QuidelOrtho Corp 10-Q

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations In this Quarterly Report on Form 10-Q (the “Quarterly Report”), all references to “we,” “our” and “us” refer to QuidelOrtho Corporation and its subsidiaries. Future Uncertainties and Forward-Looking Statements This Quarterly Report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements include any statements contained herein that are not strictly historical, including, but not limited to, certain statements under Part I, Item 2, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and located elsewhere herein regarding our commercial and other strategic goals, industry prospects, our expected results of operations or financial position, and future plans, objectives, strategies, expectations and intentions. Without limiting the foregoing, the words “may,” “will,” “would,” “should,” “might,” “expect,” “anticipate,” “believe,” “estimate,” “plan,” “intend,” “goal,” “project,” “strategy,” “future,” “continue” 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 our management as of the date of this Quarterly Report 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 to differ from those set forth or implied in the forward-looking statements: the challenges and costs of integrating, restructuring and achieving anticipated synergies as a result of the Combinations (as defined in this Quarterly Report); the ability to retain key employees; and other economic, business, competitive and/or regulatory factors affecting our business generally, including those discussed under Part II, Item 1A, “Risk Factors” of this Quarterly Report and Part I, Item 1A, “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended January 1, 2023. Investors 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. We undertake no obligation to update any of the forward-looking information or time-sensitive information included in this Quarterly Report, whether as a result of new information, future events, changed expectations or otherwise, except as required by law. All forward-looking statements are based on information currently available to us and speak only as of the date of this Quarterly Report. Information Available on Our Website This Quarterly Report and each of our other periodic and current reports, including any amendments thereto, are available, free of charge, on our website, www.quidelortho.com, as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission (the “SEC”). From time to time, we may use our website as a channel of distribution of material information related to the Company. Financial and other material information regarding the Company is routinely posted on and accessible at https://ir.quidelortho.com/. The information contained on or connected to our website is provided for convenience and is not deemed to be incorporated by reference into this Quarterly Report or filed with or furnished to the SEC and should not be considered part of this Quarterly Report. Overview Our mission is to develop and manufacture intelligent diagnostic solutions that transform the power of diagnostics into a healthier future for everyone. Our expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine helps clinicians and patients make better informed decisions across the globe. Our global infrastructure and commercial reach support our customers across more than 130 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. We operate globally with manufacturing facilities in the U.S. and U.K. and with sales centers, administrative offices and warehouses located throughout the world. We currently sell our products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, leading universities, retail clinics, pharmacies, wellness screening centers, other point-of-care settings, blood banks and donor centers, as well as for individual, non-professional, over-the-counter use. We reached new markets as we introduced our QuickVue ® At-Home OTC COVID-19 test for at-home consumer use, school districts, health departments and many other locations. We manage our business geographically to better align with the market dynamics of the specific geographic regions in which we operate, with our reportable segments being North America; Europe, the Middle East and Africa (“EMEA”); and China. Latin America, Japan and Asia Pacific are immaterial operating segments that are not considered reportable segments and are included in “Other.” We generate our revenue primarily in the following business units: Labs, Transfusion Medicine, Point of Care and Molecular Diagnostics. 23 On May 27, 2022, pursuant to the BCA, Quidel and Ortho consummated the Combinations and each of Quidel and Ortho became a wholly owned subsidiary of QuidelOrtho. For additional information about the Combinations, see Note 2 to the unaudited Consolidated Financial Statements. For the six months ended July 2, 2023, Total revenues decreased by 6% to $1,511.2 million as compared to the same period in the prior year. Currency exchange rates had a favorable impact of 100 basis points on our growth rate. Our revenues can be highly concentrated over a small number of products, including certain of our respiratory products. For the six months ended July 2, 2023 and July 3, 2022, revenues related to our respiratory products accounted for approximately 23% and 78% of our Total revenues, respectively, primarily driven by sales of our COVID-19 products. For the six months ended July 2, 2023, no