Hologic, Inc. (HOLX) Earnings Call Transcript & Summary

Thanks, everyone, for joining us this afternoon. I'm Vijay Kumar, the Life Sciences Device Analyst at Evercore. A pleasure to have with us Hologic. We have CFO, Karleen Oberton, with us. Karleen, thanks for spending the time with us.

Great to be here. Thank you.

Fantastic. So maybe given your fiscal just ended, and we have the guidance out of the way -- we have fiscal '25 guidance, maybe if you had to review Q4 and how it progressed versus internal expectations? Were there any surprises for you versus your internal expectations?

For Q4 specifically, I think we achieved expectations. We finished the year strong. It was the second quarter in a row where we returned to reported growth, both on the top line and bottom line and we really continue to see that pattern to continue to have that top line growth, bottom line growth, even including the COVID declines that we really, I think, fully lapsed here -- of lapsing here in '25.

Understood. And when you look at the macro environment here, how would you characterize the macro environment, stable, positive utilization, any changes in macro?

Obviously, the macro environment is something that we continue to monitor. I think both here in the U.S. and abroad. I think we are probably under-indexed with some of the more geopolitical items such as China, less than 2% of revenue at this point and less than 1% from a cost perspective. In the U.S., we continue to look at the geopolitical administrative changes. And at this point, we don't want to speculate on changes but don't see any outsized impact to Hologic in any areas.

That's helpful. And you did bring up China, what is your exposure to Mexico? Do you have any manufacturing in Mexico?

Beyond China, our largest foreign manufacturing is actually Costa Rica. We manufacture most of our surgical products there and most of our disposable breast health products manufactured in Costa Rica. We do have a partnership for our manufacturing of skeletal products in Mexico, but pretty limited in nature.

Fantastic. And I guess maybe one more on post elections here, any change here from customer behavior that you've observed?

From a customer perspective, we're not seeing any changes in behavior at this point in time. Obviously, again, we continue to monitor changes in the administration and personnel. But at this time, I feel like we're in good shape to handle any changes that might come our way.

Got you. And maybe turning to your fiscal '25 assumptions. I think this is a year where we've had a first half versus second half cadence with some unique items impacting your first half. Maybe talk about the first half assumptions here and the impact of these specific items. You called out, I think IV fluids was one of them. What are the other factors that hit you in the first half?

Sure. So if we look at our guide for the full year '25, the midpoint was roughly at 4%. And if you look at the first 2 quarters are going to be closer to the 2% range. And both of them have unique headwinds that given that guide lapse as we get into the second half of the year and therefore, implied higher growth rate for Q3 and Q4. In Q1 and Q2, there's a couple of things. One, it's our skeletal stop ship that began in -- late in our fiscal third quarter of '24. We have indicated that we expect to start shipping again in Q1, and we believe that we're on track to do that probably a little later in the quarter than we had originally anticipated. We also talked about the IV fluid shortage and really the impact in elective procedures, both eliminating or canceling elective procedures, but also the prioritization of procedures and how that might impact our surgical business. I think we've all heard from Baxter that they are on track to be back to normal production capacity at the end of the calendar year. While that is great news, not clear how that flows back through the supply chain and how do our customers get back to a normal state as we exit the year. So that could impact Q1 for surgical and maybe bleed a little into Q2. Again, as we get that supply normalized throughout the supply chain. Then it's respiratory. So we had a pretty strong respiratory season Q1 and Q2, both in '24 and '23. We guided conservatively. And actually, what we've seen is the CDC has indicated that the current year flu season is definitely below the last 2 years. So again, that would be something that would impact revenue for Q1 and Q2. And then in terms of margin profile, we have also talked about improvements over the course of the year. Again, probably more of a first half, second half way to think about it. So the first half, we have those revenue headwinds abating, but also seasonally, Q1 is higher operating expenses for Hologic. In Q2 -- Q1, in particular, higher in regards to our national sales meeting and certain other trade show expenses that we incur. And then from a variable compensation perspective, the structure is such that more of the expenses taken in the first half of the year versus the second half. So those are the 2 clear things that we see that step up in gross margins and operating margins in Q3 and Q4.

That's helpful, Karleen. The -- I guess, on your comment first half being -- first 2 quarters being like 2% organic. I think that's a first half comment, right?

