US Market News
1月前
QuidelOrtho and Allo Hope Foundation Join Forces to Advance Education, Connection and Early Testing for Alloimmunized PregnanciesJune 2, 2026 7:12 AM
PR Newswire (US) SAN DIEGO, June 2, 2026 /PRNewswire/ -- QuidelOrtho, a global leader in diagnostic innovation, and the Allo Hope Foundation, a nonprofit dedicated to supporting families and clinicians managing maternal alloimmunization, announced a new collaboration focused on improving prenatal care through education, early testing and stronger connections between laboratory providers, clinicians and patients. Maternal red blood cell alloimmunization is a serious, often misunderstood condition that can pose significant risks to the child during pregnancy. Red cell antibodies can cross the placenta and destroy fetal and neonatal red blood cells, causing hemolytic disease of the fetus and newborn (HDFN), a temporary but life-threatening condition that requires timely, specialized treatment. Many families struggle to find clear, early and actionable information, creating gaps in care that disproportionately affect underserved populations. This collaboration aims to change that.Rooted in a shared purpose, QuidelOrtho and Allo Hope will jointly develop resources that elevate patient voices, increase awareness among healthcare providers and help ensure women receive informed, equitable prenatal testing and care from the very beginning."At QuidelOrtho, our mission is to advance diagnostics for a healthier future for all," said Bryan Hanson, Executive Vice President, Global Portfolio Management and Marketing, QuidelOrtho. "Through this collaboration with the Allo Hope Foundation, we are activating that mission in a meaningful new way, helping ensure alloimmunized patients receive the early testing, accurate information and compassionate support they deserve. This is the perfect moment to highlight how diagnostics can directly improve maternal health outcomes, especially for those who have historically been underserved."The collaboration also reinforces a commitment to patient-centered authenticity."At Allo Hope, our work begins and ends with the patient experience," said Bethany Weathersby, Founder and Executive Director, Allo Hope Foundation. "Families facing alloimmunization often feel overwhelmed and isolated. By collaborating with QuidelOrtho, we're able to bring together clinical expertise, trusted diagnostics and lived experience to provide education that is both accurate and deeply human. We're excited to broaden awareness and reach more families earlier, with clarity, compassion, and the support needed, to make survival the standard for children with HDFN."Beginning this summer, QuidelOrtho and the Allo Hope Foundation will release a series of co-produced educational materials designed for both lab technicians and families.These educational assets will be made available through both organizations' digital channels.QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.About QuidelOrtho CorporationWith expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, delivering fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.About the Allo Hope FoundationThe Allo Hope Foundation (AHF) serves families and clinicians globally navigating red cell alloimmunization and hemolytic disease of the fetus and newborn (HDFN). Led by patients with expertise in education, research, and clinical practice and guided by a multidisciplinary Medical Advisory Board, Patient Advisory Board, and Board of Directors, AHF believes survival from HDFN should be an expectation and global reality. AHF provides daily patient counsel for thousands of families, facilitates specialty referrals, conducts and publishes disease research and clinical practice guidelines, and raises global awareness through provider education and public health initiatives.Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com Media Contact:
Stephanie Kleewein
Senior Corporate Communication and PR Manager
Media@QuidelOrtho.com View original content to download multimedia:https://www.prnewswire.com/news-releases/quidelortho-and-allo-hope-foundation-join-forces-to-advance-education-connection-and-early-testing-for-alloimmunized-pregnancies-302787974.htmlSOURCE QuidelOrtho Corporation Original: QuidelOrtho and Allo Hope Foundation Join Forces to Advance Education, Connection and Early Testing for Alloimmunized Pregnancies
US Market News
2月前
QuidelOrtho Reports First Quarter 2026 Financial ResultsMay 5, 2026 4:05 PM
PR Newswire (US) ? LEX Diagnostics Acquisition Expected to Accelerate Growth in Point-of-Care Molecular Diagnostics ?
? Key Product Launches in U.S. and International Markets Expected to Drive Future Growth ?
? Company Updates Full-Year 2026 Financial Guidance ? SAN DIEGO, May 5, 2026 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of innovative in vitro diagnostics, today announced financial results for the first quarter ended March 29, 2026. Key First Quarter 2026 Results:
(all comparisons are to the prior year period)Total revenue was $620 million, as reportedPoint of Care revenue of $113 million declined by 34% as reported and 35% in constant currency, primarily due to a significantly weaker respiratory season compared to the first quarter of 2025.Labs revenue of $353 million declined by 5% as reported and 8% in constant currency, primarily due to slower distributor sales in China that the Company believes is related to pending changes to the China National Health Security Administration ("NHSA") In Vitro Diagnostics ("IVD") pricing guidelines, business disruption related to the Middle East conflict, and a decrease in revenue related in part to the Company's termination of its joint business arrangement with Grifols.Immunohematology revenue of $138 million grew 8% as reported and 3% in constant currency, primarily driven by growth in North America, China and JPAC.GAAP net loss was $92 million; GAAP operating loss was $32 million; adjusted EBITDA was $109 million.GAAP diluted loss per share was $1.35; adjusted diluted loss per share was $0.04."Our first quarter results were in line with our preliminary revenue announcement and reflected a significantly weaker respiratory season and business disruption in China and the Middle East," said Brian J. Blaser, President and Chief Executive Officer of QuidelOrtho. "Importantly, we believe the underlying business remains strong and we are well positioned to deliver on our objectives to expand our adjusted EBITDA margin and improve cash flow in 2026.""We completed our acquisition of LEX Diagnostics in April, adding an ultra-fast molecular diagnostics platform for point-of-care testing. We also advanced our key strategic priorities, including the U.S. launch of our High-Sensitivity Troponin assay and the rollout of the VITROS 450 platform in select international markets. We believe these innovations enhance our portfolio and position us to drive sustainable, long-term growth," Blaser continued.Full-year 2026 Financial GuidanceThe Company provided its initial financial guidance for full-year 2026 on February 11, 2026. On April 15, 2026, the Company announced preliminary revenue for the first quarter 2026 and indicated that the low end of its full-year 2026 financial guidance ranges remained achievable. Considering first-quarter performance and current market dynamics in China, the Company has updated its previously provided financial guidance. This guidance includes expected 2026 impact from the current draft of the China NHSA IVD pricing guidelines. The Company cannot fully assess the impact until the final NHSA guidelines and implementation timelines are confirmed. In addition, this guidance does not assume a significant, prolonged impact related to the Middle East conflict. Full-year 2026 Financial GuidanceUpdated (as of 5/5/26)Previous (as of 2/11/26)Total revenues (reported)$2.70 - $2.75 billion$2.7 - $2.9 billionAdjusted EBITDA$615 - $630 million$630 - $670 millionAdjusted EBITDA margin 23 %23.3 %Adjusted diluted earnings per share$1.80 - $2.00$2.00 - $2.42Free cash flow$100 - $120 million$120 - $160 million
Please see page 6 of the First Quarter 2026 Financial Results presentation on the "Investor Relations" page of the Company's website for the full list of assumptions on which the Company's current 2026 financial guidance is based.A reconciliation of forward-looking non-GAAP measures, including adjusted EBITDA, adjusted EBITDA margin, adjusted diluted earnings per share and free cash flow, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. We are not, without unreasonable effort, able to reliably predict the impact of impairment charges and related tax benefits and other non-recurring adjustments. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. In addition, the Company believes any such reconciliation would imply a degree of precision and certainty that could be confusing to investors. See "Forward-Looking Statements" and "Non-GAAP Financial Measures."Conference Call InformationFollowing the release of financial results, QuidelOrtho will hold a conference call today beginning at 2:00 p.m. PT / 5:00 p.m. ET to discuss its financial results. Interested parties can access the call from the "Events & Presentations" section of the "Investor Relations" page of the Company's website at https://ir.quidelortho.com. 