customers individually accounted for more than 10% of our Total revenues. For the six months ended July 3, 2022, one customer and one distributor each represented more than 10% of our Total revenues. COVID-19 Pandemic The healthcare challenge and other impacts surrounding the SARS-CoV-2 virus that emerged in late 2019 and the ensuing global pandemic have presented significant business uncertainty and had a dramatic impact on businesses globally, including ours. On April 10, 2023, H.J.Res. 7 was signed into law, which terminated the national emergency in the U.S. related to the COVID-19 pandemic. As the COVID-19 pandemic transitions to an endemic state, the degree to which it will continue to impact our business operations, strategy, financial condition and results of operations depends on future developments that are uncertain and difficult to predict. Supply Chains As a result of the COVID-19 pandemic and other macroeconomic and geopolitical conditions, including inflationary pressures, general economic slowdown or a recession, rising interest rates, foreign exchange rate volatility and changes in monetary policy, we have experienced shortages and delays in receiving certain raw materials and other components for our products and have experienced logistics and distribution challenges, as well as challenges in labor availability and rising labor costs, all of which have affected our ability to fulfill customer orders, including instrument placements, on a timely basis. Supply chain, production, logistics and distribution challenges, including shortages of raw materials and components, cost inflation, shipping delays, labor availability constraints and rising labor costs, have impacted, and we expect will largely continue for some period of time to impact, our results of operations. Some of our raw materials are available from a limited number of sources. During 2022 and through the second quarter of 2023, we encountered some increasing pressures on raw material pricing. To mitigate these supply chain challenges, we continue to (i) partner with suppliers to invest in additional capacity and raw material inventory, (ii) diversify our supply base, where possible, to minimize reliance on a single source of supply for key raw materials and components and (iii) create redundancy in our global supply chain. In addition, we routinely evaluate our supply chain for potential gaps and continue to take other steps intended to help address continuity. In our distribution operations, we have been investing in and implementing automation capabilities to help improve accuracy and timeliness of customer shipments. We continue to monitor these developments, as well as other international developments, including the Russia-Ukraine conflict, rising tensions between China and Taiwan and localization efforts, and the impact of such factors on our business. We cannot currently predict the frequency, duration or scope of these supply, production, logistics, distribution and labor disruptions and challenges. However, we proactively work with our suppliers, manufacturers, distributors, industry partners and government agencies to address these challenges in our efforts to meet the needs of our customers. Despite our mitigation efforts, such disruptions and challenges have materially affected and could further materially affect our ability to timely manufacture and distribute our products and could unfavorably impact our results of operations depending on the nature and duration of such disruptions and challenges. Outlook Our financial performance and results of operations will depend on future developments and other factors that are highly uncertain, continuously evolving and unpredictable, including the occurrence, spread, severity, duration and emergence of new variants of respiratory diseases, including flu, strep, respiratory syncytial virus (RSV) and COVID-19, as well as the ongoing supply, production and logistics challenges. Demand for our respiratory products, which includes our COVID-19 products, declined in the first half of 2023 compared to prior periods due to the end of the U.S. public health emergency regarding COVID-19, the transition of COVID-19 from a pandemic to an endemic environment, and the early onset of the respiratory season that pulled certain 2023 demand for our respiratory products into the fourth quarter of 2022. For the remainder of the year, we expect demand for our respiratory products to continue to fluctuate and pricing pressures on certain products to persist as a result of a number of factors, including 24 increased supply, emergence and spread of new variants, and the seasonal demands of the cold, flu and RSV, which are typically more prevalent during the fall and winter. With respect to our core products, excluding respiratory products, we anticipate revenue growth for the remainder of 2023. Because our business environment is highly competitive, our long-term growth and profitability will depend in part on our ability to retain and grow our current customers and attract new customers through developing and delivering new and improved products and services that meet our customers’ needs and expectations, including with respect to product performance, product offerings, cost, automation and other work-flow efficiency. As a result, we expect to continue to maintain our emphasis on R&D investments for longer term growth, including for our next generation platforms and assays, as