[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)

PART I—FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=ITEM%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited consolidated financial statements for QuidelOrtho Corporation for the quarterly period ended April 2, 2023, including various statements and detailed notes on accounting policies [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets) The Consolidated Balance Sheet as of April 2, 2023, shows total assets of **$8.79 billion**, a slight decrease from **$8.86 billion** at the beginning of the year, with total liabilities decreasing to **$3.79 billion** from **$3.92 billion**, and total stockholders' equity increasing to **$5.00 billion** from **$4.93 billion** Consolidated Balance Sheet Highlights (in millions) | Account | April 2, 2023 | January 1, 2023 | | :--- | :--- | :--- | | **Total Assets** | **$8,787.1** | **$8,855.8** | | Total Current Assets | $1,498.9 | $1,575.1 | | Goodwill | $2,491.3 | $2,476.8 | | Intangible assets, net | $3,078.5 | $3,123.8 | | **Total Liabilities** | **$3,790.6** | **$3,921.2** | | Total Current Liabilities | $907.8 | $1,007.0 | | Long-term borrowings | $2,379.6 | $2,430.8 | | **Total Stockholders' Equity** | **$4,996.5** | **$4,934.6** | [Consolidated Statements of Income](index=4&type=section&id=Consolidated%20Statements%20of%20Income) For the three months ended April 2, 2023, total revenues were **$846.1 million**, a decrease from **$1,002.3 million** in the prior-year period, leading to a significant decline in net income to **$48.8 million** from **$479.9 million** Consolidated Statement of Income (in millions, except per share data) | Metric | Three Months Ended April 2, 2023 | Three Months Ended April 3, 2022 | | :--- | :--- | :--- | | Total revenues | $846.1 | $1,002.3 | | Operating income | $99.6 | $620.7 | | Net income | $48.8 | $479.9 | | Diluted earnings per share | $0.73 | $11.31 | [Consolidated Statements of Cash Flows](index=7&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the first three months of 2023, net cash provided by operating activities was **$188.9 million**, a decrease from **$500.9 million** in the same period of 2022, resulting in a net increase in cash of **$61.0 million** Cash Flow Summary (in millions) | Activity | Three Months Ended April 2, 2023 | Three Months Ended April 3, 2022 | | :--- | :--- | :--- | | Net cash provided by operating activities | $188.9 | $500.9 | | Net cash used for investing activities | $(68.9) | $(24.7) | | Net cash used for financing activities | $(59.6) | $(3.4) | | **Net increase in cash** | **$61.0** | **$472.7** | [Notes to Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes provide detailed explanations of the company's accounting policies and financial results, covering topics such as the Ortho business combination, revenue recognition, segment information, and long-term borrowings - The business combination with Ortho Clinical Diagnostics Holdings plc was completed on May 27, 2022, with Quidel considered the accounting and legal acquirer. The total consideration was approximately **$4.3 billion**[31](index=31&type=chunk)[32](index=32&type=chunk) - For the three months ended April 2, 2023, sales of COVID-19 products accounted for **26%** of total revenues, a significant decrease from **83%** in the same period of 2022[42](index=42&type=chunk) - The company entered into a credit agreement on May 27, 2022, which includes a **$2.75 billion** senior secured term loan and an **$800.0 million** revolving credit facility[64](index=64&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=21&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's Q1 2023 financial performance, highlighting a **16%** revenue decrease due to declining COVID-19 testing demand, the impact of the Ortho business combination, and the outlook for core product growth [Overview and Outlook](index=21&type=section&id=Overview%20and%20Outlook) The company's Q1 2023 revenue decreased by **16%** year-over-year, primarily due to a sharp decline in respiratory product sales, with an outlook anticipating fluctuating COVID-19 test demand but growth in core non-respiratory products - Total revenues for Q1 2023 decreased by **16%** to **$846.1 million** compared to the prior year[100](index=100&type=chunk) - Revenues from respiratory products accounted for approximately **31%** of total revenues in Q1 2023, down from **93%** in Q1 2022[100](index=100&type=chunk) - The company expects demand for COVID-19 testing products to continue to fluctuate, but anticipates revenue growth for its core products (excluding respiratory) for the remainder of 2023[106](index=106&type=chunk)[107](index=107&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) Total revenues for Q1 2023 fell **16%** to **$846.1 million**, driven by decreased Point of Care and Molecular Diagnostics sales, partially offset by growth in Labs and Transfusion Medicine units due to the Ortho combination, leading to a sharp drop in operating income Revenues by Business Unit (in millions) | Business Unit | Q1 2023 | Q1 2022 | % Change | | :--- | :--- | :--- | :--- | | Labs | $370.7 | $13.3 | 2,687% | | Transfusion Medicine | $155.9 | — | N/A | | Point of Care | $308.1 | $943.0 | (67)% | | Molecular Diagnostics | $11.4 | $46.0 | (75)% | | **Total revenues** | **$846.1** | **$1,002.3** | **(16)%** | - Cost of sales increased to **47.0%** of total revenues, compared to **26.0%** in the prior year, driven by new product sales from the Combinations[111](index=111&type=chunk) - Operating expenses increased significantly, with Selling, marketing and administrative expenses up **138.7%** and R&D expenses up **136.0%**, primarily due to the business