Good afternoon and welcome to the Hologic's First Quarter 2022 Earnings Conference Call. My name is Ron and I am your operator for today's call. Today’s conference is being recorded. All lines have been placed on mute. I would now like to introduce Ryan Simon, Vice President, Investor Relations to begin the call.

Thank you, Ron. Good afternoon and thank you for joining Hologic's first quarter fiscal 2022 earnings call. With me today are Steve MacMillan, the company's Chairman, President and Chief Executive Officer; and Karleen Oberton, our Chief Financial Officer. Our first quarter press release is available now on the Investors section of our website along with an updated corporate presentation. We also will post our prepared remarks to our website shortly after we deliver them. And a replay of this call will be available through March 4. Before we begin, I'd like to inform you that certain statements we make today will be forward-looking. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Such factors include those referenced in the Safe Harbor statement included in our earnings release and SEC filings. Also during this call, we will be discussing certain non-GAAP financial measures. A reconciliation to GAAP can be found in our earnings release. One of these non-GAAP measures is organic revenue, which we define as constant currency revenue excluding the divested Blood Screening business and revenue from acquired businesses owned by Hologic for less than one year. Finally, any percentage changes we discuss will be on a year-over-year basis and revenue growth rates will be in constant currency unless otherwise noted. Now I'd like to turn the call over to Steve MacMillan, Hologic's CEO.

Thank you, Ryan, and good afternoon, everyone. We are pleased to discuss our financial results for the first quarter of fiscal 2022. Once again, our results are strong. We are off to a great start in all divisions with diagnostics, breast and skeletal health and surgical each delivering more than 8% global organic growth, excluding COVID revenue. For the quarter, revenue was $1.47 billion and non-GAAP earnings per share were $2.17. Both numbers significantly exceeded the high-end of our guidance by 28% on the top-line, and 74% on the bottom. Over the last several quarters. And most recently at the JPMorgan conference, we've been communicating three major themes. First, our base business is stronger, with more diverse growth drivers than ever before. Second, as the COVID pandemic remains, we continue to help meet the world's testing needs and generate financial upside. And third, because of the first two points, we are well positioned to generate strong results regardless of how various uncertainties evolve from the pandemic, to supply chain challenges to health care utilization. In other words, you can count on us to deliver in today's uncertain business environment. These themes are certainly playing out as we look at our first quarter results and our dramatically improved outlook for the fiscal year. Our base businesses are performing well. And we are making a massive difference against COVID. As a result, we are raising our revenue and earnings guidance significantly as we expect upside from COVID-19 testing, along with strength in our diagnostics and surgical businesses to more than compensate for temporary supply chain challenges that have emerged in our breast health business. As we shared at JPMorgan, we are a fundamentally different company than eight years ago. Now more than ever before, Hologic has more diverse and higher margin recurring…

Thank you, Steve, and good afternoon, everyone. We are very pleased to share first quarter results that are significantly exceeded our guidance on both the top-line and bottom-line. Our first quarter highlights an improving based business that grew 9% organically excluding COVID-19 revenues. As Steve mentioned, our diversified business model is paying off. Each of our franchises excluding COVID grew more than 8% in the quarter, broadly exceeding our long-term revenue growth target of 5% to 7%. It is also important to note that our base business strength occurred in a quarter that started with the Delta wave and ended with COVID cases surging due to Omicron. Total revenues for the quarter of 1.47 billion showcased strength in every business and was significantly ahead of our previous guidance. EPS of $2.17 in the first quarter, far surpassed our initial guidance range of $1.15 to $1.25. We also continued to generate healthy free cash flow, funding our capital deployment priorities of tuck in M&A and share repurchases. We believe our balance sheet is a significant advantage in times of market uncertainty, which I'll touch on shortly. Before I do that, let me provide some detail on our divisional revenue results. Like clarity on our performance, I will exclude the impact of COVID-19 where applicable. In diagnostics, global revenue of $950.4 million declined 15.2% compared to the prior year. However, excluding COVID assay sales related ancillary items in a small level of discontinued products, worldwide diagnostics revenue increased just over 10%. To better understand the underlying performance of our non-COVID molecular business, I will again exclude COVID-19 benefits. By doing this base molecular revenue grew about 14% organically in the first quarter. The growth was run by strong execution across our global portfolio as our largest non-COVID assay. chlamydia, gonorrhea was above…

Thank you. [Operator Instructions] We'll take the first question from the line of Dan Leonard with Wells Fargo.

My first question on capital deployment. Could you elaborate or offer a bit more color on how aggressive you plan to be on the capital deployment front as cash builds on the balance sheet?

