QuidelOrtho Corp (QDEL) 2023 Q2 法說會逐字稿

Welcome to QuidelOrtho Second Quarter 2023 Financial Results Conference Call and Webcast. (Operator Instructions) Please note, this conference call is being recorded. An audio replay of 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 Bryan Brokmeier, Vice President of Investor Relations. Bryan?

Thank you, operator. Good afternoon, everyone, and welcome to the QuidelOrtho Second Quarter Financial Results Conference Call. With me today to discuss our financial results are Doug Bryant, QuidelOrtho's President and CEO; and Joe Busky, QuidelOrtho's Chief Financial Officer.

This conference call is being simultaneously webcast to the Investor Relations page of our website, and a version of today's presentation can be downloaded there.

Before we begin, I will cover our safe harbor statement. The statements we will make during this call about the company's expectations, plans, future performance and prospects are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which provides a safe harbor for such statements.

Forward-looking statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied in these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors identified under Risk Factors in our annual report on Form 10-K filed with the SEC on February 23, 2023 and subsequent reports filed with the SEC. Please refer to our SEC filings for more detailed discussion of forward-looking statements, the risks and uncertainties of such statements.

We cannot assure you that the forward-looking statements we make or are implied by our statements will be realized. Furthermore, such forward-looking statements represent management's judgments and expectations as of today. Except as required by law, we undertake no obligation to update any forward-looking statement or any time-sensitive information to reflect future events, developments or changed circumstances or for any other reason.

Also during today's call to facilitate a comparison of the company's operating performance from the second quarter of 2022 before the QuidelOrtho combination the second quarter of 2023, we will be discussing supplemental revenue and other supplemental adjusted earning results as if Quidel and Ortho have been combined for the applicable periods. We will refer to this information as our supplemental combined information. Certain supplemental provide information as well as certain other items we will discuss do not conform to U.S. generally accepted accounting principles or GAAP. Please see Slide 3 for a list of non-GAAP measures.

Reconciliations of these non-GAAP measures to their most directly comparable GAAP measures are included in the appendix to the investor presentation and press release issued this afternoon, both of which are available on the Investor Relations page of the QuidelOrtho website.

Lastly, unless stated otherwise, all year-over-year revenue growth rates, including revenue growth ranges given on today's call, are given on a constant currency -- on a comparable constant currency basis.

Now I'd like to turn the call over to Doug Bryant, QuidelOrtho's Vice President and CEO. Doug?

Thanks, Bryan. Welcome, everybody, and thanks for joining our call. We've just marked an incredibly exciting first year of harmonization and integration across the global Quidel organization. Our colleagues have performed admirably and we, as a united team have successfully achieved major milestones in a very short time frame.

We delivered solid financial results in the second quarter with revenue of $665 million and nonrespiratory revenue was up 4% on a supplemental combined basis. Demand for diagnostics across the health care continuum remain strong. And our Labs business delivered high single-digit growth. Our team was steadfast in executing our key growth drivers this quarter and our Labs business backlog approached normalized levels, and we saw utilization increase.

Sofia non-COVID-19 pull-through continued to increase, and we completed both the Savanna EUA and 510(k) FDA submissions as planned, including 510(k)s for the instrument and both RVP and HSV/VZV lesion panels.

Drilling down into the results from our 4 business units. First, our Labs business delivered 9% growth in nonrespiratory revenue with growth across all major geographic regions. The notable global strength in clinical chemistry was driven by expected utilization levels per instrument and the strong integrated instrument placements over the last few years, which also drove solid growth in immunoassay, and is clearly helpful to gross margin.

Instrument demand remained healthy across all regions. Focused execution by our operations team enabled us to produce nearly 10% more instruments than our record-breaking first quarter and reduced our instrument backlog in our Labs business by approximately 40%. These efforts enabled us to ship more instruments than previously anticipated in the quarter. As a result, our integrated installed base grew 13% and automation increased 20%, continuing the positive trend that we've seen since implementing our Commercial Excellence program and launching our VITROS XT 7600 Integrated System in late 2018. As these shipped instruments are installed, validated and come online, we believe these placements will have a modest positive impact in 2023, and will set us up in 2024 for additional growth.

