What changed in this filing

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Item 1. Financial Statements

2025-10-28 compared with 2025-07-30 · 66 added, 55 removed, 495 unchanged (20% of the section changed)

3 unchanged sentences

(in millions, except per share data)

September 30,

2025 December 31,

3 unchanged sentences

Accounts receivable

Prepaid expenses

Other current assets 68.2 63.6

33 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(in millions, except per share data) 2025 2024 2025 2024

11 unchanged sentences

Other income (expense):

Unrealized loss on equity investments

Unrealized gain (loss) on equity investments

30.6 ( 16.9 ) ( 6.7 ) ( 35.2 )

9 unchanged sentences

Foreign currency translation adjustments, net of tax 1.6 2.9 3.9 2.5

Unrealized gain (loss) on available-for-sale debt securities, net of tax

Unrealized (loss) gain on available-for-sale debt securities, net of tax

( 0.9 ) 9.1 3.5 5.0

9 unchanged sentences

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

Accumulated Other Comprehensive Income (Loss) Retained Earnings (Accumulated Deficit)

Accumulated Other Comprehensive Income

Retained Earnings (Accumulated Deficit)

Common Stock Additional Paid-In Capital

(in millions) Shares $ Total

Balance at March 31, 2025

Balance at June 30, 2025

99.0 $ 0.1 $ 2,597.2 $ 12.5 $ 84.5 $ 2,694.3

4 unchanged sentences

Issuances of common stock under stock plans 0.7 — 45.4 — — 45.4

Repurchases of common stock

Balance at September 30, 2025

99.7 $ 0.1 $ 2,696.3 $ 13.2 $ 294.0 $ 3,003.6

1 unchanged sentence

100.9 $ 0.1 $ 2,555.3 $ 2.5 $ ( 48.7 ) $ 2,509.2

Balance at March 31, 2024

100.6 $ 0.1 $ 2,496.4 $ 3.3 $ ( 113.7 ) $ 2,386.1

Net income — — — — 129.8 129.8

Other comprehensive loss, net of tax — — — ( 0.8 ) — ( 0.8 )

Other comprehensive income, net of tax

— — — 12.0 — 12.0

Stock-based compensation expense — — 41.5 — — 41.5

Issuances of common stock under stock plans 0.3 — 26.4 — — 26.4

Balance at June 30, 2024

Balance at September 30, 2024

101.2 $ 0.1 $ 2,623.2 $ 14.5 $ 81.1 $ 2,718.9

8 unchanged sentences

( 1.8 ) — ( 107.6 ) — ( 60.1 ) ( 167.7 )

Balance at June 30, 2025

Balance at September 30, 2025

99.7 $ 0.1 $ 2,696.3 $ 13.2 $ 294.0 $ 3,003.6

2 unchanged sentences

Net income — — — — 238.2 238.2

Other comprehensive loss, net of tax

Other comprehensive income, net of tax

— — — 7.5 — 7.5

1 unchanged sentence

Issuances of common stock under stock plans 2.5 — 112.1 — — 112.1

Balance at June 30, 2024

Balance at September 30, 2024

101.2 $ 0.1 $ 2,623.2 $ 14.5 $ 81.1 $ 2,718.9

2 unchanged sentences

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

Six Months Ended

Nine Months Ended

September 30,

(in millions) 2025 2024

15 unchanged sentences

Accounts payable and accrued liabilities 83.7 ( 33.9 )

Income tax assets and liabilities

( 54.3 ) ( 4.8 )

Other assets and liabilities, net ( 16.6 ) ( 25.5 )

29 unchanged sentences

All significant intercompany balances and transactions have been eliminated in consolidation.

Certain reclassifications have been made to previously reported amounts to conform to the current period presentation.

These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2024, included in our Annual Report on Form 10-K (the 2024 Form 10-K) filed with the SEC.

23 unchanged sentences

We are responsible for all development, manufacturing, and commercialization costs of any collaboration product.

NBI-1117568 is a first-in-class, orally active, highly selective investigational M4 agonist in development as a potential treatment for schizophrenia.

In connection with the initiation of a Phase 3 clinical study for NBI-1117568 in schizophrenia in May 2025, we paid Nxera a milestone of $ 15.0 million, which was expensed as research and development (R&D) in the second quarter of 2025.