Yes.

And so Q2 should be better than Q1 from an organic standpoint?

I would say it's going to be similar, again, because of those headwinds, how they manage out over the course of those quarters.

Understood. And so on, I guess, the IV fluid shortage situation, like whatever guidance assumptions you guys made, is that consistent with how the quarter is progressing so far relative to your guidance assumptions?

Yes. So I would say how it's progressing now is within the range that we provided.

Got you. And how -- from a procedure standpoint, right, are there any -- because these are electives, should there be any backlog or catch up of procedures?

So that's an interesting question. So theoretically, you would think that if to the extent procedures were canceled or deprioritized from our fiscal Q1, which is calendar Q4, you would see that come back in Q2 to the extent supply was normalized or Q3 for supply was normalized. But the reality is this is an elective procedure. And so calendar Q4, many patients have used through all their deductibles. So you might have a situation where a customer's procedure in calendar Q4 is canceled, their deductible resets in calendar Q1 of '25, and they might wait till later in the year to when their deductibles have lapsed to reschedule the procedure. So that's a little bit of the nuance to this item in particularly.

Got you. So it's really -- if customers do decide to, I guess, spend, there is always the potential, but you do think there is some seasonality because of deductibles and that's why...

Yes, we've always had a seasonality where Q1 is typically for our surgical business, our strongest quarter, and we always see a step down in Q2 as those deductible resets and kind of rebuilds in the balance of the year. So we could have that same impact for any procedures that were canceled in our fiscal Q1.

Got you. And I guess, on the skeletal, it looks like it's coming in a little bit later than expectation, perhaps some impact in fiscal 2Q as well. Can you just remind us what this issue was and why have timelines sort of, I guess, got pushed out by a few weeks?

Yes. Sure. So we identified a noncompliant component within the supply chain related to our skeletal unit. It was essentially related to some electrical magnetic distribution, if you will, that could potentially interfere if a patient had a pacemaker or the like. So there was a modification that needed to be made to the unit in the event, again, a patient had such a device. So it's not every patient, it's a very small subset that would be impacted. So the teams worked on a solution to, again, that modification to address the issue doing thorough testing. There was a couple of reworks that probably pushed the timing a little later than we originally thought. But again, as we guided, we said Q1, it's in Q1, but just a little later.

Understood. And from a -- similar to the IV fluid kind of question, shouldn't there be a backlog here because customers were on pause for about 5 months here, should that benefit in second quarter and second half?

Well, again, we are -- what I'd say, as we have identified the fix ramping up production, so there's kind of a ramp-up as well in our capacity to have units available that will continue through Q2. I think while there is probably some backlog given the situation, there are competitive products available, and customers may have budgetary reasons that they might decide that they can't wait. Internationally, this is our most global product where 50% of the revenue is outside the U.S. And sometimes, these are tied to tenders and other issues that customers may not be able to wait. So feel good about the recovery that we have. But again, I guess I'd frame it as I wouldn't expect an outsized quarter for skeletal as we move forward.

Understood. Then maybe moving on to some of the segments here, molecular has been a bright spot for Hologic. It's done really well. Part of it's driven by Panther placements. In a high level, can you talk about the -- what's been molecular CAGR versus 2019 levels? And what have been the incremental tests that have driven this growth?

Yes. We're really proud of the molecular business and the performance that we've seen since 2019. And I think there's a couple of elements to that performance. So one would be the acceleration of Panther placements through the pandemic. We started the pandemic about 1,700 units placed globally. We're about 3,300 plus now placed globally. We also have the menu. So we have over 20 assays approved on Panther and Panther Fusion. So while a lot of people in the pandemic placed a lot of instruments, not all of those instruments had the high throughput, great workflow that our instrument has, and certainly, none of them had the menu, right? So a lot of those instruments are placed under emergencies, approvals, where all of our assays are FDA approved at this point. So it's the twofold. It's this outstanding instrument plus the menu that really drives the performance for the molecular business. And even though Panther placements have slow down in the past couple of years, given the acceleration earlier in the pandemic, we're still seeing that solid double-digit growth from our molecular business led by BV/CV, but also contributions from Biotheranostics, an acquisition that we did in 2021.

