Welcome to Ortho Clinical Diagnostics fourth quarter and fiscal year 2021 earnings conference call and webcast. At this time, all participant lines are in 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 comments. Please note this conference is being recorded. An audio replay of the conference call will be available on the company's website within a few hours after this call. I would now like to turn the call over to Bryan Ingram, Vice President of Investor Relations. Bryan. Thank you, operator. Good afternoon, everyone, and welcome to the Ortho Clinical Diagnostics fourth quarter and fiscal year 2021 earnings conference call. With me today to discuss our financial results are Chris Smith, Ortho's Chairman and CEO, and Joe Busky, Ortho's Chief Financial Officer. Mike Iskra, our EVP of Commercial Excellence and Strategy, will join us for the Q&A portion of the call. This conference call is being simultaneously webcast on the investor section of our website, and a version of today's presentation can be downloaded there. Before I begin, I will cover our safe harbor statement. Some of the statements we will make during today's call about the company's future expectations, plans, and prospects constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, which provides a safe harbor from such statements. Our use of forward-looking statements is subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from our current expectations. These risks and uncertainties include, but are not limited to, those factors identified on slide two of today's presentation and our other filings 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 will be realized. We undertake no obligation to update any forward-looking statement to reflect future events, developments, or changed circumstances, or for any other reason, except as required by law. Also, during today's call, there will be a discussion of some items that do not conform to U.S. Generally Accepted Accounting Principles, or GAAP. Please see slide 3 for a list of these non-GAAP measures, including but not limited to core revenue, constant currency, EBITDA, adjusted EBITDA, adjusted free cash flow, and adjusted diluted earnings per share. 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 in the investor section of the Ortho website. In addition, on today's call, we will refer to our core and our non-core business. Our clinical laboratories, also known as clinical labs and transfusion medicine businesses, represent our core business. Our non-core business is comprised of our contract manufacturing and licensing revenue. 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 Chris Smith, Ortho's Chairman and CEO. Chris? Thanks, Bryan, and good afternoon, everyone, and thanks for joining us for the call today. It's great to be with you and to be able to share the fourth quarter results as well as the full year results for 2021. We're gonna start on slide 4, and I always love to start with this slide because it's the mission statement, it's our credo, because every test is a life. This is why we do what we do every single day, and we embrace this credo as a whole leadership team and our company worldwide as we go to work every single day. Just to give you an example, today we'll help over 800,000 patients around the world. I just wanna thank our teammates in particular and all our professional customers out there that we partner with. With that, let's get into the fourth quarter results, which starts on slide 5. First off, we have broad diagnostics portfolio, so COVID assays have not been a meaningful factor on our business throughout the pandemic as it has been for some companies. That said, we only generated $68 million of COVID assay revenue in 2021. Consequently, COVID was approximately 4 percentage point headwind on the growth in the fourth quarter and 1% headwind for the full year results. Given that, today we will largely focus on the underlying base business, which excludes COVID assay revenue. Core revenue excluding COVID assay revenue grew 8% with particular strength in our clinical labs business. Including a 4% headwind from the COVID test, our core revenue grew 4% in constant currency to $519 million. In addition to the underlying strength of our revenue, adjusted EBITDA margins of 24.6% is down about 130 basis points, reflecting an estimated 230 basis points of headwind from the decline of this high-margin COVID assay test revenue compared to prior year. Looking at the full results on slide 6, core revenue excluding the COVID assay revenue grew 16% with strength in both our clinical lab and our transfusion medicine businesses. Including a 1 percentage point headwind from COVID tests for the year, our core revenue grew 15% in constant currency to just over $2 billion, a huge milestone for the company. Adjusted EBITDA grew 20% to $548 million, representing margin expansion of 100 basis points to 26.8%, despite an approximately 60 basis points of headwind from the decline in this high-margin COVID assay revenue. In summary, we concluded the year with another excellent quarter demonstrating the strength and stability of our recurring revenue business model in our base business. This continued revenue momentum in our business is a clear result of the strong execution by our global commercial teammates and their dedication to customers and patients they serve. We talk about the importance of lifetime customer value and the long-term relationships that we build with our customers. We believe this is resonating in the marketplace and continues to be reflected in our results. Continuing with our fourth quarter performance review, let's look more closely at the core geographies, excluding COVID assay revenue on slide 8. The Americas, our largest geography, grew 8%, with the U.S., commercial growth, excluding COVID assays, being up 7%. This was driven by strong clinical lab integrated system placements, menu expansion, and recurring revenue pull-through, as well as our CTS partnership in our transfusion medicine business. In EMEA, the growth excluding COVID was 6%, driven by strength across our clinical lab business, with particular strength in Eastern Europe and Middle East in the fourth quarter. Greater China grew 8% with strength in recurring revenues, including both immunoassay, clinical chemistry, and immunohematology consumables. However, due to timing of distributor instrument placements, we had several instrument orders that did not ship in the fourth quarter. I'll expand on this more broadly in a moment. We believe our install base growth in China of 6% and our integrated system growth of 14% are very good leading indicators for future growth. In addition, during the fourth quarter, our immunoassay business grew over 30%. We're pleased with the growth excluding COVID assay in both our core developed markets as well as our emerging markets, which grew 6% and 12%, respectively. Growth was particularly strong in India, Latin America, and the Middle East. Looking at our core geographies for the full year, excluding COVID revenue, the Americas, our largest geography, grew 18%, with the U.S., up 16%. EMEA grew 10%, which is a significant result given how that business has continued to perform incredibly well over the last 12 months, with Western Europe up 7%. Greater China grew 12%, and the other regions, which include Japan and Asia Pacific, were up 17%. Really strong performance from all regions. Next, on slide 10, we remain steadfastly focused on executing against our three strategic priorities to drive profitable growth and shareholder value. These priorities are product innovation, global commercial excellence, and operational efficiency. We continue to