What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-04-22 compared with 2024-10-22 · 66 added, 96 removed, 152 unchanged (52% of the section changed)

15 unchanged sentences

industry trends;

general economic conditions, including inflation and other pricing pressures that could decrease our operating margins;

general economic conditions, including inflation, interest rates and other pricing pressures that could impact our operating margins;

expectations regarding consumer behaviors and trends;

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We caution you therefore against relying on these forward-looking statements.

Some of the important factors that could cause actual results to differ from our expectations include regional, national, or global political, economic, business, competitive, market and regulatory conditions and the other important factors included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 in “Item 1A Risk Factors,” “Item 7 Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Item 7A Quantitative and Qualitative Disclosures About Market Risk.

We qualify all of our forward-looking statements by these cautionary statements.

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We believe this combination results in timely and cost-effective delivery of clinical development services for our customers.

We believe that we are a partner of choice for small- and mid-sized biopharmaceutical companies based on our ability to consistently utilize our full-service, disciplined operating model to deliver timely and high-quality results for our customers.

We believe that we are a partner of choice for small-

and mid-sized biopharmaceutical companies based on our ability to consistently utilize our full-service, disciplined operating model to deliver timely and high-quality results for our customers.

We focus on conducting clinical trials across all major therapeutic areas, with particular strength in Oncology, Metabolic Disease, Cardiology, Central Nervous System, or CNS, and Antiviral and Anti-infective, or AVAI.

Our global platform includes approximately 5,900 employees across 43 countries as of September 30, 2024, providing our customers with broad access to diverse markets and patient populations as well as local regulatory expertise and market knowledge.

Our global platform includes approximately 5,900 employees across 44 countries as of March 31, 2025, providing our customers with broad access to diverse markets and patient populations as well as local regulatory expertise and market knowledge.

How We Generate Revenue

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Selling, general and administrative expenses are primarily driven by compensation and related employee benefits, as well as rent, utilities, supplies, software licenses, professional fees (e.g., legal and accounting expenses), bad debt expense, travel, marketing and other operating expenses.

Depreciation is provided on our property and equipment on the straight-line method at rates adequate to allocate the cost of the applicable assets over their estimated useful lives, which is three to five years for computer hardware, software, phone, and medical imaging equipment, five to seven years for furniture and fixtures and other equipment, and thirty to forty years for buildings.

for buildings.

Leasehold improvements are amortized on a straight-line basis over the shorter of the estimated useful life of the improvement or the associated remaining lease term.

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Net new business awards represent gross new business awards received in a period offset by total cancellations in that period.

Net new business awards were $533.7 million and $1,700.3 million for the three and nine months ended September 30, 2024, respectively.

Net new business awards were $611.5 million and $1,742.1 million for the three and nine months ended September 30, 2023, respectively.

Net new business awards were $500.0 million and $615.6 million for the three months ended March 31, 2025 and 2024, respectively.

Backlog represents anticipated future net revenue from net new business awards that have not commenced or are currently in process but not complete.

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dollar denominated backlog.

As of September 30, 2024, our backlog increased by $237.9 million, or 8.8%, to $2,927.4 million compared to $2,689.5 million as of September 30, 2023.

Included within backlog as of September 30, 2024 was approximately $1,610.0 million to $1,630.0 million that we expect to convert to net revenue over the next twelve months, with the remainder expected to convert to net revenue thereafter.

As of March 31, 2025, our backlog decreased by $61.1 million, or 2.1%, to $2,846.0 million compared to $2,907.1 million as of March 31, 2024.

Included within backlog as of March 31, 2025 was approximately $1,600.0 million to $1,620.0 million that we expect to convert to net revenue over the next twelve months, with the remainder expected to convert to net revenue thereafter.

The effect of foreign currency adjustments on backlog was as follows:

favorable foreign currency adjustments of $5.8 million for the three months ended September 30, 2024;

unfavorable foreign currency adjustments of $2.2 million for the nine months ended September 30, 2024;

favorable foreign currency adjustments of $1.3 million for the three months ended September 30, 2023;

and favorable foreign currency adjustments of $5.3 million for the nine months ended September 30, 2023.

favorable foreign currency adjustments of $6.9 million for the three months ended March 31, 2025 and unfavorable foreign currency adjustments of $6.8 million for the three months ended March 31, 2024.

