The QuidelOrtho Second Quarter 2024 Financial Results Conference Call and Webcast. At this time, all participants are in a listen-only mode. 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 Juliet Cunningham, Vice President of Investor Relations. Thank you. Good afternoon, everyone, and thanks for joining the QuidelOrtho Second Quarter 2024 Financial Results conference call. With me today are Brian Blaser, President and Chief Executive Officer, and Joe Busky. We've posted a supplemental presentation on the investor relations page that will be referenced throughout this call. This conference call contains 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, future performance, and prospects, are forward-looking statements that are subject to certain risks, uncertainties, assumptions, and other factors. Actual results may vary materially from those expressed or implied 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 2023 fiscal year and subsequent reports filed with the SEC, including Risk Factor sections. Forward-looking statements are made as of today, July 31, 2024, and we assume no obligation to update any forward-looking statements except as required by law. In addition, today's call will include a 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 presentation, 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 given on a comparable constant currency basis. Now I'd like to turn the call over to our CEO, Brian Blaser. Thanks, Juliet. Good afternoon, everyone. I'm pleased to be here with you to discuss our second quarter results. Today, we reported second quarter revenue of $637,000,000 and Adjusted EBITDA of $90,000,000, which are in line with our expectations across our businesses and global geographies. Joe will cover our detailed quarterly financials later in this call, but I'd like to start by providing some observations from my nearly 90 days here at QuidelOrtho, as well as outline our key priorities as we move forward. During times of change, it's important to take a step back and assess where we are versus where we need to be. We began that process in earnest when I arrived in early May, and I can assure you, we are leaving no stone unturned. The leadership team and I have been reviewing every aspect of our business fundamentals and product portfolio to define our mission-critical near-term programs. We believe these programs will yield the highest returns in growth and profitability. After completing many of these reviews, it is clear to me that our value proposition is strong, our underlying business is stable, and we see a clear pathway to our Adjusted EBITDA margin expansion goal in the mid- to high-20% range over the next 2 to 3 years. Let me provide some context on why I have confidence that we can achieve this goal. First, QuidelOrtho's broad product portfolio spans the entire continuum of care, from hospital reference labs to near-patient point-of-care testing. In vitro diagnostics is a $48,000,000,000 industry, and QuidelOrtho directly serves segments of approximately $19,000,000,000, growing at mid-single digits. Our overarching mission is to improve patient outcomes in each care setting at every step of the healthcare journey, and our product portfolio is uniquely suited for both centralized and decentralized testing settings. We serve the patient from prevention to diagnosis and in treatment to monitoring. Few companies in our space have this breadth, and this is particularly exciting because of what it represents in terms of opportunity for growth and impact. Of course, most opportunities can present themselves initially as challenges, and QuidelOrtho has certainly had its share of these over the last several months. In my view, our challenges are not structural to our business. Rather, they are mainly internal cost, execution, and process issues, which are largely under our control. We are taking aggressive action targeted to resolve these issues as quickly as possible. I see many corollaries to similar challenges I previously faced in my years in the diagnostics industry and the journey we are on today. Over the last few months, I've had the opportunity to meet with and gather insights from many key customers, suppliers, employees, investors, which have helped us align our near-term priorities. From these conversations, it is clear that our highest priority remains delivering on our customer commitments at the highest levels of quality and compliance.... We must improve the way we run the business and our financial performance with a critical eye on consistency. Lastly, we must be steadfast in driving our product timelines and delivering on our portfolio commitments. Savanna is the perfect example. After multiple delays and disappointments, Savanna is admittedly late to the party. But despite being late, we see Savanna continuing to provide significant competitive advantages in the molecular point-of-care market, both today and well into the future. A successful U.S. launch of Savanna will offer incremental revenue and margin growth opportunities for us, and we are committed to getting it across the finish line. Building on the Savanna instrument and HSV panel approvals in the U.S., we expect to enter clinical trials on a respiratory panel later this year. And while we won't attempt to predict regulatory timelines, our goal is to be in the market with both the respiratory panel and the STI panel in 2025. In parallel, we are realigning our cost structure to support improved profitability and achieve durable long-term growth. We executed on our previously