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.A replay of the conference call will be available shortly after the event on the "Investor Relations" page of the Company's website under the "Events & Presentations" section.QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.About QuidelOrtho CorporationWith expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, dedicated to advancing fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's commercial and other strategic goals, financial guidance for 2026 and related assumptions and other future financial condition and operating results, including growth expectations and expected results of operations, financial position or cost-savings and operational improvement initiatives, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words "may," "will," "could," "would," "should," "might," "expect," "anticipate," "believe," "estimate," "plan," "intend," "goal," "project," "strategy," "future," "continue," "aim," "strive," "seek" or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho's management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for QuidelOrtho's non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions, strategic restructurings, divestitures, spin-offs or discontinuances of certain business operations, or debt financings, on the anticipated timelines, or at all; delays in the development of or failures or delays in the receipt of approvals for new or enhanced products; failure of new products and services to be commercially viable or accepted; changes in reimbursement rates for our products, including reimbursement rate reductions proposed by the China NHSA; disruptions and challenges related to the ongoing conflicts in the Middle East; and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those arising from the effects of announced or future or amended tariffs, trade policies, investigations, global trade relations and other tariff-related developments, as well as those discussed in QuidelOrtho's Annual Report on Form 10-K for the fiscal year ended December 28, 2025 and subsequent reports filed with the Securities and Exchange Commission (the "Commission"), including under Part I, Item 1A, "Risk Factors" of the Form 10-K. 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. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.Non-GAAP Financial MeasuresThis press release contains financial measures that are considered non-GAAP financial measures under applicable rules and regulations of the Commission, including but not limited to "constant currency Point of Care revenue changes," "constant currency Labs revenue changes," "constant currency Immunohematology revenue changes," "adjusted EBITDA," "adjusted EBITDA margin," "adjusted diluted loss per share," "free cash flow" and other non-GAAP financial measures included in the reconciliation tables accompanying this press release. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures eliminate impacts of certain non-cash, unusual or other items that the Company does not consider indicative of its ongoing operating performance, and the Company generally uses these non-GAAP financial measures to facilitate management's financial and operational decision-making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. The Company's definitions of these non-GAAP measures may differ from similarly titled measures used by others. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting the Company's business. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and reports filed with the Commission in their entirety. Reconciliations of the historical non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release.Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com Media Contact:
Stephanie Kleewein
Senior Corporate Communications and PR Manager
media@QuidelOrtho.com QuidelOrtho
Consolidated Statements of Loss
(Unaudited)
(In millions, except per share data)
Three Months Ended
March 29, 2026
March 30, 2025Total revenues$ 619.8
$ 692.8Cost of sales, excluding amortization of intangibles356.0
349.5Selling, marketing and administrative199.3
187.0Research and development44.9
53.2Amortization of intangible assets46.8
48.0Restructuring, integration and other charges4.4
16.1Other operating expenses0.2
6.4Operating (loss) income(31.8)
32.6Interest expense, net51.1
40.0Other (income) expense, net(3.4)
1.4Loss before income taxes(79.5)
(8.8)Provision for income taxes12.3
3.9Net loss$ (91.8)
$ (12.7)Basic loss per share$ (1.35)
$ (0.19)Diluted loss per share$ (1.35)
$ (0.19)Weighted-average shares outstanding - basic68.2
67.5Weighted-average shares outstanding - diluted68.2
67.5 QuidelOrtho
Condensed Consolidated Balance Sheets
(Unaudited)
(In millions)
March 29, 2026
December 28, 2025ASSETS
Current assets:
Cash and cash equivalents$ 140.4
$ 169.8Accounts receivable, net359.9
417.0Inventories611.5
577.6Prepaid expenses and other current assets232.8
250.5Assets held for sale32.4
32.4Total current assets1,377.0
1,447.3Property, plant and equipment, net1,339.3
1,358.3Right-of-use assets158.0
155.5Intangible assets, net2,520.2
2,563.8Other assets234.2
244.4Total assets$ 5,628.7
$ 5,769.3LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable$ 243.5
$ 279.4Accrued payroll and related expenses135.4
120.3Income tax payable12.7
11.5Current portion of borrowings228.2
178.3Other current liabilities342.6
376.6Total current liabilities962.4
966.1Operating lease liabilities155.4
154.4Long-term borrowings2,459.8
2,471.9Deferred tax liabilities87.3
90.0Other liabilities112.4
166.4Total liabilities3,777.3
3,848.8Total stockholders' equity1,851.4
1,920.5Total liabilities and stockholders' equity$ 5,628.7
$ 5,769.3 QuidelOrtho
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In millions)
Three Months Ended
March 29, 2026
March 30, 2025Cash (used for) provided by operating activities$ (33.0)
$ 65.6Cash used for investing activities(34.0)
(56.2)Cash provided by financing activities37.6
17.6Effect of exchange rates on cash—
1.7Net (decrease) increase in cash, cash equivalents and restricted cash(29.4)
28.7Cash, cash equivalents and restricted cash at beginning of period169.8
98.5Cash, cash equivalents and restricted cash at end of period$ 140.4
$ 127.2
Reconciliation to amounts within the consolidated balance sheets:
Cash and cash equivalents$ 140.4
$ 127.1Restricted cash in Other assets—
0.1Cash, cash equivalents and restricted cash$ 140.4
$ 127.2 QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Adjusted Net (Loss) Income
(In millions, except per share data; unaudited)
Three Months Ended
March 29, 2026
Diluted EPS
March 30, 2025
Diluted EPSNet loss$ (91.8)
$ (1.35)
$ (12.7)
$ (0.19)Adjustments:
Amortization of intangibles46.8
48.0
Restructuring, integration and other charges4.4
16.1
Amortization of deferred cloud computing implementation costs8.0
4.3
Employee compensation charges5.5
—
Incremental depreciation on PP&E fair value adjustment3.3
5.2
Accelerated depreciation2.0
—
Loss (gain) on investments0.9
(0.3)
EU medical device regulation transition costs0.7
0.2
Other adjustments4.7
1.2
Income tax impact of adjustments13.1
(11.8)
Adjusted net (loss) income$ (2.4)
$ (0.04)
$ 50.2
$ 0.74Weighted-average shares outstanding - diluted
68.2
67.9 QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Adjusted EBITDA
(In millions, unaudited)
Three Months Ended
March 29, 2026
March 30, 2025Net loss$ (91.8)
$ (12.7)Depreciation and amortization112.9
107.1Interest expense, net51.1
40.0Provision for income taxes12.3
3.9Restructuring, integration and other charges4.4
16.1Amortization of deferred cloud computing implementation costs8.0
4.3Employee compensation charges5.5
—Loss (gain) on investments0.9
(0.3)EU medical device regulation transition costs0.7
0.2Other adjustments4.7
1.2Adjusted EBITDA$ 108.7
$ 159.8
Total revenues$ 619.8
$ 692.8Adjusted EBITDA margin17.5 %
23.1 % QuidelOrtho
Reconciliation of Non-GAAP Financial Information - Revenues by Business Unit
(In millions, unaudited)
Three Months Ended
March 29, 2026
March 30, 2025
% Change
Currency
Impact
Constant
Currency (a)Labs$ 353.1
$ 373.0
(5.3) %
2.3 %
(7.6) %Immunohematology138.3
128.5
7.6 %
4.2 %
3.4 %Donor Screening7.8
12.8
(39.1) %
0.4 %
(39.5) %Point of Care112.8
170.9
(34.0) %
0.6 %
(34.6) %Molecular Diagnostics7.8
7.6
2.6 %
4.4 %
(1.8) %Total revenues$ 619.8
$ 692.8
(10.5) %
2.1 %
(12.6) %
(a)The term "constant currency" means we have translated local currency revenues for all reporting periods to U.S. dollars using currency exchange rates held constant for each period. This additional non-GAAP financial information is not meant to be considered in isolation from or as a substitute for financial information prepared in accordance with GAAP. View original content to download multimedia:https://www.prnewswire.com/news-releases/quidelortho-reports-first-quarter-2026-financial-results-302762818.htmlSOURCE QuidelOrtho Corporation Original: QuidelOrtho Reports First Quarter 2026 Financial Results
US Market News
3月前
QuidelOrtho Corporation Completes Acquisition of LEX DiagnosticsApril 20, 2026 7:12 AM
PR Newswire (US)
– Marks a Milestone in QuidelOrtho's Plans to Accelerate Growth in Point-of-Care Molecular Diagnostics –
– Expands Portfolio with Ultra-Fast PCR Platform Designed to Deliver Results in Approximately Ten Minutes or Less –
– Company Expects to Initiate U.S. Commercial Launch of the LEX VELO System Later This Year –SAN DIEGO, April 20, 2026 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of innovative in vitro diagnostics, announced today it has completed the acquisition of LEX Diagnostics ("LEX") for cash consideration of approximately $100 million. The LEX VELO System received U.S. Food and Drug Administration ("FDA") 510(k) clearance and CLIA waiver in February 2026.