Backlog and net new business award metrics may not be reliable indicators of our future period revenue as they are subject to a variety of factors that may cause material fluctuations from period to period.

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dollars using the following average exchange rates based on data obtained from www.xe.com:

Three Months Ended September 30, Nine Months Ended September 30,

2024 2023 2024 2023

Three Months Ended March 31,

Dollars per Euro:

1.10 1.09 1.09 1.08

Results of Operations

Three Months Ended September 30, 2024 compared to Three Months Ended September 30, 2023

Three Months Ended September 30,

(Amounts in thousands, except percentages) 2024 2023 Change

Revenue, net $ 533,317 $ 492,499 $ 40,818 8.3 %

Direct service costs, excluding depreciation and amortization 171,540 164,364 7,176 4.4 %

Reimbursed out-of-pocket expenses 192,769 194,942 (2,173) (1.1) %

Total direct costs 364,309 359,306 5,003 1.4 %

Selling, general and administrative 49,217 41,407 7,810 18.9 %

Depreciation 7,158 6,329 829 13.1 %

Amortization 360 549 (189) (34.4) %

Total operating expenses 421,044 407,591 13,453 3.3 %

Income from operations 112,273 84,908 27,365

Miscellaneous expense, net (1,025) (1,602) 577

Interest income (expense), net 7,528 (105) 7,633

Income before income taxes 118,776 83,201 35,575

Income tax provision 22,350 12,651 9,699

Net income $ 96,426 $ 70,550 $ 25,876

Nine Months Ended September 30, 2024 compared to Nine Months Ended September 30, 2023

Nine Months Ended September 30,

Three Months Ended March 31, 2025 compared to Three Months Ended March 31, 2024

Three Months Ended March 31,

(Amounts in thousands, except percentages) 2025 2024 Change

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Income from operations 113,523 104,069 9,454

Miscellaneous income (expense), net 3,435 (2,198) 5,633

Interest income (expense), net 17,113 (2,332) 19,445

Miscellaneous (expense) income, net (1,816) 4,593 (6,409)

Interest income, net 6,463 4,120 2,343

Income before income taxes 118,170 112,782 5,388

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Total revenue

Total revenue increased by $40.8 million to $533.3 million for the three months ended September 30, 2024, from $492.5 million for the three months ended September 30, 2023.

Total revenue increased by $185.0 million to $1,572.5 million for the nine months ended September 30, 2024, from $1,387.4 million for the nine months ended September 30, 2023.

The increase for the three months ended September 30, 2024 was primarily driven by growth within the Metabolic, Oncology and Cardiology therapeutic areas, compared to the same period in the prior year.

The increase for the nine months ended September 30, 2024 was broad based, but was primarily driven by growth within the Metabolic, Oncology, Cardiology and other therapeutic areas, compared to the same period in the prior year.

Total revenue increased by $47.5 million, to $558.6 million for the three months ended March 31, 2025, from $511.0 million for the three months ended March 31, 2024.

The increase for the three months ended March 31, 2025 was primarily driven by growth within the Metabolic, Oncology, and Central Nervous System therapeutic areas, compared to the same period in the prior year.

Total direct costs

Total direct costs increased by $5.0 million, to $364.3 million for the three months ended September 30, 2024 from $359.3 million for the three months ended September 30, 2023.

Total direct costs increased by $94.7 million, to $1,094.5 million for the nine months ended September 30, 2024 from $999.7 million for the nine months ended September 30, 2023.

The increase for the three months ended September 30, 2024 was primarily attributed to higher personnel costs to support the growth in service activities, partially offset by lower reimbursed out-of-pocket expenses.

The increase for the nine months ended September 30, 2024 was primarily attributed to higher reimbursed out-of-pocket expenses and higher personnel costs to support the growth in service activities.

The higher personnel costs portion increased by $9.5 million and $41.7 million for the three and nine months ended September 30, 2024, compared to the same periods in the prior year.