Turning to our Point-of-Care business unit. Respiratory revenue declined, driven by a reduction in our retail business as expected, following the end of the COVID-19 public health emergency in May and the continued transition to an endemic state. With insurance companies no longer supporting free at-home COVID-19 tests including our QuickVue over-the-counter test, our overall COVID-19 business faced a challenging comp on a year-over-year basis.

And as reported by several other diagnostic companies, the end of the public health emergency had a significant dampening effect on molecular COVID test volumes. For us, this helped to drive double-digit year-over-year growth of our Point-of-Care COVID business as many customers shifted testing for symptomatic patients back to antigen tests and more specifically to our Sofia SARS Antigen assay.

Looking at nonrespiratory. Revenue was down 4% year-over-year due to quarterly variability and our component sales to Beckman for its BNP business, which, as a reminder, is contracted to be $70 million to $75 million per year. Our overall Sofia business continues to be strong globally with cumulative placements about flat at 87,000 instruments. In the U.S., non-COVID-19 trailing 12-month out sales per instrument grew 14% year-over-year.

Outside the U.S., we're seeing double-digit year-to-date instrument placement growth in Europe, Middle East and Africa and triple-digit year-to-date placement growth in China, albeit on a small base.

Moreover, we saw a healthy performance from our Triage business, which was up 7% compared to last year, with particularly strength from China, Asia Pacific and Latin America, which is evidence of the cross-selling revenue synergies that we have anticipated. Our Transfusion Medicine business was down approximately 3% from this time last year due to continued weakness in our donor screening business, partially offset by strength in immunohematology.

The donor screening weakness was due to strong revenue in the prior year and a broader macro trend of declining blood donations in the United States. However, our strong Immunohematology business, which represents about 70% of our Transfusion Medicine business unit revenue, achieved a 5% year-over-year improvement in revenue, normalizing our year-to-date growth following a soft first quarter.

And last, our MolecularMolecular Diagnostics business declined as one would expect with sales of our Lyra assays declining as the molecular testing market continues to shift from high-volume centralized testing to more automated decentralized solutions. Notably, this was partially offset by Savanna, which continued to perform well in the EU with a modest improvement in sales year-over-year. Given the product's ease of use and industry-leading speed, we are seeing a lot of customer interest and have expanded our reach to more customers across Europe.

Following the 2022 early-access launch in Italy and Austria, we are now placing instruments in France, Germany, Spain, Belgium and Switzerland. I'm quite encouraged by the positive response Savanna has received from leading diagnostics providers across a growing number of markets. As I mentioned earlier, we completed both the Savanna EUA and 510(k) FDA submissions as planned, including 510(k)s for the instrument and both RVP4 and HSV/VZV lesion panels.

The launch of our revolutionary Savanna molecular platform is a high priority. Savanna uses real-time PCR and clinically relevant syndromic panels to address a variety of pain points across the diagnostic continuum. The platform offers speed and flexibility and is easy to use, making it suitable for use in multiple customer environments, including physician office, labs, emergency departments, pharmacies, urgent care settings as well as hospital and reference labs.

We completed validation of our second low-volume Savanna cartridge manufacturing line during Q2 and are currently building inventory in anticipation of Savanna's launch in the U.S. following regulatory clearance. Our initial menu includes our RVP4 respiratory viral panel and HSV/VZV lesion panel to be followed throughout 2024 by RVP11 and HSV/VZV syphilis panel, a panel for sexually transmitted infections, including chlamydia, gonorrhea, micro-plasma in genitalia and trichomonas vaginalis; plus 2 gastrointestinal panels, one bacterial and/or viral; and the second parasitic panel; a pharyngitis panel that tests for 4 bacterial pathogens; and finally, a vaginitis panel.

We've focused our offering on syndromic testing needs to take advantage of the unique features of Savanna including rapid turnaround time, simple workflow and test flexibility, allowing more clinically relevant information to be generated closer to the patient in a time frame that can be -- that actually can affect treatment. On behalf of our customers and shareholders, I'm thrilled that the U.S. Savanna launch is progressing. As the platform is robust, the total addressable market is huge and the outlook is very exciting.

