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

Thank you, Cody. Good afternoon and thank you for joining Hologic's third 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 third quarter press release is available now on the investors section of our website, along with an updated corporate presentation. We will also post our prepared remarks to our website shortly after we deliver them. And a replay of this call will be available through August 26th. Before we begin, we would 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 discuss certain non-GAAP financial measures. A reconciliation to GAAP can be found in our earnings release. Two of these non-GAAP measures are, one, 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. And two, organic revenue excluding COVID- 19, which excludes COVID-19 assay revenue, revenue related to COVID-19, and discontinued product sales in Diagnostics. 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 third quarter of fiscal 2022. Our results continue to showcase the strength, durability and diversity of our business. Total revenue was just over $1 billion and non-GAAP earnings per share was $0.95. Both numbers exceeded the midpoint of our guidance on the top and bottom lines – the result of both enduring COVID revenue and also strong performances in our core Diagnostics and Surgical businesses. In this dynamic and ever-changing world, we continue to live our purpose, passion and promise – to enable healthier lives everywhere, every day – and be global champions for women's health. In doing so, our industry-leading products continue to reach even more patients around the world, while our business delivers strong financial performance and value for our shareholders. To put it simply, the durability and diversity of our business enables Hologic to succeed in this challenging macro environment. As we navigate a multitude of headwinds, our confidence in our business remains steady and remains high. Looking longer term, our message is also unchanged. We are confident, despite the current turbulence, that our previously announced 5% to 7% annual organic revenue growth rate through 2025 remains an achievable target, provided the current chip headwind normalizes as we expect. Ahead of turning the call over to Karleen to discuss our financial results in more detail, we'd like to highlight growth drivers and provide updates on each of our businesses – Diagnostics, Breast Health, and Surgical. And to close, we are excited to share our experience from the World Economic Forum Annual Meeting in May, an experience that reaffirms the importance of our place and our voice on the world stage advocating for women's health, especially now. Before jumping into each…

Thank you, Steve. And good afternoon, everyone. We are very pleased to share third quarter results that once again significantly exceeded our guidance for both revenue and non-GAAP EPS. Our third quarter financial performance highlights the strength of our core Diagnostics and Surgical businesses, both of which surpassed our long-term revenue target of 5% to 7% growth in the period. And in our Breast Health business, although we continue to see headwinds related to semiconductor chip availability, as Steve mentioned, we remain optimistic that the supply environment will start to improve in our fiscal 2023. In terms of COVID-19 testing, we continue to showcase our agility in responding to highly variable global demand. And while we continue to meet our customers' COVID testing needs, we also have delivered on robust demand for our non-COVID molecular diagnostics menu. Finally, cash flow generation in the third quarter was very strong, again coming in above pre-pandemic levels. As a result, our balance sheet remains an exceptional pillar of strength. Moving on, we will now provide more color on our financial results. In the third quarter, both top line performance and bottom line profitability were well ahead of our previous estimates. Total revenue came in just over $1 billion, more than $100 million higher than the mid-point of our guidance, and non-GAAP EPS was $0.95, $0.25 higher than the mid-point of our prior guide. Turning to our business results. In Diagnostics, global revenue of $560.1 million declined 13.6% compared to the prior year. However, excluding COVID assay revenue, related ancillaries, and a small amount of revenue from discontinued products, worldwide organic Diagnostics revenue increased 15%, a great result against a solid comp in the prior year. As a reminder, our organic results for fiscal Q3 2022 include Biotheranostics and Diagenode revenue, as these transactions…

[Operator Instructions]. We'll take our first question from Jack Meehan with Nephron Research.

I wanted to go into the molecular results and the 22% organic growth ex COVID. If you look at the Panthers you've installed over the last couple of years for COVID, is it possible to call out now what portion are running something beyond COVID now as well? And also within that result, can you just break out how much the vaginitis revenue was in the quarter?

So I think from a – certainly in the US, the majority of our Panthers are running more than COVID, for sure. I think we are really pleased with the vaginitis growth, but I don't think we're going to give the absolute number at this time.

On the COVID-19 side, would just be great to hear from you what you're hearing from customers and the government around demand as we head into the fall and the winter. Just you're going to be heading into guidance next quarter. Just any early thoughts around how you approach setting guidance for the first time for 2023 as it relates to COVID?

