quidel ortho products

YOU ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THE OTHER RELEVANT DOCUMENTS FILED WITH THE COMMISSION (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT QUIDEL, ORTHO AND THE PROPOSED TRANSACTION. 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. QuidelOrtho Corporation is a major American manufacturer of diagnostic healthcare products that are sold worldwide. Click here to view our careers hub! // The Sofia Legionella Fluorescent Immunoassay For use with Sofia 2 and Sofia. Quidel is looking for talented innovators who want to be part of revolutionizing medical diagnostics. The Sofia Strep A Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. For use with Sofia 2 and Sofia. // After submitting your request, you will receive an activation email to the requested email address. Hospitals, hospital networks, clinical laboratories and blood banks around the world depend on our innovative technology and tools (including our exclusive dry-slide technology) to help ensure test results are fast, accurate, and reliable. rargueta@quidel.com. Mainz is currently marketing ColoAlert in Europe through partnerships with third-party laboratories for test kit processing. In comparison, the market breakdown for the immunoassay is larger at 68% compared to 32% for clinical chemistry. Each contains 0.02% sodium azide. [3] On May 8, 2020 the U.S. Food and Drug Administration (FDA) has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. 9975 Summers Ridge Road, San Diego, CA 92121, USA Today, QuidelOrthos comprehensive product portfolio covers a wide range of point-of-care tests for infectious diseases, critical cardiac health and autoimmune biomarkers, and a host of clinical and at-home products to detect COVID-19. Currency exchange had a favorable impact of $2.0 million. Ranked among the worlds largest in vitro diagnostics (IVD) providers, QuidelOrtho is building on more than 120 years of collective experience and innovation. The collaboration seeks to understand biomarker testing patterns and actionability of test results as a first step toward facilitating improved clinical decision-making at both the provider and health system level. The companys Labs segment has the greatest number of projects (38) followed by. These statements include, but are not limited to, the benefits of the business combination transaction involving Quidel, Ortho and Topco, including the combined companys future financial and operating results, plans, objectives, expectations and intentions and other statements that are not historical facts. Laboratory Corporation of America Holdings (LH): Free Stock Analysis Report, Thermo Fisher Scientific Inc. (TMO): Free Stock Analysis Report, Quidel Corporation (QDEL): Free Stock Analysis Report, Ortho Clinical Diagnostics Holdings PLC (OCDX): Free Stock Analysis Report. Furthermore, the company highlighted its plan to expand its IA Menu with 20-25 New/Refreshed Assays lower-cost platforms for emerging markets. All lots within expiry (listed above) as well as future lots until your laboratory receives an additional notification from Ortho: Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics, Inc. 1001 Us Highway 202 Raritan NJ 08869-1424: For Additional Information Contact: SAME 908-218-8776 Manufacturer Reason for Recall We are not an ordinary contract manufacturer providing simple services based . Sofia 2 has the power to deliver highly accurate, objective and automated Influenza A+B and RSV results fast. For Package Inserts and supporting docs visit our Document Search Tool. We then examined the companys TAM for each of its segments, to determine how much of the market it has penetrated, in comparison to management's estimated growth and market CAGR. 9975 Summers Ridge Road, San Diego, CA 92121, USA The IVD Market in 2023: $130 Billion and Growing, https://kaloramainformation.com/wp-content/uploads/sites/5/2021/12/orthoquidel.png, https://d3lstfzn07k02o.cloudfront.net/wp-content/uploads/sites/12/2019/01/08092216/logo_ki.gif, 19 Need-To-Know Developments in Cell and Gene Therapy. Total Influenza revenue was $72.4 million. 