Welcome to the QuidelOrtho Second Quarter 2023 Financial Results Conference Call and Webcast. At this time, all participant lines are in a listen-only mode. For those of you participating on the conference call, there will be an opportunity for your questions at the end of today's prepared remarks. 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 statements. 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 a more detailed discussion of forward-looking statements and the risks and uncertainties of such statements. We cannot assure you that the forward-looking statements we make or those implied by our statements will be realized. Furthermore, such forward-looking statements represent management's judgment and expectations as of today. Except as required by law, we undertake no obligation to update any forward-looking statements or any time-sensitive information to reflect future events, developments, 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 for the second quarter of 2023, we will be discussing supplemental revenue and other adjusted operating results as if Quidel and Ortho had been combined for the applicable periods. We will refer to this information as our supplemental combined information. Certain supplemental combined 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 three 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 comparable constant currency basis. Now, I'd like to turn the call over to Doug Bryant, QuidelOrtho's President and CEO. Doug?

Thanks, Bryan, and welcome, everybody, and thanks for joining our call. We 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 non-respiratory revenue was up 4% on a supplemental combined basis. Demand for diagnostics across the healthcare continuum remained strong and our Labs business delivered high-single-digit growth. Our team was steadfast in executing our key growth drivers this quarter. Our Labs business backlog approached and normalized the levels that 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) for the instrument in both RVP4 and HSV VZV lesion panels. Drilling down into the results from our four business units. First, our Labs business delivered 9% growth in non-respiratory revenue, with growth across all major geographic regions. The notable global strength in clinical chemistry was driven by expected utilization levels for instruments 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 reduce our instruments 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 tests, our overall COVID-19 business faced a challenging comparable on a year-over-year basis. 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 non-respiratory revenue, it was down 4% year-over-year due to quarterly variability in 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 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, the Middle East, and Africa and triple-digit year-to-date placement growth in China, albeit off a small base. Moreover, we saw a healthy performance from our Triage business, which was up 7% compared to last year, with particular strength from China, Asia Pacific, and Latin America, which is evidence of the cross-selling revenue synergies that we 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. Lastly, our Molecular Diagnostics business declined as expected 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 EUA, 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 hospitals 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, Mycoplasma genitalium, and Trichomonas vaginalis, plus two gastrointestinal panels, one bacterial and/or viral and a second parasitic panel, a pharyngitis panel that tests for four 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 timeframe that can actually 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 focuses on long-term growth, we continuously monitor the numerous converging trends across the healthcare sector, which we believe will strengthen our position in the diagnostics industry, including the aging population, the surge of chronic conditions and diseases, as well as emerging infectious diseases. Additionally, the diagnostic industry can play an important role in providing greater access to care and limiting the escalating costs of healthcare. 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 on 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 one-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 two 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 healthcare 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 three years, compared to our prior target of $90 million. 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, improved cash flow, and offering 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?

Okay. 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 referenced 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 seven, the demand environment continues to be strong and we delivered another strong quarter on the top line. Non-respiratory 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, non-respiratory 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 decline in COVID-related revenue following the end of the public health emergency in May, partially offset by 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 diagnostic space have been saying 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 revenues declined 2%, EMEA grew 4%, China grew 26%, and our other region, including Latin America, Japan, and other Asia-Pac markets grew 9%. In North America, our largest geography by revenue, we delivered solid revenue in the Labs business, but non-respiratory revenue declined due to the previously mentioned weakness in Donor Screening. The Labs strength included both recurring revenues and instrument leading 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 non-respiratory revenue growth was driven by Labs and immunohematology. The Labs 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, non-respiratory 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 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 is close to double our 2022 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 non-respiratory 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. Turning to slide eight, 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, which was $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 reduction in variable expenses. We expect the 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 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 the $3 million higher 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. 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 the 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 nine, in the second quarter on a GAAP basis, cash outflow from operating activities was $31 million, which 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 pay down 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 balanced and opportunistic approach to share repurchases while also continuing to prioritize our debt pay down going forward. We ended the quarter with cash, cash equivalents, and marketable securities of $248 million and total debt of $2.5 billion. We closed with 2.8 times net debt to EBITDA on a supplemental combined basis, and as COVID-related revenue has 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 from where we are now. The leverage is a top priority with our goal to be at or above two times 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 non-respiratory 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 testing has picked up share of the professional market from competitive Molecular systems. Due to these two 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 non-respiratory revenue guidance to the high end of our prior guide, while lowering our respiratory guidance. Non-respiratory revenue is expected to grow to 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. 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 the 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 down of the Labs instrument open orders. Adjusted EBITDA margin is expected to be 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. 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 non-respiratory revenue. As previously discussed and consistent with prior quarters, the first and 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 50% to 65% of adjusted EBITDA, which translates into more than 100% of adjusted net income and a full-year diluted weighted average share count of $67.2 million. 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, solid financial results driven by our Labs business unit and Triage. We raised non-respiratory 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 three 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, 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.

We will now begin the Q&A session. The first question comes from Patrick Donnelly with Citi. Please proceed.

Hi there. 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? Did you see any changes in demand as the quarter went on, and is double-digit ex-COVID growth still expected? 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-digit 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. And supportive, but we anticipate it 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 coming launch. And on the cartridge side, as I mentioned, we just finished standing up our second low-volume manufacturing line for the cartridge for both clinical trials and launches, and that's going well too. So, I think we're in really, really good shape from an ops supply chain and launch perspective.

Got it. Thank you.

Thank you. The next question comes from the line of Andrew Cooper with Raymond James. Please proceed.