Got you. And where are we -- when you look at BV/CV in BCI within Biotheranostics, how large are these product categories? What innings are we in from an adoption cycle standpoint?

Yes. So I think when you think about BV/CV, we've talked about that as currently our second largest assay. So think about our largest assay is chlamydia, gonorrhea, which is roughly $270 million to $280 million globally compared to HPV, our third largest assay, which is probably $160 million to $170 million globally. So right in that range. And at this point, we would think that BV/CV will eventually be our largest assay globally. So in terms of those numbers, you can see that we're kind of at the mid-innings, if you will, of this opportunity. And that is substantially U.S. We have very minimal contribution at this point in time outside the U.S. So we think there's significant runway for BV/CV. In terms of Biotheranostics, again, we think this is -- it is growing faster than the core molecular business, so it is accretive to molecular growth rate. We've had double-digit growth rates for the past several years since we acquired it. We are probably still double digit, but a little lower than we were before as that base grows, it's over $100 million now of annual revenue. And we think it's early days as far as penetration that we still have some room to grow as far as penetration on the market opportunity for this test.

That's helpful. When you think about the competitive landscape, is there anyone else who's launching BV/CV or should that matter from a competitive standpoint?

So we obviously have formidable competitors in the space, very large companies. I do believe that some of them may have BV/CV on their publicly announced development pipeline. But I think, certainly we have first mover advantage in this market. We've seen that play out time and time again.

Understood. And maybe if you could just give some analogy on , I think, years ago, if I remember CT/GC, there a similar sort of questions around, hey, competition and new players coming in, what enables Hologic to protect its turf within the high-volume molecular test market? Is it Panther? And what kind of advantage does it confer Hologic?

Yes. So certainly, the instrumentation is part of our competitive advantage. Think about Panther as an instrument that's probably the size of an office copier, a little bigger. So it not only serves the large labs, it serves a lot of these medium to smaller-sized labs that do this testing. It has very high throughput, random access. You don't have to wait to batch. So you really have the best workflow optimization for the lab with the least hands-on time. So that really creates a lot of value to the lab in and of itself and really that's inherent in the labs workflow. So workflow, they don't want to rip and replace instrumentation. They have an instrument that works, they want to keep that workflow going. I think the other secret sauce that we have in regards to partnerships with our customers is that we have a physician sales force. So what the physician sales force does is it partners with the lab on customer-level data to understand which customers are potentially under screening, if you will, it allows the physician sales force to grow and educate the physicians on screening that should be done. As an example, I think it was back in 2021, the CDC in regards to chlamydia, gonorrhea screening reverted to basically to have to opt-out. So universal screening. We are the ones that go out and educate physicians about that change in guideline. And so I think that partnership with that special unique sales force beyond the [ lay-up ] sales force drives value with our customers that they know that while we're growing our business, we're also growing their business, and we're actually bringing better care to women in the community.

Got you. And what is the guidance assuming for fiscal '25 molecular growth? And is there any first half versus second half growth cadence within molecular?

So certainly, molecular would be -- if we have a midpoint of 4% molecular is going to be above that, right? And what I would say that from a first half, second half would be the respiratory dynamics. So again, that respiratory testing even beyond COVID testing falls within that molecular business. And as we've indicated, very strong respiratory seasons, Q1, Q2 in '24 and '23, we guided conservatively. And at this point, the CDC is indicating that the respiratory season is muted compared to the prior 2 years.

Got you. How much of a headwind is this respiratory season 2 molecular in fiscal '25?

It's really hard to tell at this point in time. If you think about the strongest month of respiratory testing is December. So we're kind of right at the beginning of the month, but it's -- I would say it's in the $10 million to $20 million of headwind.

Got you. And these are -- just remind me, these are stand-alone test rate, not the 4-in-1?

Well, it's part of that respiratory profile portfolio, I should say.

Got you. Got you. And maybe over the LRP timeframe, I think the corporate LRP is 5% to 7%. Should molecular still be like a double-digit grower for Hologic to achieve the high end of 7%?

So I think molecular will likely be maybe not a double digit, but certainly a high single-digit grower as we move forward with the growth drivers that we talked about, the proliferation of Panther placements and the menu and our ability to drive utilization on those 3,300 Panthers that have been placed.