well as additional assays to be launched on our current platforms. In addition, we expect to continue to evaluate strategic opportunities to expand our product lines and services, production capabilities, technologies and geographic footprint and address other business challenges and opportunities. While we expect the revenues and financial results from our respiratory products to be affected by the seasonal demands of the cold, flu and RSV seasons, we intend to continue our focus on prudently managing our business and delivering improved financial results, while at the same time striving to introduce new products and services into the market. Results of Operations Revenues The following table compares Total revenues by business unit for the three and six months ended July 2, 2023 and July 3, 2022: Three Months Ended Six Months Ended (Dollars in millions) July 2, 2023 July 3, 2022 % Change July 2, 2023 July 3, 2022 % Change Labs $ 361.4 $ 157.4 130 % $ 732.1 $ 170.7 329 % Transfusion Medicine 163.3 68.2 139 % 319.2 68.2 368 % Point of Care 134.2 367.1 (63) % 442.3 1,310.1 (66) % Molecular Diagnostics 6.2 20.7 (70) % 17.6 66.7 (74) % Total revenues $ 665.1 $ 613.4 8 % $ 1,511.2 $ 1,615.7 (6) % For the three months ended July 2, 2023, Total revenues increased to $665.1 million from $613.4 million for the same period in the prior year. The increases in Labs and Transfusion Medicine were primarily related to incremental revenues from the Combinations. The decrease in Point of Care was driven primarily by lower demand for QuickVue SARS Antigen assays. Molecular Diagnostics sales decreased by $14.5 million, primarily driven by decreased demand for the Lyra ® SARS Antigen assay. Currency exchange rate did not significantly impact the growth rate for the three months ended July 2, 2023. For the six months ended July 2, 2023, Total revenues decreased to $1,511.2 million from $1,615.7 million for the same period in the prior year. The increases in Labs and Transfusion Medicine were primarily related to incremental revenues from the Combinations. Additionally, the increase in Labs revenue also included a $19.2 million settlement award from a third party related to one of our collaboration agreements. The Point of Care business unit contributed to revenue decline, driven by decreases of $698.1 million in sales of QuickVue SARS Antigen assays and $169.7 million in sales of Sofia ® assays. Molecular Diagnostics sales decreased by $49.1 million, driven primarily by lower demand for the Lyra SARS Antigen assay. Currency exchange rate had a favorable impact of approximately 100 basis points on the growth rate for the six months ended July 2, 2023. Cost of Sales, Excluding Amortization of Intangible Assets Cost of sales, excluding amortization of intangible assets, increased to $368.7 million, or 55.4% of Total revenues, for the three months ended July 2, 2023, compared to $275.9 million, or 45.0% of Total revenues, for the three months ended July 3, 2022. The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by new product sales in the Labs and Transfusion Medicine business units as a result of the Combinations, partially offset by lower sales of QuickVue SARS Antigen assays. Cost of sales, excluding amortization of intangible assets, increased to $766.2 million, or 50.7% of Total revenues, for the six months ended July 2, 2023, compared to $536.2 million, or 33.2% of Total revenues, for the six months ended July 3, 2022. The increase in cost of sales, excluding amortization of intangible assets, was driven primarily by new product sales in the Labs and Transfusion Medicine business units as a result of the Combinations, partially offset by decreases in sales of the QuickVue SARS Antigen assays and Sofia assays as well as decreases in other indirect manufacturing costs. 25 Operating Expenses The following table summarizes operating expenses for the three and six months ended July 2, 2023 and July 3, 2022: Three Months Ended Six Months Ended (Dollars in millions) July 2, 2023 % of Total Revenues July 3, 2022 % of Total Revenues July 2, 2023 % of Total Revenues July 3, 2022 % of Total Revenues Selling, marketing and administrative $ 179.1 26.9 % $ 118.4 19.3 % $ 381.5 25.2 % $ 203.2 12.6 % Research and development 62.8 9.4 % 34.2 5.6 % 125.1 8.3 % 60.6 3.8 % Amortization of intangible assets 51.4 7.7 % 21.0 3.4 % 102.2 6.8 % 28.1 1.7 % Acquisition and integration costs 24.2 3.6 % 80.2 13.1 % 53.9 3.6 % 83.2 5.1 % Other operating expense, net 5.8 0.9 % 4.0 0.7 % 9.6 0.6 % 4.0 0.2 % Selling, Marketing and Administrative Expenses Selling, marketing and administrative expenses for the three months ended July 2, 2023 increased by $60.7 million, or 51.3%, to $179.1 million from $118.4 million for the same period in the prior year, primarily due to the incremental impact of the Combinations. Selling, marketing and administrative expenses for the six months ended July 2, 2023 increased by $178.3 million, or 87.7%, to $381.5 million from $203.2 million for the same period in the prior year, primarily driven by the incremental impact of the Combinations, partially offset by a decrease in freight expense due to lower sales and shipment volume. Research and Development Expense Research and development expense for the three months ended July 2, 2023 increased by $28.6 million, or 83.6%, to $62.8 million from $34.2 million for the same period in the prior year, primarily due to the incremental impact of the