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PUMA BIOTECHNOLOGY INC

For the period ended Sep 30, 2024. Filed Nov 7, 2024.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2024 · Filed Nov 7, 2024

PBYI$8.25-15.6%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2024-06-30; filed 2024-08-01.

0001437749-24-024309

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2024-09-30; filed 2024-11-07.

0001437749-24-033955

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 91 previous paragraphs and 94 current paragraphs.

49 unchanged; 33 reworded; 12 added; 9 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 23 previous and 25 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (12)

Current report

In September 2024, the Pharmacovigilance Risk Assessment Committee approved a change in existing post approval requirements for overall results and a reduction in sample size for the Pierre Fabre NERLYFE post-marketing study in Europe. As of September 30, 2024, there is a post-marketing liability of $5.0 million, and the final costs of the study are being assessed. Any adjustment to the liability will be recorded as license revenue as the original $9.0 million estimate in study costs were recorded as a reduction to license revenue.

Current report

Cost of sales was approximately $29.1 million for the three months ended September 30, 2024, compared to approximately $13.3 million for the three months ended September 30, 2023. The increase was primarily due to royalty expense and other product costs related to thetiming of sales made to China by our sub-licensee. In 2024, the sales made to China by our sub-licensee were primarily in the third quarter, while such sales in 2023 were primarily made in the fourth quarter.

Current report

For the three months ended September 30, 2024, we recognized approximately $3.1 million in interest expense, compared to approximately $3.3 million of interest expense for the three months ended September 30, 2023. The decrease in interest expense related to a lower debt balance as we began paying down our debt principal during the three months ended September 30, 2024.

Current report

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

Current report

Royalty revenue was approximately $30.6 million for thenine months ended September 30, 2024, compared to approximately $13.5 million for the nine months ended September 30, 2023. The increase was primarily due to an increase in royalty revenue related to thetiming of sales made to China by our sub-licensee. In 2024, the sales made to China by our sub-licensee were primarily in the third quarter, while such sales in 2023 were primarily made in the fourth quarter.

Current report

Cost of sales was approximately $50.5 million for thenine months ended September 30, 2024, compared to approximately $38.4 million for thenine months ended September 30, 2023. The increase was primarily due to an increase in royalty expense and other product costs related to thetiming of sales made to China by our sub-licensee. In 2024, the sales made to China by our sub-licensee were primarily in the third quarter, while such sales in 2023 were primarily made in the fourth quarter.

Current report

SG&A expenses decreased by approximately $6.2 million for the nine months ended September 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Current report

For the nine months ended September 30, 2024, we recognized approximately $0.6 million in other income, compared to approximately $0.1 million of other income for the nine months ended September 30, 2023. The increase inother income was primarily due to increased sublease income, in addition to favorable exchange rates in Euro-denominated transactions.

Current report

(6) Non-GAAP adjusted diluted net income per share was calculated based on 47,819,234 and 47,397,209 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2023, respectively.
Removed paragraphs (9)

Previous report

Acquired in-process research and development expense includes the rights to develop new drug candidates. Payments to acquire a new drug candidate are immediately expensed as acquired in-process research and development provided that the drug candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use.

Previous report

Royalty revenue was approximately $2.7 million for the three months ended June 30, 2024, compared to approximately $3.0 million for the three months ended June 30, 2023. The decrease was primarily due to decreased international sales.

Previous report

Cost of sales was approximately $10.7 million for the three months ended June 30, 2024, compared to approximately $11.9 million for the three months ended June 30, 2023. The decrease was primarily due to lower royalty expense resulting from decreased worldwide net sales.

Previous report

SG&A expenses increased by approximately$0.5 million for the three months ended June 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Previous report

Six Months Ended June 30, 2024 Compared to Six Months Ended June 30, 2023

Previous report

Cost of sales was approximately $21.4 million for thesix months ended June 30, 2024, compared to approximately $25.1 million for thesix months ended June 30, 2023. The decrease was primarily due to lower royalty expense resulting from decreased worldwide net sales.