As the company focused on long-term growth, we continuously monitor numerous converging trends across the health care sector, of which I believe will strengthen our position in the diagnostics industry including the aging population, the surge of chronic conditions and diseases, as well as emergent infectious diseases. Additionally, the diagnostic industry can play an important role in providing greater access to care and limiting the escalating cost of health care.

We believe that we are strategically positioned to capitalize on these trends. We have the right strategy mixed with the powerful combination of our organization and the ability to serve the full diagnostics continuum from home to hospital and lab to clinic.

Our performance in the second quarter demonstrated the strength of our organization as we delivered strong value propositions to support customers across all segments, partnering with them to help solve their most immediate business needs and executing on the initiatives that drive meaningful growth and can contribute to measurable and enduring positive impacts and health outcomes for our customers, shareholders and communities.

Our ability to consistently deliver high-quality products and services is supported by our deep expertise as a pure-play in vitro diagnostics provider. In May 2023, we passed the 1-year mark of becoming QuidelOrtho, and our integration has thus far yielded better-than-expected results. Our culture continues to thrive and evolve as we leverage our strengths and examine opportunities for growth while simultaneously advancing our capabilities and improving our day-to-day operations.

As we pull our 2 companies together, major initiatives are moving forward and we are ahead of schedule on our related cost synergy targets. We are operating as a nimble and agile company that can respond to immediate needs with our industry-leading testing technologies for health care providers around the world without losing focus on the patient or our long-term growth strategy.

We've identified additional opportunities to optimize the organization by improving supplier agreements, reducing complexity, streamlining business processes and workflows, and implementing best practices. Therefore, we've now identified cost synergies of $130 million that we expect to realize over 3 years compared to our prior target of $90 million, and we continue to pursue further opportunities.

As an industry leader, we're poised for the next phase of integration, that being transformation. We've mobilized our top-tier team members, combined with a leading-edge industry transformation firm, aiming to deliver sustained revenue and margin growth, a commitment made to our shareholders. Our strategy hinges on fostering profitable growth opportunities, improve cash flow and fostering a culture of continuous improvement. It is important to note that it's still very early in our transformation journey. I look forward to sharing additional details by the end of the year.

Before I turn the call over to Joe to review our financial performance in greater depth, the team and I are incredibly excited about what's next for QuidelOrtho. We're seizing opportunities and acting decisively and we're never losing sight of the future of patient care. Our company reached historic heights during the pandemic, demonstrating our ability to quickly solve the problems of today. With the pandemic in the rearview mirror, we are on our way to demonstrating our agility and nimbleness once again, while driving long-term sustainable growth.

With that, let's turn the call over to Joe to review our financial performance and guidance for the full year. Joe?

Thanks, Doug, and good afternoon, everyone. Before I discuss our financial results for the second quarter, I want to remind you that to facilitate a year-over-year comparison of the company's operating performance, all growth rates that I reference are presented on a supplemental combined basis as if Quidel and Ortho had been combined for the applicable periods and may be referred to as supplemental combined information.

Starting with the breakdown of revenue on Slide 7. The demand environment continues to be strong, and we delivered another strong quarter on the top line. Nonrespiratory revenue grew 4% in constant currency to $576 million in the second quarter, driven by continued strength in our Labs business unit as well as increasing strength in our Triage product line and a bounce back of Immunohematology. Excluding our Donor Screening business, which was a headwind in the quarter, as Doug mentioned, nonrespiratory revenue would have been up 7% in constant currency.

Respiratory revenue totaled $89 million in the quarter, including $56 million in COVID-related revenue. Respiratory revenue was softer than expected due to a sharper-than-expected decline in COVID-related revenue following the end of the public health emergency in May, partially offset by a resilient flu revenue. In total, revenue was down 26% to $665 million, reflecting the strong COVID-related revenue in the second quarter of 2022.

The strength of our COVID-related revenue a year ago highlights what we and others in the diagnostics phase have been same for several quarters. We believe COVID-19 is transitioning to an endemic state and is continuing to circulate like any other respiratory disease. Appropriately, we now bucket COVID-19 revenue with our other respiratory revenue.