The LEX VELO System is a breakthrough molecular diagnostics platform that is designed to deliver highly sensitive, multiplex RT-PCR testing for Influenza A, Influenza B and COVID-19 directly from a swab sample in approximately six to ten minutes. Its proprietary cartridge-based design supports rapid clinical decision-making in decentralized care environments by eliminating the need for external liquid handling; delivering speed, reliability and ease of use. The acquisition of LEX marks a critical milestone in QuidelOrtho's molecular diagnostics strategy to accelerate its growth in point-of-care molecular diagnostics by acquiring innovative technology within one of the fastest-growing segments of the diagnostics market."The FDA clearance of the LEX VELO System and the completion of our acquisition of LEX mark a pivotal moment for QuidelOrtho and for our customers," said Brian J. Blaser, President and Chief Executive Officer of QuidelOrtho. "This ultra-fast PCR platform is designed to deliver lab-quality results in minutes and fits seamlessly into point-of-care workflows. It empowers providers to act faster, make better-informed decisions and ultimately improve patient outcomes. It also reflects our long-term commitment to bringing advanced diagnostics closer to the patient."Completing the acquisition of LEX expands QuidelOrtho's molecular diagnostics portfolio while complementing the Company's leadership positions in immunoassay, clinical chemistry and transfusion medicine. It reinforces QuidelOrtho's ability to deliver integrated diagnostic solutions across the continuum of care, from point of care to hospital, lab to clinic."LEX achieved an extraordinary milestone with FDA clearance and CLIA waiver of the LEX VELO System," said Ed Farrell, Chief Executive Officer of LEX. "We are proud to join QuidelOrtho and to bring this technology to customers worldwide. We believe we can redefine what is possible in point-of-care molecular diagnostics."QuidelOrtho expects to initiate the U.S. commercial launch of the LEX VELO System later this year. Global expansion is expected to follow, subject to local regulatory approvals.QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.About QuidelOrtho Corporation
With expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, dedicated to advancing fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's commercial and other strategic goals, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words "may," "will," "could," "would," "should," "might," "expect," "anticipate," "believe," "estimate," "plan," "intend," "goal," "project," "strategy," "future," "continue," "aim," "strive," "seek" or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho's management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for QuidelOrtho's non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges, including disruptions and challenges related to the 2026 Middle East conflict; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions, strategic restructurings, divestitures, spin-offs or discontinuances of certain business operations, or debt financings, on the anticipated timelines, or at all; delays in the development of or failures or delays in the receipt of approvals for new or enhanced products; failure of new products and services to be commercially viable or accepted; changes in reimbursement rates for QuidelOrtho's products, including reimbursement rate reductions proposed by the China National Health Security Administration; and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those arising from the effects of announced or future or amended tariffs, trade policies, investigations and global trade relations, as well as those discussed in QuidelOrtho's Annual Report on Form 10-K for the fiscal year ended December 28, 2025 and subsequent reports filed with the Securities and Exchange Commission, including under Part I, Item 1A, "Risk Factors" of the Form 10-K. 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. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.comMedia Contact:
Stephanie Kleewein
Senior Corporate Communications and PR Manager
media@QuidelOrtho.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/quidelortho-corporation-completes-acquisition-of-lex-diagnostics-302746364.htmlSOURCE QuidelOrtho Corporation
Original: QuidelOrtho Corporation Completes Acquisition of LEX Diagnostics
US Market News
3月前
QuidelOrtho Announces Preliminary Revenue for the First Quarter 2026 and Provides Update on Full-Year 2026 GuidanceApril 15, 2026 4:15 PM
PR Newswire (US)
SAN DIEGO, April 15, 2026 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of in vitro diagnostics, today announced preliminary unaudited revenue for the first quarter of 2026, ended March 29, 2026, and provided an update on its full-year 2026 financial guidance. The Company also announced its plan to release its full first quarter 2026 financial results on Tuesday, May 5, 2026, after the market closes.
Preliminary Unaudited First Quarter 2026 RevenueThe Company currently expects preliminary unaudited revenue, as reported, of $615-$620 million for the first quarter of 2026. This preliminary unaudited revenue was primarily driven by a weaker respiratory season, with U.S. Influenza-like Illness visits down by approximately 30% compared to the first quarter of 20251, along with slower China distributor sales that the Company believes is related to the proposed China National Health Security Administration ("NHSA") reimbursement rate reductions. Additionally, certain EMEA orders were delayed by the Middle East conflict, negatively impacting first quarter revenue."Despite macroeconomic challenges and a softer first quarter respiratory season, QuidelOrtho is taking decisive cost actions to drive full-year 2026 performance," said Brian J. Blaser, President and Chief Executive Officer, QuidelOrtho. "Our core business?representing more than 70% of total revenue?remains strong, providing a solid foundation amid near-term volatility. We remain focused on operational execution, margin expansion, cash flow improvement, and advancing our innovation pipeline to support durable long-term growth."The preliminary unaudited revenue described herein is based on management's preliminary analysis for the first quarter of 2026 and is subject to adjustments based on the Company's completion of its quarter-end financial close process.As discussed in the Company's fourth quarter and full-year 2025 conference call in February 2026, the Company expects free cash flow to be negative for the first half of 2026. The Company currently expects free cash flow to be in the range of $(65) to $(70) million in the first quarter of 2026. The Company continues to expect free cash flow to be positive for the full-year 2026.Full-year 2026 Financial Guidance Based on current information, the Company believes the low end of its full-year 2026 financial guidance (issued February 11, 2026) remains achievable. The ranges provided by the Company were intentionally broad to reflect variability in the respiratory season and other factors, and do not assume a significant, prolonged impact from China NHSA reimbursement initiatives or continued disruption related to the Middle East conflict. The Company plans to discuss its full-year 2026 financial guidance on its May 5, 2026 earnings conference call.First Quarter 2026 Earnings Conference CallFollowing the release of financial results on May 5, 2026, QuidelOrtho will hold a conference call beginning at 2:00 p.m. PT / 5:00 p.m. ET to discuss its financial results. Interested parties can access the call from the "Events & Presentations" section of the "Investor Relations" page of the Company's website at https://ir.quidelortho.com. 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. A replay of the conference call will be available shortly after the event on the "Investor Relations" page of the Company's website under the "Events & Presentations" section.QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.About QuidelOrtho CorporationWith expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, dedicated to advancing fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.Forward-looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's expected revenue and free cash flow for the first quarter 2026, commercial and other strategic goals, financial guidance and related assumptions and other future financial condition and operating results, including expected results of operations, financial position or cost-savings and operational improvement initiatives, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words "may," "will," "could," "would," "should," "might," "expect," "anticipate," "believe," "estimate," "plan," "intend," "goal," "project," "strategy," "future," "continue," "aim," "strive," "seek" or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho's management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for QuidelOrtho's non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges, including disruptions and challenges related to the 2026 Middle East conflict; failure to acquire or complete the proposed acquisition of LEX Diagnostics on the anticipated timeline, or at all, including risks and uncertainties related to LEX Diagnostics' ability to satisfy closing conditions and provisions; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions, strategic restructurings, divestitures, spin-offs or discontinuances of certain business operations, or debt financings, on the anticipated timelines, or at all; delays in the development of or failures or delays in the receipt of approvals for new or enhanced products; failure of new products and services to be commercially viable or accepted; changes in reimbursement rates for QuidelOrtho's products, including reimbursement rate reductions proposed by the China NHSA; and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those arising from the effects of announced or future or amended tariffs, trade policies, investigations and global trade relations, as well as those discussed in QuidelOrtho's Annual Report on Form 10-K for the fiscal year ended December 28, 2025 and subsequent reports filed with the Securities and Exchange Commission, including under Part I, Item 1A, "Risk Factors" of the Form 10-K. 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. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.comMedia Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com 1 As reported by the Centers for Disease Control and Prevention, April 3, 2026.
View original content to download multimedia:https://www.prnewswire.com/news-releases/quidelortho-announces-preliminary-revenue-for-the-first-quarter-2026-and-provides-update-on-full-year-2026-guidance-302743487.htmlSOURCE QuidelOrtho Corporation
Original: QuidelOrtho Announces Preliminary Revenue for the First Quarter 2026 and Provides Update on Full-Year 2026 Guidance
US Market News
5月前
QuidelOrtho Enters Strategic Supply Agreement to Expand Global Immunoassay PortfolioFebruary 16, 2026 1:00 AM
PR Newswire (US)
Agreement adds new analyzer platforms and expands assay menu across key international marketsSAN DIEGO, Feb. 16, 2026 /PRNewswire/ -- QuidelOrtho has entered a long-term strategic supply agreement with Lifotronic Technology Co., Ltd. (Lifotronic Technology Co., Ltd., stock code: 688389), to expand QuidelOrtho's global immunoassay portfolio and accelerate customer access to scalable, high quality, cost-efficient solutions across select markets outside the United States.