Combinations, as well as increased costs related to our Savanna ® development. Research and development expense for the six months ended July 2, 2023 increased by $64.5 million, or 106.4%, to $125.1 million from $60.6 million for the same period in the prior year, primarily due to the incremental impact of the Combinations, as well as increased costs related to the development of our Savanna, QuickVue OTC assays and Sofia products. Amortization of Intangible Assets Amortization of intangible assets was $51.4 million and $102.2 million for the three and six months ended July 2, 2023, respectively, and $21.0 million and $28.1 million for the three and six months ended July 3, 2022, respectively. The increase in amortization expense in the three and six months ended July 2, 2023 compared to the prior year periods was primarily due to the Combinations. Acquisition and Integration Costs Acquisition and integration costs were $24.2 million and $53.9 million for the three and six months ended July 2, 2023, respectively, and $80.2 million and $83.2 million for the three and six months ended July 3, 2022, respectively. The decrease in costs in the three and six months ended July 2, 2023 was primarily due to acquisition costs attributable to the Combinations in the prior year periods. Other Operating Expense, Net Other operating expense, net was $5.8 million and $9.6 million for the three and six months ended July 2, 2023, respectively, and $4.0 million for each of the three and six months ended July 3, 2022. Other operating expense, net was primarily related to the profit share expense for our Joint Business with Grifols, which we acquired in connection with the Combinations. Non-operating Expenses Interest Expense, Net Interest expense, net was $36.5 million and $10.3 million for the three months ended July 2, 2023 and July 3, 2022, respectively. Interest expense, net was $73.2 million and $11.3 million for the six months ended July 2, 2023 and July 3, 2022, respectively. The increase in interest expense, net in the three and six months ended July 2, 2023 compared to the prior year 26 periods was primarily related to the Term Loan under the Credit Agreement entered into in connection with the Combinations. See Note 8 to the unaudited Consolidated Financial Statements for more information related to our Term Loan. Loss on Extinguishment of Debt Loss on extinguishment of debt was $ 24.0 million for each of the three and six months ended July 3, 2022, and was related to the satisfaction and discharge of the senior notes and termination of the former term loans and revolving credit facility of Ortho, which occurred in connection with the consummation of the Combinations. Other Expense, Net Other expense, net was $1.0 million and $2.5 million for the three months ended July 2, 2023 and July 3, 2022, respectively, and $3.9 million and $1.6 million for the six months ended July 2, 2023 and July 3, 2022, respectively. Other expense, net in the three and six months ended July 2, 2023 and July 3, 2022 was primarily related to net foreign currency losses. Income Taxes For the three months ended July 2, 2023, we recognized an income tax benefit of $11.2 million in relation to loss before income taxes of $64.4 million, resulting in an effective benefit tax rate of 17.4%. For the three months ended July 3, 2022, we recognized a provision for income taxes of $23.6 million in relation to income before income taxes of $42.9 million, resulting in an effective tax rate of 55.0%. For the three months ended July 2, 2023, the effective tax rate for the period differs from the U.S. federal statutory rate primarily due to non-U.S. earnings being taxed at rates that are different than the U.S. statutory rate, operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances, R&D credits and foreign tax credits, partially offset by foreign exchange losses and Global Intangible Low-Tax Income. For the three months ended July 3, 2022, the effective tax rate was impacted primarily by income taxes owed in U.S. states. For the six months ended July 2, 2023, the recognized amount of income tax benefit was not material in relation to loss before income taxes of $4.4 million, resulting in an effective benefit tax rate of 0.7%. For the six months ended July 3, 2022, the Company recognized a provision for income taxes of $164.3 million in relation to income before income taxes of $663.5 million, resulting in an effective tax rate of 24.8%. For the six months ended July 2, 2023, the effective tax rate for the period differs from the U.S. federal statutory rate primarily due to net operating losses in certain subsidiaries not being benefited due to the establishment of valuation allowances and Global Intangible Low-Tax Income, partially offset by U.S. earnings being taxed at rates that are different than the U.S. statutory rate, R&D credit, Foreign Tax Credits and foreign exchange losses. For the six months ended July 3, 2022, the effective tax rate was primarily impacted by income taxes owed in the U.S. states. Segment Results We operate under three geographically-based reportable segments: North America; EMEA; and China. Our operations in Latin America, Japan and Asia Pacific are immaterial operating segments that are not considered reportable segments and are included in “Other.” In the fourth quarter of 2022, we revised the internal allocation of certain global costs primarily between the North America segment and Corporate to better align