HOLOGIC INC Q1 FY2025 Earnings Call

Thank you, Lisa. Good afternoon. And thank you for joining Hologic's first quarter fiscal 2025 earnings call. With me today are Steve MacMillan, the company's Chairman, President and Chief Executive Officer; Essex Mitchell, our Chief Operating 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, and a replay of this call will be available on our website for the next 30 days. Before we begin, we'd like to inform you that certain statements we make today will be forward-looking. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Such factors include those referenced in the safe harbor statement that's included in our earnings release and SEC filings. Also during this call, we will discuss certain non-GAAP financial measures. A reconciliation to GAAP can be found in our earnings release.

Good afternoon, everyone. I'd like to begin today by welcoming Mike back to the Hologic team. We are all excited to have him back. And now we are pleased to discuss our financial results for the first quarter of fiscal 2025. As we pre-announced last month, total revenue for the quarter was $1.022 billion, an increase of 1% on a constant currency basis. This was in line with our guidance as the stronger dollar subtracted about $9 million from reported revenue since we guided in early November. Non-GAAP earnings per share were $1.03 at the high end of our guidance range and an increase of 5%. This reflected strong improvement in non-GAAP operating margins of 90 basis points, as well as share buybacks and benefits of our foreign exchange hedging program. In my remarks today, I'd like to revisit some of the themes from our presentation at the JP Morgan conference last month. In that discussion, we reflected back on Hologic's strong financial performance since 2014. Our main point, however, was not about the past; it was that we believe we can continue to grow revenue and earnings at similar rates in the future. Why do we believe that? Because of our market-leading products and the strong organizational capabilities we have steadily built around them. To be more specific, from 2014 through 2024, Hologic grew revenue from about $2.5 billion to more than $4 billion. This represented a compound annual growth rate of 4.8%, including all our acquisitions and divestitures along the way. Over the same period, non-GAAP earnings per share increased from $1.46 to $4.08, representing a CAGR of 10.8%, more than double the rate of sales growth. At JP Morgan, our primary message was that we believe we can continue to grow earnings at a double-digit rate in the future. While some years, like this one, may be below this level, we are confident in our future and still believe this is an appropriate long-term goal. The financial algorithm that will get us there includes continuing mid-single-digit growth on the top line, modest expansion of our already best-in-class operating margin, and a healthy mix of acquisitions and share buybacks to increase our revenue and EPS growth rates. The foundation for this expected performance, of course, lies in our market-leading brands, which generate a tremendous amount of reliable cash flow. From Panther, Aptima and Thin Prep in Diagnostics, to Genius and Breast Health to MyoSure and NovaSure in Surgical, we enjoy leading market shares that have proven durable over time. Much of our growth comes from building around these brands and using the cash they generate to drive future innovation. For example, we now have more than 20 assays on our Panther and Panther Fusion platforms. We have built a reliable service business in Breast Health that is now larger than our capital sales, which can be more volatile. And we are adding products to our Surgical division, both organically and inorganically to leverage our excellent sales channel. Best-in-class products don't just happen. Instead, they are the result of several organizational capabilities that we have very deliberately built and nurtured over time. And these capabilities give us confidence in our ability to hit our financial targets in the future. For example, our 7,000 employees around the world are motivated by a passion for women's health. They have demonstrated an ability to create and expand markets for the benefit of patients and customers and to redefine clinical standards of care. Examples include transitioning traditional Pap testing to liquid Pap and now adding digital capabilities to catch more cancers and improve workflow. And more recently, we have partnered with our customers to literally create a market for high-throughput vaginitis testing, which has fueled our second-largest molecular diagnostics test on the Panther system. Many of these successes originated in the United States, but we have now built the capabilities to grow internationally on a consistent basis. We continue to go direct in more geographies and businesses, most recently in our Surgical division while strengthening our market access capabilities around the globe. Similarly, we have learned from past mistakes and improved our business development capabilities. We have strengthened our talent and processes for conducting due diligence on new targets, cultivating relationships with them and integrating acquired assets more effectively. This internal maturation has been reflected in the solid performance of some of our more recent acquisitions. For example, Biotheranostics, Endomagnetics, and Gynesonics should all boost our revenue growth rate. These organizational capabilities give us confidence in the future, especially our ability to be a consistent double-digit earnings compounder and deliver value to shareholders reliably over time. Now I will turn the call over to Essex.