Turning to our quarterly performance by geography on a constant currency basis and excluding respiratory revenue. North America revenue declined 2%. EMEA grew 4%. China grew 26%. And our other region, which includes Latin America, Japan and other Asia Pac markets grew 9%. North America, our largest geography by revenue, delivered solid revenue in the Labs business, but nonrespiratory revenue declined due to the previously mentioned weakness in Donor Screening. The Lab strength included both recurring revenue and instruments, leaving our major regions and instrument revenue growth contribution.

During the quarter, we made the final $4 million shipment on a previously discussed government contract for QuickVue At-Home test, and we don't anticipate any further government revenue for the remainder of the year. In the EMEA region, solid nonrespiratory revenue growth was driven by Labs and Immunohematology. The Lab strength was widespread across most major countries in the region, while the Immunohematology growth was driven by large customer orders in the Middle East.

We also saw strong double-digit growth in Triage placements, which we expect to drive incremental revenue growth in future quarters. In our China region, which makes up about 10% of our total company revenue, nonrespiratory growth of 26% was driven by broad strength in Labs. Hospital demand continued to be strong throughout the quarter, driving growth above the rate we realized in Q1, which had benefited from the surge of demand early in the year following the end of COVID-19 lockdowns at the end of '22.

Within point of care, we continue to drive double-digit growth of our Triage products, and our Sofia year-to-date revenue was close to double, our '22 full year revenue following the launch of Sofia 2 and strong instrument placements in the quarter. Both of these accomplishments are clear demonstrations of revenue cross-selling synergies.

Turning to our Q2 nonrespiratory revenue by category. Recurring revenue, which includes reagents, service and other consumables, grew 4%. Excluding our Donor Screening business, recurring revenue would have been up 6%. Instrument revenue grew 10% as instrument demand was robust, and we worked down our open labs instrument orders by approximately 40% to 300 instruments from 500 at the end of Q1 and 650 at the end of '22.

So while global supply chain challenges appear to be easing, we don't believe that we're fully resolved and customer readiness during the summer months will be a limiting factor in the near term. We continue to expect elevated open orders to modestly persist into early '24 as we work toward our goal of a normalized 150 open orders.

Now turning to Slide 8. I'd like to comment on our second quarter financial performance below revenue versus the prior year, again, on a supplemental combined basis. Gross profit margin for the quarter was 45.6%, a bit lighter than our expectation due to product mix, including the strong instrument revenue as we work down our labs instrument open orders and lower-than-expected COVID-related revenue due to the end of the public health emergency.

Moving down the P&L. R&D expense increased about $1 million sequentially, $3 million higher than expected due to the Savanna FDA regulatory submissions.

Sales, marketing and administrative expenses were down $23 million sequentially, reflecting execution on cost synergies and a reduction in variable expenses. We expect sales, marketing and administrative expenses to be flat to slightly down in Q3 and Q4 as compared to Q2.

Adjusted EBITDA also declined year-over-year to $113.3 million, slightly ahead of our expectations due to the strong revenue. Adjusted EBITDA margin contracted year-over-year to 17%, slightly below our expectations due to product mix, including strong instrument revenue and lower-than-expected COVID-related revenue due to the end of the public health emergency, as well as a $3 million higher-than-expected R&D expense due to the Savanna FDA regulatory submissions.

Net interest expense for the period was $36 million, an increase of $7 million versus the prior year as anticipated due to the increase in the average outstanding debt balances related to the combination. And as a reminder, we have swaps in place that secure approximately 70% of our term loan at a fixed rate for the life of the loan, providing for an all-in interest rate after the effect of our swaps of approximately 5.6%. Our provision for income taxes was $5 million compared to $63 million for the prior year period. This represents a second quarter adjusted tax rate of 23.4%, down from prior year period due to discrete items.

Our adjusted earnings per fully diluted share for the second quarter was $0.26 compared to $2.12 in the second quarter of '22 on a supplemental combined basis. The decrease in EPS was again driven by an exceptionally strong prior year period in COVID transitioning to an endemic state. The higher-than-expected R&D expense due to the Savanna FDA regulatory submissions negatively impacted our EPS in the quarter by $0.04.