Reimbursed out-of-pocket expenses, which can fluctuate significantly from period to period based on the timing of program initiation and closeout, decreased by $2.2 million and increased by $54.1 million for the three and nine months ended September 30, 2024, compared to the same periods in the prior year.

Total direct costs increased by $24.3 million, to $380.2 million for the three months ended March 31, 2025, from $355.9 million for the three months ended March 31, 2024.

The increase was primarily attributed to higher reimbursed out-of-pocket expenses and higher personnel costs to support the growth in service activities.

Reimbursed out-of-pocket expenses, which can fluctuate significantly from period to period based on the timing of program initiation and closeout, increased $18.0 million for the three months ended March 31, 2025, compared to the same period in the prior year.

The higher personnel costs portion increased by $5.4 million for the three months ended March 31, 2025, compared to the same period in the prior year.

Selling, general and administrative

Selling, general and administrative expenses increased by $7.8 million, to $49.2 million for the three months ended September 30, 2024 from $41.4 million for the three months ended September 30, 2023.

Selling, general and administrative expenses increased by $15.9 million, to $134.8 million for the nine months ended September 30, 2024 from $118.8 million for the nine months ended September 30, 2023.

Selling, general and administrative expenses increased by $13.8 million, to $57.9 million for the three months ended March 31, 2025, from $44.1 million for the three months ended March 31, 2024.

The increase was primarily attributed to higher personnel costs to support the growth in service activities.

The higher personnel costs portion increased by $9.5 million and $16.9 million for the three and nine months ended September 30, 2024, compared to the same periods in the prior year.

The higher personnel costs portion increased by $14.6 million for the three months ended March 31, 2025, compared to the same period in the prior year.

Depreciation and Amortization

Depreciation and amortization expense increased by $0.6 million, to $7.5 million for the three months ended September 30, 2024 from $6.9 million for the three months ended September 30, 2023.

Depreciation and amortization expense increased by $2.4 million, to $21.7 million for the nine months ended September 30, 2024 from $19.4 million for the nine months ended September 30, 2023.

The increase was primarily related to increased depreciation related to Property and equipment, net, compared to the same periods in the prior year.

Miscellaneous income (expense), net

Miscellaneous income (expense), net changed by $0.6 million to $1.0 million of expense for the three months ended September 30, 2024 from $1.6 million of expense for the three months ended September 30, 2023.

Miscellaneous income (expense), net changed by $5.6 million to $3.4 million of income for the nine months ended September 30, 2024 from $2.2 million of expense for the nine months ended September 30, 2023.

These changes were mainly attributable to foreign exchange gains and losses that arise in connection with the revaluation of short-term intercompany balances between our domestic and international subsidiaries and from the settlement of third-party accounts receivables and payables denominated in a currency other than the local currency of the entity making the payment, third-party investment gains or losses and proceeds from the recovery of a note receivable.

Interest income (expense), net

Interest income (expense), net changed by $7.6 million to $7.5 million of income for the three months ended September 30, 2024 from $0.1 million of expense for the three months ended September 30, 2023.

Interest income (expense), net changed by $19.4 million to $17.1 million of income for the nine months ended September 30, 2024 from $2.3 million of expense for the nine months ended September 30, 2023.

These changes were mainly attributable to increased interest income on Cash and cash equivalents and a reduction in short-term debt, compared to the same periods in the prior year.

Depreciation and amortization expense of $6.9 million for the three months ended March 31, 2025, remained relatively consistent with $7.0 million for the three months ended March 31, 2024.

Miscellaneous (expense) income, net

Miscellaneous (expense) income, net changed by $6.4 million, to $1.8 million of expense for the three months ended March 31, 2025, from $4.6 million of income for the three months ended March 31, 2024.

The change was mainly attributable to foreign exchange gains and losses that arise in connection with the revaluation of short-term intercompany balances between our domestic and international subsidiaries, gains or losses from foreign currency transactions, such as those resulting from the settlement of third-party accounts receivables and payables denominated in a currency other than the local currency of the entity making the payment and proceeds from the recovery of a note receivable, compared to the same period in the prior year.

