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QuidelOrtho (QDEL) - 2025 Q1 - Quarterly Results
2024-05-08 20:07
Exhibit 99.1 May 8, 2024 QuidelOrtho Reports First Quarter 2024 Financial Results - Global year-over-year revenue growth of 5% as reported and 6% in constant currency, excluding COVID-19 revenue - - Cost reduction initiatives well underway, headcount reductions expected to deliver approximately $100 million in annualized savings - - Company suspends 2024 financial guidance while it assesses business under new President and Chief Executive Officer - First Quarter 2024 Results and Recent Highlights SAN DIEGO, ...
QuidelOrtho (QDEL) - 2023 Q4 - Annual Report
2024-02-29 20:29
Global Operations - QuidelOrtho operates globally with manufacturing facilities in the U.S. and U.K., serving customers in over 130 countries[17]. - The company operates in over 130 countries with approximately 2,900 commercial sales, service, and regional marketing teammates, supporting a broad global footprint[34]. - The company manages its business geographically, with reportable segments including North America, EMEA, and China[18]. Product Offerings and Innovation - The company generated revenue primarily from Labs, Transfusion Medicine, Point of Care, and Molecular Diagnostics business units[21]. - The QuickVue At-Home OTC COVID-19 test was introduced to new markets, including school districts and health departments[18]. - The Vitros XT 7600 integrated system offers 40% greater test throughput and a 98% up-time guarantee for e-connected U.S. customers[23]. - The Savanna platform can run up to 12 unique analytes from a single patient sample in less than 25 minutes[25]. - The Triage platform aids in diagnosing critical conditions, potentially reducing hospital admissions and improving clinical outcomes[26]. - QuidelOrtho's molecular diagnostics include the Lyra and Solana platforms, which provide high-quality testing for infectious diseases[25]. - The company completed a business combination with Ortho Clinical Diagnostics, enhancing its diagnostic capabilities[18]. - QuidelOrtho's product portfolio includes over 60 immunoassay tests, utilizing enhanced chemiluminescent technology for precision[23]. - The strategic focus includes expanding into the at-home testing market, with plans for additional tests such as for flu and RSV, reflecting a response to evolving healthcare needs[37]. Research and Development - R&D expenses increased to $246.8 million for fiscal year 2023, up from $190.5 million in 2022 and $95.7 million in 2021, indicating a strong commitment to innovation and product development[41]. - The company aims to leverage third-party partnerships and acquisitions to enhance R&D capabilities and accelerate time to market for innovative offerings[39]. Supply Chain and Manufacturing - The company operates multiple manufacturing facilities in the U.S. and internationally, all certified to ISO 13485:2016 and MDSAP medical device standards, ensuring compliance with quality management systems[52][53][54][55][56][57][58]. - The company is diversifying its supply base and creating redundancy in its global supply chain to mitigate supply chain challenges[61]. - In fiscal years 2023 and 2022, the company faced increasing pressures on raw material pricing, although the pressures were less severe in 2023 compared to 2022[61]. Regulatory Compliance - The company’s diagnostic products are primarily marketed in the U.S. under 510(k) clearances and PMA approvals, which are subject to rigorous FDA regulations[70][73]. - The FDA can authorize emergency use of unapproved medical products during public health emergencies, which has applied to some of the company's respiratory products[71]. - The company must adhere to various healthcare-related laws regulating fraud, abuse, and marketing practices[87]. - The company is subject to various privacy, data security, and data protection laws, including HIPAA and GDPR, which impose significant compliance obligations and potential fines of up to €20 million or 4% of total worldwide annual turnover[90]. - The company is subject to routine inspections by the FDA and other regulatory agencies to ensure compliance with applicable requirements, including the FDA's Quality System Regulation[189]. Financial Performance and Market Risks - Sales of respiratory products accounted for approximately 24% of total revenues for the year ended December 31, 2023[127]. - A significant portion of revenues is generated from a limited number of product families, particularly respiratory products, which have higher gross margins compared to other core products[128]. - The company faces risks from global market conditions, including economic downturns, inflation, and geopolitical instability, which could adversely affect sales and profitability[125]. - The company relies on a small number of key distributors for sales, and the loss of any of these distributors could significantly disrupt business operations[129]. - The company may experience challenges in achieving market acceptance of new products, which could impact future sales levels[145]. Employee and Corporate Governance - As of December 31, 2023, the company had approximately 7,100 employees worldwide, with 4,200 in the U.S. and 2,900 outside the U.S.[101]. - Approximately 15% of global associates are covered by a union or collective bargaining agreement, with no work stoppages reported to date[101]. - The executive management team consists of 8 members, with 25% identifying as female, and the board of directors has 27% female representation[107]. - The company plans to conduct periodic pulse surveys throughout 2024 to measure employee engagement and satisfaction[103]. - Employee benefits include health insurance, retirement plans with employer match, and various voluntary benefits tailored to individual needs[108]. Environmental and Social Responsibility - The company is committed to maintaining compliance with environmental regulations, with no expected material impact on financial position from current compliance costs[110]. - The company aims to align corporate actions with environmental sustainability and social responsibility to positively impact communities and stakeholders[113]. - The company has established a charitable giving program that includes matching employee contributions up to $200 annually and donations for volunteer work[115]. Cybersecurity and Intellectual Property - Cybersecurity risks pose a threat to the company's information systems, which are critical for business operations and may lead to costly disruptions[164]. - The company employs various measures to mitigate cybersecurity risks, including technical, physical, and organizational security measures, but vulnerabilities remain due to evolving threats[166]. - The company holds significant intellectual property, including patents and trade secrets, which are crucial for maintaining competitive advantage in the diagnostic market[171]. - Failure to protect intellectual property rights could lead to loss of market share or the need to reduce prices due to competition from lower-priced products[172].