announced $100,000,000 in annualized cost savings initiatives, primarily through staffing reductions. We expect to realize savings of approximately $50,000,000 in the second half of this year and the remainder in the first half of 2025. We are not stopping there. We are in the early stages of improving our overall business efficiency with initiatives in procurement, supply chain, manufacturing, quality, and IT. These initiatives are expected to show incremental margin contribution in 2025 and 2026. I look forward to providing more details over the coming quarters as we move forward. Finally, let me reiterate that the underlying health and fundamentals of our business remain intact. We are focused on challenging every aspect of the business to improve our performance while balancing the needs to invest for future growth. Before I turn the call over to Joe, I'd like to thank our employees around the globe, without whom we could not meet our goals. I realize that periods of major change, including leadership changes and staffing reductions, are never easy. However, these changes are needed to become a stronger, more efficient company that can better serve our customers and shareholders, as well as be a great place for our employees to work and grow their careers. And so with that, I'll hand it over to Joe. Thanks, Brian. Before I get into the second quarter numbers, I'd like to share how great it's been for the entire management team to have Brian on board. He's led the portfolio review and deep dive into every aspect of our business to help identify areas to improve efficiency and productivity. I firmly believe the changes we are making now will enable us to become a significantly stronger company in the future. Now, let's begin with details of our second quarter results on slide 4 of the earnings presentation, which is posted on our IR website. Unless stated otherwise, all year-over-year revenue growth rates on today's call are provided on a comparable constant currency basis. During the second quarter of 2024, we performed in line with our expectations, and we continued to drive business momentum. As a reminder, the second quarter is typically the seasonally lowest revenue quarter of the year for our business. Total reported revenue of $637,000,000 was driven by solid performance across all geographies. Total recurring revenue, which we define as revenues from sales of our assays, reagents, consumables, and services, and excludes instrument sales, grew 5% in constant currency compared to the prior year period. This figure excludes COVID-19 and U.S. donor screening revenue, which is a business we are exiting. Our non-respiratory business, which includes labs, transfusion medicine, and portions of point of care, grew 2% in constant currency year-over-year. Our labs instrument revenue declined 15% due to higher instrument revenue in the prior period as we addressed the significant labs instrument backlog last year. We saw a continued strength, however, in labs' recurring revenue growth compared to the prior year period of 4%. After resolving the 2023 supply chain issues, Q2 2024 instrument revenue was in line with our prior normalized levels. Within our labs installed base, integrated and analyzers grew 7% and 16% respectively compared to the prior year period. And Immunohematology revenue grew 2% compared to the prior year period, in line with market growth and our expectations. The respiratory side of the business had a good quarter, with strong contribution from flu testing on the Sofia platform in the professional setting. In addition, our combo product exceeded 50% of our Q2 flu revenue in the U.S. once again. Excluding COVID, COVID-19 revenue, respiratory revenue grew 18% in Q2 2024. As a reminder, the COVID-19 public health emergency in the U.S. ended in May of 2023, and we continued to see strong sales throughout the second quarter of 2023. COVID-19 revenue was $19,000,000 in Q2 of this year, compared to $56 million in the prior year period. Year to date, COVID-19 revenue was approximately $70,000,000, which puts us nearly halfway to our full year forecast of $150,000,000. We continue to see good pull-through of respiratory consumables into the third quarter.... From a regional perspective, excluding COVID-19 revenue, we achieved the following Q2 constant currency growth rates. First, North America grew 2%, and recurring revenue, which excludes U.S. donor screening, grew 5%, driven by consumables and our combo product on the Sofia platform. EMEA grew 2%, which is driven by higher immuno, immunohematology reagents, largely offset by lower instrument revenue. China grew 4%, which is driven by labs growth of 8%, partially offset by timing factors and other lines of business. We continue to expect high single-digit growth in China for the full year. And finally, for rest of world, which includes Japan, Asia Pacific, and Latin America, we grew 3%. Moving down the P&L, slide 6 shows second quarter 2024 adjusted gross profit margin of 44.2% versus 45.6% in the prior year period. The hundred and forty basis point decrease was primarily driven by lower COVID-19 product sales, which are high margin contributors. Non-GAAP total operating expenses in the second quarter of 2024 compared to the prior year period were roughly flat in absolute dollars, but increased by 200 basis points as a percentage of revenue due to the higher COVID-19 revenue in the prior period. On a sequential basis, however, total operating expenses decreased by $13,000,000 in absolute dollars. We continue to expect continued margin improvement