Thank you, Steve. And good afternoon, everyone. In my remarks today, I will first review our divisional revenue performance in the first quarter. Then I'll provide a little color on Gynesonics, a tuck-in acquisition we recently closed in our Surgical business that we are excited about. As Steve said, we met our revenue guidance on a constant currency basis in the first quarter, growing 1%. At the highest level, we outperformed in diagnostics but lagged in Breast Health. Surgical and Skeletal were roughly in line with our expectations. Our Diagnostics business continues to be one of the best performing diversified assets in the space, and Q1 was another strong quarter. Revenue of $470.6 million grew 5.2% and 9.1% organically, excluding COVID. Growth for the division continues to be led by molecular diagnostics, which grew 6.7% or 11% excluding COVID. Within molecular, our Biotheranostics lab testing business continued to grow at a healthy double-digit rate and our BV CV/TV assay also had another outstanding quarter of strong double-digit growth. We believe we are only in the middle innings of realizing the total opportunity for this test. For example, we have just begun using our physician sales force to expand the vaginitis testing market in the US, leveraging the same playbook we have used to grow our legacy women's health test. Our core women's health assays that run on our automated Panther platform also had a strong performance in the quarter. We often get investor questions about competition in diagnostics, so I want to be clear that these assays have held leading market positions for some time and our sales force continues to win new business and grow that share despite an always competitive environment. Although respiratory testing is a relatively small piece of our business, it is seasonal and can vary significantly based on flu prevalence. This quarter, the respiratory season started slowly but worsened in late December. As a result, non-COVID respiratory sales finished close to our expectations for the quarter. These respiratory tests, as well as many of the other assays we have in development, run on our Panther Fusion sidecar. For our customers, having a Panther Fusion is the key to unlocking our full menu. We have been pleased to see our sales force grow the attachment rate of the Panther Fusion in recent quarters. Nearly 40% of our US customers now have a Fusion system. In our cytology and perinatal business within Diagnostics, we saw higher than average growth of 4.7% for the quarter. As a reminder, sales in the prior year quarter were slightly depressed, resulting in an easier comp for the current period. Moving to Breast Health, total first quarter revenue of $369.1 million was disappointing. Sales declined 2.1% or 5.8% organically when excluding SSI and Endomagnetics. The decline versus prior year was primarily driven by lower sales of capital equipment. However, we continue to see strong growth in service revenue, which tends to be more steady than gantry sales, reflecting our long-term strategy to diversify revenue in this business. Service accounts for more than 40% of sales in Q1. As we've analyzed the Breast Health market recently, we have concluded that 2025 will be a softer year for gantry placements than we initially expected. This is for a few reasons. As we recovered from the chip shortage, we saw multiple quarters of sustained double-digit growth in mammography placements. This clouded our picture of what a normal gantry market would look like entering 2025 and made for tough comps. Now that we have upgraded most 2D units in the United States to our 3D standard of care, our challenge is to drive 3D to 3D conversions. In this context, we are seeing customers lengthen their replacement cycles, especially those who are considering our new Envision platform, which we expect to launch commercially next year. On the bright side, our competitive position remains strong and we have received very positive feedback from Envision since we introduced it at RSNA, which gives us long-term confidence. Customers are excited about the systems, better image quality, patient experience, and workflow. Outside of the United States, we are also seeing pressure on capital investments as many private and government hospital customers struggle with local budgetary constraints. Turning to our interventional breast business, we are pleased with the integration and performance of Endomagnetics, which we acquired in the fourth quarter of fiscal 2024 and is well-positioned for a strong year. We are excited about Endomag's innovative market products but also its R&D capabilities, which will provide opportunities to further broaden our interventional breast portfolio. In Surgical, first quarter revenue of $166.3 million increased 2.5%. Q1 was another strong quarter for our International Surgical business with growth of nearly 20%. In the US, results were in line with our expectations considering the temporary headwind of the IV fluid shortage that we discussed on our Q4 earnings call. Most of our customers saw their IV fluid constraints resolved as we exited the quarter, so we do not expect to see this have a significant impact going forward. Finally, in our Skeletal business, first quarter revenue of $15.8 million decreased 37.4% as shipping for some of our Horizon DXA units resumed later in the quarter than originally anticipated. We expect the manufacturing of these units to progressively ramp up to full capacity before returning to normal in the third quarter. Before I hand the call over to Karleen, I wanted to highlight the Gynesonics acquisition that we completed in January. We're excited to introduce their SOMATEX system into our surgical portfolio. SOMATEX is a minimally invasive radio frequency ablation tool used to treat uterine fibroids that are less accessible by MyoSure or Accesa. So it's highly complementary to our current portfolio and fits nicely into our sales bags of the largest commercial channel we have. Gynesonics had about $28 million of revenue in its most recent fiscal year, including a healthy mix of international sales. We expect sales to grow at a healthy double-digit rate in the hands of our large Gyn sales force. Gynesonics' gross margin is solid, although planned investments will make the acquisition slightly dilutive to non-GAAP EPS this year. As Steve mentioned, strengthening our business development capabilities has been a key focus for the organization in recent years. In each division and at the corporate level, we now have teams in place that bring a deep understanding of the respective end market and significant experience in diligence and integration. The success of recent deals like Biotheranostics, Endomagnetics, and our good start with Gynesonics gives us confidence in our ability to identify and integrate future deals. As we've said many times, accessing high-growth adjacent markets through successful M&A will be key to our growth strategy moving forward. With that, I'll hand the call over to Karleen.

