Reconciliations of the non-GAAP financial measures, including the non-GAAP Supplemental Combined Information, to the most directly comparable GAAP financial measures are included in the tables accompanying this press release. So we're going to need that capacity. Presentation materials will also be posted to the "Events & Presentations" section of the "Investor Relations" page of the Company's website at the time of the call. And just to remind you, our Investor Day will be in New York on December 13. QuidelOrtho to Host Investor Day on December 13, 2022 - Yahoo Finance 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 the Company and Ortho generally. Together, we will continue to advance life-changing diagnostic solutions to improve patient outcomes and deliver economic benefits to the healthcare system.. Excluding COVID-related revenue, we grew 6% in North America, driven by pull-through of our respiratory revenue on our large Sofia installed base as well as strength in donor screening. These better-than-expected results position us to raise our guidance for the full year, which Joe will share in further detail in a few minutes. It's just so hard to predict. Expected strong operating cash flow and margin enhancement opportunities will enable Quidel to pursue organic and inorganic growth. I end by speculating about the form that a unified psychology-based model of investor behavior might take. Thanks. So on behalf of the entire team, I'd like to thank you for your continued support and interest in QuidelOrtho. Please see Slide 3 for a list of non-GAAP measures. Reconciliation of Non-GAAP Financial Information - Adjusted EBITDA. date shows that a few simple assumptions about investor psychology capture a wide range of facts about prices and volume and lead to concrete new predictions. QuidelOrtho Corporation (Nasdaq: QDEL) (the Company or QuidelOrtho), a global provider of innovative in vitro diagnostics technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced financial results for the third quarter ended October 2, 2022. Prepaid expenses and other current assets, Total liabilities and stockholders equity, Condensed Consolidated Statements of Cash Flows, Cash provided by (used for) financing activities, (Decrease) increase in cash, cash equivalents and restricted cash, Cash, cash equivalents and restricted cash at beginning of period, Cash, cash equivalents and restricted cash at end of period. Quidel management will host a conference call to discuss the transaction today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). Like Doug said, we brought on new suppliers. Moreover, our cumulative Sofia placements now total 83,000 instruments, up from 80,000 last quarter, which may suggest healthy new instrument placement demand over the next several quarters. The transition of Beckman BNP assay sales to Beckman was a 3% net headwind to revenue, so the underlying base business is up 6% year-over-year. View source version on businesswire.com: The combined company will also acquire Orthos existing net debt of $2.0 billion. Our commercial teams outside the U.S. are also fully integrated. The only addition is that we're pulling up some of our thoughts with respect to 510(k) submission. There's -- we definitely -- the charts are out there that we can all see, started a little earlier. The following is an illustration of the company's major mergers and acquisitions and historical predecessors: Since its merger, Quidel has expanded its product base through internal development and acquisition with a focus on increasing its research and development efforts to accelerate the rate of new product introductions. Looking into 2023 and beyond, China continues to be a very profitable market and a big investment area for us. While it's still the early days since the close of the transaction, we're off to a strong start. We put the repurchase program in place to take advantage of what we view as a dislocation on the value of our shares. We continue to participate in the process and have advanced to the final stage. With products made in America, Quidels mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We expect full year flu-related revenue to be $230 million to $270 million, up from $200 million to $260 million, and this includes $176 million in the first three quarters. Currency translation decreased sales growth by 230 basis points, resulting in total sales decline of 24%. The transaction is expected to accelerate an innovative pipeline and milestone execution through complementary capabilities and product development synergies. While we believe our success at some level is likely, the timing is uncertain. So -- anything else you want to add? And generally, what's their plan to triage fevers and coughs between testing for flu, testing for COVID or the combo? Also, during today's call, to facilitate a comparison of the company's operating performance from the third quarter of 2021 to the third quarter of 2022, we'll be discussing supplemental third quarter 2021 revenue and other supplemental adjusted operating results as of Quidel and Ortho to be combined for the applicable periods. Quidel's core competencies and capabilities include immunoassay development, automated manufacturing, monoclonal antibody characterization and development, and molecular assay development. As I've mentioned previously, the integration of the organizations and preserving the best attributes of both cultures is the top priority for the executive team and especially for me. (a) Adjusted EBITDA includes Ortho activities from May 27, 2022 through October 2, 2022. We're particularly pleased with the pace of our integration and the milestones that we've achieved thus far as well as the broad portfolio pull-through on our growing placements of Sofia instruments and the strong performance of our donor screening business. No, that makes sense. hasContentIssue false. However, the