in the second half of 2024 from the cost savings actions we've taken. As Brian mentioned, we have executed $100 million in annualized cost savings measures in 2024, which primarily involves staffing reductions of approximately 7% of our global workforce compared to the end of 2023. We expect the benefits from these cost-saving measures to be realized in the second half of 2024 and the first half of 2025. As part of our ongoing business efficiency efforts, and as previously communicated, we reviewed our real estate footprint and are consolidating where it makes sense to do so. As a result, we expect to sell 2 of our facilities, one, Morristown, New Jersey, manufacturing and administrative building, which we expect to lease back, and our McKellar, San Diego, manufacturing facility. These facility sales, which we expect to occur by year-end, will generate cash and decrease ongoing operating costs. Due to our decision to sell these properties, we have moved these assets on our balance sheet to a line called assets held for sale. We have also recognized a non-cash accounting book loss of $57,000,000 related to the sale of these two properties. This loss is primarily driven by the purchase accounting step-up two years ago and the unfavorable San Diego commercial real estate market, driven by excess capacity. Adjusted EBITDA was $90,000,000, compared to $113,000,000 in the prior year period, and adjusted EBITDA margin was 14%, compared to 17% in the prior period, mainly due to the factors mentioned above. Adjusted diluted loss per share was $0.07, compared to annualized diluted EPS of $0.26 in the prior year period. Again, this year-over-year change was primarily due to the lower COVID-19 revenue in 2024. Our second quarter effective adjusted net income tax rate was 23%, which was consistent with the prior year and in line with our current year full year expectations. Turning now to the balance sheet on slide 7, we finished the quarter with $107,000,000 of cash. As expected, given the seasonality of the business and the timing of the benefit of the cost reductions, we drew $253,000,000 on our $800,000,000 revolver year to date. Recurring free cash flow was negative $66,000,000, as anticipated, given seasonally lower second quarter revenue. We expect cash flow generation to improve in the second half of 2024 as our cost-saving initiatives take, along with seasonally higher revenue expected in Q4. We continue to expect full year recurring free cash flow generation to be positive. During the second quarter of 2024, our consolidated leverage ratio was 3.4 times, including pro forma EBITDA adjustments as permitted and defined under our credit agreement for staffing reductions, business efficiencies, and integration costs. Based on our current expectations, we expect our consolidated leverage ratio to remain flat to current levels at year-end, including the pro forma EBITDA adjustments, compared to the 4.25 maximum leverage ratio specified in the amended credit agreement. I'd also like to now address a 10-K amendment that we will file later today. Ernst & Young, our independent auditor, underwent a regulatory inspection of their audit of QuidelOrtho. In response to this inspection, Ernst & Young determined that an additional critical audit matter should have been included in the EY auditor report filed with our 2023 10-K. Apart from the additional paragraphs, there were no changes to the unqualified opinion in the EY auditor report or to the reported financial statements. Lastly, as you know, with Brian coming on board in early May, we suspended our 2024 financial guidance. On our first quarter earnings call to give him an opportunity to assess the business and evaluate our plans for the rest of the year. Our Q2 performance was in line with our expectations, and this reinforces what we articulated in our February call. That is, that we continue to expect to be at or slightly below the low end of our previously communicated 2024 financial guidance ranges for revenue, Adjusted EBITDA, and adjusted EPS. Recall that this view factored in removing U.S. Savanna revenue and lowering our COVID-19 revenue forecast to $150,000,000 for the full year. In addition, our first half 2024 performance reinforces our belief that going into 2025, our business is a solid mid-single-digit growth company, excluding COVID-19 and U.S. donor screening revenue. Over time, however, with the expected addition of Savanna respiratory and CLIA waiver regulatory approvals on the U.S., as well as anticipated menu expansion, we believe we can achieve incremental revenue growth. As Brian said, we expect to provide additional color on our margin improvement plans and milestones in the coming quarters. I would now like to ask the operator to please open up the call for questions. Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two to exit the queue. In the interest of taking as many of your questions as possible, please limit yourself to one question each. And finally, when preparing to ask your question, please ensure that your phone is unmuted locally. And our first question today is from the line of Jack Meehan of Nephron Research. Please go ahead. Your line is open. Thank you. Good afternoon, everyone. Solid results here. For Brian, I wanted to start, you talked about no stone unturned when it comes to the margin initiatives, flagged a bunch of different opportunities. Was wondering, you know, as you look at them relative to the $100,000,000, in terms of the staffing reduction, do you think collectively some of these other opportunities can be in that zip code? Or just any relative framing for, you know, the opportunities beyond the initial cost targets you've laid out. Yeah. Hi, Jack. Thanks for the question. You know, as I, as I said, in my prepared remarks, we've, we've achieved $100,000,000 in savings. We're not stopping there. You know, most of that initial round of savings was from staffing reductions. You know, we took about a 7% staffing reduction. We're going to see somewhere in the order of 10-12 hitting the bottom line, just because of the mix of the higher-level positions there. But, you know, we're in terms of leaving no stone unturned, we're very aggressively going after additional savings in operations, supply chain, procurement, IT, really every corner of the company. You know, I think where we're at is we're going to continue to provide updates on the savings position as we go through the years in the coming quarters, but it is significant. Yeah, Jack, I would add on to that, just to reiterate what Brian said in the prepared remarks. You know, we do believe that we will get this company to mid- to high-20s adjusted EBITDA margin over the next 2 to 3 years. So, you know, you can do the math on that, and we'll obviously provide more updates as we move through the next several quarters. Thank you. Our next question today is from the line of Casey Woodring of J.P. Morgan. Please go ahead. Your line is now open. Great. Thank you for taking my questions. I just wanted to walk through the cash flow in the quarter, the negative $66,000,000 in free cash. Maybe if you could just provide some guideposts on how we should think about that number for the rest of the year. I think you said you expect positive free cash in the quarter, but, you know, anything to add to that? And then also just on leverage, can you just elaborate on the draw in the quarter? You brought that up. We'll get to $2,600,000,000 versus last quarter. So confidence in just maintaining the leverage ratio through the rest of the year. Yeah. Hey, Casey, it's Joe. So, we had always expected that the recurring free cash flow for Q2 would be negative, primarily based on the fact that it is seasonally our lowest revenue quarter of the year, typically. And the fact that the cost savings initiatives that we have executed will largely impact the second half of the year. So the draw on the revolver and the -$66,000,000 recurring free cash flow is honestly in line with our expectations and frankly, a little bit better because we did perform well in the P&L. CapEx was right where we expected it to be, no surprises there, and I would say the same with operating cash flow and working capital, you know, no surprises there. We did pay down $52,000,000 on the debt as provided in the credit agreement. So again, that's in line, no, no surprise there. We do expect in the second half that we will generate recurring free cash flow. I will say it's probably a little more heavily weighted into Q4, again, primarily related to Q4 being our seasonally heaviest quarter for revenue, typically. And I do expect us to bring down the draw. ... amount drawn on that revolver quite a bit by year-end. And I do expect that the leverage ratio will be in a relatively consistent place to where we are right now under the credit agreement, with, again, plenty of cushion versus that 4.25 leverage ratio covenant in the credit agreement. Thank you. Our next question today is from the line of Andrew Brackmann of William Blair. Please go ahead, your line's open. Hi, everyone. This is Maggie on for Andrew today. Thanks for taking our questions. Maybe just to expand on the cost savings initiatives a little bit that you've talked about in the past. I think an area that you were taking a look at was R&D. So recognize that it, it still might be a little bit early here to give details on specifics, but at a high level, can you talk about the specific criteria you're going to use when looking at the spend there, and just any areas of prioritization for the team? Thanks. Yeah. So maybe I'll answer that question a little more broadly. Really what we've done is take the last couple of months that I've come on board to focus the business down to really four critical priorities. The first is, you know, we have to operate this business to achieve the very highest level of customer satisfaction and efficiency if possible. So that's job one. Second is, as we've discussed, going after this cost structure to get our cost structure in line with competitive benchmarks. And then, you know, as you're discussing, we've been focusing our R&D organization down on the very critical few programs that we need to deliver and execute on, really as a matter of creating focus and getting the job done. And those have been in the areas of, you know, Savanna, making sure that we can get that across the finish line, menu expansion for our point-of-care and our lab products, and then a number of life cycle management tasks that are critical to maintaining our on-market products at a very high level of quality. And then the fourth thing is refreshing our commercial growth strategies, you know, both in the U.S. and outside the U.S., and so working with the commercial team there. So every area of the business, we focus down, including our R&D group, which has meant that we have taken some resource out of that area of the business. But, I think we've really doubled down in the areas that are the most important for us, you know, in that segment of our business. And so if you extend the line and the SG&A line, and again, it'll be more heavily weighted