Thank you, Essex. And good afternoon, everyone. In my comments today, I will start by walking through the rest of our non-GAAP income statement, then touch on several key financial metrics and finish with our guidance for fiscal Q2 and the full year. Let me begin by saying we are pleased to grow non-GAAP earnings per share by 5% this quarter when revenue only grew 1%. Although we clearly want revenue to grow faster and we believe it will, this demonstrates the substantial operating leverage we can generate and gives us confidence that we can grow earnings at a double-digit rate over time. So how did we do that in the first quarter? Start, non-GAAP gross margin of 61.6% increased 80 basis points. This margin expansion was primarily the result of favorable product mix and operating efficiencies. Moving down the P&L, first quarter operating expenses of $329 million increased approximately 0.5%. As a reminder, Q1 usually represents our highest level of operating expense for the year due to several large commercial initiatives. Despite this, the year-over-year increase was driven by the addition of Endomagnetics. Excluding Endomagnetics, operating expenses would have decreased 2.3%. First quarter operating margin finished at 29.4%, representing an increase of 90 basis points. This operating margin expansion came primarily from drop-through of our higher gross margin and good expense control. As Steve said, leveraging the P&L to drive modest margin expansion from already best-in-class levels and strong EPS growth remains a key focus. Below operating income, other income net loss in our fiscal first quarter came in slightly more than $4 million. This result was better than expected due to the benefit of our foreign exchange hedging program. As a reminder, this hedging program seeks to minimize the negative or positive bottom line impact of currency fluctuations. Finally, our tax rate in Q1 was 19.5% as expected. Altogether, net margin for the quarter was 23.4%, approximately flat to the prior year and very strong relative to our diagnostics and med tech peers. Because we have tremendous confidence in our long-term future, we continue to bet on ourselves and use our balance sheet to enhance shareholder value. In the first quarter, we repurchased 6.8 million shares for a total of $517 million, including the completion of the $250 million ASR announced on our Q4 earnings call. As a result, we brought our weighted average diluted share count down to $232 million, a decrease of 8 million shares compared to the prior year. All of this led to non-GAAP earnings per share of $1.03, which we were pleased to deliver at the high end of our guidance range. With strong operating cash flow of $189 million in the first quarter and $2 billion in cash and investments on our balance sheet at the end of the quarter, we are well positioned to continue to execute our capital deployment strategy to drive both top and bottom line growth. Now let's move on to our updated non-GAAP financial guidance for the full fiscal year and for the second half. I'd like to start by acknowledging the dramatic shift in the geopolitical and macro environment since we first provided guidance in early November. As everyone knows, we are seeing an immediate impact from the new administration in the US, both in terms of policy changes and a strengthening US dollar. Entering the new calendar year, we also have greater visibility on our end market landscape for 2025. Combining these pieces together, we are using this opportunity to reset our financial expectations for the year. For the full year, we are lowering our revenue guidance range by $100 million to $4.05 billion to $4.10 billion, but we are maintaining our non-GAAP EPS guidance of $4.25 to $4.35. Our Diagnostics and Surgical businesses are performing well and we are adding roughly $25 million of Gynesonics' revenue to our reported results. However, these positive developments are being offset by three factors. First, like everyone else, we have experienced a significant strengthening of the US dollar since early November. We now expect FX to represent a headwind of $30 million for the full year. This represents a swing of more than $60 million from our original expectations, which we are baking into our reduced guidance today. Second, we are expecting lower sales of our Breast Health capital for the year. As Essex detailed, we didn't have a clear picture of the gantry market, which led to two aggressive forecasts for 2025, especially