QDEL - NASDAQ

Welcome to the QuidelOrtho First Quarter 2025 Financial Results Conference Call and Webcast. At this time, all participant lines are in listen mode only. For those of you participating in the conference call, there will be an opportunity for questions at the end of the prepared remarks. Please note this conference call is being recorded. An audio replay for the conference call will be available on the company's website shortly after this call. I would now like to turn the call over to Juliet Cunningham, Vice President of Investor Relations.

Thank you. Good afternoon, everyone, and thanks for joining the QuidelOrtho first quarter 2025 financial results conference call. Joining me today are Brian Blaser, President and Chief Executive Officer; and Joe Busky, Chief Financial Officer. This conference call is being simultaneously webcast on the Investor Relations page of our website. To aid in the presentation, we also posted supplemental information on the Investor Relations page that will be referenced throughout this call. This conference call and supplemental information contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not strictly historical, including the company's expectations, plans, financial guidance, future performance, and prospects, are forward-looking statements that are subject to certain risks, uncertainties, assumptions, and other factors. This includes the expected impact of tariffs and macroeconomic conditions. Actual results may vary materially from those expressed or applied in these forward-looking statements. Information about potential factors that could affect our actual results is available in our annual report on Form 10-K for the 2024 fiscal year and subsequent reports filed with the SEC, including the Risk Factors section. Forward-looking statements are made as of today, May 7, 2025, and we assume no obligation to update any forward-looking statements except as required by law. In addition, today's call includes discussion of certain non-GAAP financial measures. Tables reconciling these non-GAAP measures to their most directly comparable GAAP measures are available in our earnings release and the supplemental information, which are on the Investor Relations page of our website at quidelortho.com. Lastly, unless stated otherwise, all year-over-year revenue growth rates given on today's call are on a constant currency basis. Now I'd like to turn the call over to our CEO, Brian Blaser.

Thanks, Juliet, and good afternoon, everyone. As I reflect on my first anniversary since joining the company, I first want to thank all our employees and our leadership team for their unwavering support as we implemented difficult but necessary changes to our business over the last year. Together, we refocused the organization on a narrow set of priorities and set in motion key initiatives to improve our performance and our cost structure. Our business faced unique challenges and increasingly dynamic environment. The organization came together around our common mission with our customers at the center of everything we do. The team's efforts played a critical role in the strong results we delivered in Q1, reinforcing my confidence in our strategy and operational discipline. Let me start by taking a closer look at our first quarter results, followed by my thoughts on the evolving tariff situation. During Q1, we delivered solid bid single-digit revenue growth of 6%, excluding COVID and donor screening. This performance was primarily driven by our labs business, as well as stable growth in immunohematology and a strong flu season. We also recognized cost savings from our previously announced initiatives that drove a 450 basis point year-over-year improvement in adjusted EBITDA margin and a 68% increase in adjusted diluted earnings per share compared to the prior year period. From a business unit perspective, our labs business, which was 54% of total company revenue in Q1, achieved revenue growth of 7% with strength in both clinical chemistry and immunoassay testing. Our immunohematology business continued its global leadership position and consistent trajectory with 4% growth during the quarter. Our point-of-care business represented 25% of our Q1 revenue and grew 8%, excluding COVID. Q1 COVID testing was down compared to the prior year period, but flu sales were strong, resulting in 18% year-over-year growth. This performance was led by our COVID flu combo test, which has continued to deliver durable revenue. And our molecular diagnostics business grew 11%, excluding COVID, albeit off a smaller revenue base. We are currently in the last stages of the clinical trial for our Savanna respiratory panel and are completing verification and validation testing. Once our trial data has been fully successfully finalized, we expect to make our submission to the FDA this summer. Our Q1 performance is further proof that the initiatives we launched in 2024 are having a positive impact on the performance of the business. As we look forward to the balance of 2025, we continue to be focused on our narrow set of strategic initiatives, including increasing the content and utility of our platforms, expanding margins, and commercial and operational execution. Our commercial teams are more focused than ever before on driving profitable growth by targeting the most attractive customers and market segments where we can drive value with our unique solutions. And we are on track to realize the remainder of the $100 million in annualized cost savings we defined in 2024, with $50 million in cost savings expected in the first half of 2025. And while much of our work last year was focused on staffing reductions, we have expanded our efforts to improve cash flow generation with initiatives targeting direct and indirect procurement, inventory utilization, capital expense management, and optimization of our cash conversion cycle. We expect these initiatives to yield an incremental $30 million to $50 million in cost savings in 2025. I'd now like to turn to the evolving developments at the macro level, including the expected impact on our business and the actions we're taking to address these challenges. Obviously, this is a very dynamic situation, so my comments reflect our assessment based on current information. Our business is based on a recurring revenue model with more than 90% of our sales coming from consumables and a small percentage coming from instrument placements. The majority of our manufacturing is based in the United States, and over the past three years, we have invested nearly $1 billion in U.S.-based manufacturing and R&D. Over half our employees are based in the U.S., and over the next several years, we expect to continue to invest and expand our capabilities to support the growth of our business, both domestically and globally. We also have company and third-party manufacturing located in the UK, China, Europe, and Mexico. These locations further our strategy of being close to our important customers, as well as reinforcing our business continuity objectives. With our global operating footprint, we estimate the potential tariff headwinds prior to mitigations is roughly $30 million to $40 million of impact in 2025. But since the discussion of tariffs began in 2024, we have been diligently working on plans to mitigate potential impacts. These plans include changing the origin of source materials, repositioning inventory, shifting our supply chain to alternate suppliers, as well as implementing select pricing actions and additional reductions to our controllable costs. Collectively, we believe the incremental actions we are taking are sufficient to fully offset the tariff impacts as they stand today. And while the environment can always change, we are maintaining our full year 2025 financial guidance based on our current business outlook. We remain focused on our key priorities and achieving our previously communicated cost savings initiatives over and above any tariff-related offsets. So to wrap up, we are pleased with the strength of our first quarter results and the progress we have made in our key priorities over the last 12 months. We remain focused on supporting our customers and believe we are well positioned to continue to drive consistent growth, while also expanding our profitability and value for shareholders in 2025 and beyond. So thank you for your time and continued support. And with that, I'll now turn the call over to Joe to take you through our first quarter financials in more detail. Joe?