In connection with the successful completion of a long-term toxicity program for NBI-1117568 in April 2024, we paid Nxera a milestone of $ 15.0 million, which was expensed as R&D in the second quarter of 2024.

Direclidine (NBI-1117568) is a first-in-class, orally active, highly selective investigational M4 agonist in development as a potential treatment for schizophrenia.

In connection with the initiation of a Phase 3 clinical study for direclidine in schizophrenia in May 2025, we paid Nxera a milestone of $ 15.0 million, which was expensed as research and development (R&D) in the second quarter of 2025.

In connection with the successful completion of a long-term toxicity program for direclidine in April 2024, we paid Nxera a milestone of $ 15.0 million, which was expensed as R&D in the second quarter of 2024.

In connection with the successful completion of the Phase 2 clinical study for direclidine in August 2024, we paid Nxera a milestone of $ 35.0 million, which was expensed as R&D in the third quarter of 2024.

Under the terms of the agreement, Nxera may be entitled to receive potential future payments of up to $ 2.5 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of any collaboration product.

5 unchanged sentences

Takeda Pharmaceutical Company Limited (Takeda)

In 2020, we entered into an exclusive license agreement with Takeda (the 2020 Takeda Agreement), pursuant to which we acquired the exclusive rights to develop and commercialize certain early to mid-stage psychiatry compounds, including luvadaxistat, NBI-1070770, osavampator (formerly NBI-1065845), NBI-1065846, and three non-clinical stage compounds.

In 2020, we entered into an exclusive license agreement with Takeda (the 2020 Takeda Agreement), pursuant to which we acquired the exclusive rights to develop and commercialize certain early to mid-stage psychiatry compounds, including luvadaxistat, NBI-1070770, osavampator (NBI-1065845), NBI-1065846, and three non-clinical stage compounds.

Pursuant to the 2020 Takeda Agreement, osavampator was designated as a profit-share product, meaning we and Takeda would equally share in the operating profits and losses.

25 unchanged sentences

NBI-921355 is an investigational, selective inhibitor of voltage-gated sodium channels Na v 1.2 and Na v 1.6 in development as a potential treatment of certain types of epilepsy.

In connection with the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-921355 in healthy adult participants in February 2025, we paid Xenon a milestone of $ 7.5 million in the second quarter of 2025, which was expensed as R&D in the first quarter of 2025.

In connection with the initiation of a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-921355 in healthy adult participants in February 2025, we paid Xenon a milestone of $ 7.5 million, which was expensed as R&D in the first quarter of 2025.

Under the terms of the agreement, Xenon may be entitled to receive potential future payments of up to $ 1.7 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of any collaboration product.

30 unchanged sentences

We elected the fair value option to account for our equity investment in Voyager as we believe it creates greater transparency regarding the investment's fair value at future reporting dates.

In connection with the selection of a development candidate under the GBA1 program pursuant to our collaboration with Voyager, we paid Voyager a milestone of $ 3.0 million, which was expensed as R&D in the second quarter of 2024.

In connection with the selection of development candidates under the GBA1 program pursuant to our collaboration with Voyager, we expensed milestones of $ 3.0 million as R&D in both the second and third quarters of 2024.

Under the terms of the 2023 Voyager Agreement, Voyager may be entitled to receive potential future payments of up to $ 6.1 billion upon the achievement of certain event-based milestones and is entitled to receive royalties on the future net sales of any collaboration product, subject to certain co-development and co-commercialization rights retained by Voyager.

30 unchanged sentences

The following table presents a summary of certain financial assets, which were measured at fair value on a recurring basis.

September 30,

2025 December 31,

10 unchanged sentences

Our investment portfolio is maintained in accordance with our investment policy, which defines allowable investments, specifies credit quality standards, and limits the credit exposure of any single issuer.

As of June 30, 2025 and December 31, 2024, we held available-for-sale debt securities with a total fair value of $ 401.8 million and $ 458.7 million, respectively, that were in unrealized loss positions totaling $ 0.5 million and $ 1.7 million, respectively.

Available-for-sale debt securities that had been in unrealized loss positions for longer than twelve months were not significant as of June 30, 2025 or December 31, 2024.

