What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-07 compared with 2024-08-07 · 62 added, 61 removed, 192 unchanged (39% of the section changed)

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These forward-looking statements involve a number of risks and uncertainties.

Such forward-looking statements include statements about the benefits to be derived from NUPLAZID, DAYBUE and our drug candidates, the potential market opportunities for NUPLAZID and DAYBUE and our drug candidates, our strategy for the commercialization of NUPLAZID and DAYBUE, our plans for exploring and developing DAYBUE for indications other than in Rett syndrome, and the commercialization of DAYBUE in jurisdictions other than the U.S., our plans and timing with respect to seeking regulatory approvals, the potential commercialization of any of our drug candidates that receive regulatory approval, the progress, timing, results or implications of clinical trials and other development activities involving DAYBUE and our drug candidates, our strategy for discovering, developing and, if approved, commercializing drug candidates, our existing and potential future collaborations, our estimates of future payments, revenues and profitability, our estimates regarding our capital requirements, future expenses and need for additional financing, possible changes in legislation, and other statements that are not historical facts, including statements which may be preceded by the words “believes,” “expects,” “hopes,” “may,” “will,” “plans,” “intends,” “estimates,” “could,” “should,” “would,” “continues,” “seeks,” “aims,” “projects,” “predicts,” “pro forma,” “anticipates,” “potential” or similar words.

Such forward-looking statements include statements about the benefits to be derived from NUPLAZID, DAYBUE and our drug candidates, the potential market opportunities for NUPLAZID and DAYBUE and our drug candidates, our strategy for the commercialization of NUPLAZID and DAYBUE, our plans for exploring and developing DAYBUE for indications other than in Rett syndrome, and the commercialization of DAYBUE in jurisdictions other than the U.S., our plans and timing with respect to seeking regulatory approvals, the potential commercialization of any of our drug candidates that receive regulatory approval, the progress, timing, results or implications of clinical trials and other development activities involving DAYBUE and our drug candidates, our strategy for discovering, developing and, if approved, commercializing drug candidates, our existing and potential future collaborations, our estimates of future payments, revenues and profitability, our estimates regarding our capital requirements, future expenses and need for additional financing, possible changes in legislation, the closing of the transactions contemplated by the PRV Transfer Agreement (as defined in Part II, Item 5 of this Quarterly Report), our receipt of the payment for the PRV, payment of certain proceeds under the PRV Transfer Agreement to Neuren, and other statements that are not historical facts, including statements which may be preceded by the words “believes,” “expects,” “hopes,” “may,” “will,” “plans,” “intends,” “estimates,” “could,” “should,” “would,” “continues,” “seeks,” “aims,” “projects,” “predicts,” “pro forma,” “anticipates,” “potential” or similar words.

For forward-looking statements, we claim the protection of the Private Securities Litigation Reform Act of 1995.

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We hold worldwide commercialization rights to pimavanserin.

A Phase 2 trial to evaluate the efficacy and safety of pimavanserin for the treatment of irritability associated with autism spectrum disorder in pediatric populations was completed in October 2024.

The trial did not meet either of its primary or secondary endpoints.

With the completion of the trial, we believe we now have completed the FDA’s requirements to qualify for a pediatric exclusivity for pimavanserin.

If the period exclusivity is granted, exclusivity of the NUPLAZID franchise would be extended by six months.

In August 2018, we acquired an exclusive North American license to develop and commercialize DAYBUE for Rett syndrome and other indications from Neuren.

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In Japan, we held our first formal meeting with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second quarter of 2024 to discuss our proposed clinical plan.

And in Canada, we announced in April 2024 that our New Drug Submission was accepted for filing and granted priority review by Health Canada, potentially leading to an approval in that market around the end of this year.

And in Canada, we announced in October 2024 that Health Canada granted marketing authorization of DAYBUE (trofinetide) for the treatment of Rett syndrome in adult and pediatric patients two years of age and older, making DAYBUE (trofinetide) the first and only drug approved in Canada for the treatment of Rett syndrome.