9975 Summers Ridge Road, San Diego, CA 92121, USA Quidel, owing to Ortho Clinical Diagnostics enhanced global commercial reach and expansive product portfolio, expects to drive strong cross-selling revenue synergies exceeding $100 million by 2025 and substantial adjusted EBITDA benefits. Actual results may differ from those set forth in the forward-looking statements. The telephone replay will be available for 14 days beginning at 8:00 p.m. Eastern Time (5:00 p.m. Pacific Time) on February 17, 2022 by dialing 866-813-9403 from the U.S., or +44 204-525-0658 for international callers, and entering access code 885823. The protein concentration of each is approximately 0.2 mg/mL. You can see the complete list of todays Zacks #1 Rank stocks here. Get the latest business insights from Dun & Bradstreet. The buyout is expected to significantly expand Quidels point-of-care diagnostics portfolio with access to Ortho Clinical Diagnostics broad global reach across many countries. The deal will add Ortho Clinical's COVID-19 antigen and antibody tests to Quidel's own range of tests, including antigen and PCR for coronavirus. The 2% increase in revenue was driven primarily by incremental COVID-19 Rapid Immunoassay product sales, and to a lesser extent, by increased sales of Cardiometabolic Immunoassay products. Opened new highly automated QuickVue manufacturing facility in Carlsbad, California. Acquisition and integration costs of $7.8 million for the three months ended December 31, 2021 were primarily related to due diligence and other costs mostly associated with the pending Ortho transaction. The change in sales from the fourth quarter of 2020 was mostly driven by a $249 million revenue decline of the Sofia 2 Flu + SARS antigen FIA in the quarter versus 2020. Continuing without changing cookie settings assumes you consent to our use of cookies on this device. It currently carries a Zacks Rank #2 (Buy). From the small physician office laboratory to larger hospital labs or emergency departments, Sofia's high performance, objectivity, quality control, fail-safe measures, LIS capabilities and expanding test menu make Sofia the perfect solution for those looking to improve their rapid testing algorithm. All in all, we believe this highlights Quidels superior performance relative to other healthcare equipment competitors with its highest growth rate in the period which surpassed analyst estimates and revenue guidance for Q4 2022 above the average. We compared its performance against the top 15 healthcare equipment industry companies and guidance to examine how it fared compared to competitors. Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today financial results for the fourth quarter and year ended December 31, 2021. products, and services. Neither Quidel nor Ortho undertakes an 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. It could become the mother of all technological revolutions. The protein concentration for Factor D is 0.1 mg/mL. Mr. Bryant noted, While the years headlines were mostly about COVID-19, we remained focused on developing the growth drivers that will shape our future when COVID-19 ultimately reaches the endemic stage. Additional risks and factors are identified under Risk Factors in the joint proxy statement/prospectus and Quidel's Annual Report on Form 10-K filed on February 19, 2021 and subsequent reports filed with the Commission. Also, we believe this partnership could benefit Quidel as the company and Runda Medical has a relationship for almost 2 decades. LHs earnings surpassed estimates in the trailing four quarters, the average surprise being 25.73%. 858.646.8023 These kits allow for the analysis of bone markers and tissue remodeling in serum, plasma and other biological fluids. Factors like technological advancements in POC devices, rising incidence of infectious diseases and growing investments by key players are likely to drive the market. To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. If you experience any issues with this process, please contact us for further assistance. And we stood at the forefront of diagnostics innovation throughout the coronavirus pandemic, developing one of the earliest molecular PCR assays for SARS-CoV-2, the first FDA emergency use authorized rapid antigen test that delivers results in 15 minutes, and high-volume antibody and antigen tests for COVID-19. 858.552.1100 Tel 858.453.4338 Fax Ortho Clinical also makes products for diagnosing diseases and other equipment used for in-vitro diagnostics, a nearly $80 billion market that serves hospitals and clinics. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. Most of the companys Lab segment projects (13 out of 38) are at the design optimization stage. They added that BreastIHC can increase throughput and reporting speed. The companys Labs segment represented its largest segment at 42.7% of total revenue in Q3 2022. The S&P 500 rose 10.5% in the same time frame. The fairly priced QuickVue At-Home OTC gave Quidel the. LabCorp has gained 48.1% compared with the industrys 15.2% rise over the past year. We further analyzed its revenue breakdown by immunoassay and clinical chemistry for its Labs segment to examine its growth opportunities. Except for the C3-dpl, C3/C4-dpl and the C4-deficient guinea pig sera, a specific complement protein has been removed immunochemically from each depleted human serum reagent. The Sofia S. pneumoniae Fluorescent For use with Sofia Q, Sofia 2, and Sofia. Information about Quidels directors and executive officers and their ownership of Quidels common stock is set forth in the joint proxy statement/prospectus. Per a report by MarketsandMarkets, the global point of care diagnostics market is projected to reach $50.6 billion by 2025 from $29.5 billion in 2020 at a CAGR of 11.4%. Additionally, Molecular Diagnostics Solutions revenue decreased due to lower volumes and selling prices for our COVID-19 PCR products. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market. However, we believe that the companys growth outlook could be impacted if it fails to obtain regulatory approval for its products. The decrease from the fourth quarter of 2020 was primarily due to the impact of the transition and settlement agreements with Beckman Coulter for the BNP business. Cardiometabolic Immunoassay revenue in the fourth quarter of 2021 were lower compared to the fourth quarter of 2020 driven primarily by Beckman BNP products, due to the transition and settlement agreements with Beckman Coulter for the BNP business. A new partnership between Syapse and Illumina focuses on research to evaluate large panel biomarker testing patterns across U.S. community oncology practices. We combine industry-leading expertise in immunoassay and molecular testing with a global footprint in point-of-care settings, clinical labs and transfusion medicine to advance critical diagnostic solutions at scale. The company plans a clinical study in Europe to evaluate whether the biomarkers improve ColoAlerts utility for identifying AA while increasing rates of diagnostic sensitivity and specificity. Quidel brings innovation and distribution in near-patient channels, Ortho Clinical brings in large clinical laboratories internationally, and a reputation for service (Ortho Clinical was a winner for Service and Support in IMVs Service Trak awards https://ir.orthoclinicaldiagnostics.com/news-releases/news-release-details/ortho-customers-rank-company-no-1-service-and-support-sixth). . The legacy Quidel business develops,. We believe that the portfolios and customer base of the combined company will prove to be powerfully complementary, and that the addition of Orthos global commercial operations will provide opportunities to significantly accelerate market penetration of Savanna as well as our full range of diagnostics worldwide. how it fared compared to competitors. Cardiometabolic Immunoassay revenue totaled $255.8 million in the twelve months ended December 31, 2021, representing a 5% increase from 2020. Quidel-Ortho: A Merger of Contrasts In 2021's most notable IVD merger and acquisition, San-Diego, CA-based Quidel announced an acquisition of Raritan, N.J.-based Ortho Clinical Diagnostics. The industry leader for online information for tax, accounting and finance professionals. The buyout is expected to significantly boost Quidels global position in the diagnostics space by combining highly complementary diagnostic portfolios with enhanced technologies and platforms spanning high-throughput systems to near-patient and at-home testing. Among the notable developments, Quidel, in September, had announced that it would make its non-prescription QuickVue At-Home OTC COVID-19 Test available to consumers at more than 7,000 CVS Healths pharmacy locations across the United States as well as online at cvs.com. BioReference Laboratories will use new artificial intelligence (AI)-based diagnostic tools developed by MindPeak and Gestalt Diagnostics for aspects of routine clinical pathology. Quidel to Acquire Ortho Clinical Diagnostics; . *All MicroVue Bone IVD products are also CE marked. Revenue for COVID-19 products was $511.8 million, versus $405.3 million in the fourth quarter of 2020. Based on our previous analysis of Quidel, we obtained a price target of $330.66 which is an upside of 284%, thus maintaining our Strong Buy rating. In phosphate buffered saline containing 40% glycerol. Moreover, we believe the companys Labs Segment could benefit from its focus on the faster-growing immunoassay segment as it highlighted its planned product launches and partnership in China. Moreover, we believe the Labs segment has the greatest opportunity for growth for the company based on its TAM which is the largest among its segments and has a low revenue as a % of TAM relative to other segments. We serve accredited investors throughout the globe, which include HNW individuals, SMEs, associations, and institutions. As