combination[113](index=113&type=chunk)[114](index=114&type=chunk) [Segment Results](index=25&type=section&id=Segment%20Results) North America revenues declined **39%** due to lower COVID-19 test demand, while EMEA, China, and Other segments experienced substantial revenue growth of **435%**, **711%**, and **559%** respectively, primarily driven by the Ortho business inclusion Segment Total Revenues (in millions) | Segment | Q1 2023 | Q1 2022 | % Change | | :--- | :--- | :--- | :--- | | North America | $582.8 | $961.5 | (39)% | | EMEA | $81.3 | $15.2 | 435% | | China | $70.6 | $8.7 | 711% | | Other | $111.4 | $16.9 | 559% | Segment Adjusted EBITDA (in millions) | Segment | Q1 2023 | Q1 2022 | % Change | | :--- | :--- | :--- | :--- | | North America | $278.4 | $713.4 | (61)% | | EMEA | $7.2 | $3.5 | 106% | | China | $28.5 | $3.8 | 650% | | Other | $21.8 | $9.5 | 129% | [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of April 2, 2023, the company's liquidity included **$353.9 million** in cash and cash equivalents and **$787.0 million** available under its Revolving Credit Facility, deemed sufficient to fund operations for at least the next 12 months Sources of Liquidity (in millions) | Source | April 2, 2023 | January 1, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $353.9 | $292.9 | | Total cash, cash equivalents and marketable securities | $430.5 | $366.0 | | Amount available to borrow under Revolving Credit Facility | $787.0 | $786.9 | - The company's Credit Agreement includes a **$2.75 billion** Term Loan and an **$800.0 million** Revolving Credit Facility, both maturing on May 27, 2027[130](index=130&type=chunk)[131](index=131&type=chunk) - The company is focused on expanding instrument placements through a reagent rental model, which lowers upfront customer costs and is expected to grow the installed base and increase sales of higher-margin consumables[144](index=144&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to market risks from interest rate fluctuations on variable-rate debt and foreign currency exchange rate volatility, which it manages using derivative instruments for hedging purposes - The company is subject to interest rate risk on its variable rate debt, including a **$2.75 billion** Term Loan and an **$800.0 million** Revolving Credit Facility. A **0.125%** change in interest rates would impact annual interest expense by approximately **$4.2 million** before hedges[152](index=152&type=chunk) - To mitigate interest rate risk, the company has entered into interest rate swap agreements with a total notional value of **$1.3 billion** through December 2023, increasing to **$1.8 billion** subsequently[154](index=154&type=chunk) - Approximately **33%** of total revenues for Q1 2023 were derived from operations outside the U.S., exposing the company to foreign currency exchange risk. The company uses foreign currency forward contracts to manage this exposure, with a total notional amount of **$970.7 million** outstanding as of April 2, 2023[156](index=156&type=chunk)[160](index=160&type=chunk) [Controls and Procedures](index=31&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of April 2, 2023, with ongoing integration of the acquired Ortho business's internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of April 2, 2023[162](index=162&type=chunk) - As of April 2, 2023, the company is in the process of integrating the internal controls of the acquired Ortho business[163](index=163&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is involved in various legal proceedings, but management believes the aggregate outcome of current actions will not have a material adverse effect on the company - The company accrues for legal claims when losses become probable and reasonably estimable. Management does not expect current legal actions to have a material adverse effect on the company[72](index=72&type=chunk)[73](index=73&type=chunk)[165](index=165&type=chunk) [Risk Factors](index=32&type=page&id=ITEM%201A.%20Risk%20Factors) There have been no material changes to the company's risk factors since those disclosed in its Annual Report on Form 10-K for the fiscal year ended January 1, 2023 - No material changes have occurred in the company's risk factors from those previously disclosed in the 2022 Annual Report on Form 10-K[166](index=166&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2023, the company repurchased **107,155** shares of common stock at an average price of **$88.07** per share to satisfy tax withholding obligations, with approximately **$225.7 million** remaining under its stock repurchase program Issuer Purchases of Equity Securities (Q1 2023) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | Jan 2 - Jan 29, 2023 | **1,988** | $85.69 | | Jan 30 - Feb 26, 2023 | **92,488** | $88.22 | | Feb 27 - Apr 2, 2023 | **12,679** | $87.33 | | **Total** | **107,155** | **$88.07** | - The shares were surrendered to the company to satisfy minimum tax withholding obligations and were not part of a publicly announced repurchase program[168](index=168&type=chunk) - As of April 2, 2023, approximately **$225.7 million** remained available for repurchase under the company's stock repurchase program authorized on August 17, 2022[168](index=168&type=chunk)[169](index=169&type=chunk) [Exhibits](index=33&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, new material agreements, and certifications by the Principal Executive Officer and Principal Financial Officer - Exhibits filed include certifications by the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[174](index=174&type=chunk) - A Special Advisor Agreement with Randall Steward and an Amended and Restated Individual Retirement Program for Werner Kroll are listed as new exhibits[174](index=174&type=chunk)