make progress against all these areas in the fourth quarter. Let me cover some of the highlights. Beginning with product innovation, as we discussed last quarter, we received emergency use authorization in the U.S., for our quantitative COVID spike antibody assay. We're seeing emerging adoption for testing convalescent plasma, which has created an incremental growth opportunity beginning this year. Though we still expect COVID-related revenue to be a headwind on our 2022 revenue growth, we believe this new growth avenue is meaningful. Longer term, there are multiple studies underway to advance our understanding of COVID immunity, including immunity from infection, immunity from vaccination, as well as immunity from different variants. Notably, we're collaborating with academics and government agencies to develop studies to enable broader clinical utility of our quant assay. Turning to our second priority, global commercial excellence, we continue the implementation of our commercial excellence program and our growth strategy, which is driven by the penetration in the market with our integrated analyzer systems and the pull-through of this recurring revenue. Our integrated installed base continued to grow double digits through 2021, and our recurring revenues ended the year of 93% of our total revenue. Finally, our third priority, operational efficiencies. Thanks to the strong revenue performance and the execution by our entire team throughout 2021, we further reduced our net leverage in the fourth quarter to 3.6%, and this is from 7.9% at the time of our IPO last February, an incredible result. Lastly, I'd like to comment on industry-wide supply chain disruption. Global supply chain challenges, combined with the strength of our business over the last several quarters, are putting increased demand on our supply chain. Like most diagnostic companies, these challenges include shortages of microchips, resins, and certain plastics, as well as freight and logistics costs and pressure on pricing. Our management team is working diligently on adding additional suppliers, managing the ongoing flow of raw materials and the distribution challenges, including spot rates. Though our financial performance has remained strong, we are managing instrument allocation at a regional level, and this has pushed out delivery of our instruments to some customers. We closed the fourth quarter with our install base growth of 3%. However, if we had shipped all the open orders on instruments, it would have been 5%. Turning to slide 11, I'm really excited to talk to you about the proposed transaction with Quidel as announced on December twenty-third. The HSR waiting period recently expired, and other regulatory approvals and closing conditions are progressing, and we believe that the transaction remains on track to hold our shareholder votes and close in the first half of 2022. As we said at the time of the announcement, we believe bringing Quidel and Ortho together creates a leading global diagnostics company with the ability to offer long-term value to patients, customers, teammates, shareholders, and the communities in which they serve. While the transaction is structured as an acquisition of Ortho, these are two similar-sized companies, and the leadership and the employee base will be a mix of both companies. Strategically, we're coming together more as a merger of equals, structured in a way that enhances growth. Since the announcement, we've spent a lot of time talking with key stakeholders and are confident as ever this exciting combination represents the best path forward for Ortho and its shareholders. I'd like to take this opportunity to share some insights from the combination of the two companies. first on the revenue visibility of the combined company, as you know, Ortho has a very stable and predictable business model driven by recurring revenues of 93%, usually 5- to 7-year contracts, and our lifetime customer value that represents our 98%+ revenue retention rates. As you know, Quidel currently realizes a significant amount of their revenue in the U.S. Quidel's business has historically been heavily tied to the U.S. seasonal flu and more recently to the COVID trends, even as it's added new menu and test platforms such as their Savanna molecular platform that would drive a new leg of diversified growth. Like many experts and analysts are predicting, we expect COVID to be endemic and be managed much like seasonal flu going forward. While the need for COVID testing will go away, we are projecting a more conservative view of COVID testing volumes, and we're anticipating these volumes will stabilize at a level that is meaningfully lower than where we are today. When the volumes do stabilize, we expect testing to consist mostly of respiratory panels that includes COVID and flu. We also believe that the global diversification of Quidel's revenue stream through the global reach of Ortho's commercial team and the penetration of hospital segment with the new Savanna molecular product will provide further visibility and stability in the combined company's revenues. Second, on the growth potential. We believe shareholder value will be enhanced by the combination of Quidel and Ortho, establishing a diagnostic company with enhanced competitive position, expanded global presence, and robust product offering, serving a wide range of customers and markets with a total addressable market of approximately $50 billion. We believe the company's highly complementary world-class products and service offering will provide opportunities to capture significant growth globally through Ortho's commercial footprint in 130 countries and approximately 2,300 field teammates, while enhancing cross-selling opportunities across a diversified customer and channel mix. Let's look at Quidel's new Savanna rapid multiplex molecular platform, for example. This is a differentiated product that is easy to use, one of the fastest times to results, has a small laboratory footprint, has significant cost advantages compared to competitors, and has a range across point of care and clinical labs, particularly in the mid to high-throughput labs that are already Ortho's sweet spot where our commercialization program has driven ongoing growth. By using our global regulatory expertise and putting that platform in the hands of our global commercial team and supporting those placements with our broad service engineers, we believe we will accelerate the launch of this compelling rapid testing platform in both hospitals and point of care call points. The transaction is expected to generate substantial synergies on both top and bottom lines. We estimate that the combined company will realize $90 million run rate cost-related synergies, excluding one-time costs, by the end of year 3, driven primarily from operational efficiencies, supply chain optimization, and shared administrative functions, including public company costs. In addition, given Ortho's enhanced global commercial reach and expansive product portfolio, Quidel expects to drive cross-selling synergies in excess of $100 million by the end of fiscal 2025 and a meaningful adjustment to EBITDA. Third, the combined company will have broad product portfolio and a pipeline which is best in class from a technology perspective. Ortho is well-positioned in the clinical lab and transfusion medicine markets with our dry slide technology. Quidel is a leader in point of care and was very successful during the COVID pandemic, delivering significant growth in their installed base of the Sofia instruments. Their QuickVue COVID over-the-counter test is sold in drugstores all across the country, is making a significant impact as we