Okay, thanks, Brian. And hello, everyone. I'll start by walking through our first quarter results, which are detailed on Slide 3 of the supplemental information available on the Investor Relations page of our website. And unless otherwise noted, all year-over-year revenue growth figures discussed today are presented on a constant currency basis. As Brian noted, our first quarter performance was in line with our expectations, and we anticipate continued momentum through the rest of 2025, particularly with our labs business, where we see strong recurring revenue with long contracts and a loyal customer base. Let me begin by taking you through our first quarter performance, followed by a discussion of our full year 2025 financial guidance, which remains unchanged. After that, we'll open up the call for questions. Total reported revenue for the first quarter of 2025 was $693 million, compared to $711 million in the prior year period. The year-over-year decrease in total revenue was primarily due to lower COVID revenue and lower donor screening revenue related to the planned wind-down of that business. Excluding COVID and donor screening revenue, we achieved mid-single-digit revenue growth of 6%. This performance was primarily driven by strength in our labs business, as well as consistent growth in immunohematology and a strong flu season. Foreign currency translation had an unfavorable impact of 150 basis points during the first quarter. From a regional perspective, our Q1 revenue performance was led by our other region, which is comprised of Japan, Asia-Pac, and Latin America, with 12% growth, driven by strong 17% growth in labs revenue. And looking at our other regions, North America declined by 6% compared to the prior year period due to the year-over-year decrease in COVID revenue and the ongoing wind-down of our donor screening business. But absent these headwinds, North America grew by 5%. Europe, Middle East, and Africa grew 9%, driven by strong contribution from labs and immunohematology. Finally, China revenue was flat compared to the prior year period, primarily related to order timing and a decrease in triage revenue related to lower reimbursement rates for certain cardiac markers. Labs revenue in China grew 2%, with strong contribution from clin chemistry testing. We continue to expect mid- to high-single-digit growth in China for the full year, assuming no change in the current tariff situation. Now looking at our non-respiratory business in the first quarter of 2025, revenue grew 2%. Now within that non-respiratory category, our labs business grew 7%, driven by good performance in both clin chemistry and immunoassay testing. We had strong recurring revenue growth, which was partially offset by an approximately $8 million decline in instrument revenue due to order timing. Non-core revenue was flat year-over-year, with an increase in collaboration revenue offset by a timing of contract manufacturing revenue. In transfusion medicine, immunohematology revenue continued its consistent growth of 4%, with particular strength in Europe, Middle East, and Africa. Donor screening revenue declined by 62% due to the continued wind-down of that business, as expected. And then lastly, our Triage business performed nice, up 9% year-over-year. Turning now to our respiratory business, revenue of $120 million grew 11%, excluding COVID. We saw strong flu sales in Q1, with year-over-year growth of 18%. COVID revenue was $23 million during the quarter, which was a 53% year-over-year decline. Moving down the P&L, Q1 '25 adjusted gross profit margin was 50.1% versus 47.5% in the prior year period. The year-over-year increase was primarily driven by product mix, with higher margin contribution from flu and COVID flu combo test. Non-GAAP operating expenses of $233 million, including SG&A and R&D, decreased by a net $18 million compared to the prior year period, which resulted primarily from our ongoing cost savings actions. The primary areas of savings included staffing reductions, decreased travel, and lower outside services expense. Adjusted EBITDA was $160 million compared to $132 million in the prior year period. Adjusted EBITDA margin was 23%, a 450 basis point improvement, which again reflects the cost savings actions we have taken. And adjusted diluted EPS was $0.74 compared to $0.44 