costs that impact the Company as a whole. Prior periods have been revised to align with the current period presentation. The key indicators that we monitor are as follows: • Total revenues — This measure is discussed in the section entitled “Results of Operations.” • Adjusted EBITDA — Adjusted EBITDA by reportable segment is used by our management to measure and evaluate the internal operating performance of our reportable segments. It is also the basis for calculating certain management incentive compensation programs. We believe that this measurement is useful to investors as a way to analyze the underlying trends in our core business, including at the segment level, consistently across the periods presented and to evaluate performance under management incentive compensation programs. Adjusted EBITDA consists of Net (loss) income before Interest expense, net, Provision for (benefit from) income taxes and depreciation and amortization and eliminates (i) certain non-operating income or expense items, and (ii) impacts of certain noncash, unusual or other items that are included in net (loss) income and that we do not consider indicative of our ongoing operating performance. See Note 5 to the unaudited Consolidated Financial Statements for a reconciliation of Adjusted EBITDA by reportable segment to (Loss) income before provision for income taxes. 27 North America Total revenues and Adjusted EBITDA for North America were as follows: Three Months Ended Six Months Ended (Dollars in millions) July 2, 2023 July 3, 2022 % Change July 2, 2023 July 3, 2022 % Change Total revenues $ 378.8 $ 438.2 (14) % $ 961.6 $ 1,399.7 (31) % Adjusted EBITDA $ 176.3 $ 239.2 (26) % $ 454.7 $ 952.6 (52) % Total revenues were $378.8 million for the three months ended July 2, 2023, compared to Total revenues of $438.2 million for the three months ended July 3, 2022. The decrease was primarily driven by lower demand for the QuickVue SARS Antigen assays, which was partially offset by incremental revenues of $150.2 million from the Combinations. Total revenues wer e $961.6 million for the six months ended July 2, 2023, compared to Total revenues of $1,399.7 million for the six months ended July 3, 2022. The decrease was primarily driven by decreased demand for the QuickVue SARS Antigen assays and the Sofia SARS Antigen assay, partially offset by incremental revenues of $433.8 million from the Combinations. Adjusted EBITDA was $176.3 million for the three months ended July 2, 2023, compared to Adjusted EBITDA of $239.2 million for the three months ended July 3, 2022. The decrease was primarily driven by decreased COVID-19 revenues, partially offset by decreased distribution and selling costs and approximately $50 million of incremental impact of the Combinations. Adjusted EBITDA was $454.7 million for the six months ended July 2, 2023, compared to Adjusted EBITDA of $952.6 million for the six months ended July 3, 2022. The decrease was primarily driven by lower COVID-19 revenues, partially offset by decreased distribution and selling costs and approximately $160 million of incremental impact of the Combinations. EMEA Total revenues and Adjusted EBITDA for EMEA were as follows: Three Months Ended Six Months Ended (Dollars in millions) July 2, 2023 July 3, 2022 % Change July 2, 2023 July 3, 2022 % Change Total revenues $ 80.6 $ 42.1 91 % $ 161.9 $ 57.3 183 % Adjusted EBITDA $ 5.3 $ 12.7 (58) % $ 12.5 $ 16.2 (23) % Total revenues were $80.6 million for the three months ended July 2, 2023, compared to Total revenues of $42.1 million for the three months ended July 3, 2022. The increase was primarily driven by incremental revenues of $44.0 million from the Combinations, partially offset by a decrease in Point of Care revenues, driven by lower sales of the Sofia SARS Antigen assay. Total revenues were $161.9 million for the six months ended July 2, 2023, compared to Total revenues of $57.3 million for the six months ended July 3, 2022. The increase was primarily driven by incremental revenues of $110.1 million from the Combinations, partially offset by a decrease in Point of Care revenues, driven by lower sales of the Sofia SARS Antigen assay. Adjusted EBITDA was $5.3 million for the three months ended July 2, 2023, compared to Adjusted EBITDA of $12.7 million for the three months ended July 3, 2022. The decrease was primarily driven by lower Point of Care revenues and the impact of the Combinations. Adjusted EBITDA was $12.5 million for the six months ended July 2, 2023, compared to Adjusted EBITDA of $16.2 million for the six months ended July 3, 2022. The decrease was primarily driven by lower Point of Care revenues. China Total revenues and Adjusted EBITDA for China were as follows: Three Months Ended Six Months Ended (Dollars in millions) July 2, 2023 July 3, 2022 % Change July 2, 2023 July 3, 2022 % Change Total revenues $ 81.3 $ 73.6 10 % $ 151.9 $ 82.3 85 % Adjusted EBITDA $ 30.2 $ 35.4 (15) % $ 58.7 $ 39.2 50 % Total revenues were $81.3 million for the three months ended July 2, 2023, compared to Total revenues of $73.6 million for the three months ended July 3, 2022. The increase was primarily driven by incremental revenues of $33.5 million from the Combinations, partially offset by lower Point of Care revenues, driven by decreased demand for the QuickVue SARS Antigen assays. 