Hi, everyone. Thanks for the questions. Maybe first, I just want to talk a little bit adjusted EBITDA here in the guide. The margins moving a little bit lower, I think the conversations we’ve had about COVID and respiratory prior was that it was really working closer to the consolidated average. You talked about some expense offset as well. But we do see that margin going lower. So 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 offset helping, helping drop down, limit the drop down a little bit more.

Yeah. Hi, Andrew, it's Joe. Yes, so there are two big changes to the guide on the revenue side. We are taking the non-respiratory 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 that instrument backlog. But in the quarter and then early in this Q3, and like a lot of other diagnostic companies that have already reported, we are seeing some softness on the COVID revenue side. And so, the areas where we're seeing that softness on COVID are particularly on the Molecular side where that testing is moving to 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. There is definitely a margin impact to those two 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 as we drive more instrument revenue, which has lower margins compared to the recurring reagent revenue. 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, there are still pretty strong margins relative to the rest of the product mix. So by pulling down that COVID revenue in the second half, it is going to have an impact. If you work through the math and look at 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 on the bottom line.

That’s great to hear. I have one more question regarding the Triage business and its various aspects in the U.S., especially considering the recent recall. It seems like the quarter was quite strong overall. Could you help us understand the implications of these factors for the current quarter and beyond? Additionally, what key drivers might be contributing to growth through 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 units that were affected. The financial impact is more than offset by the growth that we're seeing, particularly ex-U.S. of the Triage business.

Yes. By the way, Andrew, Triage did have a nice quarter, up high-single-digit in the quarter. We are starting to see those nice cross-selling opportunities, particularly outside the U.S., which is driving that growth and it's going to drive a nice full-year growth in the Triage business.

Okay. I'll stop there. Thank you.

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

Okay. Great. Good afternoon, everyone. 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 of another COVID variant potentially floating around. We're seeing positivity spiking. So, what are you hearing out there in the channel? And then just remind us how much COVID and flu inventories ultimately is still sitting out there?

On flu, this is the same answer that I've been giving for the last 14 years. We see a correlation between the Southern Hemisphere and Northern Hemisphere. When I last saw that, we had looked at the last 20 or 25 years or something, and that correlation is pretty high, but it's not necessarily causing effect. We are hearing from the government some concern about what's going to happen in the upcoming respiratory season. I believe that we’ll see an influenza season this year that is more traditional in size, I just can’t predict how much of that is going to occur in the fourth quarter and how much may remain for the first quarter. Our sales have been reasonable because most of the inventory that would have been shipped to distribution is the product that gets shipped into the professional segment. I don't believe we are sitting with a lot of inventory out there right at the moment.

Yes, I'm looking at it. Distributor inventory is down quite a bit from the prior year, and it's also down from Q1. We are looking at pretty low levels of distributor inventory of SARS in the U.S.

Right. When we see their out sales report, we know that they shipped. We suspect that what will happen is, as is typical, during the respiratory season that, 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 the moment. That is true for both COVID and 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?

I think it’s a bit of foreshadowing for what we might expect. The competitors that we saw based on European feedback might be vulnerable. We're indeed those same two competitors. We've done quite well there. 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, that's a product. It's not a huge market, but we already do quite well in it.

Alright. Appreciate the update. Thanks.

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

Thank you. Good afternoon. 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 4Q needs to be over 300 million or so. Is that the magnitude, the step up you're looking for? And just what drives that?

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

The qualitative. It is a pretty big step up in the first quarter.

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. 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're going to have quite a bit of nice step down in OpEx year-over-year. We're going to have a decent amount of cost synergies starting to hit the P&L.

Okay. And then another one on Savanna. It's good to see the submissions are in. When do you pencil in now an approval for 510k? 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 further. So, I think the first part of your question was, asking me to forecast when we probably would get approval. I can'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.

Yeah. On the magnitude, Jack, there's no change from what we said the last quarter or maybe two quarters about the Savanna revenue in the guide. It's less than 1% of total revenue. It's just not a big number.

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

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

Okay. Excellent. Thank you.

Thank you. The next question comes from the line of Casey Woodring with JPMorgan. Please proceed.

Hi. Thanks for taking my question. So maybe just picking up piggybacking off of Jack's question. 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 end 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 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 regarding drilling down the Labs backlog creating more instrument revenue, and then less COVID revenue than we originally thought. I'm still thinking that the relevant long-term range for us is that low to mid-50s. I hate to give this answer, but it's a little too early to talk 2024 because there are so many moving variables for 2024. So I'll just reiterate that we still believe that the appropriate gross margin range for us is that low to mid-50s. 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, the early launch of Savanna in the U.S. is going to be a headwind to margins. Until we really get that high volume line up and running, at some point in 2024, that's when the margins will 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 EBITDA that we provided today. 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. It looks like the Labs business beat the street by more than $30 million here in Q2. But just looking at the non-respiratory guide for the year, it looks like it's only going up by $5 million. Can you maybe just talk about some trends in the non-respiratory business and in Labs for the back half of the year? Thank you.

Yes. I think the two big variables here, no surprise. We've talked about both these things already is China and the continued recovery there throughout the year. Then instrument backlog drill down and how fast that happens. I wouldn't say we are probably being a little bit prudent with the guide on the non-respiratory. You're right, the midpoint is 105 million.

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

Thank you.

Thank you. There are no additional questions 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 that they were the right questions. On behalf of our entire management team, I want to thank you for your continued support and interest in QuidelOrtho. 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 line.