The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: failure to complete the proposed transaction on the proposed terms or on the anticipated timeline, or at all, including risks and uncertainties related to securing the necessary regulatory and shareholder approvals, the sanction of the High Court of Justice of England and Wales and satisfaction of other closing conditions to consummate the proposed transaction; the occurrence of any event, change or other circumstance that could give rise to the termination of the definitive transaction agreement relating to the proposed transaction; the challenges and costs of closing, integrating, restructuring and achieving anticipated synergies; the ability to retain key employees; and other economic, business, competitive, and/or regulatory factors affecting the businesses of Quidel and Ortho generally. In connection with the proposed business combination transaction among Quidel Corporation (the "Company"), Ortho Clinical Diagnostics Holdings plc ("Ortho") and Coronado Topco, Inc. ("Topco"), Topco will file a registration statement on Form S-4 with the Securities and Exchange Commission (the "Commission") that will contain a joint proxy state. QuidelOrtho Corporation (Nasdaq: QDEL) unites the power of Quidel Corporation and Ortho Clinical Diagnostics behind a shared mission of developing and manufacturing innovative technologies that. This additional non-GAAP financial information is not meant to be considered in isolation from or as substitute for financial information prepared in accordance with GAAP. Molecular Diagnostics revenue declined 72% in the quarter and declined 1%, excluding COVID-related revenue business. Information about Ortho's directors and executive officers and their ownership of Ortho's ordinary shares is set forth in Ortho's Annual Report on Form 10-K filed with the Commission on March. It's just so hard to predict. So we're by no means slowing down the launch in the U.S., but we do recognize that if we get too far into the -- in the first quarter, we're going to miss the respiratory season here in the United States. The Company and Ortho and their respective directors and executive officers may be deemed under the rules of the Commission to be participants in the solicitation of proxies. I'm not going to suggest that we have 100% confidence in it, whether it's point of care, mod complex, but we've been having a number of different conversations around the additional data needed to give the FDA comfort that we should move forward with an EUA. [17], During 2011, the US Food and Drug Administration (FDA) and the European Conformity Mark provided Quidel with 510(k) clearance for selling Sofia Analyzer, and another 510(k) clearance for the Quidel Molecular hMPV Assay.[18]. We expect our transfusion medicine business to grow mid-single digits, but instrument supply issues are negatively affecting labs revenue. While we believe our success at some level is likely, the timing is uncertain. But at the end of the day, all those things that we're suggesting we're needing to spend capital is because we think that we're going to need the additional volume. Quidel Corporation Signs Definitive Agreement to Acquire Ortho Clinical During the quarter, we returned to shelves at all major retail distributors. And finally, net interest expense is expected to be in the range of $125 million to $128 million, from a prior $118 million to $123 million. [15], in December 2021, Quidel announced it would acquire Ortho Clinical Diagnostics Holdings for $6 billion in cash and stock, increasing the range of COVID-19 antigen and antibody tests the business is able to offer.[16]. In light of these dynamics, we are updating supplemental combined fiscal year 2022 guidance as follows: Revenue growth, excluding COVID-related sales narrowed to the high end of the range at 7% to 9% from a prior 6% to 9% on a constant currency basis. As a new organization, we are supporting customers, patients, and communities in the moments that matter most. So it's hard to forecast now because you've been covering it for long time. And importantly, we received China's regulatory clearance for the vitros-XT3400 chemistry system. https://event.on24.com/wcc/r/3578343/A9A0A0558343FD8A113A45315FB34143. That concludes today's call. QuidelOrtho So there's more customers ordering. QuidelOrtho Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide. Quidel (QDEL) Inks Buyout Deal to Solidify Its Diagnostics Arm SAN DIEGO--(BUSINESS WIRE)-- View all Google Scholar citations In the third quarter, we recorded revenue, excluding COVID-related revenue of $613 million. While the accretion of our share repurchase program was particularly attractive in the third quarter, relative to debt pay down, looking ahead, we intend to prudently balance our share repurchase program and our debt paydown. I'll begin with a bit more detail on our operating results for the quarter. So I want to thank everybody for all your great questions. And at this stage, being in market at the tail end of the respiratory season in the U.S., would we like to do that? Together, we will continue to advance life-changing diagnostic solutions to improve patient outcomes and deliver economic benefits to the healthcare system.. 