Teleflex Inc: Form 10-Q for the period ended Oct 1, 2023

Overview

Teleflex Incorporated (“we,” “us,” “our" and “Teleflex”) is a global provider of medical technology products focused on enhancing clinical benefits, improving patient and provider safety and reducing total procedural costs. We primarily design, develop, manufacture and supply single-use medical devices used by hospitals and healthcare providers for common diagnostic and therapeutic procedures in critical care and surgical applications. We market and sell our products worldwide through a combination of our direct sales force and distributors. Because our products are used in numerous markets and for a variety of procedures, we are not dependent upon any one end-market or procedure. We are focused on achieving consistent, sustainable and profitable growth by increasing our market share and improving our operating efficiencies.

We evaluate our portfolio of products and businesses on an ongoing basis to ensure alignment with our overall objectives. Based on our evaluation, we may identify opportunities to divest businesses and product lines that do not meet our objectives. In addition, we may seek to optimize utilization of our facilities through restructuring initiatives designed to further improve our cost structure and enhance our competitive position. We also may continue to explore opportunities to expand the size of our business and improve operating margins through a combination of acquisitions and distributor to direct sales conversions, which generally involve our elimination of a distributor from the sales channel, either by acquiring the distributor or terminating the distributor relationship (in some instances, particularly in Asia, the conversions involve our acquisition or termination of a master distributor and the continued sale of our products through sub-distributors or through new distributors). Distributor to direct sales conversions are designed to facilitate improved product pricing and more direct access to the end users of our products within the sales channel.

In May 2023, our Board of Directors approved the termination of the Teleflex Incorporated Retirement Income Plan (the “TRIP”), a U.S. defined benefit plan, effective as of August 1, 2023. The TRIP is subject to the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), and is intended to be tax-qualified under Section 401(a) of the Internal Revenue Code of 1986, as amended (“Code”). Participation in and accrual of benefits under the TRIP have been frozen since 2012, and, as of October 1, 2023, the TRIP assets exceeded the liabilities. In June 2023, we notified participants of our intent to terminate the TRIP and requested a determination letter from the Internal Revenue Services (“IRS”) stating that the TRIP satisfies the requirements, in form, to be tax-qualified under Code Section 401(a) upon termination. In September 2023, a notice of benefits was sent to participants, beneficiaries and alternate payees in connection with the proposed termination. Participants, beneficiaries and alternate payees who had not started their TRIP benefits were offered the opportunity to elect to receive their benefits in the form of a lump sum distribution in connection with the termination of the TRIP or to commence their benefits in the form of monthly annuity payments in accordance with TRIP terms. Because the TRIP is an ERISA plan, the termination is subject to approval by the Pension Benefit Guaranty Corporation (“PBGC”). In September 2023, we filed a termination notice with the PBGC for approval. After the termination has been approved by the PBGC, one or more annuity contracts with a qualifying insurer(s) will be purchased to provide TRIP benefits that have not already been distributed. While we expect to proceed with the termination, we may decide not to proceed for certain reasons including, for example, if the cost to terminate the TRIP exceeds our current expectations. Should the Company proceed with the termination, participants, beneficiaries, and alternate payees will each receive the full value of their benefit under the TRIP, paid either from TRIP assets or from an annuity contract purchase as described under this paragraph.

Upon settlement of the TRIP, we are required to remeasure the plan assets and obligation and will recognize a settlement loss for the recognition of the unrecognized losses in accumulated other comprehensive income including the effects of the remeasurement. As of October 1, 2023, the pre-tax accumulated other comprehensive loss related to the TRIP was approximately $200 million. We expect to recognize a portion of the settlement charge during the fourth quarter of 2023, when eligible participants who elect the lump sum option receive their payments, and we expect to recognize the remainder of the settlement charge upon annuitization of the TRIP benefits, which we expect to occur during 2024. Based on notices we have processed from participants electing the lump sum option to receive their payments, we estimate we will recognize a settlement charge of between $45 million and $55 million during the fourth quarter of 2023.