The agreement provides QuidelOrtho access to multiple high-throughput and low-to-mid volume immunoassay analyzer platforms, each supported by a broad menu of assays spanning routine and specialty testing. The collaboration is expected to expand QuidelOrtho's immunoassay menu with more than 25 new assays on these systems that are not currently available on the VITROS system, within a total menu of over 70 assays on these new partner platforms.These additions are planned to increase QuidelOrtho's ability to compete for full-menu tenders and serve a wider range of laboratory settings, from smaller laboratories seeking low-volume solutions to larger, high-throughput environments that require scalable capacity and broad test menus.Bryan Hanson, Senior Vice President of Global Clinical Laboratory and Transfusion Medicine at QuidelOrtho, said:
"Through our collaboration with Lifotronic Technology, QuidelOrtho will rapidly introduce scalable testing solutions that further advance our long-term innovation strategy in core growth markets. This agreement strengthens our portfolio in markets where assay breadth and cost efficiency are key requirements, while offering customers a broader and more diverse set of solutions."Mr. Liu Xiancheng, Chairman of Lifotronic Technology, said:
"This strategic partnership with QuidelOrtho marks an important milestone in Lifotronic Technology's global expansion strategy. Going forward, we will work closely with QuidelOrtho, continuing to leverage our in-house R&D strengths to deliver high-value diagnostic solutions that meet real clinical needs for customers worldwide."The commercial focus will be on Europe, the Middle East, Africa, Mexico, Central America, South America, India, China, Japan, and Asia-Pacific regions. This strategic expansion is planned to support QuidelOrtho's ability to address menu gaps, increase competitiveness in international tenders, and deliver more complete immunoassay solutions to laboratories seeking broader menus and flexible system options.Source: QuidelOrtho CorporationAbout QuidelOrtho
QuidelOrtho (Nasdaq: QDEL) is a global leader in diagnostic solutions, with expertise in clinical chemistry, immunoassay, immunohematology, and molecular diagnostics. The company is dedicated to delivering fast, accurate, and reliable test results to help improve patient outcomes across settings ranging from point-of-care to hospitals, laboratories, and clinics. Building on a strong legacy of innovation, QuidelOrtho partners with healthcare providers to advance diagnostic technologies, connecting insights with solutions to enable informed decision-making and better healthcare delivery.About Lifotronic Technology
Shenzhen Lifotronic Technology Co., Ltd. (stock code: 688389) is a high-tech medical device company driven by both R&D and commercialization, recognized as a National High-Tech Enterprise and a "Specialized and Innovative Little Giant" enterprise in China. The company focuses on two major business areas: in vitro diagnostics, and therapy and rehabilitation, and is committed to providing innovative, reliable, and cost-effective medical products and solutions to healthcare institutions worldwide. In the IVD field, Lifotronic Technology has built a comprehensive product portfolio covering electrochemiluminescence, HbA1c, and specific protein technologies. In electrochemiluminescence, the company has achieved a full lineup of low-, mid-, and high-throughput immunoassay instruments and reagents. Its products have obtained international certifications such as CE and are distributed globally, continuing to advance precision medicine and global health through technological innovation.The products referenced in this press release are not currently planned for sale in the United States. These products have not received approval, clearance, or authorization for marketing in any jurisdiction, including the United States, and are not currently marketed or sold. Product launch, sale, and use are subject to obtaining the required regulatory approvals, clearances, or authorizations in each jurisdiction, and there can be no assurance that such approvals will be obtained or obtained within a specific timeframe. Statements regarding future product availability, features, performance, or timing are based on current expectations and are subject to change.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, those relating to the agreement entered into by and between QuidelOrtho and Lifotronic and the transactions contemplated therein, and other future plans, objectives, strategies, expectations and intentions. Such statements are based on the beliefs and expectations of QuidelOrtho's management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. Factors, including those discussed under Part I, Item 1A, "Risk Factors" of QuidelOrtho's Annual Report on Form 10-K for the fiscal year ended December 29, 2024 and subsequent reports filed with the Securities and Exchange Commission, among others, could cause actual results to differ from those set forth or implied in the forward-looking statements. 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. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.comMedia Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com Photo - https://mma.prnewswire.com/media/2904220/Lifotronic_QO_image_2.jpgPhoto - https://mma.prnewswire.com/media/2904219/Lifotronic_QO_image_3.jpgPhoto - https://mma.prnewswire.com/media/2904218/Lifotronic_QO_image_1.jpgLogo - https://mma.prnewswire.com/media/2838981/QuidelOrtho_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/quidelortho-enters-strategic-supply-agreement-to-expand-global-immunoassay-portfolio-302688273.html
Original: QuidelOrtho Enters Strategic Supply Agreement to Expand Global Immunoassay Portfolio
US Market News
5月前
QuidelOrtho Reports Fourth Quarter and Full-Year 2025 Financial ResultsFebruary 11, 2026 4:05 PM
PR Newswire (US)
? Delivered 6% Labs and 9% TRIAGE™ growth, as reported, and 240 bps of adjusted EBITDA margin expansion in FY25 ?? Continued growth and margin expansion expected in FY26; free cash flow expected to improve by over $200 million ?SAN DIEGO, Feb. 11, 2026 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) (the "Company" or "QuidelOrtho"), a global leader of innovative in vitro diagnostics, today announced financial results for the fourth quarter and full-year ended December 28, 2025.
"In 2025, we transitioned from COVID-driven volatility to a more durable, diversified diagnostics business," said Brian J. Blaser, President and Chief Executive Officer of QuidelOrtho. "Our Labs, Immunohematology and Cardiac businesses delivered consistent growth, while cost-savings initiatives drove meaningful margin expansion. As a result, we are well positioned to generate substantially stronger free cash flow in 2026, which we believe more accurately reflects the earnings power of our business."Key Fourth Quarter 2025 Results:
(all comparisons are to the prior year period)Total revenue was $724 million, as reportedNon-respiratory revenue of $600 million; excluding Donor Screening1, non-respiratory revenue grew 7% in constant currency.Labs revenue grew 8% as reported and 7% in constant currency.Respiratory revenue was $123 million, as reported, which declined 14% due to lower COVID-19 testing.Flu revenue grew 6% both as reported and in constant currency.GAAP operating cash flow was $132 million; free cash flow2 was $87 million.GAAP net loss was $131 million; GAAP operating loss was $66 million; underlying business delivered adjusted EBITDA of $153 million.GAAP net loss margin was (18)%; GAAP operating margin was (9)%; adjusted EBITDA margin was 21%.GAAP diluted loss per share was $1.92; adjusted diluted earnings per share ("EPS") was $0.46.Key Full-Year 2025 Results:
(all comparisons are to the prior year)Total revenue was $2.73 billion, as reportedNon-respiratory revenue of $2.33 billion; excluding Donor Screening1, non-respiratory revenue grew 5% in constant currency.Labs revenue grew 6% both as reported and in constant currency.Respiratory revenue was $402 million, as reported, which declined by 20% due to lower COVID-19 testing.Flu revenue grew 3% both as reported and in constant currency.GAAP operating expenses3 and non-GAAP operating expenses both decreased by 5%, driven by the Company's cost-savings initiatives.GAAP operating cash flow was $105 million; free cash flow2 of $(77) million includes one-time investments in the Company's ERP system conversion, which was completed in the third quarter of 2025.GAAP net loss was $1.13 billion; GAAP operating loss was $0.92 billion. FY 2025 GAAP results included a non-cash goodwill impairment charge of $701 million recorded in the third quarter of 2025 related to prior acquisition accounting; underlying business delivered adjusted EBITDA of $597 million.GAAP net loss margin was (41)%; GAAP operating margin was (34)%; adjusted EBITDA margin was 22%, a 240 basis point improvement.GAAP diluted loss per share was $16.69; adjusted diluted EPS was $2.12.Full-year 2025 Results Summary
FY 2025 GuidanceFY 2025 ActualResultsTotal revenues (reported)$2.68–$2.74 billion$2.73 billionIn rangeAdjusted EBITDA$585–$605 million$597 millionIn rangeAdjusted EBITDA margin22 %22 %AchievedAdjusted diluted EPS$2.00–$2.15$2.12In rangeFull-year 2026 Financial Guidance Based on its current business outlook, the Company is providing its fiscal year 2026 financial guidance, as follows:
FY 2025 ActualFY 2026 GuidanceTotal revenues (reported)$2.73 billion$2.7 - $2.9 billion*Adjusted EBITDA$597 million$630 – $670 millionAdjusted EBITDA margin 22 %23.3 %Adjusted diluted EPS$2.12$2.00 - $2.42Free cash flow$(77) million$120 - $160 million