Previous report

For the six months ended June 30, 2024, we recognized approximately $6.7 million in interest expense, compared to approximately $6.6 million of interest expense for the six months ended June 30, 2023.

Previous report

(5) Potentially dilutive common stock equivalents (stock options restricted stock units and warrants) were not included in this non-GAAP adjusted diluted net loss per share for the three and six months ended June 30, 2024, as these shares would be considered anti-dilutive.
Reworded paragraphs (33)

Previous wording

In September 2022, we entered into an exclusive license agreement with Takeda Pharmaceutical Company Limited (“Takeda”) to license the worldwide research and development and commercial rights to alisertib. Alisertib is an investigational, reversible, ATP-competitive inhibitor that is designed to be highly selective for aurora kinase A. Inhibition of aurora kinase A can lead to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. In clinical trials to date, alisertibhas shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. We initiated the ALISertib in CAncer (ALISCA™ -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we plan to commence the ALISCA™ -Breast1 trial in the second half of 2024.

Current wording

In September 2022, we entered into an exclusive license agreement with Takeda to license the worldwide research and development and commercial rights to alisertib. Alisertib is an investigational, reversible, ATP-competitive inhibitor that is designed to be highly selective for aurora kinase A. Inhibition of aurora kinase A can lead to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. In clinical trials to date, alisertibhas shown single agent activity and activity in combination with other cancer drugs in the treatment of many different types of cancers, including hormone receptor-positive breast cancer, triple-negative breast cancer, small cell lung cancer and head and neck cancer. We initiated the ALISertib in CAncer (ALISCA™ -Lung1) Phase II trial (PUMA-ALI-4201) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer in February 2024, and we plan to commence the ALISCA™ -Breast1 Phase II trial (PUMA-ALI-1201) in the fourth quarter of 2024.

Previous wording

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2024 from our accounting policies at December 31, 2023, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Current wording

As of the date of the filing of this Quarterly Report, we believe there have been no material changes to our critical accounting policies and estimates during the nine months ended September 30, 2024 from our accounting policies at December 31, 2023, as reported in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.

Previous wording

Research and development expenses (“R&D expenses”) include costs associated with services provided by consultants who conduct and perform clinical services on our behalf and contract organizations for the manufacturing of clinical materials. During the three and six months ended June 30, 2024 and 2023, our R&D expenses consisted primarily of clinical research organization (“CRO fees”), fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D expenses as they are incurred. Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses and supplies.

Current wording

Research and development expenses (“R&D expenses”) include costs associated with services provided by consultants who conduct and perform clinical services on our behalf and contract organizations for the manufacturing of clinical materials. During the three and nine months ended September 30, 2024 and 2023, our R&D expenses consisted primarily of clinical research organization (“CRO fees”); fees paid to consultants; salaries and related personnel costs; and stock-based compensation. We expense our R&D expenses as they are incurred. Internal R&D expenses primarily consist of payroll-related costs and also include equipment costs, travel expenses and supplies.

Previous wording

Total revenue for the three months ended June 30, 2024 was approximately $47.1 million, compared to $54.6 million for the three months ended June 30, 2023. This decrease in total revenue was primarily due to a decrease in product revenue, net of approximately $7.2 million and a decrease in royalty revenue of $0.3 million.

Current wording

Total revenue for the three months ended September 30, 2024 was approximately $80.5 million, compared to $56.1 million for the three months ended September 30, 2023. This increase in total revenue was primarily due to an increase in royalty revenue of $19.9 million and an increase in product revenue, net of approximately $4.5 million.

Previous wording

Product revenue, net was approximately $44.4 million for the three months ended June 30, 2024, compared to $51.6 million for the three months ended June 30, 2023. This decrease in product revenue, net was primarily attributable a decrease of approximately 16.8% in bottles of NERLYNX sold compared to the three months ended June 30, 2023, partially offset by an increase in net selling price compared to the three months ended June 30, 2023.