Got you. From a pipeline standpoint, any new assays, anything that we need to look out for fiscal '25, '26 timeframe?

I think we've talked about that we do have several assays still in development, most notably would be a GI and a hospital-acquired infection. But I would consider those more complementary to the portfolio with some revenue generation in the '26 timeframe.

That's helpful. I guess, switching gears to cytology and perinatal. It's a mature market, flattish, up low-singles growth market. I think you launched new additional Pap system recently. Could that be an accelerator for that segment?

So I wouldn't call it an accelerator, but more of a stabilization of securing that business. Our customers are so thrilled to get the opportunity to have our digital Genius cytology platform. Really think about there's been very limited innovation in this space. There is a lack of cytologists. So this AI and automation really can be a game changer and actually, the volume of slides that can be read in a given day by cytologists, coupled with more accuracy in detection. So we view it as when you look at cytology, the revenue opportunity for digital is really an up-charge in one of the service elements. So we already have a charge for imaging. So this will transform to the digitization and an up-charge related to that. So again, we placed the box. We sell the kit at the kind of normal pricing, there is this up-charge in the digitization of the slide. But it also creates opportunity internationally, if you think about the ability to capture the specimen, put it on the slide and digitize it and so that it can be read anywhere in the world. So where we do have areas of the world with lack of cytologists, we can still gather that sample and have it read in a speedy timeframe.

And have you quantified that upsell opportunity, Karleen, if 100% of your customer base adopts this digital tech what it means to revenues?

We haven't quantified that. And as I just said, I don't think we view it as an accelerator to revenue at this point in time. We are being very, what I'd say, methodical in the rollout, and it's actually -- again, this changes the workflow within the lab. And so the rollout is over time. And so what we'll see is more and more customers over quarters adopting this new workflow, this new technology. And so it's going to take time to really have any impact.

Understood. In USPSTF, we've all been waiting for guideline changes. Any clarity on when we might get the updated guidelines and maybe talk about what is the Street worried about? And why is Hologic confident that this shouldn't necessarily occupy a whole lot of investor time?

Yes. So no new insight on timing, unfortunately, this seems to be a little bit of a black box. But what I would say is a couple of things. So let's go back to 2018 when draft guidelines were issued at that point in time and co-testing was not in the guidelines. Our teams rallied with KOLs and other societies to get the final guidelines to have co-testing in that. But since that time, HPV primary co-testing have had a similar rating but only less than 2% of the market actually practices HPV primary, right? So that tells you the best science, the practitioners understand what the best science is and that co-testing detects more cancers, right? This is the best treatment for women. So that's what gives us confidence, one, that it's hard to see that the USPSTF would step back at this point in time from what's best for women's health. And in fact, we just saw them on the breast cancer screening guidelines revert back and lower the age to 40. So hopefully, there's some awareness of what's best for women's health. And then secondly, again, if you played out a scenario where it wasn't covered, draft guidelines come out, it's about a year to final. And that doesn't mean that private insurance would stop covering it necessarily. Most of our patients wouldn't be Medicare, Medicaid, which is what USPSTF governs. We have basically commercial insurance. And so that's why we tend to think about it as -- again, in this worst-case scenario, which we don't believe it will be, a leaky bucket, that it would be something that would impact over time. And certainly, cytology would not go away. Even if you had an HPV primary, you would reflex to cytology at different points.

Understood. And just can you give us the sizing of how large is the U.S. business at this point in time?

I'd say it's roughly $250 million is the U.S. business.

Got you. And then since you brought up breast screening guidelines within the context of USPSTF. On breast health, its CAGR in low-singles from 2019 levels. It's very interesting, right? Its -- I didn't realized it's become such a big component. International has done really well for you guys. But maybe talk about service, which is now almost 40% of breast health, what has driven this growth? Why has it grown mid-singles? In my mind, I think if placements are going up low singles, maybe service should be up like low single. So perhaps it signals maybe you're gaining share? Is that what's driving service growth?

Yes, there's a couple of things there. One, I think there's been an intentional focus on our global service organization and really investing in leadership and capabilities there to manage what is our largest product most effectively. There has been focus on continuing to gain, capture attach rate as well as more diligent focus on pricing strategies given the complexity of our portfolio, developing the appropriate pricing strategies based on the equipment and the age of the equipment. So we see that discipline, that focus really paying off. Coupled with, year after year, we get recognized, there are some standard industry awards that we get recognized for best service organization and really, that's how we lead as an organization to be the most admired service organization in health care. And that creates a level of stickiness with our customers as well. So there's a number of things, I would say, Vijay, that are all contributing to really tremendous performance from our service organization.

Got you. And how should we think about the service opportunity longer term, right? Like what is your attach rate to your existing installed base? And is that increasing over time?

Yes. So we have, I would say, depends on products. So our 3D definitely has the highest attach rate, probably in the 80%. But then we have a whole host of capital equipment within the -- our total global portfolio that have various attach rates that create opportunity to increase that service revenue.

Understood. And you did bring up RSNA. We were expecting this new gantry launch. Maybe talk about RSNA, what kind of feedback did you hear for the new gantry? What is different about the new gantry?

Yes. So we did launch it last week at RSNA -- or this week, I should say. Probably not really commercially contributing until calendar '26. So really being intentful on how we launch this commercially to the market, really want to seed the market, develop the market over the next year. I think about this as, always focus on improved image quality, improved workflow and improved patient experience. One of the things that this new gantry does is that it actually tilts forward, the arm tilts forward to not only address patients with disabilities, but also to capture more breast tissue. The more breast tissue that we capture, the better the images and the better possibility of detecting cancer. So there's been a lot of great positive reaction at RSNA with our customers that are seeing that as well as the portfolio of introductions that will come along the next couple of years related to that gantry. But what I would say is that we've been very -- a lot of the improvements, image quality, for instance, have been upgrades that have been backwards compatible and available to the installed base for the past several years. So we've intentionally have developed improvements that customers could access. So we didn't create all this pent-up demand for a next-gen gantry. So we view it as not a kind of a boom bust launch, but more of a continued steady placements of gantries in the U.S.

You said the launch was calendar '26. As customers look at the new system, could that create a temporary pause in the market where customers await the new system?

So I don't think it will create a pause or an air pocket. We did talk about maybe a little softness as we get closer to the launch. But again, because we've intentionally had some of the improvements already available to customers. We're not creating this pent-up demand where people feel like I don't want the current because the next one has all this great stuff. They can get a lot of what is in the next-gen in their current 3D unit.

Understood. And outside of gantries and services. I think interventional has done really well for you guys. It's grown 6-plus percent CAGR from 2019. What is driving this interventional growth? And I think that's where you have BioZorb. There was some FDA recall noise. Maybe talk about what's going on in the business?

Yes. So certainly, I'll start with BioZorb, recall on that product. I would tell you that revenue in '24 was less than $7 million. So really nothing significant that represents a significant challenge here in '25. I think the interventional business has been where we've invested both organically and inorganically over the past couple of years, where it's more disposable in nature compared to the capital element of the breast business, an opportunity for us to gain share. And we're continuing on that with even the recent acquisition of Endomag, which closed in Q4. Really excited about what that asset will do and really the capabilities it's bringing to enhance that interventional business.

Got you. And then when you look at the LRP of 5% to 7%, I think in the past, you guys have said, look, breast health should be within that range, perhaps at the lower end of that range. Maybe talk about what drives that 5-ish kind of growth for overall breast health? What's the algorithm? Is that services? Is that interventional?

Yes. I think if you look at the 3 pieces, with services, the largest piece of that organization, we believe that, that can be a mid-single-digit grower. As we talked about interventional should grow a little higher than that. And then you have the gantry business is more of a flattish low single-digit grower plus international growing faster than the U.S. that gives you that collective closer to 5%.

Got you. And since you brought up international, that's about 1/4 of Hologic's revenues, and it's grown high-single CAGR versus 2019. And I feel like that part, it's either underappreciated or not well understood. What's changed within your international go-to-market strategy? Are you going now more direct? Is that what's driving the growth? Is this maybe perhaps a fuller product menu, characterize the drivers of this high single-digit international growth?