28 Total revenues were $151.9 million for the six months ended July 2, 2023, compared to Total revenues of $82.3 million for the six months ended July 3, 2022. The increase was primarily driven by incremental revenues of $95.0 million from the Combinations, partially offset by lower Point of Care revenues, driven by decreased demand for the QuickVue SARS Antigen assays. Adjusted EBITDA was $30.2 million for the three months ended July 2, 2023, compared to Adjusted EBITDA of $35.4 million for the three months ended July 3, 2022. The decrease was primarily driven by lower Point of Care revenues, partially offset by favorable product mix, decreased selling costs and approximately $4 million of incremental impact of the Combinations. Adjusted EBITDA was $58.7 million for the six months ended July 2, 2023, compared to Adjusted EBITDA of $39.2 million for the six months ended July 3, 2022. The increase was primarily driven by approximately $29 million of incremental impact of the Combinations, favorable product mix and decreased selling costs, partially offset by lower Point of Care revenues. Other Total revenues and Adjusted EBITDA for Other, which includes our Latin America, Japan and Asia Pacific operating segments, were as follows: Three Months Ended Six Months Ended (Dollars in millions) July 2, 2023 July 3, 2022 % Change July 2, 2023 July 3, 2022 % Change Total revenues $ 124.4 $ 59.5 109 % $ 235.8 $ 76.4 209 % Adjusted EBITDA $ 36.3 $ 24.8 46 % $ 58.1 $ 34.3 69 % Total revenues were $124.4 million for the three months ended July 2, 2023, compared to Total revenues of $59.5 million for the three months ended July 3, 2022. The increase was primarily driven by incremental revenues of $72.1 million from the Combinations, partially offset by lower sales of the Sofia SARS Antigen and Solana® SARS assays. Total revenues w ere $235.8 million for the six months ended July 2, 2023, compared to Total revenues of $76.4 million for the six months ended July 3, 2022. The increase was primarily driven by incremental revenues of $177.1 million from the Combinations, partially offset by lower Point of Care revenues, driven primarily by lower demand for QuickVue SARS Antigen and Sofia assays, and lower sales of Solana SARS assay. Adjusted EBITDA was $36.3 million for the three months ended July 2, 2023, compared to Adjusted EBITDA of $24.8 million for the three months ended July 3, 2022. The increase was primarily driven by approximately $18 million of incremental impact of the Combinations, partially offset by lower Point of Care and Molecular Diagnostics revenues. Adjusted EBITDA was $58.1 million for the six months ended July 2, 2023, compared to Adjusted EBITDA of $34.3 million for the six months ended July 3, 2022. The increase was primarily driven by approximately $37 million of incremental impact of the Combinations, partially offset by lower Point of Care revenues. Liquidity and Capital Resources As of July 2, 2023 and January 1, 2023, our principal sources of liquidity consisted of the following: (Dollars in millions) July 2, 2023 January 1, 2023 Cash and cash equivalents $ 178.6 $ 292.9 Marketable securities, current 45.1 52.1 Marketable securities, non-current 24.7 21.0 Total cash, cash equivalents and marketable securities $ 248.4 $ 366.0 Amount available to borrow under the Revolving Credit Facility $ 787.1 $ 786.9 Working capital including cash and cash equivalents and marketable securities, current $ 518.1 $ 568.1 As of July 2, 2023, we had $178.6 million in Cash and cash equivalents, a $114.3 million decrease from January 1, 2023. Our cash requirements fluctuate as a result of numerous factors, including cash generated from operations, progress in R&D, capital expansion projects and acquisition and business development activities. We believe our organizational structure allows us the necessary flexibility to move funds throughout our subsidiaries to meet our operational working capital needs. 29 Debt Capitalization Our Credit Agreement consists of a $2,750.0 million Term Loan and an $800.0 million Revolving Credit Facility. As of July 2, 2023 and January 1, 2023, there were no amounts outstanding under the Revolving Credit Facility. As of July 2, 2023, letters of credit issued under the Revolving Credit Facility totaled $12.9 million, which reduced the available amount under the Revolving Credit Facility to $787.1 million. The Term Loan is subject to quarterly amortization of the principal amount on the last business day of each of our fiscal quarters. The required quarterly payments are 1.875% of the aggregate initial principal amount of the Term Loan through the fiscal second quarter of 2024, and 1.250% thereafter. The final remaining principal installment is due on the maturity date. The Term Loan and the Revolving Credit Facility will mature on May 27, 2027. We must prepay loans outstanding under the Credit Agreement in an amount equal to the Net Cash Proceeds from (i) certain property dispositions and (ii) the receipt of certain other amounts not in the ordinary course of business, such as certain insurance proceeds and condemnation awards, in each case, if not reinvested within a specified time period as contemplated in the Credit Agreement. During the six months ended July 2, 2023, we made $123.1 million in payments on our Term Loan, including a voluntary prepayment of $20.0 million. The Credit Agreement contains affirmative and negative covenants that are customary for credit agreements of this nature. The negative covenants include, among other things, limitations on asset sales, mergers, indebtedness, liens, investments