treat this pandemic. I just discussed their Savanna rapid multiplex molecular platform. The combination of these portfolios position us to be a provider of choice for both centralized and decentralized labs and testing, looking for clinical chemistry, immunoassays, and molecular solutions. Fourth, we're making great progress on the integration planning. I've been able to spend a lot of time with Doug, Quidel's President and CEO, over the last 8 months, and he has been in this diagnostic industry for 40 years and knows the space incredibly well. In addition to Doug, other key executives of the combined organization have already been identified, including Ortho's CFO, Joe Busky, and Mike Iskra, who will be the chief commercial officer in the new business. The integration process will be complex. However, we're purposely delineating roles between focus group driving integration planning and the majority of our business leaders and colleagues who will stay focused on the execution of our standalone strategies. We have engaged a well-known third-party consultant to support pre-closing integration planning, and we'll be tapping into the expertise of employees from both Quidel and Ortho to help plan and execute the integration through functional integration teams. There is little integration required of the commercial organizations, given that the U.S., focus of Quidel and the global focus of Ortho, which should minimize our commercial disruption, especially to our customers. There currently aren't areas with known integration complexity like manufacturing, consolidation or closing plants, et cetera. While we're currently operating as completely separate organizations, we feel confident in the clear integration path that these two complementary companies have, and we will move swiftly to execute the integration once we have closed the transaction. I look forward to continuing to advise the executive team as a member of the board of directors of the new company, as well as being a special advisor to Doug and the board. Lastly, the combination of the two companies creates a great business going forward. It'll have 9%-11% growth profile ex-COVID, greater than 30% EBITDA margins and more than $700 million in annual cash flow generation, and a very strong balance sheet with pro forma net debt adjusted EBITDA of about 2x at closing, after accounting and financing for the transaction. In looking at the largest IVD companies in the world, this combination of these two companies make us one of the most competitive financially strong companies in the industry. As you can tell, we're really excited about it. With that, I'll turn it over to Joe to further discuss some of our financial results. Joe? Okay. Thanks, Chris, and good afternoon to everyone on the call today. I'll begin with a bit more detail on our operating results for the quarter, starting with a breakdown of our fourth quarter revenues on slide 13. In the fourth quarter, we recorded total revenue of $521 million, which is an increase of 2% in constant currency. Currency translation decreased sales growth by 80 basis points, resulting in approximately 1% sales growth on a reported basis. Core revenue, which excludes contract manufacturing and other licensing revenue, increased 4% on a constant currency basis to $519 million. Excluding a 370 basis point headwind from the COVID assay sales, core revenue growth was up 8%, primarily driven by the strong recurring revenue pull-through on the instruments we placed over the last couple of years across our geographies in both clinical labs and TM segments. Now turning to our Q4 performance by line of business. Clinical labs revenue grew 5% in the quarter, largely driven by strength in both clinical chemistry and immunoassays. In the TM segment, we grew 4%, driven by strength in the U.S., and China. As a reminder, the fourth quarter growth also benefited from our new partnership with CTS, which was a new customer in 2021. The non-core revenue in the fourth quarter actually declined to two million from sixteen million a year ago due to the completion of certain contract manufacturing arrangements on a collaboration agreement in fourth quarter of 2020. Looking ahead, we expect non-core revenue to be in the $3 million-$5 million per quarter range. Turning to Q4 core performance by geography. On a constant currency basis, Americas revenue increased 2%, with a 2% increase in the U.S. Excluding COVID assay revenue, however, Americas was up 8%. EMEA grew 3%, with 17% growth in the Middle East, Africa emerging market. Western Europe was about flat year over year, excluding COVID assay revenue. Greater China grew 8%, and other segment, which includes Japan and other Asia Pacific markets, grew 10%. Now looking at our Q4 revenue by category. Recurring revenue, which includes reagents, service, and other consumables, grew 6% driven by strength in both clinical chemistry and immunoassays, as well as the donor screening market. Instrument revenue actually declined 19% in the quarter due to the instrument supply chain challenges Chris mentioned earlier. Turning to slide 14, for our full year 2021 revenue results. We recorded revenue of $2.043 billion, an increase of 14% in constant currency. Currency translation increased sales growth by 150 basis points, resulting in 16% sales growth on a reported basis. Core revenue increased 15% on a constant currency basis to just over $2 billion. In excluding a 110 basis point headwind from COVID assay sales, core revenue growth was up 16%. Turning to the full year performance by line of business. Clinical Labs revenue grew 15% and transfusion medicine grew 13%. Non-core revenue in the full year declined to $28 million from $31 million a year ago. Looking at full year core performance by geography. On a constant currency basis, Americas revenue grew 15%, including 13% growth in the U.S. Excluding the COVID assay revenue, Americas was up 17%. EMEA grew 12%, including 10% growth in Western Europe. Greater China grew 12% and other segment grew 16%. Lastly, for the full year 2021, looking at our core revenue by category. Recurring revenue, I should say, which includes reagent service and other consumables, grew 15% and instruments grew 13%. Now turning to slide 15, I'd like to comment on our fourth quarter and full year financial performance versus the prior year. We delivered another solid quarter performance below the top line, with improvements of gross margin, operating expenses, and free cash flow in the quarter. Gross profit margin for the fourth quarter was 50.5%, which is a 40 basis point increase due to currency translation, volume, and base business mix, partially offset by a 180 basis point headwind from high-margin COVID assay revenue. Additionally, within both cost of sales and operating expenses, we have seen higher spot air freight rates as we have previously discussed. This trend continues, but we are actively managing and monitoring the situation. On a full year basis, gross profit margin was 50.7%, a 210 basis point increase, mostly due to currency translation volume and lower manufacturing costs. Moving down the P&L for the fourth quarter. Sales, marketing, and administrative as a percent of revenue increased 30 basis points to 27.7%. R&D as a percent of revenue increased 70 basis points to 6.7% as we continue to invest in our test menu and new platforms, most notably our dry slide platform. For the year, despite an increase in public company costs, sales, marketing and administrative expense as a percent of revenue decreased 50 basis points to 27.2%, and R&D as a percent of revenue decreased 20 basis points to 6.2%. Excluding the $7.5 million upfront payment to Quotient in 2020 