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Jefferies 2024 Global Healthcare Conference

Jun 5, 2024

Operator

I'm glad to have this kicked off and all the preparation come to fruition. I'm very pleased to have Fortrea Holdings here, and Tom Pike, the company's CEO, Jill McConnell, the company's CFO, Hima Inguva is IR and Market Intelligence, I believe.

Tom Pike
CEO, Fortrea Holdings

That's right.

Operator

The extended title, yeah, Corp Dev and Market Intelligence. So, all three of them here. I think Tom's gonna make some quick remarks, and then we'll get into some Q&A. So Tom, I'll hand it over to you. Thank you.

Tom Pike
CEO, Fortrea Holdings

Very good. Thanks, Dave. Thanks, everybody, for coming on this nice New York City day. You know, so we're Fortrea. We're actually just about to hit our one-year anniversary of spinning out of Labcorp. We're a leading clinical services company. What that means is we focus on phase I to phase IV clinical research. We sit in that interesting space where pharmaceutical firms need help when they're investigating their products and trying to understand whether they're safe and whether they work. We sit in that niche where we work with the pharmaceutical firm, we work with the physician investigator, we make sure that these trials, which are typically, if they're a larger trial, it can be in 20-30 countries around the world, have thousands of patients as part of it. We make sure that the trials work and the data is sound.

Now, we can get into all that, but many of you know us. We've been public for about a year, so we've had three quarters where we've gone out. I think we're very happy that our book-to-bill, which is a very important element of this industry, a 1.2 book-to-bill or better is always the target in this industry, that our average book-to-bill has been 1.2 since we went public. We were coming off kind of a tough year, but it's been 1.2. I will also add, we said in our last conference call, that our pipeline is strong, so we serve both biotechs, we serve large pharma. Both sides of that are strong for the remainder of the year, and what that means is that we, you know, believe we can achieve a 1.2 book-to-bill.

This is always a question in our industry, you know, can you do it? Can you not? A couple of transactions can push you one way or the other. But we do believe that with our excellent commercial team, that is transforming as we speak into a better commercial team, with the pipeline, we see the opportunities in both large pharma and biotech, that we have a solid opportunity to hit that 1.2 book-to-bill. We did just close a transaction. We had two businesses. One is in the randomization side. It's not directly... It's, it's kind of like a tools business. It's out within our business. So Endpoint, we just sold that, and another one called Patient Access, which is primarily a post-approval business. We sold that to Arsenal Capital. That closed on Tuesday, I guess.

On Monday, really. I was busy on Tuesday. We closed on Monday, late in the afternoon, and what we're gonna do with that is use the debt proceeds, probably about $275 million, to pay down debt that we have. As you know, when you do a spin, you get levered up, and we thought it's important to show that we're aware of that, so we're gonna pay down about $275 million. Regarding TSAs, so we're a spin company. Every spin company has transition services agreements with its parent, and so that means that they continue to operate services, operate systems for us, and we continue to make progress on those.

We announced that we're over 50% out of those, and we continue to be on track to exit the majority of those by the end of this year. In terms of our book-to-bill last quarter, I probably should have mentioned this when I did my prior remarks, but we were slightly under that 1.2 book-to-bill. We had a 1.1 book-to-bill, and we did close the transaction that slipped into this quarter since the last earnings call. I think we're reiterating guidance, no change to that. We wouldn't want to change that. There's no change to that. And then I would just add that, you know, anything associated with all the filings are in place, the Qs are in place, so we can talk about that if you like. But we had a minor...

In my view, as a business person, we had an issue that was in our books that was not material to us as a going-forward organization, but it was an issue that was in our books that was, you know, from our parent company years ago. And, you know, that what ended up being essentially an immaterial adjustment that caused a restatement of 2023 has been complete, and now, you know, that's behind us in terms of those accounting issues. So we worked hard on it, but it's behind us. I think with that, Dave, you know, those are kind of our updates, and we feel good about the business. Just to give you a sense of my schedule, I was at BIO in San Diego yesterday, meeting with biotech customers, holding a panel. It was well attended.

We had about three times, four times as many people as we have in the room here, who were attending it in terms of biotechs. The next couple of weeks, I'll be going out to Europe to visit with customers, going out again to visit with them a couple of weeks after that, in mid-July. And the receptivity to Fortrea as an independent clinical research organization has been very strong. So I think with that, Dave, we'll go to questions.