Yes. I think what we've talked about is, managing our free cash flow that we want to fully deploy our annual free cash flow between tuck in M&A and share repurchase. But having said that, Dan, we obviously will continue to be disciplined as it relates to tuck in M&A that would be the priority. So we might let some cash build on the balance sheet while again, disciplined and looking for the right deal.

And then, an unrelated follow up, have your views on endemic COVID testing needs evolved at all?

We believe COVID will be endemic. And we believe there will be ongoing molecular testing and probably feel even stronger about it than ever. Right? If you go back two years ago, none of us would have imagined we'd be having the amount of testing going on now. And at the end of the day, I think most governments and most people around the world have realized while there's antigen testing out there for true population health and frankly, to truly capture what's going on molecular is the answer. And I think we feel better and better. That's going to be an ongoing part of our business for many, many years. It's a virus, it mutates. And Omicron is not the last mutation of this thing. And I think we feel that we're well poised.

We'll take the next question from the line of Vijay Kumar with Evercore ISI.

Just one on the supply chain that you brought up, Steve. What I guess is this on the breast health segment or which segment is this impacting? I'm curious what, we've been hearing this from other companies. I feel like when we had the guidance three months ago, right, things weren't as bad and now the things changed in the last three months. And what's been the base guidance reduction because of the supply chain impact, because I do feel like other parts of the base business are coming in better. So maybe if you could just talk about if the gross impact from supply chain was 200 million of revenue push out? How much of that was offset by better base performance?

Yes. Certainly, some of it is, as we've highlighted with both surgical and diagnostics-based businesses, strengthening. Just as we've forecasted, COVID, conservatively, we want to put that out there. You don't have to anybody that's looked around at supply chain issues, the semiconductor and chip issues have not gotten better. And we're not totally sure exactly when that will fully work its way out. We're lengthening lead times, for our deliveries, and it's all in the breast health primarily in the gantry business. And we've got obviously maintained some chips for service. So, we're being conservative and taking care of our existing customers. And we'll lengthen and, frankly, it'll make next year probably look better. And it's great, we can absorb this, what I call annoyance right now, when the rest of the businesses are firing.

Yes. I would just build on that, Vijay is that, I think what we have here in Q2 is, we have inventory to cover that 50 million of revenue shortfall. But we're actively allocating to Steve's point to service because that's the most important thing is that we've got Inventory to keep that installed base up and running so that women can get back to screening.

Understood. And then maybe one follow-up, I think the prior guidance had 150 million contribution from M&A, did that change Karlene and Steve, I think you mentioned something about 90% of U.S. Panther customers, are they using an additional assay. Maybe talk about what kind of assays are they using? Are these CTGC high volume? What kind of revenue pull through can we expect in a post pandemic given the higher install base?

Yes, yes. So I think on the total revenue from acquisitions in 2022, is roughly 170 million. And then we talked about the inorganic piece that we're pulling out $110 million. And I think you went to another question there on the assays, I think, certainly, the STI assays are our biggest asset. So I would say that a lot of customers, that would be primarily what they're running.

And we'll now take the next question from the line of Jack Meehan with Nephron Research.

Wanted to maybe continue on that path. Steve, your comment around the vaginitis panel feel like it's a pretty big statement to say, you think it could become your most successful launch outside of COVID? If memory serves me, right, I'm pretty sure chlamydia, gonorrhea is over $300 million business for you. So maybe just talk about the adoption you're seeing, like, what you think the ramp looks like for revenue?

Yes. I think clearly, it's taken us a long time to get chlamydia, gonorrhea up into that into that multi 100 million range. But I think we feel really, this is going to be over years. But I think we're feeling pretty good about that ramp, you figure if we just did 13 million in the first quarter, multiply that by four and you've got the very bare minimum of, I think what we expect to do this year. So they'll probably continue to build through the quarters. And I think if we fast forward a few years from now, certainly goes north of 100 now its way to 200.

Yes. And I think, again, when we talk about the launch, I think for comparison, Jack and think about the [trick] [ph] assay took about five to six years to get to that 70 million, and we're getting close to that here, only a couple years out. So that's kind of the success of the launch that I want to highlight.

It's a very meaningful indication, it's been completely under diagnosed and I think it's part of the rapid uptake. And it's really a great reason to go to the doctor.

Great. And then, also wanted to follow up just on the supply chain point. I'm looking at the -- in my model, the breast imaging product sales didn't look like you really had much of an impact in the fiscal first quarter. So is this something that really is just kind of picking up in the last few weeks, and 200 million in context seems pretty significant in light of that line item, so maybe just help put a little bit more color around that would be helpful.