however, R&D as a percent of revenue would actually have been up 20 basis points. Looking at adjusted EBITDA margins, we had 24.6% margin for the fourth quarter, and it's down 130 basis points, including an estimated 230 basis points headwind from the decline in high margin COVID asset revenues. Margin expansion, excluding COVID asset revenue, is therefore 100 basis points better and is underpinned by positive base business mix, efficiency improvements, and the successful execution of our value capture program. For the year, adjusted EBITDA margin of 26.8% is up 100 basis points and would have been up 160 basis points excluding the decline in high margin COVID asset revenue. Net interest expense for the quarter was $33 million, a decrease of $16 million as anticipated, due mainly to lower average outstanding debt balances. Our provision for income taxes was $5 million of expense in the quarter, compared to a benefit of $11 million in the year-ago quarter. For the full year, net interest expense was $146 million, a decrease of $52 million, and our provision for income taxes was $26 million of expense, compared to a benefit of $13 million in 2020. Our adjusted earnings per fully diluted share for the fourth quarter decreased $0.01 year-over-year to $0.18, including a $0.06 year-over-year impact from the previously mentioned COVID headwind, as well as a negative $0.07 impact from the increase in our share count, resulting from the February 2021 IPO. Our adjusted net income actually increased 47% year-over-year, driven by our solid operating performance as well as lower interest expense. Excluding the COVID assay testing and normalizing the share count for the IPO, our Q4 EPS would have been up $0.12 versus the prior year. On a GAAP basis, we reported a net loss per share of $0.04, compared to a net loss per share of $0.28 in Q4 of 2020. For the full year, our adjusted earnings per fully diluted share increased $0.46 year-over-year to $0.80, despite a negative $0.13 impact from the increase in our share count, resulting from our February IPO. Our adjusted net income actually increased 266% year-over-year. Normalizing the share count for the IPO, our full year adjusted EPS would have been up $0.59 versus the prior year. On a GAAP basis, we reported full year net loss per share of $0.24 compared to a net loss per share of $1.45 in 2020. All right. Now looking at free cash flow, capital deployment and balance sheet on slide 16. In the fourth quarter, we generated $73 million in adjusted free cash flow after funding $31 million in CapEx. For the full year, we generated $260 million in adjusted free cash flow after funding $58 million in CapEx. Our day sales outstanding came in at 46 days, an improvement of 16 days compared to the fourth quarter of last year. Now, this includes the securitization of $75 million of our U.S. AR in an off-balance sheet transaction, as discussed in prior quarters. Without the benefit of this financing transaction, our DSO still would have improved by three days compared to the fourth quarter of last year. Our strong cash generation enabled us to continue to deleverage our balance sheet and reduce our net debt to EBITDA ratio to 3.6 times, down from 3.7 at the end of Q3, and down from 7.9 at the time of our IPO in early 2021. We ended the quarter with net debt of $2 billion, including cash and cash equivalents of $310 million. We continue to expect to reduce this leverage ratio by at least half a turn a year going forward as we move towards a more normalized leverage range of 2.5-3.5. Lastly, turning to slide 17, I wanna make a few comments on our outlook. Giving the pending combination with Quidel, we are holding off on providing detailed guidance until the transaction closes. However, I'd like to provide you with some directional color on how we're viewing market conditions. Clinical lab utilization trends are expected to improve as we move through 2022. Transfusion medicine markets have still not fully recovered to pre-COVID run rates as global blood supply shortages persist and labs remain focused on fighting the pandemic. We expect China to grow low double digits in both the first half of 2022 and second half of 2022, but due to instrument supply timing, we expect China growth to be about flat in the first quarter of 2022. Lastly, inflation and global supply chain disruptions are interconnected as supply chains have not been able to catch up to the strong demand for our products. This certainly is not unique to us, and we're seeing these impacts across transportation costs, labor, manufacturing, and commodities. These supply chain challenges are most acutely affecting our instrument placements, as Chris mentioned earlier. Through ongoing actions we discussed on the third quarter call, we expect the instrument supply chain challenges to moderate in the second half of the year, and we expect our integrated install base to continue to grow double digits each quarter in 2022. In light of these dynamics, we expect 2022 core revenue, excluding COVID assay revenue, will increase at mid-single digit growth rates on a constant currency basis. In addition, I'd like to provide assumptions that will be helpful for modeling purposes. We expect our COVID assay revenue to be in the range of $25 million-$35 million in 2022, compared to the $68 million we did in 2021, representing a 150-250 basis point headwind on total company core growth. At current FX rates, currency translation is expected to negatively impact sales growth by about 50-100 basis points. There are no differences in the number of billing days in 2022 compared to 2021. Next, given that our contract with CTS went live in Q1 of 2021, we expect growth in our TM business to normalize to be more in line with the market in 2022. We expect full-year sales, marketing, and administrative expenses to grow at a rate slower than sales. We've been saying all through 2021, for every percentage point of core revenue growth, we expect our adjusted EBITDA margin to grow by 1.2 to 2 times, excluding COVID assay revenue. Net interest expense is expected to be in the range of $120 million-$130 million, with most of the decrease from the fourth quarter run rate to be in the second half of 2022. Cash taxes are expected to be about $25 million, and we expect to generate approximately $200 million in free cash flow. With that, I'll turn the call back now over to Chris to make some summary comments. Thanks, Joe. Look, just in summary, I just wanna kind of talk about, you know, kind of how things finished the year. It really was an amazing year for the company, where our core revenue grew 15% and really that base business, or excluding COVID, we grew 16%. As Joe mentioned, we're expecting mid-single digits growth, ex-COVID related, going forward. We really are excited about what the acquisition of Quidel means to both those companies, because we think it does create significant upside for everyone. On that, let's, Bryan, move it back to you, and we will move to Q&A. Thank you. Operator, we'll take the first question. Our first question comes from Tejas Savant with Morgan Stanley. Tejas, how you doing? This is Neil on for Tejas. Doing well. Thanks for taking my call. Good. Good. Starting with the Quidel transaction, is there anything you started working on to prep for the integration ahead of close? Yeah. You know, look, Mike and Joe are in the room, and I would just tell you, I mean, I think that we would say one of the biggest things we did is we took one of our best executives, the gentleman that ran the IPO, Bob Dunn, and he's running the integration team for us. We pulled him out of his day job, and he's on this now, you know, 24 hours a day, 7 