underlying base business was up 7% year-over-year, which excludes COVID-related revenue and the impact from the Beckman BNP assay transition. We don't exactly know the duration of this flu season. Compelling Strategic Rationale and Value Creation Opportunity, Run-RateCost-related Synergies end of year 3, Ortho Clinical Diagnostics Business Overview, Compelling Scale With Established Installed Base and Rich Development Pipeline. As those headwinds subside, we expect further penetration into the mid- and high throughput lab segment with our integrated analyzers. (a) Includes Ortho results of operations from May 27, 2022 through October 2, 2022. And importantly, we received China's regulatory clearance for the vitros-XT3400 chemistry system. QuidelOrtho Corp (NASDAQ:NASDAQ:QDEL) Q4 2022 Earnings Conference Call February 15, 2023 5:00 PM ETCompany ParticipantsBryan Brokmeier - Vice President, Investor RelationsDoug Bryant. We're counting on a respiratory season that creates disease and creates the need for people to want to know and -- whether that's at the doctor's office or on their own at retail. In the meantime, despite industry-wide challenges in China and with supply chains, our vitro's integrated analyzer installed base grew 11% year-over-year, and automation grew 24%. We look forward to advancing all our initiatives to drive sustainable growth and create long-term stockholder value, Mr. Bryant concluded. Presentation materials will also be posted to the Events & Presentations section of the Investor Relations page of the Companys website at the time of the call. You talked a little bit about kind of some of the instrument supply chain issues, obviously not alone on that front. Thank you. 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. Has data issue: false And then Doug, maybe a crystal ball sort of question for you. We will further expand on all of these at our December Investor Day. Is this happening to you frequently? Savanna sales in Europe are expected to drive growth within our molecular diagnostics business, but off a small base. And at the midpoint, this assumes about a 40% sequential growth for flu and ABC combo from Q3 to Q4. [5], In 1988, Dr. Katz, a founder and chief scientific officer at Quidel, resigned to devote his energies to the Medical Biology Institute, a nonprofit research group in La Jolla, California that is closely allied with Quidel. Gross margins were up sequentially from Q2 due to product mix and exceeded our expectations due to strong revenue. 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. An innovator for over 40 years in the medical device industry, Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S. The progress weve made thus far is a testament to the underlying strength of our combined business, our exceptional team and our global market strategy. And we've got an analyst coming day coming up here. Although the company was authorized to repurchase 300 million of our common stock for a period of two years, we aren't committed to spend the full amount and will instead maintain a flexible and balanced approach to share repurchase and debt pay down. Our next question is from Alex Nowak from Craig-Hallum. Copyright 2023 Surperformance. Or is there something else going on there? 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. Yeah, I think that's conservative. ET to discuss its financial results for the third quarter ended October 2, 2022. I mean, am I reading through the lines correctly that essentially is -- I think you have the $300 million guide out there for a three-year period. It does not count anything from the government. Recurring revenue, which includes reagents, service and other consumables, declined 26%. [6], On June 18, 1997 Quidel settled a lawsuit with Becton Dickinson. To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. Close this message to accept cookies or find out how to manage your cookie settings. These risks and uncertainties include, but are not limited to, those factors identified under Risk Factors in our quarterly report on Form 10-Q filed with the SEC on August 5, 2022, and subsequent reports filed with the SEC. That's super helpful. We are, therefore, not including any additional government revenue in our 2022 guidance. That same month, Quidel countersued against Inverness. I know you know all that, I'm just -- I'm reminding you. Bryan? Yet in the U.S., there are signs that the expedited regulatory path for FDA emergency use authorization is changing. Information regarding the identity of the potential participants, and their direct or indirect interests in the transaction, by security holdings or otherwise, will be contained in the joint proxy statement/prospectus and other relevant materials when they are filed with the Commission. QuidelOrtho will hold a conference call today at 2:00 p.m. PT / 5:00 p.m. In summary, the strong third quarter results enabled us to raise our full year guidance. That said, customer demand continues to be strong, and we are prioritizing new instrument placements and integrated instruments in order to maximize our recurring revenue pull-through. Overall, positivity rates have reached 25.5%, the highest in 31 months and positivity rates continue to climb. We ended the quarter with a 1.4 times net debt-to-EBITDA leverage ratio on a supplemental combined basis. I argue that some of these extensions may lead to a reconsideration of the evidence. And then as far as the EBITDA, yes, we're still in that same range. At our McKellar site, we have capacity and manufacture up to 4 million Sofia kits per week. Yeah, I would just add, Alex, that this flu season did start a little earlier than expected. And traditionally, about half of those placements on the lab side would be reagent rental where we keep the CapEx on our balance sheet and the other half will be cash sales.
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