QuidelOrtho (QDEL) - 2023 Q4 - Earnings Call Presentation
2024-02-14 02:09
Supplemental Combined Financial Measures: This presentation contains unaudited supplemental combined financial information ("Supplemental Combined Information") that gives effect to the Combinations as if Quidel and Ortho had been combined for the applicable periods. Certain Supplemental Combined Information presented is based on the historical financial statements of Quidel and Ortho with reclassification adjustments only and do not include all of the pro forma adjustments required under Regulation S-X Art ...
QuidelOrtho (QDEL) - 2023 Q4 - Earnings Call Transcript
2024-02-14 02:09
QuidelOrtho Corporation (NASDAQ:QDEL) Q4 2023 Earnings Conference Call February 13, 2024 5:00 PM ET Company Participants Juliet Cunningham - VP, IR Douglas Bryant - President & CEO Joseph Busky - CFO Conference Call Participants Andrew Brackmann - William Blair Alex Nowak - Craig-Hallum Casey Woodring - JPMorgan Jack Meehan - Nephron Research Conor McNamara - RBC Andrew Cooper - Raymond James Patrick Donnelly - Citi John Sourbeer - UBS Operator Welcome to the QuidelOrtho Fourth Quarter and Full Year 2023 Fi ...
QuidelOrtho (QDEL) - 2023 Q3 - Earnings Call Transcript
2023-11-02 01:32
QuidelOrtho Corporation (NASDAQ:QDEL) Q3 2023 Earnings Conference Call November 1, 2023 5:00 PM ET Company Participants Juliet Cunningham - VP, IR Douglas Bryant - President and CEO Joseph Busky - CFO Conference Call Participants Patrick Donnelly - Citi Alex Nowak - Craig-Hallum Jack Meehan - Nephron Research Andrew Cooper - Raymond James John Sourbeer - UBS Operator Welcome to the QuidelOrtho Third Quarter 2023 Financial Results Conference Call and Webcast. At this time, all participant lines are in a list ...
QuidelOrtho (QDEL) - 2024 Q3 - Quarterly Report
2023-11-01 22:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________________________________________ FORM 10-Q ____________________________________________________________________________ (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended October 1, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Comm ...
QuidelOrtho (QDEL) - 2023 Q3 - Earnings Call Presentation
2023-11-01 21:10
November 1, 2023 QuidelOrtho 2023 Third Quarter 2023 Financial Results Forward-Looking Statements Forward-Looking Statements: This presentation of QuidelOrtho Corporation ("QuidelOrtho" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include any statement contained herein that is not strictly historical, including, but not limited to, QuidelOrtho's commercial, regulatory and other strategic goals, financial ...
QuidelOrtho (QDEL) - 2023 Q2 - Earnings Call Presentation
2023-08-10 07:38
Forward-Looking Statements QuidelOrtho Financial Results 2Q 2023 Forward-Looking Statements: This presentation of QuidelOrtho Corporation ("QuidelOrtho" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include any statements contained herein that are not strictly historical, including, but not limited to, the synergies and other benefits and results of the business combination (the "Combinations") of Quidel C ...
QuidelOrtho (QDEL) - 2023 Q2 - Earnings Call Transcript
2023-08-09 00:54
QuidelOrtho Corporation (NASDAQ:QDEL) Q2 2023 Earnings Call August 8, 2023 5:00 PM ET Company Participants Bryan Brokmeier - Vice President of Investor Relations Douglas C. Bryant - President and Chief Executive Officer Joseph M. Busky - Chief Financial Officer Conference Call Participants Andrew Cooper - Raymond James Alex Nowak - Craig-Hallum Capital Group Jack Meehan - Nephron Research Casey Woodring - JPMorgan Operator Welcome to the QuidelOrtho Second Quarter 2023 Financial Results Conference Call and ...