Current wording

Product revenue, net was approximately $56.1 million for the three months ended September 30, 2024, compared to $51.6 million for the three months ended September 30, 2023. This increase in product revenue, net was primarily attributable to an increase in product sales to our China sub-licensee, and an increase in net selling price compared to the three months ended September 30, 2023, partially offset by a decrease of approximately 5.2% in bottles of NERLYNX sold in the U.S. market, and an increase of approximately 2.5% in related deductions to gross revenue for variable consideration compared to the three months ended September 30, 2023.

Previous wording

Royalty revenue was approximately $6.2 million for thesix months ended June 30, 2024, compared to approximately $9.0 million for the six months ended June 30, 2023. The decrease was primarily due to the timing of sales made in China by our sub-licensee.

Current wording

Royalty revenue was approximately $24.4 million for the three months ended September 30, 2024, compared to approximately $4.5 million for the three months ended September 30, 2023. The increase was primarily due to timing of sales made to China by our sub-licensee. In 2024, the sales made to China by our sub-licensee were primarily in the third quarter, while such sales in 2023 were primarily made in the fourth quarter.

Previous wording

SG&A expenses were approximately $25.0 million for the three months ended June 30, 2024, compared to approximately $24.5 million for the three months ended June 30, 2023. SG&A expenses for the three months ended June 30, 2024 and 2023 were as follows:

Current wording

SG&A expenses were approximately $16.8 million for the three months ended September 30, 2024, compared to approximately $22.8 million for the three months ended September 30, 2023. SG&A expenses for the three months ended September 30, 2024 and 2023 were as follows:

Previous wording

SG&A expenses decreased by approximately $0.2 million for the six months ended June 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Current wording

SG&A expenses decreased by approximately$6.0 million for the three months ended September 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Previous wording

R&D expenses were approxi mately$13.6 million for thethree months ended June 30, 2024, compared to approximately $13.4 million for the three months ended June 30, 2023. R&D expenses for the three months ended June 30, 2024 and 2023, were as follows:

Current wording

R&D expenses were approxi mately$12.6 million for thethree months ended September 30, 2024, compared to approximately $11.5 million for the three months ended September 30, 2023. R&D expenses for the three months ended September 30, 2024 and 2023, were as follows:

Previous wording

R&D expenses increased by approxim ately$0.3 million for the three months ended June 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Current wording

R&D expenses increased by approxim ately$1.1 million for the three months ended September 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Previous wording

For the three months ended June 30, 2024, we recognized approximately $1.2 million in interest income, compared to approximately $0.7 million of interest income for the three months ended June 30, 2023. The increase in interest income was primarily the result of higher interest rates and increased cash equivalents and marketable securities.

Current wording

For the three months ended September 30, 2024, we recognized approximately $1.3 million in interest income, compared to approximately $0.7 million of interest income for the three months ended September 30, 2023. The increase in interest income was primarily the result of increased balances in cash equivalents and marketable securities.

Previous wording

For the six months ended June 30, 2024, we recognized approximately $0.2 million in other income, compared to approximately $44 thousand of other income for the six months ended June 30, 2023 primarily due to additional sublease income.

Current wording

For the three months ended September 30, 2024, we recognized approximately $0.3 million in other income, compared to approximately $0.1 million of other income for the three months ended September 30, 2023. The increase inother income was primarily due to increased sublease income, in addition to favorable exchange rates in Euro-denominated transactions.

Previous wording

Total revenue for the six months ended June 30, 2024 was approximately $90.8 million, compared to $107.3 million for the six months ended June 30, 2023. This decrease in total revenue was primarily due to a decrease in product revenue, net of approximately $13.7 million and a decrease in royalty revenue of $2.8 million.