Operator

Great. That's great. So Tom, I went back and looked at the spin deck, I'll call it, the kind of, "Here is Fortrea, here, here's who we are" deck, and what you had set as your goals to try to do, and among those were things like establishing world-class customer relationship development, solving the last-mile problem, next-gen data strategies, complementary tech strategies, and there were a couple others too. But those were ones that I highlighted, and I would basket them all in the: what levers are we trying to pull to differentiate? You know, how are we trying to be better, and how are we trying to differentiate? And I was hoping you could kind of discuss the investments you've made or the tangible progress you've made against some of those goals.

Tom Pike
CEO, Fortrea Holdings

Yeah, it's, it's interesting, Dave. It's almost exactly the one-year anniversary of our Investor Day, you might recall, and so, one year into this, basically, many of those elements of the strategy are the same, and they're proving to work. So we did start a commercial transformation. We brought in a new Chief Commercial Officer. His name's Drayton Virkler. Experienced in the industry, Duke MBA, experienced outside of the industry as well, and he's done a terrific job taking our commercial organization and really making it, I would call it the leading organization right now in terms of both processes and the style that they go to market and how they communicate. I think we've made a huge amount of progress on that. We now have the discipline in our processes.

When you talk about what, you know, what you just said there, we did identify a number of ways that we wanted to differentiate, and so we've executed on that this year. So you've actually seen, if you look at our press releases, you'll see press releases that relate to all of these areas, where, in terms of data, we do believe that this industry has changed. You don't need proprietary data anymore. Over the last five years, you know, billions of dollars has been spent around data associated with electronic medical records and genetic information and other types of things, ophthalmology information, you know, things that are really important to our industry in terms of finding patients and having the right sites. And so we're leveraging multiple sources of data, and that's being very well- received by the customers.

We're trying to do it on with a piece of software we developed while we were with Labcorp, having that access multiple sources. We're partnering with some of the larger tech organizations, so rather than building our own, organizations like Veeva are spending hundreds of millions a year on this industry, being very successful with it. So we have a very close relationship with Veeva. I had Advarra on the stage with me yesterday at BIO, very close to the CEO of Medidata. You know, we've kept in touch for a decade, and so we're working very closely with those spending a lot of money on this industry, and we're adding our own little layer of intellectual property over the top of what they do to manage these businesses better but leveraging them well. You mentioned sites.

Actually, this week, there's something called the Society of Clinical Research Sites that's meeting in Scottsdale, Arizona, and so we are holding our site advisory board. So this is the last mile that Dave referred to. So in our business, and it's a little bit of a complicated business, but pharmaceutical firms need physician investigators to actually find patients and test the product. The satisfaction of those physician investigators is key to them recruiting patients effectively. And so I worked a lot in this world over the last five years, and so yesterday I had somebody who runs sites on stage with me to give you the commitment that I have to this. And so we're meeting with that site advisory board, where we really feel like we're leading the industry in terms of: How do you try to support sites?

How do you try to get them to be more productive? We had an announcement with Advarra and with Veeva about reducing the complexity of technologies at sites. Yesterday on stage, Dave, I was with the CEO of Advarra, Gadi Saarony, and he was saying he just visited a site, and there were 20 different technologies that were being used for clinical research, and the person literally had to have a rolling chair to move from one computer to the next to deal with all these technologies. And so, you know, I think our goal is to really simplify how clinical research is done at the sites. And so all of those things are really differentiating us, and they're ringing true with customers, and that's one of the reasons that we have this access that we have.

Operator

Right. We call armchair interoperability.

Tom Pike
CEO, Fortrea Holdings

Yeah.

Operator

Desk chair interoperability.

Tom Pike
CEO, Fortrea Holdings

Exactly.

Operator

Yeah. So, on the site element that you're—the site advisory board is an interesting one. I suspect you had something similar when you were at Quintiles. Some of the other CROs have—You may come at it a little differently, and I'd—

Tom Pike
CEO, Fortrea Holdings

Yeah

Operator

... I'd give you the opportunity to talk about that. But how do you think about working with sites as Fortrea compared to ICON, PPD, IQVIA owning some of their sites?

Tom Pike
CEO, Fortrea Holdings

Yeah, I... It's a good question. I actually don't believe that a CRO should own a site or needs to own the site. I think when CROs get larger, they look for diverse sources of revenue, and, and we all have pass-throughs in our books. But any one site organization. You know, the way clinical research works, about 50% is done by pharmaceutical firms without companies like ours. The other 50% is done by companies like ours working in concert with pharmaceutical firms, and no one of us has more than 15% of that, of the total. So if you're a site organization, you have to work with other CROs, not just the one that owns you. So personally, I don't feel any particular need to own a site because they have to give me access.