and transactions with affiliates. The Credit Agreement contains two financial covenants: (i) a maximum Consolidated Leverage Ratio (as defined in the Credit Agreement) as of the last day of each fiscal quarter of (a) 4.50 to 1.00 for the Initial Measurement Period, (b) 4.00 to 1.00 for the first four fiscal quarters ending after the Initial Measurement Period and (c) 3.50 to 1.00 for each fiscal quarter thereafter; and (ii) a minimum Consolidated Interest Coverage Ratio (as defined in the Credit Agreement) of 3.00 to 1.00 as of the end of any fiscal quarter for the most recently completed four fiscal quarters. We were in compliance with the financial covenants as of July 2, 2023. In connection with the acquisition of the BNP Business, we paid the final installment payment of $40.0 million during the three months ended July 2, 2023. On March 31, 2023, the Company entered into an amendment to its existing receivables purchase agreement (the “RPA”), by and among Ortho-Clinical Diagnostics US FinanceCo I, LLC (“Ortho FinanceCo I”), as Seller, a wholly owned receivables financing subsidiary of the Company, Wells Fargo Bank, N.A., as administrative agent (the “Agent”), Ortho-Clinical Diagnostics, Inc., as the Master Servicer and as an Originator (“Ortho Inc.”), Quidel Corporation, as an Originator, and certain Purchasers. Under the RPA, as amended, Ortho FinanceCo I may sell receivables in amounts up to a $150.0 million limit, subject to certain conditions, including that, at any date of determination, the aggregate capital paid to Ortho FinanceCo I does not exceed a “capital coverage amount,” equal to an adjusted net receivables pool balance minus a required reserve. Ortho FinanceCo I has guaranteed the prompt payment of the sold receivables, and to secure the prompt payment and performance of such guaranteed obligations, Ortho FinanceCo I has granted a security interest to the Agent, for the benefit of the Purchasers, in all assets of Ortho FinanceCo I. Ortho Inc., in its capacity as Master Servicer under the RPA, is responsible for administering and collecting the receivables and has made customary representations, warranties, covenants and indemnities. The Company has also provided a performance guaranty for the benefit of Ortho FinanceCo I to cause the due and punctual performance by Ortho Inc. of its obligations as Master Servicer. Cash Flow Summary Six Months Ended (In millions) July 2, 2023 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 Effect of exchange rates on cash (2.1) (2.4) Net decrease in cash, cash equivalents and restricted cash $ (114.3) $ (422.2) Six Months Ended July 2, 2023 Cash provided by operating activities was $158.3 million for the six months ended July 2, 2023, and reflected a net loss of $4.4 million and non-cash adjustments of $243.7 million, primarily associated with depreciation and amortization, stock-based compensation expense and accretion of interest on deferred consideration. In addition, we benefited from collections on accounts receivables, which contributed $214.5 million to Cash provided by operating activities, offset by other changes in working capital. 30 Cash used for investing activities was $111.2 million for the six months ended July 2, 2023, and was primarily related to $117.3 million in purchases of property, plant, equipment and intangibles. We also purchased $50.6 million and sold $53.9 million of marketable securities. Cash used for financing activities was $159.3 million for the six months ended July 2, 2023 and was primarily related to payments on long-term borrowings of $123.8 million, payments for deferred consideration of $30.3 million and payments of tax withholdings related to vesting of stock-based awards of $12.5 million. Six Months Ended July 3, 2022 Cash provided by operating activities was $725.6 million for the six months ended July 3, 2022, and reflected net income of $499.2 million and non-cash adjustments of $123.3 million, primarily associated with depreciation and amortization, stock-based compensation expense, net change in operating lease right-of-use assets and liabilities, accretion of interest on deferred consideration, and loss on extinguishment of debt. In addition, we benefited from collections on accounts receivables, which contributed $232.3 million to Cash provided by operating activities. Cash used for investing activities was $1,555.1 million for the six months ended July 3, 2022, and was primarily related to the Combinations. Additionally, we purchased $48.7 million of property, equipment, investments and intangibles, and we also purchased $33.6 million and sold $28.2 million of available-for-sale securities. Cash provided by financing activities was $409.7 million for the six months ended July 3, 2022, and was primarily related to proceeds from long-term borrowings, net of debt issuance costs of $2,734.8 million, payments on long-term borrowings of $2,284.4 million and payments of $37.6 million for contingent and deferred consideration. Liquidity Outlook Short-term Liquidity Outlook Our primary source of liquidity, other than our holdings of Cash and cash equivalents, has been cash flows from operations. Cash generated from operations provides us with the financial flexibility we need to meet normal operating, investing and financing needs. We anticipate that our current Cash and cash equivalents, together with cash provided by operating activities and amounts available under our Revolving