 20s for R&DS revenue growth. And even if you take out all COVID-related work, you were still strong teens growth.

So COVID did contribute, of course, and the work will trail down over time. But the underlying business in other therapeutic areas is very strong and ramping up as we go forward in R&DS..

Your next question is from the line of Jack Meehan with Nephron Research..

I wanted to continue on the COVID conversation. But looking at the TAS business, I think you referenced when talking about the fourth quarter guidance some headwinds versus the prior year.

But could you just maybe talk a little bit about how you feel like the longer-term durability of COVID work in the segment? Just your thoughts around that?.

Yes. Again, there's no headwinds in the fourth quarter for TAS. The growth rate is slower simply because it's a mass question. We're comparing last year's fourth quarter, which was -- which included the COVID work and a bunch of noise with the fourth quarter here, which eliminates that noise.

Again, when you eliminate all of that, the underlying organic growth rate for TAS is in high single digits in the fourth quarter. So there is no headwind in the underlying business, and we expect that trend and momentum to continue.

We will, as you know, provide -- we generally provide guidance on the year concurrent with the release of our fourth quarter earnings. Last year, because it was such an unusual year, we decided to give guidance for 2021 concurrent with the release of our third quarter earnings.

And this year, we plan to do it at our November investor conference, which is just 3 weeks away..

Great. And I don't want to steal any thunder from the Investor Day a few weeks from now, but I was curious if you could talk a little bit about some of the puts and takes for 2022. The funding environment, as you referenced, seems very strong. Are there any takes that you would consider? And then the one thing that stands out to me is pass-throughs.

They've obviously been elevated this year. Just any color around how that might phase in the next year would be helpful..

Yes. So I mean, look, it's always important to put things in context and look at the longer-term trends as you're asking. And if you go back to June '19, we gave a 3-year set of targets for revenue, profit, EPS, capital deployment leverage, et cetera.

Now no one could have predicted then that 6 months later, we would be starting the pandemic, and we would have such disruption across the world for all businesses and including for ours. But when you -- and I think people like to look at '19 to '21 to kind of try to eliminate COVID.

I don't think that's fair because the whole COVID effect is not gone yet because of that. And a little bit of this is because of COVID and the pass-throughs that you just referred to. But even if you strip that out, we're still ahead on every single one of the metrics.

Now I don't know if you had that conference, but as you're doing now and as your colleagues are doing, trying to push me for even more precision on what the numbers would be, I said then that I was hoping to exit 2022 at a 10% growth rate for the company. Now I've said before, earlier this year, that we reached our end of '22 targets in '21.

And I believe that, that momentum will continue into '22. So that's all I can say, and I have to wait for more precision to 3 weeks. But I totally sitting here feel very, very confident that we will certainly exceed those numbers that we gave you years ago and set the stage for further acceleration beyond..

Your next question is from the line of Shlomo Rosenbaum with Stifel..

Ari, can you talk about where you are in general with the OCE implementations, particularly with like Roche and AstraZeneca? Have you gotten to the point where the implementations are not a significant drag on the margins that you have to offset in other areas? And just where are you seeing the business progress in terms of hitting kind of a steady state of revenue or revenue exceeding the cost to implement..

I mean, you bring up a report, implementations are very costly. And because we have the large annual wins, and I referenced an additional 10 new wins. So every time a new award, again, you have to implement.

So it's not like when you are behind the curve of implementation and start generating the license revenue, you still have to implement the new one that you sold and we're happy we did. So we not pass that headwind, if you will, in terms of the implementation costs.

That's a significant drag, and we've not seen yet we haven't passed, if you will, that inflection point where you're now essentially plateaued your market penetration and you're essentially sitting tight and collecting license revenue for Moody's installations. We're not there in aggregate..

Okay. And then just maybe this one's for Ron. The free cash flow was incredibly strong. Something -- there's more of this year, 33% more than you had all of last year, which was, I think, a record quarter.

Could you talk about what's going on? There was a significant increase in unearned revenue and some other working capital changes? And how should we be thinking about this on a go-forward basis? Obviously, very healthy numbers.

Is this something that you can keep up? Or is it or adjusting and catching up on some of the working capital items?.

Well, Shlomo, we've made a really concerted effort internally here to improve our processes around receivables, which, of course, is one of our largest classes of assets. We don't have inventory, as you would have in a manufacturing firm receivables are really where we have a lot of our assets other than our deferred software investment.

And that's been -- our efforts have been on several fronts. First off is collecting on time. We had a -- go back a little while, we had a large amount of overdue receivables. And that's just kind of focused to go and collect what's due from us. The next is billing on time. I mean, we had a large amount of unbilled receivables.

And that comes down to internal processes about billing more quickly, more -- in a more timely fashion. So we get paid in a more timely fashion. And of course, the third that you mentioned is the deferred revenue that the customer advances that we get.