4Q & FY 2022 Forward-Looking Statements Forward-Looking Statements: This presentation of QuidelOrtho Corporation ("QuidelOrtho" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To join the live webcast, participants may click the following link directly:https://event.on24.com/wcc/r/3578343/A9A0A0558343FD8A113A45315FB34143, or access the event via the Investor Relations section of Quidels website (http://ir.quidel.com). The statements we will make during this call about the company's future expectations, plans and prospects include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which provides a Safe Harbor for such statements. Our commercial teams outside the U.S. are also fully integrated. You may now disconnect your lines. And Alex, we'll also provide a three-year outlook, too. Influenza test revenue was therefore higher than we had anticipated or have seen in a non-flu quarter. So that's the math that gets you there. The Supplemental Combined Information presented is based on the historical financial statements of Quidel and Ortho with reclassification adjustments only and do not include all of the pro forma adjustments required under Regulation S-X Article 11 or Accounting Standards Codification 805, Business Combinations (ASC 805). Now turning to our quarterly performance by geography. The leadership team's two levels below the office of the chief executive are established. These results reinforce our view that the Sofia system has been the beneficiary of tailwinds associated with increased respiratory testing, especially among the 83,000 cumulative instrument placements. Sure. Importantly, our complementary cultures are underpinned by a commitment to our customers, patients, and the communities we serve, reinforcing our confidence in the long-term value creation of this transaction. There's nothing really that's changed in terms of when the panels will be launched. And then the visibility into that normalizing, I think you said kind of throughout '23. But for sure, more to come as we close out 2022 and then get into providing the '23 guidance as we move into next year. Secondly, Savanna. You should not rely on forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. Neither the Company or Ortho undertakes an obligation to update any of the forward-looking information included in this document, whether as a result of new information, future events, changed expectations or otherwise, except as required by law. Adjusted EBITDA margin contracted 1,300 basis points year-over-year to 28.9%, better than our expectations due to the strong revenue. I know you know all that, I'm just -- I'm reminding you. Is the FDA still backlogged due to COVID? And how do we think about how those pace through the year? 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 or changed circumstances for any other reason. On a per instrument basis, non-COVID Sofia revenue for the trailing 12 months was the highest since the third quarter of 2021 and continues to strengthen, driven by our full respiratory menu. This combination is expected to benefit patients, customers, and suppliers, and provide greater opportunities for the approximately 6,000 employees of both companies. Gross margins were up sequentially from Q2 due to product mix and exceeded our expectations due to strong revenue. These products include assays such as QuickVue, Thyretain and the new Sofia and AmpliVue brands, which focus on diagnosing influenza, thyroid disease, and many other diseases, and can improve the healthcare quality of hospitals. And we now believe that the surest pathway to full availability of Savanna instruments and panels is to include immediately 510(k) clearance and CLIA waivers. Inspired by a spirit of service, QuidelOrtho is committed to enhancing the well-being of people worldwide and happy in the knowledge we are making a difference. Forward-Looking Statements and Additional Information An audio replay of the conference call will be available on the company's website shortly after this call. The website replay will be available for one year. As Doug discussed, we are concentrating both our product output and all near-term commercial activities for Savanna in Europe and select other CE Mark countries to meet demand in 2023. Bryan Brokmeier, CFA We ended the quarter with cash and marketable securities of $284.3 million and total debt of $2.7 billion after paying down $52 million in the quarter. [7], In 1999, Quidel acquired Metra Biosystems, Inc.to participate in bone health assessment. Thank you. For the second quarter in a row, the Labs business unit launched seven new and refreshed assays globally. Is that right? All rights reserved. Alex, your line is open. [9], In February 2004, Inverness Medical Innovations sued Quidel for patent infringement. So it is fairly significant, and we are