*Foreign currency exchange is expected to be neutral to full-year 2026 revenue based on currency rates as of January 25, 2026. Please see page 7 of the Fourth Quarter and Full-year 2025 Financial Results presentation on the "Investor Relations" page of the Company's website for the full list of assumptions on which the Company's current 2026 financial guidance is based.A reconciliation of forward-looking non-GAAP measures, including adjusted EBITDA, adjusted EBITDA margin, adjusted diluted EPS and free cash flow, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. We are not, without unreasonable effort, able to reliably predict the impact of impairment charges and related tax benefits, employee compensation costs and other adjustments. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. In addition, the Company believes any such reconciliation would imply a degree of precision and certainty that could be confusing to investors. See "Forward-Looking Statements" and "Non-GAAP Financial Measures."CFO Retirement and TransitionThe Company announced that Joseph M. Busky, Chief Financial Officer, has decided to retire, effective June 30, 2026. The Company has begun a search to identify a successor. Mr. Busky will serve in an advisory role following his retirement to facilitate a smooth transition."Joe has been instrumental in strengthening our financial discipline and delivering $140 million in cost-savings by the end of 2025," Blaser said. "With our financial strategy firmly in place and a strong team supporting the transition, we are confident in our ability to execute our 2026 priorities and maintain momentum."Conference Call InformationFollowing the release of financial results, QuidelOrtho will hold a conference call today beginning at 2:00 p.m. PT / 5:00 p.m. ET to discuss its financial results. Interested parties can access the call from the "Events & Presentations" section of the "Investor Relations" page of the Company's website at https://ir.quidelortho.com. 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. Those unable to access the webcast may join the call via phone by dialing 833-470-1428 (domestic) or +1 929-526-1599 (international) and entering Conference ID number 690468.A replay of the conference call will be available shortly after the event on the "Investor Relations" page of the Company's website under the "Events & Presentations" section.QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.____________________1 The Company is in the process of winding down its U.S. Donor Screening portfolio.2 Free cash flow is defined as operating cash flow minus capital expenditures, including investments, net of proceeds
from government assistance allocated to fixed assets.3 Operating expenses is comprised of Selling, marketing and administrative and Research and development expenses.About QuidelOrtho CorporationWith expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, dedicated to advancing fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.QuidelOrtho and TRIAGE are trademarks of QuidelOrtho Corporation or its affiliates. All rights reserved.Forward-Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's commercial and other strategic goals, financial guidance and related assumptions and other future financial condition and operating results, including growth expectations for 2026 and expected results of operations, financial position or cost-savings and operational improvement initiatives, and other future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words "may," "will," "could," "would," "should," "might," "expect," "anticipate," "believe," "estimate," "plan," "intend," "goal," "project," "strategy," "future," "continue," "aim," "strive," "seek" or similar words, expressions or the negative of such terms or other comparable terminology are intended to identify forward-looking statements. Such statements are based on the beliefs and expectations of QuidelOrtho's management as of the date of this press release and are subject to significant known and unknown risks and uncertainties. Actual results or outcomes may differ significantly from those set forth or implied in the forward-looking statements. The following factors, among others, could cause actual results or outcomes to differ from those set forth or implied in the forward-looking statements: fluctuations in demand for QuidelOrtho's non-respiratory and respiratory products; supply chain, production, logistics, distribution and labor disruptions and challenges; failure to acquire or complete the proposed acquisition of LEX Diagnostics on the anticipated timeline, or at all, including risks and uncertainties related to LEX Diagnostics' ability to secure FDA clearance and satisfy closing conditions and provisions; inability to successfully identify, consummate or realize the anticipated benefits of strategic transactions, strategic restructurings, divestitures, spin-offs or discontinuances of certain business operations, or debt financings, on the anticipated timelines, or at all; delays in the development of or failures or delays in the receipt of approvals for new or enhanced products; failure of new products and services to be commercially viable or accepted, and other macroeconomic, geopolitical, market, business, competitive and/or regulatory factors affecting the business of QuidelOrtho generally, including those arising from the effects of announced or future or amended tariffs, trade policies, investigations and global trade relations, as well as those discussed in QuidelOrtho's Annual Report on Form 10-K for the fiscal year ended December 29, 2024 and subsequent reports filed with the Securities and Exchange Commission (the "Commission"), including under Part I, Item 1A, "Risk Factors" of the Form 10-K. 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. All forward-looking statements are based on information currently available to QuidelOrtho and speak only as of the date of this press release. QuidelOrtho undertakes no obligation to update any of the forward-looking information or time-sensitive information included in this press release, whether as a result of new information, future events, changed expectations or otherwise, except as required by law.Non-GAAP Financial MeasuresThis press release contains financial measures that are considered non-GAAP financial measures under applicable rules and regulations of the Commission, including but not limited to "adjusted EBITDA," "adjusted EBITDA margin," "adjusted diluted EPS," "constant currency non-respiratory revenue changes, excluding Donor Screening revenue," "constant currency Labs revenue changes," "constant currency Flu revenue changes," "free cash flow," "non-GAAP operating expenses" and other non-GAAP financial measures included in the reconciliation tables accompanying this press release. These non-GAAP financial measures should be considered supplemental to, and not a substitute for, financial information prepared in accordance with U.S. generally accepted accounting principles ("GAAP"). These non-GAAP financial measures eliminate impacts of certain non-cash, unusual or other items that the Company does not consider indicative of its ongoing operating performance, and the Company generally uses these non-GAAP financial measures to facilitate management's financial and operational decision-making, including evaluation of the Company's historical operating results and comparison to competitors' operating results. The Company's definitions of these non-GAAP measures may differ from similarly titled measures used by others. These non-GAAP financial measures reflect an additional way of viewing aspects of the Company's operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures, may provide a more complete understanding of factors and trends affecting the Company's business. Because non-GAAP financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management strongly encourages investors to review the Company's consolidated financial statements and reports filed with the Commission in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the tables accompanying this press release.Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com QuidelOrthoConsolidated Statements of Loss(Unaudited)(In millions except per share data)
Three Months Ended
Fiscal Year Ended
December 28,
2025
December 29,
2024
December 28,
2025
December 29,
2024Total revenues$ 723.6
$ 707.8
$ 2,730.2
$ 2,782.9Cost of sales, excluding amortization of intangibles403.2
381.7
1,456.0
1,496.4Selling, marketing and administrative194.4
187.5
746.3
766.8Research and development45.8
47.3
186.2
218.7Amortization of intangible assets45.6
47.9
189.2
203.4Restructuring, integration and other charges29.0
36.9
263.6
127.2Goodwill impairment charge—
78.7
700.7
1,822.6Asset impairment charge—
—
9.7
56.9Other operating expenses71.9
28.2
97.7
51.8Operating loss(66.3)
(100.4)
(919.2)
(1,960.9)Interest expense, net51.0
40.6
177.6
163.5Loss on extinguishment of debt—
—
5.1
—Other expense, net(4.9)
(0.1)
5.8
7.1Loss before income taxes(112.4)
(140.9)
(1,107.7)
(2,131.5)Provision for (benefit from) income taxes18.3
37.5
24.1
(79.5)Net loss$ (130.7)
$ (178.4)
$ (1,131.8)
$ (2,052.0)Basic loss per share$ (1.92)
$ (2.65)
$ (16.69)
$ (30.54)Diluted loss per share$ (1.92)
$ (2.65)
$ (16.69)
$ (30.54)Weighted-average shares outstanding - basic68.0
67.3
67.8
67.2Weighted-average shares outstanding - diluted68.0
67.3
67.8
67.2 QuidelOrthoCondensed Consolidated Balance Sheets(Unaudited)(In millions)
December 28,
2025
December 29,
2024ASSETS
Current assets:
Cash and cash equivalents$ 169.8
$ 98.3Accounts receivable, net417.0
282.4Inventories577.6
533.7Prepaid expenses and other current assets250.5
262.4Assets held for sale32.4
42.1Total current assets1,447.3
1,218.9Property, plant and equipment, net1,358.3
1,380.2Right-of-use assets155.5
168.7Goodwill—
649.5Intangible assets, net2,563.8
2,735.6Other assets244.4
270.7Total assets$ 5,769.3
$ 6,423.6LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable$ 279.4
$ 246.0Accrued payroll and related expenses120.3
116.9Income tax payable11.5
5.4Current portion of borrowings178.3
341.8Other current liabilities376.6
288.7Total current liabilities966.1
998.8Operating lease liabilities154.4
167.2Long-term borrowings2,471.9
2,141.3Deferred tax liabilities90.0
76.5Other liabilities166.4
55.3Total liabilities3,848.8
3,439.1Total stockholders' equity1,920.5
2,984.5Total liabilities and stockholders' equity$ 5,769.3
$ 6,423.6 QuidelOrthoCondensed Consolidated Statements of Cash Flows(Unaudited)(In millions)
Fiscal Year Ended
December 28, 2025
December 29, 2024Cash provided by operating activities$ 105.2
$ 83.0Cash used for investing activities(192.7)
(149.9)Cash provided by financing activities155.8
48.8Effect of exchange rates on cash3.0
(2.9)Net increase (decrease) in cash, cash equivalents and restricted cash71.3
(21.0)Cash, cash equivalents and restricted cash at beginning of period98.5