In terms of capital deployment in the first quarter, we paid down $52 million of debt working towards the $206 million minimum payments in 2023. And while we did not buy back any shares in the quarter, we intend to maintain a balanced and opportunistic approach to share repurchases while also continuing to prioritize our debt paydown going forward. Notably, following the end of the quarter, we made our final $40 million payment to Abbott for the $680 million purchase of the Alere cardiometabolic assets. We ...

• Non-respiratory revenue up 7% y/y on a supplemental combined basis QuidelOrtho – Proprietary & Confidential. | © 2023. All Rights Reserved. 8 • China strength was driven by the end of lockdowns Non-GAAP Financial Measures: This presentation contains financial measures, including but not limited to "constant currency" revenue changes, "adjusted net income," "adjusted diluted EPS," "adjusted EBITDA," "adjusted EBITDA margin," "supplemental combined adjusted net income," "supplemental combined adjusted dilut ...

February 15, 2023 QuidelOrtho Financial Results 4Q & FY 2022 © 2023. All Rights Reserved. 2 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. You can identify these statements in this presentation by words such as "may," "will," "would," "expect," "anticipate," "believe," "estimate," "plan," "intend," "continue" o ...

Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $866.5 million, a 36% increase year-over-year, with supplemental combined revenue for the full year at $4.1 billion [137] - Adjusted EBITDA for the quarter was $245.1 million, with an adjusted EBITDA margin of 28.3%, which contracted year-over-year [177] - Adjusted earnings per fully diluted share for Q4 was $1.76, compared to $5.12 in the same quarter of 2021 [178] Business Line Data and Key Metrics Changes - Labs unit revenue declined 10% year-over-year, primarily due to lockdowns in China, but would have been up mid-single digits if normalized for those impacts [138] - Transfusion Medicine revenue was flat at 1%, while Point-of-Care revenue surged by 138% and Molecular Diagnostics revenue increased by 45% [138] - Revenue excluding COVID-related revenue for Q4 was $734 million, up 18.6% in constant currency [105] Market Data and Key Metrics Changes - North America revenue grew 38%, while EMEA declined 3%, and China saw a significant decline of 27% [12] - The company expects strong double-digit growth in China, excluding COVID-related revenue, driven by increased demand and new product launches [19][55] - The overall market for Point-of-Care is healthy and expected to deliver strong revenue growth in 2023 [180] Company Strategy and Development Direction - The company is focusing on three key growth drivers: Sofia, Savanna, and VITROS systems, with over 85,000 Sofia instruments installed worldwide [141] - A joint venture with Shanghai Runda Medical aims to develop and manufacture VITROS assays in China, enhancing market responsiveness [122] - The company plans to bucket COVID-19 revenue with other respiratory revenues moving forward, reflecting a transition to an endemic state [152] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a strong 2023, with expectations of a normal respiratory season and a rebound in Labs business [184] - The company anticipates a two-year CAGR for revenue, excluding COVID, in line with a long-term outlook of 6% to 9% [184] - Management noted that the headwinds previously anticipated may not be as significant as originally thought, setting a positive tone for future growth [128] Other Important Information - The company ended the quarter with cash, cash equivalents, and marketable securities of $366 million, and total debt of $2.6 billion [179] - The integration of Quidel and Ortho is ahead of schedule, with over 70% of interim state milestones completed [125] - The company realized approximately $15 million in cost synergies last year and expects to exceed the 2023 target of $30 million [126] Q&A Session Summary Question: What are the expectations for the respiratory business in 2023? - Management expects a reasonable first quarter driven by COVID, with a more typical respiratory season anticipated in Q4 [94][95] Question: Can you provide granularity on the molecular diagnostics forecast for 2023? - Management indicated that Savanna sales in Europe are expected to drive strong growth within the Molecular Diagnostics business [181] Question: How does the company view the impact of government contracts on future revenue? - The company has secured significant government contracts for COVID tests, which are expected to contribute to revenue in the upcoming quarters [174][175]