considering that our next-generation gantry is still a ways off. Third, two potential policy changes in the new US administration are introducing uncertainty in our business. First, the freeze on foreign aid has affected our main partner for HIV testing in developing countries. The President's Emergency Plan for AIDS Relief or PEPFAR. Although PEPFAR has been granted an exemption based on the life-saving work they do, activities on the ground have still been disrupted. This disruption could affect our revenue by as much as $30 million for the balance of our fiscal year. Second, contract manufacturers in Mexico make our Skeletal and Gynesonics products, so we could be subject to tariffs that lower our gross margins as we import them into the United States. Although these are relatively small pieces of our businesses and the tariffs have been delayed for now, we believe it is appropriate to risk-adjust our forecast for the potential impact. Despite these headwinds, we are maintaining our full-year EPS guidance of $4.25 to $4.35. The strong financial discipline and capabilities we've established as an organization are enabling us to mitigate the bottom line impact of these issues. For the second quarter, we are expecting total revenues in the range of $995 million to $1.005 billion, including a $10 million FX headwind, and non-GAAP EPS in the range of $1 to $1.03. Now let me provide some additional details that underpin our guidance. In terms of quarterly pacing, we expect our revenue growth rate to improve in the third quarter and further in Q4, so we should exit the year above our long-term mid-single-digit target on a quarterly basis. In terms of the divisions, we expect Diagnostics to grow mid-single digits for the year, excluding the impact of declining COVID-19 sales. We continue to forecast that growth will be driven by strength in our molecular women's health assays and Biotheranostics' lab testing. For COVID revenue, we expect assay sales to be about $9 million in the second quarter and approximately $35 million for the full year. COVID-related items are expected to be about $25 million in the second quarter and approximately $100 million for the year. Finally, in Diagnostics, we expect led screening revenue of about $5 million in Q2 and about $20 million for the full year. As you know, both COVID-related sales and blood screening revenue are backed out of our organic growth calculation. Within Breast Health, as mentioned, we are lowering our expectations for the full year based on softer capital equipment sales. We now expect this business to decline in the low single digits for the full year, including Endomagnetics. We do, however, expect revenue growth to build in the second half with good year-over-year growth in Q4 as we exit our fiscal year. Lastly, in Surgical, we expect high single-digit growth for the year with the inclusion of Gynesonics in our results for the three quarters. In our core surgical business, we expect growth to be powered by international with contributions in the US for MyoSure Fluent. Moving to the rest of the P&L, we expect gross margin in the low 60s for the full year. We anticipate gross margins to step up in the second half with higher sales, the elimination of redundant manufacturing facilities in Breast Health, and direct sales in Endomagnetics. For operating margin, we're expecting to be in the low 30s for the full year with steady margin expansion as we move through the year. Below operating income, we estimate other income net to be an expense of $10 million to $15 million in Q2 and an expense between $40 million and $45 million for the full fiscal year. Our effective tax rate of approximately 19.5% for the full year remains unchanged from our prior guidance. To reflect the share repurchase activity we completed in Q1, diluted shares outstanding are expected to be approximately 230 million for the full year. To conclude, our financial discipline and strength have us in a position to meet our EPS commitments even in a year where we're seeing pressure on the top line. We believe these pressures are largely transitory in nature and we expect top line growth to be healthy as we exit the year. We feel great about the long-term outlook for each of our divisions, driven by our ability to retain and grow our market-leading positions while continuing to add new growth drivers through internal innovation and business development. With that, we ask the operator to open the call for questions.