QuidelOrtho (QDEL) - 2024 Q2 - Quarterly Report
2023-08-08 22:11
[PART I—FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=3&type=section&id=ITEM%201.%20Financial%20Statements%20(unaudited)) The company's financials reflect a business shift post-Ortho combination, with declining respiratory sales causing a net loss and reduced operating cash flow [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) Total assets and liabilities decreased slightly, while stockholders' equity saw a minor increase as of July 2, 2023 Consolidated Balance Sheet Highlights (in millions) | Account | July 2, 2023 | January 1, 2023 | | :--- | :--- | :--- | | **Total Assets** | **$8,550.3** | **$8,855.8** | | Cash and cash equivalents | $178.6 | $292.9 | | Accounts receivable, net | $246.7 | $453.9 | | Goodwill | $2,470.9 | $2,476.8 | | **Total Liabilities** | **$3,547.8** | **$3,921.2** | | Long-term borrowings | $2,308.5 | $2,430.8 | | **Total Stockholders' Equity** | **$5,002.5** | **$4,934.6** | [Consolidated Statements of (Loss) Income](index=4&type=section&id=Consolidated%20Statements%20of%20(Loss)%20Income) The company shifted from net income to a net loss in Q2 and H1 2023 due to lower COVID-19 product sales and higher operating expenses Key Income Statement Data (in millions, except per share data) | Metric | Q2 2023 | Q2 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $665.1 | $613.4 | $1,511.2 | $1,615.7 | | Operating (loss) income | $(26.9) | $79.7 | $72.7 | $700.4 | | Net (loss) income | $(53.2) | $19.3 | $(4.4) | $499.2 | | Diluted (loss) EPS | $(0.80) | $0.36 | $(0.07) | $10.47 | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operations decreased significantly, while investing and financing activities resulted in a net cash reduction for the period Six-Month Cash Flow Summary (in millions) | Activity | Six Months Ended July 2, 2023 | Six Months Ended July 3, 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $158.3 | $725.6 | | Net cash used for investing activities | $(111.2) | $(1,555.1) | | Net cash (used for) provided by financing activities | $(159.3) | $409.7 | | **Net decrease in cash** | **$(114.3)** | **$(422.2)** | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) Notes detail the Ortho business combination, revenue disaggregation, debt structure, and the use of derivative hedging instruments - The business combination with Ortho was consummated on May 27, 2022, for a total consideration of approximately **$4.3 billion**, with goodwill adjusted downward by **$23.9 million** in H1 2023[27](index=27&type=chunk)[28](index=28&type=chunk)[29](index=29&type=chunk) Revenue by Business Unit (in millions) | Business Unit | Q2 2023 | Q2 2022 | YTD 2023 | YTD 2022 | | :--- | :--- | :--- | :--- | :--- | | Labs | $361.4 | $157.4 | $732.1 | $170.7 | | Transfusion Medicine | $163.3 | $68.2 | $319.2 | $68.2 | | Point of Care | $134.2 | $367.1 | $442.3 | $1,310.1 | | Molecular Diagnostics | $6.2 | $20.7 | $17.6 | $66.7 | - The company's long-term borrowings primarily consist of a **$2.75 billion** senior secured term loan facility, with an outstanding balance of approximately **$2.52 billion** as of July 2, 2023[61](index=61&type=chunk) - The company utilizes interest rate swaps and foreign currency forward contracts to hedge against market risks, with total notional amounts of over **$1.8 billion** and **$865.0 million**, respectively[81](index=81&type=chunk)[84](index=84&type=chunk)[177](index=177&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the financial impact of the Ortho combination, highlighting a revenue mix shift and decreased profitability from lower COVID-19 sales [Overview and Outlook](index=23&type=section&id=Overview%20and%20Outlook) The business combination transformed the revenue profile, with respiratory products declining significantly while the company navigates supply chain issues - Revenues from respiratory products fell to approximately **23% of total revenues** in H1 2023, down from **78%** in the prior year, due to declining COVID-19 product sales[100](index=100&type=chunk) - The company is experiencing ongoing supply chain challenges, including raw material shortages, logistics issues, and rising labor costs[102](index=102&type=chunk) - For the remainder of 2023, the company expects fluctuating respiratory product demand but anticipates revenue growth in its core, non-respiratory products[106](index=106&type=chunk)[107](index=107&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) H1 2023 revenues decreased 6% as a sharp drop in Point of Care sales offset growth from the Ortho combination, compressing gross margins Six Months Ended July 2, 2023 vs. July 3, 2022 (in millions) | Line Item | YTD 2023 | YTD 2022 | % Change | | :--- | :--- | :--- | :--- | | **Total revenues** | **$1,511.2** | **$1,615.7** | **(6)%** | | Cost of sales | $766.2 | $536.2 | 43% | | *Gross Margin %* | *49.3%* | *66.8%* | *N/A* | | Selling, marketing and administrative | $381.5 | $203.2 | 88% | | Research and development | $125.1 | $60.6 | 106% | | **Operating income** | **$72.7** | **$700.4** | **(90)%** | - The decrease in Point of Care revenue for the first six months was driven by a **$698.1 million** decline in QuickVue SARS Antigen assays and a **$169.7 million** decline in Sofia assays[110](index=110&type=chunk) [Segment Results](index=27&type=section&id=Segment%20Results) North America revenue declined due to lower COVID-19 sales, while international segments grew substantially from the Ortho business combination Six-Month Revenue by Segment (in millions) | Segment | YTD 2023 | YTD 2022 | % Change | | :--- | :--- | :--- | :--- | | North America | $961.6 | $1,399.7 | (31)% | | EMEA | $161.9 | $57.3 | 183% | | China | $151.9 | $82.3 | 85% | | Other | $235.8 | $76.4 | 209% | Six-Month Adjusted EBITDA by Segment (in millions) | Segment | YTD 2023 | YTD 2022 | % Change | | :--- | :--- | :--- | :--- | | North America | $454.7 | $952.6 | (52)% | | EMEA | $12.5 | $16.2 | (23)% | | China | $58.7 | $39.2 | 50% | | Other | $58.1 | $34.3 | 69% | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains sufficient liquidity through cash and its credit facility despite a significant decrease in operating cash flow Liquidity Position (in millions) | Item | July 2, 2023 | January 1, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $178.6 | $292.9 | | Total cash, cash equivalents and marketable securities | $248.4 | $366.0 | | Amount available under Revolving Credit Facility | $787.1 | $786.9 | - The company was in compliance with all financial covenants under its Credit Agreement as of July 2, 2023[147](index=147&type=chunk) - The company is increasingly using a reagent rental model, transferring **$67.3 million** of instrument inventories to Property, Plant, and Equipment in H1 2023[160](index=160&type=chunk)[161](index=161&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to interest rate and foreign currency risks, which it manages using derivative hedging instruments - The company has significant interest rate risk from its variable rate debt; a **0.125%** rate change would impact annual interest expense by approximately **$4.1 million** before hedges[168](index=168&type=chunk) - To manage interest rate risk, the company has entered into interest rate swap agreements with a total notional value expected to increase to **$1.8 billion** in December 2023[171](index=171&type=chunk) - With **45% of Q2 2023 revenue** from outside the U.S., the company uses foreign currency forward contracts with a notional amount of **$865.0 million** to manage FX risk[173](index=173&type=chunk)[177](index=177&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes to internal controls during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period, July 2, 2023[180](index=180&type=chunk) - No changes occurred in the company's internal control over financial reporting during the second fiscal quarter that have materially affected, or are reasonably likely to materially affect, these controls[181](index=181&type=chunk) [PART II—OTHER INFORMATION](index=35&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=35&type=section&id=ITEM%201.%20Legal%20Proceedings) Current legal actions are not expected to have a material adverse effect on the company's financial condition or operations - Management believes that current legal actions, in aggregate, are not expected to have a material adverse effect on the company's financial condition or results of operations[71](index=71&type=chunk)[183](index=183&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=ITEM%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since its last Annual Report on Form 10-K - No material changes in risk factors were reported since the company's 2022 Annual Report on Form 10-K[184](index=184&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company repurchased shares to satisfy employee tax obligations, with $225.7 million remaining under its authorized repurchase program - The company repurchased **35,005 shares** during the quarter, which were surrendered by employees to satisfy tax withholding obligations on vested stock awards[186](index=186&type=chunk) - A stock repurchase program authorized on August 17, 2022, allows for up to **$300.0 million** in repurchases, with approximately **$225.7 million** remaining available as of July 2, 2023[186](index=186&type=chunk)[187](index=187&type=chunk) [Item 6. Exhibits](index=36&type=section&id=ITEM%206.%20Exhibits) This section lists filed exhibits, including corporate governance documents and required CEO/CFO Sarbanes-Oxley certifications - The exhibits include certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[192](index=192&type=chunk)