Now turning to cash flow and balance sheet on Slide 9. In the second quarter, on a GAAP basis, cash outflow from operating activities was $31 million. This is in line with our expectations. After funding $49 million in CapEx and adding back $16 million in integration-related capital expenditures and $33 million in acquisition, integration and other costs, we estimate adjusted free cash flow to be a negative $30 million for the quarter, again, in line with our expectations.

In terms of capital deployment in the second quarter, we used $112 million of cash to make our final $40 million payment to Abbott for the $680 million purchase of the Alere Cardiometabolic assets and we paid down $72 million of our term debt. Our debt paydown was $20 million more than the contractual requirement of our term loan as we take a key step towards reducing our leverage.

While we did not buy back any shares in the quarter, we intend to maintain a balance and opportunistic approach to share repurchases while also continuing to prioritize our debt paydown going forward.

We ended the quarter with cash, cash equivalents and marketable securities of $248 million and total debt of $2.5 billion. We ended with 2.8x net debt-to-EBITDA on a supplemental combined basis. And as COVID-related revenues declined due to the transition from a pandemic to an endemic, our leverage has modestly increased, but we expect leverage to finish the year slightly down to where we are now. Deleveraging is a top priority with our goal to be at or below 2x net leverage by the end of '24, while maintaining flexibility for strategic M&A opportunities.

Now turning to our fiscal year '23 guidance on Slide 10. First, I'd like to provide some broader context on our outlook. Labs, instrument supply issues are expected to continue to alleviate as we move through the second half of the year, which, along with the continued recovery in China are expected to drive high single-digit nonrespiratory growth in Labs.

The end of the public health emergency caused a meaningful decline in the retail COVID market as well as molecular even as the antigen testing has picked up share of the professional market from competitive molecular systems. Due to these 2 headwinds on the COVID market, our COVID outlook has come down. In light of these dynamics, we are updating our fiscal '23 full year guidance as follows: total revenue of $2.88 billion to $3.08 billion compared to our prior guidance of $2.87 billion to $3.18 billion.

Breaking this down a little further, we are raising our nonrespiratory revenue guidance to the high end of our prior guide, while lowering our respiratory guidance. Nonrespiratory revenue is expected to grow 5% to 6.5% on a constant currency basis to $2.27 billion to $2.31 billion, up from our prior guidance of 4.5% to 6.5% on a constant currency basis to $2.26 billion to $2.31 billion.

We now have a respiratory revenue guide of $610 million to $775 million including COVID revenue of $300 million to $400 million compared to our prior guide of $610 million to $875 million, including COVID revenue of $300 million to $500 million. And it's interesting to note that in the second half of '23, we expect that more than 93% of our COVID revenue forecast is in the professional market.

We now expect full year gross margins to be at the low end of our prior expectations of low to mid-50s due to product mix, including higher instrument revenues from the faster-than-expected drilling on the labs instrument open orders. Adjusted EBITDA margin expected of 26.9% to 27.7% in the range of $800 million to $830 million compared to our prior guidance of $815 million to $865 million.

And despite the reduction in our guidance for higher-margin COVID-related revenue, we are offsetting the full P&L impact of the revenue drop with expense reductions. Adjusted diluted EPS is now expected to be in the range of $4.85 to $5.30 compared to our prior guidance of $5.15 to $5.70.

In addition, I'd like to discuss the assumptions I covered last quarter that may be helpful for modeling purposes. At current rates, currency translation is expected to be about neutral to full year sales and adjusted EBITDA with a higher FX impact on nonrespiratory revenue. As previously discussed and consistent with prior quarter or prior years, the first and the fourth quarters are seasonally the strongest quarters of the year.

Net interest expense continues to be expected in the range of $145 million to $150 million for the year. We continue to expect the full year adjusted tax rate of approximately 23.5%. We continue to expect adjusted free cash flow to be at the low end of the 50% to 65% of adjusted EBITDA, which translates into more than 100% of adjusted net income and full year diluted weighted average share count is 67.2 million.

So with that, I'll turn the call back over to Doug to make a few summary comments.

Thanks, Joe. In conclusion, the second quarter demonstrated the strength of our combined organization, the solid financial results driven by our Labs business unit and Triage. We raised nonrespiratory revenue guidance to the high end of our prior guide while lowering our respiratory guidance to the low end of our prior guide.