Interest income, net

Interest income, net increased by $2.3 million, to $6.5 million for the three months ended March 31, 2025, from $4.1 million for the three months ended March 31, 2024.

This change was mainly attributable to increased interest income on Cash and cash equivalents, compared to the same period in the prior year.

Income tax provision

Income tax provision increased by $9.7 million, to $22.4 million for the three months ended September 30, 2024 from $12.7 million for the three months ended September 30, 2023.

Income tax provision increased by $14.2 million, to $54.7 million for the nine months ended September 30, 2024 from $40.5 million for the nine months ended September 30, 2023.

The overall effective tax rate for the three months ended September 30, 2024 was 18.8%, compared to an overall effective tax rate of 15.2% for the three months ended September 30, 2023.

The overall effective tax rate for the nine months ended September 30, 2024 was 16.0% compared to an overall effective tax rate of 16.5% for the nine months ended September 30, 2023.

The increase in the income tax provision and overall effective tax rate for the three months ended September 30, 2024 was primarily attributable to an increase in pre-tax book income, which was partially offset by an increase in tax benefits related to Foreign Derived Intangible Income (FDII) compared to the same period in the prior year.

The increase in the income tax provision for the nine months ended September 30, 2024 was primarily attributable to an increase in pre-tax book income, which was partially offset by an increase in excess tax benefits recognized from share-based compensation and tax benefits related to FDII compared to the same period in the prior year.

The decrease in the overall effective tax rate for the nine months ended September 30, 2024 was primarily attributable to an increase in excess tax benefits recognized from share-based compensation and tax benefits related to FDII compared to the same period in the prior year.

Income tax provision decreased by $6.6 million, to $3.6 million for the three months ended March 31, 2025, from $10.2 million for the three months ended March 31, 2024.

The overall effective tax rate for the three months ended March 31, 2025 was 3.0%, compared to an overall effective tax rate of 9.0% for the three months ended March 31, 2024.

The decrease in the income tax provision was primarily attributable to an increase in excess tax benefits recognized from share-based compensation, which was partially offset by an increase in pre-tax book income compared to the same period in the prior year.

The decrease in the overall effective tax rate was primarily attributable to an increase in excess tax benefits recognized from share-based compensation compared to the same period in the prior year.

Liquidity and Capital Resources

We assess our liquidity in terms of our ability to generate cash to fund our operating, investing and financing activities.

Our principal sources of liquidity are operating cash flows and from borrowings under our unsecured credit facility consisting of up to a $10.0 million revolving line of credit which we entered into on September 30, 2019 (the “Credit Facility”), and has subsequently been amended.

As of September 30, 2024, we had cash and cash equivalents of $656.9 million which increased from $245.4 million as of December 31, 2023.

Approximately $24.8 million of cash and cash equivalents, none of which was restricted, was held by our foreign subsidiaries as of September 30, 2024.

As of September 30, 2024, we had $10.0 million available for borrowing under the Credit Facility.

Our principal sources of liquidity as of March 31, 2025 are operating cash flows and from borrowings under our unsecured credit facility consisting of up to a $10.0 million revolving line of credit which we entered into on September 30, 2019 (the “Credit Facility”), and has subsequently been amended.

As of March 31, 2025, we had cash and cash equivalents of $441.4 million which decreased from $669.4 million as of December 31, 2024.

Approximately $40.4 million of cash and cash equivalents, none of which was restricted, was held by our foreign subsidiaries as of March 31, 2025.

As of March 31, 2025, we had $10.0 million available for borrowing under the Credit Facility.

On April 18, 2025, the Company entered into Amendment No.

8 to the Loan Agreement, which increased the aggregate principal amount that may be borrowed under the facility’s line of credit to up to $600.0 million, adjusted the interest rate charged on the credit facility and extended the expiration date of revolving credit note to April 30, 2027.

Our expected primary cash needs on both a short and long-term basis are for investment in operational growth, including additional lease commitments, capital expenditures, share repurchases, selective strategic bolt-on acquisitions, other investments, and other general corporate needs.

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We expect to continue expanding our operations through organic growth and potentially highly selective bolt-on acquisitions and investments.