In June 2023, we announced that we added a new Phase 3 development candidate to our rare disease portfolio, ACP-101 (intranasal carbetocin), for the treatment of hyperphagia (an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety) in Prader-Willi syndrome (PWS).

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We have incurred substantial operating losses since our inception due in large part to expenditures for our research and development activities.

As of June 30, 2024, we had an accumulated deficit of $2.4 billion.

As of September 30, 2024, we had an accumulated deficit of $2.3 billion.

Contingent on the level of business development activities we may complete as well as pipeline programs we may advance, we may continue to incur operating losses for the next few years as we incur significant research and development costs and costs for continued commercialization of NUPLAZID and DAYBUE.

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Cost of sales for a newly launched product does not include the full cost of manufacturing until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold.

Thus, the cost of sales as a percentage of net sales of DAYBUE for the three and six months ended June 30, 2024 was affected by use of the initial pre-launch inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories.

Thus, the cost of sales as a percentage of net sales of DAYBUE for the three and nine months ended September 30, 2024 was affected by use of the initial pre-launch inventory, which was previously expensed as research and development expense, and is referred to as zero cost inventories.

However, we do not expect that the cost of sales as a percentage of net sales of DAYBUE will increase significantly once we commence the sales of full cost inventories.

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In connection with the FDA approval of DAYBUE, we are required to conduct post-marketing work, including a clinical study of renal impairment in healthy volunteers, nonclinical carcinogenicity studies, and nonclinical in vitro and clinical in vivo drug interaction studies.

We have completed two of the five studies and we are awaiting FDA’s acknowledgement and acceptance of those completed studies.

We will be responsible for all costs incurred for these post-marketing requirements.

FDA has released us from one of the five post-marketing requirements (PMRs).

In addition, we have fulfilled one of the five PMRs.

Of the remaining three PMRs, we have also completed one and we are awaiting FDA’s acknowledgement and acceptance of that completed PMR.

We will be responsible for all costs incurred for these PMRs.

In addition, we expect to incur increased research and development expenses as a result of advancement of our early-stage development pipeline programs.

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To the extent that external expenses are not attributable to a specific project, they are allocated proportionally to each of the projects.

The following table summarizes our research and development expenses for the three and six months ended June 30, 2024 and 2023 (in thousands):

Three Months Ended June 30,

Six Months Ended June 30,

The following table summarizes our research and development expenses for the three and nine months ended September 30, 2024 and 2023 (in thousands):

Three Months Ended September 30,

Nine Months Ended September 30,

Costs of external service providers:

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Similarly, we are unable to estimate with certainty the costs we will incur for post-marketing studies that we committed to conduct in connection with FDA approval of DAYBUE.

We expect our research and development expenses will continue to be substantial as we conduct studies pursuant to our post-marketing requirements and pursue the further development of ACP-101, ACP-204 and other early-stage pipeline programs.

We expect our research and development expenses will continue to be substantial as we conduct studies pursuant to our PMRs and pursue the further development of ACP-101, ACP-204 and other early-stage pipeline programs.

The lengthy process of completing clinical trials and supporting development activities and seeking regulatory approval for our product candidates requires the expenditure of substantial resources.

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Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future.

We anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including the progress and timing of expenditures related to our commercial activities associated with NUPLAZID and DAYBUE and the extent to which we generate revenue from product sales, our further development of our early-stage pipeline programs and the progress and timing of expenditures related to studies of DAYBUE pursuant to our post-marketing requirements.

Further, we expect our sales allowances to vary from quarter to quarter due to fluctuations in our Medicare Part D Coverage Gap liability and the volume of purchases eligible for government mandated discounts and rebates, as well as changes in discount percentages that may be impacted by potential future price increases and other factors.

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Due to these fluctuations, we believe that the period-to-period comparisons of our operating results are not a good indication of our future performance.

Comparison of the Three Months Ended June 30, 2024 and 2023

Comparison of the Three Months Ended September 30, 2024 and 2023

Product Sales, Net

Net product sales, comprised of NUPLAZID and DAYBUE, were $242.0 million and $165.2 million for the three months ended June 30, 2024 and 2023, respectively.

Net product sales of NUPLAZID were $157.4 million and $142.0 million for the three months ended June 30, 2024 and 2023, respectively.

Net product sales, comprised of NUPLAZID and DAYBUE, were $250.4 million and $211.7 million for the three months ended September 30, 2024 and 2023, respectively.

Net product sales of NUPLAZID were $159.2 million and $144.8 million for the three months ended September 30, 2024 and 2023, respectively.

The increase in net product sales of NUPLAZID of $14.4 million was due to the growth in NUPLAZID unit sales as well as a higher average net selling price of NUPLAZID in 2024 compared to 2023.

Net product sales of DAYBUE were $84.6 million and $23.2 million for the three months ended June 30, 2024 and 2023, respectively.

The increase in net product sales of DAYBUE of $61.4 million was due to the growth in DAYBUE unit sales.

Net product sales of DAYBUE were $91.2 million and $66.9 million for the three months ended September 30, 2024 and 2023, respectively.

The increase in net product sales of DAYBUE of $24.3 million was due to the growth in DAYBUE unit sales as well as a higher average net selling price of DAYBUE.

Cost of Product Sales

Cost of product sales was $18.2 million and $7.5 million for the three months ended June 30, 2024 and 2023, respectively, or approximately 8% and 5% of net product sales, respectively.

Cost of product sales as a percentage of net product sales for NUPLAZID remained relatively flat during the three months ended June 30, 2024 as compared to the same period of 2023.

Cost of product sales was $18.9 million and $14.6 million for the three months ended September 30, 2024 and 2023, respectively, or approximately 8% and 7% of net product sales, respectively.

Cost of product sales as a percentage of net product sales for NUPLAZID remained relatively flat during the three months ended September 30, 2024 as compared to the same period of 2023.

The increase in cost of product sales was primarily due to the increase in license fees and royalties expensed for DAYBUE, including royalties due to Neuren based on net sales of DAYBUE and the amortization of the milestone payments capitalized under our 2018 license agreement with Neuren.

The license fees and royalties expensed during the three months ended June 30, 2024 were $10.8 million as compared to $3.7 million in the same period of 2023.

The license fees and royalties expensed during the three months ended September 30, 2024 were $11.5 million as compared to $8.1 million in the same period of 2023.

We are required to pay Neuren tiered and escalating royalties between 10% to 15% based on annual net sales of DAYBUE in North America.

Currently, we are required to pay 10% of royalties to Neuren.

If our annual net sales of DAYBUE in North America exceed $250.0 million, we will be required to pay 12% of royalties to Neuren on net sales that exceed $250.0 million.

We will be required to pay higher royalties if net sales exceeds next scales.

Since our aggregate net sales of DAYBUE in North America exceeded $250.0 million in September 2024, we are required to pay 10% of royalties to Neuren on net sales less than or equal to $250.0 million and 12% of royalties on net sales that exceed $250.0 million.

Certain manufacturing related expenses incurred prior to DAYBUE receiving FDA approval were classified as research and development expenses, resulting in zero cost inventory.

If cost of product sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the three months ended June 30, 2024 would have increased by approximately $3.7 million.

If cost of product sales included previously expensed inventories, the total cost of sales with these manufacturing costs included for the three months ended September 30, 2024 would have increased by approximately $3.9 million.

Research and Development Expenses

Research and development expenses increased to $76.2 million for the three months ended June 30, 2024, including $3.7 million in stock-based compensation expense, from $58.8 million for the three months ended June 30, 2023, including $3.7 million in stock-based compensation expense.

The increase in research and development expenses was mainly due to increased costs from ACP101, ACP-204 and early-stage programs, partially offset by a reduction in costs associated with our pimavanserin negative symptoms of schizophrenia program.

Research and development expenses decreased to $66.6 million for the three months ended September 30, 2024, including $3.9 million in stock-based compensation expense, from $157.0 million for the three months ended September 30, 2023, including $5.1 million in stock-based compensation expense.

The decrease in research and development expenses was mainly due to decreased business development payments, which in the period ending September 30, 2023 included the $100.0 million payment to Neuren under the expanded license agreement for trofinetide.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased to $117.1 million for the three months ended June 30, 2024, including $11.6 million in stock-based compensation expense, from $96.0 million for the six months ended June 30, 2023, including $11.3 million in stock-based compensation expense.

The increase in selling, general and administrative expenses was primarily driven by upfront costs related to a new consumer activation program to support the NUPLAZID franchise, increased marketing costs in the U.S.

to support DAYBUE, and investments to support commercialization of trofinetide outside the U.S.

Comparison of the Six Months Ended June 30, 2024 and 2023

Selling, general and administrative expenses increased to $133.3 million for the three months ended September 30, 2024, including $21.9 million in stock-based compensation expense, from $97.9 million for the three months ended September 30, 2023, including $13.2 million in stock-based compensation expense.

The increase in selling, general and administrative expenses was primarily driven by costs related to a consumer activation program to support the NUPLAZID franchise and the transition costs of approximately $14.9 million as a result of the departure of our former CEO and appointment of our new CEO.

Comparison of the Nine Months Ended September 30, 2024 and 2023

Product Sales, Net

Net product sales, comprised of NUPLAZID and DAYBUE, were $447.8 million and $283.7 million for the six months ended June 30, 2024 and 2023, respectively.

Net product sales of NUPLAZID were $287.3 million and $260.5 million for the six months ended June 30, 2024 and 2023, respectively.

Net product sales, comprised of NUPLAZID and DAYBUE, were $698.2 million and $495.4 million for the nine months ended September 30, 2024 and 2023, respectively.

Net product sales of NUPLAZID were $446.5 million and $405.3 million for the nine months ended September 30, 2024 and 2023, respectively.

The increase in net product sales of NUPLAZID of $41.2 million was due to the growth in NUPLAZID unit sales as well as a higher average net selling price of NUPLAZID in 2024 compared to 2023.

Net product sales of DAYBUE were $160.5 million and $23.2 million for the six months ended June 30, 2024 and 2023, respectively.

The increase in net product sales of DAYBUE of $137.3 million was due to the growth in DAYBUE unit sales.

The following table provides a summary of activity with respect to our sales allowances and accruals for the six months ended June 30, 2024 (in thousands):

Net product sales of DAYBUE were $251.7 million and $90.1 million for the nine months ended September 30, 2024 and 2023, respectively.

The increase in net product sales of DAYBUE of $161.6 million was primarily due to the growth in DAYBUE unit sales.

The following table provides a summary of activity with respect to our sales allowances and accruals for the nine months ended September 30, 2024 (in thousands):

Distribution Fees,

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Credits/payments for prior period sales

Balance as of June 30, 2024

Balance as of September 30, 2024

Cost of Product Sales

Cost of product sales was $41.2 million and $9.1 million for the six months ended June 30, 2024 and 2023, respectively, or approximately 9% and 3% of net product sales, respectively.

Cost of product sales as a percentage of net product sales for NUPLAZID remained relatively flat during the six months ended June 30, 2024 as compared to the same period of 2023.

Cost of product sales was $60.0 million and $23.7 million for the nine months ended September 30, 2024 and 2023, respectively, or approximately 9% and 5% of net product sales, respectively.

Cost of product sales as a percentage of net product sales for NUPLAZID remained relatively flat during the nine months ended September 30, 2024 as compared to the same period of 2023.

The license fees and royalties expensed during the six months ended June 30, 2024 were $23.7 million as compared to $3.7 million in the same period of 2023.

Currently, we are required to pay 10% of royalties to Neuren based on the annual net sales of DAYBUE in North America.

If our annual net sales of DAYBUE in North America exceed $250.0 million, we will be required to pay 12% of royalties to Neuren on net sales that exceed $250.0 million.

The license fees and royalties expensed during the nine months ended September 30, 2024 were $35.2 million as compared to $11.7 million in the same period of 2023.

Certain manufacturing related expenses incurred prior to DAYBUE receiving FDA approval were classified as research and development expenses, resulting in zero cost inventory.

Prior to receiving FDA approval for DAYBUE in March 2023, we manufactured inventory and recorded approximately $29.9 million related to the zero cost inventory as research and development expense.

Utilizing the actual direct costs to manufacture DAYBUE prior to receiving FDA approval, had the previously expensed inventory been capitalized and recognized when sold, the total cost of sales with these manufacturing costs included for the six months ended June 30, 2024 would have increased by approximately $7.2 million.

Utilizing the actual direct costs to manufacture DAYBUE prior to receiving FDA approval, had the previously expensed inventory been capitalized and recognized when sold, the total cost of sales with these manufacturing costs included for the nine months ended September 30, 2024 would have increased by approximately $11.2 million.

We do not expect our cost of product sales for DAYBUE to increase significantly as a percentage of net product sales in future periods as we continue to produce inventory for future sales.

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Research and Development Expenses

Research and development expenses increased to $135.9 million for the six months ended June 30, 2024, including $7.8 million in stock-based compensation expense, from $127.9 million for the six months ended June 30, 2023, including $7.6 million in stock-based compensation expense.

The increase in research and development expenses was mainly due to increased costs from ACP-101, ACP-204 and early stage programs, partially offset by the elimination of pre-FDA approval trofinetide commercial supply expenses that were included in the previous year as well as a reduction costs associated with our pimavanserin negative symptoms of schizophrenia program.

Research and development expenses decreased to $202.5 million for the nine months ended September 30, 2024, including $11.7 million in stock-based compensation expense, from $284.9 million for the nine months ended September 30, 2023, including $12.7 million in stock-based compensation expense.

Selling, General and Administrative Expenses

Selling, general and administrative expenses increased to $225.1 million for the six months ended June 30, 2024, including $22.1 million in stock-based compensation expense, from $197.2 million for the six months ended June 30, 2023, including $21.9 million in stock-based compensation expense.

The increase in selling, general and administrative expenses was primarily driven upfront costs related to a new consumer activation program to support the NUPLAZID franchise, increased marketing costs in the U.S.

to support DAYBUE, and investments to support commercialization of trofinetide outside the U.S.

Selling, general and administrative expenses increased to $358.3 million for the nine months ended September 30, 2024, including $44.0 million in stock-based compensation expense, from $295.1 million for the nine months ended September 30, 2023, including $35.1 million in stock-based compensation expense.

The increase in selling, general and administrative expenses was primarily driven by the costs related to the consumer activation program to support the NUPLAZID franchise, the transition costs as a result of the departure of our former CEO and appointment of our new CEO, increased marketing costs in the U.S.

to support DAYBUE and investments to support commercialization of DAYBUE outside the U.S.

Liquidity and Capital Resources

We have funded our operations primarily with revenues from sales of NUPLAZID and DAYBUE since their approvals, and through sales of our equity securities and interest income.

We anticipate that the level of cash used in our operations will fluctuate in future periods depending on the levels of spending required for our ongoing and planned commercial activities for NUPLAZID and DAYBUE, our ongoing and planned development activities for ACP-101 as a treatment for PWS and ACP-204 as a treatment for ADP, studies to be conducted pursuant to our post-marketing requirements, our ongoing and planned development activities for other early-stage pipeline programs and strategic business development to further expand our portfolio.

We anticipate that the level of cash used in our operations will fluctuate in future periods depending on the levels of spending required for our ongoing and planned commercial activities for NUPLAZID and DAYBUE, our ongoing and planned development activities for ACP-101 as a treatment for PWS and ACP-204 as a treatment for ADP, studies to be conducted pursuant to our PMRs, our ongoing and planned development activities for other early-stage pipeline programs and strategic business development to further expand our portfolio.

We expect that our cash, cash equivalents, and investment securities will be sufficient to fund our planned operations through and beyond the next 12 months.