I think when we get to that point, Jack, we'll probably continue to be conservative on the COVID side. It's been such a roller coaster for the last 27, 28 months or whatever that – it's almost been hard to predict within a quarter. We've watched a quarter start strong and then it dries up. And conversely, almost like this quarter, last year, it looked like everything was gone in July and August and then Omicron thing hit in – or Delta hit in September and things started to spike up. So we've had so many ups and downs that I think we'll be cautious as we forecast it. Having said that, I think a lot of what we've said at the very beginning continues to play out. And for those who thought the business was going to be dead when vaccines came in, 18, 19 months ago, we continue to say that we always thought this was going to leave a residual business that was probably going to be around for quite some time and might be one of our top three or four assays. And as we sit here today in the world with Japan and a whole bunch of other countries, very high and the US, as you know, is still running fairly rampant, and we said all along, the goal of herd immunity was not going to be achieved in a mutating virus, that this thing would become more endemic and probably create an opportunity for us to have a more ongoing business. I think we would see that and full expectations as we go into next fall and winter. This thing is not burned away from the world. So there will be some business. But I think we'll certainly model it on the lower side as we go in because it's just – we can count on our base businesses. This one truly is, call it, opportunistic or it's subject – we can't put a linear forecast on it.

We'll take our next question from Tejas Savant with Morgan Stanley.

Steve, one on the CapEx environment here. I know you mentioned demand for gantries is pretty strong. You don't see an elevated cancellation rate, et cetera. What's your sort of line of sight into the order book here? We've had some sort of messaging from some of your medtech peers. Some of them not seeing any impact, others kind of like pointing to a softened CapEx environment here. So just curious as to get your take.

Yeah, we're not really seeing or hearing it from our customers. And I think to a large degree, it's probably dependent on what products you're offering. Ours in the grand scheme are not a huge capital outlay for the hospital systems. We're also a both revenue and patient generating – top line generating procedure for the hospitals. So I think they will certainly find it. So, I think we're not hearing it. But I would say, as always, we're going to plan a little more cautiously and would expect that somewhere over the next couple of years does – is there a little bit of contraction here or there in all likelihood if we go into a recessionary environment. The flip side is, I think we've got pent-up demand. And I think even if there's a macro slowdown, we actually believe we've got some micro benefits working that will help us power right through that.

Just a follow-up on your commentary around the slope of the recovery here on the gantry chips. I know in the past, you've talked about sort of having to figure out sort of construction timelines and installation timelines with your customers. Have you started to work on any of that here as you look to fiscal 2023? And your comments around perhaps the full recovery having to wait until FY 2024 here, are we on the margin a little bit more cautious than what you had shared earlier?

I wouldn't say it's any more cautious. I think for anybody that's listened to the leaders of the semiconductor industry speak over the last six months plus, they've all been saying, look, recovery is not going to even happen throughout 2023, and it's going to go into 2024. And we're largely operating on kind of a quarter-to-quarter allocation right now. So we're at a cadence that is at least better than where it was, but I do think it's important for us to indicate this doesn't come bouncing back miraculously on the day you flip a calendar to a new fiscal year.

I'd just add that our field service engineers who want to maintain the gantries and the installed base are the ones that also do the install. So there is the balancing of our own resources to that recovery as well as hospital schedules.

We'll now take our next question from Patrick Donnelly with Citi.

Steve, maybe one on the 2023 setup. Again, I know you guys aren't going to give guidance. But in terms of the costs, and I know Karleen touched on it a little bit there at the end, what's the right way to think about some of those, whether it's higher input costs, the dollar, obviously, the supply chain on the chips, is the expectation that kind of lingers throughout most of 2023 and it's going to slowly work its way back? Just in terms of thinking about the margin cadence, it seems like most models would have it flipping pretty normal almost day one of 2023. So, I'm just trying to wrap our heads around the right way to think about that cadence and some of that cost pressure lingering into 2023. Again, not surprising that year 2023 obviously starts pretty soon here. But just trying to get a handle on the right way to think about that piece.

Patrick, it's Karleen. Let me try to give you some insight there. So when you look at our Q4, the Breast Health revenue headwind is probably roughly 400 to 450 basis points of a headwind on operating margins. Now that – I think as that business recovers over 2023, that will come back over the course of 2023. As far as costs, higher costs are probably about 200 to 250 basis points headwind on Q4. Now that we think might persist a little longer as inflationary pressures continue. So we think we've got good line of sight to how we get improvement from where we end Q4.

Just on the molecular growth rates, another question – obviously, the number jumps off the page a little bit. Can you just talk through, Steve, I guess, what goes into that? Again, obviously, the acquisitions rolling into it, they flipped organic. Obviously, Mobidiag. Maybe just talk through kind of the different components where the real drivers of strength were because, again, I think that will be a focus coming out of it. It's obviously a big number.

Yes. Clearly, our new product launches and especially BV/CV/TV, as we've talked to the vaginitis panel, is off to a very nice start. But it's kind of across the board. It's also still more customers that we sold more Panthers to during the pandemic that are now able to start to take on our core women's health assays. So, I think what's remarkable is it's fairly dispersed growth, which I think both geographically and across product lines. So, there's no one that completely dominates it. And I think that's what gives us a lot of confidence for the future.

Yes. I would say, of the acquisitions, Biotheranostics is probably the most significant component of growth in the quarter, as we would expect that one to be…

Which we called out.

And we'll take our next question from Derik De Bruin with Bank of America.

This is Nisarg on for Derik. So I want to start off on the margins. Do you guys still think the 32% to 33% range is the right way to think about fiscal year 2023 margins?

Yes. So what I would say is when we have a normalized chip supply, that is exactly the way to think about them in the low 30s. I'd point to our Q2 of 2020, which was 31.5% operating margin. We believe that is a normalized baseline, if you will. But, again, that recovery on the chip is going to occur over the course of 2023. We're still in that planning stages of how and when. So it won't be kind of Q1 out of the gate likely.

One more. Like have you seen any changes on the order book for Breast Health, how much catch-up do you think we could see there as the chip shortage issues gradually go away in.

I think as we said in our prepared remarks, the sales teams are hitting quota that were set prior to the chip shortage. So we haven't seen any deviation in the booking rate. And again, as Steve mentioned, no increase in the cancellation rate. So we think the business is still solid. We're not losing any share, and then it will just be, again, availability of chips in the scheduling of the installs that we'll be working on to manage through the recovery.

We'll take our next question from Vijay Kumar with Evercore.

Karleen, I have two on the guidance. One on breast imaging. I think the prior guidance had $250 million of headwind for fiscal 2022. I think that number changed. Looks like 3Q came in better. What is that updated number? And what is the implied breast imaging headwind for Q4? Shouldn't Q4 be improving based on 3Q trends?

So you're right, we did guide to $250 million. It was $50 million in Q2, $100 million in Q3 and $100 million in Q4. We did slightly better, like you said, about $10 million better here in Q3. I think we're holding to the $100 million in Q4, again, because that favorability, Vijay, was done by kind of blood, sweat and tears of reclaiming and recertifying circuit boards and just don't know if we'll continue to have those yields in this quarter. So we just – it's best to be conservative and that's the $100 million for Q4.

I did have an OpEx question. If we look at the Q4 guidance at the high end, $870 million of revenues, $0.65 EPS, I think the guide implies OpEx on a dollar basis as sequentially flattish. If we annualize that Q4 number, I think the implied OpEx for next year, somewhere north of $1.2 billion. Is that math correct just based on, I think, your commentary on – you'd hold the OpEx line on the assumption that the chip shortage will resolve eventually?

Again, Vijay, for 2023, we're still in the planning process, budgeting process. So, not going to comment. But I would just – the only insight I would give you is that, with our partnership with the WTA, is that the expense of that is loaded into calendar 2022. So most of that then expenses – disproportionate amount of expenses in our fiscal 2022, which will be a tailwind as we get into 2023 and 2024.

We'll move on to our next question from Mike Matson with Needham.

This is Joseph on for Mike. So, I guess there in the pandemic, STI rates seem to have spiked and, currently, they still seem to be at or near record highs. Maybe just to start off, can you talk about maybe some of the barriers that are currently in place in the industry that if removed could increase screening rates? And then maybe similar question. As we saw with COVID testing moving to the at-home testing, do you see this as a potential market for STI testing? And then, if that were to introduce, I guess, what will the Hologic's solution there for staying competitive and if that includes looking at at-home testing options?

On the first part of that, in terms of barriers to STIs, we did see a lot of, call it, intercity clinics and everything that either shut down or got their resources redeployed during COVID time from serving STIs and just serving their community folks really focusing on COVID. So as some of those come back, I think we feel good about hopefully the ability to get back to more screening. And as you say, there's probably been an increase, certainly, we've seen in many pockets of STIs during this time. So, hopefully, the ability to pick those up. On the idea of home testing, there's a lot more complications to women testing themselves at home in terms of administering the test and in terms of shipping it in a proper container and everything else. So, candidly, we were approached by lots of companies in COVID time who all were convinced that they were going to be the next great savior of home testing for COVID as well as home testing for STIs that don't – we're not as sure that market is going to move nearly as quickly to home testing when you actually think about the pragmatic realities of it. And so, I think we continue to feel very good. We continue to broaden out our own portfolios, our partnerships to be able to try to capture them. But I would not expect that market to move nearly as quickly as some companies might be hoping. By the way, I'd also say, if it were, it's where our cash balance puts us in a really good position.