119.5Cash, cash equivalents and restricted cash at end of period$ 169.8
$ 98.5
Reconciliation to amounts within the consolidated balance sheets:
Cash and cash equivalents$ 169.8
$ 98.3Restricted cash in Other assets—
0.2Cash, cash equivalents and restricted cash$ 169.8
$ 98.5 QuidelOrthoReconciliation of Non-GAAP Financial Information - Adjusted Net Income(In millions, except per share data; unaudited)
Three Months Ended
Fiscal Year Ended
December 28,
2025
Diluted EPS
December 29,
2024
Diluted EPS
December 28,
2025
Diluted EPS
December 29,
2024
Diluted EPSNet loss$ (130.7)
$ (1.92)
$ (178.4)
$ (2.65)
$ (1,131.8)
$ (16.69)
$ (2,052.0)
$ (30.54)Adjustments:
Amortization of intangibles45.6
47.9
189.2
203.4
Restructuring, integration and other charges29.0
36.9
263.6
127.2
Goodwill impairment charge—
78.7
700.7
1,822.6
Asset impairment charge—
—
9.7
56.9
Loss on extinguishment of debt—
—
5.1
—
Contract termination cost65.0
—
65.0
—
Amortization of deferred cloud computingimplementation costs8.0
4.1
27.0
14.7
Incremental depreciation on PP&E fair value adjustment4.7
8.3
20.4
35.1
Accelerated depreciation1.3
—
3.8
—
EU medical device regulation transition costs0.2
0.5
0.7
2.0
Asset write off—
20.0
—
20.0
Loss on disposal—
1.2
—
1.2
Legal accrual—
—
9.4
—
Employee compensation charges—
—
—
5.6
Prior Credit Agreement amendment fees—
—
—
4.0
Gain on investments(1.8)
(0.7)
(2.5)
(0.7)
Other adjustments1.8
0.6
6.4
4.0
Income tax impact of adjustments8.0
23.5
(22.8)
(119.0)
Adjusted net income$ 31.1
$ 0.46
$ 42.6
$ 0.63
$ 143.9
$ 2.12
$ 125.0
$ 1.85Weighted-average shares outstanding -
diluted
68.3
67.6
68.0
67.4 QuidelOrthoReconciliation of Non-GAAP Financial Information - Non-GAAP Operating Expenses(In millions, unaudited)
Fiscal Year Ended December 28, 2025
Fiscal Year Ended December 29, 2024
GAAP
Adjustments
(a)
Non-GAAP
GAAP
Adjustments
(a)
Non-GAAPSelling, marketing and administrative$ 746.3
$ (36.8)
$ 709.5
$ 766.8
$ (37.1)
$ 729.7Research and development186.2
(2.1)
184.1
218.7
(3.0)
215.7Operating expenses$ 932.5
$ (38.9)
$ 893.6
$ 985.5
$ (40.1)
$ 945.4
(a)Includes the following non-GAAP adjustments: amortization of deferred cloud computing implementation costs, incremental depreciation on PP&E fair value adjustment, EU medical device regulation transition costs, employee compensation charges and other adjustments. QuidelOrthoReconciliation of Non-GAAP Financial Information - Adjusted EBITDA(In millions, unaudited)
Three Months Ended
Fiscal Year Ended
December 28,
2025
December 29,
2024
December 28,
2025
December 29,
2024Net loss$ (130.7)
$ (178.4)
$ (1,131.8)
$ (2,052.0)Depreciation and amortization112.5
109.3
442.0
453.4Interest expense, net51.0
40.6
177.6
163.5Provision for (benefit from) income taxes18.3
37.5
24.1
(79.5)Restructuring, integration and other charges29.0
36.9
263.6
127.2Goodwill impairment charge—
78.7
700.7
1,822.6Asset impairment charge—
—
9.7
56.9Loss on extinguishment of debt—
—
5.1
—Contract termination cost65.0
—
65.0
—Amortization of deferred cloud computing implementation costs8.0
4.1
27.0
14.7EU medical device regulation transition costs0.2
0.5
0.7
2.0Asset write off—
20.0
—
20.0Loss on disposal—
1.2
—
1.2Legal accrual—
—
9.4
—Employee compensation charges—
—
—
5.6Prior Credit Agreement amendment fees—
—
—
4.0Gain on investments(1.8)
(0.7)
(2.5)
(0.7)Other adjustments1.8
0.6
6.4
4.0Adjusted EBITDA$ 153.3
$ 150.3
$ 597.0
$ 542.9
Total revenues723.6
707.8
2,730.2
2,782.9Adjusted EBITDA margin21.2 %
21.2 %
21.9 %
19.5 % QuidelOrthoReconciliation of Non-GAAP Financial Information - Revenues by Business Unit and Region(In millions, unaudited)
Three Months Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)
Less: COVID-19
revenue impact
Constant Currency (a) ex COVID-19 RevenueRespiratory revenues$ 123.3
$ 143.2
(13.9) %
0.3 %
(14.2) %
(17.1) %
2.9 %Non-Respiratory revenues600.3
564.6
6.3 %
1.4 %
4.9 %
— %
4.9 %Total revenues$ 723.6
$ 707.8
2.2 %
1.1 %
1.1 %
(3.5) %
4.6 %
Three Months Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)
Less: COVID-19
revenue impact
Constant Currency (a) ex COVID-19 RevenueLabs$ 389.2
$ 359.9
8.1 %
1.1 %
7.0 %
(0.2) %
7.2 %Immunohematology141.0
136.4
3.4 %
2.2 %
1.2 %
— %
1.2 %Donor Screening11.8
19.7
(40.1) %
0.6 %
(40.7) %
— %
(40.7) %Point of Care173.1
185.0
(6.4) %
0.5 %
(6.9) %
(13.6) %
6.7 %Molecular Diagnostics8.5
6.8
25.0 %
1.3 %
23.7 %
(5.8) %
29.5 %Total revenues$ 723.6
$ 707.8
2.2 %
1.1 %
1.1 %
(3.5) %
4.6 %
Three Months Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)
Less: COVID-19
revenue impact
Constant Currency (a) ex COVID-19 RevenueNorth America$ 390.1
$ 399.6
(2.4) %
— %
(2.4) %
(6.2) %
3.8 %EMEA92.7
85.9
7.9 %
8.5 %
(0.6) %
(0.3) %
(0.3) %China91.7
86.9
5.5 %
0.2 %
5.3 %
— %
5.3 %JPAC75.9
75.4
0.7 %
(3.1) %
3.8 %
(0.1) %
3.9 %Latin America73.2
60.0
22.0 %
5.0 %
17.0 %
— %
17.0 %Total revenues$ 723.6
$ 707.8
2.2 %
1.1 %
1.1 %
(3.5) %
4.6 %
(a)The term "constant currency" means we have translated local currency revenues for all reporting periods to U.S. dollars using currency exchange rates held constant for each period. This additional non-GAAP financial information is not meant to be considered in isolation from or as a substitute for financial information prepared in accordance with GAAP.
Fiscal Year Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)
Less: COVID-19
revenue impact
Constant Currency (a) ex COVID-19 RevenueRespiratory revenues$ 402.1
$ 503.9
(20.2) %
0.1 %
(20.3) %
(21.1) %
0.8 %Non-Respiratory revenues2,328.1
2,279.0
2.2 %
0.2 %
2.0 %
— %
2.0 %Total revenues$ 2,730.2
$ 2,782.9
(1.9) %
0.2 %
(2.1) %
(3.9) %
1.8 %
Fiscal Year Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)
Less: COVID-19
revenue impact
Constant Currency (a) ex COVID-19 RevenueLabs $ 1,505.7
$ 1,427.2
5.5 %
(0.2) %
5.7 %
(0.1) %
5.8 %Immunohematology543.8
522.0
4.2 %
1.0 %
3.2 %
— %
3.2 %Donor Screening52.6
115.1
(54.3) %
0.1 %
(54.4) %
— %
(54.4) %Point of Care601.6
694.6
(13.4) %
0.2 %
(13.6) %
(15.1) %
1.5 %Molecular Diagnostics26.5
24.0
10.4 %
0.6 %
9.8 %
(4.7) %
14.5 %Total revenues$ 2,730.2
$ 2,782.9
(1.9) %
0.2 %
(2.1) %
(3.9) %
1.8 %
Fiscal Year Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)
Less: COVID-19
revenue impact
Constant Currency (a) ex COVID-19 RevenueNorth America$ 1,488.9
$ 1,619.8
(8.1) %
0.1 %
(8.2) %
(6.1) %
(2.1) %EMEA360.7
335.8
7.4 %
4.0 %
3.4 %
(0.4) %
3.8 %China334.7
325.0
3.0 %
(0.2) %
3.2 %
— %
3.2 %JPAC293.0
279.4
4.9 %
(1.1) %
6.0 %
— %
6.0 %Latin America252.9
222.9
13.5 %
(3.9) %
17.4 %
(0.6) %
18.0 %Total revenues$ 2,730.2
$ 2,782.9
(1.9) %
0.2 %
(2.1) %
(3.9) %
1.8 %
(a)The term "constant currency" means we have translated local currency revenues for all reporting periods to U.S. dollars using currency exchange rates held constant for each period. This additional non-GAAP financial information is not meant to be considered in isolation from or as a substitute for financial information prepared in accordance with GAAP. QuidelOrthoReconciliation of Non-GAAP Financial Information - Non-Respiratory Revenue excluding Donor Screening(In millions, unaudited)
Three Months Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)Non-Respiratory revenues$ 600.3
$ 564.6
6.3 %
1.4 %
4.9 %Donor Screening revenue(11.8)
(19.7)
Total non-respiratory revenue, excluding
Donor Screening$ 588.5
$ 544.9
8.0 %
1.4 %
6.6 %
Fiscal Year Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)Non-Respiratory revenues$ 2,328.1
$ 2,279.0
2.2 %
0.2 %
2.0 %Donor Screening revenue(52.6)
(115.1)
Total non-respiratory revenue, excluding
Donor Screening$ 2,275.5
$ 2,163.9
5.2 %
0.2 %
5.0 %
QuidelOrthoReconciliation of Non-GAAP Financial Information - Respiratory Revenue(In millions, unaudited)
Three Months Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)Flu revenue$ 80.7
$ 75.9
6.3 %
— %
6.3 %COVID-19 revenue20.4
43.5
All other22.2
23.8
Total respiratory revenue$ 123.3
$ 143.2
(13.9) %
0.3 %
(14.2) %
Fiscal Year Ended
December 28,
2025
December 29,
2024
% Change
Currency
Impact
Constant
Currency (a)Flu revenue$ 254.6
$ 246.2
3.4 %
— %
3.4 %COVID-19 revenue80.2
184.9
All other67.3
72.8
Total respiratory revenue$ 402.1
$ 503.9
(20.2) %
0.1 %
(20.3) %
(a)The term "constant currency" means we have translated local currency revenues for all reporting periods to U.S. dollars using currency exchange rates held constant for each period. This additional non-GAAP financial information is not meant to be considered in isolation from or as a substitute for financial information prepared in accordance with GAAP. QuidelOrthoReconciliation of Non-GAAP Financial Information - Triage Growth(In millions, unaudited)
Fiscal Year Ended
December 28,
2025
December 29,
2024
% ChangeTriage revenue$ 132.7
$ 121.8
8.9 %Other cardiac revenue75.0
75.0
All other393.9
497.8
Point of Care Revenue$ 601.6
$ 694.6
(13.4) % QuidelOrthoReconciliation of Non-GAAP Financial Information - Free Cash Flow(In millions, unaudited)
Three Months Ended
Fiscal Year Ended
December 28, 2025
December 28, 2025Net cash provided by operating activities$ 131.9
$ 105.2Less:
Acquisitions of property, plant, equipment, investments and intangibles45.3
188.2Proceeds from government assistance allocated to fixed assets—
(6.5)Free cash flow$ 86.6
$ (76.5)
View original content to download multimedia:https://www.prnewswire.com/news-releases/quidelortho-reports-fourth-quarter-and-full-year-2025-financial-results-302685589.htmlSOURCE QuidelOrtho Corporation
Original: QuidelOrtho Reports Fourth Quarter and Full-Year 2025 Financial Results
US Market News
5月前
QuidelOrtho Receives Excellence Services Label in EMEA and Two Stevie® AwardsFebruary 3, 2026 7:12 AM
PR Newswire (US)
– First medical device company to receive excellence recognition in accordance with ISO 23592
– Gold Stevie® Award for Customer Service Success
– Bronze Stevie® Award for AI & Tech Focused Digital Transformation Team of the YearSAN DIEGO, Feb. 3, 2026 /PRNewswire/ -- QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho") received the Excellence Services Label for its Customer and Technical Services in EMEA, awarded by the independent association Esprit de Service France, and in accordance with the international standard ISO 23592, a global framework for designing and delivering outstanding customer experiences. QuidelOrtho is the first medical device company to receive this distinction.