Financial Data and Key Metrics Changes - The underlying base business grew 6% year-over-year despite industrywide headwinds, with constant currency revenue growth, excluding COVID-related revenue, growing 3% [8][49] - Adjusted EBITDA margin was 29%, and adjusted EPS was $1.85, reflecting strong operating leverage and solid earnings for the quarter [9][63] - Total revenue for Q3 was $784 million, a year-over-year decrease of 22% in constant currency, primarily due to a decline in COVID-related revenue [49][59] Business Line Data and Key Metrics Changes - Point-of-care revenue declined 39% in the quarter but grew 29% when excluding COVID-related revenue, driven by increased respiratory testing [50] - Labs revenue declined 5% in the quarter, and molecular diagnostics revenue declined 72%, with a focus on Savanna in Europe and select CE Mark countries [51][52] - Transfusion medicine revenue grew 1%, with mid-single-digit growth in donor screening driven by plasma demand [51] Market Data and Key Metrics Changes - North America revenue declined 29%, while EMEA grew 1% and China declined 13% [52] - Excluding COVID-related revenue, North America revenue grew 6%, driven by point-of-care and transfusion medicine [53] - In EMEA, the underlying base business grew 6% year-over-year, excluding COVID-related revenue [54] Company Strategy and Development Direction - The company is focused on integration and corporate culture, product innovation, global commercial excellence, operational excellence, and capital deployment [10][11] - Cost synergies identified are at least $50 million, exceeding the $30 million target for 2023 [19] - The company is managing approximately 100 R&D projects, prioritizing resources for the most important projects [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the integration process and the potential for strong growth in the point-of-care market [76] - The company expects to see strong non-COVID recurring revenue pull-through due to a large base of Sofia instrument placements [68] - Challenges in China and global supply chains are acknowledged, but the company remains optimistic about future growth in the region [56][70] Other Important Information - The company announced a $300 million share repurchase authorization, reflecting confidence in its long-term growth strategy [43] - The company ended the quarter with cash and marketable securities of $284.3 million and total debt of $2.7 billion [66] - Adjusted free cash flow for the second half of 2022 is expected to be in the range of $130 million to $150 million [64] Q&A Session Summary Question: Update on Savanna timelines - Management indicated that while U.S. shipments may be delayed, they will focus on European sales where demand is strong, with no significant changes to revenue expectations [80][81] Question: Thoughts on cost basis and margins - Management noted that as COVID moves to an endemic stage, margins on COVID-related products are expected to align more closely with other respiratory panels, maintaining historical gross margins [86][87] Question: Instrument supply chain issues - Management acknowledged that the backlog of 600 units is primarily on the lab side, with expectations to make significant progress in winding it down throughout 2023 [92][95] Question: High single-digit growth expectations for 2023 - Management confirmed that high single-digit growth is still expected, driven by various business units, with EBITDA estimates remaining in the $850 million to $900 million range [99][100] Question: Endemic market numbers for COVID testing - Management provided a conservative estimate of $150 million to $200 million for the endemic stage, focusing on respiratory season demand rather than asymptomatic testing [106][107]