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• the amount of U.S.

product sales from NUPLAZID and DAYBUE;

• the costs of preparing applications for regulatory approvals for DAYBUE in jurisdictions other than the U.S.

and for other product candidates, as well as the costs required to support review of such applications;

• the costs of manufacturing and distributing NUPLAZID and DAYBUE for commercial use in the U.S.;

• our ability to obtain regulatory approval for, and subsequently generate product sales from DAYBUE in jurisdictions other than the U.S.

and our product candidates;

product sales from NUPLAZID and DAYBUE, and the amount of non-U.S.

product sales from DAYBYUE;

• the costs of preparing applications for regulatory approvals for DAYBUE in jurisdictions outside of North America and for other product candidates, as well as the costs required to support review of such applications;

• the costs of manufacturing and distributing NUPLAZID and DAYBUE for commercial use in the U.S., and the costs of manufacturing and distributing DAYBUE for commercial use outside the U.S.;

• our ability to obtain regulatory approval for, and subsequently generate product sales from DAYBUE in jurisdictions outside of North America and our product candidates;

• the extent to which we are obligated to reimburse collaborators or collaborators are obligated to reimburse us for costs under collaboration agreements;

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As discussed above, we have entered into various collaboration, licensing and merger agreements which generally include upfront license fees, development and commercial milestone payments upon achievement of certain clinical and commercial development and annual net sales milestones, as well as royalties calculated as a percentage of net product sales, with rates that vary by agreement.

We may be required to make milestone payments of $50.0 million in the next 12 months for the first calendar year in which aggregate net revenue of trofinetide in North America for the treatment of Rett syndrome exceeds $250.0 million.

We are required to make milestone payments of $50.0 million within 60 days following Neuren’s invoice delivery after December 31, 2024 as our aggregate net revenue of trofinetide in North America for the treatment of Rett syndrome exceeded $250.0 million in September 2024.

We are also required to make royalty payments in connection with the product sales for DAYBUE under the agreements.

At June 30, 2024, we had $500.9 million in cash, cash equivalents, and investment securities, compared to $438.9 million at December 31, 2023.

At September 30, 2024, we had $565.3 million in cash, cash equivalents, and investment securities, compared to $438.9 million at December 31, 2023.

This $126.4 million increase was primarily due to cash provided by operating activities.

Net cash provided by operating activities increased to $54.1 million for the six months ended June 30, 2024 compared to $9.7 million of net cash used in operating activities for the six months ended June 30, 2023.

Net cash provided by operating activities increased to $117.3 million for the nine months ended September 30, 2024 compared to $68.7 million of net cash used in operating activities for the nine months ended September 30, 2023.

This increase in cash provided by operations primarily resulted from an increase in our net revenues partially offset by the increase cost of product sales and selling, general and administrative cost.

Net cash used in investing activities totaled $70.2 million for the six months ended June 30, 2024 compared to $1.8 million for the six months ended June 30, 2023.

The increase in net cash used in investing activities for the six months ended June 30, 2024 compared to the six months ended June 30, 2023 was primarily due to increased net purchases of investment securities.

Net cash provided by financing activities decreased to $4.6 million for the six months ended June 30, 2024 compared to $6.9 million for the six months ended June 30, 2023.

This decrease in net cash provided by financing activities for the six months ended June 30, 2024 was attributable primarily to a decrease in proceeds resulting from the exercise of employee stock options.

Net cash used in investing activities totaled $152.7 million for the nine months ended September 30, 2024 compared to $32.3 million of net cash provided by investing activities for the nine months ended September 30, 2023.

The increase in net cash used in investing activities for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023 was primarily due to increased net purchases of investment securities.

Net cash provided by financing activities decreased to $4.9 million for the nine months ended September 30, 2024 compared to $19.7 million for the nine months ended September 30, 2023.

This decrease in net cash provided by financing activities for the nine months ended September 30, 2024 was attributable primarily to a decrease in proceeds resulting from the exercise of employee stock options.

Off-Balance Sheet Arrangements

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We do not have any direct investments in auction-rate securities or securities that are collateralized by assets that include mortgages or subprime debt.

If a 10 percent change in interest rates were to have occurred on June 30, 2024, this change would not have had a material effect on the fair value of our investment portfolio as of that date.

If a 10 percent change in interest rates were to have occurred on September 30, 2024, this change would not have had a material effect on the fair value of our investment portfolio as of that date.

Due to our investment in investment-grade, interest-bearing securities, as of the date of this Quarterly Report on Form 10-Q, we do not expect anticipated changes in interest rates to have a material effect on our interest rate risk in future reporting periods.

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