We again made an effort internally to negotiate contracts with our customers, so we get paid more upfront. So we're not out of pocket, and this has helped substantially. And I expect all 3 of those that continue to be a driver of strong cash flow in the future. Now, of course, having said that cash flow is lumpy.

Quarter-to-quarter, it's difficult to predict. And you do get instances where you'll get an unusual amount of advances to some of the work you're doing that will burn out off over time and then rebuild up. So I would urge you not to focus too much on the quarter-to-quarter.

But yes, what you're saying is that fundamentally, we've improved our collections processes and improved our underlying free cash flow generation as a result..

Yes. I mean if I just might add to that, we're very pleased with the performance, but let's be honest. This was a bad a bad point for us. And I think some of you had pulled that out in the past 3 years or so, our cash flow performance was simply very poor. So the fact that we are now performing very well is not an unusual thing.

I mean I think not too long ago, in 2018, we generated just barely over $600 million of free cash flow for the entire year. And here we are, 3 quarters into the year, we've already generated 3x that number. Obviously, we are a much bigger company and so on. But look, the outperformance was just not good.

and we said that and was on us, and we work on it, and we will continue to pay attention and have the right metrics and the right incentives and the team focused on it. And as always, when you shine the light on something, it improves. And that's what will happen here. And where we are now is the normal, not unusual..

Your next question is from the line of Dave Windley with Jefferies..

Wanted to follow up on, I believe, a John Kreger question around DCT. He asked around operational. Ari, I wanted to ask around financial. It seems like you now have a pretty substantial number of trials where you're running pretty fully on your DCT platform.

I'm wondering if you could relate to us what -- how that changes the dollar value of a trial? And does that give you the opportunity to garner more margin in that trial because of the technology-enabled efficiency?.

Yes. I mean, look, there's a high degree of interest from clients, okay, around how to operational DCT, and it's not like it's going to overwhelm and all of sudden become 100% overnight. As I said, large pharma, in particular, is experimenting. A lot of trials are using one composite or the other. So it's going to take time.

So this is not next year or the year after that we're going to have to face the issue that you're raising. Our experience, customers are striving with how to make various point solutions fit together. So we are actually very -- being very aggressive here. We want to move to DCT.

We've said this since the merger got 5 years ago, we want to accelerate and not slow down technology introduction and changing the model.

Now obviously, your question you asked is a question what I asked of us many years ago, which is as you seek to replace labor in a model that where pricing is largely based on labor inputs, then aren't you lowering the value of the trial and the -- and et cetera, what are implications on the margin. So we don't believe so.

We have -- as you know, we've had a long run effort to switch pricing to value and deliverables and outputs. That's number one, and that has made substantial progress. Our clients are not really looking at saving a couple of pennies here or there.

They're looking at getting what they need -- the answers that they want faster, more efficiently with less error and with higher quality. And they are willing to pay a premium for that. Now they're not going to pay more than what they were paying before, but they're not going to pay less than what they're paying before.

And so now the margin implication is correct. Over time, the more we deploy technology, the less we need people, the more there's going to be margin accretion. But again, this is going to take time. There are also new delivery roles, which offset some of the reduced CRA visit activity.

So I think it's too early to comment on the exact margin impact for this overall. We are monitoring -- we do not anticipate this to disrupt our margin performance. R&DS is a very long-cycle business. We have -- I mentioned 89 fully decentralized trial ongoing that we won.

But we're working on -- if you look at, as I said, just under maybe 900 to also full-service trials. So it's a fraction of that. If you look at the total trials we're involved with, this over 2,500 clinical trials that we're involved in globally. So it does take some time to penetrate. It's a slow-moving business. But it's a good point.

We are totally focused on it. We do not anticipate a margin -- I'm sorry, a value deterioration. We do anticipate a margin accretion over the long term..

Great. If I could ask a second follow-up around a question on COVID. It seems like a lot of focus on how much revenue now and how much in backlog now, it seems equally important to me, if not more so, to focus on how that will phase out. And I think you've made comments in the past that you see projects booked out through '22 and maybe even into '23.

Would it be appropriate to call the COVID contribution kind of a soft landing, so to speak, that it's not going to drop off, it's just going to slowly taper over time.

Is that the right way to think about it?.

On the R&DS business, absolutely. No question. What you said is exactly what I would say. It's a soft landing '22, '23, and it -- frankly, we get lost in the rounding, by the time we get to '23. Unless, of course, it's not complete. There is another variant or another COVID.

But right now, as we see based on what we know today, it's a soft landing, we get lost in the rounding by '23..

Your last question is from the line of Dan Leonard with Wells Fargo..

Can you comment on trial site operations? Are there any continued bottlenecks you flag? Or is site activity normalizing?.

Ron?.

Yes. Look, the site accessibility numbers remain around 80% or so. But look, we've managed to work around that and operate it close to normal. And not all sites are equal, the larger sites are open, and that hasn't been an issue for us.