| --- | --- | |-----------------------------------|-------| | | | | | | | Forging the Future of Diagnostics | | | Financial Results 3Q 2022 | | Forward-Looking Statements Forward-Looking Statements: This presentation of QuidelOrtho Corporation ("QuidelOrtho" or the "Company") contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements and other forward-looking statements in this presentation by words such as "may," "will ...

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 July 3, 2022 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commi ...

Financial Data and Key Metrics Changes - QuidelOrtho reported supplemental combined revenue of $898.5 million for Q2 2022, reflecting a 37.5% growth year-over-year [12][52] - Adjusted EBITDA margin was 32%, with adjusted EPS growth exceeding 100% [12][63] - Excluding COVID-related revenue, total revenue increased by 9% year-over-year [53] Business Line Data and Key Metrics Changes - Point of care revenue grew by 181% in Q2, with a 19% increase when excluding COVID-related revenues [54] - Labs revenue grew by 3%, and 6% excluding COVID-related revenues, driven by strength in clinic and asset revenue [54] - Transfusion Medicine revenue increased by 9%, while Molecular diagnostics revenue declined by 40% [54] Market Data and Key Metrics Changes - North America revenue grew by 59%, while EMEA grew by 6% and China by 25% [55] - Excluding COVID-related revenue, North America grew by 16%, EMEA by 8%, and China declined by 10% [55] Company Strategy and Development Direction - The integration of Quidel and Ortho is the top priority, with over 240 integration milestones achieved [16][19] - Five strategic priorities include integration and corporate culture, product innovation, global commercial excellence, operational excellence, and capital deployment [14][47] - Significant investments in R&D are planned to advance product pipelines and expand market penetration [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cost synergies and maintaining a focus on growth despite macroeconomic challenges [81][108] - The company anticipates a strong performance in the point of care market and expects mid-single-digit growth in labs and transfusion medicine businesses [66] - Inflation and global supply chain disruptions are ongoing challenges, but improvements in semiconductor access are expected [67] Other Important Information - The company plans to host an investor day on December 13, 2022, to provide deeper insights into growth initiatives [74][75] - The company has a strong balance sheet with cash and marketable securities of $446.7 million and total debt of $2.7 billion [65] Q&A Session Summary Question: Can you provide more detail on the different business segments as we move to the third and fourth quarter? - Management indicated that Q3 is typically a softer quarter and will share guidance for the second half [78][79] Question: How should we think about next year in terms of numbers and business segments? - Management expects to deliver on cost synergies and anticipates high single-digit to low double-digit growth excluding COVID revenue [80][81] Question: Can you provide clarity on the EPS guidance and how it relates to the second half of the year? - Management noted that Q3 is historically a low quarter, with the majority of EPS expected to fall into Q4 [89][90] Question: What are the sales figures for the Sofia business in the quarter? - Sofia revenue increased by approximately 25% year-over-year, primarily driven by volume [93][94] Question: What is the status of the Savanna timeline for 510-K approval? - The company expects to submit the 510-K by the end of the year, with a full launch in Europe planned [97][99] Question: How do you view the long-term EBITDA margin target of 30%? - Management remains committed to the 30% target but acknowledges challenges due to inflation and supply chain issues [106][108]