Yes, it clearly has emerged here, we kept hoping we would find solutions. I've watched our operations team over the last couple of years. They've just been a Herculean first on MTUs and Tecan tips, swabs on, glass tubes on everything, we did the scale during COVID time to getting more Panthers out the door. And we were hearing a lot of the issues from our chip suppliers, but kept thinking we would find some alternatives and some solutions, and really is it's come down. At the end of the day, as you can see where we were able to call it manufacture additional plastic or find other things. In the COVID piece, we haven't been able to manufacture semiconductor chips and we're at the beck and call of the global supply chain here, where everybody's been tugging on it. So as we've gotten into -- so yes, clearly, it didn't impact last quarter at all, it’s technically not even hurting us in the very moment right now but it's as we go forth. And then, there's two pieces of right, one is, we could sell a lot more of the chips that we will have on allocation into new gantries. So we want to make sure that we keep every gantry that's out there up and running. So we're keeping a good chunk of the chips that will be coming for ongoing service. And if we were just trying to maximize short-term revenue, the hit wouldn't be nearly as big, but we want to make sure we're taking care of the service side. So definitely an annoyance, it's one and to your point, it's a fairly big number that we want to call out right now, in the midst of an overall thing. I think it does underscore how far we've come as a company, right? You think about that kind of a hit eight years ago would have been a big deal, even three or four years ago would have been a very sizable knockdown punch. And now it's kind of annoying little body blow that we know will work right through and set ourselves up to continue to win.

We’ll now take the next question from the line of Patrick Donnelly with Citi.

Hey, thanks for taking the questions, guys. Steve, you touched a little bit on kind of the Panther outlook beyond COVID. Certainly the question we get most as well, kind of stretching beyond that is utilization is going to be the right number to look at anymore beyond this. How are you framing the right way to look at this business beyond COVID? Because, again, obviously, the installed base is far bigger. I think everyone tries to put a utilization number on it, how do you frame that view, kind of setting it up and looking at that business beyond COVID, or at least when COVID is endemic that's why?

Why we kind of think about in a real simplistic term Patrick, which is our total revenue that comes from it. And so, to that point, right, we're going to have over 3000 Panthers, clearly, the pure dollar volume will likely come down from what it was pre pandemic on a global basis, in the near term, because we've placed a whole bunch more internationally where we don't have quite as much revenue for Panther. And we've also gone to some smaller customers, where it will clearly pay off over time. So the way we think about it, I mean, ultimately comes down to number of Panthers, times the amount of revenue generated per Panther. And we see enormous upside to where that's going to go here over time. So many of the folks that have brought bought Panthers in the last year plus, or where we've installed Panthers, they keep wanting, they keep getting ready to put the regular assays on. And then, COVID spikes yet again, and so it's still out there. So we have so much pent-up volume, all those [torques] [ph] that were generated largely in 2020, 2021, are all still delayed, and it comes down to we just generated 14% growth in this quarter, even while COVID was surging. So I think it's hard to exactly model it, per se, but it's just going to come down to we're going to be selling a lot more assays on a lot more machines. And that's going to generate clearly accretive growth rates above the company average for a long time.

And just to add maybe a finer point to that even versus Q1 ‘19. That's basically like your business is up over 40% I mean, that's a tremendous growth over the past couple years.

Sure. That's helpful, hard number to peck down for sure on the [go] [ph] through. Karleen, maybe one for you just on the margin setup. Obviously, you talked a bit about the supply chain stuff, I imagine that you're adding to some of the inflationary pressures. Can you just talk through kind of that core margin as we as we try to back COVID out a bit? How that sets up for the rest of the year? And again, any impact from some of the supply chain noise you're seeing there on breast?

Yes, certainly. Yes, the supply chain is both the revenue on breast and some of the higher cost as well, though, that we mentioned. I think absent of the revenue headwind, certainly that base business operating margins, if we had minimal COVID are still in that low 30%, that we were prior to the pandemic. So we continue to keep an eye on that. And I think, again, some of the strengths that we talked about are continue to contribute to that base business is still healthy on the operating margin line.

We'll now take the next question from the line of Tejas Savant with Morgan Stanley.

Just sort of following up on Patrick's second question there. Karleen, can you just give us your updated views on what is a good sort of blended ASP to use, given the U.S. versus OUS mix in the COVID testing side? And to what degree do you expect some of the investments you've made in commercial capabilities and operating leverage as well, to cushion the COVID testing margin over time as the mix evolves?