days a week. But Mike and Joe, do you guys want to talk a little bit how you're partnering with Randy and Rob? There's two executives from our side, Mike and Joe, and two from the Quidel side that are working hand in hand on that. Do you want to talk a little bit about where you guys are going and what we're doing on the integration? Yeah. Sure. You know, we have a steering team, which is comprised of Doug, Randy, me, and Mike, and Rob. Then below that, there are two leads on each side. You know, Chris has mentioned the lead on our side, and the Quidel side has a equally talented person on their side leading. Then we've got functional leads below that. You know, there have been several meetings so far. We've brought in a service provider to help us stay on track with the integration process. I would say it's gotten off to a very good start. We've identified most of the day one deliverables and, you know, we're just driving towards meeting all those needs. Yeah. I think that being said, you know, while we're gonna have a dedicated group focused on it, and really helping to do those work streams, it's also important that we continue to run the day-to-day business. That's why I think we're carving out specific people and subject matter experts or super users to be on that team. Got it. Very helpful. Quick one on China. Have you seen any recent impacts from zero tolerance COVID policies, such as site access issues? You know, we really haven't as of yet. I mean, I know that, you know, there I think what happens in China, you'll see these one-off things happen, like last quarter was the tender in one of the provinces, and it really didn't impact it. We really haven't seen an impact to our business yet. Our business continues to do really well there. I mean, you saw the growth on the integrated placements, you know, immunoassay up 30%. I think there, you know, the reason it was a little bit of a challenging quarter was the shipment of instruments, but mainly to distributors. Because remember, in that market, we really almost go through box movers. So our stuff will go into a distributor and then go out. Very different than shipping an instrument into a hospital, for example, in the U.S., where we have a G3 account where we won a competitive bid. We're really backfilling inventory with distributors. We haven't really seen an impact there on the zero policy. Got it. You know, while we're on the topic of geographies, can you tell us about your progress and how it's evolving in high growth regions like India and Latin America? I think, for example, last quarter, you mentioned share gains over large multinationals in India, driven by your- Look, I almost feel like I planted that question with you. Just to give you an idea, I mean, Latin America for the year was up 21%, up 27% in the quarter. Seeing incredible growth in Brazil, you know, over 30% for the year, Mexico over 20% for the year. So I'd say Latin America continues to do really well. We have an amazing leader down there running that business. I would say for emerging markets is at the front end of the integrated strategy, and we're really seeing that nice pull-through. If you go over kind of to India, you know, just to give you an idea, we grew over 50% this year in India. It was amazing growth. Like, I think the 50% maybe shakes you. What we do is we go back and compare it to 2019. Our growth in India compared to 2019 is up 26%. I mean, just continued robust growth in these emerging markets where the teams I think are really doing a great job executing. Then I think Mike bringing these, what we call enGen internally, but these commercial excellence programs in helping to optimize the sales force has really gotten this really nice pull-through. Got it. Just one last one for me, switching topics again. How should we be thinking about the potential contribution from the antibody spike asset? With the current expectation for assay sales for COVID, how should we also be thinking about your previous expectations for a notable headwind to gross margin expansion this year? Yeah, we did talk about the headwind, but Joe, do you want to talk about a little bit how you see that impacting financials in 2022? Yeah. I mean, we're expecting, as I said in the prepared remarks, the COVID-19 assay revenue for 2022 to be in the $25 million-$35 million range. So it's gonna be, you know, about a 150-250 basis points headwind on the top line. You know, it will have an impact for sure on the gross profit expansion and EBITDA expansion. But if again you look at the gross profit and EBITDA line post-COVID or ex-COVID, you know, we'll still hit those expansion numbers that we've talked about. But you know, maybe I'll let Mike talk a little bit about, you know, of that $25 million-$35 million, kind of how that of revenue, how that's gonna play out in 2022. Yeah. Thanks, Joe. I think one of the things for us to just continue to communicate, you know, COVID is very unpredictable, hard to forecast. As we've done, I think we aligned on a number we feel comfortable with in the financial forecast, but I don't think that fully reflects what our true efforts are. We have a number of studies underway, as Chris mentioned in the commentary. We see opportunity for the quantitative antibody test that's out there. We'll continue to push on that. I mean, most recently a good example is that we've seen sort of a reemergence in the U.S., for convalescent plasma. We've played a big role in that testing for that over the number of years, leveraging our great partnerships with our donor screening customers. You know, that may continue to be an opportunity, not just through the Omicron variant, but others to come. We continue to invest in those things. If few things go one way or the other, there could be upside to those numbers. Yeah. I think especially around this quant, I mean, there's a day where people are going to wanna know what their immunity levels are. That's why I talked about the clinical trials which really need to come in front of the sales. Working closely with some government agencies and some large university hospitals on clinical trials that really give you what do you do with that quantitative number on immunity once you know it. I think especially as you think about is there gonna be another vaccine nine months from now? When do you get that vaccine? How do you test? Look, again, I think we've always been conservative on COVID. We'll continue to be conservative on the COVID number, but if some of these things hit in 2022, it'd be incredibly helpful. Our next question comes from Vijay Kumar with Evercore ISI. Hey, Vijay. Hey, guys. Hi, Chris. How are you doing? Thanks for taking my questions. Two for me. Sure. Maybe one big picture first. On the deal, you did mention a shareholder approval coming up in that first half. You know, look at the stock price here, it's well below deal price, 30% below. Perhaps some of it is market. I'm just curious how should we think about this shareholder vote upcoming. How confident is Ortho Clinical on getting approval. And what is the investment community missing here, Chris, just on this transaction itself. Yeah. Um- Look, Vijay, I know you've been following the company since the IPO, and I think you really do a nice job of digging into the business, and I think you're probably as surprised as where we are with the share price and where investors have viewed this deal. I think strategically, candidly, I don't think there's a better deal out there. I mean, we're a unique market leader in the central labs, especially of what I would call these kind of 250-bed to 500-bed hospitals. I think if you look at Quidel, one of the world leaders in point of