As of September 30, 2024, cash commitments to support

operating business needs include lease liabilities discussed in Note 8 of the Condensed Consolidated Financial Statements, purchase commitments discussed in Note 11 of the Condensed Consolidated Financial Statements and capital expenditures primarily related to infrastructure investments in our facilities, equipment and technology.

Capital spending as a percentage of revenue decreased by 8 basis points to 1.84% in the nine months ended September 30, 2024, compared to the same period in the prior year.

As of March 31, 2025, cash commitments to support operating business needs include lease liabilities discussed in Note 8 of the Condensed Consolidated Financial Statements, purchase commitments discussed in Note 11 of the Condensed Consolidated Financial Statements and capital expenditures primarily related to infrastructure investments in our facilities, equipment and technology.

Capital spending as a percentage of revenue increased by 71 basis points to 1.79% in the three months ended March 31, 2025, compared to the same period in the prior year.

We expect these activities will be funded from existing cash, cash flow from operations and, if necessary, borrowings under our existing or future credit facilities or other debt.

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While we do not anticipate the need to repatriate these foreign earnings for liquidity purposes given our cash flows from operations and borrowings under existing and future credit facilities, we would incur taxes on these earnings if the need for repatriation due to liquidity purposes arises.

Nine Months Ended September 30,

Three Months Ended March 31,

Cash Flows (Amounts in thousands) 2025 2024

Net cash provided by operating activities $ 125,836 $ 152,677

Net cash used in investing activities (20,746) (26,632)

Net cash provided by (used in) financing activities 14,600 (184,165)

Net cash (used in) provided by investing activities (9,987) 2,530

Net cash (used in) provided by financing activities (345,966) 7,660

Effect of exchange rates on cash, cash equivalents and restricted cash 2,117 (1,306)

Increase in cash, cash equivalents and restricted cash $ 411,451 $ 66,942

(Decrease) increase in cash, cash equivalents and restricted cash $ (228,000) $ 161,561

Cash Flow from Operating Activities

Cash flows from operations are driven mainly by net income, depreciation, stock-based compensation expense, noncash lease expense and net movement in advanced billings and accounts receivable and unbilled, net.

Advanced billings and accounts receivable and unbilled, net fluctuate on a regular basis as we perform our services, bill our customers and ultimately collect on those receivables.

Cash flows from operations are driven mainly by net income, stock-based compensation expense, depreciation, noncash lease expense and net movement in advanced billings, accrued expenses and accounts receivable and unbilled, net.

Accounts receivable and unbilled, net and advanced billings fluctuate on a regular basis as we perform our services, bill our customers and ultimately collect on those receivables.

We attempt to negotiate payment terms in order to provide for payments prior to or soon after the provision of services, but this timing of collection can vary significantly on a period by period comparative basis.

Net cash flows provided by operating activities was $418.1 million for the nine months ended September 30, 2024 beginning with net income of $287.4 million.

Adjustments to reconcile net income to net cash provided by operating activities were $52.4 million, primarily related to depreciation of $20.7 million, stock-based compensation expense of $19.6 million and noncash lease expense of $17.3 million.

Changes in operating assets and liabilities provided $78.4 million in operating cash flows and was primarily driven by increased advanced billings of $111.1 million, partially offset by decreased lease liabilities of $15.4 million and increased accounts receivable and unbilled, net of $13.0 million.

Net cash flows provided by operating activities was $277.0 million for the nine months ended September 30, 2023 beginning with net income of $204.5 million.

Adjustments to reconcile net income to net cash provided by operating activities were $38.8 million, primarily related to deprecation of $17.7 million, stock-based compensation expense of $15.4 million and noncash lease expense of $14.6 million.

Changes in operating assets and liabilities provided $33.7 million in operating cash flows and was primarily driven by increased advanced billings of $56.0 million and increased accrued expenses of $54.9 million, partially offset by increased accounts receivable and unbilled, net of $39.3 million, decreased lease liabilities of $14.4 million and a change in other assets and liabilities, net of $13.7 million.

Net cash flows provided by operating activities was $125.8 million for the three months ended March 31, 2025 beginning with net income of $114.6 million.