Steve, maybe starting on the gantry side, not surprisingly, you've obviously lived through a lot of different CapEx cycles on the hospital side. Maybe just take us through what you're seeing there? How much of it is again, maybe a little bit of a pause before the product launch? Just the right way to think about that piece as that number came down a little bit, just wanted to talk through that?

Let's put this in perspective. I think we somewhat missed the mark when we experienced three consecutive quarters of over 27% growth in Breast Health late in '23 and early '24. That surge inflated the market more than the long-term trend suggests. Similarly, Surgical also benefited from a few strong orders post-COVID, and Breast Health experienced a spike due to chip availability. In '23, we saw growth exceeding 17% for the year, and we achieved an additional 6% growth last year. Rather than reassessing the long-term market trend, we focused on the temporary growth. The long-term trend is clearly below 2023 levels. This year, we anticipate a slight decline in the overall market, similar to other sectors post-COVID, including chips, alongside the upcoming launch of a new gantry. While the global market might be down this year, we have promising developments on the horizon that should help revive both the market and our business by '26. This situation seems primarily cyclical, and we have a strong history of accurately identifying cyclical and structural issues. Therefore, this appears to be a cyclical matter.

And then maybe one on the diagnostics side, helpful to perhaps some more color on the script there on just what you're seeing on the competitive side. We get some questions there, clearly you do as well. Any changes there, whether it's BV CV/TV or other parts of the portfolio that the competitive landscape has changed at all? And then just curious when we think about the growth outlook there, the key thing in the pipeline we should be focusing on that could supplement the growth as we move forward here?

Good job, Patrick, working several questions into your one follow-up. So kudos to you. So high level, I can't tell you how excited we are about our Diagnostics business. And what we said when we went into COVID by placing all the Panthers around the world and even as we saw the ups and downs, as Omicron, Delta, everything else was hitting, we just systematically got stronger in terms of our Panther placements and then rolling out the menu of particularly BV, CV, where we've rolled out a new assay and then we've created the market. And we're still, as Essex mentioned, we're still in the mid-innings at most as it relates to the BV, CV opportunity. And I think when you look at our molecular business and you add in Biotheranostics, I don't think I've ever been more excited about where this Diagnostics business is going, particularly in a world where there's a lot of noise, as you well know, in the diagnostic space right now. And the way we try to look at it is that core molecular lab channel are we winning or losing, and we feel really good about our position as we build out from there. And then we've still got the international opportunities on top of it all and still a lot of growth in Biotheranostics as well. So Karleen?

I would just add that our unique approach in molecular diagnostics involves a physician sales force that collaborates closely with our lab customers to promote guidelines. As mentioned in our prepared remarks, we are just beginning to roll out BV and CV, which gives us confidence in the potential for growth of this new assay.

Maybe a high level one, just for the long-term sort of medium-term financial outlook. I mean Steve and/or Essex. When you think about that mid-single digit sort of profile, I think -- and we look at the last time that range was out there was 5% to 7% and we're trending here, obviously, in the low single digits right now. We're in a low point of a cyclical gantry cycle here. What sort of gets you back to 5% to 7%, how long do you think that will take and what amount of that will come organically versus inorganically? And then quickly, just on the second one, Diagnostics. Late last year, you had H5N1 bird flu development CBC. It sounds like that actually could be an assay this year. Is that something we should expect?

Yes, I think the highest level I kind of laugh a little bit in that as you all, we put out the 5% to 7% for a three-year window, the '23, '24, '25 window. In our very first year, we probably delivered about 17% organic in that year and everybody was challenging us to raise that number. And effectively, what we're really saying is we're mid-single digits, and this year, frankly, just for a few quarters, we think we're below it, not for the full year to be below that but just as it was way above, we said we weren't that good we're also not as bad in a cyclical period where we're recovering from a lot of those big comps. So what gives us excitement going forward really is each franchise, right? The surgical business keeps strengthening and the addition of Gynesonics, the international expansion there is looking great. Our Diagnostics business, as we've said, is great. By the way, we'd love to view that H1N1 is going to be anything. I probably put this one in my world, kind of like the Zika virus. We're always there for the government and for the CDC to be one of the quickest to develop any of these. And even as we did in COVID right at the beginning, we didn't know it would amount to anything. Obviously, that would have amounted to something very big. I wouldn't assume a lot for H1N1. If that came, that would be upside to our business. And then the Breast Health business, as we continue to build out the disposable side of the business, the interventional side with things like Endomagnetics. And then as the new gantry kicks in next year, I think that gets us back very solidly into our longer-term consistent trajectory in that mid-single range of top line growth.

Two, that I'd like to touch on. One is it's just a little bit unclear to me how much of the change in your assumption that you've embedded into guidance for Breast Health as a function of market conditions versus a reassessment of the impact of market stalling in advance of the new gantry launch? If it's more stalling that lead to a big acceleration in revenue growth down the line if it's a market that's something else. So could you just provide a little more color there? And then the second topic is really M&A. In your prepared remarks, you talked about the importance of M&A as part of the long-term strategy. Can you just provide any updated thoughts on, one, the environment given the new administration and two, what parameters you're using in assessing potential targets, revenue growth, margins, accretion, ROIC?