Current wording

Total revenue for the nine months ended September 30, 2024 was approximately $171.4 million, compared to $163.5 million for the nine months ended September 30, 2023. This increase in total revenue was primarily due to an increase of $17.1 million in royalty revenue offset by a decrease of $9.1 million in product revenue, net.

Previous wording

Product revenue, net was approximately $84.7 million for the six months ended June 30, 2024, compared to $98.3 million for the six months ended June 30, 2023. This decrease in product revenue, net was primarily attributable to a decrease of approximately 16.1% in bottles of NERLYNX sold compared to the six months ended June 30, 2023, and an increase in the related dedu ctions to gross revenue for variable considerations for the six months ended June 30, 2024 compared to the six months ended June 30, 2023, partially offset by an increase in net selling price compared to the six months ended June 30, 2023.

Current wording

Product revenue, net was approximately $140.8 million for the nine months ended September 30, 2024, compared to $149.9 million for the nine months ended September 30, 2023. This decrease in product revenue, net was primarily attributable to a decrease of approximately 12.5% in bottles of NERLYNX sold compared to the nine months ended September 30, 2023, and an increase of approximately 2.1% in related dedu ctions to gross revenue for variable consideration compared to the nine months ended September 30, 2023, partially offset by an increase in net selling price and an increase in product sales to our China sub-licensee compared to the nine months ended September 30, 2023.

Previous wording

SG&A expenses were approximately $46.7 million for the six months ended June 30, 2024, compared to approximately $46.9 for the six months ended June 30, 2023. SG&A expenses for the six months ended June 30, 2024 and 2023 were as follows:

Current wording

SG&A expenses were approximately $63.5 million for the nine months ended September 30, 2024, compared to approximately $69.7 million for the nine months ended September 30, 2023. SG&A expenses for the nine months ended September 30, 2024 and 2023 were as follows:

Previous wording

R&D expenses were approxi mately $27.2 million for thesix months ended June 30, 2024, compared to approximately $26.1 million for the six months ended June 30, 2023. R&D expenses for the six months ended June 30, 2024 and 2023, were as follows:

Current wording

R&D expenses were approxi mately $39.8 million for thenine months ended September 30, 2024, compared to approximately $37.5 million for the nine months ended September 30, 2023. R&D expenses for the nine months ended September 30, 2024 and 2023, were as follows:

Previous wording

R&D expenses increased by approxim ately $1.2 million for thesix months ended June 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Current wording

R&D expenses increased by approxim ately $2.3 million for thenine months ended September 30, 2024, compared to the same period in 2023, primarily attributable to the following:

Previous wording

For thesix months ended June 30, 2024, we recognized approximately $2.2 million in interest income, compared to approximately $1.2 million of interest income for thesix months ended June 30, 2023. The increase in interest income was primarily the result of higher interest rates and increased cash equivalents and marketable securities.

Current wording

For thenine months ended September 30, 2024, we recognized approximately $3.5 million in interest income, compared to approximately $1.9 million of interest income for thenine months ended September 30, 2023. The increase in interest income was primarily the result of increased balances in cash equivalents and marketable securities.

Previous wording

The following table, which summarizes our liquidity and capital resources as of June 30, 2024 and December 31, 2023 and for the six months ended June 30, 2024 and 2023, is intended to supplement the more detailed discussion that follows:

Current wording

The following table, which summarizes our liquidity and capital resources as of September 30, 2024 and December 31, 2023 and for the nine months ended September 30, 2024 and 2023, is intended to supplement the more detailed discussion that follows:

Previous wording

Cash provided by operating activities for thesix months ended June 30, 2024 was$12.3 million and consisted of a net loss of approximately$9.3 million, adjusted for non-cash items of approximately$10.2 million, including stock-based compensation of $4.4 million, depreciation and amortization of $5.8 million and provision for credit loss of $0.1 million. Total changes in cash flows from operations were due to an increase in working capital, primarily related to a decrease in accounts receivable of approximately $19.8 million, a decrease in prepaid expenses and other of $1.4 million and an increase in accounts payable of approximately $6.6 million, partially offset by a decrease in accrued expenses and other of approximately $13.7 million and an increase in inventory of approximately $2.0 million.