care, which really doesn't have a distribution arm outside the United States, which we now bring them, and I think testing is gonna become more and more decentralized. For us, having a new platform, a molecular platform. Look, I think strategically it makes a lot of sense. Look, as far as the shareholder vote, I will tell you, look, we're doing calls with individual shareholders, both Doug and I, with our teams to kind of try to walk through the strategy. You know, sometimes, when something like this happens, it takes telling the story one or two times for people really to understand it. That's, look, on us to make sure that they really understand the strategy. I think you had two very different companies. You had a high growth company with no debt, and you had us, which is really more of a predictable mid-single digits company with a lot of debt. If you love the high growth, no debt or you love the other one, you may not like it. I think part of it's just educating the financial markets. Look, COVID's made it tough. I, you know, I would have loved to and we still are trying to do this, get us all, you know, on an airplane or in a Winnebago and go out and do a roadshow and sit in front of people and have them, you know, a chance to talk about it. I think it's been more about an education process, because when you really look at the strategy, I don't know that there's a better deal out there. That's a helpful perspective, Chris. Joe, maybe one for you. The guidance, you did mention some supply chain impact. Is the guidance making any top line impact or any gross margin impact? Because I look at this operating leverage, like there is some EBITDA expansion. I'm curious, is that coming from gross margin or is this perhaps more OpEx driven in fiscal 2022? Yeah. Hey, Vijay. The outlook that I just gave in the prepared remarks is inclusive of the supply chain challenges that we've talked about today and on the last quarter call. You know, we believe that the way we are managing the challenges and, you know, cutting costs in other areas and passing on the increased cost to customers where we can, that we can still hit the guidance that we've talked about for the last year or so, which is, you know, mid-single-digit top line growth, ex-COVID, and EBITDA expansion in the 1.2 to 2 times net revenue expansion. You know, we still feel pretty good about that. Once the deal closes, we will give, you know, more granular, more specific guidance for 2022. We feel pretty good about the long-term guidance we've given out for the last 12, 13 months and sticking with it as we move, you know, through 2022, despite the supply chain challenges that we've talked about. Thank you, guys. Our next question comes from Tycho Peterson with J.P. Morgan. Hey, Tycho. Hey, thanks. Hey. Hey, Chris, can you talk a little bit about customer feedback on the deal? You know, any difference from IDNs, you know, versus traditional hospital labs in terms of excitement, any areas of pushback? You know, how is it resonating as you're out talking to customers? Yeah. Look, Tycho, I think the place where I've heard the best comment has been around the Savanna and the molecular opportunity that we're going to have. I think if you think about a lot of this molecular, which used to be outsourced, a lot more hospitals are, especially post-COVID, bringing that in. I would say the second component is the service that we're able to bring. A lot of these molecular companies don't have the service organization that we have, and so I think that has created a positive. I probably have not had as much on point of care. Mike's here too. Mike, do you wanna talk a little bit about any other additional customer feedback you guys have been getting? Well, I think in general, it's all positive. Again, the biggest overlap is the U.S. Quidel is very well known, very strong, and does a nice job with their business, as do we. I think there's certainly an opportunity for a customer to take that combined experience, and we're seeing the fact that they would like to purchase all those products from one company will help, right? That's a benefit. ex-U.S., what we see is a lot of our customers that we've talked to, really, as Chris said, like the idea of accessing new products that they may not get from us today and some products that may not be available in their market yet. All in all, I think it's a good reception from customers. I think as always, customers, some of the feedback that I would say we listen to and are paying attention to is they're concerned about distraction and disruption, which I think comes back to one of the points that both Chris and Joe made. Both companies have agreed that we're gonna limit who's involved in integration up front so that the vast majority of our people are not distracted, and I think that will be important. We recognize that need. I think we're doing all we can to meet it. You know, thinking a little bit about, you know, the synergies here, any updated thoughts on kind of porting over some of their content to your products and vice versa? Is that factored in any of the synergy targets? I think you mentioned on manufacturing, you know, you haven't planned on real consolidation here in the near term, but how are you thinking about that opportunity long term? Yeah. Mike, why don't you take that? Sorry. Tycho, could you repeat the second part of your question? I got the first part. Manufacturing and, you know, maybe leveraging their Carlsbad facilities as COVID demand drops down. Joe, you may wanna talk about the manufacturing piece. I'll take the first piece. When you think about the synergies we talked about on the cost side and the revenue side, the combination of the company, that's really taking what's in play today with both companies, leveraging each company's footprint, commercial capabilities, product portfolio. What you don't see that I think you touched on that I think is a real upside is when we put the two R&D companies together, one that's been talked a lot about is when you look at our dry slide format, its ability to play in a point of care space, in a decentralized testing space, and you look at Quidel's ability to deliver instruments, manufacture instruments that fit that space, we see that as a real opportunity. Those are all upsides. We did not bake them in. Those are things that we will be looking at implementing, you know, post-close, and I think are future opportunities. Tycho, this is Joe, on the manufacturing part of your question. I know this is a question that Doug and Randy have gotten as well on investor calls. You know, we think the same in that there's no plan at this point to create synergies through manufacturing. That's not part of the $90 million. However, you know, down the road, as we continue to you know, pull these businesses together, there very well may be an opportunity there, but at this point, there's nothing really there. Yeah. Look, I would say the one, Tycho, which may be interesting is we've started the process in India with our follow the sun kind of shared service center. You know, we'll now think about that globally of the two companies, and we are looking at a lot of stuff in China from a manufacturing, so I think there would be some interesting stuff there. Finally, we've been pretty clear, like our business has grown significantly fast, and we're expanding all of our manufacturing facilities. I think when you look at that next expansion, if it's a situation where Quidel has the space and we don't, we would look at doing something there, but there's nothing formal. Okay, thank you. Thanks, Tycho. Our next question comes from Derik De Bruin with Bank of America. Hey, Derik. Hey. Hi, how are