I'll start with the breast comments here. So I do think we tried to outline that it is a blend of both market conditions, and given our high market share, our new launch slowing the market down. But if you had to weight it, I would say market conditions are the bigger impact. And so that does give us confidence about our future moving forward and do expect this business to accelerate as we exit the year moving forward. The big thing I would say is that if you think about coming out of the chip shortage with a significant amount of pent-up demand we got through a ton of that, I would say, over the '23 and '24 time period. In addition to that, as we've seen other areas of acceleration, those were driven by large innovation advances, primarily driven by us. And so when you saw going from 2D to 3D, that was a huge catalyst not only technological advance but also with regard to reimbursement and a number of factors that helped physicians and caregivers. So as we look at technological events coming up here, I would say, from us early in '26, we do believe that has an impact. But largely, I think the chip shortage rebound is playing a bigger impact on the slower year this year with the breast business. So I still would say it's both, but if I had to lean one way or another, I would tell you that it's a bigger impact on the market. And I'll probably start with the M&A and then kick it to Karleen. And I would say our capital allocation strategy is M&A first. And obviously, anything we can do to help the bottom line, if needed, we have the luxury of being able to do both. I think if you look at our most recent acquisitions of Endomagnetics and Gynesonics, that's exactly in the wheelhouse of what we would like to continue to do. Nice size, on-market products that we can grow at a top line at an accretive rate to our core growth rate is exactly the place we'd like to be.

And just to build off of that, when we look at financial metrics, it clearly starts with the revenue, we are looking at assets that are accretive to the growth rate. We're looking at things that hopefully have a gross margin that is at the corporate average or may be accretive. And like we've seen with Gynesonics, sometimes they're going to be dilutive on the bottom line, but I think we've got the flexibility to manage that. And then I think over the longer term, we look for a double-digit return on invested capital within a reasonable time frame in terms of return on that investment. So -- and I think if you look at both Endomagnetics and Gynesonics, they played nicely within that framework.

Steve, a couple of guidance related questions here. One on Breast, I think Breast Health guidance here, is the organic for the segment assuming down mid-singles? Steve, I thought I heard you say the year-on-year decline includes the acquisitions. So I guess the organic implied is down mid-single. Is that right? And I guess looking at Q1, why wouldn't trends improve from Q1?

So you are right that the organic would be closer to a mid-digit decline year-over-year. And I think as we think about sequentially Q1 to Q2, we're looking at similar performance, Q1 to Q2 in terms of absolute dollars. I think we're looking for improvement into Q3 and into Q4, and I think we specifically said Q4 would have a nice growth rate as we exited the year.

Two for me. One on Breast, and I know you've talked a lot about it this evening. But as we think about 2026 when you do launch the new gantry, arguably, that would carry a price increase with it. And given where we're assuming kind of growth is today, are you suggesting or implied in that would be a decline in units just in terms of unit volume, which is offset by potential price increase? And just taking in the context of Essex's comments that you're selling 3D to 3D now going forward?

I think what you'll start to see in '26 is units will start to improve again as the new launch comes out, and we will have a combination of both units as well as additional price from a mix standpoint. So it's why we feel really good about where we're going to head. We're not going to guide to '26 at this stage. But it's very nice to be sitting where we are, feeling like we've got line of sight and we know a couple of down quarters here and then we come roaring back.

Karleen, I have a few questions related to guidance for you. The first is regarding the policy uncertainty connected to HIV testing. I wanted to clarify whether the $30 million in sales disruption you mentioned is included in the guidance or if you incorporated a risk-adjusted number in the guidance, or how exactly you addressed that.

It's clearly reflected in the guidance, and even with a waiver, there is evident disruption on the ground that could significantly impact the supply chain. That's the reason we chose to include it.

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

We don't expect a big impact from that. At the end of the day, we feel really good about the products that we're providing are meaningful for both patients and frankly, ones that ensures we'll want to continue to take care of. So I think with all the stuff we have going on we're not worried about that and feel very good about where we'll be.

This concludes our question-and-answer session. We will now conclude today's conference call. Thank you for your participation. You may now disconnect, and have a great day.