We've seen site start-ups and patient recruitment at near pre-pandemic levels, not quite, but near pre-pandemic levels. The patient visits are still lagging a little bit. just gradually coming back.

And so when we look at our overall operations, we're not totally back to pre-pandemic level yet and we'll expect a gradual improvement over time back to pre-pandemic level, but it really hasn't been a major issue for our operations. As Ari mentioned in his opening remarks, we've learned how to manage driving around the....

Yes. I mean the numbers that -- I got the numbers here in detail, but basically, we're over between -- it's 80% or so across all of those metrics. A little bit higher for site start-up, which is more -- again, as a percentage of 2019 base levels, okay? So site startup is a little higher, is that more 85% or thereabouts globally.

The bottom line is these metrics that we see provide confidence that the non-COVID trial pipeline is not only being awarded, as you can see from the strong bookings, but it's also starting to be delivered. And the sites are enrolling, the patients are enrolling and the patient visits are ongoing.

So I think there hasn't been any major change from this as a result of the new variant or anything like that..

And as a follow-up, Ari, can you comment on perceived market share trends in R&DS in the quarter? You've been pretty open about the various strategic actions by your competitors potentially allowing an opportunity for share gain..

Look, it's hard to look at market share in a given quarter. Okay? It's lumpy trial, it can be awarded the quarter or the first or the following. I wouldn't look at -- we like -- as we always say, look, we've -- we were defeated and gave you quarterly book-to-bill ratios.

But really, we don't -- we believe we should focus on longer-term book-to-bill ratios because it's lumpy and focus also on business from the backlog over the next 12 months. Now if you look at our competitors, there's been a lot of disruption.

And yes, I mean, we've had conversations with customers, but just as we do to win a new customer overnight, you don't throw out a CRO overnight or in the middle of trials, right? So some of those mergers will have an impact on market share. I think it's favorable to us. Maybe we remain the last CRO standing, I don't know.

But we feel that -- and we know from experience what a merger and a large acquisition does to the underlying business. There's all of disruptions, there's -- people lose their jobs, people who don't like the new arrangement, and that's just life. And the result of that is some market share. We had that problem after our merger in '16.

Let's be honest about it, then we have some market share issues which we rebounded once we put together the company and integrated. I think we are -- the future is very bright for us. We continue to gain new customers. And the biotech environment in particular, is extremely, extremely hot right now. We are gaining new clients.

In Europe, we're making inbounds with the customers we never had before. In Asia as well, and the teams are extremely energized and I think we are on a winning momentum here and no doubt that when we look back, we will see that our market share has improved..

Can -- this is going to be our last question of the day..

And your last question comes from the line of Patrick Donnelly with Citi..

Ari, maybe a follow-up on that last question. You talked a little bit about kind of all the mergers going on in the space, again, headcount disruption.

Following up on one of the earlier questions in terms of labor costs, does that position you guys better in terms of being able to acquire some talent that got modeled around during some of these mergers, kind of being a stable shift there and kind of grab some people, maybe not quite the inflationary costs you're seeing on the labor side? And then secondarily to that, maybe with a focus on R&Ds.

How much can you pass some of these price increases on to customers? I know full-service contracts and backlog are particularly tough to adjust.

But just wondering how much you can pass on in terms of some so the price pressure you're getting there?.

Okay. Well, on the personnel question, you've got to differentiate between the executive management leadership level and then the actual field force with CRAs, et cetera.

So on the first group, in general, the first category, yes, there is an opportunity to bringing challenge that somehow dissatisfied with where they are and that will only occur and it has happened already in a few cases. But again, these are small numbers.

On the CRAs and the project lead and so on, that's much more difficult because it's driven by the book of business and by the execution that our competitors are also in the midst of trials and they need those people as much as we do.

And so there's not much -- there's just an inflation on wages, which is the result of all the factors we talked about before, but that doesn't -- the mergers don't affect at least immediately the CRAs and the people in the field. Your other question had to do.

With pricing. And do we need a passing on cost..

Yes. So as you noted yourself in your question, it's very hard. You can't -- we sold projects with certain assumptions. And there are some escalations and some factors built into those contracts. So that will be reflected. But by and large, the pricing was set based on different assumptions and when you have higher cost, then you have to absorb.

But then as we move forward, obviously, the pricing is affected. There's no magic here. It's all going to get fast on and there's no secret. But it's going to lag because of the nature of our business, certainly in the R&DS business..

Right. And of course, on the TAS side of the business, shorter-cycle business, a greater ability to pass along cost increases..

Right, but there's less labor. So that's...

Less labor. correct..

Thank you, everyone, for joining us today. We look forward to seeing everyone at our Investor Day in a few weeks. If you have any other follow-up questions, feel free to reach out. We're happy to answer them. Thanks for joining today..

This concludes today's conference call. You may now disconnect..