Yes, from an ASP perspective, certainly, pricing has held pretty nicely here, I think, roughly $20, with the overall average in the quarter, I think as we look forward, we do expect that pricing will come down, one as we renew international contracts, which are lower ASP, as well as in the U.S., when the higher -- when the public health emergency ends in this higher lower payment for the testing will probably come down. But still, we have a way to go on that pricing to come down to still have that revenue be accretive to the overall corporate average. And think about the overall business and margins, certainly our supply chain, folks, you annually have improvement targets that they go after that some of them even in this year of buffering some of the higher costs that we're seeing. We have network optimization opportunities that we're focused on. And certainly we've talked about investing internationally, intentionally, over the past several years, that we believe that international revenue continues to grow, we'll have more margin accretion from the international business.

Got it. And one for you, Steve, on the launch of the Panther tracks here in December. Can you sort of quantify the cost savings that some of your high throughput customers could see from the added automation here? And overtime do you expect us to drive an uptick in Panther sales in new accounts? Or is this more of a convenience for your current high throughput customers given some of the labor issues everybody's seeing at the moment?

Yes, absolutely. We do think this would be a labor efficiency for our labs. This is something that there's a really long lead time to the track system, so 18 to 24 months. So we won't have any kind of data on actual cost savings for a couple of years. But this is something that we actually have partnered with our customers on, on the development of how it will work in the lab. And we're excited to officially launch it here.

We will now take the next questions from the line of Brian Weinstein with William Blair.

So I guess let's talk a little bit about geographic performance. Did you continue to lean into that, and maybe you can be a little bit more specific about territories and products and kind of run through where you're seeing the strings? I recognize it's kind of across the board. But if there's anything that you would kind of call out there? And then, what maybe I missed a bit. Can you talk also about what the U.S. growth rate was? And I'll have a follow up after that. Thanks.

Yes, I think, overall, international, obviously, we said is a double-digit grower. And I think, we'd said years ago, we expected that international would become probably a double-digit grower for many, many years. And I think we're exactly into that. A lot of it candidly, Brian is really coming out of Western Europe, because that's where our biggest footprint is. And it's where we've placed a ton of the Panthers. We're starting to get certainly more of it out of out of Asia Pac as well. But the bigger chunk is really Western Europe, a little bit of Africa and I think continue to feel good. And overall, that the international growth rate is above the U.S rate.

Yes. Is there anything on kind of a product side? I mean, obviously diagnostics is, I'm guessing, driving that, but are any of the other kinds of businesses seeing significant acceleration OUS? That you'd want to call out there?

I think the magic is, it's actually largely across the board. Even our psychology business is actually doing well, particularly in a few key markets in Western Europe, the overall diagnostics as we've been placing those Panthers, I think you can go back really over three, four -- three or four years now, where the molecular business outside the U.S. is oftentimes been at 20-ish percent growth rate, and if anything, it's just going to be turbocharged here. Going forward, breast health has been very solid as well and even things like the SOMATEX acquisition we did in breast health, 15 months ago, whatever, a German-based company with some of the markers, it's helped put us on the on the map there. Surgicals picking up a little bit. So, there's no one -- I think the magic of it that makes us feel actually even better is, it's not like a one hit wonder. It's not one country, one geography, one product line, even one franchise is doing it. It's really a whole bunch of incremental things, just inexorably getting stronger. And then, that's what gives us more confidence for the future.

We will now take the next question from the line of Tycho Peterson with JPMorgan.

This is Casey on for Tycho. Thanks for taking my questions. First one is on breast health. So how should we think about breast health margins given the shift towards recurring revenue now, the 23% of the business is gantries? How's that margin profile change alongside this mixed shift? And I guess in the near term, what sort of impact to margins is embedded in the 2022 numbers with lower gantry sales?

Yes. So I think on the breast health business, if we think about operating margins, certainly the service business is accretive to the operating margins, which is the biggest part of revenue for that division, Then I would say, then there's probably equal contribution from gantries and interventional from an operating module perspective. Certainly, the headwind, the $200 million headwind is significant to that division. But, fortunately here, we were able to raise our full year guidance based on the performance of the rest of the business and the COVID contributions. So we can well manage this headwind and not have to do things like -- manage headcount or the other things. So preserve our great salesforce that we have our service engineers and still feel good about managing through this headwind.

Got it. That's helpful. I was wondering if you can give us some updated test of record metrics in the molecular side. How did those trends in the last few quarters and how much of this x-COVID growth is coming from existing customers that are just reporting more of them menu over to Panther versus new customers? Thank you.

Yes. Casey, we think of the test record as an annual number. So to put it in perspective, prior to the pandemic, our largest year was 20 million, we did about 34 million in 2020, and about 40 million in 2021. And we expect that 2022 will be another number in that $30 million to $40 million range.

We'll now take the next question from Derik De Bruin with BofA.