Yes. So let me take it in a couple of buckets. So if you go back to 2017, we brought in new leadership really that really started to build commercial capabilities, market access, market development capabilities that we just didn't have in the region, I would say. Prior to that, Hologic itself, we weren't really focused internationally. We were using primarily a network of dealers and distributors. And typically, they were mom-and-pop and just didn't have the market development capabilities that we really required. So one, we invested in commercial capabilities. Two, we started to grow direct in key markets, again, where we find that when we go direct, primarily in the breast business, we see better performance with our market development capabilities. And then I think you kind of round it out then with expanding on those commercial capabilities and then starting to really get focused on market opportunities. And in particular, what we've seen over the past couple of years is strong performance in surgical as those folks that we have on the ground develop strategies of where do we want to seek a guideline, where do we want to seek reimbursement. And we've seen solid double-digit surgical growth internationally over the last couple of years. So it's a combination of things that are contributing. Having said all that, there's the other reality, Vijay, is we're a women's health company. And women just don't have access to the quality of care, the standard of care that we have here in the U.S. And so it's -- and structurally, there are things like lack of cytologists, lack of radiologists. So even there are emerging markets that even if we had gantries there, women had a mammogram, there's not a treatment pathway, there's not an infrastructure to treat it appropriately like we do here at the very early stage. So -- and those -- to change those dynamics are long-term kind of investments on the ground and trying to change clinical pathways. So those are the things that we do, right, that we look for those opportunities where we can really influence. And for us, this is really living into our purpose, right? So to the extent we can grow this business internationally, not only are we rewarded financially, we are actually making the health of women around the world better.

Understood. And maybe the last element here from surgical GYN that's been a really nice driver for you guys growing high-singles CAGR versus 2019. MyoSure and Fluid Management stand out. Similar sort of questions on what innings are we for MyoSure and Fluid Management and what drives growth going forward?

Yes, that's an interesting question because when we launched MyoSure well over a decade ago, we never thought it would surpass NovaSure, right? And so here we are, to your point, MyoSure and Fluent really leading that division. And that is really our ability to develop markets, right, and to develop utilization of our technology for different procedures and really start to educate or work with physicians on how do we have a different -- we don't revert to hysterectomy, right? How do we have uterus preserving procedures. And MyoSure is something that can do that, that it can treat different size fibroids and then you layer on Fluent, which fluid management is a very difficult part of the procedure, and you bring in some technology that is an eloquent solution to what is literally fluid on the floor of the operating room and really messy, then you can really then continue the twofold, continue to expand the market opportunities for the MyoSure product. And then as over time, we develop different size blades that are different -- treat different size fibroids. And over time, people are seeing better samples as well. So it's, again, leveraging our great commercial capabilities, layering on some innovation that continues to drive that market.

Got you. Any new products within those segments in next-gen products we should be thinking about?

Well, I know the team is working on a next-gen Fluent, improving on the existing capabilities that we have and continue to work with customers to say how do we improve and do better. On breast, we talked about Envision coming. And then in diagnostics, we just launched digital cytology, and we talked about additions to the assay menu. So I think across all of the divisions, there's different organic investments that are being made and developed upon.

Got you. And sorry, on what innings are we in, whether it's MyoSure or Fluid Management?

Again, I guess we're hesitant to say what innings it is, right, because we continue to expand that market beyond what we ever anticipated it would be. Again, through this combination of innovation, education, partnering with customers did continue to grow the market.

Got you. I guess switching gears to margins here. Q1, I think we're starting at 60% gross and 30% op margins. Clearly, there's some timing element of OpEx impact in Q1. When you think about the 50 to 100 basis points of margin improvement from Q1 levels, how much of that is being driven by just this timing of expenses versus you need real volumes to grow in the back actual leverage?

So let me phrase this -- put this in perspective. I think we've taken our comments on the earnings release as specific 60% and 30%. And I think let's think about those as 60-ish, 30-ish and that the improvements were directional order of magnitude improvements, right? So just to give people a perspective of why we're thinking about margins over the course of the year. I would view margins Q1 and Q2 similar given we talked about the revenue headwinds, we talked about the higher operating expenses in those 2 quarters. And then as those revenue headwinds abate and operating expense seasonally drops, then you have a Q3, Q4 improving margin profile.

Is that the biggest -- sort of when you look at the first half versus second half, Karleen, the cadence of OpEx, is that the biggest driver? Or I guess, said another way, the visibility here should be high if it's just a cadence of OpEx timing?