On July 25, 2023, we executed a definitive agreement to acquire Palette Life Sciences AB (“Palette”), a privately held medical device company that sells a portfolio of hyaluronic acid gel-based products primarily utilized in the treatment of urology diseases including a rectal spacing product used in connection with radiation therapy treatment of prostate cancer. The acquisition will complement our interventional urology product portfolio. On October 10,

2023, we completed the acquisition of Palette using borrowings under our revolving credit facility and cash on hand. Under the terms of the agreement, we acquired Palette for an initial cash payment of $600 million, with additional consideration of up to $50 million payable upon the achievement of certain commercial milestones.

Results of Operations

As used in this discussion, "new products" are products for which commercial sales have commenced within the past 36 months, and “existing products” are products for which commercial sales commenced more than 36 months ago. Discussion of results of operations items that reference the effect of one or more acquired and/or divested businesses or assets (except as noted below with respect to acquired distributors) generally reflects the impact of the acquisitions and/or divestitures within the first 12 months following the date of the acquisition and/or divestiture. In addition to increases and decreases in the per unit selling prices of our products to our customers, our discussion of the impact of product price increases and decreases also reflects the impact on the pricing of our products resulting from the elimination of the distributor, either through acquisition or termination of the distributor, from the sales channel. All of the dollar amounts in the tables are presented in millions unless otherwise noted.

Certain financial information is presented on a rounded basis, which may cause minor differences.

Net revenues

Net revenues for the three months ended October 1, 2023 increased $59.6 million, or 8.7%, compared to the prior year period, primarily due to a $29.9 million increase in sales of new products, price increases and, to a lesser extent, favorable fluctuations in foreign currency exchange rates.

Net revenues for the nine months ended October 1, 2023 increased $167.6 million, or 8.2%, compared to the prior year period, primarily due to a $142.0 million increase in sales of new products and price increases, partially offset by a $31.4 million decrease in sales volume of existing products, notwithstanding the impact of a five-day increase in the number of shipping days during the nine months ended October 1, 2023. The increase in sales of new products and the decrease in sales of volumes of existing products primarily reflect the conversion to the next generation of an existing product.

Gross profit

Gross margin for the three months ended October 1, 2023 increased 140 basis points, or 2.6%, compared to the prior year period, primarily due to price increases, benefits from cost improvement initiatives and lower logistics and distribution related costs, partially offset by continued cost inflation from macro-economic factors, specifically, raw materials and unfavorable fluctuations in foreign currency exchange rates.

Gross margin for the nine months ended October 1, 2023 increased 70 basis points, or 1.3%, compared to the prior year period, primarily due to price increases, lower logistics and distribution related costs and benefits from cost improvement initiatives, partially offset by continued cost inflation from macro-economic factors, specifically, raw materials, an unfavorable impact on manufacturing productivity due to raw material supply and an increase in costs associated with product recalls and quality issues.

On April 4, 2023, one of our Mexican subsidiaries received a notification from the Mexican Federal Tax Administration Service (“SAT”) setting forth its preliminary findings with respect to a foreign trade operations audit carried out by SAT for the period from July 1, 2017 to June 6, 2019. The preliminary findings stated that our Mexican subsidiary did not evidence the export of goods temporarily imported under Mexico’s Manufacturing, Maquila and Export Services Industries Program (“IMMEX Program”), therefore triggering the potential obligation for payment of import duties, value added tax, customs processing fees and other fines and penalties. In response to the notification, our Mexican subsidiary has requested that the matter be referred to the Procuraduría de la Defensa del Contribuyente, or “PRODECON,” (local tax ombudsperson) to help facilitate the process. In June, SAT was provided with the appropriate documentation evidencing the export of the goods in accordance with the requirements of the IMMEX Program.

While we cannot predict with certainty the outcome of this audit, based on currently known information, we do not believe a loss is either probable or estimable. Accordingly, no loss contingency has been recorded in our financial statements as of October 1, 2023 related to this matter. However, if the final resolution of the matter is not favorable to us, our Mexican subsidiary may be required to make payment of certain import duties, fines and surcharges, which could be material.