in the prior year period, which is a 68% year-over-year improvement. Turning now to the balance sheet on Slide 5, we finished the quarter with $127 million in cash and $250 million in borrowings on our $800 million revolving credit facility. Reminder, our capital allocation priority continues to be debt pay down. Our first quarter of '25 adjusted free cash flow was $47 million, which represents 29% of our adjusted EBITDA and 94% of adjusted net income in the quarter. This is in line with our previously communicated targets. During Q1, our net debt to adjusted EBITDA ratio decreased sequentially from 4.4 times at year end '24 to 4.2 times. Our consolidated leverage ratio, including pro forma EBITDA adjustments, was 3.4 times as permitted and defined under our credit agreement. Now, turning to Slide 6, based on our current business outlook, we are maintaining our full year 2025 financial guidance as follows. We expect gross tariff impacts of $30 million to $40 million to be neutral to our overall financial results based on the expected mitigation plans that Brian discussed earlier. We continue to expect full year 2025 total reported revenue of between $2.6 billion and $2.81 billion. Note that the U.S. dollar has weakened since year end 2024, creating an opportunity for FX tailwinds of approximately $26 million. However, we are leaving total reported revenue guidance unchanged at this time due to current currency volatility. We continue to expect COVID revenue of between $110 million to $140 million. This assumes that we see a summerslide of COVID activity as we've seen in the past two years. Of course, we will monitor this closely and will look to mitigate any impact with further cost reductions if the seasonal cases don't materialize as expected. We expect adjusted EBITDA between $575 million and $615 million, which equates to 22% adjusted EBITDA margin, which is a 250 basis point improvement over full year '24. And we expect adjusted diluted EPS of between $2.07 and $2.57. Other key points related to our assumptions for full year 2025 guidance include, we assume a typical quarterly seasonality with Q2 revenue being our lowest quarter, Q4 being our highest quarter for revenue and margins. And further, we expect Q2 performance in China to be lower compared to the prior year period due to our decision to delay some shipments early in this quarter as the tariff situation evolved. Since then, regular shipments to China have resumed and we do not expect any impact on our full year 2025 guidance. Again, this is timing only between Q2 and second half 2025. We assume cost savings of approximately $50 million in the first half of 2025 as part of our previously implemented $100 million annualized cost savings initiatives. We continue to expect incremental cost savings in '25 between $30 million to $50 million primarily related to procurement efforts. And again, this is in addition to any tariff related offsets. We assume positive adjusted free cash flow for the full year '25 to be approximately 25% to 30% of adjusted EBITDA conversion and approximately 100% of adjusted net income. We expect higher cash flow in the second half of '25, which is in line with seasonally higher revenue and the realization of our cost savings. And we continue to target free cash flow conversion of 50% of adjusted EBITDA on the same timeline as our margin improvements. We also continue to expect our net debt leverage ratio to between 3.5x and 4x by year end. And since our credit facility matures in May of 2027, we plan to refinance the debt sometime in the second half of 2025 or early '26. Timing of this refinancing, of course, depends upon market conditions. So in summary, our continued operational improvements played a meaningful role in our performance this quarter. We're actively navigating a fluid macro environment and believe our current business outlook is in lockstep with our 2025 full year financial guidance. Looking ahead, we remain focused on execution, commercial excellence, and cost savings initiatives to deliver profitable growth. And despite recent macro challenges and the impact of tariffs, we continue to see a clear pathway to our adjusted EBITDA margin goal in the mid to high 20% range over the next couple of years. With that, I'll ask the operator to please open up the line for questions.