Current wording

Cash provided by operating activities for thenine months ended September 30, 2024 was$23.3 million and consisted of net income of approximately$11.0 million, adjusted for non-cash items of approximately$15.1 million, including stock-based compensation of $6.5 million, depreciation and amortization of $8.7 million and provision for credit loss of $0.1 million. Total changes in cash flows from operations were due to a decrease in working capital, primarily related to an increase in accounts receivable of approximately $6.7 million (primarily sales to China) and a decrease in accrued expenses and other of approximately $2.1 million, partially offset by a decrease in inventory of $4.4 million (primarily sales to China) and a decrease in prepaid expenses and other of $2.4 million.

Previous wording

Cash provided by operating activities for the six months ended June 30, 2023 was $5.9 million and consisted of net income of approximately $3.5 million, a decrease of approximately $11.5 million of non-cash items, including stock-based compensation, depreciation and amortization and provision for credit loss. Further changes in cash flows from operations included a decrease in accrued expenses and other of approximately $17.4 million primarily due to an $8.0 million payment related to the Eshelman settlement, net decrease of $4.3 million in the employee bonus accrual and a net decrease of $4.8 million in our Pfizer royalty accrual, and a decrease in our post-marketing commitment liability of approximately $0.5 million, partially offset by a decrease of $8.5 million in accounts receivable, an increase $3.1 million in inventory, a decrease of $0.6 million in prepaid expenses and other, a decrease of $1.9 million in other current assets (related to receipt of CARES Act funds), and an increase of $1.4 million in accounts payable.

Current wording

Cash provided by operating activities for the nine months ended September 30, 2023 was $16.6 million and consisted of net income of approximately $9.3 million, offset by a decrease of approximately $17.6 million of non-cash items. These non-cash items included stock-based compensation, depreciation and amortization, provision for credit loss and loss on impairment of asset. In addition, there were decreases in cash flows from operations due to a decrease in accrued expenses and other of approximately $18.9 million, which included an $8.0 million payment related to the Eshelman litigation settlement, net, a decrease of $3.3 million in variable consideration and $2.5 million in the employee bonus accrual, and a net decrease of $4.0 million in our Pfizer royalty accrual. Additional decreases in cash flows were due to a decrease in our post-marketing commitment liability of approximately $0.7 million, a decrease of $1.4 million in accounts payable and an increase of $1.2 million in inventory. These decreases in cash flows were partially offset by increases in cash flows due to a decrease of $10.9 million in accounts receivable from collections and a decrease of $1.4 million in prepaid and other expenses. The decrease of $0.4 million in other current assets was due to receipt of CARES Act funds, partially offset by an increase of a $1.7 million receivable from a vendor related to damaged inventory.

Previous wording

Cash used in investing activities for thesix months ended June 30, 2024 was approximately$18.4 million, compared to net cash used by investing activities of approximately$22.1 million for the same period in 2023. Cash used in investing activities was primarily due to the purchase of available-for-sale securities of approximately $44.9 million, offset by the maturity of available-for-sale securities of approximately $26.5 million.

Current wording

Cash used in investing activities for thenine months ended September 30, 2024 was approximately$18.1 million, compared to net cash used in investing activities of approximately$11.0 million for the same period in 2023. Cash used in investing activities was primarily due to the purchase of available-for-sale securities of approximately $61.0 million, offset by the maturity of available-for-sale securities of approximately $42.9 million.

Previous wording

Cash used in investing activities for the six months ended June 30, 2023 was approximately $22.1 million. Cash used in investing activities was primarily due to the purchase of the intangible asset of $12.5 million, and the purchase of available-for-sale securities of approximately $10.5 million for the six months ended June 30, 2023.