Selling, general and administrative

Selling, general and administrative expenses for the three months ended October 1, 2023 increased $3.6 million, compared to the prior year period primarily due to higher sales expenses across certain of our product portfolios, higher performance related employee-benefit costs, higher expenses incurred by acquired businesses, primarily Standard Bariatrics, unfavorable fluctuations in foreign currency exchange rates and, to a lesser extent, higher IT related costs. The increases in selling, general and administrative expenses were partially offset by a decrease in contingent consideration expense resulting from changes in the estimated fair value of our contingent consideration liabilities.

Selling, general and administrative expenses for the nine months ended October 1, 2023 increased $38.8 million, compared to the prior year period primarily due to higher sales expenses across certain of our product portfolios, higher operating expenses incurred by acquired businesses, primarily Standard Bariatrics, higher IT related costs and higher performance related employee-benefit costs. The increases in selling, general and administrative expenses were partially offset by a decrease in contingent consideration expense resulting from changes in the estimated fair value of our contingent consideration liabilities.

Research and development

The decrease in research and development expenses for the three months ended October 1, 2023 compared to the prior year period was primarily attributable to lower expenses related to the European Union Medical Device Regulation related costs, partially offset by higher project spend within certain of our product portfolios and expenses incurred by Standard Bariatrics.

The increase in research and development expenses for the nine months ended October 1, 2023 compared to the prior year period was primarily attributable to higher project spend within certain of our product portfolios and expenses incurred by Standard Bariatrics, partially offset by lower expenses related to the European Union Medical Device Regulation related costs.

Restructuring and impairment charges

Restructuring charges for the three months ended October 1, 2023 primarily consisted of termination benefits related to the 2023 Footprint realignment plan, partially offset by credits due to changes in estimates with respect to termination benefits related to the Respiratory divestiture plan.

Restructuring charges for the nine months ended October 1, 2023 primarily consisted of termination benefits related to the 2023 Footprint realignment plan and the 2022 Restructuring plan, partially offset by credits due to changes in estimates with respect to termination benefits related to the Respiratory divestiture plan.

2023 Footprint Realignment plan

During the third quarter of 2023, we initiated a restructuring plan primarily involving the relocation of certain manufacturing operations to existing lower-cost locations, the outsourcing of certain manufacturing processes and related workforce reductions (the "2023 Footprint realignment plan"). We estimate that we will incur $11 million to $15 million in aggregate pre-tax restructuring and restructuring related charges in connection with the 2023 Footprint Realignment plan. We expect this plan will be substantially completed by the end of 2027.

We expect to begin realizing plan-related savings in 2024 and expect to achieve annual pre-tax savings of $2 million to $4 million once the plan is fully implemented.

Respiratory divestiture plan

We have an ongoing restructuring initiative, initiated in connection with the Respiratory business divestiture, designed to separate the manufacturing operations to be transferred to Medline from those that will remain with Teleflex (the “Respiratory divestiture plan”). We estimate that we will incur aggregate pre-tax restructuring and restructuring related charges in connection with the Respiratory divestiture plan of $22 million to $24 million. We expect this plan will be substantially completed by the end of 2023.

For additional information regarding our restructuring plans, refer to Note 5 within the condensed consolidated financial statements included in this report.

Interest income and expense

The increase in interest expense for the three months ended October 1, 2023 compared to the prior year period was primarily due to higher average interest rates resulting from increases in interest rates associated with our variable interest rate debt instruments and an increase in average debt outstanding.

The increase in interest expense for the nine months ended October 1, 2023 compared to the prior year period was primarily due to higher average interest rates resulting from increases in interest rates associated with our variable interest rate debt instruments.

Interest income for the three and nine months ended October 1, 2023 increased compared to the prior year periods primarily due to higher investments in time deposits and money market mutual funds.

Taxes on income from continuing operations

The effective income tax rates for the three and nine months ended October 1, 2023 reflect the tax impact of a non-taxable contingent consideration adjustment recognized in connection with a decrease in the estimated fair value of our contingent consideration liabilities and tax benefits related to the 2023 Footprint Realignment plan and the 2022 Restructuring plan. The effective income tax rates for all periods reflect a tax benefit from research and development credits.