QuidelOrtho also won a Gold Stevie Award in the Customer Service Success category and a Bronze Stevie Award in the AI & Tech Focused Digital Transformation Team of the Year category in the 20th annual Stevie Awards for Sales & Customer Service.These awards underscore the customer experience at QuidelOrtho, which is designed to be predictive, connected, intelligent and grounded in the QuidelOrthoCQ™ Philosophy of turning intelligence and ease into care customers can feel."These 2026 recognitions are a testament to the passion and discipline of our teams across the globe," said Karen Taylor, Senior Vice President, Customer Experience, QuidelOrtho. "Achieving the Excellence Services Label reflects not only our commitment to customer-centricity, but also the strength of our quality management system, processes, training and culture of continuous improvement. Earning both the Gold and Bronze Stevie Awards further reflects the strength of our customer-first approach and our ability to harness innovation, technology and teamwork to deliver meaningful improvements in service."ISO 23592, first published in 2021, provides organizations with guidance to build customer-centric systems that go beyond basic expectations to deliver memorable, high-quality experiences across every touchpoint. While ISO 23592 is not yet a certifiable standard, the Excellence Services Label affirms that the organization has been evaluated in accordance with ISO 23592 requirements and has demonstrated maturity, innovation and consistent customer focus. The certification scope spans Customer Service, the Technical Solutions Center, Technical Training, and Field Service, supporting a unified service model designed to deliver consistent value throughout the customer journey.The Stevie Awards for Sales & Customer Service are the world's top honors for customer service, contact center, business development and sales professionals. The Stevie Awards organize nine of the world's leading business awards programs, including the prestigious American Business Awards® and International Business Awards®.Strengthening customer trust
The Excellence Services Label provides customers across the region with a trusted, third-party-validated assurance of QuidelOrtho's commitment to delivering high-quality, consistent service experience. While the label does not directly change operational processes, it validates the systems, methods and culture that underpin exceptional support, training, problem-solving and overall service reliability.QuidelOrthoCQ, or Care Quotient, is QuidelOrtho's company-wide program designed to reflect its customers' beliefs and values, brought to life through QuidelOrtho's people and the solutions they create. It is the measure of the level of care, empathy and compassion QuidelOrtho has for their customers and their customers' experience working with QuidelOrtho.To learn more about QuidelOrtho's commitment to its customer experience, listen to this episode of Repertoire Magazine Podcast with Karen Taylor, where she discusses the QuidelOrthoCQ Customer Experience Program.QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.About QuidelOrtho Corporation
With expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, dedicated to advancing fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.About the Excellence Services Label & ISO 23592
The Excellence Services Label is issued by Esprit de Service France, an independent association specializing in customer experience maturity assessments and audits. The label confirms that the evaluated organization has implemented tools, frameworks and cultural practices aligned with ISO 23592 and has demonstrated a commitment to innovation and continuous improvement in customer experiences.About The Stevie® Awards
Stevie Awards are conferred in nine programs: the Asia-Pacific Stevie Awards, the German Stevie Awards, the Middle East & North Africa Stevie Awards, The American Business Awards®, The International Business Awards®, the Stevie Awards for Great Employers, the Stevie Awards for Sales & Customer Service, the Stevie Awards for Technology Excellence, and the Stevie Awards for Women in Business. Stevie Awards competitions receive more than 12,000 entries each year from organizations in more than 70 nations and territories. More than 1,000 professionals around the world participate in the Stevie Awards judging process each year. Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide. Learn more about the Stevie Awards at http://www.StevieAwards.com.Source: QuidelOrtho CorporationInvestor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.comMedia Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/quidelortho-receives-excellence-services-label-in-emea-and-two-stevie-awards-302676865.htmlSOURCE QuidelOrtho Corporation
Original: QuidelOrtho Receives Excellence Services Label in EMEA and Two Stevie® Awards
sidesh0wb0b
18年前
Income Statement Get Income Statement for: QDEL
View: Annual Data | Quarterly Data All numbers in thousands
PERIOD ENDING 31-Mar-08 31-Dec-07 30-Sep-07 30-Jun-07
Total Revenue 40,865 37,981 27,570 18,580
Cost of Revenue 14,127 15,146 11,159 9,316
Gross Profit 26,738 22,835 16,411 9,264
Operating Expenses
Research Development 3,067 3,081 3,128 3,282
Selling General and Administrative 8,959 7,248 8,213 7,846
Non Recurring - - - -
Others 1,151 1,342 1,329 1,298
Total Operating Expenses - - - -
Operating Income or Loss 13,561 11,164 3,741 (3,162)
Income from Continuing Operations
Total Other Income/Expenses Net 516 406 440 526
Earnings Before Interest And Taxes 14,077 11,570 4,181 (2,636)
Interest Expense 175 178 182 193
Income Before Tax 13,902 11,392 3,999 (2,829)
Income Tax Expense 5,352 3,286 1,579 (1,117)
Minority Interest - - - -
Net Income From Continuing Ops 8,550 8,106 2,420 (1,712)
Non-recurring Events
Discontinued Operations - - - -
Extraordinary Items - - - -
Effect Of Accounting Changes - - - -
Other Items - - - -
Net Income 8,550 8,106 2,420 (1,712)
Preferred Stock And Other Adjustments - - - -
Net Income Applicable To Common Shares $8,550 $8,106 $2,420 ($1,712)
sidesh0wb0b
18年前
Form 10-Q for QUIDEL CORP /DE/
25-Apr-2008
Quarterly Report
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
In this quarterly report, all references to "we," "our" and "us" refer to Quidel Corporation and its subsidiaries.
Future Uncertainties and Forward-Looking Statements
This Report on Form 10-Q contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially. As a result, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, seasonality, the timing of onset, length and severity of cold and flu seasons, uncertainty surrounding the detection of novel influenza viruses involving human specimens, adverse changes in the competitive and economic conditions in domestic and international markets, actions of our major distributors, technological changes and uncertainty with research and technology development, including any future molecular-based technology, the reimbursement system currently in place and future changes to that system, manufacturing and production delays or difficulties, adverse actions or delays in product reviews by the U.S. Food and Drug Administration (the "FDA"), intellectual property, product liability, environmental or other litigation, required patent license fee payments not currently reflected in our costs, potential inadequacy of booked reserves and possible impairment of goodwill, and lower-than-anticipated sales or market penetration of our new products. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," and similar words, although some forward-looking statements are expressed differently. The risks described under "Risk Factors" in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2007, and elsewhere herein and in reports and registration statements that we file with the Securities and Exchange Commission (the "SEC") from time to time, should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this Quarterly Report. The following should be read in conjunction with the Consolidated Financial Statements and notes thereto beginning on page 3 of this Quarterly Report. Except as required by law, we undertake no obligation to publicly release the results of any revision or update of these forward-looking statements.