Current wording

Cash used in investing activities for the nine months ended September 30, 2023 was approximately $11.0 million. Cash used in investing activities was primarily due to the purchase of the intangible asset of $12.5 million, and the purchase of available-for-sale securities of approximately $12.5 million, offset by the maturity of available-for-sale securities of approximately $14.2 million for the nine months ended September 30, 2023.

Previous wording

Cash used in financing activities for the six months ended June 30, 2024 was approximately $11.3 million as we began paying down the principal, as well as exit fees, on our debt with Athyrium.

Current wording

Cash used in financing activities for the nine months ended September 30, 2024 was approximately $22.5 million. Of this amount, $22.7 million related to the payment of principal, as well as exit fees, on our debt with Athyrium, partially offset byapproximately $0.2 million of proceeds from employee stock options exercised.

Previous wording

There was no cash provided by or used in financing activities for the six months ended June 30, 2023.

Current wording

There was no cash provided by or used in financing activities for the nine months ended September 30, 2023.

Previous wording

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”). The modification of the Note Purchase Agreement pursuant to the Third Amendment did not meet the requirements of a debt extinguishment under ASC 470-50 -Debt Modifications and Exchanges and no gain or loss was recognized. We performed a quantitative analysis and determined that the terms of the new debt and original debt instrument are not substantially different. Accordingly, the Third Amendment is accounted for as a debt modification.

Current wording

Interest on the Athyrium Notes is calculated in part based on the Secured Overnight Financing Rate (“SOFR”), which replaced the “London Interbank Offering Rate” as the floating benchmark for interest rate calculations applicable to the Athyrium Notes pursuant to the terms of the Third Amendment to the Note Purchase Agreement dated as of September 16, 2022 (the “Third Amendment”). The modification of the Note Purchase Agreement pursuant to the Third Amendment did not meet the requirements of a debt extinguishment under ASC 470-50 -Debt Modifications and Exchanges and no gain or loss was recognized. We performed a quantitative analysis and determined that the terms of the new debt and original debt instrument are not substantially different. Accordingly, the Third Amendment is accounted for as a debt modification.

Previous wording

Following the effectiveness of the Third Amendment, the Athyrium Notes bear interest at an annual rate equal to the sum of (a) eight percent (8.00%) plus (b) the lesser of (i) the sum of (x) three-month term SOFR for an interest period of three months plus (y) 0.26161% (26.161 basis points) and (ii) three and one-half of one percent (3.50%) per annum. Interest is payable quarterly on the last business day of March, June, September and December each year. As of June 30, 2024, we began paying the principal payments required to be made quarterly at 11.11% of the original face amount with the remaining balance paid at maturity. Each principal payment also includes a 2.0% exit payment. Each quarterly principal payment approximates $11.1 million, and each quarterly exit fee payment approximates $0.2 million. As of June 30, 2024, the effective interest rate for the loan was 12.99%.

Current wording

Following the effectiveness of the Third Amendment, the Athyrium Notes bear interest at an annual rate equal to the sum of (a) eight percent (8.00%) plus (b) the lesser of (i) the sum of (x) three-month term SOFR for an interest period of three months plus (y) 0.26161% (26.161 basis points) and (ii) three and one-half of one percent (3.50%) per annum. Interest is payable quarterly on the last business day of March, June, September and December each year. In the second quarter of 2024, we began paying the principal payments required to be made quarterly at 11.11% of the original face amount. The remaining balance will be paid at maturity. Each principal payment also includes a 2.0% exit payment. Each quarterly principal payment approximates $11.1 million, and each quarterly exit fee payment approximates $0.2 million. As of September 30, 2024, the effective interest rate for the loan was 12.99%.

Previous wording

As of June 30, 2024, the principal balance outstanding under the Athyrium Notes was $88.9 million, representing all of our debt. We are in compliance with all applicable covenants under the Athyrium Notes.