So actually, I just wanted to follow up on that last question. And just, look, you're placing enormously impressive number of Panthers at 100, this quarter, that was certainly more than I thought you would have. Just a little bit color on where your installs are, add-on servicing customers, greenfields, competitive replacements. And I guess where is, if you go back and look pre-pandemic and you look at the number of labs that were not doing molecular diagnostics, how is that sort of like overall -- in step of that overall market expanded, just try to get some script, this idea and just the continued pace of Panther placements in the market opportunity.

In terms of where they're going Derek. It's really again, it's very broad based, some are to existing customers and some might have three and they add a fourth. We've definitely got new customers as well, they're going into -- the hospitals are going into small labs, they're going into the big labs, they're going into some -- certainly some are new customers for us. And, therefore, whether it's a competitive win or just an expansion of that, labs business, we're certainly seeing that. And we do think, the overall focus on high throughput instruments is going to be a very good thing for us going forth. And we feel like that's where we've got a real winning edge, as you you've known Panther well.

Great. And then just one other question. As you're sort of like, the geographic mix shifts, how should we sort of think about the tax rate on the out years is there sort of [indiscernible], or it's still up in the air because of all the potential changes in tax laws that are being contemplated? Thank you.

Yes. Certainly hard to comment on the future tax rate when there's no real legislation really in place. And, as you know, the devils in the details on something like that. But certainly if the federal headline rate went up, our overall non-GAAP tax rate would go up. But I would tell you that, we certainly have an active tax department that is partnering with our operations team to put in efficiency strategies.

We'll now take the next question from the line of Ryan Zimmerman with BTIG.

Karleen, just on the COVID guidance, if I think back to your four number, originally, I think was around 200 million. We kind of assumed about 50 million a quarter. And now you guys are at a billion you did 500 and change this quarter? The pacing of that number, is it fair to assume, given the line and say you have that 300 million to 400 million can be done in this upcoming quarter? And we should think 50 and 50 in the back half of the year? Or are you thinking about the pace into those COVID sales a little differently than what I laid out?

Yes, Ryan. So as I said in my prepared remarks, we are assuming about a minimum of 400 million here in the second quarter. So that would lead to your mass of roughly 50 and 50 in the Q3 and Q4.

Okay. I must have missed that. [Indiscernible]. And then, Steve, just on breast, you guys have moved downstream. And you're in much more surgery now than you were before. Obviously, mammography was kind of your beachhead when you think about the surgical options. And where you could go beyond your existing procedure categories. Is there room to go deeper? Is there room to go broader in surgery and breast? Curious kind of how you think about how rounded of a portfolio you have today, relative to where you want to take that?

Yes. We're looking both ways actually, as we think about it, whether we -- obviously, we've done smaller build-ons in terms of the markers and Faxitron Focal, kind of the breast conserving surgery stuff. I think we see various different ways we can go and are really assessing what else we can be doing across the broad continuum of care. And particularly on the treatment side of breast, so more of that would be potential in organic, some of its organic and we continue to look at things that way. We have time for one more question.

We'll take the next question from line of Puneet Souda with SVB Leerink.

So maybe just one for me, obviously, great cash flow position that you have and existing cash position as well. So just, a frequent question in these times happens to be around valuation. And what appears to be somewhat of a disconnect between sort of the buyers and the sellers, given the sudden pullback in the public markets. So it seems like expectations have been normalized, so to speak in the public markets, but wondering if you're seeing anything different in the private market? Or if you're seeing just overall broadly, this disconnect to sort of normalize and how do you look at the -- sort of the current timing and evaluations out there? Thank you.

Yes. It's great question. Certainly when valuation is correct, you always have the sellers, kind of remembering the good old days that might have been and I think right now we feel we're in a great position. There's a lot of stuff that, we had every banker and we had a bunch of both privates and companies went public last year in our face that wanted us to buy them then. And we said to a lot of them, why don't you go ahead and go public? And we'll keep our eyes on you and look at you later. So I think a lot of the corrections may create opportunities for us at the right time, they've got to settle in themselves. And candidly, when you have a really successful business, which we have right now, there's no urgency. So I think we were in that magical spot where our core businesses are so strong and growing, that we don't need to do anything. Meanwhile, we keep racking up cash, that puts us in a great position when we do want to act. And, we think whether it's this year or whether it's next year, opportunities will present themselves that we'll be able to take advantage of but absolutely no urgency from our standpoint, while people readjust to what might be that the true realities, not what they want to believe the realities could be

And that's all the time we have for questions. This now concludes Hologic’s first quarter fiscal 2022 earnings conference call. Have a good evening.