you? I jumped on late, so my apologies if you covered this in your prepared remarks, but- No, that's why we made you do, like, the fourth question. We had to push you back a little bit. I'm just kidding. We didn't know you joined late, but yeah. Yeah, my apologies if you covered this in prepared remarks, but we've obviously been getting a lot of questions on the, you know, the buy China, the buy local there, and- Yeah. Sort of pushback. We've seen some diagnostic companies have made some noise about this as well. Are you seeing any sort of, like, pressure in that market, you know, given that there are local options for both clinical chemistry and immunoassay platforms? Yeah. Look, I would say there is a lot of discussion going on that, Derik, in China. We've been talking with government officials. I think we've talked about Iris Lin before. We have an amazing president or leader in China. We are very far along on a couple of projects. One is an instrument. Our next kind of low volume instrument is well under development, probably nine months under development. We've talked publicly about this, that it'll be made in half the time for half the cost. That has started. In addition, we have started a project with one of our largest distributors, which is an immunoassay development company. Those two things are underway, where we would bring out a number of assays with that partner. That being said, I will say that we are in the evaluation process of this, you know, buy local, buy China and what can we do with our existing mainly around instruments. There's a big work stream that's been going on probably for about 3 months, because it is why we have not lost any business or any tenders. We believe that by the time you get to the end of next year, it's gonna become much more significant, and all diagnostic companies are gonna have to have a solution. Mike's working really closely with it. Mike, do you have anything else to add for any of those three? Yeah. Chris, I think we've had a couple initiatives underway that are now happening. Yeah. We continue to monitor the situation. What I would say is, Derek, you know, the market opportunity for us in China, despite some of these programs that we're hearing about, isn't limiting the opportunity so much so that we can't accomplish what we've projected here. What we know is, and we anticipate, is that's going to get more challenging over time, and that's why we're doing all the things Chris said. It does go across a number of fronts. It is one of our core strategic focus items that we've been working on. What I think the long story short is, we expect we will have a presence and a capability in China that's gonna meet whatever needs are required to continue to sell and grow our share. Yeah. To give you an idea, Derik, we have 10 major initiatives for the company for the year, and China's one, like, it literally is pulled out as one. We don't have any other region where we would have that kind of thing, where it's much fully integrated. That is kinda how we're running that business there with the president of China. We'll continue to keep you posted, but I do think it's real. For us, it's the second largest market. You know, seven years from now, five years from now, it'll be the largest market. We realize we've gotta be out in front of it. Hey, hey, Derik. I would just add to what these guys said, just to continue on the point. You know, a lot of our business in China goes to distributors and is sold to hospitals where there's non-government funding, which helps in this situation where, you know, they're not following these buy local rules. In addition, our business is big enough in China that, you know, there's lots of parts of China that aren't following these requirements. To Chris's point a minute ago, we're really not seeing any impact to our business. Yeah. It's not impacting. Just the bottom line. Great. Thank you very much. Thank you, Derik. Our next question comes from Matthew Sykes with Goldman Sachs. Hey, Matt. Hi. Hey, good evening, everybody. Thanks for taking my questions. It's kinda similar to Derik's question on China. I mean, you guys have talked about trying to replicate what you've done in the U.S., and China in terms of transitioning customers to integrated. I'm also curious, just given how much of your, the value of your platform is to Quidel and the combined company, can you talk a little bit about your expansion in China and some of the new customers and what portion of that growth that you've seen in China, which has been impressive, has been from kind of existing customers purchasing more or moving to integrated versus establishing new customers in China? Yeah. Matt, if you... We didn't show it today, but we've shown this slide before where we show the penetration rate of the integrated analyzer, and China's actually our second-best country region for integrated. I think they've done a very nice job, and that's why you see things like the immunoassay business there being up over 30% this quarter. Again, I think they're following that playbook incredibly well. It's a little bit of a different model because while we have a direct sales force and we'll have, you know, 400 people direct in China, we still go through distributors. It really is a partnership. I would say where our growth has really occurred is moving over the last 24 months into these tier two and tier three distributors, which is hospitals that are further away from kind of the centralized market. I think that has worked really well. I would say that I think one of the biggest exciting opportunities for our merger acquisition, whatever it is the ability to get some of these Quidel products into China and through our distribution channel in the way that that's market's growing. I'm really excited about that. I know Mike's been working really closely with Iris on some of these programs, and it's disappointing that we haven't done an investor day because Iris was one of the ones we were going to bring in to speak at the investor day, but we haven't done that yet. Mike, do you wanna- Yeah. The answer is all fronts, right? All fronts are driving the growth. Chris, I think you hit on the big point. You know, if you look at the immunoassay growth that's coming through, a lot of that's pull-through on integrated. We've talked about a program that China does. Again, in those top-tier hospitals, we are in the stat lab, and part of the team's effort there is move testing where the laboratory and the clinicians can benefit from faster turnaround time to the stat lab on some key immunoassays, and the team's executing well. That's driving growth, same-store sales. Again, as the market expands, we're pushing down into those tiers where we can move from a stat lab to a routine player. If you look at where the development and opportunity is coming from in China, they're pushing out more care into the communities, which really moves, for Ortho, a lot of that size testing to what we call our sweet spot. We believe there's a lot of opportunity for us still there. Now we come back to the Quidel question. You know, that positioning in the stat labs is a great spot to be when we take a look at the Quidel portfolio of products. You know, one last area of focus for us is, you know, we have some differentiation ability in pediatric and geriatric, and so one of the opportunities, there's a focus on maternity hospitals being built. We have a good value proposition there that we expect is contributing to some of our growth and we'll continue to help that in the future. Great. Just one quick follow-up. I know you guys talked about $100 million in cross-selling synergies by 2025. Have you guys talked about