Adjustments to reconcile net income to net cash provided by operating activities were $30.1 million, primarily related to stock based compensation expense of $16.9 million, depreciation of $6.7 million and noncash lease expense of $6.1 million.

Changes in operating assets and liabilities used $18.9 million in operating cash flows and was primarily driven by decreased accrued expenses of $23.2 million and increased prepaid expenses and other current assets of $17.6 million, partially offset by changes in other assets and liabilities, net of $11.6 million, increased accounts payable of $10.7 million and increased advanced billings of $8.1 million.

Net cash flows provided by operating activities was $152.7 million for the three months ended March 31, 2024 beginning with net income of $102.6 million.

Adjustments to reconcile net income to net cash provided by operating activities were $11.9 million, primarily related to depreciation of $6.6 million, noncash lease expense of $5.7 million and stock based compensation expense of $4.3 million.

Changes in operating assets and liabilities provided $38.2 million in operating cash flows and was primarily driven by increased advanced billings of $56.8 million and decreased accounts receivable and unbilled, net of $19.1 million, partially offset by decreased accrued expenses of $21.1 million and increased prepaid expenses and other current assets of $9.2 million.

Cash Flow from Investing Activities

Net cash used in investing activities was $20.7 million for the nine months ended September 30, 2024 primarily consisting of property and equipment expenditures of $28.9 million, partially offset by $8.2 million in other investing activity.

Net cash used in investing activities was $26.6 million for the nine months ended September 30, 2023 primarily consisting of property and equipment expenditures.

Net cash used in investing activities was $10.0 million for the three months ended March 31, 2025 primarily consisting of property and equipment expenditures.

Net cash provided by investing activities was $2.5 million for the three months ended March 31, 2024 primarily consisting of 8.0 million in other investing activity, partially offset by $5.5 million of property and equipment expenditures.

Cash Flow from Financing Activities

Net cash provided by financing activities was $14.6 million for the nine months ended September 30, 2024 related to proceeds from stock option exercises.

Net cash used in financing activities was $184.2 million for the nine months ended September 30, 2023 primarily related to $144.0 million in repurchases of common stock and $155.0 million in repayments of the Credit Facility, partially offset by $105.0 million in proceeds related to the Credit Facility and $9.9 million in proceeds from stock option exercises.

Net cash used in financing activities was $346.0 million for the three months ended March 31, 2025 primarily related to $371.9 million in repurchases of common stock, partially offset by proceeds from stock option exercises of $25.9 million.

Net cash provided by financing activities was $7.7 million for the three months ended March 31, 2024 related to proceeds from stock option exercises.

Share Repurchases

In the fourth quarter of 2022, the Board approved a stock repurchase program of up to $500.0 million.

The Company did not execute any share repurchases during the three and nine months ended September 30, 2024.

The Company did not execute any share repurchases during the three months ended September 30, 2023.

During the nine months ended September 30, 2023, the Company repurchased 781,068 shares for $144.0 million.

As of September 30, 2024, the Company has remaining authorization of $308.8 million under the repurchase program.

In 2022, the Board approved a stock repurchase program of up to $500.0 million.

In the first quarter of 2025, the Board approved an increase of $600.0 million to the Company’s stock repurchase program bringing the total repurchase authorization up to $1.1 billion.

During the three months ended March 31, 2025, the Company repurchased 1,193,011 shares for $389.8 million.

The Company did not execute any share repurchases during the three months ended March 31, 2024.

As of March 31, 2025, the Company has remaining authorization of $344.8 million under the repurchase program.

On April 17, 2025, the Company's Board of Directors approved an increase of $1.0 billion to the Company's stock repurchase program.

Repurchases under the share repurchase program are executed in the open market or negotiated transactions under trading plans put in place pursuant to Rule 10b5-1.

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Retired share repurchase amounts paid in excess of par value are reflected within Accumulated deficit/Retained earnings in the Company’s condensed consolidated balance sheets.

As of September 30, 2024, we had no indebtedness.

As of March 31, 2025, we had no indebtedness.

Refer to Note 7 of the Notes to Condensed Consolidated Financial Statements for details regarding our Credit Facility.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis