Hologic - Q1 2023

Transcript

Operator (participant)

Good afternoon, welcome to Hologic's first quarter fiscal 2023 earnings conference call. My name is Justin. 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.

Ryan Simon (VP of Investor Relations)

Thank you, Justin. Good afternoon and thank you for joining Hologic's first quarter fiscal 2023 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. We will also post our prepared remarks to our website shortly after we deliver them, as well as an updated corporate presentation. A replay of this call will be available for the next 30 days. 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.

During this call, we will also 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 related to COVID-19, and sales from discontinued products 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 Stephen MacMillan, Hologic's CEO.

Stephen MacMillan (Chairman, President, and CEO)

Thank you, Ryan. Good afternoon, everyone. We're pleased to discuss our financial results for the first quarter of fiscal 2023. Our results highlight the strength of our three divisions, the power of our commercial channels, and the increasing impact of our transformative growth drivers from R&D and acquisitions. For the quarter, total revenue was $1.07 billion, and non-GAAP earnings per share was $1.07, both above the high end of our guidance. We also repurchased 1.5 million shares of our stock for $100 million in the quarter. To recap our pre-release, while we did have the benefit of three extra selling days, our top-line performance was strong. Diagnostics grew 15.8%, powered by molecular diagnostics, which grew 24.5%. Both figures are organic and exclude COVID.

Surgical also delivered an impressive quarter, growing 14.7% organically. Breast Health finished the quarter down only 5.2%, a signal that our recovery from chip-related supply chain headwinds is indeed underway. While the extra days contributed approximately 250 basis points of growth, net, even without the extra days, Diagnostics and Surgical both grew double digits and Breast Health exceeded prior guidance. All in, we are well positioned to achieve our full year guidance of low double-digit organic growth ex-COVID in all three of our franchises, well above our 5%-7% long-term growth rate. Our balance sheet and cash flow are exceptionally strong, and we continue to create value for our stakeholders. Today, we'd like to cover two main topics.

First, we'll build on the thesis from our JP Morgan presentation three weeks ago, a theme that encapsulates how we improve women's health globally, drive our commercial success, and elevate Hologic's reputation at the same time. Second, we'll highlight the transformation of our business and showcase the growth we are driving in each division, which we hope is now becoming much more evident in recent quarters. We are incredibly excited about today and confident about our future. Jumping right in. Purpose-driven, results-driven. These four words comprise the theme of our JP Morgan presentation this year, and these four words underpin the success of our entire business. At Hologic, we have an unparalleled commitment to women's health. When we speak purpose-driven, results-driven, nothing symbolizes these words better than our virtuous circle, which we feature in our corporate presentation. It is simple and powerful at the same time.

Most importantly, it unifies and inspires our thousands of employees around the world and points our talented workforce in one singular direction, to elevate women's health, where we have leadership positions in each segment in which we operate. Our business starts with innovative, clinically differentiated, life-changing, life-saving technologies. Whether through R&D or by M&A, it all starts with innovation. As we bring these new innovative products to market, they grow our sales and profits. Here's the key to our success, what we believe sets us apart and allow us to thrive. We invest these profits into championing women's health on a global scale. We are expanding policy and access, which then allows our products to reach more women and have an even greater impact on the world. As our business grows, the cycle continues. Simple and powerful.

Two weeks ago, for the second straight year, we had the opportunity to engage with global leaders at the World Economic Forum in Davos, Switzerland. This is an incredible platform that was not available to us just three years ago. We've earned our access through our leadership in women's health, our pioneering Hologic Global Women's Health Index, and our outstanding response to COVID that continues today. As we've grown our business, we have significantly elevated the Hologic brand around the world. With our engagement at Davos, making powerful connections and building strong relationships, combined with recognition from our global partnership with the Women's Tennis Association. Hologic, and what we stand for, is more recognized globally than ever before, which in turn helps us attract the best and the brightest to the Hologic team, an important advantage in today's labor market.

Quite frankly, the best thing we can do for the world, and also for our business, is to raise awareness and opportunities for women's health globally. For a sense of scale, there are approximately 170 million women in the U.S., our largest market. This is only a fraction of the nearly 4 billion women in the world. We have a long way to go. As the importance of women's health is elevated and these markets grow, Hologic will be there at each step along the way. Shifting gears to our second topic, understanding the growth that is driving our business. With our strong performance for the quarter, the number one question we are asked is, how are we growing our top line? To answer this question, we will first reflect on our business transformation, a powerful mix of organic innovation and strategic tuck-in acquisitions.

Second, we will discuss each division and highlight examples of our growth engines and the multitude of market strategies deployed across each division. Reflecting on our transformation, it really started well before COVID. Three years ago, we were ready to show the world how we had diligently and thoughtfully strengthened our business for growth. The pandemic hit. When it did, we established three goals. One, take care of our employees, which we have done. Two, meet the world's needs for highly accurate molecular diagnostic COVID testing, which we continue today. Three, emerge as a fundamentally stronger company, which is happening now. Under the cloud of COVID, while successfully deploying Panthers and producing our COVID assays, we strengthened Hologic for the long term to a level higher than even we had imagined prior to the pandemic.

We achieved this through the combination of innovative internal R&D efforts, plus a series of tuck-in acquisitions. As a result, we've had continuous new product releases that have fundamentally transformed our business and boosted our growth profile. As the COVID cloud begins to clear, it is increasingly more evident that we are geared for success, geared for growth, and geared to sustain performance over the long term. To fully appreciate our growth potential is to understand the transformation and diversification of our portfolio and growth strategies. Across all divisions, we are innovating, acquiring, and building new markets, entering underdeveloped markets, and penetrating existing segments, all while continuing to defend and even grow share in the markets we lead. Our growth in each division is grounded in strong and durable core products.

These resilient core franchises are backed by long-established clinical needs and commercial relationships, which provide a rock-solid foundation to leverage into our newer growth drivers. We leverage our installed bases and customer relationships to advance our newer products, which we expect to both diversify the portfolio and accelerate growth. Moving on to the divisions. In diagnostics, we have leading positions in core women's health product lines such as STIs and cervical cancer. Our women's health molecular diagnostics and cytology base drives steady growth and supports positive relationships with top laboratories and key opinion leaders, which opens the door for additional new products. Today, diagnostics has grown from primarily a U.S. women's health business to a global diagnostics franchise with many more growth drivers.

For example, we now have over 3,250 Panthers worldwide, a number beyond what we had even imagined, along with 19 assays and the Fusion system that enables even further menu expansion. We also have a vastly expanded footprint with three acquisitions, Biotheranostics, Diagenode, and Mobidiag, that are contributing today and will even more so in the future. More specifically, driving future growth for diagnostics means leveraging our expanded Panther installed base. These customers are adopters of our newer assays, including BV, CVTV, and Mgen. We add menu, promote guidelines, and drive adoption through our women's health clinical channel. Likewise, we also leverage our Panther installed base to enter established categories such as virology and respiratory testing. Focusing on our diagnostics acquisitions, with Biotheranostics, we are already seeing solid contributions as we build a new market that is currently minimally penetrated.

With Mobidiag, the Novodiag platform allows for significant future contributions as we prepare to enter the large and emerging syndromic panel market that is adjacent to our core molecular diagnostics franchise. In breast health, revenue from our 3D mammography equipment and the related service represents the core revenue foundation of the division. While our fiscal 2023 growth is primarily driven by the return of chip supply and gantry availability, the division is primed for future growth via further portfolio expansion. The breast health business now spans the breast continuum of care with more recurring growth drivers than ever before. We have expanded from what was once a capital-intensive business by growing service revenue and adding more recurring disposable revenue. In doing so, we are creating new markets, as with our Brevera breast biopsy system, while also entering existing markets where we compete with clinically differentiated products.

While we are leaders in the screening space, our R&D teams are poised to keep us ahead of the pack. In surgical, the business has changed dramatically, evolving from essentially a two-product division to one which is now much more robust and diverse. Last quarter, revenue outside of NovaSure and Core MyoSure represented approximately 25% of the division's total, compared to only approximately 10% in fiscal 2019. While NovaSure and Core MyoSure still form the strong, durable base of the division, the business is far more dynamic than pre-pandemic. We now have meaningful growth drivers outside of these two core product lines from acquisitions, new in-house products, and also improvements to existing products. Going a level deeper, the growth in surgical is driven by products like Fluent as well as NovaSure V5, both from our internal R&D efforts.

With Fluent, we created an elegant solution to hysteroscopic fluid management that stands alone. With our NovaSure V5 line extension, we have proven that even the best can get better, and that we are never satisfied and never done innovating. By acquisition, the Acessa procedure and the Bolder advanced vessel sealing portfolio also diversify and elevate the division's growth trajectory. These are both laparoscopic tools that we've moved swiftly to acquire during COVID times and have added to our prior hysteroscopic only offering. Acessa is a unique radiofrequency fibroid removal solution where we are building a new market and improving payer coverage. In Bolder, we are entering an underdeveloped market by deploying our large surgical sales force to introduce our advanced sealing portfolio to the OBGYN market. Finally, our international business is so much stronger and poised for exceptional future growth post-pandemic.

Bolstering the individual product growth drivers in each division, we continue to penetrate our markets international. For example, in the quarter, our diagnostics business ex COVID and surgical businesses each grew more than 20%. As we've stated before, we expect international growth rates to be accretive to our overall growth rate for years to come. In summary, our commitment to our purpose has paved the way for our success during the pandemic and is a beacon for our future. We are now a transformed, much stronger Hologic, with more diverse growth drivers across each business and a much larger, more capable international presence. Through our innovative R&D and effective tuck-in acquisition strategy. We are well positioned to continue to drive strong, sustainable growth for years to come. With that, let me turn the call over to Karleen.

Karleen Oberton (CFO)

Thank you, Steve. Good afternoon, everyone. We are pleased to share first quarter results that exceeded our guidance on both the top line and bottom line. Our strong performance was once again driven by our diagnostics and surgical businesses, with each growing mid-teens organically in the period, excluding COVID-19 revenue. In breast health, we are encouraged by results that show the chip supply is moving in the right direction and that our mammography business is recovering. Before moving into our divisional results, it is important to highlight our balance sheet. Our leverage ratio of 0.2x shows a capital structure that is strong as it has ever been, providing our business a tremendous amount of flexibility for internal investment and capital deployment opportunities. Moving on, I will now provide more color on our financial results.

In the first quarter, revenue and profitability once again meaningfully surpassed our estimates, with a balanced beat split between our base business and COVID. Total revenue came in at $1.074 billion, a result more than $100 million higher than the midpoint of our guidance. non-GAAP EPS was $1.07, more than $0.20 higher than the midpoint of our prior guide. Turning to our business results. In diagnostics, global revenue of $559.3 million declined 41.2% compared to the prior year. It is important to remember that COVID testing revenue was elevated in our fiscal first quarter of 2022, given the surge in infections from the Omicron variant. A more accurate representation of the diagnostics business is to exclude COVID assay revenue, related ancillaries, and a small amount of revenue from discontinued products.

When making this normalization, we see that organic diagnostics revenue increased 15.8% in the quarter. Within diagnostics, we continue to see momentum in molecular. For the third quarter in a row, we delivered healthy double-digit growth. Specifically, molecular diagnostics grew nearly 25% in our first quarter, excluding the impact of COVID. This outstanding result demonstrates strong utilization across our significantly larger Panther install base. Performance was driven by a mix of our legacy portfolio and newer assays. For example, the collective revenue of our core STI menu was well above pre-pandemic levels in the quarter. In addition, BVCV TV had another strong quarter, more than doubling compared to the prior year, as our progress continues growing the IVD vaginitis market.

Our non-COVID respiratory portfolio delivered revenue ahead of expectations in the period, as we saw uptake in testing for flu and RSV, given heightened prevalence and public awareness of these pathogens. The Biotheranostics contribution to our base molecular performance continues to increase with accretive revenue growth in the quarter. Moving to our COVID results, we generated $127 million of COVID assay revenue in the quarter, exceeding our previous guidance of $75 million. In terms of the COVID assay revenue split by geography, domestic sales led most of our upside and represented nearly 80% of COVID assay revenue in the period. The demand for our COVID assay remains primarily COVID only. We did see above-trend demand for our COVID flu multiplex test. Rounding out diagnostics, our cytology and perinatal businesses increased 1.6% compared to the prior year.

In breast health, total revenue of $334.2 million was down 5.2%, better than expected. These results were driven by strong demand for our mammography equipment and improving semiconductor chip supply. We remain cautiously optimistic that Q1 revenue performance in our breast imaging segment, being down only 4.5%, highlights that the worst of the chip supply headwinds are likely behind us. We would remind everyone we are still on allocation and that the macro backdrop could change quickly. As it relates to our interventional business, revenue was down 8% in the period, driven by lingering supply chain issues outside of chip availability. We expect these headwinds to subside for the balance of the year and the segment to resume a cadence of strong growth starting in fiscal Q2.

In surgical, first quarter revenue of $154.1 million grew more than 17%. Excluding the Bolder acquisition, the business grew nearly 15%. These results underscore a more diverse surgical business with more growth drivers than in the past. In addition to strong performance from MyoSure and better than expected results from NovaSure, the quarter showcased increasing contributions from Fluent and our laparoscopic portfolio of Acessa and Bolder. Lastly, in our skeletal business, revenue of $26.6 million increased slightly less than 1% compared to the prior year period. Let's move on to the rest of the non-GAAP P&L for the first quarter. Gross margin of 62.7% was driven by higher than expected COVID-19 testing revenues and strong performance in our base business in the period.

Total operating expenses of $339.4 million in the first quarter increased 1.6%, but were up less than 1% when excluding expenses from Bolder, which closed at the end of November 2021. The increase was led by higher marketing spend, given the timing of certain initiatives. We expect marketing expense to move lower starting in our fiscal second quarter of 2023. Below operating income, other expense was less than anticipated, primarily due to higher interest income from investing our elevated cash balances at higher interest rates. Finally, our tax rate in Q1 was 19%, as expected. Putting these pieces together, operating margin for Q1 came in at 31.1%, and net margin was 24.9%, both ahead of our previous estimates.

Non-GAAP net income finished at $267.9 million, and non-GAAP EPS was $1.07. Moving on from the P&L, cash flow from operation was $253.4 million in the first quarter. We had $2.4 billion of cash on our balance sheet, and our leverage re-ratio remained at 0.2x. Although it may appear to the outside eye that we are letting our cash balance build, rest assured, our M&A teams in each division are incredibly active. Our capital allocation strategy remains unchanged. Our first priority remains pursuing growth accretive tuck-in deals that align with our divisions and leverage our core strengths and strong commercial channels. More recently, given the stability of our balance sheet and the strength of our business, we have widened our aperture to consider slightly larger EBITDA of generating deals.

That said, it is important to make clear that we expect any transaction we pursue will be complementary to our core strengths and not represent a completely new or unrelated vertical. Our second priority will continue to be share repurchases, and as Steve highlighted, in the first quarter, we repurchased 1.5 million shares for $100 million. Let's move on to our updated non-GAAP financial guidance for the second quarter and full year fiscal 2023. As a reminder, our organic guidance excludes acquisition revenue until each deal annualizes. Therefore, all deals are part of our organic base starting in Q2 2023. In the second quarter of fiscal 2023, we again expect strong financial results with total revenue in the range of $930 million-$980 million.

For all of fiscal 2023, we are increasing our full year guidance and expect total revenue in the range of $3.85 billion-$4 billion, reflecting low double-digit organic growth ex-COVID across each of our divisions. To help with constant currency modeling, we are assuming foreign currency exchange headwinds of slightly less than $20 million in the second quarter of 2023 and approximately $50 million for the full year. These headwinds have improved compared to our previous guidance as the U.S. dollar has depreciated over the past several months. Turning to our divisions, we are thrilled with the outlook for each business as we continue to anticipate that core diagnostics, excluding COVID, breast health, and surgical will organically grow low double digits for our fiscal 2023. In diagnostics, molecular should continue to lead the way.

We expect our assays to drive growth as non-COVID utilization improves and customers add additional menu to their Panther systems. As a reminder, our molecular diagnostics growth is not predicated on placing more Panther instruments but rather helping our existing customers grow their business. As we have said consistently, even though Panther placements are likely to slow in the near term, given the huge pull forward during the pandemic, additional placements do not influence the trajectory of our molecular outlook. Closing out on diagnostics, we expect blood revenue of slightly less than $25 million for the year. Moving to breast health, we see an improving environment for chip supply, and our position is unchanged from last quarter. Our expectation is that for a gradual improvement in our breast imaging business throughout 2023, we maintain our view that the business should exit fiscal 2023 at or near normal levels.

However, we'd like to make clear that you should not expect an outsized revenue catch-up in any particular quarter. Instead, our plan is to incrementally work down our backlog over time as we look to efficiently manage the resources of our outstanding field service team. Finally, in surgical, as evidenced by our first quarter's results, the business has quietly transformed into a dynamic franchise, moving beyond what was once a two-product division. Low double-digit organic growth for fiscal 2023 will be driven by a combination of MyoSure, the related Fluent fluid management system and our laparoscopic portfolio of Acessa and Bolder. In terms of COVID sales, we expect COVID assay sales to be approximately $50 million in the second quarter of 2023 and $225 million for the full year.

COVID-related items, inclusive of a small amount of discontinued product revenue, are expected to be approximately $35 million in the second quarter and $130 million for the full year. Moving down the P&L, for the full year, we continue to expect our non-GAAP gross margin percentage to be in the low 60s% and our non-GAAP operating margin percentage to be approximately 30%. Within this operating margin profile, we have again incorporated elevated inflationary pressures into our guidance of approximately 200-250 basis points, which we anticipate will persist throughout our fiscal 2023. In terms of operating expenses, we expect spending to step down starting in our second quarter, given the timing of marketing expenses primarily associated with our WTA partnership. We foresee operating expense dollars as fairly flat sequentially from Q2 through Q4.

Below operating income, we expect other income net to be an expense of around $50 million for the rest of the year. Our guidance is based on an annual effective tax rate of approximately 19% and diluted shares outstanding are expected to be approximately 251 million for the full year. All this nets out to expected non-GAAP EPS of $0.80-$0.90 in the second quarter and $3.55-$3.85 for the year. To conclude, let me wrap up by repeating that our strong first quarter results exceeded our guidance in spite of persistent macro uncertainty. Performance was driven by tremendous growth in our molecular diagnostics and surgical businesses, combined with a better than expected progress in breast health.

As we look forward to the remainder of our fiscal 2023, we are excited to showcase our transformed business with our updated guidance reinforcing our expectations of low double-digit growth in each division for the remainder of the year. Hologic is a much stronger company than prior to the pandemic, and we believe our 2023 performance will further prove this out. With that, we ask the operator to open the call for questions.

Operator (participant)

Thank you. If you would like to signal with questions, please press star one on your touch tone telephone. If you're joining us today using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, that is star one if you would like to signal with questions, star one. Our first question will come from Patrick Donnelly with Citi.

Patrick Donnelly (Managing Director and Equity Research Analyst)

Hey, guys. Thank you for taking the questions. Carleen, maybe just picking up on the margin side there, you know, obviously pretty good performance in the quarter. You know, still talking about obviously some of the headwinds throughout the year. Can you just talk about the cadence? I know previously you were talking kind of 30%-ish every quarter. Can you just walk us through, I guess, obviously the tailwinds we saw in 1Q and, you know, what the rest of the year looks like in terms of headwinds versus tailwinds and how that cadence works?

Karleen Oberton (CFO)

Yeah, sure. I think the outlook would say that each quarter is roughly 30% operating margin. What you see happening is, you have the marketing expenses coming down from Q1. You have lower COVID revenue, which is a headwind, but then you have higher breast health re-revenue, which is a tailwind. They kind of offset, those headwinds and tailwinds offset over the course of the year. We maintain at that 30, again, the 30 a little lower than pre-pandemic 'cause we have the higher inflationary costs still anticipated.

Patrick Donnelly (Managing Director and Equity Research Analyst)

Okay. That's understood. Steve, maybe just on molecular diagnostics, you know, really strong core performance there. Can you just flesh out a little bit more on the drivers you saw? I guess, sustainability, again, obviously some pretty big numbers you guys have put up there. Just trying to get a sense for the drivers and what we could expect going forward on that front.

Stephen MacMillan (Chairman, President, and CEO)

Yeah, you know, you probably got it in multiple buckets, Patrick. Part is just a return of the Panther systems being used for the core STI business, you know, most of our women's health business. You've got a, you know, increase in growth in our new product launches, especially BVCV, which is off to a tremendous start and we said we think will be, you know, a major driver of growth. You really have, you know, what we kept saying over the last couple of years, and it wasn't as obvious, is so many of our customers around the world that were running COVID are now putting the menu onto the Panther systems, and it's really that simple. You know, a huge part of it. There's a little bit of Africa and some viral stuff.

Karleen Oberton (CFO)

Yeah, the only thing I would add to that, Patrick, is we had some nice contribution from our respiratory assays, which will be seasonal as we move forward.

Operator (participant)

Our next question will come from Jack Meehan with Nephron Research.

Stephen MacMillan (Chairman, President, and CEO)

Fly, Eagles, fly.

Jack Meehan (Equity Research Analyst)

Thank you. Good to get the formalities out of the way. Go Birds. Feels like our year, but I say that every year.

Stephen MacMillan (Chairman, President, and CEO)

Fly, Eagles, fly. Fly, Hologic, fly. Okay, go ahead, Jack.

Jack Meehan (Equity Research Analyst)

Excellent. Had a couple of 10-Q-derived questions that I personally thought were kind of interesting, want to get your thoughts on. The first is, you report international molecular sales of $97 million. Karleen, based on your COVID assay disclosures, I think it's like $25 million of international COVID, so it implies about $72 million of base molecular international. Prior to the pandemic, it was like $30 million a quarter. I was just wondering, like, could this be an interesting gauge of what, you know, the international installed base could look like, you know, in terms of the stickiness of Panther? Just any thoughts on that would be helpful.

Karleen Oberton (CFO)

Yeah. As you said, that number includes the COVID assay revenue. I think you've attempted to take some of that up. We also have the ancillaries, which are part of that are elevated because of COVID. I think certainly, you know, we're seeing the uptake, again, with newer customers in more than COVID, as well as our initiatives like in Africa, what Steve talked about, the virals picking up some nice traction there as well. I think as we think about international molecular, we would think that that is gonna grow a little faster than U.S., given the commercial investments that we've made there in the Panther placements.

Stephen MacMillan (Chairman, President, and CEO)

Yeah, Jack, just to pick up on that point that you've noticed. You know, we placed a lot of Panthers with so many of, especially the European countries, as we responded with COVID, and every one of those was coming with trailing shifts over to the STI business. I think that's a big piece of it.

Jack Meehan (Equity Research Analyst)

Interesting. Okay. My second question is on breast imaging. The U.S. sales in the quarter were $212 million. I think that's actually, like, the largest first quarter you've had, you know, at least several years. You know, international is still seeing some pressure. I'm just trying to juxtapose this versus your comment about, you know, you're still seeing ongoing semiconductor pressure. What was going on in the U.S. in the quarter? Was there any flush of some sort as chips came in, and just what does 2Q assume?

Stephen MacMillan (Chairman, President, and CEO)

Yeah, there was absolutely no flush, we can tell you. We did get a little bit more supply that we were able to install. Candidly, Jack, we had the extra week. We got a little bit of service revenue in there because of that extra week in the quarter. That kind of pushed us into the growth. Without that extra week, that would've been, you know, slightly down a bit. We like where we're coming, and we were able to kind of refurb a few more chips, got a few more chips in, and we're able to get a little more product out. We're feeling really good about where we're headed this quarter and for the rest of the year in breast health.

Operator (participant)

Our next question will come from Max Masucci with Cowen and Company.

Max Masucci (Managing Director and Senior Research Analyst)

Great. Thanks for taking the question. First one on operating margins. It looks like the COVID testing and related items were about 15% of the organic revenues. Just based on your expectations for global COVID testing revenues this year, and as we near the end of the U.S. government's PHE program, does COVID testing and reimbursement remain yeah, the big needle mover for 2023 operating margins, or is the operating margin expansion opportunity now more dependent on the breast health rebounds, you know, and/or continued strength in non-COVID molecular Dx?

Karleen Oberton (CFO)

I would say that the margin accretion from COVID is less and less dependent on COVID as we move throughout the year. It's gonna be more driven by the breast health recovery and certainly Q1-Q2 lower operating expenses, which will persist throughout the year.

Max Masucci (Managing Director and Senior Research Analyst)

Okay. Got it. Just in terms of M&A, I think if you look at your free cash flow deployment, about 28% over the past five years, I think it's been for share buybacks. In any sense, I would just be curious to hear about the potential size of any M&A deal you'd be willing to pursue, any recent conversations amongst the biz dev team in terms of what types of companies fit best with the Hologic of today. Just a general update on capital deployment would be great. Thanks.

Stephen MacMillan (Chairman, President, and CEO)

Sure, Max. To reiterate what Karleen said, our primary goal is still tuck-in acquisitions, followed by share buybacks. We certainly have been opportunistic on the on the buybacks because we generated a whole bunch more cash during that time and thought that made a lot of sense. You know, going forth, we're looking across the businesses all being led by the divisions. We're not going to get into, you know, particular scale or targets for obvious reasons. You know, I think what we would say is we might go a little bit bigger on scale if it brought more EBITDA. There'd be a, you know, a proportionate, you know, thought process there. I think we're, you know, the biggest takeaway, frankly, is we're in a position of strength where our base businesses are very strong. We don't have to go do anything.

You know, candidly, when I think there's a lot of folks around trying to figure out what they wanna be when they grow up right now, we know exactly where we're going and what we wanna be, and that is championing women's health and having every business going well. It gives us the luxury of being patient and smart on the business development front.

Operator (participant)

Our next question will come from Puneet Souda with SVB Securities.

Puneet Souda (Senior Research Analyst)

Yeah, hi Steve. Thanks for taking the question. Maybe, for you know, given the low double-digit growth rate that you're highlighting here, obviously the business, all three segments are doing great. What's holding you back on the long-term guide of 5%-7%? Why couldn't that be higher now in your, you know, long-term outlook?

Stephen MacMillan (Chairman, President, and CEO)

Because we're running the business for the long term. You know, fundamentally, let's look at it. You know, we're still bouncing off of some comps from last year where things were a little depressed from COVID, everything else. We are a company that delivers and plans for the long haul and, you know, everything we've done to move up to the five-seven has been very smart, and we're gonna continue to be prudent.

Puneet Souda (Senior Research Analyst)

Okay, great. Then just, you know, on capital deployment, maybe Karleen, what's your ability to lever up? What ratio are you comfortable with? Just given the sort of the interest rates that are there right now and potential for those to continue to ramp up a bit higher?

Karleen Oberton (CFO)

Yeah, I mean, I think we have indicated that we'd be comfortable in a 2x-3x leverage ratio. That's something certainly we talk to and supported by our credit agency. To your point, we would continue to evaluate based on interest rate environment. Certainly, at this point, we have plenty of cash and we have a credit line that, again, we can fully deploy. We feel like we've got good flexibility to do what we want in that event.

Operator (participant)

Moving on to Vijay Kumar with Evercore ISI.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

Hey guys, congratulations on a solid Q here. Thanks for taking my question. Steve, I wanted to ask one on this guidance update here. It looks like you beat the quarter versus your midpoint of your prior guidance by about $120 million-ish. The annual guide was raised by about $125. Looks like most of that's coming from FX and change in code assumptions. When I look at Q1 print here, your underlying organic came in better. Why wouldn't some of that underlying strength we saw in Q1 flow through the rest of the year? Is there any timing impact of revenue recognition or is this just conservatism?

Stephen MacMillan (Chairman, President, and CEO)

We continue to deliver. I can promise you it's nothing to do with timing of revenue recognition, Vijay. The underlying business is very strong. We're one quarter in. Think about where we were a year ago at this time. Suddenly, Russia invaded Ukraine. Nobody saw that coming. I've lived through the downturn of 2008, 2009. We've watched the world go up and down, and we're the first quarter over a year. We're going to continue to be very prudent. Do not underestimate our confidence in our ability to run the business.

Vijay Kumar (Senior Managing Director and Equity Research Analyst)

Understood. Then maybe another way to ask this question, Steve, is, you know, diagnostics clearly was a highlight, 16% organic. What is driving this? You know, is this, is this like reagents? You know, what kind of testing is driving this? Was this easy code comp? When I look at Q1, overall underlying organic was 6%. They hit double digits for the year. The base has to do, you know, teams drill to the back half. How should we think about this diagnostics, which was 15% in Q1, ramping up in back half? Is the back half being carried by normalization of breast imaging revenues?

Stephen MacMillan (Chairman, President, and CEO)

Look, clearly the comps on molecular and diagnostics will get harder in the back half. Fundamentally, what's driving it, and we sort of answered this, I think earlier, you know, we placed a whole bunch of Panthers, you know, almost 1,500 Panthers in COVID time over the last three years. We've got more customers adopting our core menu. We have our new products being launched, doing very well. You know, those are really the main drivers as well as a little bit of flu and a little bit of viral stuff as we've been penetrating a little more Africa. Go ahead, Carleen.

Karleen Oberton (CFO)

Yeah, I mean, I think it is, you know, the Panther placements and new customers as well. I think we've talked about in our corporate presentation that, you know, of newly acquired customers, 85% are running at least 1 other assay, and over 55% are running at least 2 other assays. I think that is the value of the Panther and the menu that we have, you know, driving that growth.

Operator (participant)

Our next question will come from Tim Daley with Wells Fargo.

Tim Daley (VP and Senior Equity Research Analyst)

Great. Steve, I love the comments on some parties are out there trying to figure out who they wanna be when they grow up. Just running with that, we've seen a lot of players in molecular diagnostics seem to be adding menu in women's health arena. Given your legacy foothold there, you know, how can you think about the current competitive environment? Are you worried about any price pressures maybe from new entrants trying to gain share via that lever? Yeah, just kind of defensible stance here and kind of what you would, you know, answer to any questions around that?

Stephen MacMillan (Chairman, President, and CEO)

Yeah, we worry all the time, you know. At the end of the day, you know, we've also built an incredible sales force that has partnered both with the labs but also with the clinicians. Our assays have proven themselves over time, as well as do not underestimate the workflow advantages of our Panther system. There's a lot of people that can talk a good game, and especially, let's face it, there were so many startups that all were working on stuff, and then they got money in COVID time, and they start talking about all their women's health assays. You know, it's an interesting little landscape right now. We never take anybody for granted.

We face some very formidable competitors, but we always have, and we will continue to, and we frankly think we continue to innovate, you know, things like BVCV. We continue to bring new assays and new tests and new education to our customers, and that continues to provide, strength for us.

Tim Daley (VP and Senior Equity Research Analyst)

All right. No, appreciate that. One for Karleen. You know, surgical, great to hear about the performance outside of the legacy products and appreciate the detail on the growth drivers this year. Could you kind of give us a bit more, you know, quantified detail about, you know, growth ranges here across the various buckets? Kind of the legacy products versus the new in-house developed versus kind of the recent acquisitions. You know, any additional kind of, you know, above, below ranges or anything like that you could provide? Thank you.