[Operator Instructions] Our first question is from Conor McNamara with RBC. Your line is now open.

Just wanted to dig into the tariff impact a little bit more. You've got a lot of business that's on reagent rental contracts. So to the extent that you're able to pass through pricing, how much of the tariffs can you offset with that if they are to get worse? From here, I'll start there.

Hey, Conor. Thanks for the question. Yeah, we are looking at selected pricing actions, where we can take them. But these are competitive markets and we have to be concerned about the impact there. I would say the business has had some experience in doing this during the pandemic when the business went through some, the high inflation time period. And we were able to pass some of that through. So I think we'll be doing it on a selective basis as we can.

And then, again, appreciate the color on plans for mitigating some of the tariff impacts. But longer term, is this likely to impact any of your longer term manufacturing buildout plans by region?

At this point, I don't expect any change in our overall manufacturing footprint. Obviously, it's a fluid situation. So we need to understand how things develop. We have, as we said, major manufacturing centers in the United States, the UK, China, and some third party manufacturing in Mexico. Those sources and that global footprint has served us well, as we tried to get closer to our customers and also manage some of our supply continuity risk. So we'll continue to utilize that network. And as we always do make modifications as we see the dynamics change here.

Our next question is from Patrick Donnelly with Citi. Your line is now open.

Joe, maybe another one just on the tariff side. Again, encouraging to see the offsets here. Can you just talk about the exposures? Obviously, the China, the U.S. or U.S. to China piece, I should say, was a big concern coming in. How are you thinking about, just quantifying that? And again, how the offsets, the confidence level that you guys can get there? Again, I think maintaining the guidelines would be a good outcome here.

Hey, Patrick. Thanks for the question. Yeah, as we said in the remarks, most of our products are actually manufactured in the U.S.. And so our largest tariff impacts are immunoassay products that are manufactured in the U.K. and shipped to the U.S.. We also ship products to China, but we're only seeing that a small portion of these are being subject to tariffs. And then finally, I would say we have some impact of some subcomponent materials that are purchased around the world that are being surcharged as we come in. So that is what makes up the gross $30 million to $40 million tariff impact that we just mentioned. That, again, is fully mitigated through identifying incremental controllable costs that we can take down, as well as passing on where it's appropriate some of these tariffs to our customers. And moving, realigning inventories and changing suppliers. So, through all those actions that we feel really comfortable with and confident in, because we've identified them all and we've implemented them all, that we feel we can fully mitigate the tariff impacts and leave our financial guidance as is.

And then maybe just on Savanna, just an update there. I guess the commitment, the ongoing commitment to that program, how are you thinking about that piece? If there are additional pushouts, you guys walk away from it. What's the right way to think about just the commitment level and the confidence in some of those timelines? And what should we be keeping an eye on that piece? Thank you, guys.

Yeah. Thanks, Patrick. What I can say at this point is really we are just so focused on getting our RVP4 submission into the FDA that I really don't want to speculate on outcomes beyond that. Molecular continues to be one of the fastest growing segments in diagnostics. We want to participate in that and benefit from that. And so we're just laser focused on getting the job done here. And we'll update you accordingly as we make our progress.

Our next question is from Andrew Brackmann with William Blair. Your line is now open.