We have now identified cost synergies of $130 million that we expect to realize over 3 years as we are making steady progress across the organization, improving the efficiency of the business, paying down debt, generating cash and being good stewards of shareholder capital. We're laying the necessary groundwork for our transformation to an organization that's positioned for long-term top line and bottom line growth.

Now let's open the line for Q&A.

(Operator Instructions) The first question comes from the line of Patrick Donnelly with Citi.

You got Jason on for Patrick. Maybe first on the China performance in the quarter growing 26% ex-COVID. How did things trend in the country throughout the quarter? Do you see any changes in demand as the quarter went on? And is double-digit ex-COVID growth still? How are you thinking about the guide there for the year?

Well, what we saw was stabilization of the business there, and we had a bit of a surge in the first quarter. I think what you're seeing in Q2 is more of a return to normalcy. And what would you add, Joe, in terms of the actual numbers?

Yes. No change in expectations there for the full year. We're still expecting high single digits total revenue growth and high teens full year revenue growth, excluding SARS.

Got it. Okay. That's helpful. And then maybe just on the Savanna manufacturing. How has that been ramping? How should we be thinking about production capacity relative to initial demand as well as the automated production line coming online next year?

That's a great question. We're actually at the phase now where we're stocking instruments in support of what we anticipate to be a reasonably good launch assuming that we're in market for this upcoming respiratory season. So again, we're already at the stage from an instrument position that we feel like we can address the upcoming launch.

And on the cartridge side, as I mentioned, we're just finished standing up our second low-volume manufacturing line for the cartridges for both clinical trials and launches, and that's going well, too. So I think we're in really good shape from an op supply chain and launch perspective.

The next question comes from the line of Andrew Cooper with Raymond James.

Maybe first, I just want to talk a little bit about adjusted EBITDA here in the guide. The margin is moving a little bit lower. I think the conversations we had about COVID and respiratory prior was that those had really worked closer to the consolidated average. You talked about some expense offset as well, but we do see that margin going lower. Can you just help me kind of think through some of the moving parts there and maybe why we aren't seeing more of those synergies and more of those cost offsets helping drop that -- limit the drop down a little bit more?

Andrew, it's Joe. Yes. So there are 2 big changes to the guide on the revenue side. We are taking the nonrespiratory revenue guide up to the upper end of the range, and that's really driven by the strong results we're seeing on the Labs business and the continued success we're seeing unwinding instrument backlog. But in the quarter and then early in this Q3, like a lot of other diagnostic companies that have already reported, we are seeing some softness on the COVID revenue side.

And so those -- the areas where we're seeing that softness on COVID are particularly on the molecular side, where that test is moving to the antigen and on the retail side, where it seems that the asymptomatic testing is just not happening as much as it was last year and earlier this year. So we did bring down the revenue guide there. So there is definitely a margin impact to those 2 things that I just mentioned. As we drill down the Labs backlog faster than we had expected earlier in the year, it's a good thing because we're producing more instruments and we're getting more instruments out to our customers, and that's going to drive more recurring revenue in the future.

But in the short term, it is going to drive margins down a bit as we drive more instrument revenue which -- it just has lower margins -- significantly lower margins than the recurring reagent revenue.

And then on the COVID revenue, most of the commentary we made about the margins approximating the overall total company margin were related to the government contract that we fulfilled in Q1 and early in Q2. But as you look at the COVID margins for retail and professional, they're still pretty strong margins relative to the rest of our product mix. And so by pulling down that COVID revenue in the second half, it is going to have an impact.

And if you work through the math, and I'm sure you all will do this after the call, if you work through the math and looking to the midpoints of the revenue drop on the guidance and then the EBITDA and EPS drop, you will see that we did actually offset some of the margin impact with cost reductions to soften that EBITDA and EPS impact from the bottom line.

Okay. Great. That's helpful. And then maybe just one more. One, we got a lot on the -- in the quarter, just around the Triage business and some of the moving parts here in the U.S., specifically with the recall. Obviously, it sounds like a really strong quarter there overall. So maybe just help size some of those impacts for folks, how we should think about it for this quarter and into the future? And then some of the key factors may be helping drive that growth with the cross-selling in international markets?