22

(1) See Note 14 to our condensed consolidated financial statements included in this report for a reconciliation of segment operating profit to our condensed consolidated income from continuing operations before interest and taxes.

Comparison of the three and nine months ended October 1, 2023 and September 25, 2022

Americas

Americas net revenues for the three months ended October 1, 2023 increased $23.1 million, or 5.7%, compared to the prior year period, which was primarily attributable to a $20.6 million increase in sales of new products and price increases, partially offset by a $12.2 million decrease in sales volume of existing products.

Americas net revenues for the nine months ended October 1, 2023 increased $69.0 million, or 5.8%, compared to the prior year period, which was primarily attributable to a $120.6 million increase in sales of new products and price increases, partially offset by a $86.4 million decrease in sales volume of existing products, notwithstanding the impact of a five-day increase in the number of shipping days during the nine months ended October 1, 2023.

The increase in sales of new products and the decrease in sales of volumes of existing products in both periods primarily reflect the conversion to the next generation of an existing product.

Americas operating profit for the three months ended October 1, 2023 increased $19.1 million, or 17.9%, compared to the prior year period, which was primarily attributable to a decrease in contingent consideration expense resulting from changes in the estimated fair value of our contingent consideration liabilities and an increase in gross profit resulting from higher sales and price increases. The increases in operating profit were partially offset by an increase in sales expenses to support higher sales.

Americas operating profit for the nine months ended October 1, 2023 increased $22.8 million, or 7.1%, compared to the prior year period, which was primarily attributable to an increase in gross profit resulting from higher sales and price increases and a decrease in contingent consideration expense resulting from changes in the estimated fair value of our contingent consideration liabilities. The increases in operating profit were partially offset by an increase in sales expenses to support higher sales and an increase in research and development expenses across certain of our product portfolios.

EMEA

EMEA net revenues for the three months ended October 1, 2023 increased $14.3 million, or 11.1%, compared to the prior year period, which was primarily attributable to $8.8 million in favorable fluctuations in foreign currency exchange rates and price increases.

EMEA net revenues for the nine months ended October 1, 2023 increased $23.4 million, or 5.7%, compared to the prior year period, which was primarily attributable to a $8.3 million increase in sales volume of existing products reflecting, in part, the impact of an increase in the number of shipping days, price increases and an increase in sales of new products.

EMEA operating profit for the three and nine months ended October 1, 2023 increased $10.4 million, or 139.2%, and $14.4 million, or 49.3%, respectively, compared to the prior year periods, which was primarily attributable to favorable fluctuations in foreign currency exchange rates and lower expenses related to the European Union Medical Device Regulation within research and development expenses.

Asia

Asia net revenues for the three months ended October 1, 2023 increased $11.2 million, or 13.6%, compared to the prior year period, which was primarily attributable to a $7.6 million increase in sales of new products, an increase in sales volume of existing products and, to a lesser extent, price increases. The increases in net revenues were partially offset by unfavorable fluctuations in foreign currency exchange rates.

Asia net revenues for the nine months ended October 1, 2023 increased $30.8 million, or 13.5%, compared to the prior year period, which was primarily attributable to a $20.1 million increase in sales volume of existing products and a $17.2 million increase in sales of new products, partially offset by unfavorable fluctuations in foreign currency exchange rates.

Asia operating profit for the three and nine months ended October 1, 2023 increased $3.1 million, or 13.5%, and $8.3 million, or 13.5%, respectively, compared to the prior year periods, which was primarily attributable to an increase in gross profit resulting from higher sales, partially offset by unfavorable fluctuations in foreign currency exchange rates and an increase in sales expenses to support higher sales.

OEM

OEM net revenues for the three months ended October 1, 2023 increased $11.0 million, or 15.5%, compared to the prior year period, which was primarily attributable to price increases and a $3.9 million increase in sales volume of existing products.

OEM net revenues for the nine months ended October 1, 2023 increased $44.4 million, or 22.4%, compared to the prior year period, which was primarily attributable to a $26.6 million increase in sales volume of existing products and price increases.