Joe, I think in the assumptions you said that China is still expecting to grow mid to high single digits for the year. What sort of underpins your confidence in that growth rate? And is there anything that you can share with respect to maybe what you've seen in the region in April which supports that? Thanks.

Yeah. Hey, Andrew. Again, thanks for the question. Even though we're seeing some softness in the triage sales due to the reimbursement rates on certain cardiac markers, we are seeing good growth in labs and immunohematology. And as you know those businesses have good visibility to us forecasting going forward. So, that's really what gives us the confidence that our China team can hit that mid to high single digit growth target for the full year. And again, as we've said many times, the VPP is not really having an impact on us as it is with others in our space. And so that's not really a concern for us right now. So it's just really the visibility to that non-respiratory business that we have in China that gives us the confidence that we can still hit those numbers.

And then maybe just a clarification to your answer to Patrick's question. I think you said only a small percentage of products being shipped to China are subject to tariffs right now. Are those exemptions that are specifically called out or any color on why you're not seeing those be subject to tariffs? Thank you.

Yeah, really, all we can say at this point is that with all of the shipments that have gone into the country over the last couple of weeks since the tariffs went into effect, we're just -- we're really just seeing a small number of those being subjected to the tariffs in practicality.

Our next question is from Jack Meehan with Nephron Research. Your line is now open.

I wanted to start by asking about the respiratory sales in the quarter. So you hit our forecast, but got there in a way, wasn't exactly expecting less COVID, more flu combo. Brian, I was curious, do you think we're seeing some sort of permanent shift here toward combo/Sofia? And maybe for Joe, like, what are the implications for the guide? Like, if COVID came down, like, do you think you can make up for it kind of on the other respiratory piece?

Yeah, well, hi, Jack. Thanks for the question. We did see COVID down year over year and flu is up. I think we're still expecting that $110 million to $140 million range that we provided in the guidance, which includes the summer spike that's happened for the last couple of years. So, we'll be monitoring that very carefully to see what happens here. But I would say on the -- on the cobit flu question, that test has just been very durable now for the last couple of years and we've just seen very stable performance from it.

Yeah, and Jack, I would just add to what Brian said, even though we did see COVID come down in the quarter year over year, we did expect to be less this year. We took it down from $185 million down to a midpoint of $125 million, and most of that decline was due to the lack of a government order fulfillment this year versus last year and then a decline in retail. But, so we expected a decline and we still think that our range is a reasonable place to be for the full year. But as I said, in the prepared remarks, we'll obviously keep a close eye on it as we move through the year.

And I did want to follow up on Patrick's question related to Savanna. It sounds like the trial might be wrapping up. Was curious if you've seen any of the data was a success, and if it's too early for that, I was also curious how the engagement's been with the FDA around commission. There's been some discussion around kind of turnover in the approval office. I was curious if you've seen any of that and just thoughts on if that could delay the approval at all.

Yeah, no, we're just, Jack, in the last stages of our process here before submission, doing some of our studies around reproducibility shelf life, et cetera. We need to get those completed. We really haven't seen any sort of negative negative impact in terms of our interactions with FDA. We are hearing things in the industry that pre submission meetings are taking a while are being delayed, but nothing that is affecting the submission process itself. That's obviously something we're going to have our finger on very carefully here as, as we go through the process. But that's really what I can share at this point about where we're at in the process.

The next question is from Lu Li with UBS. Your line is now open.

So, on the medication effort, are we going to see some timing impact here? Like, maybe some of the mitigation impact not going to show up in Q2 and then more in the second half. I was just wondering how the margin progression on this one.

Yeah, it's Joe. Yeah, I don't think there's going to be a lot of timing impact because I think we've got the mitigation actions pretty well paired up with the impacts of the tariff, the gross impact of the tariffs. So I don't think there's any real timing impact there to speak of, maybe a little bit, but nothing significant. I do think that the only real timing impact's going to be in Q2 because we did slow down shipments to China early this quarter as we waited for the tariff situation to evolve. And we're doing our best to catch up on those shipments, but I don't think we're going to fully catch up. And I think -- so I do think there'll be, we'll see some softness in China, revenue in Q2 that will make up as timing in Q3 and Q4. I think that's really the only timing impact that we'll see from the tariffs.