seen in the table, its Transfusion Medicine segment has the highest % of TAM (29.4%) but has the lowest CAGR. We were a pioneer in womens health diagnostics, developing the earliest lateral-flow pregnancy test strips. The related constant currency fluctuation rate (expressed as a percentage) is calculated by determining the change in current period constant currency revenue compared to prior period revenue. Want the latest recommendations from Zacks Investment Research? Additionally, the average revenue guidance for Q4 2022 for the top 15 healthcare companies is 5.2%, with only 3 companies guiding negative growth. Quidel Molecular Programs extend the continuum of diagnostic choices from rapid immunoassays to confirmatory nucleic acid testing. The deal, expected to close in the first half of 2022, will deliver estimated cost savings of $90 million by the end of year three after its completion, the companies said. Cardiometabolic Immunoassay revenue totaled $52.8 million in the fourth quarter of 2021. Reported non-GAAP EPS of $17.72 per diluted share in 2021, compared to $19.92 per diluted share in 2020. The transaction is expected to close during the first half of fiscal year 2022, subject to customary closing conditions. Constant currency revenue is calculated by (i) translating current period revenues using prior period exchange rates and (ii) excluding any hedging effect recognized in the current period. Quidels responses to these questions, as well as other matters discussed during the conference call, may contain or constitute material information that has not been previously disclosed. Quidel Corporation and Ortho Clinical Diagnostics are now QuidelOrtho. Ortho Clinical Diagnostics management believes that the takeover will enable the combined company to continue making progress in diagnostic solutions, improving patient outcomes and providing economic benefits to the healthcare system. Visit our Technical Support page to get help with product specifications, supporting docs or general support issues. Net income for the fourth quarter of 2021 was $291.3 million, or $6.85 per diluted share, as compared to net income of $470.1 million, or $10.78 per diluted share, for the fourth quarter of 2020. From the small physician office laboratory to larger hospital labs or emergency departments, Sofia's high performance, objectivity, quality control, fail-safe measures, LIS capabilities and expanding test menu make Sofia the perfect solution for those looking to improve their rapid testing algorithm. They are both good names, and good at what they choose to do. Thermo Fisher has gained 42.1% compared with the industrys 10.2% rise over the past year. Their steadfast commitment to our mission of advancing diagnostics to improve human health is responsible for our success as a company and as a corporate citizen.. You must click the activation link in order to complete your subscription. Zacks Investment Research, Quidel (QDEL) Inks Buyout Deal to Solidify Its Diagnostics Arm, Here are your picks for the Best of the Capital Region 2023. Ortho also develops and markets equipment and assays for blood and plasma screening for infectious diseases. If you got your blood typed in a hospital, it might have been Ortho. Click here to browse webinars focused on various disease states and diagnostic solutions. 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. WHO Reports Lowered Threat Level of COVID-19; What Does it Mean for Testing? To participate in the live call by telephone from the U.S., dial 844-200-6205, or from outside the U.S., dial 929-526-1599, and enter access code 636452. Sales and marketing expense increased by $18.0 million in the fourth quarter of 2021, as compared to the same period in 2020, primarily due to increased freight and promotional spending driven by OTC marketing, corporate sponsorships, higher travel and meeting costs, as well as higher labor costs associated with additional headcount, partially offset by lower bad debt expense. We believe the company's superior performance relative to other top healthcare equipment competitors is highlighted by its highest growth in Q3 2022. G&A expense increased by $17.7 million in 2021, primarily due to increased compensation costs, increased charitable contributions, higher stock compensation expense and increased costs for third-party services. The Human Complement Standard comes with a data sheet indicating the functional activity and antigen levels of each of the major complement proteins. Shares of Quidel have gained 15.4% in the past six months against the industrys 7.7% fall. Quidel, which has benefited from high demand for these tests in the past two