OEM operating profit for the three and nine months ended October 1, 2023 increased $5.1 million, or 27.4%, and $20.1 million, or 42.6%, respectively, compared to the respective prior year periods, which was primarily attributable to an increase in gross profit resulting from price increases and higher sales, partially offset by higher research and development expenses.

Liquidity and Capital Resources

We believe our cash flow from operations, available cash and cash equivalents and borrowings under our revolving credit facility will enable us to fund our operating requirements, capital expenditures and debt obligations for the next 12 months and the foreseeable future. We have net cash provided by United States based operating activities as well as non-United States sources of cash available to help fund our debt service requirements in the United States. We manage our worldwide cash requirements by monitoring the funds available among our subsidiaries and determining the extent to which we can access those funds on a cost effective basis.

On October 4, 2023, the third day of our fourth quarter, the agreements related to our 2018 Cross-currency swap matured resulting in $43.0 million in cash settlement proceeds. On October 2, 2023, we executed new cross-currency swap agreements with six different financial institution counterparties to hedge against the effect of variability in the U.S. dollar to euro exchange rate. Under the terms of the swap agreements, we notionally exchanged $500 million at an interest rate of 4.63% for €474.7 million at an interest rate of 3.05%. The swap agreements, which expire on October 4, 2025, are designated as net investment hedges and require an exchange of the notional amounts upon expiration or the earlier termination of the agreements. We and the counterparties have agreed to effect the exchange through a net settlement. As a result, we may be required to pay (or be entitled to receive) an amount equal to the difference, on the expiration or earlier termination date, between the U.S. dollar equivalent of the €474.7 million notional amount and the $500 million notional amount. The swap agreements entail risk that the counterparties will not fulfill their obligations under the agreements. However, we believe the risk is reduced because we have entered into separate agreements with six different counterparties, all of whom are large, well-established financial institutions. Based on the U.S. dollar to euro currency exchange rate in effect on October 4, 2023, and assuming exchange rates remain constant throughout the two-year term of the swap agreements, we would realize a reduction in annual cash interest expense of $7.9 million.

Cash Flows

Net cash provided by operating activities from continuing operations was $372.4 million for the nine months ended October 1, 2023 as compared to $244.4 million for the nine months ended September 25, 2022. The $128.0 million increase was primarily attributable to favorable operating results, lower tax payments and favorable changes in working capital. The favorable changes in working capital were primarily driven by lower inventory purchases stemming from the build up on inventory in the prior year due to elevated global supply chain volatility.

Net cash used in investing activities from continuing operations was $57.7 million for the nine months ended October 1, 2023, and primarily consisted of $63.8 million of capital expenditures, partially offset by net interest proceeds on swaps designated as net investment hedges of $10.3 million.

Net cash provided by financing activities from continuing operations was $276.0 million for the nine months ended October 1, 2023, and primarily consisted of $324.4 million net proceeds from borrowings resulting from a $600 million draw on our Senior Credit facility to fund the fourth quarter acquisition of Palette, partially offset by previous payments against the Senior Credit facility. Net cash provided by financing activities for the year also reflects $47.9 million in dividend payments.

Borrowings

The indentures governing our 4.625% Senior Notes due 2027 (the “2027 Notes”) and 4.25% Senior Notes due 2028 (the "2028 Notes") contain covenants that, among other things and subject to certain exceptions, limit or restrict our ability, and the ability of our subsidiaries, to create liens; consolidate, merge or dispose of certain assets; and enter into sale leaseback transactions. As of October 1, 2023, we were in compliance with these requirements.

The obligations under our senior credit agreement (the "Credit Agreement"), the 2027 Notes and 2028 Notes are guaranteed (subject to certain exceptions) by substantially all of our material domestic subsidiaries, and the obligations under the Credit Agreement are (subject to certain exceptions and limitations) secured by a lien on substantially all of the assets owned by us and each guarantor.