I did happen to see – I don't know if you guys already got a chance to look at it, but it seems that NCCN posted new guidelines for breast cancer screening and diagnosis. Just like a quick look at it. It didn't seem like anything really changed, more or less just solidifying diagnosis pathways based on your risk. But can you maybe talk about anything that was seen in that update? And then maybe just a similar question on that. What's maybe been the reception of some of the mobile mammogram screening that Hologic has put out? How has that been received during the pandemic and recently?

I think as it relates to guidelines, we continue to push for the proper guidelines. I think sometimes USPSTF and some other folks have gone too far. But in general, most of the folks, I think, are adhering to pretty sensible guidelines. And candidly, I think there's still a lot of pent-up demand. There's still a lot of women that put off their screenings during COVID time and are running behind. So I think we'll still catch up. In terms of the mobile, we made those available here and there. It's de minimis in terms of any real impact on the business.

Right. We've been doing mobile mammograms well before the pandemic really to reach underserved communities, is really the intent there.

We'll now take our next question from Puneet Souda with SVB Securities.

First one, maybe for Karleen. How much of an offset are you getting today from repurposing of these prior boards and chips? And how much of that do you expect will happen in FY 2023 versus new chips?

It's pretty de minimis. And if I look at Q3, we did better than the original forecasted $100 million of headwind by roughly $10 million. So it's in the millions of dollars. And again, I wouldn't think that it's going to be the most significant solution to the challenges of supply. It's going to be getting higher allocations.

Steve, on the first fiscal quarter call, you said corrections do create opportunities for Hologic at the right time, but valuations hadn't settled back at that time in your view. So, obviously, macro backdrop hasn't improved, but valuations have come down here meaningfully. So wondering if you have updated thoughts and views on how you're viewing the market and valuations now given your sort of vantage point and the growing cash position and still strong cash flow.

Yes. We like seeing some of the valuations start to truly settle in. The fascinating part always becomes – people are always still looking at the past 52 months – past 52-week high and wanting premiums off of that, even though it's long since history. So the more time that goes by, we believe, puts us in a better position and really puts the potential sellers in a more realistic position. We feel great right now being patient and feel like – we don't see something that's going to snap a lot of these, especially earlier stage or smaller companies back. And we're looking both early stage, and we're also looking at things that bring some legitimate EBITDA in this time, but really like our position. And we're in no urgent need, given the strength of our base business, to act, which I think also just puts us in a much better place while these companies come to grips with their true realities.

We'll now take our next question from Casey Woodring with J.P. Morgan.

I guess the first one, so on the Diagnostics growth rate here, wondering how much of that was pent-up demand from the last quarter or two. So last quarter, you guys made the comment that women's wellness business have softened given COVID impact. So curious to hear if there's a catch-up in visits this quarter and if there's some more pent-up demand to your left in 4Q and maybe even the beginning of fiscal 2023?

Yes. It's probably a little bit. It's so hard for us to say that these things just keep ebbing and flowing by geography. Both within the US, you see regions that move to different paces in COVID time, and certainly on a global basis, different countries. So it feels like a little bit of pent-up, but I wouldn't say that created a big bolus. I think it just more allowed a lot of the visits to come through that weren't happening before. So, I think it's a pop, but it's not like it was necessarily restrained. And again, hard to exactly know. We don't have that information from our customers or anything else. But I think it's where we just keep saying, let's keep watching these trends over time.

Just on the international diagnostics piece, you called out 16.5% ex COVID growth was driven by virology. You did mention women's health there. So I guess can you just sort of remind us how much of that diagnostics business you have is outside the US and if there's material greenfield opportunity on the molecular side with women's health, especially given all the Panthers you've placed?

Yes. Our molecular business outside the US has been underdeveloped. And I think that's been one of the magical pieces of the – being able to place so many Panthers during the pandemic that we're very excited about the opportunity, really in the core women's health business, which has also been underdeveloped. So it's a combination of both the virals and the core women's health as we start to transition from some of those Panthers internationally that we used for COVID into our core business. And I think that's something we expect to be generating certainly double-digit growth internationally for quite some time in that molecular business.

We'll take our next question from Max Masucci with Cowen and Company.

First one, I think you're nearly done integrating Biotheranostics lab operations into the San Diego headquarters, if not finished. The growth is tracking nicely there. So, once Biotheranostics has fully settled into the San Diego headquarters, how motivated will you be to pursue additional M&A deals for, say, a breast-focused specialty lab that you would be able to serve with Biotheranostics, the new lab operations and the commercial team that's in place?

We're continuing to look at all options. I think what we do feel good about, and as you say, Matt, we did a whole bunch of acquisitions in a relatively compressed period of time. and then really had to digest those. And I think between Biotheranostics, which is not fully integrated, we're probably slightly behind exactly your rosy synopsis here. We're integrating it into the San Diego facility and moving the CLIA lab in and all of that, but we still have a little bit of work to be done. The same with Diagenode and Mobidiag getting integrated nicely. Boulder, Acessa, those have all been being integrated to where I would say we're getting to the point where we can certainly handle more integrations, but we're casting the net fairly broadly within our existing state of business, the existing three businesses.

Just sort of following up there, if you look at all of the companies and the products that you have integrated over the past 18 to 24 months, which of the recently acquired products or services, whether it's Acessa or some of the expanded interventional breast offerings, which of them have benefited the most under Hologic's ownership or when they started being marketed alongside some of your cornerstone and marquee products.

I think they're all benefiting very nicely. If you think about what we've been able to do from a covered live standpoint within Acessa, early stages even for Boulder, our surgical sales force is dying to get their hands on it. It's been more a supply issue that we've been holding them back a little bit while we ramp up. Biotheranostics, that team, when you talk to the commercial leader of that team, very excited by what the Hologic team and breadth and marketing capabilities and everything have brought to that business as well. The Diagenode, Mobidiag teams, I think, also in Europe, very excited, particularly having to just have gone through the whole IVDR process, which was a hugely labor-intensive business now to get that behind us and really focus to the future. So I think they're all looking at us and saying, you know what, nice part is they're proud to be a part of us. I was talking to a CEO of another company recently who actually been involved in ones we bought, and he was still close to one of the members of the team at the company we bought, and he said, 'you know what, that team loves being a part of Hologic.' And that's exactly what we always want to strive for. So I feel pretty good that each of them are really fitting that bill.

We will now take the next question from Ryan Zimmerman with BTIG.

And I wanted to just ask one, Karleen. It's already been asked a lot about op margins for next year. And I appreciate the color there. I think you had said maybe 400, 450 basis point headwind on op margins and that will come back over 2023 in a normalized environment. But if I look at the fourth quarter number next quarter, op margins are kind of sitting at 26%. And so, you add back kind of that 400 basis point dynamic. And it puts it closer – and maybe I'm splitting hairs here, but closer to 30%. And I just want to know if I'm thinking about it the right way versus – and, again, in a normalized environment, 32-ish percent, 31.5%. Are we still maybe 100, 150 basis points off of kind of that normalized margin as we enter 2023? And then I have a follow-up.

Yes. So I think beyond, as I talked about the 400 to 450 basis points is this, the higher cost of roughly 200 basis points to 250 basis points, which from a planning perspective, we don't have line of sight to that resolving, but eventually, that will resolve. And I think the other piece was some higher marketing expenses, which is probably about another 200 basis points headwind to op margin that will also abate over 2023. So we have clear line of sight back to those normalized margin levels.

I think Mobidiag laps next quarter in terms of the time of acquisition becomes organic. The disclosure today for both Mobidiag and Boulder was about $8 million. If I go back to the revenue contribution from Mobidiag, I think it was something in the 40s. I just want to understand kind of how that's tracking relative to maybe its previous disclosures. Maybe I'm misunderstanding.

It's tracking a little bit below that, and there's two reasons. One, that 4 handle would have had COVID revenue in there that has come down. That COVID revenue was on their legacy Amplidiag platform, not the Novodiag platform. And as well as there's been some supply chain challenges. We've worked through those. And we're ramping up inventory to kind of go hard commercially at the beginning of 2023. So, a couple of choppiness here in the year, but feel still really good about what that's going to do.

We'll take the next question from Andrew Cooper with Raymond James.

A lot has already been asked. So maybe I'll just give one quick one and let everybody go on. So, on Mobidiag, maybe just an update on Novodiag potentially coming to the US and sort of what's the latest and greatest thinking on the pathway there and what we should be looking for for that product?

I think to Steve's earlier comments about the benefits of these acquisitions in Hologic's hand, I think our R&D teams have spent a lot of time in Finland and Mobidiag's teams have come to San Diego to really work through what that clinical road map is for approval in the US. And I think we're in a much better position of understanding of what is required for approval in the US, in that understanding based on our expertise has pushed out the time line a little. So looking now more like early 2025. But we still feel really good about that acquisition. We feel good about what's going to happen with the EU approvals that we already have here in 2023.

Thank you. And this now concludes Hologic's third quarter fiscal 2022 earnings conference call. Have a good evening.