So it's the OpEx timing, but also the revenue and think about when we talk about like the IV shortage impacting our surgical products and whether that recovers in Q2 or recovers in Q1 of '26, surgical, our highest gross margin product, right? So it's both. It's both the timing of the operating expense in this how we deal with this headwind, how this manages through on the IV piece of it specifically given those are such high-margin products for us.

Got you. Maybe one more sort of modeling kind of question here. Shouldn't second quarter margins improve sequentially because if the OpEx -- operating expenses are being front-loaded into Q1?

So to clarify, OpEx are higher in both Q1 and Q2. They are a little higher in Q1 versus Q2. The other thing that I'll note, seasonally, Q1 is usually our strongest quarter because of the dynamic I talked about on deductibles resetting. So our highest quarter for both our surgical and our diagnostics business and Q2 seasonally steps down for both of those businesses. So that's why the dynamics are such that we're expecting them to be similar for the first half.

I see. That's helpful. Any FX? I know rates have moved around recently post elections. Any FX impact that we need to be aware of at current rates?

Yes. I think they certainly have moved since our original guide, probably not as favorable. So I think it could be some in a several million impact on Q1 on the top line. But I think from a bottom line perspective, we have hedges in place that would mitigate any bottom line impact.

Got you. That's helpful. Sorry, those hedges, do they go below the line or above the line...

They're below the line in OI&E.

Got you. And then on capital deployment front, I think you guys are in an unenviable position with $2.4 billion of cash. I think one of really, really strong position. I think M&A has been -- you've had some really good tuck-ins and there have been a couple which haven't played out according to -- I think the SSI comes to my mind, the recent sale. How are you thinking about capital deployment and M&A funnel activity?

Yes. So our capital allocation strategy really hasn't changed. It is all about deploying our free cash flow. We just happen to have bolus of cash on the balance sheet from the pandemic and the COVID revenue. So when we think about deploying that free cash flow, the priority is M&A, and we're very fortunate given the financial position we are in, and we can say and share repurchase. But given that M&A would be focused on growth accretive assets, that would be the prioritization. So I think we've maintained our discipline despite having excess cash on the balance sheet. I think over the past several years, valuation expectations were maybe misaligned. We've seen those probably course correct a little over the last year or so as interest rates are higher for longer, it looks like. And that ability for us then to execute on things like Endomag, which we closed in Q4 and then announced Gynesonics, which we're hopeful will close sometime in calendar '26 -- '25, I'm sorry.

Got you. I think I mixed up my comments. You're in a very enviable position with the cash balance. What's the revenue contribution from Gynesonics and Endomag?

So Gynesonics has no revenue contribution at this point. We haven't closed on that acquisition. And I think Endomagnetics, we said that the trailing 12-month revenue prior to close was roughly $35 million and growing faster than the corporate average.

Got you. And I think your guidance did assume some capital deployment activities, right, based on your interest expense assumption. What is your like $50 million to $60 million interest expense assumption baking in, in terms of capital deployment?

Yes. I would say for capital deployment, certainly, we contemplated the ASR that we announced, and we contemplated the Gynesonics acquisition that we announced. We also, I would say, Vijay, were conservative on the interest income that we forecasted and probably as well as conservative on the interest expense given the dynamic nature of rates at this point in time.

Got you. Got you. And any qualitative comments on size of the deal? Like for me, when I look at your surgical franchise, I think you have one of the largest sales force. That seems like a very interesting area for you guys to add assets. But how is that funnel looking? And any comments on size of the deal?

Yes. So I think the funnel looks good. Again, as we talked about Endomagnetics and Gynesonics, the funnel is rich in all of our divisions. There's no clear prioritization of one division versus the other. We've also added some corporate capabilities. We've added a leader of strategic development -- corporate and strategic development to really help with the scan kind of in between the divisions, right? So the divisions kind of get focused on their sweet spot, but then what are the what we call tweeners that might be interesting assets for us to own and really bring a unique point of leverage or expertise.

Got you. Maybe last quick one here. I know you had the $250 million ASR. Did the cap deployment assume share repurchases beyond the ASR?

I would say minimal, yes.

Fantastic. With that, we're out of time. Karleen, thank you for the time. This is helpful.

Thank you.