As of September 30, 2025 and December 31, 2024, we held available-for-sale debt securities with a total fair value of $ 349.8 million and $ 458.7 million, respectively, that were in unrealized loss positions totaling $ 0.5 million and $ 1.7 million, respectively.

Available-for-sale debt securities that had been in unrealized loss positions for longer than twelve months were not significant as of September 30, 2025 or December 31, 2024.

Unrealized losses on available-for-sale debt securities are primarily caused by changes in interest rates.

Our investments in available-for-sale debt securities are of high credit quality, and we do not intend to sell these investments and it is not more likely than not that we will be required to sell these investments before their maturity.

Accrued interest receivables on available-for-sale debt securities totaled $ 16.7 million and $ 14.4 million, respectively, as of June 30, 2025 and December 31, 2024 and are included in other current assets on the condensed consolidated balance sheets.

Accrued interest receivables on available-for-sale debt securities totaled $ 18.4 million and $ 14.4 million, respectively, as of September 30, 2025 and December 31, 2024 and are included in other current assets on the condensed consolidated balance sheets.

We do not measure an allowance for credit losses for accrued interest receivables.

3 unchanged sentences

The following table presents the percent of total gross product sales for each of our customers who individually accounted for 10% or more of total gross product sales.

Six Months Ended

Nine Months Ended

September 30,

Customer A 41 % 44 %

2 unchanged sentences

The following table presents the percent of total accounts receivable for each of our customers who individually accounted for 10% or more of total accounts receivable.

September 30,

2025 December 31,

6 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(in millions, except per share data) 2025 2024 2025 2024

12 unchanged sentences

The following table presents supplemental operating lease information for operating leases that have commenced.

Six Months Ended

Nine Months Ended

September 30,

(in millions, except weighted average data) 2025 2024

3 unchanged sentences

Cash paid for amounts included in the measurement of operating lease liabilities $ 28.2 $ 24.0

September 30,

Weighted average remaining lease term

2 unchanged sentences

Restricted cash related to letters of credit issued in lieu of cash security deposits $ 7.8 $ 7.8

The following table presents approximate future non-cancelable minimum lease payments under operating leases and sublease income as of June 30, 2025.

The following table presents approximate future non-cancelable minimum lease payments under operating leases and sublease income as of September 30, 2025.

(in millions) Operating

7 unchanged sentences

Noncurrent operating lease liabilities $ 428.4

_________________________

(1) Amounts presented in the table above exclude $ 1.5 million for 2025, $ 3.0 million for 2026, and $ 1.5 million for 2027 of approximate non-cancelable future minimum lease payments under operating leases that have not yet commenced.

New Campus Facility

9 unchanged sentences

We recognized impairment charges totaling $ 14.0 million in the second quarter of 2024, of which $ 11.3 million and $ 2.7 million, respectively, was related to the ROU assets and tenant improvements associated with the underlying leased properties.

Impairment charges were not significant for the first six months of 2025.

Impairment charges were not significant for the first nine months of 2025.

Stockholders’ Equity

1 unchanged sentence

In February 2025, our Board of Directors authorized a new share repurchase program (the 2025 Repurchase Program) under which we may repurchase up to $ 500.0 million of our common stock, subject to market conditions.

Under the 2025 Repurchase Program, we repurchased 1.5 million shares on the open market for a cost of $ 167.7 million during the first six months of 2025.

As of June 30, 2025, we had $ 332.3 million remaining under the 2025 Repurchase Program.

Under the 2025 Repurchase Program, we repurchased 1.5 million shares on the open market for a cost of $ 167.7 million during the first nine months of 2025.

As of September 30, 2025, we had $ 332.3 million remaining under the 2025 Repurchase Program.

Under the 2025 Repurchase Program, share repurchases may be made from time to time at management's discretion through a variety of methods, such as open-market transactions including pre-set trading plans, privately negotiated transactions, accelerated share repurchases, and other transactions in accordance with applicable securities laws.

10 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(in millions, except per share data)

7 unchanged sentences

The following table presents information relating to our recognized intangible assets.

September 30,

2025 December 31,

11 unchanged sentences

(2) Acquired IPR&D is considered indefinite lived until the completion or abandonment of the associated research and development efforts.