seeing signs of improvement on the chip market. COVID-related revenue totaled $171 million in the quarter. While peak respiratory virus season is just now beginning, QuidelOrtho's Virena data indicate and the CDC has reported increasing positivity rates of respiratory diseases, including COVID-19, influenza and RSV. QuidelOrtho has no obligation to update any of the forward-looking information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law. Published online by Cambridge University Press: It's more that we're hedging. Distributed by Public, unedited and unaltered, on 23 December 2021 12:26:04 UTC. Actual results may differ significantly from those set forth in the forward-looking statements. The availability of the products is subject to compliance with the regulatory requirements of each market. Ortho supports over one million of these tests every day, impacting over 800,000 patients. What's the launch assay? As anticipated, we didn't see distributors stock up influenza tests significantly in the quarter, but we did see them build significantly higher inventories for RSV and strep, which are much smaller than influenza volumes. Because Every Test Is A Life, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate and reliable. Thanks, Doug, and good afternoon, everyone. Adjusted EBITDA margin of 29% and adjusted EPS of $1.85 reflect very good operating leverage and solid earnings for the quarter. NO OFFER OR SOLICITATION The information in this communication is for informational purposes only and is neither an offer to purchase, nor a solicitation of an offer to sell, subscribe for or buy any securities or the solicitation of any vote or approval in any jurisdiction pursuant to or in connection with the proposed transactions or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. Please disable your ad-blocker and refresh. GAAP operating income for the third quarter of 2022 was $56.8 million, compared to $281.8 million for the third quarter of 2021, and GAAP operating margin was 7% and 55% for the third quarters of 2022 and 2021, respectively. Andrew, your line is open. Revenue dollars, excluding COVID-related sales, is now expected to be $2.48 billion to $2.53 billion from a prior $2.49 billion to $2.57 billion due to increasing currency headwinds. Just to reiterate it, as we move into this endemic stage of COVID, which we think is going to be '23, but we don't really know. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date hereof. Media Contact You should not rely upon forward-looking statements as predictions of future events because these statements are based on assumptions that may not come true and are speculative by their nature. It sounds like you're basically kind of saying if the U.S. gets pushed out, well, to sell more in Europe. We're monitoring the situation closely for further outbreaks and regional lockdowns and will increasingly manage our channel to meet demand in other regions. The point-of-care market is showing signs of strength, which we expect to translate into strong non-COVID recurring revenue pull-through on our large base of Sofia instrument placements. And we did raise the range on that as to what we thought a normal respiratory season would look like, particularly with influenza. You can sign up for additional alert options at any time. Well, first, welcome back, Andrew. hasContentIssue false. Quidel's current products fall generally into these categories: (1) lateral flow, where it focuses on infectious disease and reproductive health; (2) direct fluorescent antibodies (DFA), with expertise in infectious disease and virology; (3) micro-titer production, with a focus on bone and complement pathway markets; (4) fluorescent immunoassay products (Sofia); and (5) molecular diagnostic products. So we're going to have to the vitro systems there for you to take a look at and see how all that works and the converse would be true. Yet in the U.S., there are signs that the expedited regulatory path for FDA emergency use authorization is changing. (a) Adjusted net income includes Ortho activities from May 27, 2022 through October 2, 2022. Why are some countries so much richer than others? It does not count anything from the government. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Yeah. All rights reserved. But we think it's going to be 2023. This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. We are, therefore, not including any additional government revenue in our 2022 guidance. This press release contains financial measures, including but not limited to constant currency revenue growth, adjusted net income, adjusted diluted EPS, adjusted EBITDA, adjusted EBITDA margin, supplemental combined revenue, supplemental combined adjusted net income, supplemental combined adjusted diluted EPS, supplemental combined adjusted EBITDA and supplemental combined adjusted EBITDA margin, which are considered non-GAAP financial measures under applicable rules and regulations of the Commission.
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