Overview
We have a leadership position in the development, manufacturing and marketing of rapid diagnostic solutions at the point-of-care ("POC") in infectious diseases and reproductive and women's health. We focus on POC testing solutions specifically developed for the physician office lab and acute care markets globally. We sell our products to professionals for use in physician offices, hospitals, clinical laboratories, retail clinics and wellness screening centers. We market our products in the U.S. through a network of national and regional distributors, supported by a direct sales force. Internationally, we sell and market primarily in Japan and Europe by channeling products through distributor organizations and sales agents.
Our total revenues increased to $40.9 million for the three months ended March 31, 2008 from $33.9 million for the three months ended March 31, 2007. This growth was largely driven by increased domestic sales of our infectious disease products and included the impact of the timing of the 2007/2008 flu season. We continued to focus our efforts to strengthen market and brand leadership in infectious disease and reproductive and women's health by delivering economic and clinical proof through our Quidel Value Build™ ("QVB™") program.
We derive a significant portion of our total revenue from two product categories. For the three months ended March, 31 2008 and 2007, we derived approximately 92% and 88%, respectively, of our total revenue from sales of our infectious disease and reproductive and women's health categories. Additionally, we derive a significant portion of our total revenue from a relatively small number of distributors. Approximately 56% and 52% of our total revenue for the three months ended March 31, 2008 and 2007, respectively, were derived from sales through our four largest distributors.
Outlook
For fiscal year 2008, we anticipate continued year-over-year revenue growth in our infectious disease and reproductive and women's health product lines. We expect gross margins will continue to be positively affected by a more favorable product and geographical mix, increased unit volumes and to a lesser extent overall increased average selling prices. While we experienced significant year-over-year growth of our immunoassay fecal occult blood ("iFOB") test in 2007, we continue to expect a gradual conversion of the fecal occult blood test market from the current guaiac-based test to an immunochemical-based test. Successful conversion of this market requires changing physician behavior through education, focused in part on clinical and economic validation. Additionally, we expect our QuickVue® RSV test for the qualitative detection of respiratory syncytial virus ("RSV") to be a well-received companion test to our QuickVue® Influenza test so that physicians are well prepared to diagnose and appropriately manage patients with influenza and/or RSV. We received Clinical Laboratory Improvement Amendments of 1988 ("CLIA") waiver on our RSV test in February 2008. Internationally, we expect our previously announced global alliance with bioMérieux to increase the reach of our products to markets around the world. Consistent with recent historical periods, the Company has grown operating expenses at a rate less than our revenue growth rate, and we expect this to continue for fiscal 2008.
Results of Operations
Total Revenues and Gross Margin
Three months ended March 31, 2008 compared to three months ended March 31, 2007
The following table compares revenues and gross margin for the three months
ended March 31, 2008 and 2007 (in thousands, except percentages):
For the three months
ended March 31,
------------------------- $ increase % increase
2008 2007 (decrease) (decrease)
---------- ---------- ------------ ----------
Net product sales $ 40,614 $ 33,654 $ 6,960 21 %
Royalty income 251 280 (29 ) (10 )%
---------- ---------- ------------ ----------
Total revenues $ 40,865 $ 33,934 $ 6,931 20 %
---------- ---------- ------------ ----------
sidesh0wb0b
18年前
Quidel Corporation Q1 2008 Earnings Call Transcript
Quidel Corporation (QDEL)
Q1 2008 Earnings Call
April 23, 2008 5:00 pm ET
Executives
John Radak - CFO
Caren Mason - President and CEO
Analysts
Jeff Frelick - Lazard Capital Markets
Un Kwon-Casado - Pacific Growth Equities
Keay Nakae from Collins Stewart
Zarak Khurshid - Caris & Company
Scott Gleason - Stephens Inc
Steven Crowley - Craig-Hallum
Presentation
Operator
Good day, ladies and gentlemen, and welcome to the Quidel first quarter 2008 conference call. My name is Cynthia, and I will be your operator for today's call. (Operator Instructions) As a reminder, this call is being recorded for replay purposes.
I would now like to turn the call over to your host, Mr. John Radak, Chief Financial Officer. Please proceed.
John Radak
Thank you, and good afternoon to everyone. Thank you for participating in today's call. Joining me today is our President and Chief Executive Officer, Caren Mason. Earlier this afternoon Quidel released financial results for its three months ended March 31, 2008. If you've not received this news release, or if you would like to be added to the Company's distribution list, please call, Rachel Lipsit at Porter Novelli Life Sciences, at 619-849-5378.
Please note that this conference call will include forward-looking statements within the meaning of federal securities laws. It is possible that actual results and performance could differ materially from these stated expectations. For a discussion of risk factors, please review Quidel's Annual Report on Form 10-K and subsequent quarterly reports on Form 10-Q as filed with the SEC.
Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, today, April 23, 2008. Quidel undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
Turning to the financial results for the first quarter of 2008. We are very pleased with our business performance this quarter, as our margin expansion continued on double-digit revenue growth. Total revenues for the first quarter were $40.9 million, a 20% increase over the same quarter a year ago. We saw very strong growth in the U.S. market, where revenues increased 26% over Q1 of 2007. As expected, our international revenues declined 13%, largely as a result of continued pricing and reimbursement issues in the Japan flu market.
Excluding Japan flu sales, our international business posted a 48% revenue growth over Q1 of 2007. For the first quarter of 2008, worldwide infectious disease revenues increased 34% to $32.2 million, compared to $24 million in the first quarter of 2007. As we discussed on our previous earnings call, we experienced a shift in normal distribution reorders of our QuickVue influenza test from December of '07 into the first quarter of '08, contributing to record domestic quarterly flu growth of 80%. While a portion of this growth can be attributed to the impact of the late influenza season.
The primary growth drivers also include additional flu test adoption, higher test utilization and increased acute-care market share, all in the U.S. If we compare the '07 and '08 flu season to the '06 to '07 flu season, our domestic test sales increased 44%, and we expect distributor's to have an appropriate level of inventory heading into next year's flu season.
Also contributing to the infectious disease growth was a very solid performance from our RSV test, as a result of gains in the acute-care market. Even though, we received CLIA waiver for our QuickVue RSV test in late February, it was too late in the quarter, for a meaningful contribution from the physician office market. However, we have high expectations for this product next season, as we have already begun to market it to physician offices. In the first quarter of this year, revenues from our reproduct in women's health product family were $5.5 million, compared to $5.9 million, a decline of 6% from the corresponding quarter of 2007. The softness in the first quarter is not unusual given the strong performance of this product category in the fourth quarter of 2007.
Revenues from our other product lines, which include fecal immunochemical test, FIT, for colorectal cancer screening, and our veterinary product line, were $3.1 million in the first quarter of 2008, compared to $4 million in the first quarter of the prior year. The majority of this decline came from our veterinary products that had an exceptionally strong Q1 of 2007. Gross margin came in at 65.4% for the first quarter, a 360 basis point improvement over last year's first quarter, primarily due to higher than normal flu test sales in the quarter.
***more at***
http://seekingalpha.com/article/74418-quidel-corporation-q1-2008-earnings-call-transcript?source=yahoo
sidesh0wb0b
18年前
QDEL financials
PERIOD ENDING 31-Dec-07 30-Sep-07 30-Jun-07 31-Mar-07
Total Revenue 37,981 27,570 18,580 33,934
Cost of Revenue 15,146 11,159 9,316 12,952
Gross Profit 22,835 16,411 9,264 20,982
Operating Expenses
Research Development 3,081 3,128 3,282 3,364
Selling General and Administrative 7,248 8,213 7,846 8,351
Non Recurring - - - -
Others 1,342 1,329 1,298 1,524
Total Operating Expenses - - - -
Operating Income or Loss 11,164 3,741 (3,162) 7,743
Income from Continuing Operations
Total Other Income/Expenses Net 406 440 526 402
Earnings Before Interest And Taxes 11,570 4,181 (2,636) 8,145
Interest Expense 178 182 193 183
Income Before Tax 11,392 3,999 (2,829) 7,962
Income Tax Expense 3,286 1,579 (1,117) 3,145
Minority Interest - - - -
Net Income From Continuing Ops 8,106 2,420 (1,712) 4,817
Non-recurring Events
Discontinued Operations - - - -
Extraordinary Items - - - -
Effect Of Accounting Changes - - - -
Other Items - - - -
Net Income 8,106 2,420 (1,712) 4,817
Preferred Stock And Other Adjustments - - - -
Net Income Applicable To Common Shares $8,106 $2,420 ($1,712) $4,817
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