Current wording

As of September 30, 2024, the principal balance outstanding under the Athyrium Notes was $77.8 million representing all of our debt. We are in compliance with all applicable covenants under the Athyrium Notes.

Previous wording

We may choose to begin new R&D efforts, or we may choose to launch additional marketing efforts. For example, we in-licensed alisertib from Takeda in 2022 and assumed sole responsibility for its global development and commercialization. These efforts will require funding in addition to the cash and cash equivalents totaling approximately $67.1 million and approximately $29.7 million in marketable securities available at June 30, 2024. While our consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib. While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future. Our ability to obtain funding may be adversely impacted by uncertain market conditions, our success in commercializing neratinib, our success in developing alisertib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. We believe that our existing cash and cash equivalents and marketable securities as of June 30, 2024, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report.

Current wording

We may choose to begin new R&D efforts, or we may choose to launch additional marketing efforts. For example, we in-licensed alisertib from Takeda in 2022 and assumed sole responsibility for its global development and commercialization. These efforts will require funding in addition to the cash and cash equivalents totaling approximately $67.3 million and approximately $29.5 million in marketable securities available at September 30, 2024. While our consolidated financial statements have been prepared on a going concern basis, we may incur significant losses in the future and will need to generate significant revenue to sustain operations and successfully commercialize neratinib and develop alisertib. While we have been successful in raising financing in the past, there can be no assurance that we will be able to do so in the future. Our ability to obtain funding may be adversely impacted by uncertain market conditions, our success in commercializing neratinib, our success in developing alisertib, unfavorable decisions of regulatory authorities or adverse clinical trial results. The outcome of these matters cannot be predicted at this time. We believe that our existing cash and cash equivalents and marketable securities as of September 30, 2024, and proceeds that will become available to us through product sales and sub-license payments are sufficient to satisfy our operating cash and capital needs for at least one year after the filing of this Quarterly Report.

Previous wording

In addition to our operating results, as calculated in accordance with Generally Accepted Accounting Principles (“GAAP”) we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net (loss) income and net (loss) income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three and six months ended June 30, 2024, stock-based compensation represented approximately 5.3% and 6.0% of our operating expenses, respectively, compared to 6.4% and 7.2% for the same respective periods in 2023, in each case excluding cost of sales. Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

Current wording

In addition to our operating results, as calculated in accordance with Generally Accepted Accounting Principles (“GAAP”) we use certain non-GAAP financial measures when planning, monitoring, and evaluating our operational performance. The following table presents our net (loss) income and net (loss) income per share, as calculated in accordance with GAAP, as adjusted to remove the impact of stock-based compensation. For the three and nine months ended September 30, 2024, stock-based compensation represented approximately 7.0% and 6.3% of our operating expenses, respectively, compared to 7.4% and 7.3% for the same respective periods in 2023, in each case excluding cost of sales. Our management believes that these non-GAAP financial measures are useful to enhance understanding of our financial performance, are more indicative of our operational performance and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures.

Previous wording

(4) Non-GAAP adjusted basic net income per share was calculated based on 46,759,062 and 46,697,912 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2023, respectively.

Current wording

(3) Non-GAAP adjusted basic net income per share was calculated based on 49,008,464 and 48,498,579 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.

Previous wording

(3) Non-GAAP adjusted basic net loss per share was calculated based on 48,292,414 and 48,240,835 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2024 respectively.

Current wording

(4) Non-GAAP adjusted basic net income per share was calculated based on 47,520,338 and 46,977,127 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2023, respectively.

Previous wording

(6) Non-GAAP adjusted diluted net income per share was calculated based on 47,201,185 and 47,172,752 weighted-average shares of common stock outstanding for the three and six months ended June 30, 2023, respectively.

Current wording

(5) Non-GAAP adjusted diluted net income per share was calculated based on 49,173,361 and 49,025,103 weighted-average shares of common stock outstanding for the three and nine months ended September 30, 2024, respectively.