They can't provide enough work to a site to keep it busy enough, so I have to get access anyway. I don't have the capital costs associated with it. They're actually very limited that they only can do certain types of disease categories, Dave. Like, they're great on things like vaccine trials because they have general physicians associated with them, but they're not great in something like oncology because they can't handle oncology. They can't handle specialist functions, you know, sometimes like nephrology, and so, you know, for the kidneys. And so, you know, personally, I don't think we need to own them. We have great site relationships, and what we wanna do is make sure those sites are profitable, efficient, run well, have the resources they need.

Operator

... Right. So on that point, you mentioned simplifying the technology morass in the site, which certainly is a theme that resonates and has been a problem for a long time. Do you think about a model where you would parachute resources into sites to, you know, into, say, your diamond sites-

Tom Pike
CEO, Fortrea Holdings

Yeah

Operator

or your, you know, high-volume sites to help them process the trial load that you're putting on them? How do you think-

Tom Pike
CEO, Fortrea Holdings

Yeah

Operator

about helping them?

Tom Pike
CEO, Fortrea Holdings

We do. We will do that, but I will say that since COVID, their need for clinical coordinators and site coordinators has lessened. They had the same great resignation you saw in so many industries, in hospitals, and in sites. But they've staffed back up to a degree, Dave, so we're seeing a little bit less of that. So I do think it's reducing the complexity associated with it, making sure that they're trained well, making sure that we're using. Like, one of the things we're exploring that's really interesting is. How can we use artificial intelligence to understand our interactions with the sites? If you think about it, sites have. There's all kinds of tacit data. You email sites. You text with sites.

How do you make sure that you understand that your relationship with the site is healthy, and can we start looking through some of that tacit information to say, "Are we talking about the right things? Are our teams communicating the right information?" So we're looking at really more advanced things like that in terms of determining: Are we supporting them fully? Are people communicating well? Are they engaged in what we're doing? And then also, how do we get sponsors? We talked about this at BIO yesterday. How do we actually get sponsors more actively engaged with sites, and when do we need to do it? So, like, do we need somebody with medical knowledge or, or knowledge of the product and passion around the product to meet with certain key investigators to get them excited about the product to increase the pace of recruiting?

And so those are the types of things that we're doing, just very hands-on. About many times, about 20%. I had a quote yesterday, 'cause we had this person who runs sites with us, that about 20% of the people in a trial actually aren't in the existing electronic medical records of the site. And so we helped them develop marketing plans. You know, so these are the kinds of things we do hands-on. It's just what Jill and I talk about is, we're managing this business at a greater level of detail than it's been managed before. We're at a size where we're accessible to the customers. We actually I would meet with sites. I mean, I'm willing to do that. I'm gonna go to the next site advisory board.

You know, I think we're at a size where we can manage these details, Dave, and get it done.

Operator

Got it. Okay, so I've probably beaten that up enough. Let's move on to some numbers. So thinking about your progression of revenue towards your guidance that you're reaffirming today, backlog conversion in the first quarter dropped from about 10% in the fourth quarter to 9% in the first quarter because of some factors related to historical bookings and maybe some other things. Maybe talk about what those drivers were and then also some of the efforts that we discussed after the quarter that you as a management team are taking to re-accelerate that.

Tom Pike
CEO, Fortrea Holdings

I'm gonna introduce my partner, Jill McConnell .

Jill McConnell
CFO, Fortrea Holdings

Yeah, sure. Happy to take that one. So, I mean, we knew... We were very transparent about the fact that in the spin year, so the year just before we spun, revenue or new business awards were low. They were low. The focus wasn't there. There was a lot of uncertainty that a spin or a transaction like that creates, and, you know, the management team wasn't introduced really until the first quarter of 2023, and that just left a lot of questions in people's minds. So we clearly suffered from that, and we knew a full year of lower sales wasn't gonna turn itself around in a quarter or two.

So we expected Q1 to be the nadir in terms of sales performance in terms of the dollar amount, and a lot of that was just due to you know, the aging of what was happening in the portfolio, given that we'd had that lower year of sales. So Tom talked a lot about the commercial transformation, which has helped to turn that around. I think that trailing nine months, 1.2+ that we have at the end of Q1, we're very focused on that, and that's gonna be critical going forward. The other issue that we saw, and we've been really digging in on this over the last several months, is, you know, a little bit of slowness in the burn. As the new work was coming on, we've been incredibly focused on that.

We're talking with the teams every week, going through all those projects for the new work, and we were seeing it, you know, come in a little bit more slowly than we would have expected. And I think there's a number of factors that are driving that. One is, you know, we are a heavy oncology organization. As those oncology treatments get more specialized, it is more challenging a little bit sometimes to find the patients and get those started. But the, you know, it's a great book of work. It's a growing area. There's still so much unmet medical need. It's us trying to help leverage all the data sources that Tom talked about and working with the sites to determine how you can get those patients faster and speed that up.

The other piece is that we're finding some of our smaller sponsors were not quite what we'd say maybe game-time ready, in that we were finding we would get sites initiated, and then they didn't have all the materials ready to actually start enrolling patients, all the consents, all the, you know, things around the protocol, everything to be able to do that. So now that we know some of those things are in play, we're getting in front of it more in that RFP process to be able to hit the ground running. We're also changing the way that our teams think about what's important.

So there was a significant focus on just, you know, the number of visits, for example, but maybe less in the past around achieving milestones and things that are really important for our customers, and those are also important for us in terms of not just the revenue recognition, but also being able to invoice. Since under 606, there isn't always the direct connection between when you can bill somebody for something and when you've actually done work. So trying to connect those dots and increase the acumen of the organization and think about what are the right metrics to incentivize revenue burn, those are all things we've been putting in place over the last few months, and we're starting to see initial signs those are improving, but we expect that to improve over the course of the year to help with burn in the second half and beyond.

Operator

Okay, so some of the site activation points that you made, documentation readiness on the part of the customer, those certainly seem like things that you can get in front of. Some of the things like complexity of oncology trials are kind of an always, right?

Jill McConnell
CFO, Fortrea Holdings

Mm-hmm. Yes.

Operator

That's, that-

Jill McConnell
CFO, Fortrea Holdings

Yes

Operator

... that becomes a little bit difficult needle to move. Not to get too detailed here, but when you think about the guidance, how much would you lean on these various issues to, to drive you or, drive conversion back up?

Jill McConnell
CFO, Fortrea Holdings

So for this year's guidance, there's the changes. A lot of it is around the things that we can control in terms of the internal focus, mechanics, metrics, drivers, just really the hygiene around projects. And also, obviously, as these new awards are coming in and starting to burn revenue, we have been—you know, we incentivized the commercial organization differently last year when we spun around the mix and making sure that we were focused on the right types of work, including and especially on full-service clinical, you know, in that higher margin. So, you know, as that starts to become back into the mix at a greater rate with the wins that we've had over the last year, that's gonna help as well.

One of the things we can't control, and I think this is an issue for all of the CRO industry, many people talk about it, is pass-throughs, and sometimes some of the volatility in pass-throughs, which can impact burn and also revenue as reported. But as we know, if you know, some of the, when we changed our guidance, some of that was related to pass-throughs. Those aren't. Those are actually not helpful from a margin perspective. Those aren't as challenging.

So I think it's us really focusing on the things that we can control, and I, and I think just that awareness and even things like execution on change orders and, and really improving the financial acumen of the organization to understand when to raise the flag, when they start to see, "Hey, it's taking me a little bit longer to do something than I thought," versus working away within a project for a long time, trying to sort it out themselves. And so we're just really changing the dynamic and the escalation paths. And Tom and I being in meetings where we're, you know, talking to the project leaders and the teams and really digging in on that is having some impact in terms of people understanding how to really properly manage the financials of the trial, not just the delivery of the trial.

Operator

That's very helpful. And it's a good segue, the point that you make, and revisit about the incentivization of, of the sales force and what they're, they're targeting, what they're going after, full service work. How do I think about maybe before that, the spin year bookings that were low? Was their composition also heavy FSP or heavy pass-through, or like—I'm fishing for in this first quarter where revenue is low but margin is also really low, is that a function of the composition of that revenue is also challenging? It's not just low revenue, it's also the composition of the revenue?

Jill McConnell
CFO, Fortrea Holdings

Yeah. Yes.

Tom Pike
CEO, Fortrea Holdings

Yeah.

Jill McConnell
CFO, Fortrea Holdings

Yes. I mean, I think yes and yes on the FSP, and then, and, you know, things with pass-through. So one of the things we've been focused on as we meet with the teams every Friday, going through all of the opportunities, understanding the, you know, the, the pipeline and the book of work in front of us, we're looking not just at the 606 numbers, but the 605, and making sure that... And we're seeing those be more consistent in terms of the delivery and opportunity, which is a little bit different from maybe how it was in the past. And then the incentives on that full service work, because that is where the higher margin opportunities sit.

And I think the way that we're incentivizing the organization, including bringing in more of our medical professionals, we have, you know, 700 doctors, you know, 1,500 PhDs, getting them more involved in the sales process, that's been resonating as well. And I think just all the combination of those things, and that's, I mean, that's less important in, say, things like FSP. The other, you know, I think we talked about the methodology change that we made at the end of the second quarter, right when we spun, so that when we talk about a book-to-bill, it's telling you that it's a healthier book-to-bill and should lead to revenue growth.

I think in the past, things like the way FSP was recognized and even the fact that pass-throughs were maybe a higher portion relative to 605, are creating some of the challenges we're working through now. But as the new book of work starts to burn, you know, later in this quarter, but into the second half and beyond, that will hopefully start to rectify. That's what we're expecting.

Operator

Got it. And so maybe to come at this a slightly different way, when you think about the strengths of the 1.21 book-to-bill for the last three quarters since the spin, what is the composition of that across—I think you think about your clinical business being three big buckets: FSP, full service, and then the clin pharm phase I. How should I think about the relative strength or contributions of those?

Tom Pike
CEO, Fortrea Holdings

Yeah, why don't I give you a little break. I think the basic configuration that Dave said is right. So clinical pharmacology is our smallest business. It's phase I. It's actually very important. We work with big and small pharmaceutical firms on it, on some really interesting products. And basically, they have had a very strong pipeline. They've switched more toward large pharma, and we do want them to just continue to grow as fast as they can grow. But it is a facilities-based business, so, you know, essentially what you're trying to do is grow and increase occupancy, and it can only grow a certain amount. FSP is our next largest business. FSP is less profitable.

Very important for FSP, for large pharma, that you provide this service, and we want to serve both large pharma and biotech, but it's a solid business, but it's less profitable than the other two. And then the most attractive is full service outsourcing, and that has the best margins and frankly, a lot of growth potential in biotech. So our goal is really to maintain all three, and interestingly, we've pretty much maintained and met our goals since we spun, Dave. So-

Jill McConnell
CFO, Fortrea Holdings

On the proportionality.

Tom Pike
CEO, Fortrea Holdings

... we feel good about that. Yeah, we've maintained that proportionality.

Operator

Got it. Maybe a last question, just to, because I know it's on some folks' minds: As you think about your margin targets for this year and your debt levels, perhaps you could help us, Jill, a little bit with the difference between guided EBITDA and covenant EBITDA.

Jill McConnell
CFO, Fortrea Holdings

Sure. Sure. Yeah, so I think, you know, Tom mentioned the fact, you know, paying down more than a turn with the net proceeds from the first tranche is really helpful. But we do have add backs, things like public company costs, the impact of restructuring programs that we have initiated. We did one. We kicked one off late Q3, early Q4 last year. We have another one that we're working on, and, you know, at the moment that we started earlier in this quarter. And so I think we're trying to be thoughtful about managing a spend with, you know, the timing of that revenue growth, but we do have a number of add backs. It gives us, you know, more than a turn of benefit relative to where we are.

We announced just before we released the queue, that we had done some covenant amendments, just to give us a little bit of headroom, particularly on that interest coverage, because that one's a little bit unique. It looks at trailing 12, and you know, you lose the EBITDA of those disposed businesses immediately, but you keep the interest costs, right? So that was one where we weren't gonna violate, but we were getting, it was getting a bit tighter than we liked, and we wanted to give ourselves that headroom. So we feel really confident, especially now that we're doing this debt paydown, that the transaction is closed. We feel good about our ability to be within those covenants, and, you know, we're continuing to focus on our capital structure.

We know that's important, and, you know, we're taking steps to continue to secure that.

Operator

Great. Thanks to Fortrea for being here. Good to see you all.

Tom Pike
CEO, Fortrea Holdings

Thank you Dave.

Operator

Thanks for your interest.

Jill McConnell
CFO, Fortrea Holdings

Thank you Dave.

Operator

We'll hand it over to the next group.

Tom Pike
CEO, Fortrea Holdings

Great.

Operator

Thank you.

Tom Pike
CEO, Fortrea Holdings

Thank you so much.

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