Karleen Oberton (CFO)

Yeah. What I would say is dollar contribution is probably evenly split between the legacy platform and Fluent, our new innovative, and then the acquisitions. Certainly, the % growth rate is much higher from the acquisitions building off a smaller base. At the end of the day, I think the key takeaway is there's not just one growth driver, there's multiple growth drivers that are driving the success of that business.

Operator (participant)

Our next question will come from Tejas Savant with Morgan Stanley.

Tejas Savant (Executive Director and Senior Healthcare Equity Analyst)

Hey, guys. Good evening and thanks for the time here. Maybe I'll start with a couple on some of the recent deals for you, Steve. On Mobidiag, can you just remind us again where things stand in terms of, you know, I think you had said there's an inventory buildup underway ahead of the launch. How big do you think the revenue opportunity could be in fiscal 2023? Similarly, you highlighted Biotheranostics a couple of times today, and, you know, obviously they've gotten to guidelines. They have the recent data from December as well. How big do you see this opportunity becoming for you, perhaps not this year, but a couple of years out?

Stephen MacMillan (Chairman, President, and CEO)

Sure. I think on Mobi, you know, Mobi will still be pretty small this year. You know, Mobi will hit its stride ultimately when we bring it to the U.S., which is still several years away. We love the platform we have there. On, you know, Biotheranostics, you know, it's still very small penetration. The reality is, you know, clearly, it's, you know, gonna be probably potentially a few hundred million dollars. We're not sure at this point. I'm never great at... When you're creating new markets, it's always really hard because you go back eight years ago, people ask me, you know, Could MyoSure someday be the size of NovaSure? At that point in time, it was hard to picture that. Today, MyoSure is, you know, way bigger than NovaSure.

I think this magic that we have where we really are creating and building markets, it's sometimes hard to fully put a number on it other than to see, we think there's a lot of runway here, a lot.

Tejas Savant (Executive Director and Senior Healthcare Equity Analyst)

Got it. That's helpful. Then a couple of follow-ups here. One on just the hospital CapEx environment and any sort of change in either sort of decision timelines or perhaps cancellation rates here a month into the new calendar year. China, I know it's small for you guys. I think it's less than 3% of sales. Is there anything going on there in terms of the COVID case surge that we should be factoring in, at least, in the fiscal second quarter here?

Stephen MacMillan (Chairman, President, and CEO)

I think on the first on CapEx, we continue to stay really close to our sales teams on it and seeing very tiny, you know, nothing outside of historical cancellation rates, which is de minimis. On China, I think what you will see is probably most of the hospitals in China over the last 60-ish days and probably here for a little period before, are probably cutting down on normal procedures as they've been treating the COVID patients. But I think, you know, for our business, again, pretty small, but I think that's the kind of macro way I'd be thinking about China right now. My hunch is, you know, after the Chinese New Year and everything else, they're gonna largely come back online and that'll start to pick back up, probably later this actual calendar quarter.

I think they're gonna get through it fine.

Operator (participant)

Moving on to Derik de Bruin with Bank of America.

Derik de Bruin (Managing Director, Life Sciences Tools, and Diagnostics Analyst)

Hi. Good afternoon.

Stephen MacMillan (Chairman, President, and CEO)

Hey, Derik.

Derik de Bruin (Managing Director, Life Sciences Tools, and Diagnostics Analyst)

Hey. A question. You know, you're talking about 30-ish%, you know, adjusted operating margin for this year. I'm looking at the consensus for 2024, it's about 30.5%. You're talking about 200-250 basis points of inflationary pressures that are sort of in there. Can you walk us through how you're thinking about operating margins as you sort of invest in the business and as some of these inflationary pressures normalize? Just sort of trying to get a sense of where we go from here.

Karleen Oberton (CFO)

Yeah, Derik, it's Karleen. I'll take this one. If you think about prior to the pandemic, you know, what we'd say is our normal operating margin was roughly 30%-31.5%. Very rich margins for our industry. You know, I see us probably over time getting back to that level. What I would say is think about our 5%-7% top-line long-term growth rate, we will grow EPS faster than that, so likely low double digits. That EPS growth comes from more than just operating margin expansion. It comes from higher revenue growth, as well as some things that we can do below the line. That's how we think about our long-term outlook for earnings growing faster than revenue, and again, anchored on that 5%-7%.

Derik de Bruin (Managing Director, Life Sciences Tools, and Diagnostics Analyst)

Great.

Stephen MacMillan (Chairman, President, and CEO)

Derik, to put a little point on it too. I've been around this business long enough to watch either divisions of big companies or companies themselves try to push that operating margin so far that they cut into R&D. You don't see it immediately, but over time, your innovation falls. You know, we know a lot of folks wanna just keep seeing every number go up like that. We're thinking very much, as Karleen said, about driving the EPS number, but continuing to invest in R&D and not try to drive the operating margin as high as humanly possible.