Yes. I'll start with the recall part of the question and just point out that we're talking about a very small number of tests, across a small number of [tubes] that were affected. And so the financial impact that happened was de minimus more than offset by the growth that we're seeing, particularly ex-U.S. of the Triage business.

Yes. And by the way, Andrew, Triage did have a nice quarter up high single digits in the quarter. And so up nicely sequentially from Q1. So we are starting to see those nice cross-selling opportunities, particularly outside of the U.S., which is driving that growth and it's going to drive nice full year growth in the Triage business.

The next question comes from the line of Alex Nowak with Craig-Hallum Capital Group.

I know you're adjusting the respiratory guidance here today, but we are entering the second half, so I got to ask the question anyway. Just how are you thinking about the flu season? There's a big Australian flu season that they're going through right now. We're also hearing news about another COVID variant potentially floating around. We're seeing tests of positivity spiking. So what are you hearing out there in the channel? And then just remind us how much COVID and flu inventory is ultimately still sitting out there?

Yes. On flu, this is the same answer this time of the year that I've been giving, I think, for the last 14 years, and that is, we see correlation between Southern Hemisphere and Northern Hemisphere. And I think when I last saw the Lab, we had looked at the last 20 or 25 years or something. And the R-Squared between the 2 is pretty high, but it's not as -- it's not necessarily cause-and-effect.

So I do think that we're hearing from the government some concern about what's going to happen in the upcoming respiratory season. But what I would normally say, Alex, is I never know when it's going to start and when it's going to stop. So do I believe that we'll see an influenza season this year that is more traditional in terms of size? I think so. I just can't predict how much of that's going to occur in the fourth quarter and how much of that would remain for the first quarter. In terms of COVID inventory...

Yes, go ahead.

Yes, out-sales have been reasonable because for most of the inventory that would have been shipped to distribution, that's the product that gets shipped into the professional segment. And so I'm not thinking that we are sitting with a lot of inventory out there right at the moment.

I can -- there's not -- yes, I'm looking at distributors' inventories down quite a bit from prior year and it's also down from Q1. So we're looking at pretty low levels of distributor inventory of SARS in the U.S.

Right. And then when we see their out-sales report, we know that they shipped and we suspect that what will happen as is typical is that during the respiratory season, that same set of distributors will reorder before we get too far into the fourth quarter. Sometimes it occurs earlier as early as late third quarter, but we're not modeling that at much. So that is true for both COVID and for flu.

Okay. Very helpful. And then maybe going back over to Savanna. Can you remind us how the initial launch of Savanna in Europe went? Were you seeing those competitive conversions happen like you outlined at the Analyst Day, the share gains take place? And how has that changed the initial U.S. game plan once we get the approval?

Well, I think it's a bit of foreshadowing of what we might expect. The competitors that we thought based on European feedback might be vulnerable were indeed those same 2 competitors. And we've done there quite well. The issues that are reported in Europe we see as being applicable here in the United States, too. So particularly with respect to the respiratory launch, I think we're in really good shape here in the U.S. And for HSV/VZV, that's a product. It's not a huge market, but we already do quite well in it.

The next question comes from the line of Jack Meehan with Nephron Research.

Joe, so the new EBITDA forecast for the year, the EBITDA forecast, $800 million to $830 million. Can you talk about the pacing in the back half? I'm getting the 4Q needs to be over $300 million or so. Is that the magnitude of the step-up you're looking for? And just what drives that?

I don't know that it's that steep. Jack, give me one second. Let me just pull up a file.

Qualitative, it's a pretty big step up in the fourth quarter.

It is. You're right. It is a big step because sequentially we've been saying Q2 is our lightest revenue quarter and that is going to be true. Q3 will step up sequentially. Q3 will step up sequentially. And then Q4 will step up quite a bit with the respiratory season. So yes, the Europe...

And cardiovascular, frankly in the fourth quarter steps up a little bit normally, too. So fourth quarter typically is our second biggest quarter across the combined business.

But remember also, Jack, in addition, you've got -- we're going to have a decent amount of cost synergies starting to hit the P&L. So your OpEx number will be coming down quite a bit. If you're comparing to Q4 last year, you're going to have quite a bit of a nice step down in OpEx year-over-year.