Credit Facility, will be sufficient to fund our near-term capital and operating needs for at least the next 12 months. Normal operating needs include the planned costs to operate our business, including amounts required to fund working capital, R&D and capital expenditures. Our primary short-term needs for capital, which are subject to change, include expenditures related to: • interest on and repayments of our long-term borrowings, deferred consideration, contingent consideration and lease obligations; • acquisitions of property, equipment and other fixed assets in support of our manufacturing facility expansions; • the continued advancement of R&D efforts; • our integration of the Ortho business arising from the Combinations; • support of commercialization efforts related to our current and future products, including support of our direct sales force and field support resources; and • potential strategic acquisitions and investments. Due to the risks inherent in the product development process, we are unable to estimate with meaningful certainty the costs we will incur in the continued development of our product candidates for commercialization. Our R&D costs may be substantial as we move product candidates into preclinical and clinical trials and advance our existing product candidates into later stages of development. The primary purposes of our capital expenditures are to invest in manufacturing capacity expansion, acquire certain of our instruments, acquire scientific equipment, purchase or develop IT and implement facility improvements. We plan to fund the capital expenditures with the cash on our balance sheet. We are focused on expanding the number of instruments placed in the field and solidifying long-term contractual relationships with customers. In order to achieve this goal, in certain jurisdictions where it is permitted, we have leveraged a reagent rental model that has been recognized as more attractive to certain customers. In this model, we lease, rather than sell, instruments to our customers. Over the term of the contract, the purchase price of the instrument is embedded in the price of the assays and reagents. Going forward, we intend to increase the number of reagent rental placements in developed markets, a strategy that we believe is beneficial to our commercial goals because it lowers our customers’ upfront capital costs and therefore allows purchasing decisions to be made at the lab manager level. For these same reasons, the reagent rental model also benefits our commercial strategy in emerging markets. We believe that the shift in our sales strategy will grow our installed base, thereby 31 increasing sales of higher-margin assays, reagents and other consumables over the life of the customer contracts and enhancing our recurring revenue and cash flows. During the six months ended July 2, 2023, we transferred $67.3 million of instrument inventories from Inventories to Property, plant and equipment, net, further increasing our investment in property, plant and equipment. Long-term Liquidity Outlook Our future capital requirements and the adequacy of our available funds to service any long-term debt outstanding and to fund working capital expenditures and business development efforts will depend on many factors, including: • our ability to successfully integrate the recently acquired Ortho business and realize cross-selling revenue synergies; • our ability to realize revenue growth from our new technologies and create innovative products in our markets; • outstanding debt and covenant restrictions; • our ability to leverage our operating expenses to realize operating profits as we grow revenue; • competing technological and market developments; and • our entry into strategic collaborations with other companies or acquisitions of other companies or technologies to enhance or complement our product and service offerings. In January 2023, we entered into a lease for warehouse space that has not yet commenced, with total lease payments of approximately $36 million. This lease is expected to commence during the second half of 2023 with a lease term of five years. Seasonality Sales of our respiratory products are subject to, and significantly affected by, the seasonal demands of the cold, flu and RSV seasons, typically more prevalent during the fall and winter. H istorically, sales of our influenza products have varied from year to year based, in large part, on the severity, length and timing of the onset of the cold, flu and RSV season. Recent Accounting Pronouncements There have been no accounting pronouncements issued or adopted during the six months ended July 2, 2023 that are expected to have a material impact on the Company’s financial statements. Critical Accounting Estimates Our discussion and analysis of our financial condition and results of operations are based on our unaudited Consolidated Financial Statements, which have been prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to reserve for contractual rebates, goodwill and intangible assets and income taxes. We base our estimates on historical experience and on various other assumptions that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. A comprehensive discussion of our critical accounting estimates is included in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended January 1, 2023. There were no material changes to our critical accounting estimates during the six months ended July 2, 2023.