And then I assume the $30 million to $40 million gross impact is mostly 2025 numbers. So I wonder if anything will linger into '26, and then are you maintaining your 23% to 24% EBITDA margin that you presented a few months ago?

Yeah, Lu, good question. Yeah, the numbers that we talked about, the $30 million to $40 million, that is a 2025 impact number. So obviously, the annualized impact would be a little larger than that, but the tariff impacts, the mitigation impacts, I should say, that we talked to will fully offset the annualized impacts as well. And so there's no change to our margin targets and where we expect to be for 2026, no change.

Our next question is from Casey Woodring with JPMorgan. Your line is now open.

I'll just stick to one. Can you just elaborate on the shipments into China and only a small percentage of those subject to tariffs right now? Can you just, why is that exactly? And what's your visibility into that continuing? And is there any kind of risk that a larger percentage would eventually get hit with tariffs here? Just kind of curious on that piece. Thank you.

Yeah, hi, Casey. Thank you for the question. Again, I can really only say that our experience here over the last several weeks in what has been a very fluid situation is that we aren't experiencing the tariffs on the bulk of our products going in. It's very, just a small subset where we're seeing that. And we'll look to understand if that changes, but it looks like, that's going to be the case for a while.

Yeah, there's no indication that it's not the case at this point.

Yeah, it's not going to be permanent.

Our next question is from Andrew Cooper with Raymond James. Your line is now open.

Maybe first, just if I think back to a couple of years ago, visiting the Rochester, and in some IA manufacturing capacity, if I remember right with COVID grants there, can you just give us a sense, what are you able to manufacture in the U.S. for immunoassay versus relying on that Wales facility to support this country's utilization there?

Yeah, we do have some immunoassay manufacturing capacity in our Rochester facility, but the bulk of it is in the UK at this point.

And then maybe just to touch on China again as well, you called out the 2% growth and called out clinical chemistry, especially. I know IA has historically been smaller for you in China, but any change in wind rates there across clin chemistry versus IA? And then maybe can you give us a sense for the penetration of integrated instruments in China versus globally?

Well, Andrew, we can start with the penetration of integrated instruments that our business there is primarily clinical chemistry. So, most of what we have there are standalone clin chem boxes. And so we've got plenty of runway to expand our immunoassay presence there. And in terms of the results that we saw in the quarter, our growth rate there was primarily impacted by triage. We did see lower clinical chemistry growth, but I would say that some of that is kind of shift across the quarters and I wouldn't read too much into that.

Our next question is from Tycho Peterson with Jefferies. Your line is now open.

Wondering if you can maybe just talk a little bit more on some of the strengths you're seeing on core lab and any noticeable change among your hospital customers given some of the funding uncertainty set?

Yeah, Tycho, thank you. Appreciate the question. We really saw across the board strong performance in labs, 7% overall growth. And then you look across North America, EMEA, our LATAM area, all reporting, pretty strong growth there in the lab segment. We continue to have a very strong value proposition in the lower volume setting where customers value, our technology value proposition with the dry slides, as well as our immunoassay capability. So strong growth in Q1, no real significant competitive headwinds at this point, and we continue to really just drive our value proposition there to continue to drive growth.

And maybe a follow-up on that, on the competitive front, others have tried mass spec and not had much success. Roche is obviously going to try to go at this, I think with 50 analytes at first, but they've talked about scaling up to thousands. And maybe, can you just touch on how you view mass spec as a competitive technology going forward?

Yeah, I saw the launch of their new product. It's really focused on a testing segment that is not mainstream and not in our sort of central area of competition. So it's not something that we're overly concerned about. It seems to have a specialty utilization. I do know they have aspirations for it, but I think it's going to take some time for them to provide an alternative there that really competes with kind of mainstream core laboratory technology at this point.

We have no more questions waiting at this time. So I'll pass the call back over to Brian Blaser.

Well, thank you, operator, and thanks everyone for your interest in the company. We're very pleased with our first quarter results. We are going to keep focused on our key priorities and we look forward to updating you on our progress in the coming quarters. So thank you very much.