Derik de Bruin (Managing Director, Life Sciences Tools, and Diagnostics Analyst)

Thanks for setting me up, Steve. That's exactly where I was going next. I appreciate that. When you think, you know, you've got Biotheranostics, which is your entry into sort of like the oncology world. I mean, you know, there was some dabbling in the past with some things with like, I think it was PCA3 or some of this like stuff. How do you sort of think about an oncology market? I mean, there's obviously a lot of real estate out there, I think you pointed out that you don't wanna do anything that's super dilutive in those areas. Clearly, there's a lot that's going on in that market and, you know, opportunities for Hologic.

Can you sort of like flesh out where you sort of think your genomics focus is, where this is going, how it is? Thanks.

Stephen MacMillan (Chairman, President, and CEO)

Sure, Derik. Yeah, you're probably the only person that remembers PCA3. You know, I think we're comfortable continuing to be fairly patient. If I look at this overall, right? I go back seven or eight years, liquid biopsy, you know, is gonna be the greatest thing ever. You know, everybody thought by 2018, 2020, you know, it'd be this massive thing. We kept saying, "Look, we just don't know that there's gonna be a lot of money made." We continue, and particularly on our acquisitions, everything we look at is thinking about what is the long-term value creation from an earnings standpoint, not just a revenue.

Let's face it, as you well know, in this industry as well, there's a whole bunch of companies that generate a lot of top line, but no bottom line, and they get great valuations when they're standalones. You try to drop those into a healthy company where suddenly the EPS starts to get looked at, you never get that same expansion on the multiple. I also think for all of the promise, the promise never comes as quickly as everybody thinks it's going to do. You know, I'm still waiting for gain sharing orthopedics to take over the full world, you know, 20 years later.

I just think as we continue to watch the space, we believe there will be winners that will emerge, but we're still letting some of those play out, candidly, and trying to see it's not just a revenue game or a number of boxes sold or, you know, number of kits sold or whatever else. It really is, okay, what's that long-term trajectory is how we're trying to think about these things. Thank you for asking that.

Operator (participant)

We will take a question from Dustin Scaringe with William Blair.

Dustin Scaringe (Equity Research Associate)

Hey, this is Dustin on the line for Andrew. Going back to a comment you made earlier on Mobidiag and the entry into syndromic testing market, can you be more specific on the timelines and how you plan to leverage your Panther relationships to drive that forward?

Stephen MacMillan (Chairman, President, and CEO)

Yeah, you know, we're clearly entering in Europe right now on a smaller scale. You know, the U.S. clearance will be ultimately the bigger part. As we said, that's probably at least a 2025-ish, you know, event at this point. We're still a few years away as we prepare for it. We'll certainly be able to leverage a lot of the strength that we have in the labs, especially the medium-sized labs, as we go into that point.

Dustin Scaringe (Equity Research Associate)

Okay. I recognize that you've talked a lot about M&A already, but I'm wondering if you can be more specific and speak to how you're thinking about valuations, both in the public and private space.

Stephen MacMillan (Chairman, President, and CEO)

You know, we're always looking at the end of the day, we're thinking about, you know, long-term top and bottom line growth. We're very focused on ROIC. You know, a key part of our senior leadership team, comp is tied on ROIC, so we look at it on every deal. We've watched a whole bunch of things that even that have come down 80% or 90%, and some of them, you know, we still don't necessarily like. Again, I think we've got the luxury of time on our side, given the strength of an underlying business and the strength of our balance sheet, which gives us a chance to be, you know, relatively picky around what might be out there.

Operator (participant)

We have a question from Navann Ty with BNP Paribas Exane.

Navann Ty (Lead Analyst for Healthcare)

Hi. Thanks for taking my question. On women's health, I believe vaginitis drove Q1 growth ex-COVID. Should it continue to drive growth for the rest of the year? Longer term, could you discuss your women's health focus being potentially a competitive advantage versus your non-focused peers? Thank you.

Stephen MacMillan (Chairman, President, and CEO)

Yeah. I think we continue to see growth, certainly in our women's health assays. That's been, you know. And it kind of piggies to your second point about it. If you think about something like BV TV that we've launched, you know, we discovered and realized about that because we're so tapped into the key opinion leaders and starting to realize that there are other tests that may be able to be developed that we can bring to the market to bring greater levels of certainty and specificity. I think when we have that knowledge, because we surround those customers, our focused approach certainly benefits us well and I think helps us on the innovation side. You know, the same in 3D mammography and how that's led to, you know, better biopsy stuff.

The same in our surgical business, where, you know, understanding fibroids better than anybody else and being able to innovate and, you know, endometrial ablation. We kind of, you know, surround these, you know, call them large niches, but it's really the insights that we have from working with the KOLs that I think does provide us a level of competitive advantage. Thank you.

Navann Ty (Lead Analyst for Healthcare)

Thanks. staying at women's health, you mentioned future portfolio expansion in breast health. Are you able to tell us more about any breast health innovation?

Stephen MacMillan (Chairman, President, and CEO)

Any breast health innovation? You know, I think the way to think about that is we just continue to innovate. We've always been, you know, we've brought, you know, enhanced detectors, enhanced, you know, workflow solutions and, enhanced imaging along the way, and we'll continue that.

Karleen Oberton (CFO)

Yeah. I think we, you know, One important focus on innovation is patient experience, focus on that as well as machine learning, what we can do to make radiologists more efficient. Certainly, that's a big issue outside the U.S., where there's much fewer radiologists.

Operator (participant)

Thank you. This now concludes Hologic's earnings conference call. Have a good evening.