Okay. And then another one on Savanna. So the -- it's good to see the submissions are in. When do you pencil in now an approval for 510(k) and can you just tell us what the second half guide for respiratory includes for Savanna sales?

I'll let Joe answer the second part of the question. The first part of the question is, traditionally, once we make submissions to the FDA and they are under active review, we don't comment any further. So I think the first part of your question was asking me to forecast when we would get approval, and I won't do that. Obviously, we have ongoing dialogue, we have a number of things as part of the process, not one of which we can discuss while the products are under active review.

Yes. And on the magnitude, Jack, there's no change from what we said the last quarter or maybe 2 quarters that -- the Savanna revenue that's in the guide is less than 1% of total revenue. It's just not a big number.

It's been largely theoretical is another way of saying that.

Okay. And just to be clear, given we're still waiting for the EUA in the 510(k). Are the sales baked in for Savanna in the back half, just all from Europe?

It's a bit of mix. Obviously, the larger is European and ex-U.S. sales, but we do expect still sales in the fourth quarter in the United States.

The next question comes from the line of Casey Woodring with JPMorgan.

So maybe just piggybacking off of Jack's question. It looks like the implied back half EBITDA margin is something around 29% to 30%. Can you just walk us through the puts and takes there on what would get you to the low and the high end of the range that you gave today? And I know it's tough to run rate the second half margins given the annual strong fourth quarter. But maybe can you just talk about what the right jump-off point would look like for 2024 margins?

Yes, I can answer the last question first, Casey, on the -- and I assume you're talking about -- I'll speak to gross margins. As I said on the call, we are going to trend to the low end of the previously communicated range of low to mid-50s because of those reasons I mentioned earlier of the drill down of the Labs backlog creating more instrument revenue and then less COVID revenue than we originally thought. So we'll be at the low end.

I still think that the relevant long-term range for us is that low to mid-50s in -- I hate to give this answer, but it's a little too early to talk about '24 because there's so many moving variables for '24. So I'll just reiterate that we still believe that the appropriate gross margin range for us is that low to mid-50s. And what's going to move us within that range is going to be the pace of cost synergy achievement as well as the slope of the Savanna revenue ramp and how fast that goes up because as we've said many times, and we've talked about with you, the early launch of Savanna in the U.S., it's going to be a headwind to margins. And until we get -- we really get that high volume line up and running at some point in '24, that's when the margins start to get accretive.

And then as far as your first question, I think it's a similar answer on where we end up in the range of the EBITDA that we provided today, it's going to be -- it's going to hinge on how much more of the Labs backlog we can drill down and drive more Labs growth, what exactly does the respiratory season look like and where does it land in the range, and then how fast we can achieve cost synergies this year versus first half next year.

Got it. That's helpful. And then maybe just one follow-up. So it looks like the Labs business beat the Street by more than $30 million here in 2Q. But just looking at the nonrespiratory guide for the year, it looks like it's only going up to $5 million. Can you maybe just talk about some trends in the nonrespiratory business and in Labs for the back half of the year?

Yes. I think the 2 big variables here, no surprise, we talked about both these things already is China, the continued recovery there throughout the year and then the back -- the instrument back-order drill down and how fast that happens. And that creates a little bit of variability, I would say, Casey, that we're probably being a little bit prudent with the guide on the nonrespiratory because you're right, the midpoint went up $5 million.

Yes. And Casey, the other variable worth considering is the speed with which our field service engineers install the instruments and the speed with which the customer actually validates and gets the instrument and assays to what they call, test of record. That's the variable.

And so when you look at these installations at this point moving forward, the biggest gain from a revenue and margin perspective, obviously is going to incur in 2024. So that's kind of the variable that we're looking at. And I think we have been prudent, we certainly haven't ever called it.

There are no additional questions left at this time. I will now hand it back to Doug for closing remarks.

Thank you. I want to thank everybody for your great questions. In fact, I would just add, they were the right questions. And on behalf of our entire management team, I want to thank you for your continued support and interest in QuidelOrtho. Now this is a journey for sure, and we look forward to sharing our journey with you.

That concludes today's conference call. Thank you. You may now disconnect your lines.