what portion that would be international, or broken that down any more in terms of regional contribution to the synergies? Yeah, I don't think we've declared the percentages, but Mike worked really closely with an outside consulting firm as we went through due diligence. Mike, do you wanna talk about how you broke up the categories of growth? Yeah. Just for quick, we triangulated. We both companies did separate models on growth, then we brought in a third party and then came to our final number that we use. I think pretty well thought through. You're looking at probably about 80% of revenue synergies come from ex-U.S. Of that, the main biggest one we're looking at is Savanna. Savanna is probably 80% when you look at it from a product view. Great. Thank you very much. Our next question comes from Luke Sergott with Barclays. Hey, Luke. Hey, guys. Great, thanks for taking my questions here. When you talk about the instrument slowdown in the quarter, just from a modeling and a theoretical perspective, like how long does the instrument growth need to be weak like that before it actually starts hitting the integrated conversion into the actual, you know, the increased pull-through? Yeah, look, I. It depends. As we've discussed publicly prior is about 50% of our instruments are cash, and about 50% of those instruments are reagent rentals. Look, without question, you're exactly right that if we think we're gonna ship an instrument in 30 days and we ship that instrument in 90 days, it's a challenge. I will say this, Luke, there's a big difference between. Remember, a lot of our business is taking existing instruments, contract expires, and we upscale into another instrument. In those cases, we're extending agreements. I would say the places where it would be a challenge, which you're talking about, is what we call our P3 or our competitive accounts. From a modeling perspective, Joe, do you wanna talk about, like, the impact? What would that be, like, if it delayed 30 days? We have never really declared what that kind of stuff is. We've not really talked publicly about that. Yeah. I don't know what. Look, I- Yeah. The one thing. Yeah, we're just more directional, right? Like, 'cause these are long duration contracts. Yeah. No, we're trying to give you as much. 17-year average contract. Yeah, yeah, I know. It's just. Yeah, we're trying to give you as much- I'm thinking 17-year contract, one quarter down shouldn't really hit it. Well, remember that our average customer on an integrated is pushing 14 years. Got it. I mean, the cool thing about us is when we get a customer, we don't lose them. Mike, go ahead. Share what you're gonna- All I was gonna say, Luke, is, you know, we've talked about a range for some time of 3%-4% overall install base growth and needing integrated double digits. As you guys have heard now over the last year plus, we've been right in the middle to just above middle of the teens. We've been outperforming, and that's because of retention and competitive wins. Even if we drop into the 11%-12% range on integrated, that's still well within our model and our projections, right? I think that- Got it. You know, we have a dip, but over time. Yeah. We're gonna still be where we need to be in the double digits. Yeah, I think it got lost kind of, Luke, in the quarter. I mean, the quarter was actually really a pretty good quarter. Like, when I said our installed base was 3%, we kinda say we wanna be in 3%-5%, but if we'd shipped the instruments that we had orders on, it would have been 5+. We actually had a good order. I think the pipeline is robust. Look, a lot's going on to get those instruments out. Yeah, that was my follow-up, just gonna be, can you just give us an update on what that pipeline looks like? You know, where there's extra demand or, you know, any customers that have kind of pulled back a little bit because of Omicron? Any update there is helpful for thinking forward. Yeah. Look, at this point, we have not lost any business. You're saying, have we lost business because of the delay? No, either that or just give us an update on the actual funnel here. Because if you're not able to- Yeah. get to the sales or 'cause of Omicron, just any type of weakness there to the pipeline. Look, I would say that a lot of manufacturing plants around the world, including ours, has been hit with Omicron, right? Or like, you get COVID. That definitely has had it. I would say it's more around the supply chain. The way that I you know, as you kind of think about this, you know, it has not really impacted because you're signing a 5-7-year contract with us. Like you said, if it's a month later than you thought, it really hasn't impacted our ability. I think what's happened, candidly, is like everything in our supply chain. This company three years ago was built to grow 1%. I kind of kid our sales organization. If there was no supply chain challenges out there and we grew the business 15%, it's probably okay. If we were the old company that only grew 1% and there's supply chain challenges, we're probably okay. When you're growing a business 15%+, emerging markets well above that, and we're also managing these supply chain challenges, I think what you saw is kind of that it all came together in the fourth quarter, especially in the instruments, you know, that our team has done a fantastic job. The instrument flow is significantly higher than it's been before. I would say, again, this is all manageable because of these relationships and partnerships, and you're looking at a 5- to 7-year contract, and you're looking at a you know, 30- to 60-day delay. It hasn't negatively impacted any of it. All right. Thank you. Yeah. We'll take one last question, operator. This question comes from Yi Chen with H.C. Wainwright. Hi, thank you for taking my questions. Could you give us some additional color on the planned menu expansion, menu extension in 2022, in various geographic areas and also in clinical laboratories versus transfusion medicine and whether the plan could be affected by the merger. Thank you. Mike, do you wanna take that? Yeah. I don't expect the plan, the integration to cause any challenges to the near-term product release. We've talked about probably 20-30 new or improved assays over the next few years. That continues to be the case. Again, I think, you know, if anything, we'll be looking for ways to leverage more menu for our customers as a combined company. I don't think that anything that we're currently working on that timeframe comes off. Major things that we have coming for calcitonin, we'll be launching in China. Hemoglobin A1c on the slide, we just released ex-U.S., and first orders are coming in there. That's very exciting for us. We expect to release that later in the year for the U.S., as well. There are a number of smaller runners that we will release to round out our menu capability in 2022. Nothing, you know, that's happening through the integration that would cause any concern to what we deliver in 2022. Yeah. I would say the growth strategy is unchanged. I mean, we're gonna continue to focus on integration strategy, and that's unaffected by the deal with Quidel. Yeah, and we still have 20-30 tests on the pipeline over the next three years. So. Okay. Thank you. Hey, guys, I think. Thank you. We are out of time. Listen, we really appreciate just you taking the time today and the questions and walking through the fourth quarter of the year with us. We'll continue to, I know we're gonna have some one-on-ones with you guys, but we again appreciate the coverage, and we'll look forward to talking soon. Take care. This concludes today's conference call. Thank you for participating. You may now disconnect.