in the second half. We got some benefit in Q2, small, most of be in the second half and first half, but it will be hitting several of those line items on the finance- on the P&L. Thank you. Our next question today is from the line of Patrick Donnelly of Citi. Patrick, please go ahead. Your line is open. Hey, guys. Thanks for taking the questions. Maybe another one, Joe, on the margin side. Apologize for the focus here. Just when you think about the path to that mid- to high-20% margins, is there a certain, you know, level of revenue that you need, particularly on the respiratory side, that you guys view? Obviously, the incremental, decrementals there are pretty important. How do you think about just the top line profile to reach that? And again, if revenue is a little bit slower, maybe just talk about the key levers that you have there to lean on to get the margin story going. Thank you, guys. Hey, Patrick. Yeah, thanks for the question. So, you know, every margin improvement story is typically a combination of cost reductions as well as revenue growth. It's usually not done with one and only one. It is gonna be a combination. So, you know, we are going to continue to identify efficiencies and productivity. As we've said several times on the call today, we're not done. We're gonna instill a continuous improvement culture here, led by Brian, to find those efficiencies and productivities. But it's also about the revenue, to your point. And, as I said in the scripted remarks, you know, we are a mid-single digit top line growth company now with the products we have. We certainly have aspirations to be a higher growth company, and, you know, we believe that Savanna, that once we've got the panel filled out and approved in the U.S., and we have a full launch, we believe that we can add to that mid-single-digit growth profile. That will certainly help us move closer to that mid- to high-20 Adjusted EBITDA margin profile, for sure. Thank you. Our next question today is from the line of Andrew Cooper of Raymond James. Please go ahead. Your line is open. Thanks for the time. Maybe just first, you know, Brian, now that you've dug a little bit deeper on Savanna and some of the moving parts there, would love your thoughts on sort of the menu trajectory there, and then how you think about RVP4 specifically relative to, you know, maybe the larger panel, and how you think about the menu and building a differentiated set of assays there in the molecular space? ... Yeah, sure, Andrew, thank you for the question. And, you know, as I said, Savanna, you know, we know we're late into the party here with the product, but, you know, as I've looked at this product, I truly believe it's got a compelling value proposition. I think, now and well into the, you know, our team is working tirelessly to get this product done and onto the market. And when you look at this product, you've got to... In the market, you've really got to have the right balance of workflow, turnaround time, the number of targets, you know, as well as the cost profile. And, you know, Savanna, we think that it offers advantages over many of the systems that are on the market, and will be on the market, in the future there. You know, if you look at workflow, you know, it's truly a sample in, results out platform, turnaround time, less than 30 minutes. You know, the menu, and I'll discuss that more, but I think the menu, when approved, you know, will be a real feature of the platform. And importantly, the cost of the test is positioned well below our competitors. I think, and that advantage, I think, will hold for some time. You know, as you mentioned, we're on the market now with the herpes and shingles markers that were already approved. We have the RVP4 assay that is, it will be entering trials in the fall. We hope to be in the market in 2025 with that. Following that, we are already underway in clinicals with the STI panel, should get, again, without predicting regulatory timelines in 2025. And then following that, we have a GI panel for both a bacterial and viral vectors and also parasites. So, you know, we've got a, we've got a nice string of content coming. We also—I didn't mention, we have syphilis underway for approval there as well. So a nice group of content on the platform, I think, you know, competitive differentiation. And although, you know, it certainly had its challenges, we're very near the finish line here and, you know, truly focused on getting across the finish line. Thank you. Our next question comes from the line of Conor McNamara of RBC. Please go ahead. Your line is open. Hey, thanks for the time. Just quickly on guidance, do you plan on reinstating guidance for 2024? And if so, is that going to be around an event? No, I don't think, Conor, we've said previously, and we can reiterate, first of all, that - and we said this in the prepared remarks, that we believe that this was a good quarter for us. Nothing happened in this quarter that would meaningfully change what we said on the last earnings call, which was we think we are still at or slightly below the low end of the guidance provided back in February for the full year. We are still in a suspended guidance mode, though, just to be clear, to give Brian time to assess the business. And it's most likely that we will unsuspend guidance on the Q3 earnings call. Thank you. With no further questions in the queue at this time, this will conclude the QuidelOrtho second quarter 2024 Financial Results Conference Call and Webcast. Thank you all for joining. You may now disconnect your lines.