years, also sells molecular diagnostics and cell culture tests. This industry first feature provides near real-time infectious disease mapping and reporting. Dec 23 (Reuters) - COVID-19 test maker Quidel Corp (QDEL.O) agreed to buy Ortho Clinical Diagnostics Holdings (OCDX.O) for about $6 billion in a cash and stock deal, less than a year since the Carlyle-backed firm went public. Two VITROS SARS-CoV-2 antibody tests from our partner QuidelOrtho are the 72nd and 73rd BARDA-supported products to receive FDA approval, licensure, or clearance. Quidel Corporation (Nasdaq: QDEL) is a leading manufacturer of diagnostic solutions at the point of care, delivering a continuum of rapid testing technologies that further improve the quality of health care throughout the globe. Total revenue for 2021 increased to $1,698.6 million, a 2% increase from $1,661.7 million in 2020. NEW: Visit ConnectMe.quidel.com for help connecting your Quidel Instruments to the cloud, including the Virena surveillance system. These transformational opportunities more than double our addressable market and fuel our excitement for 2022 and beyond., Mr. Bryant concluded, As we close the books on 2021, I want to thank our Quidel team for the courage, creativity and resilience they showed personally and collectively in driving our business forward amid all the challenges of a second pandemic year. Orthos largest segment, Clinical Laboratories, develops clinical chemistry and immunoassay tests, targeting primarily small/medium size hospitals. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. Prior to joining Quidel, Dr. Kroll was Vice President and Global Head of Research and Innovation for Novartis Molecular Diagnostics . Quidel Corporation has acquired Ortho Clinical Diagnostics, one of the worlds largest in vitro diagnostics companies. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the unsubscribe section below. Diagnostic kits for assessment of bone/joint activity. The company is scheduled to release third-quarter results on Nov 2 after the closing bell. Point of Care (25) and Molecular Diagnostics (17). In November, the company reported third-quarter 2021 results where it recorded robust top-line performance. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. The City Code on Takeovers and Mergers does not apply to the proposed business combination. Our performance was exceptional across the board from shipping a record number of QuickVue COVID-19 and Sofia SARS antigen tests, to the successful launch of our Savanna MDx instrumented system in select ex-U.S. markets, to our definitive agreement to acquire Ortho the Quidel team overcame obstacles and seized opportunities to dramatically broaden the range of patients, partners and providers we serve. Also impacting revenue was a shift in product mix for our Rapid Immunoassay COVID-19 products from higher-priced Sofia products sold in the professional market to lower-priced QuickVue products sold in the retail, pharmacy and employer testing markets. The Sofia 2 Flu + SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative For use with Sofia 2. Total revenue for the fourth quarter of 2021 was $636.9 million, versus $809.2 million for the fourth quarter of 2020. Quidel recently launched the test, which can detect two types of influenza and COVID-19, among others, in Europe. QAD Inc. is a leading provider of next-generation manufacturing and supply chain solutions in the cloud. 900 Seventh Street, NW Suite 400 Rapid Immunoassay product revenue in the fourth quarter of 2021 was $521.0 million. In the fourth quarter of 2021, Quidel recorded an income tax expense of $84.1 million, as compared to $145.4 million in the same quarter last year. >350 units/vial. On a non-GAAP basis, net income for the fourth quarter of 2021 was $309.8 million, or $7.29 per diluted share, as compared to net income of $482.8 million, or $11.07 per diluted share, for the same period in 2020. Find company research, competitor information, contact details & financial data for ORTHOLAB BEATA OLESIAK of Wrocaw, dolnolskie. Quidel Corporation Headquarters: https://www.businesswire.com/news/home/20220217005897/en/, Quidel Contact: Each contains 0.02% sodium azide. Our Standards: The Thomson Reuters Trust Principles. The combined organization will unite the companies technologies and platforms to benefit customers with expanded access to clinical chemistry, immunoassay, molecular diagnostics, immunohematology, donor screening, and point-of-care diagnostics offerings, Quidel said. The lower tax expense for the three months ended December 31, 2021 as compared to the same period in the prior year is a result of lower pre-tax profits.