The following table presents approximate future annual amortization expense for our finite-lived intangible assets as of June 30, 2025.

The following table presents approximate future annual amortization expense for our finite-lived intangible assets as of September 30, 2025.

(in millions) Amount

16 unchanged sentences

The 2024 Notes were settled in full upon maturity on May 15, 2024.

The following table presents a summary of charges recognized in connection with the bifurcation of the conversion feature of the 2024 Notes and conversions of the 2024 Notes by holders during the first six months of 2024.

(in millions)

(in millions) Amount

Accretion of debt discount associated with derivative liability $ 126.6

4 unchanged sentences

Inventory consisted of the following:

(in millions) June 30,

(in millions) September 30,

2025 December 31,

6 unchanged sentences

Prior to FDA approval of CRENESSITY in December 2024, all costs related to its manufacturing were expensed as R&D in the period incurred.

As a result, our physical inventories as of June 30, 2025 and December 31, 2024 included active pharmaceutical product with no cost basis.

Costs related to the manufacturing of bulk drug product, finished bottling, and other labeling activities that occurred post-FDA approval are included in the inventory values as of June 30, 2025 and December 31, 2024.

As a result, our physical inventories as of September 30, 2025 and December 31, 2024 included active pharmaceutical product with no cost basis.

Accounts payable and accrued liabilities consisted of the following:

(in millions) June 30,

(in millions) September 30,

2025 December 31,

1 unchanged sentence

Accrued employee related costs 105.1 107.5

Accrued development costs (including unpaid development milestones)

Accrued development costs

Current branded prescription drug fee 39.0 49.2

Current income taxes payable

Accounts payable and other accrued liabilities 119.9 109.9

1 unchanged sentence

Other noncurrent liabilities consisted of the following:

(in millions) June 30,

(in millions) September 30,

2025 December 31,

4 unchanged sentences

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows.

(in millions) June 30,

2025 June 30,

(in millions) September 30,

2025 September 30,

Cash and cash equivalents $ 340.2 $ 349.1

11 unchanged sentences

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

(in millions) 2025 2024 2025 2024

14 unchanged sentences

Selling, general, and administrative 291.6 234.3 854.4 719.4

Unrealized loss on equity investments

Unrealized (gain) loss on equity investments

( 30.6 ) 16.9 6.7 35.2

13 unchanged sentences

District Court for the District of Delaware in April 2025 against Zydus Pharmaceuticals (USA) Inc.

and its affiliates Zydus FZE, Zydus Worldwide DMCC, Zydus Lifesciences Limited, and Zydus Healthcare (USA) LLC (collectively, Zydus).

and its affiliates Zydus FZE, Zydus Worldwide DMCC (entity subsequently dismissed), Zydus Lifesciences Limited, and Zydus Healthcare (USA) LLC (entity subsequently dismissed) (collectively, Zydus).

We also filed suit in the U.S.

4 unchanged sentences

In June 2025, the Court dismissed the case without prejudice for lack of case or controversy.

In addition, we have initiated (1) administrative proceedings against another Spruce patent in the U.S.

Patent and Trademark Office, and (2) both judicial and administrative proceedings against Spruce patents in other jurisdictions.

In January 2025, we also initiated post-grant review against another Spruce patent in the U.S.

Patent and Trademark Office.

Spruce disclaimed all challenged claims of that patent.

In addition, we have initiated judicial and administrative proceedings against Spruce patents in other jurisdictions.

From time to time, we may also become subject to other legal proceedings or claims arising in the ordinary course of our business.

1 unchanged sentence

Given the unpredictability inherent in litigation, however, we cannot predict the outcome of these matters.

Subsequent Events

On July 4, 2025, President Trump signed into law the One Big Beautiful Bill Act (the OBBBA).

The OBBBA makes permanent key elements of the Tax Cuts and Jobs Act, including 100 % bonus depreciation, domestic research cost expensing, and the business interest expense limitation.

ASC 740, Income Taxes, requires the effects of changes in tax rates and laws on deferred tax balances to be recognized in the period in which the legislation is enacted.

Given the date of enactment, the effects of the OBBBA, which we are still evaluating, will be reflected in our Quarterly Report on Form 10-Q for the quarter ending September 30, 2025.

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 1. Financial Statements