Summarized Financial Information – Obligor Group

The 2027 Notes are issued by Teleflex Incorporated (the “Parent Company”), and payment of the Parent Company's obligations under the Senior Notes is guaranteed, jointly and severally, by an enumerated group of the Parent Company’s subsidiaries (each, a “Guarantor Subsidiary” and collectively, the “Guarantor Subsidiaries”). The guarantees are full and unconditional, subject to certain customary release provisions. Each Guarantor Subsidiary is directly or indirectly 100% owned by the Parent Company. Summarized financial information for the Parent and Guarantor Subsidiaries (collectively, the “Obligor Group”) as of October 1, 2023 and December 31, 2022 and for the nine months ended October 1, 2023 is as follows:

The same accounting policies as described in Note 1 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022 are used by the Parent Company and each of its subsidiaries in connection with the summarized financial information presented above. The Intercompany column in the table above represents transactions between and among the Obligor Group and non-guarantor subsidiaries (i.e. those subsidiaries of the Parent Company that have not guaranteed payment of the Senior Notes). Obligor investments in non-guarantor subsidiaries and any related activity are excluded from the financial information presented above.

Critical Accounting Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and assumptions.

In our Annual Report on Form 10-K for the year ended December 31, 2022, we provided disclosure regarding our critical accounting estimates, which are reflective of significant judgments and uncertainties, are important to the presentation of our financial condition and results of operations and could potentially result in materially different results under different assumptions and conditions.

New Accounting Standards

See Note 2 to the condensed consolidated financial statements included in this report for a discussion of recently issued accounting guidance, including estimated effects, if any, of adoption of the guidance on our financial statements.

Forward-Looking Statements

All statements made in this Quarterly Report on Form 10-Q, other than statements of historical fact, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “will,” “would,” “should,” “guidance,” “potential,” “continue,” “project,” “forecast,” “confident,” “prospects” and similar expressions typically are used to identify forward-looking statements. Forward-looking statements are based on the then-current expectations, beliefs, assumptions, estimates and forecasts about our business and the industry and markets in which we operate. These statements are not guarantees of future performance and are subject to risks and uncertainties, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements due to a number of factors, including changes in business relationships with and purchases by or from major customers or suppliers; delays or cancellations in shipments; demand for and market acceptance of new and existing products; the impact of inflation and disruptions in our global supply chain on us and our suppliers (particularly sole-source suppliers and providers of sterilization services), including fluctuations in the cost and availability of resins and other raw materials, as well as certain components, used in the production or sterilization of our products, transportation constraints and delays, product shortages, energy shortages or increased energy costs, labor shortages in the United States and elsewhere, and increased operating and labor costs; our inability to integrate acquired businesses into our operations, realize planned synergies and operate such businesses profitably in accordance with our expectations; our inability to effectively execute our restructuring programs; our inability to realize anticipated savings resulting from restructuring plans and programs; the impact of enacted healthcare reform legislation and proposals to amend, replace or repeal the legislation; changes in Medicare, Medicaid and third party coverage and reimbursements; the impact of tax legislation and related regulations; competitive market conditions and resulting effects on revenues and pricing; global economic factors, including currency exchange rates, interest rates, trade disputes, sovereign debt issues, and international conflicts and hostilities, such as the ongoing conflicts in Ukraine and Israel; public health epidemics including the novel coronavirus (referred to as COVID-19); difficulties entering new markets; and general economic conditions. For a further discussion of the risks relating to our business, see Item 1A, Risk Factors, in our Annual Report on Form 10-K for the year ended December 31, 2022. We expressly disclaim any obligation to update these forward-looking statements, except as otherwise explicitly stated by us or as required by law or regulation.

There have been no material changes to the information set forth in Part II, Item 7A of our Annual Report on Form 10-K for the year ended December 31, 2022.

(a) Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures as of the end of the period covered by this report are functioning effectively to provide reasonable assurance that the information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934 is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including the Chief Executive Officer and Chief

Financial Officer, as appropriate to allow timely decisions regarding disclosure. A controls system cannot provide absolute assurance that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.

(b) Change in Internal Control over Financial Reporting

No change in our internal control over financial reporting occurred during our most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

See the information set forth in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2022. There have been no significant changes in risk factors for the quarter ended October 1, 2023.